Confronting Biopiracy: Challenges, Cases and International Debates

‘Biopiracy’ refers either to the unauthorized extraction of biological resources, such as plants with medicinal properti...

Author: Daniel F. Robinson

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‘Biopiracy’ refers either to the unauthorized extraction of biological resources, such as plants with medicinal properties, and associated traditional knowledge from indigenous peoples and local communities, or to the patenting of spurious ‘inventions’ based on such knowledge or resources without compensation. Biopiracy cases continue to emerge in the media and public eye, yet they remain the source of considerable disagreement, confusion, controversy and grief. The aim of this book is to provide the most detailed, coherent analysis of the issue of biopiracy to date.

Daniel F. Robinson is Lecturer at the Institute of Environmental Studies, University of New South Wales, Australia.

Confronting Biopiracy Challenges, Cases and International Debates

Daniel F. Robinson

The book synthesizes the rise of the issue and increasing use of the term by activists and negotiators in the World Trade Organization (WTO) and the Convention on Biological Diversity (CBD), to form a critical understanding of the themes, implications and politics of biopiracy. Taking a case study-based approach, derived from interviews and fieldwork with researchers, government, industry, local farmers, healers and indigenous people, the author sequentially documents events that have occurred in biopiracy and bioprospecting controversies. Implications and ethical dilemmas are explored, particularly relating to work with local communities, and the power relations entailed. Detailing international debates from the WTO, CBD and other fora in an accessible manner, the book provides a unique overview of current institutional limitations and suggests ways forward. Options and solutions are suggested which are relevant for local communities, national governments, international negotiators, NGO and interest groups, researchers and industry.

Confronting Biopiracy

‘Daniel Robinson’s timely and authoritative book will inform the contemporary, but until now unproductive, discussions in WIPO and the WTO about ways in which spurious intellectual property claims over biological resources and traditional knowledge can be sanctioned as “biopiracy”.’ Michael Blakeney, Herchel Smith Professor of Intellectual Property, Queen Mary, University of London, UK

Cover image credits: ‘Overprint of Hand’ © Anton Batanin/istockphoto.com

‘Biopiracy has emerged as a powerful concept inspiring critical perspectives on the commercial use of biodiversity and traditional knowledge. But what does it really mean? This well-researched and thoughtful book provides a thorough investigation of the theory and practice of biopiracy that scholars and policy makers alike will find illuminating.’ Graham Dutfield, Professor of International Governance, University of Leeds, UK

publishing for a sustainable future

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Environment / Law

Daniel F. Robinson

Confronting Biopiracy

Confronting Biopiracy Challenges, Cases and International Debates

Daniel F. Robinson

publishing for a sustainable future

London • Washington, DC

First published in 2010 by Earthscan Copyright © Dr Daniel F. Robinson, 2010 The moral right of the author has been asserted. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as expressly permitted by law, without the prior, written permission of the publisher. Earthscan Ltd, Dunstan House, 14a St Cross Street, London EC1N 8XA, UK Earthscan LLC, 1616 P Street, NW, Washington, DC 20036, USA Earthscan publishes in association with the International Institute for Environment and Development For more information on Earthscan publications, see www.earthscan.co.uk or write to [email protected] ISBN: 978-1-84407-722-9 Typeset by JS Typsetting Ltd, Porthcawl, Mid Glamorgan Cover design by Susanne Harris A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data Robinson, Daniel F. Confronting biopiracy : challenges, cases and international debates / Daniel F. Robinson. p. cm. Includes bibliographical references and index. ISBN 978-1-84407-722-9 (hardback) 1. Biopiracy. 2. Biotechnology–Patents. 3. Traditional ecological knowledge–Law and legislation. I. Title. K1519.B54R63 2010 346.04’86–dc22 2009032844 At Earthscan we strive to minimize our environmental impacts and carbon footprint through reducing waste, recycling and offsetting our CO2 emissions, including those created through publication of this book. For more details of our environmental policy, see www.earthscan.co.uk. Printed and bound in the UK by CPI Antony Rowe. The paper used is FSC certiﬁed.

Contents

List of Boxes and Figures Acknowledgements Abbreviations and Acronyms Introduction Research Insights Structure of the Book

viii ix x xiii xiv xiv

1 Collecting – Prospecting – Piracy Plant Hunting, Collecting and Trade Ethnobotany Intended or Unintended Impact? Bioprospecting Biopiracy Deﬁnitions and Ambiguity

1 3 6 7 11 14 17

2 International Legal Backdrop The Convention on Biological Diversity The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights Patents, Plant-Variety Protection or Sui Generis Systems The Expanded Review of Article 27.3(b) The World Intellectual Property Organization The Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore The International Convention for the Protection of New Varieties of Plants The International Treaty on Plant Genetic Resources for Food and Agriculture Human Rights and Traditional Knowledge Bilateral and Regional Trends Following Current Developments – Research Sources

23 26

3 Patent-Related Biopiracy Cases Basmati Rice Hawai’ian Taro

28 29 30 31 33 34 35 39 40 42 45 47 49

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CONFRONTING BIOPIRACY

Yellow Enola Beans Camu Camu Patents Kwao Krua Local Patents on Kwao Krua Foreign Patents on Kwao Krua Artemisia judaica Hoodia Japanese Patents on Plao Noi Blight-Resistant Rice Peruvian Maca Ayahuasca Other Reported Biopiracy Cases and Controversies Are More Cases Likely? 4 Non-Patent Biopiracy Cases Plant-Variety Protection as Biopiracy ‘Plant-Breeders’ Wrongs’ in Australia Peanuts from Malawi Habanero Pepper Other Cases of Dubious Plant-Breeder Rights Trademarks as Biopiracy? The ‘Jasmati’ Trademark Rooibos Tea Açaí and Other Brazilian Cases Misappropriations of Biological Resources and Traditional Knowledge The Biotec/University of Portsmouth Marine Fungi Case Stepwise Program for the Improvement of Jasmine Rice for the US The Blurry Line between Bioprospecting and Misappropriation – An Example from Chiang Mai

51 53 55 55 57 59 61 63 66 67 68 70 73 77 78 79 81 82 84 85 87 89 91 92 93 95 97

5 Implications and Ethical Dilemmas – What have the Cases Shown? Exclusion from Further Sale or Export Inequities Cultural Affront Overexploitation of a Biological Resource Breakdown of Research Relationships and Trust

101 102 105 108 112 114

6 Current Debates and Ways Forward: Internationally and Regionally ‘No Life Patents!’ Amendments to the Patent System Controlling Access and Transfer of Biological Resources and/or Traditional Knowledge Other Intellectual Property Opportunities Indigenous Rights and Traditional Knowledge Traditional Knowledge, Customary Protocols and Laws

117 118 119 124 127 129 130

CONTENTS

Summary – International Governance Regional Initiatives on Biological Resources and Traditional Knowledge ASEAN Framework Agreement on Access and Beneﬁt-sharing African Model Law Regional Biodiversity Strategy for the Tropical Andean Countries Paciﬁc Model Laws

vii

133 134 134 135 138 139

7 Current Debates and Ways Forward: National and Local Approaches Peru’s National Anti-Biopiracy Commission Biodiversity Laws and Regulations Non-UPOV Sui Generis Plant-Variety Protection Laws Sui Generis Traditional Knowledge and Community Rights Laws Databases and Registers Traditional Knowledge and Customary Laws: Local Contexts The Role of Non-Government Interest Groups and Stakeholders

141 142 143 144 149 151 153 154

Conclusions

157

Bibliography and Sources

161

Index

179

List of Boxes and Figures

Boxes 1.1 1.2 2.1 2.2 2.3 3.1 4.1 4.2 7.1 7.2

Selected Bioprospecting Cases Typologies and Categories of Biopiracy Review of the Potential Impacts of the ITPGRFA for Thailand Ofﬁcial and Government Information Sources Non-Government News Sources and Analysis Other Reported Biopiracy Cases Australian ‘Plant-Breeders’ Wrongs’ Article 15.1 of the TRIPS Agreement – Protectable Subject Matter of Trademarks National Systems for Regulation of Biological Resources and Associated Traditional Knowledge Key Customary Law Principles from the La Papa Park in the Cuzco Region, Peru

13 21 38 43 43 71 80 85 145 154

Figures 1.1 3.1 4.1

5.1 5.2

A collection of more than 65 seeds and herbs on display to demonstrate the breadth of Khon Pga k’nyau (Karen) local knowledge of plant-based medicines and foods 8 The white kwao krua (Pueraria miriﬁca) vine. This is a slowgrowing plant found mostly in forest areas in the north and northeast regions of Thailand 56 Plant breeder Daycha Siripat demonstrates the selection of seeds for replanting in the following season resulting in genetic improvements. The rice grain – Suphan Buri 60 – shares a similar history of breeding and development to khao hom mali (jasmine rice) and is now considered a ‘modern’ variety 96 Knowledge domains and knowledge ﬂows under informal and formal regulatory regimes 110 Four different customary practices of the Khon Pga k’nyau (Karen) including customs relating to plants 111

Acknowledgements

I would like to thank Prof. Philip Hirsch for helping me get this book off the ground, as well as Dr Jakkrit Kuanpoth, Prof. Graham Dutﬁeld and an anonymous reviewer for their comments on draft chapters and their invaluable advice. Thank you to Prof. Saneh Chamarik, Buntoon Srethasirote, Pii Sa and M from the National Human Rights Commission of Thailand for all their assistance with my research. I thank Ae (Aphatsorn Somboonwattanakun) for making much of my ﬁeldwork possible. I owe both Kylie Bailin and Melissa Sinclair from the University of New South Wales (UNSW) many thanks for their research assistance. Thanks to Chris Patterson from the Traditional Knowledge Revival Project for an inspiring trip to Cape York. I also thank David Vivas-Eugui from the International Centre for Trade and Sustainable Development for helping me contact lots of useful people. A number of individuals have provided useful information towards the case studies for which I am very grateful, including: Begoña Venero (World Intellectual Property Organization), Andres Valladolid (El Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual), Noel Oettle (Environmental Monitoring Group), Tim Roberts, and Tony Taubman (World Trade Organization, formerly World Intellectual Property Organization). Thanks also to the staff and students at the Institute of Environmental Studies, UNSW, for their encouraging comments on a presentation made while ﬁnalizing this book. Lastly, I want to thank my beautiful wife Rachel for her love and patience.

Abbreviations and Acronyms

ABS ARIPO ASEAN BIT BMC Bonn Guidelines CBD CIAT CGIAR CIEL CITES COICA CONAP CSIRO DIP disclosure requirement

DUS EC/EU EMG EPA EPO ETC Group

access and beneﬁt-sharing African Regional Intellectual Property Organization Association of South-East Asian Nations bilateral investment treaty Biodiversity Management Committee, India Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization United Nations Convention on Biological Diversity International Center for Tropical Agriculture Consultative Group on International Agricultural Research Centre for International Environmental Law Convention on International Trade in Endangered Species of Wild Fauna and Flora Coordinating Body of Indigenous Organizations of the Amazon Basin Confederación de Nacionalidades Amazónicas del Perú Australian Commonwealth Scientiﬁc and Research Organization Department of Intellectual Property, Thailand A proposed patent requirement that applicants disclose the source and/or country/place of origin or legal provenance of genetic resources used in an invention distinctness, uniformity and stability (of plant varieties) European Communities/European Union Environmental Monitoring Group, Southern Africa economic partnership agreement European Patent Ofﬁce Action Group on Erosion, Technology and Concentration

ABBREVIATIONS AND ACRONYMS

FAO FDA FTA GATT GI GM GRAIN GRIN

xi

Food and Agriculture Organization US Food and Drug Administration free trade agreement General Agreements on Tariffs and Trade geographical indication genetically modiﬁed Genetic Resources Action International Genetic Resources Information Network, US Department of Agriculture GRRF Genetic Resources Recognition Fund GURTs genetic-use restriction technologies HSCA Heritage Seed Curators Australia IARC International Agricultural Research Centre IBIS Indian Biodiversity Information System ICARDA International Centre for Agricultural Research in the Dry Areas ICBG International Cooperative Biodiversity Groups Programs ICRISAT International Crop Research Institute for the Semi-Arid Tropics ICSIR Indian Council for Scientiﬁc and Industrial Research ICTSD International Centre for Trade and Sustainable Development, Geneva IGC World Intellectual Property Organization Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore ILO International Labour Ofﬁce IP intellectual property IPC International Patent Classiﬁcation IPR intellectual property right IRRI International Rice Research Institute ITPGRFA International Treaty on Plant Genetic Resources for Food and Agriculture IUCN International Union for the Conservation of Nature IUPGR International Undertaking on Plant Genetic Resources JPO Japanese Patent Ofﬁce MTA material transfer agreement NGO non-governmental organization OAU Organization for African Unity (now African Union) OCCAAM Organización Central de Comunidades Aguarunas del Alto Marañon PBR plant-breeder rights PCT Patent Cooperation Treaty of the World Intellectual Property Organization PeBR People’s Biodiversity Registers PIC prior informed consent PVP plant-variety protection PVPFR Plant-Variety Protection and Farmers’ Rights Act, India RAFI Rural Advancement Foundation International

xii

CONFRONTING BIOPIRACY

R&D SACSIR TK TKDL TRIPS

research and development South African Council for Scientiﬁc and Industrial Research traditional knowledge Traditional Knowledge Digital Library World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights UNCTAD United Nations Conference on Trade and Development UNDP United Nations Development Programme UNEP United Nations Environment Programme UPOV International Union for the Protection of New Varieties of Plants USDA US Department of Agriculture USPTO US Patent and Trademark Ofﬁce WG-ABS Ad Hoc Open-Ended Working Group on Access and Beneﬁtsharing, United Nations Convention on Biological Diversity WHO World Health Organization WIMSA Working Group on Indigenous Minorities in Southern Africa WIPO World Intellectual Property Organization WTO World Trade Organization

Introduction

This book has been written to address a lack of direct engagement with the issue of biopiracy by researchers, academics and policy-makers. Biopiracy has largely been a term utilized by activists and some speciﬁc non-governmental organizations (NGOs) until recently. While a considerable amount of literature has emerged dealing with the protection of indigenous or traditional knowledge, the success or failure of bioprospecting ventures and related areas, there has been a tendency to side-step the issue of biopiracy or to avoid using the term. Despite the frequent international negotiations on issues relating to intellectual property, biological resources, traditional knowledge and folklore, there has been hesitancy among these international negotiators regarding the overt use of biopiracy to describe speciﬁc cases of unfair or spurious intellectual property claims over biological resources and traditional knowledge. This is a result of the lack of an appropriate deﬁnition of biopiracy, concerning which international organizations like the Secretariat of the United Nations Convention on Biological Diversity (CBD), the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) have not been forthcoming. This is probably a deliberate avoidance of the direct recognition of the polemical and often emotionally charged nature of incidents claimed as biopiracy. These organizations have instead tended to deal with the issues indirectly, thereby avoiding possible conﬂicts between their mandates – particularly between the international laws administered by the CBD Secretariat and the WTO. The title of this book is Confronting Biopiracy precisely because it directly acknowledges and addresses the main issues and implications of biopiracy. This text gives a detailed historical context, the background to the use of the term ‘biopiracy’, and a description of the international legal framework, followed by a case-study based approach. A typology or deﬁnition of biopiracy is provided that draws upon some previous descriptions of biopiracy, the biopiracy cases discussed and the international debates surrounding the issue. Several cases of biopiracy are analysed and critiqued including both patent-based and nonpatent biopiracy incidents. The implications and impacts of these cases are then described before making suggestions for ways of resolving these problems at different scales and in different contexts. As a result, it is hoped that this will encourage a more direct acknowledgement and engagement with the issue.

xiv

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Research Insights Key research insights for this book were drawn from the author’s PhD and postdoctoral research; working as a reporter on WTO trade negotiations in a Geneva-based organization (the International Centre for Trade and Sustainable Development – ICTSD); acting as a consultant to international organizations; ﬁeldwork in Asia (particularly in Thailand); and working as a policy advisor to national governments and regional organizations between 2004 and 2009. Much of the research involved the use of qualitative methods including interviewing and the direct observation of stakeholders. Twelve ofﬁcials and country delegates to the WTO, WIPO and other UN organizations were interviewed in 2005 and 2006 in Geneva, Switzerland. Following this, a steady stream of interviews and discussions with these and other delegates and ofﬁcials have informed the research. In Geneva the author helped coordinate high-level meetings for ICTSD, bringing together WTO and UN delegates, and NGO stakeholders on a number of intellectual property (IP) issues including copyright and education, biodiversity and traditional knowledge, and access to medicines. Further insights were drawn from ongoing WTO reporting, research and consulting for ICTSD in conjunction with the United Nations Conference on Trade and Development (UNCTAD) between 2005 and 2007, and as a consultant advisor on intellectual property, biodiversity and traditional knowledge to the United Nations Development Programme (UNDP) in 2008 and the Paciﬁc Islands Forum Secretariat in 2007. From 2005 to 2007 more than 60 interviews were conducted with relevant government ofﬁcials, academics, industry representatives, farmers, indigenous communities and NGOs in Asia (particularly Thailand and India), as well as subsequent interviews and discussions with government ofﬁcials and NGOs from Africa, the Paciﬁc and South America. Additionally, a number of local community case studies in Thailand have been inﬂuential for understanding some of the complex and spiritually informed customary norms and rules associated with the use of plants and other biological resources. It is important to note that some of the interviewees can only be cited anonymously here and at many of the ‘roundtable’ meetings attended comments from various ofﬁcials had to remain conﬁdential. Instead, where relevant, observations of the conduct of meetings are made in such a way as to protect the anonymity of participants – unfortunately without direct quotation. Indeed, this highlights a key issue: the negotiation politics of ‘trade-related’ intellectual property are often deliberately designed to lack transparency and to be publicly inaccessible, despite the signiﬁcant social, economic and environmental impacts they may have, either directly or indirectly.

Structure of the Book This book should be accessible to most people who are interested in the issues as it attempts to avoid an overuse of jargon, which can inhibit clear understandings of what is at stake. In this respect it is hoped that it will be of

INTRODUCTION

xv

beneﬁt to a range of stakeholders and interested parties including university students, indigenous and local communities, NGOs, researchers, academics, industry, plant breeders and agriculturalists, as well as decision-makers at various levels of government. Chapter 1 provides some historical discussion of the collection of plants, biological resources and the use of the associated traditional knowledge of indigenous or local communities. This chapter contextualizes modern bioprospecting as having emerged amid new technological, economic and legal frameworks from an era of colonial collections and abuses. While some observers have implied that bioprospecting can provide a ‘win–win’ situation for scientiﬁc research and development, conservation and for indigenous or local communities, others have been far more sceptical. Consequently, the term ‘biopiracy’ was developed in dissatisfaction with the current frameworks surrounding biodiversity and particularly relating to the expansion of exclusive individual rights under intellectual property agreements. Chapter 2 then provides an overview of the international legal framework that has been established in the past few decades. This framework has internationalized the system of intellectual property rights. Many would argue that this has contributed to biopiracy, but there are a number of international agreements and forums that have provided some opportunities to acknowledge issues surrounding the exploitation of biological resources and traditional knowledge, and hopefully to resolve them. This discussion is furthered in Chapter 6. Chapter 3 analyses a number of speciﬁc cases of patent-related biopiracy that have proved highly controversial and have received considerable attention from NGOs and the media. In addition, some lesser known and more recent cases are examined to identify why each speciﬁc case came about, the stakeholders involved and the legal and territorial issues they raised, in order to then explore how the resolution of biopiracy cases might be found. Common themes are identiﬁed among the cases and the key issues are highlighted with regards to the patent system. Chapter 4 continues to explore biopiracy cases, but focuses on ‘nonpatent biopiracy’. Cases are discussed which involve spurious claims of plantvariety protection where there is little evidence of breeding or where the speciﬁc characteristics and traits of a plant variety have likely been developed beforehand by farmers and breeders in developing countries. Next, the chapter looks at trademarks that have been sought and obtained for generic plant names which may be deceptive to consumers about the origins and qualities of the plant-related product. Finally, the chapter discusses a number of misappropriation cases, whereby researchers have obtained biological resources without appropriate prior informed consent and/or without providing beneﬁts back to the original provider countries or local communities. Chapter 5 draws out the main implications of both patent-based and nonpatent biopiracy, with reference to the case studies. The chapter highlights: the possibilities of producers being excluded from the further sale or export of speciﬁc products; inequities whereby local communities, researchers, companies

xvi

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or government bodies are left out of the commercial development process of products; where biopiracy causes cultural affront; overexploitation of a biological resource; and the breakdown of research relationships and trust. Chapter 6 returns to the international legal framework described in Chapter 2, discussing the main international and regional debates and initiatives that may be able to address biopiracy. Because biopiracy concerns are generally raised as a result of international transfers of biological resources and the use of associated traditional knowledge, it is important to deal with it at this scale. The discussion analyses the potential of various agreements, model laws and negotiations as well as their limitations. Finally, Chapter 7 provides an analysis of some national and local laws and initiatives that attempt to mitigate the effects of biopiracy or that may impact upon the protection of biological resources and traditional knowledge. This includes discussion of speciﬁc laws on biodiversity, sui generis (i.e. unique) plant-variety protection laws, community rights laws, databases and registers, local initiatives to document and recognize customary laws relating to traditional knowledge and the role of non-government stakeholders.

1

Collecting – Prospecting – Piracy

Concerns about the collection or prospecting of plants and biological materials have recently received unprecedented international attention. This has largely centred on the concentration of intellectual property control over biological resources in the hands of large biotechnological and pharmaceutical corporations. New international agreements establishing legal and institutional arrangements for the intellectual property protection of these resources are increasingly leading to their privatization. Furthermore, biotechnological advances have meant that biological resources can now be manipulated through recombinant DNA technology, or genetic engineering, creating a new and often controversial realm of bio-innovations. These changes have led to a variety of concerns about the appropriation of biological resources and associated knowledge, particularly from the most biodiverse developing countries and from farmers, indigenous peoples and local communities. In turn, these trends raise considerable ethical, economic, cultural and political questions about the ownership and stewardship of biological resources and also about the increasing commoditization of knowledge as ‘innovations’ from the ‘public domain’ or from local customary domains. These questions are explored in detail in the following chapters. Here it is noted that these recent changes should be seen as a dramatic heightening of past appropriations and colonializations that were often controversial and political for various – but often related – reasons, which come back to core questions about the ownership of nature and knowledge. The hunting and collecting of plants, seeds and natural curiosities from many of the world’s regions and populations have been enduring activities. These collections have been made for direct use as food or medicine, but also for economic and scientiﬁc gains. Throughout recent centuries, there are many recorded activities and explorations of foreign objects from nature, particularly by the major colonial powers, but interest in collecting plants may even go back far further. As Fowler (2002) notes, Queen Hatshepsut, one of the ﬁrst female pharaohs of Ancient Egypt, sent her army on a plant-collecting expedition to East Africa around 1482 BC. The queen sought out frankincense from the gum of a tree now known as Boswellia. Thirty-one of the trees were successfully

2

CONFRONTING BIOPIRACY

collected, transported and established in her temple gardens at Karnak where an ofﬁcial record was carved on the walls to mark the success of the expedition (Tyler-Whittle, 1970, p16; Juma, 1989, p38). Others became famous for studying the local knowledge of plants. Dioscorides, a Greek surgeon who explored the botany of the Mediterranean at the behest of the Roman Emperor Nero, may have been the ﬁrst ‘ethnobotanist’. He wrote the De Materia Medica in AD 77 with detailed descriptions of the botany and medicinal uses of some 600 plants and spices, noting their therapeutic beneﬁts, recipes and formulae. This work was so inﬂuential that it was studied by botanists for another thousand years (Davis, 1995, p41). New sources of food were also sought out by explorers, traders and agriculturalists. Since the domestication of agriculture some 10,000 years ago, crops have been developed, traded and adapted locally, regionally and internationally, such that their speciﬁc geographic origins are often difﬁcult to determine. The countries of the world today thus have a historically interdependent reliance on agricultural crops (Murphy, 2007, pp9–10; Kloppenberg, 1988). For example, common or bread wheat (Triticum aestivum) was domesticated from wild einkorn (T. boeoticum) in southeastern Turkey or the southwestern Caucasus and spread to Egypt, India, China and Europe (Aitken, 2006, p8). Beyond crop staples were vegetables, fruits, nuts, spices, herbs, plant-based beverages, plant-based medicines, stimulants and narcotics, and also ﬁbres such as cotton, which became increasingly widely used and traded as processing techniques were developed. Ancient overland spice routes and coastal transport were increasingly supplemented by the colonial period’s expansion of shipping with the improvement of ocean-going sailing vessels. As an early example, the Venetian merchant-explorer Marco Polo provides some interesting and detailed descriptions (and also some obvious ﬁctions) of his travels throughout Asia in the 1300s. Within his descriptions of The Customs of the Kingdoms of India he regularly describes the trade in plant and animal-based goods and curiosities: We shall tell you next of the great kingdom of Malabar [southwestern India] … there is a great abundance of pepper and also of ginger, besides cinnamon in plenty and other spices, turbit and coconuts. (Latham, 2007, pp55–6) He not only describes the trade in plants, but also various local customs and practices for the use of plants: There is also plenty of good indigo, which is produced from a herb: they take this herb without the roots and put it in a big tub and add water and leave it till the herb is all rotted. Then they leave it in the sun, which is very hot and makes it evaporate and coagulate into a paste. Then it is chopped up into small pieces, as you have seen it. (Latham, 2007, p52)

COLLECTING – PROSPECTING – PIRACY

3

Marco Polo’s descriptions are useful for their detail of the development of spice routes. Many of the colonial ‘discoveries’ were in fact mere observations of the practices of local communities that would then come to be adopted for larger scale colonial and commercial enterprises. Some of the goods described were traded back to Europe as a commodity, while other plants were brought in their entirety in the attempt to establish new agricultural industries. In fact, it was the Republic of Venice that in 1474 developed the ﬁrst patent statute for this purpose. The monopolies were intended to provide an incentive sufﬁcient to develop or import new technologies in the republic (see David, 1993; May, 2002). These collecting activities had various scientiﬁc, economic and political motives and impacts. Therefore, we might ask if recent accounts of bioprospecting and ‘biopiracy’ are really any different to past exploitations of biological resources. One obvious change is the independence and decolonization of many countries, along with much more widespread political and public concern for the respect of human rights including indigenous rights. What has also changed is the scale and speed with which the objects of interest may be transmitted (Parry, 2000, p392). There have been scientiﬁc developments which allow detailed biochemical understandings of the active compounds drawn from biological extracts and of the functional genes within organisms. With these scientiﬁc developments have come concerns about the ethical, cultural, environmental and human health implications arising from the genetic modiﬁcations of organisms. Lastly, there have been a number of changes in the institutional and legal frameworks within which plants and biological resources are regulated. All of these factors have led to very lively international discussions over the use of biological resources and associated knowledge. To explore these ideas in greater detail, this chapter provides historical, political and geographical contexts in which plants, animals and biological resources have been sought out, collected or appropriated, exchanged and traded. The discussion highlights the emergence of a discourse of ‘bioprospecting’ (in the late 1980s or early 1990s) as a relatively positive depiction of the way biological resource prospecting could help contribute to conservation as well as useful product discovery. This has since been countered by a discourse of ‘biopiracy’ which has been used to depict the exploitation of biological resources and traditional knowledge without the consent of local people or authorities, and without adequate compensation.

Plant Hunting, Collecting and Trade Transported to the other side of the world, bits of the fruit of Myristica fragrans (nutmeg and mace) once tamed rough Attic wines, immobilized the bowels of dysenteric Egyptian sailors and lent a lip-smacking distinction to frothy steins of Augsburg ale. Today essences from the same fruit scent bars of cosmetic soap, add zest to Christmas puddings and supposedly constitute one of the top-secret ingredients in such proprietary brands as Vicks VapoRub and Coca-Cola (Keay, 2006, p1).

4

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Plants have been used for a diverse range of purposes for millennia: in foods, ﬂavourings, spices, medicines, cosmetics, fabrics and materials, dyes and for other functions. Over time, the varied qualities of plants have been developed and then ‘discovered’ by people from different parts of the globe. Often this has meant learning about a plant’s traits and uses by observing how other people use it, as well as by discovery through experimentation and chance. Throughout this long period of exploration, the manner in which plants have been collected and traded has been tied up in the political and economic threads of empire. A distinct colonial period of plant hunting and collecting began as early as the 1400s before booming in the sixteenth and seventeenth centuries (TylerWhittle, 1970). Cotton (1996) notes that in 1492 Christopher Columbus collected a number of useful plants from what is now Cuba (including the ‘discovery’ of tobacco) based on the observation of local practices. What started as the exploratory collection of exotic curiosities and foreign spices resulted in a global scale shipping trade as well as the political endeavours of conquest. Columbus’ voyage across the Atlantic Ocean was backed by the Spanish Court and sought out a new route to the (East) Indies from which knowledge of various plant-based riches had been obtained. Believing he had reached the Indies, Columbus made a number of voyages between what is now known as the Bahamas and Caribbean between 1493 and 1504 (Aitken, 2006; Keay, 2006). He turned to plants for proof of his ﬁnds, mistaking the small inedible nut nogal de pais for the coconut described by Marco Polo. In their explorations of Central and South America the Spanish and Portuguese ‘discovered’ and returned to Europe such botanical marvels as maize, cinchona, potatoes, tomatoes, coca, manioc, chocolate, chillies, pineapples, pawpaws and rubber (Davis, 1995, p41). The uses of these plants were typically observed from indigenous people. The Portuguese established trade routes into Latin America and found a sea route to South, East and Southeast Asia past the southern Cape of Good Hope in Africa and across the Indian Ocean from 1488. Due to the rivalry that had emerged between the two Catholic countries that shared the Iberian Peninsula, Pope Alexander II attempted to divide the unconquered world between them with the Treaty of Tordesillas in 1494. The treaty conferred on Portugal all non-European territory east of a line at 370 leagues west of Cape Verde (or longitudinally 50° west), including Brazil, Africa and Southeast Asia (Aitken, 2006, p79; Brierley, 1994, pp39–41). Subsequently, the Portuguese established colonies on the Malabar Coast and Goa in India, Malacca (Malaysia) and Brazil in the early 1500s. Portugal was able to establish a trade in the clove market, but it was unsuccessful at monopolizing the nutmeg trade of the Banda Islands. Due to the treacherous murder of the Sultan of Ternate in Molucca (Indonesia) by the Portuguese, the colonists became embroiled in regular conﬂicts with the local Muslim population of North Sumatra adjacent to Malacca. Portugal’s extraction of eastern riches was subsequently chronicled as piratical and

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conquest-like (Boxer, 1969; Marsden, 1738; Brierley, 1994). Between 1571 and 1610 Portuguese ships carried average annual spice cargoes of over 1000 tons of cinnamon, cloves, nutmeg, ginger and, most importantly, pepper from Sumatra and Java, with spices in Europe considered to be literally worth their weight in gold (Brierley, 1994, pp39–43). Spain was given the rest of America under the Treaty of Tordesillas and concentrated on New Spain (Mexico) and the Caribbean during much of the sixteenth century (Aitken, 2006, p79). Eventually a Spanish-sponsored mission under the Portuguese Ferdinand Magellan reached the Moluccas or Spice Islands (the Indonesian archipelago) via a western route across the Paciﬁc in 1521. Spain went on to colonize the Philippines in 1570. On Magellan’s voyage, an Italian named Antonio Pigafetta recorded in his diary the rare spices they found during their explorations and conquest (Brierley, 1994). The documentation of plants and the trade in spices continued from the 1500s. For example, Aztec artists from Mesoamerica were employed to help create the Badianus Manuscript: An Aztec Herbal (1552), which combined their local knowledge with European traditions. This occurred despite the widespread destruction of indigenous gardens by Spanish conquistadors: Hernán Cortés in Mexico, Francisco Pizarro in Peru and Gonzalo Jiménez de Quesada in Columbia. As Aitken (2006) notes, it was economic rather than ornamental imperatives that governed the early European study of the rich and ‘undiscovered’ fauna. The exploration and conquest of the ‘New World’ and much of Asia was often brutal and exploitative (Voeks, 2004, pp869–70). During the seventeenth century, competition from Dutch and British traders increased dramatically in the East Indies, capitalizing on the decline of Portuguese control in the region. The Briton Sir Francis Drake arrived in Ternate in 1579 as part of a circumnavigation of the globe. Drake was provided with a load of spices and a treaty with the new Sultan of Ternate and, after various victories over the Portuguese and Spanish, he captured the imagination of the English for further exploration and trade into the East Indies (Keay, 2006; Lawson, 1993). During the same period, a Dutch explorer named Jan Huygen van Linschoten published his Itinerario, providing important information about the navigation of the Indian Ocean and triggering a raft of Dutch expeditions to Southeast and East Asia in 1598. This further incentivized the English who created the East India Company, which was granted a royal charter and monopoly in 1600 to coordinate trading expeditions to the ‘East’. What followed was a series of signiﬁcant geopolitical events stemming from the trading companies formed by the Dutch and English. The Dutch formed the United East India Company, known as the VOC,1 in 1602 which had a 20-year monopoly over trade between the Cape of Good Hope, across the Indian Ocean and Southeast Asia to the edge of Russia at the Bering Sea. As Brierley (1994, p49) notes, the VOC could: write its own treaties, declare war or peace, build and maintain forts, establish colonies, execute justice, and coin its own money. Wielding enormous power, it was a state within a state.

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Dutch atrocities in response to an encroaching English presence in the 1600s were targeted not only at the English trading outposts, but at the local people of the East Indies so as to ensure submission to their monopoly in the spice trade (Keay, 2006, p237; Prakash, 1996). The British East India Company also had extensive powers, colonizing India and employing their own exploitations, repressions and brutality. Various cultural and religious affronts and exploitations by the company led to the Great Rebellion of 1857 and subsequent interventions by the British government in India. The East India Company’s activities were not isolated to India and included conﬂicts in Burma (in 1824 and 1852) as well as in China (the Opium Wars in 1839 and 1856) and the establishment of trading operations and ports in places such as Malaya, modern-day Pakistan and Afghanistan, Singapore and Canton (Hong Kong) (Lawson, 1993). Its trade continued to be dominated by spices such as pepper, tea, opium, cotton and indigo (see Juma, 1989, p48, on the British Empire). As well as these economic (and geopolitical) pursuits, corresponding scientiﬁc studies were conducted. The classiﬁcation of plants was undertaken by naturalists such as John Ray, who offered the ﬁrst species concept in Methodus Plantarum (1682) and went on, with his three-volume Historia Plantarum (1686–1704), to provide the ﬁrst systematic treatment of plants then known to Europe (Davis, 1995, p42). Carl Linnaeus then continued this process through his studies at the botanic gardens at Uppsala and then in the Netherlands between 1730 and 1753. He developed the concept of binomial nomenclature (Species Plantarum, 1753) that would be used to classify the thousands of plants then coming into Europe from all parts of the world. Linnaeus’ students then began travelling the world seeking out new plants for use as foods, textiles and medicines that would beneﬁt Europe, and much of their research was informed by observation of local people (Aitken, 2006; Davis, 1995). Naturalists such as Daniel Solander and Joseph Banks, who circumnavigated the globe with English Captain James Cook, returned with some 1200 new species including more than 100 new genera largely obtained from the islands of the South Paciﬁc and Australia (Davis, 1995). The work of these botanists and others such as Joseph Hooker led to the establishment of the Royal Botanic Gardens at Kew, England. In the nineteenth century various explorers continued to document and engage the knowledge of indigenous peoples in various circumstances, from outright exploitation to what have been depicted as more positive exchanges.

Ethnobotany

The ﬁeld of ethnobotany has its roots in the ‘numerous observations of explorers, traders, missionaries, naturalists, anthropologists, and botanists concerning the use of plants by the seemingly exotic cultures of the world’ (Davis, 1995). An expanded emphasis on scientiﬁc endeavours that corresponds with the Age of Enlightenment saw increasing attention to the systematic study of local or indigenous knowledge of plants. In 1874 Stephen Powers

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coined the term ‘aboriginal botany’ to describe the use of plants by indigenous people for ‘medicine, food, textile fabrics, ornaments, etc.’ (Davis, 1995, p43). Subsequently, the study of local and indigenous knowledge of plants became its own widespread and formal discipline following the coining of the term ‘ethno-botany’ by John Harshberger (see Harshberger, 1896). Ethnobotany rapidly expanded in the early 1900s. The work of prominent ethnologists and cultural ecologists (as these ﬁelds emerged) broadened studies into the development of understandings of the cultural context of plant use and on the complexity of human roles in ecology (Gilmore, 1919 and 1932; Rappaport, 1968). Cotton (1996) notes that the middle of the twentieth century saw changing attitudes towards traditional peoples. ‘Ethnoecology’ emerged from the work of Harold Conklin, famous for his 1954 thesis The Relation of the Hanunuo Culture to the Plant World (see also Conklin, 1961, on shifting agricultural systems). These scholars helped demonstrate that these indigenous societies had ways of thinking that differed from Western thought and sciences, but were equally as valid. Aboriginal taxonomies and folk classiﬁcations were studied and revealed to be as complex as Linnaean concepts and categories. This helped dispel notions of indigenous knowledge as simple, naive or ignorant (see Figure 1.1). Following this, scholarly attention was seen as part of an ‘anthropological rescue operation’ with emerging concern that the world’s indigenous peoples and their societies were about to disappear (Cotton, 1996). However, the insensitivities of colonial research practices that objectify indigenous people as research objects have also continued to frustrate and offend them, despite the often ‘good intentions’ and ‘beneﬁts for humankind’ that the researchers pursue (Tuhiwai Smith, 2005).

Intended or Unintended Impacts?

Over time, a consciousness and respect for both local environments and the plant-based knowledge of local and indigenous peoples has gradually emerged, particularly in the past few decades. Yet this is certainly not a uniform occurrence and there are still many ecological and cultural abuses that endure today. So what are some of the enduring impacts of these exploitations? Often, collecting activities have been so vigorous that they have entirely cleared vegetation and caused signiﬁcant damage to ecosystems. For example, Tyler-Whittle (1970, p9) writ that in 1847 the orchid Laelia elegans grew naturally and abundantly on a small island off Brazil. Collectors at the time said that they had never seen such a mass of plants, but by 1897 not a single living specimen remained. Tyler-Whittle notes that: In order to meet the demand for more and more and more, Orchid hunters went to unprecedented lengths, being prepared to travel far through unmapped and dangerous country simply on the hint that a new species or a considerable colony of others might be at the end of their journey; razing thousands of forest trees to the

Figure 1.1 A collection of more than 65 seeds and herbs on display to demonstrate the breadth of Khon Pga k’nyau (Karen) local knowledge of plant-based medicines and foods

Source: D.F. Robinson, 26 March 2005, Baan Mae Ka Pu, Amphoe Samoeng, Chiang Mai, Thailand

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ground in order to collect the epiphytic Orchids which lived like birds in their branches; denuding great areas of Orchid stocks – in some cases actually removing all traces of a species from its original habitat so that it only continued to exist in captivity. This sort of overexploitation has continued into recent decades at the hands of local populations as well as the former colonial powers. Trade in plants and other biological resources for use as foods, medicines and ﬁbres has expanded according to the demands of booming populations and increased global consumption. As a result, widespread ecological degradation is occurring, with targeted species suffering at the hands of collectors and poachers from all corners of the globe. For example, the International Union for the Conservation of Nature (IUCN) and the organization Trafﬁc have reported on the dire conservation implications for ﬂora and fauna that are used prevalently in traditional medicines systems in Vietnam and Cambodia. In Cambodia, 80 of the species of plants used in traditional medicine are now considered high priority for national conservation, while in Vietnam, 71 animals traded and sold openly on the market for medicinal uses (such as bear, rhinoceros, elephant and tiger) are listed on the IUCN Red List of globally threatened species (Huong, 2008). The impacts upon indigenous and local people have also been extensive. Fundamental human rights, including civil, political, economic and cultural rights, have been denied historically to many peoples in the colonial process of expansion and exploitation. As Posey (2002, p3) notes, indigenous and traditional peoples have: long been targets for expropriation of their music, art, crafts, and images. Trade has removed materials, ideas, expressions of culture – and even human genes – from their social and spiritual contexts to convert them into objects for commoditization. This shows not only disrespect for other cultures, but also violates basic human rights. Until relatively recently, many countries did not even recognize the basic rights of indigenous peoples to exist, let alone grant them self-determination, landownership or control over traditional resources (Posey, 1999). In Australia, for example, the British colonists declared the country ‘terra nullius’ (‘land belonging to no one’) despite the long historical presence of indigenous Australians across the continent for perhaps up to 100,000 years. As a consequence of these colonial actions many languages, customs, traditions and much environmental knowledge have tragically been lost. Eventually, these oppressions have slowed or subsided through various political and cultural evolutions and since the intellectual movements of the Enlightenment ushered in a wave of new humanitarianism. In our recent history, the post-World War II period saw the development of the United Nations, geopolitical recalibrations and the eventual emergence of a global

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protest movement involving indigenous and colonized peoples. As the humanrights movement also took hold, the rights of ethnic minorities and indigenous people came to be more broadly recognized. As Coates (2005) notes, the United Nations Declaration of Human Rights challenged the cultural assumptions of the past – particularly the assertion that one culture, race or ethnicity was superior to another. An emphasis was placed on anti-discrimination in the activities of the new international organizations. The International Labour Ofﬁce (ILO) consolidated this with ILO Convention 107 (1957), which sought to allow for indigenous or tribal people to, ‘beneﬁt fully from the rights and advantages enjoyed by the other elements of the population’, among other important statements on territory/land, employment and economic development. Furthermore, as the former colonies gained independence and the dualism of the Cold-War period subsided, politics and economic opportunities of trade with the ‘third world’ took on a new importance. Indigenous populations, as well as the former colonies, began to be recognized with a newfound legitimacy and interest. In the late 1970s, 1980s and early 1990s, a considerable amount of literature from anthropology and related ﬁelds emerged on indigenous knowledge, particularly from postcolonial perspectives and settings.2 Human environment interrelations were highlighted in the 1990s with an increasing environmental awareness evidenced in events such as the Rio Earth Summit, including the UN Convention on Biological Diversity, in 1992. In the same year, Martha Johnson used the term ‘traditional ecological knowledge,’ explaining it as: A body of knowledge built by a group of people through generations living in close contact with nature. It includes a system of classiﬁcation, a set of empirical observations about the local environment, and a system of self-management that governs resource use (Johnson, 1992, pp3–4). With changing academic and public agendas, a number of authors have recently developed more optimistic views of the human capacity to exploit biological resources as a way of contributing to their conservation. Indigenous or ‘traditional’ knowledge has been enmeshed in these agendas, including many assumptions about the willingness of indigenous or local communities to participate in such activities. This leads us to the following section and a discussion of the term ‘bioprospecting’ which has come to be used to positively portray the collection of biological specimens for scientiﬁc research and/or commercialization, in contrast to ‘biopiracy’.

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Bioprospecting As Cori Hayden (2003a, p1) indicates: Bioprospecting is the new name for an old practice: it refers to corporate drug development based on medicinal plants, traditional knowledge, and microbes culled from the ‘biodiversityrich’ regions of the globe – most of which reside in the so-called developing nations. The origins of the term bioprospecting are usually associated with the 1993 book Biodiversity Prospecting by Reid et al. from the World Resources Institute, where it was defined as, ‘the exploration of biodiversity for commercially valuable genetic and biochemical resources’.3 For these authors, when conducted appropriately, bioprospecting can: contribute greatly to environmentally sound development and return beneﬁts to the custodians of genetic resources – the national public at large, the staff of conservation units, the farmers, the forest dwellers, and the indigenous people who maintain or tolerate the resources involved. The book generally champions a ‘win–win’ scenario of ‘beneﬁt-sharing’ and respect for indigenous or traditional knowledge, and also a boon for humanity through scientiﬁc research. The authors do note past instances where resource exploitation has had negligible or harmful effects on biodiversity conservation and local communities. Therefore, they premise their suggestions on the need for appropriate policies and institutions ‘to ensure that the commercial value obtained from genetic and biochemical resources is a positive force for development and conservation’ (Reid et al., 1993, pp2–3). Thus, they anticipate that researchers are now moving beyond the past exploitations of biological resources and indigenous or local knowledge, with a new awareness and new regulations to shape this research. The bioprospecting concept is based on recognition of the importance of natural product discovery for the development of new crops and medicines, often based on traditional knowledge. For example, in many developing countries a large part of the population depends upon traditional medicines for their primary healthcare needs. In India, 65 per cent of the population only has access to traditional systems of medicine, and in Africa 80 per cent of the population uses traditional medicines (WHO, 2002; Timmermans, 2003). Much of this knowledge has not been examined using the most advanced scientiﬁc methods, but this is rapidly changing. As Laird and Wynberg (2008, p12) note, natural products continue to play a dominant role in the discovery of new leads for the development of drugs. They contribute signiﬁcantly to the bottom lines of large pharmaceutical companies: between January 1981 and June 2006, for example, 47 per cent of cancer drugs and 34 per cent of small

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molecule new chemical entities for the treatment of all disease categories were either natural products or directly derived from them (Newman and Cragg, 2007). Research into speciﬁc natural products is usually initiated by existing knowledge, often directly from indigenous or local communities, but now in many cases as transferred through the ‘public domain’. Given the size of these industries, there is often an assumption that bioprospectors may in fact be able to establish multimillion dollar arrangements that have been described as ‘green gold’. Pharmaceuticals represent the biggest industry of relevance here, with a global market worth US$773.1 billion in 2008 and which has grown steadily in the past few years (IMS Health, 2009). It is difﬁcult to adequately estimate the contribution played by naturalproduct discovery from indigenous and local sources. As Laird and Wynberg (2008, p12) note, there are only four large pharmaceutical companies still maintaining natural products programmes of any size (Novartis, Wyeth, Merck and Sanoﬁ-aventis), with other large companies closing down their natural product programmes and associated bioprospecting ventures in the 1990s (e.g. Bristol Myers Squibb, Pﬁzer, GlaxoSmithKline and Monsanto). So the contribution of direct bioprospecting activities seems to be declining at least in this industry. In many cases, these pharmaceutical giants are instead screening already established libraries of compounds held by these companies or other gene-banks, or they are producing ‘me too’ drugs that are chemically similar to existing drugs on the market. Since the publication of Biodiversity Prospecting, a number of authors have examined recent bioprospecting cases to evaluate their ongoing viability politically, economically, for conservation and with regards to impacts on local communities. There are three cases in particular that have drawn considerable attention: ICBG Projects; the Merck-INBio Costa Rica agreement; and the Shaman Pharmaceuticals venture. Each of these cases has drawn fairly heavy criticism about their failure in various respects, as described in Box 1.1. These and other case studies of pharmaceutical bioprospecting and beneﬁtsharing agreements have found that only rarely have true ‘beneﬁts’ been reaped by provider parties; that the transfer, contract and conditions have been controversial; and that there is now an increasing trend away from sourcing biological materials from in situ or ‘indigenous’ sources (Robinson, 2007; Hayden, 2003a).4 This may be particularly the case for the pharmaceutical industry, but it is also likely to be true of the demand for new collections for agricultural biotechnologies and the seed industry (Laird and Wynberg, 2008, pp14–17), in which much germplasm has also already been transferred to gene-banks, research centres and company repositories. These examples do not strictly imply that beneficial arrangements between researchers and local communities are impossible, but rather they suggest that they face considerable challenges, many of them associated with deﬁning appropriate boundaries of ‘ownership’ and representation. This could be particularly relevant for industries including cosmetics, natural personal care, and food and beverage supplements, in which new natural products are regularly sought. In many cases, these companies have actively attempted to

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BOX 1.1 SELECTED BIOPROSPECTING CASES ICBG Projects Projects under the National Institute of Health (US) International Cooperative Biodiversity Groups Programs (ICBG) have been criticized in a number of contexts for their bioprospecting ventures. For example, an ICBG project seeking to establish bioprospecting beneﬁt-sharing arrangements with the Aguaruna people of the Amazon region, particularly Peru, has been criticized with respect to appropriate representation of indigenous people. This was due to a complex array of often conﬂicting negotiations between different indigenous representative groups, researchers, industry partners, NGO intervention and some undue expectations (Greene, 2004).5

The INBio Case The INBio non-proﬁt, non-government research collaboration agreement with the pharmaceutical corporation Merck, Sharpe and Dohme for bioprospecting activities in Costa Rica has been extensively studied. The main reason for controversy regarding the collaboration is that it failed to adequately engage with local farmers and indigenous groups; namely, prior informed consent procedures were not adequately applied when the agreement was established, leaving local or indigenous people entirely out of the arrangement (Mateo, 2000; Gamez, 2007).

Shaman Pharmaceuticals The bioprospecting venture of the US company Shaman Pharmaceuticals, which intended to identify traditional medicines, isolate active compounds and commercialize the product while also sharing a portion of the beneﬁts, ultimately failed. This can largely put down to the lengthy delays with regards to clinical trials, costly US Food and Drug Administration (FDA) approvals, consequently high research costs and the poor proﬁtability of the venture (Svarstad, 2000, pp145–53; Brown, 2003, pp125–35).

demonstrate ‘fair trade’ principles and an ethical engagement with the local communities that provide such resources. For example, the Body Shop claims to provide fair, reliable wages to its ‘Community Trade’ suppliers of personal care products, which contribute to 60 per cent of its range of products (Body Shop, 2009). Laird and Wynberg (2008, p75) also provide the example of the Aveda Corporation’s sourcing of sandalwood in partnership with indigenous communities in Western Australia. While these cases do not involve patents or other intellectual property rights (IPRs), they attempt to provide fair and equitable arrangements for the sourcing and use of typically plant-based products and, in some cases, traditional knowledge. The interest in establishing rules to ensure that bioprospecting activities ‘give back’ to the various groups involved in biodiversity conservation culminated in texts on ‘beneﬁt-sharing’ within the 1992 Convention on Biological Diversity

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(discussed in Chapter 2). However, ever since this agreement came about there have been dissenting and sceptical voices concerned that the international and national rules being established subsequent to the CBD are inadequate. Thus, the discourse of bioprospecting has been created and employed to place a positive emphasis on biological resource-collecting activities. At the same time, a number of inﬂuential activists and NGOs were behind the generation of a counter-discourse: ‘biopiracy’.

Biopiracy Biopiracy is a term that was ﬁrst coined by the Canada-based NGO Rural Advancement Foundation International (RAFI, now the Action Group on Erosion, Technology and Concentration [ETC Group]) and is usually attributed to activist Pat Mooney (see RAFI, 1993; 1995; Mooney, 2000). The term was developed due to growing frustrations about the appropriation and monopolization of long-held medicinal and agricultural knowledge about nature, as well as the related physical resources (plants, animals and their components). The ﬂow of these resources and knowledge, often ‘from biodiversity in the South to medicines [cosmetics and crops] in the North’ (Svarstad and Dhillion, 2000, p9), has been targeted by NGOs as a hypocritical injustice on the part of corporations and researchers predominantly from Japan, the US, Europe and other parts of the Western world. Although the colonial enterprise of plant and animal collecting has been ongoing for centuries, the biopiracy discourse was generated to illustrate that more recent technological and institutional changes have encouraged new inequities and compounded old ones. In the context of the new ‘global’ intellectual property rules, biopiracy has essentially been wielded as a counterdiscourse to intellectual property ‘piracy’. Mooney and RAFI disagreed with the assumptions asserted by Reid et al., using biopiracy as a discursive tool to point out that the socio-economic environment at the time made mutually beneﬁcial contracts between ‘providers and users of genetic resources’ virtually impossible. As Mooney (2000) notes, international agreements such as the Convention on Biological Diversity, negotiated at the Rio Earth Summit in 1992, and the WTO Agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS) consolidated some speciﬁc Euro-American ideologies about the intellectual property ownership of nature as ‘genetic resources’. According to Mooney (2000), intergovernmental regulatory mechanisms and agreements were needed if there was to be any chance of achieving fair and equitable beneﬁt-sharing in practice. Additionally, many activists, NGOs and indigenous organizations sought to highlight the incompatibility of exclusive intellectual property rights with indigenous and southern perspectives on nature. RAFI’s campaign also targeted the explicit protectionism that biotechnology companies were implementing through not only intellectual property rights, but also biotechnological advances such as genetic-use restriction technologies (GURTs) – which they dubbed ‘terminator technologies’ (RAFI, 1998).

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RAFI linked biopiracy claims to evidence that transnational seed companies were planning to use terminator technologies for seed sterilization, thus inhibiting farmer re-use of seeds. In this way, RAFI was able to highlight the ongoing legal (through intellectual property) and technical (biotechnological) institutionalization of farmers from the global south (Robinson, 2010). So, it is important to note that biopiracy is not a one-dimensional concept and that it has been used as a political tool. Nevertheless, serious issues and concerns relating to biopiracy have meant that it has been used to describe and criticize a number of incidents by other individuals and organizations beyond RAFI. Probably the most prominent individual ‘anti-biopirate’ activist is Vandana Shiva. Shiva’s attacks on the green revolution (1991), the intellectual property system (1997; 2001), and genetic reductionism gained signiﬁcant international attention. Particularly notable was her activism on several basmati rice patents in the US, which contributed to the revocation of four basmati-related claims by the patent owner (NISCIR, 2002). The use of the biopiracy discourse in these contexts is an indication that the term is politicized, reactive and, in many cases, imprecise. As Dutﬁeld (2006) notes, there has been a tendency for NGO statements and reports on biopiracy cases to be deliberately and ‘strategically’ vague. Nevertheless, alongside the political and NGO-activist response to biopiracy there has also been a parallel concern from indigenous communities, farmers and local communities about the exploitation of their knowledge and plants which they have developed over centuries. Despite the obvious alarmism and uncertainty surrounding biopiracy, the issues in question have garnered increasing local and international attention. For example, behind Shiva and other activists in India was a network of farmers and local communities with sufﬁcient power to inﬂuence public opinion and government policies, laws (such as the Indian Biodiversity Act, 2002) and Indian positions in international forums. This network of inﬂuence was expanded through engagement with other NGOs such as the Third World Network, in statements by indigenous peoples’ movements and civil society actions such as the Thammasat Resolution in Thailand (in 1997), and also in the vocabularies of intergovernmental organizations of developing countries, such as the South Centre. Thus, with the enrolment of broader public sympathies for NGO causes, the biopiracy issue has extended beyond ‘activist’ agendas. What is particularly interesting is the recent uptake of the discourse by government delegates in statements and submissions to international organizations, such as: One of the measures adopted [in Peru] was the creation of the National Anti-Biopiracy Commission, whose basic task is to develop actions to identify, prevent and avoid acts of biopiracy which involve biological resources of Peruvian origin and traditional knowledge of the indigenous peoples of Peru. (Communication from Peru to the WTO TRIPS Council, 7 November 2005)

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With the development of national bodies targeting biopiracy and ofﬁcial statements by government departments and delegates to the WTO, the issue and discourse of biopiracy has gained increasing momentum and (in certain communities) acceptance. The ofﬁcial use of ‘biopiracy’ implies public pressures on governments to ﬁnd equitable and just solutions to the issues of biological resource and knowledge ownership. However, its use has also been brought about by pressures within some states to protect (and exploit) their ‘sovereign rights’ to biodiversity according to the CBD. Out of this Convention, the discussions of ‘beneﬁt-sharing’ have been spun to serve variable interests from NGOs like RAFI to government departments and biotechnology industry lobbies (Robinson, 2010). These governmental reactions also hint at a growing awareness of what has been described as the new intellectual property ‘fundamentalism’ (Dutﬁeld, 2006) and ‘inequality’ (Drahos with Braithwaite, 2003), as raised by inﬂuential academics and researchers. Biopiracy is clearly also a counter-discourse to the complaint by corporations from the most industrialized countries of ongoing intellectual property ‘piracy’. As authors such as Drahos and Braithwaite (2002) have noted, the discourse of piracy has been conﬂated to mean the copying of the intellectual works of others, whether or not those authors/creators actually have registered copyrights in jurisdictions around the world. The hypocrisy of some of the strongest intellectual property rights advocates is evident through a historical analysis of the policies of countries like the US, Japan and those from the European Union. For example, Dutﬁeld and Suthersanen (2005, pp142–3) note that the biggest current proponent of IP expansion – the US – had a particularly negligent record for foreign copyright protection during the nineteenth and twentieth centuries as its industries developed and ﬂourished, and it did not sign the Berne Convention for the Protection of Literary and Artistic Works until 1989. In this light, the current approach of the US to IP expansion and enforcement seems highly duplicitous (Robinson, 2010). In addition, biopiracy has been used strategically in international trade and intellectual property negotiations. Due to the inequities in trade and technology ﬂows between countries in the global south and those in the global north, biological resources have emerged as a bargaining tool for those countries with less political and economic leverage. For example, Dutﬁeld (2005) notes that discussions on a ‘disclosure of origin requirement’ to limit inappropriate patenting of acquired biological resources have been used strategically by developing countries to stall negotiating progress on a Substantive Patent Law Treaty in WIPO.6 A number of authors have refuted the existence of biopiracy by carefully selecting some claims by NGOs, highlighting their vagaries and essentially arguing the lack of a legal basis for biopiracy (Chen, 2006; Heald, 2003; Oxley, 2005; 2006). Their arguments are largely based on economic (utilitarian) and legal grounds, and thus also need to be read within their situated contexts, despite their claims for universal dismantling of the ‘myth’ of biopiracy (Chen, 2006, p6):

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Ethnobiological knowledge is best characterized as the inventive transformation of genetic information into commercially valuable applications. An appropriately utilitarian view of property and its relationship to each layer of biological information thus dissolves any allegation of biopiracy. However, it is worth asking: ‘Who is Chen to judge how ethnobiological knowledge is “best” characterized? Who is a utilitarian view of property and biological information “appropriate” to?’ These characterizations might seem appropriate to some IP lawyers, some economists and some biotechnologists, but they are not appropriate characterizations or assumptions for people who view the world from many other perspectives. Thus, the protagonists behind these biopiracy counter-discourses also present a narrow and politicized worldview (Robinson, 2010). These counter-biopiracy authors also make over extended assumptions about what is being sought by proponents of patent reform towards a ‘disclosure requirement’ and the biopiracy discourse. Oxley (2005, p4) suggests that amendments to World Trade Organization intellectual property rules and the CBD rules are being sought, ‘so developing countries can reap the beneﬁts of their natural biodiversity – “green gold”.’ Similarly, Chen (2006, p29) suggests that, ‘The real point of the biopiracy narrative is that the global south wants its largest possible share of the world’s wealth.’ These assertions are misguided and overly narrow. As already noted, biopiracy is also a counter-discourse to hinder the historically hypocritical raising of IP norms, standards and policing. It is also a reaction by a diverse range of different cultures and perspectives to IP monopolization of biological resources and the genetic reductionism of nature. It seems clear that biopiracy concerns are not purely economically driven; there are many political, ethical and cultural drivers for the continued use of the term. It is in response to this vagueness, politicization and lack of an appropriate description of biopiracy that this book has been written. The following section describes some of the deﬁnitional issues associated with biopiracy.

Deﬁnitions and Ambiguity Most discussions of biopiracy have understandably been emotional and frustrated because is an issue that may impact livelihoods; it is enmeshed in people’s economic and cultural connections with plants; and in some cases it may have spiritual implications for indigenous people. This section seeks to more systematically analyse the deﬁnitions given by a number of sources and attempts to synthesize them into a clear description of biopiracy. Subsequently, the chapters in this book test the descriptions put forward, and the questions raised, through analysis of multiple biopiracy and bioprospecting case studies. Ultimately, it is hoped that this will encourage the targeted addressing of the numerous issues involved.

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Firstly, the most obvious source for a deﬁnition is the creator of the term. The ETC Group (formerly RAFI), which is under the directorship of Pat Mooney, is still highly active in the critique of cases which they label ‘biopiracy’. The organization provides the following deﬁnition: Biopiracy refers to the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions who seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge. (ETC Group, undated)7 There are several notable things about this deﬁnition. Firstly, it extends to both genetic resources and associated knowledge. Secondly, it is particularly concerned with the appropriation of these from ‘farming and indigenous communities’. Thirdly, control is sought through patents and intellectual property. Thus we have a fairly clear indication of their main concerns. However, several questions can be raised: • •

How can (traditional) knowledge be appropriately deﬁned? How can local custodianship of genetic resources be delineated (if at all possible)? • What about appropriations from developing countries more generally? • Which other forms of intellectual property control are pertinent? • Is appropriation and control of genetic resources through other means also considered biopiracy? • What if such appropriation is authorized by legitimate authorities? Clearly these are difﬁcult questions to respond to, being tied up in complexities of boundaries, both physical and immaterial, and legitimate authority. For now, let us focus on the ﬁrst question. Academic and policy-related discussions of indigenous or ‘traditional’ knowledge have often focused on the ecological or biological aspects and this has continued through current literature. As Dutﬁeld notes: Traditional knowledge commonly refers to knowledge associated with the environment rather than knowledge related to, for example, artworks, handicrafts and other cultural works and expressions (which tend to be considered as elements of folklore). (Dutﬁeld, 2004, p91) There is no single universally accepted deﬁnition of ‘traditional knowledge’ and it is a term that takes on many meanings for different people. In some cases this knowledge may be held by indigenous people and in other cases it may be held by other parts of the population (locally, in minority groups, or broadly in the public domain). There are, however, some generally accepted concepts associated with discussions on traditional knowledge. The following provides

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some general criteria based on the collective understandings of the term made in international forums, based on comments by indigenous representatives, academics and from direct research experience (from Robinson, 2008a, p122). This is by no means a ﬁnite deﬁnition. Traditional knowledge is widely understood as: • • • • • • • • • • • •

Knowledge developed over time; Transmitted from generation to generation; Typically, transmitted orally; Typically, collectively held and owned; Typically of a practical nature and relating to natural resources (as has been deﬁned in intellectual property circles, otherwise it falls under folklore or cultural expression); Dynamic and evolving with environmental and external inﬂuences; Often involving elements of innovation and experimentation; Typically embedded in speciﬁc environmental settings; Embedded in customs, language, local practices and cultural heritage; Still existing in memory when it is removed from its local cultural or environmental setting, but it becomes less ‘traditional’; Often linked to, or taking the form of, stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language and agricultural practices; Having a holistic aspect.8

Such a complex and variable entity is therefore difﬁcult to study and to make generalizations about. In the context of this book and the issue of biopiracy the focus is mostly on traditional knowledge’s contribution to useful products, but also for its role in the conservation of environments, ecosystems and biodiversity. However, traditional knowledge is important for many reasons, including the maintenance of culture and identity. Such important considerations must also be kept in mind to avoid a reductionist approach when dealing with traditional knowledge from the perspective of research and policy-making. Indeed, it must be kept in mind that often indigenous and local groups have customary norms, protocols and laws that surround traditional knowledge in order to maintain and regulate it. The recognition of these is likely to be a crucial component in the protection of traditional knowledge, as will be discussed later. For now, some further analysis of the deﬁnitions provided by other key authors may be of some use. Vandana Shiva’s interpretation of the term is that: Biopiracy refers to the use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products and processes that have been used over centuries in non-industrialized cultures. (Shiva, 2001, p49)

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Thus, Shiva broadens the deﬁnition of those victimized as being from ‘nonindustrialized cultures’, not just from farming and indigenous communities. Also, although not included in her deﬁnition, one can assume through her writings more generally that biopiracy can cover knowledge associated with biological resources. Again, in this case, Shiva’s primary concern is the use of IP systems of control. However, this is not the only circumstance that has been labelled biopiracy – unauthorized collection and use of biological resources and associated knowledge more generally has been implicated, as described by Dutﬁeld (2004, p52). Biopiracy: normally refers either to the unauthorized extraction of biological resources and/or associated traditional knowledge from developing countries, or to the patenting of spurious ‘inventions’ based on such knowledge or resources without compensation. Thus, Dutﬁeld expands the scope of the deﬁnition to include unauthorized extractions and typiﬁes developing countries as the primary victim group. Dutﬁeld also narrows the scope to typify only the patent component of IP control over biological resources and knowledge. He particularly focuses on ‘spurious’ inventions, implying that if patent examination procedures were adequate, then such cases may not fall within the typical description of biopiracy. However, RAFI/ETC Group, Shiva and others (Drahos with Braithwaite, 2002; Blakeney, 2004, p395) have also noted the impact of other IP controls over biological resources, particularly through plant-breeder rights (PBRs) established through plant-variety protection (PVP) systems, and which provide a form of IP right that is quite different in scope to a patent. These cases certainly may represent an unfair or inequitable exploitation of biological resources and knowledge and so could also be considered to be biopiracy in certain circumstances. Therefore I propose a revised description of biopiracy in Box 1.2, which draws upon the aforementioned depictions or deﬁnitions, but which nuances biopiracy into a number of categories based on its general usage. This typology draws upon the most prominent descriptions of biopiracy (discussed above) through analysis of biopiracy cases and through the emergence of international norms and laws for the treatment of traditional knowledge and biological resources. These categories of biopiracy are then further explored in the case studies in subsequent chapters. As a result, the many speciﬁc issues entailed by these biopiracy cases can be highlighted and targeted by policy-makers and relevant stakeholders working at local, national, regional and global scales. In some cases, this may be a matter of improving patent application guidelines and procedures, but in other cases the issues may reﬂect more systemic problems with the patent and broader intellectual property system, or with international regulations for biological resources transfer. More academically, an appraisal of the use of biopiracy as a political tool can also be made where it has been employed as a gauge of fairness and equity in biodiversity beneﬁt-sharing transactions.

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BOX 1.2 TYPOLOGIES AND CATEGORIES OF BIOPIRACY Patent-based Biopiracy The patenting of (often spurious) inventions based on biological resources and/or traditional knowledge that are extracted without adequate authorization and beneﬁtsharing from other (usually developing) countries, indigenous or local communities.

Non-patent Biopiracy Other intellectual property control (through PVP or deceptive trademarks) based on biological resources and/or traditional knowledge that have been extracted without adequate authorization and beneﬁt-sharing from other (usually developing) countries, indigenous or local communities.

Misappropriations The unauthorized extraction of biological resources and/or traditional knowledge from other (usually developing) countries, indigenous or local communities, without adequate beneﬁt-sharing. Note: ‘Authorization’ involves obtaining (free) prior informed consent of the appropriate government authorities and, where relevant, local communities.

Notes 1 2 3

4 5

6

7

VOC stands for the Vereenigde Oostindische Compagnie. See, for example, Geertz (1973), Said (1978), Geertz (1983) and Clifford (1988) for a critical analysis of the way anthropological thought changed through the 1970s and 1980s. The term ‘chemical prospecting’ was probably ﬁrst used in similar contexts by Thomas Eisner between 1989 and 1992 (Eisner, 1990a; 1990b; 1991). Eisner was one of the main individuals involved in the establishment of a prospecting agreement between Costa Rica’s National Biodiversity Institute (INBio) and the US pharmaceutical company Merck, Sharpe and Dohme in 1991 (Hayden, 2003a, p50). See Greene (2004); ten Kate and Laird (1999, p57). See also Berlin and Berlin (2004) on the Maya ICBG project in Chiapas, Mexico, which they indicate was ‘a bioprospecting project that should have succeeded [but] failed’ due to NGO interference in the project arguing that indigenous local community authority was delegitimized. This was also implied in a number of conﬁdential interviews and meeting comments with developing country delegates to the WTO and WIPO from regions such as South Asia, South America and Africa. Their dissatisfaction with progress on ‘development agenda’ items and the terms of trade more generally were the impetus for such a strategy (author’s interviews, 2005). See the following website: www.etcgroup.org/en/issues/biopiracy.html

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This deﬁnition draws upon the discourses of the CBD Secretariat 8(j) Working Group, the WIPO Secretariat (Traditional Knowledge Division) and discussions of traditional knowledge by Dutﬁeld (2004); Posey and Dutﬁeld (1996); Gibson (2004); and local experiences and observations made by the author.

2

International Legal Backdrop

There is no one single international treaty or agreement that fully captures all the issues involved in the regulation of bioprospecting and the prevention of biopiracy. Rather, there is an array of laws which are relevant and which arise from different governance structures, such as those underpinned by different United Nations programmes or under rules established by the WTO. This chapter discusses the legal and political frameworks in which biopiracy debates are now being pursued, either directly or indirectly. Throughout much of last century there was an understanding by many that biological materials should be considered the ‘common heritage of [hu]mankind’. This is despite there being little legal basis for this assumption. However, because there were few international frameworks which provided clear and unambiguous guidance regarding the ownership status of biological resources, and many other natural resources, they were often treated as ‘commons’ or as ‘open access’ resources. There are some sources of law that have been of relevance. The United Nations General Assembly Resolution of 1962 on Permanent Sovereignty over Natural Resources was made to mitigate foreign expropriations of natural resources (G.A. Resolution 1803 [XVII]). At the time the discussions were heavily concerned with foreign expropriation of oil, but the terms of the resolution could equally apply to biological resources (Brownlie, 2002). This resolution reafﬁrmed a markedly Western principle that states have sovereign control over their resources, which has existed as a general diplomatic rule since the Peace of Westphalia treaty signed in Europe in 1648. Notably, rules of sovereignty have evolved out of Western politico-legal systems and so other countries, populations and cultures have developed their own differing interpretations of ownership and control of resources. This is one reason why the ‘commons’ understandings of natural resources have endured into the last century. The establishment of a number of international research gene-banks in the mid-twentieth century began a new era of plant ownership. We are regularly reminded by southern NGOs that prior to this there was a period of free exchange of plant germplasm, limited exclusive ownership rights over plants

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and on-farm improvement of crop varieties by millions of small-scale farmerbreeders (Kloppenberg, 1988; Shiva, 1993; 1991).1 Colonial plant hunting occurred, but so did fairly wide scale plant exchange within and between developing countries. Over time, what seems to have changed markedly are the power relations between the different parties involved in plant exchange or extraction. The gene-banks that were established ultimately became part of the International Agricultural Research Centres (IARCs), and the Consultative Group on International Agricultural Research (CGIAR). The CGIAR was established in 1971 and came out of the Green Revolution era which emphasized the breeding and development of advanced hybrid or ‘high-yielding plant’ varieties. It also saw encouragement of international germplasm exchange and further legitimization of what we now typically describe as ‘bioprospecting activities’. The CGIAR became the umbrella body for 16 IARCs, each with their own governing body.2 With a budget of some US$340 million per annum, the CGIAR oversees the largest agricultural research effort focusing on crops and materials of interest to the developing world (Blakeney, 2002). In addition to supporting plant-breeding research in the IARCs, the CGIAR supports a collection of germplasm which currently comprises over 650,000 accessions of more than 3000 crop, forage and pasture species which are held at the research centres (CGIAR, 2009). Although intended initially for breeding to support the burgeoning populations in developing countries, much of the research undertaken by the CGIAR, as well as the raw germplasm, has been of considerable interest to biotechnology and life-science companies in the global north, which may utilize it for their own research and development. With this unitization has come the desire to protect the results of such research using the IP system, primarily in the form of patents and plant-variety protection. Blakeney (2002) and Srinivasan (2003) indicate that a commercial consequence of the intrusion of IP into agricultural research has been the concentration of key IP rights in the hands of a small and declining number of private life-science companies. A result of this market concentration has been the locking up of key intellectual property rights in the hands of a few powerful entities and the raising of barriers to market entry of others wishing to participate in these activities. For example, by the end of 1998, the top ﬁve vegetable-seed companies controlled 75 per cent of the global vegetableseed market (Blakeney, 2002). This raises serious questions about the future effects on public-sector plant breeding and for small start-up plant breeders, particularly those in developing countries. It seems that control of research and development (R&D) will increasingly move away from the public sector and from smaller enterprises – a trend of particular relevance for traditional agricultural knowledge and plant breeding in developing countries. During the 1970s there was a political push to formalize the ‘common heritage’ status of the extensive ex situ collections that had been made. In 1980, the Food and Agriculture Organization (FAO) introduced the International Undertaking on Plant Genetic Resources (IUPGR) which, although a non-

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binding international agreement, held some rhetorical importance for the consideration of plant germplasm as the ‘common heritage of [hu]mankind’. The undertaking came about at a time when many developing countries and indigenous and local communities felt cheated by an expanding realm of exclusive or private control over genetic resources, often resulting from the utilization of associated traditional knowledge. Germplasm and biological resources had been provided by these countries and their people ‘in trust’ and ‘for the beneﬁt of … particularly developing countries’ (CGIAR, 2009), with little realization that their derivatives may in the future become private property for exclusive economic gains. The IUPGR was being pushed by developing countries who sought to resist the expanding private ownership domains of industry over genetic resources that they had donated to the IARCs. Instead, the developing countries wanted to highlight the ‘commons status’ that they argued had existed before the IARCs were created and before developments in intellectual property (primarily patent and plant-variety protection) law in some developed countries. Ultimately, the international undertaking did little more than allow discursive critique of this process of increasing privatization of plant genetic resources. The increasing loss of such biological diversity, coupled with the perceived misappropriation of biological resources, prompted the international community to negotiate towards the CBD text. Whatmore (2003, p221) notes that a retrospective analysis of the IUPGR presents: an episode in the geo-politics of biodiversity management that exposed the partiality of western modes of IPR as the boundary markers between the natural and the social, a common heritage, and an exclusive claim. The key agendas, she argues, have established divisions, while other boundaries of ownership and the lines legitimizing the humanmade from the natural have been moved.3 In the period since, the IUPGR ‘commons’ status of plant genetic resources has lost considerable legal meaning – with the IUPGR now little more than a historic reminder of the rapid structural privatization of biological resources. The allocation of IP rights of patent and plant-variety protection over material originating from the CGIAR institutes has proven to be extremely controversial. Furthermore, the research conducted by such bodies or by researchers accessing the materials has often used the knowledge of indigenous or local peoples over speciﬁc traits relating to plant varieties to shortcut the many steps involved in the chain of invention resulting in commercially viable varieties. As a result, considerations of the ownership and control of the collections of the CGIAR have come into serious question, having been previously neglected. These bioresource transactions were coming across new boundaries – boundaries of resource exchange and intangible ownership, but also new boundaries between nature and society (most notably in the debates about genetic reductionism and genetic modiﬁcation), and moral, cultural and

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epistemic parameters related to ownership and science. After much meandering, the majority of the institutes have asserted that the materials contained in their gene-banks are not owned by anybody, but rather that they are held ‘in trust for the international community’ and that they would ‘not claim ownership, or seek intellectual property rights over the designated germplasm and related information’. This agreement was made in 1994 under the auspices of the FAO, which now acts as custodian for these materials. However, the ownership debate surrounding these ex situ plant genetic resources, as well as the world’s in situ genetic resources, has continued to evolve as discussed in the following sections. With the agreement of a number of other quite recent treaties and international laws the emphasis on ownership and control of resources, including intangible assets and biological resources, has shifted towards a regime that protects exclusive individual property rights. The intellectual property agreements discussed below have meant that exclusive rights of inventors, plant breeders and authors often must be recognized internationally. Although the principle of sovereign control of biodiversity has been maintained, there are now debates centred on whether this principle (as enshrined in the rules of the CBD) is essentially undermined by (and in conﬂict with) the protection of intellectual property rights. This chapter explores the main legal frameworks of relevance, returning to them in Chapter 6 to discuss the most current international negotiations.

The Convention on Biological Diversity The objectives of this Convention … are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the beneﬁts arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding. (Convention on Biological Diversity, Article 1. Objectives) The Convention on Biological Diversity was drafted at the Rio Earth Summit in 1992 and came into effect in 1993. As of September 2008 there are 191 parties to the CBD – almost every UN-recognized country in the world. The one glaring absentee from this list is the US. Although the US has signed the CBD, it has never been formally passed through the Senate and there has been heavy lobbying from various interest groups both for and against ratiﬁcation of the convention. As Jeffery (2004, p205; see also Gollin, 1993) notes, the CBD text has been referred to as ‘the grand bargain’ particularly because of the attempts to balance facilitated access to genetic resources with subsequent beneﬁt-sharing. It also indicates that intellectual property rights should be supportive of, and

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not counter to, the objectives of the CBD (Article 16.5). For conservationists this represented another compromise in light of the ongoing Uruguay Round of Multilateral Trade Negotiations of General Agreements on Tariffs and Trade (GATT, 1986–1993), in which international intellectual property rights were on the agenda. The Convention establishes and binds its parties to a range of important principles relating to biodiversity. Firstly, it afﬁrms the sovereign rights of states over natural resources (Article 15). Thus, state parties have the right to determine access regulations to biological resources. The fact that genetic resources (seeds, cuttings and samples) are replicable and that many plants or genes are not endemic to the one country (either naturally or through trade) means that the exclusiveness of access rights are generally territory-limited and are only as good as the country’s controls (such as customs). The issue of extraterritoriality has been a consistent problem in biopiracy cases between different countries with different laws. Questions relating to the knowledge of useful traits of plants, bioresources, genes and biochemicals have complicated the access and beneﬁt-sharing contexts that may arise. For example, a plant may be endemic to a number of countries, but the knowledge of its use for medicinal purposes may in some cases be isolated to one ethnic group or one local community. Yet, as communications technologies improve and expand internationally, information pathways are also opening through which any remaining distinctly local knowledge, even in remote areas, may become a rarity. Article 15.5 requires that ‘access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party’. In subsequent CBD Conferences of the Parties, in ad hoc working group meetings and in the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Beneﬁts Arising out of their Utilization (CBD Secretariat, 2002), an emphasis has been placed on extending prior informed consent to the local custodians of genetic resources and traditional knowledge holders through national laws (Robinson, 2007). However, it is worth noting that the Bonn Guidelines are not legally enforceable and in the ad hoc working groups of the CBD, the parties have had great difﬁculty agreeing upon the exact terms of prior informed consent and related concepts. Article 15 also speciﬁes the need for fair and equitable beneﬁt-sharing arising out of the research, development and commercialization of genetic resource innovations. According to the CBD and the Bonn Guidelines, beneﬁtsharing agreements must be achieved under mutually agreed terms. However, many authors (Laird, 2002; Wynberg, 2004) have pointed to the possibility of unequal power relations between researchers/commercial bioprospectors and the providers of genetic resources (including government authorities, farmers, local communities and other groups). The principles of prior informed consent and beneﬁt-sharing have since also appeared in discussions in other forums (such as those of the World Trade Organization and World Intellectual Property Organization), as well as in national laws for biodiversity regulation.

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Article 8 of the CBD relates to in situ conservation, that each Contracting Party shall, as far as possible and as appropriate: (j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the beneﬁts arising from the utilization of such knowledge, innovations and practices. The protection of biological resources and traditional knowledge represents a number of complex challenges. There is an international context in which many of the CBD parties and various interest groups are seeking to inhibit acts of ‘biopiracy’ by foreign researchers. Due to the biogeographical distribution of much of the world’s biodiversity in the tropics, a group of Like Minded Megadiverse Developing Countries has formed a negotiating group that has been strongly negotiating towards the inhibition of biopiracy. At the same time, many of the same countries are seeking to facilitate or at least to control access to bioresources on which traditional knowledge exists in their countries, with the hope of receiving various beneﬁts to society and their economies. The aforementioned principles relating to access and beneﬁt-sharing (ABS) and free prior informed consent (PIC) all provide some important tools which could also protect and promote traditional knowledge. However, there are also many more complex considerations being made around traditional knowledge. In the CBD, two working groups have been established to resolve some of these issues: the Ad Hoc Open-ended Working Group on Access and Beneﬁt-Sharing and the Ad Hoc Open-ended Working Group on Article 8(j) and Related Provisions (traditional knowledge). Some of the more sensitive issues that have proven complex, and difﬁcult to resolve, relate to the respect of customary protocols of indigenous and traditional local groups, cultural concerns over secret or sacred knowledge with spiritual connections to nature and the protection of the rights of these groups more broadly. Given the breadth of cultural and jurisprudential diversity expressed by these many groups, it may be particularly difﬁcult to develop international laws which can do justice to their concerns. There is, therefore, signiﬁcant scope for innovative national and local initiatives to protect and promote traditional knowledge, complementary to the attempts to regulate biopiracy occurring both in the CBD and by national governments.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights Following the Uruguay Round of Multilateral Trade Negotiations, the World Trade Organization was established in 1995. In the suite of legal texts that form

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the mandate of the WTO, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was included, representing a shift from the ‘goodsonly’ trade agreements of the GATT. With 150 states now members of the WTO, the TRIPS Agreement has considerable implications for the majority of the world. The TRIPS Agreement (Annex 1C of the Agreements Establishing the WTO) deals with a range of intellectual property rights including copyright, trademarks, geographical indications (GIs), patents and plant-variety protection rights. Of particular relevance in this discussion are the patent and PVP rules. One of the main concerns of this book is the proliferation of intellectual property protections on bioresources, particularly plants. While member states of the WTO are allowed some IPR exclusions on plants and animals, there is only a limited ﬂexibility. Under the TRIPS Agreement there is a discreet obligation on members to provide either patent and/or sui generis protection for plant varieties. Beyond these obligations, many member states are now also seeking further clariﬁcation of compatibilities with the CBD.

Patents, Plant-Variety Protection or Sui Generis Systems

Article 27.3(b) indicates that members may exclude from patentability: plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. In other words, members must protect plant varieties either through the use of patent protections or a sui generis (unique) system for their protection. The drafting of Article 27.3(b) in these terms reﬂected some conﬂicting concerns. These included the strong interests of some developed countries towards ensuring that biotechnological innovations could be protected; some differences within this group of countries with regards to the scope of protection; and the concerns of many developing countries about the patentability of life forms (UNCTAD-ICTSD, 2005). While the US has been a strong advocate of plant and other biotechnological patents, the EU and its member states have been more hesitant to provide patent protections, preferring plant-variety protection as enshrined under the International Union for the Protection of New Varieties of Plants (UPOV), until recently. Most developing and least-developed countries had neither system in place until TRIPS came into effect. As a result, many developing countries have sought to comply with this WTO mandate by the year 2000, while least developed countries have until 2013.4 In many cases these countries have ratiﬁed UPOV, or developed national

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laws modelled on it. With this ongoing, internationally led expansion of private property rights in plant varieties, there are a number of concerns. Of the most acute relevance here is the increasing opportunity for foreign researchers to extract, develop and then protect plant and bioresource innovations as exclusive private rights. With the proliferation of national PVP systems there could be increased opportunity for researchers to seek private rights in plantrelated innovations, and thus one might assume that incidences of biopiracy might increase. However, due to the increasing international attention surrounding the issue of biopiracy, appropriate international systems may mitigate bioprospecting activities that are deemed inappropriate and labelled as biopiracy. Other impacts from PVP systems could include the encouragement of genetically uniform monocultures and restrictions on farmers’ rights. Although many countries have quickly developed UPOV-compliant PVP systems, there is some ﬂexibility availed by the wording of Article 27.3(b). In the TRIPS Agreement, there is no further explanation as to what constitutes an ‘effective’ sui generis system, and therefore there is considerable scope for the development of truly unique national systems. Also, TRIPS does not elaborate on the term ‘plant varieties’, and it does not obligate countries to become a member of UPOV or to draft legislation identical to the UPOV Acts (see the following section). It is generally accepted that to be an effective sui generis system, PVP must be afforded as a system of legal rights (e.g. IP rights, or liability rules), which have typically been similar to existing systems like UPOV (Robinson, 2007, 2008b; Leskien and Flitner, 1997). Also, it is generally assumed that the system must accord to principles of national treatment and most-favoured-nation treatment, and must provide some sort of enforcement mechanism (UNCTAD-ICTSD, 2005). Because TRIPS only establishes a series of minimum requirements of protection, countries are not inhibited from developing sui generis systems which may include farmers’ rights provisions, respect for customary rights of local groups, protections of traditional knowledge and rights to accrue beneﬁts when plant genetic resources are accessed. Therefore, the sui generis systems that are developed could in fact be designed so that they are able to prevent or at least limit biopiracy incidents. In countries such as India, for example, a nonUPOV sui generis plant-variety protection law is coupled with a biodiversity law intended to ensure that the conservation, development and innovation on plants and biological resources, whether through modern or traditional means, is able to be protected through both individual and community rights.

The Expanded Review of Article 27.3(b)

The TRIPS Agreement automatically requires a review of Article 27.3(b), which has been ongoing. Because of the Doha ‘Development Agenda’, under Paragraph 19 of the Doha Declaration, this review was expanded to include examination of the relationship between TRIPS and the CBD, and the protection of traditional knowledge and folklore. As a consequence, these discussions have grown signiﬁcantly to engage with the issue of biopiracy.

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Recently, a range of proposals has been made, primarily by developing countries, for patent applications to disclose the country and source of origin from which genetic materials were sourced and traditional knowledge used in an invention, as well as evidence of prior informed consent and evidence of fair and equitable beneﬁt-sharing. These discussions have continued since 2005 and appear to be making some progress. Countries such as the US have consistently argued that a disclosure-of-origin patent requirement would slow down the patent examination process and burden inventors, and that beneﬁt-sharing arrangements should be made on a case-by-case basis through contracts. Other industrialized countries such as those in the EU, Switzerland and Norway have been more open-minded about these amendments to the patent system, but they were concerned about whether it should be amended in TRIPS or in the WIPO Patent Cooperation Treaty, and about technical details regarding penalties for non-compliance with disclosure-of-origin. In a submission to the Trade Negotiations Committee of the WTO in July 2008, a group of developing countries from Africa, Asia and South America, as well as the EU and some non-EU European states, reached a compromise proposal. This group has put forward a Draft Modality Text for mandatory disclosure-of-origin that depicts a considerable breakthrough in the deadlock of negotiations between developing and developed countries (see WTO doc TN/C/W/52, 2008). This could mean an amendment to TRIPS that would help combat patent-related biopiracy, provided that it is passed through the TRIPS Council. These details are discussed at the current state of play in Chapter 6.

The World Intellectual Property Organization Closely related to the discussions in TRIPS are the activities of the World Intellectual Property Organization (WIPO). WIPO, one of the 16 specialized agencies of the United Nations, claims to be dedicated to the promotion and protection of intellectual property works that relate to the expansion of science and technology and the enrichment of the world of arts. WIPO is a driving force for the international harmonization of intellectual property standards. The Patent Law Treaty and the Patent Cooperation Treaty (building upon the Paris Convention for the Protection of Industrial Property) facilitate the harmonization of patent laws internationally, attempt to facilitate and streamline the process of international patent applications, and simplify prior art searches. Although overlooked by many authors and activists, WIPO has played an important role in the politics and debate surrounding IP, traditional knowledge and biodiversity. It is important to highlight the way WIPO has constructed norms in language regarding intellectual property. In fact, it was partly due to the establishment of the Bureaux Internationaux Réunis pour la Protection de la Propiété Intellectuelle (BIRPI) in 1893 – WIPO’s predecessor – that the term ‘intellectual property’ came into regular use in the 1950s. Also, the WIPO rhetoric about IP ‘harmonization’ could be interpreted with some obvious

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irony by developing countries as well, given that the implementation of binding international IP obligations has typically been anything but harmonious. Gradually, developing countries have been convinced to join WIPOadministered treaties through a process of persuasion and advice. WIPO is the wealthiest UN organization, principally because of the fees it collects under its international registration services. Drahos and Braithwaite (2002) note that, in December 1997, WIPO’s total reserve funds amounted to 313,022,413 Swiss francs. They also note that despite concerns about the costs and beneﬁts of joining WIPO, there were attractions for the individual ofﬁcials in the form of funded trips to Geneva and other European locations: Under its development programme WIPO would target selected developing countries for assistance and pay ofﬁcials to attend WIPO meetings … More and more developing country ofﬁcials with generous per diem allowances under their belts found themselves in business class ﬂying to the right hotels to attend meetings of status on the WIPO calendar. (Drahos with Braithwaite, 2002, p111) To some extent, WIPO has been criticized for struggling to maintain its importance as a productive forum for debate on these issues. This is perhaps a product of its narrow and technical legal mandate. Also, although WIPO plays an important administrative role in the regulation of international patent systems, the WTO TRIPS Agreement retains a much stronger mechanism in its Dispute Settlement Body, and thus has had a more forceful or direct inﬂuence on the enforcement of ever-higher IP standards in developing countries. According to Braithwaite and Drahos (2000), the forum shift from WIPO to the WTO was a deliberate and calculated move pursued by key actors over more than a decade, such that it could be linked to the economic leverage given by traderelated factors. As a consequence of these issues, many discussions of importance to both developed and developing countries have been sought in the WTO. Therefore, WIPO has developed the label that it is a ‘talk-shop’. It has been criticized for the massive volumes of text it produces from meetings and reports, without producing substantive outcomes (Anonymous Asian WIPO/WTO delegate, interview, September 2005). WIPO has also been criticized for pushing a ‘maximalist rights culture’ that creates ever more individual rights and continually harmonizes them upwards without sufﬁcient consideration about public and community ramiﬁcations. Along with TRIPS, there is a sense that WIPO has adopted a ‘one-size-ﬁts-all’ approach to intellectual property for the developing world, with ﬂexibilities and retrospective ‘development-friendly’ exceptions always taking a grudging second place to IP harmonization (Boyle, 2004). In the area of genetic resources and traditional knowledge, WIPO has developed a rhetorically important, but fairly slow-moving forum in the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC).

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The Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore The IGC is intended to:

constitute a forum in which discussions could proceed among Member States on the three primary themes which they identiﬁed during consultations: intellectual property issues that arise in the context of (i) access to genetic resources and beneﬁt-sharing; (ii) protection of traditional knowledge, whether or not associated with those resources; and (iii) the protection of expressions of folklore. (WIPO, Traditional Knowledge, Genetic Resources and Folklore, undated) The IGC has provided a useful coordination point for dialogue, fact-ﬁnding missions, national case studies, the dissemination of such information and the articulation of the traditional knowledge issue in a predominantly IP context. It also tends to be the target of a range of criticisms because of its lack of progress on substantive mechanisms for protection from biopiracy in the intellectual property regime (Anonymous Asian WTO/WIPO delegate, interview, September 2005)5 and for providing a distraction point for countries such as the US to deﬂect progress on the disclosure issue in the TRIPS Council. At the WIPO General Assembly in September–October 2005, the mandate of the IGC was extended indeﬁnitely such that it can continue its work on achieving workable solutions to the protection of traditional knowledge. Recent rounds of discussions, as well as the work of the Traditional Knowledge unit of the WIPO Secretariat, have made progress on useful participatory tools such as the Voluntary Fund for Indigenous and Local Communities6 to directly facilitate and support the participation of representatives from these communities in the work of the IGC (ICTSD, 2005b). Responding to the IGC, the WIPO Secretariat has also recently attempted to develop ideas on how to respect customary laws for the protection of traditional knowledge and associated cultural expressions or folklore (WIPO, c.2005). The IGC has been useful for delving into the complex nature of traditional knowledge and developing new understandings and approaches. The secretariat, on the demands of the IGC, has produced a plethora of documents out of its sessions, but there is still some dissatisfaction and a lot of confusion about how traditional knowledge ‘protection’ should in fact be implemented. In IPR terms, ‘protection’ relates to the legal rights to exclude others from the use of the subject of protection. In general terms, however, there is a much broader meaning. Some confusion seems to have also arisen through the use of the terms ‘defensive’ and ‘positive’ protection as perpetuated in WIPO meetings. Most indigenous and local stakeholders concerned about traditional knowledge would assume that a form of IPR protection over traditional knowledge would be contrary to desires and that, in fact, traditional knowledge may need to be protected from IPRs themselves (Gibson, 2004). However, through the

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manipulation of language, the norm has become such that ‘positive’ protection of traditional knowledge occurs through the use of IPRs, property rights and liability regimes, and that ‘defensive’ measures include databases and other forms of protection which limit use of traditional knowledge and associated biological resources. In recent years, progress in the IGC has been fairly slow. At the Thirteenth Session of the IGC in October 2008, the parties consolidated some working documents including ‘draft gap analyses’ on the protection of traditional knowledge and cultural expressions, as well as a set of recommendations for recognition of traditional knowledge within patent examinations. What is perhaps most important to note is that these ongoing discussions on traditional knowledge in WIPO are likely to be restricted due to the underpinning ideologies surrounding exclusive and Western forms of intellectual property protection that endure in the organization. It seems quite paradoxical that the intimate and particular traditional knowledge and customary law systems of diverse peoples across the world might be protected through a body that has been synonymous with ‘one-size-ﬁts-all’ intellectual property harmonization approaches. This is something that is not lost on Antony Taubman (2005), who recently oversaw WIPO’s work on traditional knowledge and has noted the inherent ‘paradox of globalising jurisprudential diversity holistically’.

The International Convention for the Protection of New Varieties of Plants The scope of the International Convention for the Protection of New Varieties of Plants which established the UPOV7 is narrower than some of the conventions and forums discussed. UPOV was developed essentially for the protection of plant-breeders’ rights – a lesser form of monopoly protection than patents, intended for the protection of novel plant varieties. UPOV is important to note because it may be utilized to protect and monopolize the use of plant varieties, which in some speciﬁc cases has been labelled biopiracy. More generally, it is also an important convention because of its potential effects on farmers’ rights and the modernization of agricultural systems through the allocation of plant breeders’ rights. UPOV was developed in Europe at a time when there was still considerable resistance to the implications of patent (monopoly) control over plant varieties and biotechnological innovations. The US, although it has since come to adopt UPOV, has favoured patent protection of plant innovations since the 1930s. In recent years, membership of UPOV has expanded into many developing countries due to the requirements under TRIPS Article 27.3(b), which has already been discussed. This is despite extensive criticism from many academics, NGOs and activists that UPOV is not appropriate for the agricultural systems of developing countries or particularly the UN-deﬁned least-developed countries. The ﬁrst UPOV convention was completed in 1961 (amended in 1972) and then subsequently redrafted into the 1978 Act and then the 1991 Act.

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UPOV was established in Europe as a way of protecting the right of plant breeders to obtain reward for the breeding of new plant varieties. In response to increasing industry pressures, the 1978 UPOV system was updated to keep up with modern breeding and biotechnological techniques. To be eligible for protection under the UPOV system, plant varieties must be homogeneous (in UPOV 1978) or be novel, distinct, stable and uniform (in UPOV 1991) (Dutﬁeld, 2004). This section of the convention is particularly controversial because the homogeneity or uniformity requirements encourage the sale of genetically uniform crops to farmers. The 1991 UPOV text strengthens protection by widening the array of protectable subject matter.8 This is deliberately intended to suit the interests of large-scale breeders. Breeders’ rights are also extended between the versions.9 Furthermore, the 1991 version extends protection from at least 15 years to a minimum of 20 years, increasing the monopoly of the breeder (Leskien and Flitner, 1997; Dhar, 2002). The extension of monopoly has also been criticized by academics and NGOs on the grounds that it will further extend contract periods and farmer debt. The farmer’s exemption (or farmer’s privilege) allows farmers to keep propagating materials for sowing in the following season. The 1991 UPOV text deﬁnes the farmer’s exemption more speciﬁcally than the previous text by allowing a farmer to only use, for propagating purposes on their holding, the product of the harvest which they have obtained by planting, on their holding, the protected variety or essentially derived variety (Robinson, 2007; 2008b). Thus, UPOV limits the scope of farmers who have used protected materials and wish to save, exchange or sell their seeds to other farmers. This portion of the UPOV convention is particularly contentious for developing countries which have signiﬁcant populations of farmers who still save, exchange and sell their seeds. Therefore, many countries in this situation have preferred to adopt the 1978 version or their own national version in order to retain these farmers’ rights.10 As a consequence of TRIPS, recent versions of UPOV have been pushed on developing countries through bilateral trade negotiations, through ‘technical assistance’ and other political pressures. This is despite UPOV’s inappropriateness for small-scale farmers and breeders, the possibility that it will encourage monocultures and loss of small holder food sovereignty. Importantly, UPOV may also allow exclusive protections over plant varieties derived from farmers’ varieties and which utilize traditional agricultural knowledge – thus contributing to biopiracy concerns.

The International Treaty on Plant Genetic Resources for Food and Agriculture The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) was completed in 2001 and came into force only recently, in 2004, following its ratiﬁcation by 40 governments. The international treaty was developed to achieve what the IUPGR had failed to do – to establish a transparent

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framework for regulating plant genetic resources (for food and agriculture). Due to the numerous international agreements already discussed, the scope of the ITPGRFA, while retaining details on farmers’ rights, was changed to focus more heavily on the regulation of plant genetic resource transfers and beneﬁt-sharing. The ITPGRFA is administered by the Commission on Genetic Resources for Food and Agriculture of the FAO. In terms of its ratiﬁcation, many countries seem to have adopted a ‘wait and see’ attitude while the parties to the ITPGRFA resolve issues of implementation. The ITPGRFA is relevant to agricultural plant-based biopiracy because it seeks to globally administer the exchange of crop germplasm. The ITPGRFA has a number of notable features including the creation of a ‘Multilateral System’ of access and beneﬁt-sharing over a range of listed plant genetic resources for food and agricultural purposes. Parties which ratify the international treaty are opening up their agricultural plant genetic resources to access via a standard material transfer agreement (MTA) (Article 12.4, ITPGRFA). The Multilateral System also covers the ex situ collections in the gene-banks of the International Agricultural Research Centres of the CGIAR. The Standard MTA was adopted in June 2006 at the ﬁrst session of the ITPGRFA governing body. The Standard MTA establishes a contract between the provider and recipient of plant genetic resource products for food and agriculture incorporating materials or any of its genetic parts or components that are ready for commercialization (Article 2, Standard MTA). This excludes commodities and other products used for food, feed and processing (Robinson, 2007). Relating to the provision of materials, the provider should submit all available passport (transfer) data and descriptive information about the materials (Article 5, Standard MTA). Access to these materials protected by intellectual property rights must be consistent with international and national laws. During the period of plant genetic resource development, including material being developed by farmers, access is at the discretion of its developer. The recipient must use the materials only for the purposes of research, breeding and training for food and agriculture, and must not claim IPRs that may limit the facilitated access to the materials or their components (Article 6, Standard MTA). This article is an attempt to limit biopiracy involving the exclusion of plant usage by others. In cases where a recipient commercializes a product based on these materials they must pay 1.1 per cent of the sales of the product, less 30 per cent to be paid to the Trust Account of the Governing Body (Annex 2, Standard MTA) (Robinson, 2007). The Multilateral System coordinates beneﬁt-sharing (Article 13, ITPGRFA) through a range of mechanisms: exchange of information; access to and transfer of technology; capacity building; and the sharing of monetary and other beneﬁts arising from commercialization. This is administered under the guidance of a governing body composed of all contracting parties (Article 19, ITPGRFA), which has a rolling Global Plan of Action (Article 14, ITPGRFA). Beneﬁt-sharing arrangements are still being established, with the intention of ensuring equity between those that provide plant genetic resources and those that utilize them.

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Article 17 of the ITPGRFA also calls on parties to collaborate with each other to develop a global information system on plant genetic resources for food and agriculture to complement those systems already existing in the International Agricultural Research Centres. This should help develop an improved understanding of the distribution of both in situ and ex situ plant genetic resources. The ITPGRFA also recognizes farmers’ rights and encourages parties to take measures that protect and promote them (Article 9, ITPGRFA). These include: protection of traditional knowledge relevant to plant genetic resources for food and agriculture; the right to equitably participate in sharing beneﬁts arising from the utilization of plant genetic resources; the right to participate in decision-making at the national level; and the right to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate. The inclusion of these components illustrates an increasing international concern and recognition for the rights of indigenous groups and local farmers who maintain, use, develop and conserve an extensive amount of plant genetic diversity. However, despite these notable provisions in the ITPGRFA for the protection of agricultural traditional knowledge and farmers’ rights, the implementation of these provisions is vague and largely open to national interpretation. There is also concern about the triggering of beneﬁt-sharing provisions associated with the new Standard MTA. Although intellectual property rights cannot be claimed on the transferred resource ‘in the form received’, the claiming of intellectual property rights over the subsequent products and derivatives is more open, causing some concerns to providers (ICTSD, 2006a). Therefore, countries have been delaying signature and ratiﬁcation of the ITPGRFA until the ramiﬁcations are clearer and there are deﬁnitive examples of its potential beneﬁts and costs. Because the ITPGRFA has only recently come into force, and due to its still limited membership (55 ratiﬁed parties listed as of May 2009), its full impacts remain uncertain (Gerstetter et al., 2007, p259). Despite its entry into force in 2004, few publications have been released discussing the impacts of the treaty on the national regulation of plant genetic resources. However, there are some national experiences of note. The Peruvian government has signed and ratiﬁed the ITPGRFA, despite some misgivings about the ultimate national and local impacts. The National Institute for Natural Resources has noted several difﬁculties associated with the implementation of the treaty (Correa, 2003, pp804–5): • • • • •

deﬁning mechanisms for beneﬁt-sharing under the treaty’s provisions; giving practical effect to the provisions on farmers’ rights; establishing mechanisms to ensure that the recipient of materials under the Multilateral System complies with MTA conditions; strengthening the capacity of the competent national authorities to implement the treaty; deﬁning the relationship between the treaty and other agreements adopted in the FAO framework.

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Correa (2003, p804) also notes that Peruvian government officials had questioned the list of crops subject to the Multilateral System – particularly in relation to the inclusion of potatoes in the list of Annex 1 of the treaty. This suggests there is some concern about the unfair use of materials under the Multilateral System and non-compliance with MTA conditions. Some countries have hesitated and delayed ratiﬁcation of the ITPGRFA. For example, in Thailand there has been considerable hesitation about the impacts of the treaty (Vanakorod, interview, 2005; Sungkabuan, interview, 2006). In 2004 a research team of legal experts, academics and government ofﬁcials investigated the potential impacts of the ITPGRFA for Thailand (Kuanpoth et al., 2004). Their ﬁndings indicate that the ITPGRFA may inadvertently encourage the commoditization of biodiversity and traditional knowledge and encourage the international transfer of germplasm without adequate consultation of local custodian communities. The experts outlined negative and positive aspects of the ITPGRFA for Thailand which are detailed below in Box 2.1.

BOX 2.1 REVIEW OF THE POTENTIAL IMPACTS OF THE ITPGRFA FOR THAILAND Negative Aspects •

•

•

There must be a revision of Thai laws governing access and beneﬁt-sharing of plant genetic resources under control of the government and in the public domain for those plant genetic resources covered by Annex 1 of the ITPGRFA. The Treaty may [contribute to an outward ﬂow of plant genetic resources and traditional knowledge] if foreign entities obtain exclusive rights over their use, such as intellectual property rights. [Implementation of the Treaty may also alter customs surrounding] traditional use and farmer exchange of plant genetic resources. The membership of the International Treaty is a reduction of Thai sovereignty since Thailand needs to apply the management of her ex situ collection under the conditions set forth by the International Treaty, especially the use of the Multilateral System instead of the Thai Plant-variety Protection Act B.E. 2542 (1999).

Positive Aspects • •

Thailand will receive beneﬁts arising from the utilization of its genetic resources kept with the International Agricultural Research Centres. The country may have wider opportunity to obtain plant genetic resources in the public domain and under control of other member states.

Source: Edited translation from Kuanpoth et al. (2004).

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The treaty attempts to formalize the transfer of agricultural plant genetic resources, thus potentially inhibiting biopiracy incidents and ensuring more transparent administration of the IARC gene-banks. Nevertheless, many developing countries are likely to remain hesitant due to the facilitation of access to domestic plant genetic resources through the Multilateral System and Standard MTA.

Human Rights and Traditional Knowledge A number of authors have highlighted the potential human-rights implications of intellectual property rights vis-à-vis biodiversity and traditional knowledge (Cullet, 2005; Coombe, 1999; Daes, 2003; Haugen, 2005; Posey and Dutﬁeld, 1996; Craig, 2004). These authors recognize that there are various indigenous and local peoples and groups who have suffered from deprived selfdetermination; political exclusion or oppression; poverty; persecution; lack of legal and civil rights; and limitations or pressures on the practice of minority culture or language and the pursuit of subsistence and economic activities among others – all which have potential impacts on the maintenance of traditional knowledge, practices, culture and identity. Providing and respecting the basic rights of marginalized groups will help enable them to shape their own futures, including the protection of their own knowledge. Predominantly as a result of human rights forums, there is a wealth of relevant legally binding and non-legally binding instruments to be found. Certain aspects of these have relevance and may impact upon the protection and promotion of traditional knowledge and associated local practices. The four main legally binding instruments consist of the UN International Covenant on Civil and Political Rights 1976; UN International Covenant on Economic, Social and Cultural Rights 1976; the International Labour Organization Convention 169 Concerning Indigenous and Tribal Peoples in Independent Countries (ILO 169) 1989; and the CBD 1992, which has already been discussed. Of the non-legally binding agreements it is worth mentioning the recently adopted UN Declaration on the Rights of Indigenous Peoples 2007; the UN Draft Declaration of Principles on Human Rights and the Environment 1994; FAO Leipzig Declaration (many matters from which are now being addressed under the ITPGRFA); and the UNDP Consultation on Indigenous Peoples’ Knowledge and Intellectual Property Rights. There are also a range of other important non-legally binding agreements or pacts made outside the UN framework of international law, in which indigenous and local peoples were some of the main contributors. These include the Kari-Oca Declaration and the Indigenous Peoples’ Earth Charter (1992); the Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples (1993); the Covenant on Intellectual, Cultural and Scientiﬁc Resources (for full details of these see Posey and Dutﬁeld, 1996); and the Thammasat Resolution (1997). These agreements have all made important statements and demands for the protection of indigenous rights and traditional knowledge.

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The laws, agreements and declarations provide various binding and nonbinding principles and mechanisms for the assertion of the rights of indigenous, minority and local groups. In the context of traditional knowledge, there may be many cases in which oppressive forces, whether state, industry or otherwise, inhibit the ability to continue traditional practices or cause affront to the traditions and customs of these groups. Therefore, these sorts of rightsbased approaches may provide important emancipatory or empowering effects where indigenous, minority and local groups seek them, and where states and external authorities allow them. With respect to various forms of selfdetermination, a key challenge rests with the open-mindedness and resolve of national governments as well as the struggles of indigenous and local peoples. A policy niche also exists for the development of means for the recognition of the collective rights of minority groups (whose identity may not strictly be seen as indigenous) who may wish to be identiﬁed as distinct ‘communities’, as is noted in regional and national laws, for example the African Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources. Additionally, these laws may help persuade the gradual societal recognition of customary norms, protocols and laws that have been developed over long periods of time by indigenous and local communities.

Bilateral and Regional Trends In the lead up to the TRIPS Agreement, the US (and to a lesser extent the EU) successfully used bilateral coercive tactics on developing countries to make them raise intellectual property standards and improve enforcement. In the post-TRIPS era, the US and EU have been the predominant litigators in the WTO Dispute Settlement Body pursuing IPR infringements. The US and EU have also continued to seek raised standards outside of the WTO through further bilateral actions. Although the US government still uses its Special 301 Report and Generalized System of Preference as coercive measures, the latest tactic of both the US and the EU has been to bilaterally or regionally raise intellectual property standards that they have had difﬁculty securing in WTO negotiations. They have pursued these ‘TRIPS-plus’ actions using bilateral and regional free-trade agreements (FTAs), or in the parlance of the EU, economic partnership agreements (EPAs). Drahos (2001 and 2004) refers to this as the ‘bilateral ratchet effect’ in which IPR standards are being incrementally raised through various negotiations, particularly with developing countries who may be persuaded by trade deals touting the beneﬁts of greater market access. Although other countries such as Australia, Canada and China have also sought bilateral trade deals, intellectual property standards have not been pursued with nearly as much zeal as by the US and, recently, the EU. By 2009, the US had ﬁnalized 14 bilateral FTAs, several regional FTAs and is in the process of negotiating several more FTAs that include intellectual property standards, many of which are TRIPS-plus. The US also has another 40 bilateral investment treaties (BITs) that often contain IPR provisions.

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The EU also has dozens of bilateral and regional trade agreements. Notably they have adopted a recent strategy towards TRIPS-plus demands in their trade negotiations, particularly those involving African, Caribbean and Paciﬁc trading groups. To date, the EU has secured an EPA with the CARIFORUM (Caribbean) negotiating group, including some TRIPS-plus intellectual property provisions. Interim EPAs have been signed with countries in the negotiating groups of Central Africa, East Africa, Eastern and Southern Africa, the Paciﬁc, South African Development Community and West Africa. The impacts of these TRIPS-plus demands on the issue of biopiracy are not entirely clear. However, developing countries are regularly being required to give up the little implementation ﬂexibility that still exists in TRIPS. Speciﬁcally, there have been consistent demands from the US (and also recently from the EU) for extension of patent terms beyond 20 years (in cases where there have been administrative delays) and requirements for the protection of plants through either patents or ratiﬁcation of the UPOV 1991 Convention. Thus, sui generis laws that contain defensive protections for biological resources and patent exceptions are being undermined by these bilateral and regional agreements. This could inhibit the ability of countries to protect their resources and knowledge on their own terms through the gradual ‘harmonization’ (i.e. homogenization) of national laws. A number of bilateral and regional agreements or negotiating documents have also included components on biological diversity. For example, the US and Peru ﬁnalized an FTA in April 2006 that includes a ‘Biodiversity-TK [Traditional Knowledge] Understanding’. This understanding or ‘side-letter’ recognizes a number of key issues such as the need to obtain prior informed consent when accessing genetic resources, to establish beneﬁt-sharing arrangements and to promote quality patent examination (essentially to avoid erroneous patents and biopiracy).11 The understanding indicates a preference for contractual arrangements between users and providers, which is likely to have been pushed by the US. Despite the inclusion of this attachment to the US-Peru FTA, a number of commentators have questioned the legal standing of the document (ICTSD, 2006b). The EU EPAs with African, Caribbean and Paciﬁc groups have also ﬂagged the need to protect biological resources and traditional knowledge. However, the EU has so far made no strong commitments towards their protection. The EU-CARIFORUM agreement that was recently ﬁnalized only had weak language and commitments on the protection of biological resources and traditional knowledge, which would have been in the public policy interests of Caribbean countries (CIEL, 2008). Instead, the EU pressured for and achieved UPOV 1991 protection and patent term extensions in the agreement. Thus, the EU seems more interested in pursuing ever-higher standards of intellectual property protection, rather than assisting with the protection and promotion of biodiversity and traditional knowledge.

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Following Current Developments – Research Sources Developments in relation to intellectual property and biodiversity may occur at the regular meetings of various international forums such as the CBD, WIPO and others discussed in the previous sections. Meeting documents are often accessible to the public, but the texts can be voluminous; in other cases such documents are conﬁdential (such as many of the WTO TRIPS Council materials and details of free trade agreement negotiations). However, a number of organizations with observer status in these forums produce regular reports on the ongoing negotiations. The monitoring of multilateral negotiations, often in Geneva, is reported in the Bridges news digests and reviews produced by the International Centre for Trade and Sustainable Development (ICTSD). It has also produced documents monitoring bilateral and regional negotiations such as the Trade Negotiations Insights series. IP-Watch is another excellent source of high-frequency reporting on IP-related negotiations in organizations like the WTO and WIPO. Both of these organizations typically focus on the development implications of the negotiations on IP and related trade topics. The ETC Group provides exposé-style pieces detailing speciﬁc biopiracy cases and has also formally challenged a number of patents. Genetic Resources Action International (GRAIN), an NGO, also examines biopiracy cases and provides a repository of laws and agreements developed by different countries and regions from around the world. Organizations such as the South Centre (an intergovernmental organization), Oxfam and the Centre for International Environmental Law also regularly have studies and commentaries on the negotiations in multilateral forums, as well as bilateral or regional negotiations. These often go beyond the journalistic news reporting of the above-mentioned organizations, providing more detailed and in-depth studies. On trade negotiations, the NGO Bilaterals monitors the ongoing developments in numerous FTAs and EPAs. It regularly provides access to negotiating texts, in many cases leaked by negotiators or government ofﬁcials. Related news stories are also reported on its website, which can give insights into negotiating processes and local concerns about the FTAs. There are also ofﬁcial country sources for viewing FTA documents including the US Trade Representative and the European Union External Trade websites. Additionally, to investigate the details and status of a patent, most countries have readily accessible patent database searches. The main country ofﬁces of interest include the US Patent and Trademark Ofﬁce, the European Patent Ofﬁce, the Japan Patent Ofﬁce and the WIPO Intellectual Property Digital Library databases. These websites have been categorized into ofﬁcial government sources and non-government sources in Boxes 2.2 and 2.3 respectively.

Notes 1

Shiva (1991), for example, depicts the ‘violence of the Green Revolution’ in changing plant ownership, creating genetic uniformity in agricultural landscapes, and the

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BOX 2.2 OFFICIAL AND GOVERNMENT INFORMATION SOURCES Secretariats WTO – TRIPS, TK and Biodiversity: www.wto.org CBD: www.cbd.int ITPGRFA: www.fao.org/Ag/cgrfa/itpgr.htm UPOV: www.upov.int WIPO TK pages: www.wipo.int/tk

Intergovernmental South Centre: www.southcentre.org

Bilateral and Regional Trade Agreements US Trade Representative: ww.ustr.gov EU External Trade Relations: http://ec.europa.eu/trade/issues/bilateral

Patent Ofﬁces US Patent and Trademark Ofﬁce: www.uspto.gov European Patent Ofﬁce (EPO): www.epo.org Japan Patent Ofﬁce (JPO): www.jpo.go.jp WIPO Intellectual Property Digital Library: www.wipo.int/ipdl

BOX 2.3 NON-GOVERNMENT NEWS SOURCES AND ANALYSIS ICTSD Bridges: www.ictsd.net IP-Watch: http://ip-watch.org ETC Group: www.etcgroup.org GRAIN: www.grain.org Bilaterals: www.bilaterals.org CIEL: www.ciel.org

2

trap of contract farming with ‘high-yielding’ varieties – all of which have meant a conquest of nature and society. The major sponsors were/are the FAO, the World Bank, the Rockefeller and Ford Foundations, the United Nations Development Programme, the United Nations Environment Programme and the aid programmes of the EU and a number of individual countries.

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3 Whatmore (2002) discusses, for example, the ‘inventiveness of the life sciences to complicate the distinctions between human and non-human; social and material; subjects and objects to which we are accustomed’. 4 The implementation of the TRIPS Agreement was extended for Least Developed Countries by 7.5 years as of 2006. See IP-Watch (November 2005): ‘LDCs Agree to shorter Extension for TRIPS Implementation,’ www.ip-watch.org/weblog/index. php?p=157. 5 It has, however, made an amendment to the WIPO Patent Cooperation Treaty (PCT) such that PCT patent applications, while undergoing the examination process, must cross-check with prior art databases including journals on traditional knowledge. 6 But note that this is only a voluntary fund and relies upon state donations to support attendance of indigenous and local representatives. 7 The acronym comes from the French name ‘L’Union Internationale pour la Protection des Obtentions Végétales’. 8 The protection covers not only the propagating material of the protected variety, but also (unlike the 1978 Convention) the harvested material (including entire plants and parts of plants), the products made directly from harvested material of the protected variety and essentially derived varieties. The concept allows the protection of cosmetic modiﬁcations on already protected varieties, subject to permission from the breeder of the ‘initial variety’. Ramanna and Smale (2004) suggest that Indian NGOs have implied that within essentially derived variety provisions under their PVP law, the parent genetic material contributed by rural and tribal peoples could be included in the deﬁnition of ‘initial variety’. However, the protection of general domestic or farmers’ varieties from freeriding is not UPOV’s intention. 9 Under UPOV 1978, the scope of protection of the breeder’s right is for ‘the production for purposes of commercial marketing; the offering for sale; and the marketing of the reproductive or vegetative propagating material, as such, of the variety’. Under pressure from plant breeders the 1991 version extends the scope of the breeders’ rights by increasing the number of acts for which prior authorization of the breeder is required, including ‘production or reproduction; conditioning for the purpose of propagation; offering for sale; selling or other marketing; exporting; importing; stocking for the above purposes’. This goes beyond just reproductive or vegetative propagating matter, but also encompasses harvested material obtained through the use of propagating material and essentially derived varieties (Dutﬁeld, 2004). 10 One particularly useful thing that UPOV 1991 provides is a deﬁnition of ‘plant variety’: ‘Plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a breeders’ right are fully met, can be: • Deﬁned by the expression of the characteristics resulting from a given genotype or combination of genotypes, • Distinguished from any other plant grouping by the expression of at least one of the said characteristics, and • Considered as a unit with regard to its suitability for being propagated unchanged.’ Thus, it is a grouping below subspecies that may have distinct and useful characteristics. 11 The text is available at: www.ustr.gov/Trade_Agreements/Bilateral/Peru_TPA/ Final_Texts/Section_Index.html, accessed 4 February 2009.

3

Patent-Related Biopiracy Cases

Cases of biopiracy are most commonly associated with the grant of a patent over some product or derivative from biological resources and/or traditional knowledge. This chapter deals with these most typical cases of biopiracy, while the following chapter raises questions about the need to also recognize and address ‘non-patent biopiracy’ incidents. Incidents of biopiracy and misappropriation internationally have been poorly reported on the whole. Media reports and NGO articles are often piecemeal and at times ‘strategically vague’ (Dutﬁeld, 2006). Due to this, the validity of the biopiracy discourse has been marginalized by authors keen to downplay the incidents (Chen, 2006). Through case studies, this chapter acknowledges a number of controversies, attempts to ﬁne-tune our understanding of biopiracy and what it can conceivably entail, and indicates what the implications are for the different groups involved. The cases chosen in this chapter have been reported as biopiracy by NGOs, academics, local communities and government ofﬁcials. This case-study analysis should advance the international debate. Subsequently, this should also provide an indication of how prevalent and severe these cases really are. Initially, it is important to recognize the key criterion for obtaining a patent, as well as some of the general characteristics of patents and patent law. There are three broadly recognized criteria for obtaining a patent. As indicated in the TRIPS Agreement (Article 27.1), ‘patents shall be available for any inventions, whether products or processes, in all ﬁelds of technology provided that they are’: New (i.e. not already in the public domain or the subject of a previous patent); Involve an inventive step (i.e. it is not common sense to any accomplished practitioner in the ﬁeld when asked to solve a particular practical problem, it should not be a self-evident solution using available skills or technologies); Are capable of an industrial application (i.e. that it has a stated function and is useful and could immediately be manufactured to fulﬁl this function).

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In other national patent laws, the criterion for a ‘new’ characteristic is also often called ‘novelty’, which must not exist in the body of existing knowledge or ‘prior art’ in the relevant ﬁeld. The ‘inventive step’ requirement is often described as a criterion of ‘non-obviousness’ (WIPO, Protecting your Inventions Abroad, undated). In situations that have been depicted as biopiracy, the complainants have often highlighted the lack of real novelty – frequently due to existing art in the form of traditional knowledge or documented prior use. One major problem faced here is that, in practice, countries such as the US use a standard of national novelty which restricts the ﬁeld of prior art to US patents and documented innovations in the examination process. In other cases, the biopiracy campaigners have highlighted the lack of an inventive step in some patented innovations, arguing that inventors have been granted a monopoly over something that was already obvious to those in the relevant ﬁeld, but which is often not recognized because it is from a foreign country. The issue here is also the privileging of scientiﬁc or technical knowledge over ‘traditional’ knowledge, the importance of which has often been ignored or played down in the patent application and examination process. In addition to these main patent criteria, the subject matter of the invention must be ‘patentable’ under law. In many countries for example, plant or animal varieties cannot be patented, nor can naturally occurring substances and mathematical, scientiﬁc or medical methods. Some countries also exclude inventions subject to health, public order or morality exceptions, which are allowed under TRIPS (Article 27.2). These exceptions may be employed in national jurisdictions; for example, many African countries could employ morality exclusions on the patentability of biological products due to the strong moral and cultural concerns that have been expressed by their governments. Each country will have their own varying rules regarding patentability depending upon national interests and international obligations. So, despite the TRIPS Agreement and a number of WIPO treaties on intellectual property, there is technically no such thing as a ‘worldwide patent’. However, the WIPO Patent Cooperation Treaty streamlines this process by allowing an international application to be made, which is then scrutinized by an International Searching Authority, placed on International Publication and examined by an International Preliminary Examining Authority, before being sent to the designated national patent ofﬁces. The national patent ofﬁces then make their own ﬁnal decisions on whether to grant the patent, based on their own laws (WIPO, Protecting your Inventions Abroad, undated). Thus, many of the biopiracy concerns and complaints that we have seen to date have come from countries where the patenting of plant and animal varieties is not allowed and in many cases is seen as immoral. These concerns are usually about patents granted in other countries, usually the US, but also from countries such as Japan, Australia, Canada and from the European Patent Ofﬁce. Beyond moral complaints are concerns about fairness and equity, a desire to receive compensation on the basis of traditional knowledge and biodiversity custodianship, and national economic interests which have led to complaints of biopiracy. The following cases explore the issues involved in various

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bioprospecting incidents and surrounding a number of patents, to help develop better understandings and ﬁnd appropriate solutions.

Basmati Rice India has a long history of domestication and breeding of rice. Archaeological evidence indicates that rice has been cultivated in India from between 1500 and 1000 BC (Rai, 2002), while other sources indicate that rice may have been cultivated for up to 8000 years in the region (Singh, 2000). This history has also been documented in ancient texts (e.g. the Atharva-Veda, c.1500 BC) and passed on through folklore. More speciﬁcally, basmati rice cultivars have been grown in South Asia, across India, in Pakistan and also in Bangladesh, probably for centuries, during which time they have been improved by local farmers through seed selection and conventional breeding practices. One of the earliest mentions of basmati is in the epic Heer Ranjha, composed in 1766. The most widely used rice variety – basmati 370 – was selected from local collections and released for commercial cultivation in 1933 at the Rice Research Station Kalashah Kaku (now Pakistan) (Singh, 2000). India now grows approximately 650,000 tonnes of basmati annually, much of it exported throughout Asia and to Europe and the US (Shiva, 2001). The basmati rice controversy emerged in the late 1990s in response to a US patent. Speciﬁcally, the US Patent and Trademark Ofﬁce (USPTO) granted patent number 5,663,484 on ‘Basmati rice lines and grains’ to the Texas-based company RiceTec Inc. on 2 September 1997. Originally, the patent had 20 claims on the protected subject matter covering the novel basmati varieties that the researchers claimed to have developed. This caused signiﬁcant alarm and outrage among Indian farmers and NGOs. At the time, many interpreted the patent to mean an outright monopoly on basmati and thus restrictions on export to the US where the patent had been approved. As Ghosh (2003–4, p101) notes, RiceTec’s claims were for a speciﬁc rice plant (Claims 1–11, 14), for seeds that germinate the patented rice plant (Claim 12), for the grain that is produced by the rice plant (Claims 13, 15–17) and for the method of selecting plants for breeding and propagating particular grains of rice (Claims 18–20). The overly broad wording and scope of the patent can be blamed for much of the public outrage. Shortly after the patent was granted, Indian NGOs began a campaign against it, also garnering support from the Indian government and drawing international attention to the patent. A re-examination application was ﬁled by an organization named the Agricultural and Processed Food Products Export Development Authority in India, with government support (Ghosh, 2003–4). Subsequently, RiceTec agreed to withdraw some claims and, under a re-examination certiﬁcate (4525, 29 January 2002), these were formally retracted. Claims 1–7, 10 and 14–20 were cancelled and descriptions of the rice were altered in the certiﬁcate. However, Claims 8, 9 and 11 for speciﬁc novel rice lines were maintained.

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This has been hailed as a signiﬁcant victory against biopiracy by those NGOs and campaigners involved. However, there has been some remaining concern about the claims that were not withdrawn. Analysis of the description of the patent document indicates that Claims 8, 9 and 11 refer to crossed rice lines (varieties) to develop plant varieties that exhibit some similar characteristics to basmati rice grains. Under US patent law, novel plant varieties are eligible for protection – most countries in the world do not allow plant patents.1 South Asian activists are particularly frustrated by this because it appears that the germplasm used to cross the varieties was originally obtained from the region. The patent description for the breeding of BAS-867 and RT1117 rice lines indicates that: Twenty-two basmati lines from the USDA [United States Department of Agriculture] World Germplasm Collection, Beltsville, Md. and thirteen semi-dwarf, long-grain lines were selected for the initial crosses … The basmati seeds from the USDA were identiﬁed as having come from Pakistan. (USPTO Patent Number 5,663,484) Activists such as Vandana Shiva (2001) have continued to argue that a simple crossbreed such as this is obvious to someone trained in plant breeding (i.e. that it fails to achieve an inventive step) and that it is also not novel (new) because it free rides on the existing prior art in the basmati rice’s qualities. However, the US standards of novelty and obviousness failed to recognize the contributions of Indian farmers as applied by the USPTO. US Patent Law S102 outlines the conditions for patentability, novelty and loss of right to patent: A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the application for patent in the United States. As some author’s have noted (Kadidal, 1998, p29; Chen, 2006, p32), US patent law does not recognize ‘foreign’ prior art unless it is clearly documented and accessible. The geographical limitation on novelty is problematic in many biopiracy cases involving US patents, particularly with regards to public knowledge or the use of inventions in foreign countries which in many cases is orally transmitted rather than published or patented (Bagley, 2002–3, p680). Basmati is not patented in India because foods and medicines are excepted from patentability (but methods and processes are allowed: Indian Patent Law, 1970 as amended, S5[1][a]). However, arguably there are plenty of examples of documents describing the qualities and breeding characteristics of basmati rice.

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Most of these have been published since the 1960s when the Indian Agricultural Research Institute, under the directorship of Dr M.S. Swaminathan, initiated a systematic basmati varietal improvement programme (Singh, 2000). Further documentation of the traits of basmati has been made by International Rice Research Institute (IRRI) researchers, who have been trying to develop highyielding varieties of basmati since the 1970s (Khush et al., 2001, p123). Many of these publications have documented the breeding and characteristics of basmati rice in accessible international journals prior to the date of application of the patent (see for example Khush, 1987, p213; Buttery and Ling, 1982; Buttery et al., 1986; Vairavan et al., 1973; Vijaya Kumar and Virmani, 1992). Therefore, even according to the US’s national novelty standards, the patent should not have been granted based on the majority if not all of the claims made. Additional concern and confusion was borne out of attempts by the same company, RiceTec Inc., to trademark the name ‘Basmati’ or some similar variation of the term. Indeed the NGO and media focus on the patents may have actually distracted many stakeholders from also dealing with the trademarks – this is discussed further in the next chapter.2

Key Issues • • • •

Germplasm has been transferred to foreign gene-banks where it may be developed and improved by researchers to then compete with the original South Asian germplasm donors. US patent law allows patents on ‘novel’ plant varieties, whereas most countries in the world do not allow this. US patent law does not recognize foreign prior art unless it is patented or documented in an accessible publication. Many cultures around the world ﬁnd plant patents to be immoral for cultural as well as economic reasons (e.g. see African Group, 2003).

Hawai’ian Taro In the 1990s, a team of University of Hawai’i researchers developed three new hybridized varieties of taro that were resistant to fungal leaf blight – a major pest affecting the plant in Hawai’i. The new variety was developed by using conventional crossbreeding to cross a variety of Hawai’ian taro (named Maui Lehua) with taro from the island of Palau that is known to be resistant to the leaf blight. In 2002, Eduardo Trujillo, a researcher at the University of Hawai’i, obtained plant patents on three new hybridized varieties (Schlais, 2007, pp597–8). The taro plants were named ‘Pa’lehua’, ‘Pauakea’ and ‘Pa’akala’ under plant patent numbers PP12,361, PP12,342 and PP12,772 respectively. The patent claims for each plant are quite similar; the claim for Pa’lehua is as follows:

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A new and distinct variety of taro plant … that is characterized by resistance to taro leaf blight caused by Phytophthora colocasiae, tolerance to root rot caused by Phythium spp., vigorous growth, large mother corm size, and purple corm of very good poi and eating qualities. (US Patent PP12,361, Granted 2002) It is common practice in the US patent system to receive a patent for crossbred varieties that exhibit new qualities, such as in this case. However, in June 2006 a group of indigenous Hawai’ians and activists began to pressure the University of Hawai’i to revoke the patents. This included the submission of a letter claiming that the patented varieties were not sufﬁciently different from other taro varieties and were ‘invalidated by considerations of prior art’ (Schlais, 2007, p599).3 Thus, the protestors were targeting the novelty criterion of the patent, and suggesting that a crossbreed with another variety is obvious to someone knowledgeable in plant breeding. Additionally, local NGOs and protestors complained about the collection of royalties that would ensue if farmers were contracted to use the taro varieties. Taro (or kalo as it is known locally) is also considered a sacred ancestor of the indigenous Hawai’ian people and, as protests continued, the issues surrounding the patents came to focus on the sacredness of kalo. According to Sarah Sullivan of Hawaii Seed, ‘culturally signiﬁcant plants such as taro should not be owned’, while activist Walter Ritte Jr argued that ‘you can’t change our ancestors without our permission’ (ICTSD, 2006c). According to the epic Kumulipo, the main genealogical creation chant of the indigenous Hawai’ians, the intricate creation of all things began with the emergence of creatures from the sea, to insects, land plants, animals and, ﬁnally, human beings. The Kumulipo describes how: The gods Wakea, sky father, and Hoohokukalani, star mother, gave birth to Haloa, the ﬁrst born. Haloa was stillborn and placed in the earth outside the front door. Haloa grew into kalo, the ﬁrst taro plant. The second born of Wakea and Hoohokukalani was man, whose kuleana (responsibility) was to care for Haloa, the elder brother. Haloa, the kalo, became the staple food crop for the Hawaiian people. (Ritte and Kanehe, 2007, p131; cited by Schlais, 2007, p601). In relation to patents, monopoly rights extend to all specimens/products of the patented invention. So, in this case the patents covered all crossbred leaf blight resistant taro plants. In spiritual terms, for the indigenous Hawai’ian people this means that the patent provides private monopoly protection over their ancestors. The fact that the variety has been altered is (debatably) signiﬁcant for the criterion of invention required in a US patent. However, in the cultural embodiment context of the Hawai’ian people, it can be assumed that, altered or not, it would be highly offensive for others to hold a form of private monopoly ownership over their ancestors.

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This brings an important and relatively under reported dimension into the biopiracy debate. The cultural embodiment and personiﬁcation of plants has been largely ignored by the deniers of biopiracy and also by many legal or economic analysts. Obviously, not all plants will have the same degree of cultural signiﬁcance among indigenous or local groups, but there are often complex culturally or spiritually informed sentiments about ownership and genetic modiﬁcation of plants and animals (Posey, 1999). The continued modiﬁcation, patenting and private monopolization of culturally signiﬁcant plants is yet another offence in a long history of conquests and abuses of indigenous people. After considerable pressure, the University of Hawai’i offered to transfer the patents to an appropriate Hawai’ian entity as custodian of the patents. However Walter Ritte Jr and others objected, stating their consistent belief that no person or entity should hold patents on taro (Schlais, 2007, p600). Finally, in recognition of its cultural signiﬁcance to indigenous Hawai’ians, the University of Hawai’i abandoned its taro patents, ﬁling ‘Terminal Disclaimers’ with the USPTO in June 2006, and ending this biopiracy episode.

Key Issues • •

•

The taro plant is culturally signiﬁcant to the indigenous Hawai’ian people, representing an ancestor in key spiritual chants of their folklore. Some people have questioned whether the patents were sufﬁciently novel to warrant a patent. Similar questions could have been raised about the obviousness of the crossbred plant varieties to someone trained in plant breeding. Economic concerns about the collection of royalties from poor farmers were also raised.

Yellow Enola Beans In 1999, US patent number 5,894,079 was granted to Larry Proctor, the president of a US seed company named POD-NERS, for an ‘invention’ relating to ‘a new ﬁeld bean variety’. The patent claims cover a speciﬁc yellow-coloured bean seed (Phaseolus vulgaris), plants produced by growing the seed, all other plants with the same physiological and morphological characteristics, and also the breeding methods employed (US Patent number 5,894,079). Dutﬁeld (2004, pp54–5) notes that two things are extraordinary about this patent: The ﬁrst is that many bean cultivars exist and the speciﬁcation provides no evidence that none of these cultivars possess the same characteristics falling within the patent’s rather broad claims. The second is that Mr Proctor employed conventional crossing and selecting breeding methods that are in no way novel. Yet the patent prevents others from using the bean and other beans with similar characteristics in their own breeding programmes.

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In the patent document, Proctor acknowledges his ‘Enola’ bean originates in Mexico. Despite this, he claims that the bean is novel because it has a distinctive yellow colour and because it has never been grown in the US (Donovan, 2002–3). The Mexican government has since argued that they have grown yellow beans known as mayocoba for generations and that they are likely to be the source of Proctor’s so-called invention. Mexico also claims that a bean registered in Sinaloa, Mexico, in 1978 has the same genetic ﬁngerprint as the Enola bean4 (Rattray, 2002, p3; Pratt, 2001). This again raises concerns about the US foreign prior art rules pertaining to novelty. In any case, there is some published evidence that farmers have been growing yellow beans similar to the Enola bean in the US since the 1930s (Donovan, 2002–3, pp125–7). Following the grant of the patent, POD-NERS is reported to have written to all the importers of Mexican beans in the US, requiring the payment of a royalty of 6 cents per pound (Blakeney, 2004, p399). Shortly after, Proctor sued a company called Tutuli that had been importing Mexican yellow beans called Mayocoba and Peruano from that country since 1994 (Dutﬁeld, 2004). With customs controls inhibiting ‘patent infringing’ imports and more subsequent lawsuits, the trade of traditionally grown Mexican yellow beans to the US was signiﬁcantly impacted, with export sales reported by the Agricultural Association of Rio Fuerte to have been reduced by up to 90 per cent (Blakeney, 2004, p399). On the question of novelty, recent evidence suggests that the patent was unwarranted. DNA ﬁngerprinting analysis of the genetic makeup of the Enola beans has been compared with Mexican cultivars to determine whether they are distinct. Enola was found to be most closely related to the pre-existing Mexican cultivar Azufrado Peruano 87 and, by weight of probabilities, was directly originated from these yellow-bean cultivars (Pallottini et al., 2004, p968). Further to that, the International Center for Tropical Agriculture (Centro Internacional de Agricultura Tropical – CIAT), which holds 260 varieties of yellow beans in its gene-bank, has at least six bean cultivars that are substantially identical to the traits described in the Enola patent (Donovan, 2002–3, p126). Because of the widespread knowledge and breeding of yellow beans in Mexico, the claims made by Proctor in the patent should also fail a non-obviousness test. In December 2000, CIAT ﬁled a formal request for the re-examination of Proctor’s patent. As Blakeney notes (2004, p400), CIAT’s request stated that the claims for inventiveness contained in the patent failed to meet the statutory requirements of novelty and non-obviousness, ignored the prior art widely available in the literature and that the claims on the yellow seed colour ‘make a mockery of the patent system’. They also asserted that the original seed was ‘misappropriated’ from Mexico. Over the course of 2003 and 2005, USPTO examinations rejected the patent and subsequent attempts by Proctor to have the patent amended and reexamined. On 29 April 2008, the USPTO Board of Patent Appeals has afﬁrmed the patent re-examiner’s decisions regarding the rejection of all standing claims in the patent (USPTO Appeal 2007 – 3938). Staff at the ETC Group are calling

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this a ‘hollow victory’ because of the length of the re-examination and appeal process during which time Mexican farmer’s have lost considerable income due to blocked exports (ETC Group, 2008). They are now waiting to see if Proctor will appeal again through the federal court system.

Key Issues • • • •

The original beans used for the patented plants appear to have been misappropriated from Mexico by the inventor. The patent claims have been rejected due to a lack of description, due to prior art, and as being obvious. The patent claims are very broad, having implications for other related mayocoba cultivars. Aggressive litigation has inhibited the importing of mayocoba yellow beans, impacting upon US companies, Mexican farmers and exporters.

Camu Camu Patents The government of Peru has submitted a document to the WTO TRIPS Council (Peru, IP/C/W/458, 7 November 2005) which outlines its investigation of a number of potential cases of biopiracy.5 The document particularly focuses on a plant known as camu camu (Myrciaria dubia) which has been identiﬁed by Peruvian authorities in several foreign patents. Camu camu is a plant native to Amazonia and is believed to be particularly concentrated in the Peruvian Amazon. The fruit of the camu camu shrub is of particular interest because it has very high levels of ascorbic acid (vitamin C) when compared to other common natural sources such as lemons or oranges. An FAO report from 1993 notes that the main potential use of camu camu is as a source of vitamin C, representing one of a number of documents of prior art (Chávez Flores, 1993; Peru, 2005a, p4). Another earlier document by Alvarado (1969) also notes the use of camu camu as a juice and ﬂavouring for ice cream. It seems that there is some limited documentation of the uses of camu camu, although the Peruvian researchers note that it has been used traditionally as a food by indigenous Peruvians. The Peruvian submission analyses a series of patents, most of which have been granted in the Japanese Patent Ofﬁce for cosmetic extracts and food additives that utilize camu camu. Relating to cosmetic extracts and lotions the following patents granted in Japan are of particular interest: • • •

Patent number 3431383, ﬁled 14 February 1996: ‘Melanogenesis suppressing agent’; Publication number 11–246336, ﬁled 27 February 1998: ‘Activated oxygen scavenger and skin beautifying cosmetic composition’; Publication number 2000–327549, ﬁled 17 May 1999: ‘Cosmetic comprising extract of camu camu’;

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•

Publication number 2000–327550, ﬁled 19 May 1999: ‘Skin preparation for external use’; • Publication number 2000–327552, ﬁled 19 May 1999: ‘Skin preparation for external use’; • Publication number 2000–327525, ﬁled 19 May 1999: ‘Skin preparation for external use’; • Publication number 2001–031558, ﬁled 20 January 2000: ‘Skin lotion’; • Publication number 2001–031580, ﬁled 19 January 2000: ‘Preparation for external use for skin’. In most of these patents the claims refer to cosmetic properties and products such as ‘melanin inhibitors’, ‘an agent that eliminates activated oxygen’ and ‘a make-up base’ that use extracts of camu camu. The Peruvian researchers indicate that the existing prior art refers mostly to the use of the camu camu fruit as a juice and not in cosmetics, so they are probably novel. However, they indicate that ‘there is evidence of lack of an inventive step’ because ascorbic acid or vitamin C is known as an antioxidant and a compound that can prevent mottling and skin-ageing. Thus, it is obvious that camu camu, which is high in ascorbic acid, would have the same effect. In some cases, such as patents 2000–327525 and 2001–031558, the inventors have included camu camu extracts in ‘compositions’. For these patents, the Peruvian researchers have conceded that despite prior knowledge about the effects of ascorbic acid, and without further information available, the synergistic effects involved in the combination could constitute an inventive step. Indeed, the combination of two or more ingredients could have a cumulative or cooperative effect. On the other hand, the inventors may have simply combined two ingredients so that they can argue they have achieved something inventive. Depending upon the knowledge of the patent examiner and the level of description in the patent, it would be quite difﬁcult for an examiner to disprove novelty and non-obviousness involving synergistic effects – this is something more likely to be achieved in patent appeals where additional evidence is brought in to support or disprove the claims in a patent. Additionally, the Peruvian submission lists a number of patents related to juices or preserves which contain camu camu. A number of these have been rejected, presumably because of the existing prior art on camu camu as a juice (patent publication numbers 09–140341 and 09–215475) and in some cases because of the obvious nature of the patents as ﬂavour enhancements (patent publication numbers 09–140357 and 09–140358). Apart from these speciﬁc technical problems, the Peruvian researchers also noted a number of problems with patent transparency. These concerns relate to the lack of English translations for some Japanese patent documents; the lack of literal clarity in the English translations of others: and, in some cases, the poor descriptions of what is being protected. They also noted the difﬁculty in ﬁnding documented prior art, particularly where traditional knowledge of the uses of a plant has been transmitted verbally from generation to generation. Finally, they noted issues whereby biological resources have been exported

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overseas as commodities (in the case of camu camu, as fruit or juice), but have ended up being researched for their genetic resources and then potentially patented.

Key Issues • • • •

Inadequate patent examinations have allowed overly generic claims that are either obvious or have been established through prior art. Japanese patent documents have been unclear, untranslated or poorly described. There are difﬁculties establishing prior art where the biological resource is poorly documented but may be transmitted orally as traditional knowledge. Commodity exports of biological resources may be researched and then exploited through the patent system.

Kwao Krua The herb kwao krua (Pueraria miriﬁca) has been quite commonly known in Thailand for its cosmetic and revitalizing qualities for more than 100 years (see Figure 3.1). The medicinal use of the herb is believed to have been ﬁrst documented in Thai scriptures collated in 1931 by a herbal medicine practitioner named Luang Anusarn-Sunthorn. In more recent years, scientists have identiﬁed that the effects of kwao krua are related to the presence of phyto-oestrogens and phyto-androgens, or plant-produced female and male hormones. Scientiﬁc claims have been made that the extracts may enlarge and ﬁrm breasts (white kwao krua), assist with male sexual performance and erection (red kwao krua or Butea superba) and also ﬁrm the skin. Subsequently, a number of patents have been ﬁled on ‘inventions’ that use extracts of kwao krua both domestically and in the US.

Local Patents on Kwao Krua

In 1998 a number of patents were ﬁled with the Thailand Department of Intellectual Property (DIP) on inventions based upon the extracts of kwao krua. The ﬁrst patent granted was Thai patent application no. 8912 with the title: ‘Medicinal Herbal Composition from Kwao krua’. This patent was listed as the invention of Mrs Mantana Uawitaya, a Thai national. After the patent was granted, Mantana Panich Chiang Mai Co. Ltd, the ﬁling company, is reported to have put up advertisements and notices from a law ﬁrm in local newspapers informing the public and other producers that the company now had exclusive rights to the production of white kwao krua and was determined to enforce them (Tanasugarn, 1999). This patent was approved in May 1999, being considered to be based on an extract of a plant product as part of a composition and so narrowly avoiding the scope of the patent exclusion on plant and plant extracts under Section 9(1) of the Patent Act of Thailand. The

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Source: D.F. Robinson, 14 February 2006, Baan Soblan, Amphoe Samoeng, Chiang Mai, Thailand

Figure 3.1 The white kwao krua (Pueraria miriﬁca) vine. This is a slow-growing plant found mostly in forest areas in the north and northeast regions of Thailand

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scope of application of this exclusion is controversial in Thailand and raised questions as to why a patent was granted to such an extract when knowledge of it already existed in the public domain (Robinson and Kuanpoth, 2009, p383). A number of producers and NGOs subsequently complained publicly about this patent and the threats to enforce it. There were concerns that the patents on kwao krua extracts would inhibit other herbal medicines and cosmetic companies from continuing their original business practices (Subcharoen et al., 2001). Additionally, these groups complained that the composition was not novel, due to the existing prior art and traditional medical practices, and that the combination of ingredients would be obvious to others in the industry. Ofﬁcials at the DIP appear now to be waiting for someone to ﬁle for reexamination of the case (Tanasugarn, 1999; Assawin Tharang Khun, interview, 2006). So far no one has challenged the patent and it appears that the situation has been informally resolved between the competitors. Eventually, it seems that the aggressive claims of the lawyers have been ignored by other companies and local practitioners who use kwao krua. This case is important because it has been depicted as a ‘local biopiracy’ incident, whereby local producers were threatened with legal action and the potential payment of royalties. Tanasugarn (1999) has suggested that preventative measures for local biopiracy instances such as this could include further training for patent examiners, access to traditional medical formulations in databases or textbooks, and social responsibility by private lawyers and intellectual property counsellors such that they do not seek to inﬂate or obscure the scope of patents in the public’s mind. A number of patent applications made by Dr Wichai Cherdshewasart, a researcher from Chulalongkorn University in Bangkok, have also been queried for their claims including kwao krua (patent applications 46779, 48605 and 52443). Each of the patents refers to extracts of one or more of Pueraria miriﬁca (white kwao krua), Butea superba (red kwao krua) and/or Mucuna collettii (black kwao krua). According to the head of the Patent Division of the DIP, the approval of these patents has been challenged, having spent two to three years in the Intellectual Property and International Trade Court, and then three to four years in the Supreme Court (Assawin Tharang Khun, interview, 2006; Robinson and Kuanpoth, 2009, p385). As with the previous case, these patent applications have led to concerns among domestic producers of herbal treatments who use kwao krua extracts in their products. In addition to these domestic registrations, there are related concerns about patents registered by the same researcher in foreign jurisdictions.

Foreign Patents on Kwao Krua

As Dr Jade Donavanik (2004), an intellectual property attorney and academic, has highlighted, Thai patent number 52443 appears to be the direct foundation of USPTO patent number 6,673,377.6 The claims in both the Thai and US patent applications include an extract of kwao krua, a method for extraction

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and a method for manufacture. While the patents on processes and methods seem valid, the primary concern here is that the extract does not appear to be new or non-obvious. Cheil Jedang Corporation, a company based in Seoul, holds US Patent No 6,673,377. The patent claim covers: An extract derived from Pueraria miriﬁca having an effect on improving breast firmness, breast enlargement and wrinkle removal from the breast, wherein said extract is prepared by the steps of: drying tubers, roots, stems, leaves and/or tissue-cultured calluses of Pueraria miriﬁca, optionally by spray-drying, freezedrying and/or vacuum-drying; pulverising the dried tubers, roots, stems, leaves, and/or tissue cultured calluses into pieces or powders and then immersing the plant pieces or powders in a mixture of methanol and water; extracting the mixture; and ﬁltering the resulting extract and then concentrating it in a vacuum to remove the solvent. There is existing documented prior art relating to the use of kwao krua, bringing into question the novelty of this patent claim on the extract. Further, the steps involved do not appear to extend beyond the methods of traditional medicinal practitioners, as described in Luang Anusarn-Sunthorn’s texts. The fact that most of these texts are in Thai and therefore may not be deemed to be ‘accessible’ could mean that they are not recognized as prior art in the US. The patent abstract also makes quite broad mention of ‘foods, beverages, pharmaceutical products and/or cosmetics containing the extracts as an active ingredient’. Thus, herbalists in Thailand are concerned that the patent will affect exports of cosmetics in particular, but also other products already in the market (Subcharoen et al., 2001; Robinson and Kuanpoth, 2009, pp385–6). Additionally, the NGOs BioThai and the ETC Group have identiﬁed that a variety of kwao krua has become essential subject matter in US Patent No 6,352,685, owned by Kose Corporation of Tokyo and Shiratori Pharmaceutical Co. Ltd of China. The patent claim covers: An external composition for skin comprising, as an essential ingredient, a liquid extract of a dried root lump of Pueraria miriﬁca; wherein said liquid extract comprises an extraction solvent which is at least one selected from the group consisting of water, lower alcohol, liquid polyhydric alcohol; and wherein said external composition for skin contains 0.00001 to 5 wt % of said liquid extract of said dried root lump of Pueraria miriﬁca as dried solid in the composition. (USPTO, 2002) Again, this claim merely relates to an extract of kwao krua for use in a cream or gel to be applied to the skin. There appears to be little real novelty, given the documented prior uses of the plant and its extracts for skin-ﬁrming and whitening. Like some of the camu camu patents, the fact that it is combined in

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composition may have some synergistic effects worthy of novelty – this would need further investigation. Nevertheless, it appears to be a fairly obvious extension of practices that exist in documented prior art. Beyond these technical issues relating to the kwao krua patents, government ofﬁcials have raised concerns regarding the ongoing conservation and sustainable use of the plant. The kwao krua plant is a vine that grows in the north and northeast of Thailand, where it has been used as a folk medicine. Interviews with Karen (Khon Pga k’nyau) people from Chiang Mai province who are users of the herbal medicine suggest that past uses of this plant and others like it involve customary practices: Medicines and herbs should not be hoarded. They should only be collected as needed for the treatment of sick people. Herbs should not be over-collected, especially if the plant is rare. Before going to collect the herbs, the spirits of the herbs should be ﬁrst asked and a small donation should be made to the spirits at a shrine. (Pathii Ta-Yae, Pha Mur and Pathii Dang, interviews, 13–15 February 2006) Increasingly in recent years, the plant has been extracted by poachers from remaining forest areas to be sold to herbalists, despite its very slow growth rate. As a result, the government has listed it as a restricted herb to limit the forest collection of the plant and to encourage commercial producers to cultivate it in a controlled and sustainable way.

Key Issues • • • • •

Threats of legal action have sought to inﬂate the scope of a patent in Thailand, causing concern and disruption to local producers. Both domestic and foreign patents have been sought or granted on extracts of kwao krua, despite there being documented prior art in the Thai language and common traditional and commercial use of the plant. Some of the patent claims also appear to be obvious to someone trained in the development of herbal medicines or pharmaceuticals. The kwao krua plant is being over harvested in a time frame that does not allow regrowth. There are local customary norms associated with the use of the plants by different indigenous and Thai communities.

Artemisia judaica A US patent has become the topic of controversy following a report produced by the Washington DC based NGO, the Edmonds Institute and the African Centre for Biosafety. The author, Jay McGown (2006), criticizes US patent number 6,350,478 on an ‘Artemisia judaica fractionation method’, which is registered

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by the UK company Phytotech Ltd (a subsidiary of Phytopharm Plc). Notably, Artemisia judaica has been used in Libya and other neighbouring North African and Middle Eastern countries as a traditional medicine. McGown and others cite the traditional medicinal uses of the plant, which include treatments for diabetes (see Liu et al., 2003; Dob and Chelghoum, 2006, p343; Azaizeh et al., 2003, p99). McGown (2006, p2) depicts this as a clear case of biopiracy, citing part of the patent description: ‘Artemis judaica is used in Libyan traditional medicine as an infusion for the treatment of “wasting disease”, almost certain[ly] dia[b]etes mellitus.7 However, McGown appears to have been a bit ‘strategically vague’ in his description. The patent in question only covers a series of methods for extraction of fractions from the Artemisia judaica plant. Furthermore, the fractions derived from this process are claimed to have ‘non-mutagenic properties’. In other patent documents which cite the anti-diabetic properties of the Artemisia judaica plant (PCT Publication WO 97/35598 and USPTO patent number 6,893,627), they note the presence of a ‘deleterious mutagen’ in crude extracts of the plant, which would make it unsuitable for the treatment of mammals and humans. It seems that traditional healers may have been using it without clear knowledge of the potential for mutagenic effects. Further documentation about the traditional use and customary norms associated with use of the plant could not be found in detail in the English language. There appear to be two key factors here which suggest that perhaps this patent might not be considered to be a biopiracy case according to the deﬁnition put forward already. Firstly, the patent is on a process or method of extraction, not the actual extract itself. Therefore, the patent should not inhibit the use of the plant in any way. That is assuming that the patent owners do not artiﬁcially inﬂate the scope of the patent by threatening legal action against medicine producers or traditional medicine practitioners (as has occurred with other patents on methods, plants or extracts). Secondly, the chromatographic fractions are claimed to remove the mutagenetic properties of the plant. According to patent rules, this should satisfy the novelty and non-obviousness requirements. Nevertheless, there are still some issues that need to be considered. It is not clear under what terms the plant biological materials have been obtained – particularly whether prior informed consent was sought. The fact that this method may ultimately be used to produce medicines from this plant suggests that if commercialization is successful, then beneﬁt-sharing arrangements with the source countries and communities would be appropriate. This sort of arrangement is particularly important in principle where plant species are threatened, rare or are being over harvested because of the medical claims. Often plants only grow in very speciﬁc regions where the climatic conditions, soil and ecology are suitable – meaning commercial-scale crop cultivation operations are often launched in the countries of origin. As McGown (2006, p2) points out, Phytopharm says that it maintains good agricultural practices to minimize environmental impacts by, ‘working with local agronomists and

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horticulturalists in each of the countries where we are growing crops’. Yet the company does not specify further than this vague assurance. In any case it is not clear if products have been developed from this plant by Phytopharm. Often these pharmaceutical developments are not commercially viable or do not pass clinical trials and therefore do not reach the market.

Key Issues • •

The patent on a method appears to be novel and non-obvious, and so should not restrict continuing use of the plant by others. However, it is not clear how the plant was originally obtained, whether prior informed consent was sought and whether beneﬁts will be shared in the event of commercialization. Therefore, this case is not as clear as some of the other biopiracy cases.

Hoodia Due to the reporting of South African activist, Rachel Wynberg, the hoodia case is now very well-documented. Speciﬁc groups of the San people have been known to traditionally eat parts of the hoodia plant as an appetite suppressant when they are on long hunting trips in areas of the Kalahari Desert in Southern Africa. The San have lived off the land in a region including Botswana, Namibia, South Africa and Angola for over 20,000 years and now number approximately 100,000 people. They have been increasingly marginalized by the inﬂux of Bantu herders from the north, European immigration and the private appropriation of their lands, leaving them ranked as one of the most impoverished communities in Africa (Bavikatte et al., 2009, p2). Notably, their communities are widely distributed, including different groups with heterogeneous cultural heritage and traditional knowledge. Documented colonial ethnobotanical accounts of Francis Masson from 1798 are believed to have led to further study of the edible wild foods in the region in 1963 by the South African Council for Scientiﬁc and Industrial Research (SACSIR). In 1995, following some detailed spectroscopic analyses, a patent application (patent number 983170) for hoodia was ﬁled in South Africa by SACSIR for use of the active components of the plant which were responsible for suppressing appetite. In 1998, SACSIR signed an exclusive licensing agreement with the UK company Phytopharm and also ﬁled for additional patents in other countries (Wynberg, 2004). Currently, Phytopharm is still developing the product for future sale in US and European markets. Subsequently, the organizations involved in the patenting and commercialization of hoodia were heavily criticized by international NGOs and indigenous organizations including the Working Group on Indigenous Minorities in Southern Africa (WIMSA). The main criticisms were that they had not contacted the San people to seek their prior informed consent for the development, patenting and commercialization of hoodia, and they had

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not attempted to establish any sort of beneﬁt-sharing arrangement. After this, the SACSIR responded by negotiating a memorandum of understanding in 2001 and by establishing a ‘San Hoodia Beneﬁt-Sharing Trust’ in 2003 that should ultimately see milestone payments and royalties (Dutﬁeld, 2004, p53). Wynberg (2004; 2008a, pp88–90) explains the complexities involved in the establishment of this beneﬁt-sharing agreement, including questions about which groups speciﬁcally should be the beneﬁciaries and how San knowledge and culture can be protected. Phytopharm initially sought a licence and royalty agreement with Pﬁzer to develop hoodia products. However, the closure of Pﬁzer’s Natureceuticals group led to the withdrawal of its involvement with hoodia. In 2004 Unilever negotiated a joint-development agreement with Phytopharm to develop active ingredients of the plant into a functional weight-loss food (Wynberg, 2008a, p83). Now milestone payments are being made by SACSIR to the ‘San Hoodia Beneﬁt-Sharing Trust’ with the anticipation that these companies will soon be able to release clinically trialled hoodia products. However, Unilever has also since pulled out of the agreement because the hoodia extract was metabolizing too quickly in a liquid-based product for its Slimfast range. This has seen the share price of Phytopharm plummet, with the deal with Unilever worth an estimated half of Phytopharm’s value (Deighton, 2008). It is also clear from its website that clinical trials have been quite slow, suggesting that much like earlier plant-based pharmaceutical companies (e.g. Shaman Pharmaceuticals), they have had trouble maintaining proﬁtability. Despite this, a number of smaller (and often, it seems, less than scrupulous) companies have been obtaining hoodia from Southern Africa and selling it as a health-food supplement or drug. As a consequence of the publicity generated by the aforementioned agreements and the patent, the hoodia plant has been threatened by unregistered collection from its natural environments. As Wynberg (2008a, p83) describes: By 2006 trade had escalated exponentially – in many cases illegally – from just a few tons to more than 600 tons of wet, harvested material per year, sold as ground powder for incorporation into non-patented dietary supplements. In North America in particular, dozens of hoodia products were sold as diet bars, pills, drinks, and juice, traded by a myriad of companies ‘free-riding’ on the publicity and clinical trials of Phytopharm and Unilever. As a result, hoodia species have been included in the Appendix of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) since 2004. This listing should help restrict the international trade in hoodia to licensed companies. Seeking to address some of these issues, a Hoodia Multi-Stakeholder Meeting was facilitated by the NGO Natural Justice near Cape Town in January 2009. The meeting sought to scope a joint hoodia industry market development strategy based on regional collaboration of stakeholders. Their broader aims are to ensure beneﬁts are appropriately

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distributed to different communities across national borders, to cultivate hoodia more sustainably and to collaborate in an effort to mitigate the effects of illegal collections and trade.8 As noted by representatives from Natural Justice (Bavikatte et al., 2009, p1): ABS is a double-edged sword for communities. On the one hand it provided the San an opportunity to generate livelihoods and be rewarded for biodiversity stewardship. On the other, it presented them with conceptual and practical challenges related to granting access to their TK according to … PIC; difﬁculties in negotiating the benefit-sharing agreement; and subsequent governance upheaval [relating to the hoodia trust and distribution of funds to San Councils]. Ultimately, this has turned from being a biopiracy case because of the lack of prior informed consent into an example of the many difﬁculties faced in establishing appropriate beneﬁt-sharing arrangements. Many of these issues are still yet to be resolved and this example is worth watching over time to determine how the San will manage access, conservation of hoodia and the equitable distribution of funds.

Key Issues • • •

SACSIR and the companies involved did not engage with or seek prior informed consent from the San people regarding the patent or commercialization of the product, until NGOs raised concern. A beneﬁt-sharing arrangement was eventually established between SACSIR and the San people through some indigenous NGOs so that monetary ﬂows will be received by the San Hoodia Beneﬁt-Sharing Trust. Other herbal supplement companies have started collecting the hoodia plant excessively. The hoodia plant is now being over harvested from its natural environments, threatening its continued ex situ existence.

Japanese Patents on Plao Noi Plao noi is a local herb whose medicinal properties were recorded centuries ago on palm-leaf books in Thailand. In a series of related patents issued to the Japanese Sankyo Company Ltd protection has been sought over the process and derivative extracts of the plao noi (or plau noi) plant (scientiﬁc names of the species and subspecies include Croton sublyratus, and Croton columnaris airy shans). Related plants used in the extract of derivatives include: plau luat (Croton Hutchinsonlanus hosseus) and plau yai (Croton oblongifolius Roxb.). The patents were assigned under USPTO number 4,260,551 (ﬁled in 1979 and approved in 1981) and also number 4,192,953 (ﬁled in 1979 and approved in 1980), which is based on earlier claim 4,059,641 (ﬁled in 1975 and approved 1977), and a continuation of the abandoned patent with Serial

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Number 807,913, ﬁled 20 June 1977 (USPTO, accessed 24 February 2006). Notably the patents occurred a signiﬁcant period before the CBD came into force (Robinson, 2006). The patents are on ‘Polyprenyl derivatives … useful as medicines for treating peptic ulcer’. The claim covers a series of esters and their chemical derivatives, which when combined have been called ‘plaunotol’ (USPTO, accessed 24 February 2006). This has since become the active ingredient in a commercial drug called Kelnac-Plaunotol (which is also a registered trademark). In the description, the inventors indicate that: We have for many years been engaged in studies for ﬁnding out novel pharmaceuticals by way of isolating a physiologically active ingredient from plants. As a result of our studies, we have isolated a diterpenediol compound, (E, Z, E)-7-hydroxymethyl-3,11,15trimethyl-2,6,10,14-hexadecatetraen-1-ol, from plants belonging to the genus Croton, particularly Plau-noi (Croton columnaris airy shans), Plau-luat (Croton hutchinsonlanus hosseus) and Plauyai (Croton oblongifolius Roxb.) growing in Thailand and also succeeded in chemical synthesis of this diterpenediol compound as well as its homologs and derivatives. (USPTO, accessed 24 February 2006, emphasis added) How exactly the Japanese researchers obtained knowledge of the qualities of the plant and the biological materials is unclear. Some have speculated that during the Japanese occupation of Thailand in World War II, Japanese scientists working with local scientists and traditional healers obtained the materials and the local understandings of its use for the treatment of various ailments including peptic ulcers (Bai Mai, interview, 2005). As Sinha (1996, p159) suggests, plao noi was ‘long used by the Thai tribals for stomach ache’. Dhillion and Ampornpan (2000) indicate that researchers found out about the qualities from antique recorded medical texts on palm-leaf parchment called samutkhoi. It is most likely that a combination of these sources was utilized for the identiﬁcation of the drug. Rachan Pooma, an ofﬁcial from the Royal Forests Department, indicates that plao noi was ﬁrst actually collected for analysis from Prachin Buri, in open disturbed areas, not in protected or forest areas (personal communication, 29 August 2005). Chana Phromdej, a botanist of the Forest Herbarium, National Park Wildlife and Plant Conservation Department, apparently led the Japanese team to explore plao noi following the information from specimens recorded in the herbarium. After several trips were made, materials from Prachuap Khiri Khan had the best quality extracts. Apparently no beneﬁts were shared with the Thai authorities, local traditional knowledge holders or possible individuals conserving the plant, with the exception that Chana Phromdej was offered the role of company consultant to the Japanese researchers (Rachan Pooma, personal communication, 29 August 2005).

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However, it seems that although there are groups that knew about the qualities of plao noi, it was not taken from them and may have been fairly readily available in the public domain. The suggestion that the plant was found in ‘open, disturbed areas’ raises the question of how it came to be known about and whether that area was chosen to avoid the ire of those who use or conserve the plant. Although Dhillion and Ampornpan (2000) suggest that the plant only has limited distribution in southern Central Thailand, there is evidence today that the plant is conserved by some local groups and healers (Thai communities and groups such as the Hmong and Karen) in the north of Thailand (Robinson, 2006) and it may be found quite widely throughout Thailand and adjacent countries (Saralamp et al., 1996–7).9 In terms of fair and equitable practice, the Japanese researchers and the company holding the patent have extracted and monopolized a derivative from a plant that was located and known by various local groups (and in public documents) in Thailand. This provides some basis for argument that there should be some kind of beneﬁt-sharing, at least back to Thai authorities or to custodian groups. However, because this activity and patent were undertaken before the CBD was negotiated, there was no obligation on these researchers to provide beneﬁt-ﬂows back to Thailand. Dhillion and Ampornpan (2000) indicate that the Japanese company still gets local people to harvest the plants in areas where it apparently thrives, in southern Thailand, but does almost all the processing and technical procedures in Japan. If the company wanted to employ best practice according to current principles under the Bonn Guidelines, retrospective beneﬁt-sharing could include the transfer of technologies and manufacturing to Thailand. The original Sankyo Company patent should now have lapsed. As a postscript there are new patents relating to plao noi registered to Thai researchers in the USPTO, indicating that Thai researchers can ﬁnally capitalize on and export the medicinal herb without fear of being sued. For example, USPTO patent 5,879,916 was granted in 1999 and is assigned to the Thailand Research Fund, a government research body. This patent is on a process and an enzyme ‘geranylgeraniol-18-hydroxylase’ from Croton sublyratus to form plaunotol, the anti-ulcer medication patented under the Sankyo Company patent. This patent is described as providing a ‘less cumbersome and more effective process for the production of plaunotol’ (USPTO, accessed 21 February 2006). Similarly, USPTO Patent number 5,264,638, an older patent approved in 1993 (assigned to Chulalongkorn University, Bangkok), also covers a ‘process for extraction and puriﬁcation of plaunotol’. These patents granted to Thai researchers suggest that they are seeking to either produce drugs which will compete with the plaunotol drug sold by Sankyo, or that the patented processes will be licensed to Sankyo.

Key Issues •

The materials were extracted and patented prior to the negotiation of the CBD, at a time when there was less legal certainty over the ownership of

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plant genetic resources and little guidance on ethical ethnopharmacological practices. Although an individual was rewarded and local harvesting operations were established in Thailand, beneﬁts and technology transfer appear to have been limited. A more substantial retrospective arrangement does not appear to have been made. Thus, the patent is likely to have inhibited Thai commercial exports for the duration of the monopoly.

Blight-Resistant Rice The United Nations Environment Programme (UNEP) and WIPO have documented a number of beneﬁt-sharing case studies, including a case of blightresistant rice (Oryza longistaminata) originally sourced from the impoverished African country of Mali. In the 1970s a specimen of Oryza longistaminata from Mali was transferred to a rice research programme in India where its resistance to bacterial rice blight was identiﬁed. The blight-resistant specimen was transferred to the International Rice Research Institute in the Philippines, where it was determined that the resistance was due to a gene named Xa21. The blight-resistance was then bred into cultivated rice varieties by conventional breeding methods by researchers at IRRI. Subsequently, one of these varieties was acquired by a University of California researcher who had worked at IRRI, who then mapped, sequenced and cloned gene Xa21 (Gupta, 2004). A US patent was applied for in 1995 covering ‘Nucleic acids, from Oryza sativa, which encode leucine-rich repeat polypeptides and enhance Xanthomonas resistance in plants’. The patent was granted on 12 January 1999 (US Patent 5,859,339). This patent was subject to some criticisms by NGOs and within the CGIAR because it was the IRRI-based research that had uncovered the gene and because local farmers in Mali had conserved the plant. In 1996, University of California, Davis (UC Davis), established a Genetic Resources Recognition Fund (GRRF) as a mechanism to share beneﬁts back to agriculture students and researchers from Mali once the patented product was commercialized. Due to CGIAR pressures, UC Davis also agreed to allow non-commercial use of the gene and for IRRI to develop new varieties that incorporate the Xa21 gene for distribution to developing countries (Blakeney, 2004, p398). Gupta (2004, p21) notes that an awareness about the resistance of Oryza longistaminata to viral and bacterial diseases existed among local scientists in Mali, but they did not consider it to be a worthwhile subject of further research because the rice was generally considered by farmers to be a weed. Apparently, only the Bela and Fulani people were dependent on the wild rice for subsistence, as well as for use in some rituals and ceremonies. Gupta noted that local landholding farmers did not cultivate Oryza longistaminata and, in fact, that it ruined their crops. Instead, he notes that the Bela, a landless and marginalized community, were the main users of the plant, collecting grain for food and maintaining detailed ethnobotanical knowledge about the functions and characteristics of the rice, including its resistance to diseases under normal (non-drought) conditions. As Gupta (2004, p24) notes:

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While everybody else referred to birds as a nuisance from which they had to protect the crop, the Belas viewed the birds differently. Without birds, they stressed, the grains would not be distributed. Birds distribute the grain/seed and thus the [Bela] community can collect rice from larger areas. A concentration of birds [Chironi] in the adjoining trees indicates that the rice [Oryza longistaminata] is mature nearby and that the community can begin collection. For farmers, this bird increases the burden of weeding, but one person’s weed is another person’s food. Despite their speciﬁc interest in the wild rice plant that was the original source of the blight resistant Xa21 gene and subsequent patent, it appears that the Bela have been left out of the GRRF and have received little engagement by these organizations, despite the fact that WIPO has portrayed this as a model case of bioprospecting and beneﬁt-sharing.

Key Issues • • •

•

The materials were extracted from Mali prior to the negotiation of the CBD. The patent utilizes material from IRRI, which is a CGIAR research institute intended for furthering agricultural development, particularly in the global south. A beneﬁt-sharing arrangement was established once the patent application had been made, but some have criticized the fact that the main beneﬁciaries are scientists rather than the Bela people who rely on the wild rice as a food staple. The need to engage with indigenous and local people in research of this nature should also be extended to include other stakeholder groups – in this circumstance to the nomadic Bela people.

Peruvian Maca The government of Peru has been actively pursuing a number of patents on maca (Lepidium meyenii), which has been cultivated for centuries in the Andes as a food and for medicinal treatments. Speciﬁcally, a report submitted by Peru to the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore critiques two US patents held by the company Pure World Botanicals (Peru, WIPO/GRTKF/ IC/5/13, 2003). The patents are on the ‘treatment of sexual dysfunction with an extract of Lepidium meyenii roots’ (patent number 6,428,824) and an ‘extract of Lepidium meyenii roots for pharmaceutical applications’ (patent number 6,267,995). The Peruvian submission details several documents indicating prior art (although mostly in Spanish) including components of the maca root and their use in therapy, particularly regarding to their inﬂuence on fertility and sexual potency. They also ﬁnd the extracts to be obvious.

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In the summary of the IGC document, the Peruvian researchers note that several of the inventors recognize that they obtained dry maca roots from Peru in 1998. However, there is no evidence that these materials were lawfully obtained or that provision has been made for the equitable sharing of beneﬁts back to Peru when derived from the use of these patents (Peru, WIPO/GRTKF/ IC/5/13, 2003, p25). The authors attempted to contact Pure World Botanicals to express their concern regarding the effects that these patents might have on Peruvians exporting maca to the US and requesting an indication of the differences between the extract that the company has patented and the extracts exported by Peruvian nationals. However, no reply has ever been received to this letter (Venero, personal communication, February 2009). Dutﬁeld (2004, p50) also questions the validity of US patent number 6,093,421 (25 June 2001) on a mixture of ‘maca and antler for augmenting testosterone levels’. He notes that the consumption of both maca and antler is already known to be associated with increased testosterone levels, suggesting that this patent may not be novel and that it is obvious. However, these standards of novelty and obviousness are limited in the US to a narrow national scope and by restrictive terms on accessible published foreign prior art. Despite its ﬁndings, Peru indicates that it has had difﬁculty questioning or challenging patents in the EU or US, for reasons based on administrative, legal, technical capacities, cost and time issues. This is not surprising given the length and complexity of some patent re-examinations and appeals discussed already. As a consequence these patents have not been ﬁled for re-examination by the Peruvian authorities (Venero, personal communication, February 2009).

Key Issues •

• •

Despite some documented prior art on the effects of maca and traditional uses, a number of patents have been granted on extracts of the root. These extracts generally appear to be obvious to those knowledgeable in herbal medicines and/or pharmaceuticals. The maca root has been collected from Peru and it is unclear whether this was done legally. No beneﬁt-sharing arrangement is in place. The patent has not been ﬁled for re-examination due to administrative, legal, technical capacities, cost and time issues.

Ayahuasca In 1986, Loren Miller was granted US patent number PP5751 on a ‘new and distinct’ Banisteriopsis caapi plant named ‘Da Vine’, purported to be ‘characterized by the rose color of its ﬂower petals which fade with age to near white, and its medicinal properties’. In the background of the patent document, the patent-holder indicates that the plant was discovered growing in a domestic garden in the Amazon rainforest of South America. Banisteriopsis caapi, otherwise known as ayahuasca, is native to the Amazon rainforest

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where it is used by many indigenous groups for sacred and religious healing ceremonies. Ayahuasca has been traditionally used by preparing it into a drink that has hallucinogenic properties – reportedly shamans within a number of these indigenous groups then use their visions to interpret the ailments of their patients. Throughout the last century there was extensive documentation of these medicinal uses and the associated rituals (see, for example, Rivier and Lindgren, 1972; Naranjo, 1979). The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA), which acts as an umbrella group facilitating dialogue with 400 indigenous peoples in the region, discovered that Miller had been granted patent PP5751 in 1994. In March 1999, the Centre for International Environmental Law (CIEL) ﬁled a request for re-examination of the patent on behalf of COICA. The USPTO issued a decision rejecting the patent in November 1999 on the grounds that the claimed plant variety was not distinctive or novel. However, as CIEL (2003) notes, the USPTO did not acknowledge the argument they had put forward that the plant’s religious value warranted an exception from patenting. In a series of apparent failures to apply due process by the USPTO, Loren Miller was then allowed to submit new evidence and arguments despite a ‘ﬁnal action’ notice, but CIEL were not (Wiser, 2001; CIEL, 2003). The USPTO subsequently accepted Miller’s new evidence, reversing their rejection of the patent in January 2001 and allowing the patent to stand for the remaining two years of its term. The USPTO examiner conducted a side-by-side evaluation of images of the ‘Da Vine’ plant with a number of other examples submitted by Miller, resulting in the evaluation that the leaf size and shape differed sufﬁciently between the images of ‘Da Vine’ and other ayahuasca plants. Additionally, the examiner found that the plant was found in a cultivated area (i.e. a domestic garden) and thus is eligible for protection under the US Patent Act (Locker, 2001). As 35 USC 161 of the patent laws states: Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefore, subject to the conditions and requirements of this title. Thus, the US Patent Act statutorily condones the ‘discovery’ (i.e. extraction) and patenting of plants as long as they are not found in an uncultivated state. Apparently ﬁnding a plant in a domestic garden in a foreign country qualiﬁes the plant for patenting – in this case because of a slight variation in leaf size and shape. If Miller found this plant in a garden in South America, then it is likely that other plants with the same characteristics could be found nearby. Hence, this sort of patent criterion for admissibility makes a mockery of the US patent system.

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The USPTO examiner notes that the patent is speciﬁc to a single plant and its identical asexually reproduced progeny. Nevertheless, this does not allay the concerns of indigenous people in the Amazon Basin or herbal medicine producers in the region. CIEL (Rothschild and Wiser, 1999) notes that Miller intended to establish a pharmaceutical laboratory in Ecuador to process ayahuasca and other plants, around the same time that the US was pursuing a bilateral intellectual property reciprocity agreement with Ecuador. As a consequence, there are concerns from indigenous groups and local producers of ayahuasca products about lawsuits regarding the use of ayahuasca plants with similar descriptions to ‘Da Vine’. These are in addition to the potential spiritual impact upon indigenous healers.

Key Issues • • •

The US Patent Act allows the patenting of discovered plants as long as they are not found in an uncultivated or ‘wild’ state, and meet patent criteria. The patent holder and the USPTO have disregarded the spiritual and ritual signiﬁcance of the plant to many indigenous groups in the Amazon Basin. There appears to have been a breakdown of proper procedure at the USPTO in the handling of re-examination in this case.

Other Reported Biopiracy Cases and Controversies The cases detailed so far have been selected because of the issues involved; because of the lessons that can be learnt; to provide an international perspective on biopiracy; and because of the level of detailed information available. These are certainly not the only patent-related biopiracy cases. Box 3.1 provides brief details of a number of other cases that have been widely criticized. The sheer number of biopiracy cases that have been reported, investigated and found to be unfair and inequitable, and in some cases dubious in terms of patentability criteria, suggest that there are some serious international ethical and legal issues that need to be resolved. It seems clear that dealing with biopiracy will involve much more than clariﬁed patent criteria and improved patent examination – although this is one key area of concern. The intellectual property system, particularly the patent system, has been a primary target of the biopiracy campaigners with good reason. From the examples discussed here, there are several identiﬁable categories of ‘patent-related’ biopiracy cases. These include spurious patents on biological products (typically patents that are not novel or that are obvious); patents on extracts/derivatives that are unauthorized and/or do not provide beneﬁt ﬂows to providers; patents which utilize traditional knowledge without acknowledgement and/or cause offence to indigenous or local people; patents over an entire ‘new’ plant variety (allowable under US patent law) that utilizes unauthorized germplasm; and, potentially, there is also a category for process patents that facilitate deception and/or extraction of the aforementioned biopiracy categories.10

PATENT-RELATED BIOPIRACY CASES

BOX 3.1 OTHER REPORTED BIOPIRACY CASES Neem The neem tree (Azadirachta indica) has been described as a ‘natural pharmacy’. The extracts of the plant have many practical uses, including in pesticides, fungicides, as an anti-inﬂammatory, as a preventative measure against malaria and intestinal worms, in household products like soaps, candles and cosmetics, and as an anti-cancer agent (Posey and Dutﬁeld, 1996, p80). The use of the plant in India, where it reputedly originates, has been documented for over 2000 years and it continues to be used by local communities for agricultural and medicinal purposes. In recent years extracts of the neem tree have been the subject of numerous patent claims worldwide, some of which have fuelled biopiracy campaigns by NGOs and activists (Robinson, 2007). A challenge to a European patent on neem has seen it successfully revoked on the grounds of existing prior art in India. However, US patents on neem have remained valid due to the geographical limitations on the US Patent Act novelty requirement (Bagley, 2002–3, p682).

Turmeric Turmeric spice powder from the turmeric plant (Curcuma longa Linn.) has been used traditionally in India for the treatment of wounds, where its application is common knowledge. The natural antibacterial agents of the powder inhibit infection. This application was also the subject of a US patent which caused considerable controversy in India. The patent was ultimately revoked due to a lack of novelty, once the Indian government had produced documentation of its prior art (Dutﬁeld, 2004, p50).

Aframomum stipulatum A Montreal-based company called Option Biotech has patented a ‘composition’ of the seeds of Aframomum stipulatum (US patent number 5,879,682, issued 9 March 1999). The composition is for use as an anti-impotency drug. In the patent document, the ‘inventor’ indicates that the seeds were collected from Brazzaville in the Congo. There is prior documentation of the medicinal uses of this plant and the company notes on their website that the plant was traditionally used by African tribes. It seems unlikely that beneﬁt-sharing arrangements have been made (McGown, 2006, p5).

Andean nuna bean In March 2000, a patent was granted to a US company on a ‘bean-nut popping bean’ of the species Phaseolus vulgaris (US patent number 6,040,503 and PCT patent number WO99/11115). This was apparently derived from crosses involving 33 Andean nuna beans from Peru, Bolivia, Ecuador and Colombia that had been bred and improved by Andean farmers and indigenous people. The communities provided samples of the crop to the CGIAR’s CIAT, of which nine appear to have been used in this patent (Blakeney, 2004, pp401–2).

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There have also been other cases whereby companies have been granted very broad patents over plants. For example, patent EP0301749, which was originally ﬁled by Agracetus in 1988 and granted in 1994, made expansive claims with regards to genetically modiﬁed soybeans. Bizarrely, the patent was originally opposed by Monsanto until the company acquired Agracetus in 1996. Upon obtaining the patent, Monsanto quickly turned to defend the claims in a battle that lasted 13 years. The patent claim that was particularly of concern was claim 17: A soybean seed which will yield upon cultivation a soybean plant comprising in its genome a foreign gene effective to cause the expression of a foreign gene product in the cells of the soybean plant. (EP0301749) The appellants, including the ETC Group, Syngenta and Pioneer Hi-Bred, interpreted this to be a claim over all genetically modiﬁed soybeans. Ultimately the ETC Group won this case in May 2007 and the patent was revoked on the grounds of lack of novelty, particularly in relation to the ambiguity of the words ‘foreign gene’ (appeal number T1165/03, 3 May 2007 EPO, 2007). The appellants’ argument was strengthened by one of Monsanto’s earlier submissions that the genetic engineering process described in the patent was insufﬁcient to allow a skilled scientist to replicate the procedure, which is a necessary criterion for patentability (ETC Group, 2007; Roberts, personal communication, February 2009). Other cases of conspicuously broad patents include Agracetus’ (1992) US patent covering ‘genetic engineering of cotton plants and lines’ (US patent number 5,159,135; Bijman, 1994). This patent was re-examined by the USPTO and subsequently rejected, but the patent was going through an appeals process as recently as 2006, before proceedings were ﬁnally terminated (in 2007) and the patent was disclaimed (in 2008). Although these cases may not utilize misappropriated biological resources11 and traditional knowledge, they raise serious questions about the patent examination process and the patent system more generally. A combination of factors is contributing to the continued failure of the system. Many authors have complained that there are not enough patent examiners and that they are burdened with many highly technical patent applications, meaning that ultimately many poor quality, insufﬁciently novel and obvious patents are being issued. However, in many cases, these patent applications should not have been made in the ﬁrst place. Had there been stricter criteria required for patent applications, some of these patents may not have been granted. This has been a driving factor behind demands for improvements at the intersection of patent law and biodiversity law, namely through inclusions such as a ‘disclosure of origin requirement’ in patents that will ensure greater traceability of biological resources. However, these legal inefﬁciencies do not alleviate the blame that should be placed on the inappropriate activities of some researchers. In some circumstances

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the researchers involved in these biopiracy cases may have simply been naive about the use of biological materials that they acquired from a gene-bank, storage facility or directly from the ﬁeld by bioprospecting. In other cases it seems that the patent holders have deliberately sought to obfuscate the origins of materials and the scope of their ‘invention’ in order to secure commercial rights and exclusive use of speciﬁc plants. In many of the cases discussed, these patents have been repeatedly re-examined and challenged in the courts (at great cost) and are often ultimately revoked. However, during the years of procedural delays the patents are typically maintained and thus the exclusivity of the patent may continue to impact upon various stakeholders – highlighting further issues with patent ofﬁce processes. Where inventors have utilized, but disregarded the traditional knowledge of speciﬁc biological resources, even greater offences and deceptions have been committed. As Dutﬁeld (2004, pp58–9) notes, these practices are analogous to past colonizations: territories, ecosystems, plant varieties and traditional knowledge are treated as if they are res nullius (the property of nobody) before their ‘discovery’ by explorers, scientists, governments, corporations and conservation organizations. The indigenous people, local communities and farmers who retain such knowledge are often not a uniﬁed group. This means that it may be difﬁcult for them to make coordinated statements or challenges against patent documents. It may also make it difﬁcult for researchers to identify which individuals are the appropriate representatives from which to obtain prior informed consent and to establish appropriate beneﬁt-sharing arrangements. These are the sorts of challenges that need to be continually investigated through examples of both failures and ‘best practice’ in research relationships. It has often been left to organizations like the ETC Group and government authorities such as those in India and Peru to pursue patent re-examinations, court cases and potential beneﬁt-sharing arrangements where appropriate. In some cases, the companies involved have made a grudging or belated effort to ensure that indigenous groups are appropriately engaged, recognized and included in negotiations. However, until recently these have been too few and often too late. With increasing international awareness, there is some evidence to suggest that research relationships with resource providers and indigenous and local communities may be improving (see for example, Laird and Wynberg, 2008). The next steps are to ensure there are clearly deﬁned international legal frameworks to enable greater transparency from the patent system, as well as clear biological resource transfer procedures and frameworks for ethical research relationships.

Are More Cases likely? Given the activism of various NGOs, the challenges put forward by a number of developing countries and the various initiatives in international forums such as WIPO and the CBD, one might assume that patent applications and examinations will gradually improve and that the transfer of biological

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resources and traditional knowledge will be more closely monitored. Does this mean an end to patent-based biopiracy in the near future? Unfortunately, this seems unlikely for a number of reasons. Firstly, the US has not ratiﬁed the CBD or the ITPGRFA and in any case international legal mechanisms such as the prospective International Regime on Access and Beneﬁt-Sharing may still take some time to develop and ultimately may be very difﬁcult (and costly) to enforce. This means that US citizens and companies are not bound to the same commitments as other countries until they have ratiﬁed the international laws. For germplasm or other biological resources already in US gene-banks, there are relatively few legal obligations on those researchers when accessing that material; restraints depend upon contracts signed with the individual gene-bank or source. Given the huge quantities of biological materials collected during the Green Revolution and following it, there is ample opportunity for patent-related biopiracy to continue in the US without researchers ever having to actually leave the US on bioprospecting investigations. Secondly, the US has taken a hard line in WTO TRIPS negotiations, implying it will not back down on its present unwillingness to accept a disclosure of origin patent requirement. This suggests that researchers may continue to obscure or ignore details about the source, origins and utilization of biological resources and traditional knowledge in patent descriptions. Thirdly, the interpretation of novelty and obviousness in the US remains problematic and a number of authors have complained that patent examination quality has actually declined – particularly in the US (Hall, 2007; Barton, 2000; Merrill, 2004). There are concerns that too many patents are issued that do not meet the statutory tests of novelty or utility, or are obvious to people skilled in the respective ﬁeld. Authors such as Barton (2000; see also Drahos with Braithwaite, 2002, p47) have also noted the use of defensive patent portfolios to obtain royalties from competitors and to restrict them to speciﬁc areas of technology, which have been vigorously defended, also then resulting in more lenient standards for obviousness through court precedents. For example, the rights of patent holders have been strengthened against alleged infringers by such decisions as Polaroid v. Kodak (1986/1991), which forced Kodak out of the instant camera business (Hall, 2007, p577). Aside from the inﬂuence of the courts, many have suggested that USPTO patent examinations have deteriorated due to examiner qualifications, inexperience and inadequate examining time or to lack of access to prior art information (Merrill, 2004). Although there are few indicators to accurately gauge patent examination quality, a crude measure might be found by comparison between different patent ofﬁces. As Quillen and Webster (2001; see Martinez and Guellec, 2004, p144) note, average grant rates were around 67 per cent at the European Patent Ofﬁce (EPO) and 64 per cent at the Japanese Patent Ofﬁce (JPO) for the period 1995–9, while at the USPTO the grant rate was found to be between 87 and 97 per cent during 1993–8 including continuation applications – essentially re-ﬁlings of existing applications. Hall (2007, p580) also suggests that it is logical that patent quality is declining

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because of the increased load on patent examiners with growing numbers of applications ﬁled and granted relative to the number of examiners available, not only in the US, but also in the EPO and JPO. As a consequence, there are likely to be more dubious patent applications from researchers based in the US or elsewhere who have utilized biological resources and traditional knowledge but will benefit from poor quality patent examinations. To give a current example under examination at the time of writing, see WIPO Patent Cooperation Treaty (PCT) patent number WO/2007/084998 on ‘Compositions comprising kakadu plum extract or açaí berry extract’ (which corresponds with Australian patent application 2007205838, US patent application number 11/624985 and many other country designations, ﬁled 19 January 2007). These patent documents are assigned to the multinational US cosmetic company, Mary Kay Inc., and refer to fruits used traditionally in both Australia (Kakadu plum) and Brazil (açaí). Here we focus primarily on the Kakadu plum, while another case relating to açaí is discussed in the following chapter. The Kakadu plum (Terminalia ferdinandiana) has been used as a food and medicine for hundreds and possibly thousands of years by indigenous Australians in the northern and northwestern regions of Australia. This has been well documented by Gorman et al. (2006), Woods (1995) and Brand et al. (1982). These details are also noted in US patent number 7,175,862 on a method of producing Kakadu plum powder. These documents and others like them provide prior art with regards to the high levels of ascorbic acid or vitamin C found in the Kakadu plum – believed to be one of the highest of any fruit in the world. The same can be said of the açaí fruit discussed in the next chapter. However, the Mary Kay patent applications are seeking protection for a composition utilizing the extracts of the two fruits which ‘can include a high oxygen radical absorbance capacity (ORAC) value’ (i.e. it is high in antioxidants). The composition is intended to ‘improve the skin’s visual appearance, physiological functions, clinical properties, and/or biophysical properties’. As already discussed there are concerns from the Peruvian government about patents on camu camu (a fruit with similar qualities) for which compositions high in ascorbic acid are being claimed. The Peruvian ofﬁcials were concerned that ‘there is evidence of lack of an inventive step’ because ascorbic acid or vitamin C is well-known as an antioxidant and a compound that can prevent mottling and skin ageing. They have argued that it is obvious that camu camu would have the same effect. The same can be said of the Kakadu plum in the case of the Mary Kay patent application. Irrespective of the tenuousness of the patent application claims by Mary Kay for this composition (the patent searches and examinations will resolve this one way or the other), Mary Kay Inc. have other ethical (if not legal) obligations in terms of transparency regarding prior informed consent for access to biological resources (or, failing that, evidence of a material transfer agreement) and benefit-sharing relating to the commercialization of the ﬁnal product (if and when it is commercialized). Given that the corporation

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promotes social responsibility on its websites and reports, this could in fact turn into a fair and ethical situation, but only if the right steps are taken from the early stages. In March 2009, a number of attempts were made to clarify any prior informed consent or other arrangements that Mary Kay Inc. may have made with local suppliers, authorities and indigenous communities in northern Australia. Representatives of Mary Kay were asked where they accessed/obtained the materials for their research, development and commercialization of Kakadu plum and whether beneﬁt-sharing arrangements have or will be established with indigenous communities or via the relevant authorities in the Northern Territory or Western Australia. At the time of writing, no adequate response has been given. As a result, the patent examination and possible subsequent commercialization process will need to be monitored to determine if this can turn into a fair and equitable access and beneﬁt-sharing arrangement, or if it will become yet another case of biopiracy.

Notes 1 It is more common in developed countries, and increasingly in developing countries, to provide plant-variety protection through laws that provide plant-breeders’ rights than to allow plant patents. 2 Ultimately, this case has faded from direct public and media attention following the patent re-examination and subsequently with the patent expiring in 2005 due to non-payment of maintenance fees. Under 37 CFR 1.362 pertaining to the US Patent Act, as of 10 May 2005. 3 Schlais cites a letter from Walter Ritte, Jr and Chris Kobayashi to David McClain, Interim President, University of Hawai’i (23 February 2006). 4 This patent could not be conﬁrmed – the Mexican Patent Database at IMPI is listed only in Spanish. 5 This document can be downloaded from the WTO website at: www.wto.org/ english/tratop_e/trips_e/art27_3b_e.htm, accessed 17 February 2009. 6 This invention is registered as international patent number PCT/KR2000/000961 with WIPO. 7 This patent document, like many others, is poorly written and punctuated with spelling and grammatical errors. 8 See www.naturaljustice.org.za for details. 9 Dhillion and Ampornpan (2000) also note inconsistencies in reported distribution of the plant in their article. 10 Although some process patents may not have any deleterious impacts on other producers or indigenous peoples, there are other circumstances where the process patent may be used deceptively, or the patent scope might be artiﬁcially inﬂated through lawsuits. 11 It is worth noting that the ETC Group believes that the soybean lines used in Monsanto’s patent originated from a wild Chinese species of soybean, which was transferred to a US gene-bank where Monsanto obtained it (ETC Group, March/ April 2002).

4

Non-Patent Biopiracy Cases

Although biopiracy is often discussed in terms of injustices relating to patent monopolizations, there are other cases where biological materials and traditional knowledge are appropriated and commercialized without sufﬁcient authorization and/or compensation. Do these cases deserve the title of biopiracy? They may or may not comply with the description of biopiracy put forward in Box 1.2, depending upon the individual circumstances (e.g. if prior informed consent was obtained and beneﬁt-sharing established). Arguably, many of the following cases do create a similar injustice or inequity to the patent cases mentioned and so they do deserve a similar depiction. Certainly, other forms of intellectual property protections may offer unfair monopolization of plants through, for example, plant-variety protection, or there may be cases where the name of a plant is used misleadingly in a trademark. In other circumstances, biological materials (and the associated knowledge of their uses) may be appropriated and commercialized in a foreign country to the frustration of the country of origin (for economic, cultural or other reasons). This may also occur domestically where parts of a population pilfer the knowledge of indigenous or minority groups. This chapter discusses these other types of monopoly, deception or appropriation as forms of ‘non-patent’ biopiracy. In many of these cases, as with the patent-related biopiracy incidents, there are injustices that have occurred through a number of actions that may have been naive, unethical or, in some cases, unlawful. While it is often difﬁcult to determine precisely who the real ‘victim’ is in each case, the researchers or intellectual property owners involved are, in various ways, free riding on the knowledge or resources of foreign countries and of indigenous peoples. For the most part, international attempts to resolve issues of biopiracy have focused on the need for amendment of the patent system. The other main area of focus has been on closely regulating ‘access to genetic resources and beneﬁt-sharing’ as well as genetic resource transfer rules in the CBD and ITPGRFA respectively. These are areas of critical international law reform in their own right. However, there are areas of intellectual property law that have received lesser attention in the biopiracy context – namely plant-variety protection and trademarks. Therefore, the following section discusses cases

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where a plant appears to be the product of existing knowledge and plantbreeding developments, but a company or individual has still obtained plantvariety protection. Cases are also discussed whereby trademarks have been used that may deceive the public about the origins of a product derived from plants or other biological materials. Finally, this chapter notes some cases of ‘misappropriation’ that have caused injustices, leading in part to the aforementioned international negotiations on access and transfer of biological resources.

Plant-Variety Protection as Biopiracy National plant-variety protection (PVP) systems or plant patents are required by TRIPS Article 27.3(b). While many of the most agriculturally industrialized countries have well-established PVP systems, ‘developing’ and ‘least developed’ countries now have to implement them as a requirement of WTO membership. Most countries have adopted the UPOV model of PVP despite some ﬂexibility allowed in the wording of TRIPS. Under the 1991 Act of UPOV (Articles 6–9), for the protection of a plant variety, it must be novel, distinct, uniform in its relevant characteristics and stable (known as distinctness, uniformity and stability or DUS requirements). The uniformity and stability requirements of UPOV have been heavily criticized by NGOs, academics and also governments from the global south for encouraging genetically uniform ‘monocultures’. In addition to these complaints, some authors have noted that the less stringent ‘novelty’ requirement has meant that plant-variety protection may be easier to obtain than patent protection for plants. This is particularly a concern where breeders have obtained germplasm from a gene-bank or a foreign or ‘indigenous’ source and then sought to protect it under a PVP law. Plant-variety protection laws generally grant a form of monopoly called ‘plant-breeder rights’ (PBRs) which last for 20 years (or 25 for trees and vines) and essentially require authorization of the breeder for use of the propagating and harvested material (under the UPOV 1991 model) for: • production or reproduction; • conditioning for the purpose of propagation; • offering for sale; • selling or other marketing; • exporting; • importing; • stocking for any of the purposes mentioned above. Therefore, plant-breeder rights can provide quite a restrictive exclusive right over the use of a plant variety. In cases whereby germplasm has been obtained from speciﬁc communities or breeders and then protected in a foreign (or even local) jurisdiction, there have been concerns about the implications for the ‘providers’. In some cases, PBRs have been granted for plant varieties that are not novel, but rather were ‘discovered’ in another country. In such cases, the

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rights may be seen to unfairly restrict imports into the country where rights are held. In other cases there is concern that the PBR-protected variety may be free riding on improvements bred into it through past breeding activities. Thus, communities may not have consented to the use of the original cultivar, or they may have wanted to place conditions on its use such as a beneﬁt-sharing arrangement. Because many of the cultivars in question have already been collected or ‘donated’ and sent to international gene-banks, there appears to be little retrospective opportunity for communities to assert their own rights of control over the germplasm. The following cases explore some of these issues.

‘Plant-Breeders’ Wrongs’ in Australia

The NGOs RAFI (ETC Group) and Heritage Seed Curators Australia (HSCA) put out a report named ‘Plant Breeders’ Wrongs’ in 1998 (RAFI-HSCA, 1998), indicating that they had found as many as 147 cases of dubious plant-variety protection that they called biopiracy or potential biopiracy. The report focused primarily on PBRs for plant cultivars registered in Australia under the Australian Plant Breeder’s Rights Act 1994, prior to the report publication date. RAFI and HSCA note a number of cases whereby plant-breeder rights had been granted for a cultivar where there is no evidence of plant breeding, where testing of ‘distinctness’ was not made against the original plant germplasm, and cases where provisional protection has been granted to dubious claims on plant varieties while they are assessed. A number of interesting cases that the RAFIHSCA report highlights from Australia are included in Box 4.1. Many of the plant-breeder rights that were highlighted by RAFI and HSCA related to plant varieties that had been accessed from gene-banks under the auspices of the CGIAR. For example Blakeney (2004, p396) notes that two agencies – Agriculture Western Australia and the Grains Research and Development Corporation – had applied for PBRs in relation to two species of chickpea which had been bred from material that had been provided by the International Crop Research Institute for the Semi-Arid Tropics (ICRISAT), and which had been originally collected in India and Iran. There were concerns expressed by NGOs and academics at the time that the rights essentially covered varieties that were directly appropriated with no additional breeding. Applications AU 97/092 and 095 relating to these varieties were subsequently withdrawn by the applicants due to the negative press that the PBRs received in international media and NGO reports. The Plant Breeders Rights Australia Ofﬁce also amended its requirements for registration of a plant breeder’s right. The authority has requested ‘Detailed Descriptions’ of the characteristics, origins and breeding, comparative trial information and propagative material for this comparison in their Plant Variety Journal (Vol. 11, No. 3, 1998). By requiring detailed information about the origin of the germplasm, name of the parental material, breeding process and differentiation of the candidate variety from the parent, the PBR Ofﬁce has signiﬁcantly reduced the likelihood of PBRs for CGIAR accession varieties. Thus, the most blatant cases of free riding where there is no breeding,

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BOX 4.1 AUSTRALIAN ‘PLANT-BREEDERS’ WRONGS’ Persian Clover A Persian clover (Trifolium resupinatum) variety named ‘Persian Proliﬁc’ (App. No. 1997/036) was ﬁled by the Western Australian Agriculture Authority on 19 February 1997 and accepted by the Australian PBR Authority on 14 March 1997. Although the application has no real passport data (as in many other cases), RAFI-HSCA indicate that the original cultivar was collected on a roadside 9 kilometres north of Menemen in Turkey. The Western Australian Agriculture Authority withdrew this PBR in February 2003 due to the negative publicity it had received over a number of registered varieties.

Faba Bean A faba bean (Vicia faba) variety named ‘Icarus’ (App. No. 1992/007) was ﬁled by Adelaide Research and Innovation Pty Ltd on 29 January 1992 and was accepted as a provisional Australian PBR on 13 January 1994. According to the PBR-ﬁled description, the variety was: developed by selection within a population (accession) of Faba Beans received from ICARDA,1 Syria. The accession [was] one of many received from ICARDA with a reputation for Chocolate spot resistance. [These] were compared for resistance and yield in Australian trials … ICARDA had obtained the population originally from Colombia, South America. This ICARDA accession was apparently from an Ecuadorian farmers’ variety. This PBR certiﬁcate has since been withdrawn.

Diaz Bluestem A Diaz bluestem (Digitaria milanjiana) variety named ‘Strickland’ (App. No. 1995/136) was ﬁled by the Australian Commonwealth Scientiﬁc and Research Organization (CSIRO) on 19 April 1995, was accepted 2 May 1995 and granted 27 June 1996. According to the registered description, the tropical grass ‘Strickland’ was collected from near Lake N’Gami, Botswana by A.J. Oakes of the USDA, Beltville Maryland, US (USDA, ARS, PI 299792), and was introduced into Australia from the University of the West Indies, Trinidad, by CSIRO in 1966. There is little evidence of additional breeding in the description. The title has since been transferred to Progressive Seeds Pty Ltd and is still valid. Sources: RAFI-HSCA (1998) ‘Plant Breeders’ Wrongs’; PBR on the IP Australia website www.ipaustralia.gov.au/pbr/index/shtml

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only ‘forage’ and/or ‘discovery’, are unlikely to be accepted due to the new criteria. Nevertheless, there is still considerable scope for breeders to obscure the origins of a variety, particularly where it has been passed on between researchers several times. As a consequence of this RAFI-HSCA report and the ensuing controversy, the GCIAR also called for a moratorium on the granting of intellectual property rights over plant germplasm held in its centres. This led to the development of the standard material transfer agreement for use of CGIAR materials which has now been incorporated within the rules of the ITPGRFA and which restricts intellectual property rights over CGIAR germplasm. Although some of the issues associated with the intellectual property protection of these varieties appear to have been resolved, there are still unanswered questions about appropriate recognition and compensation for the local farmers and indigenous communities that have bred the original plant varieties, often from ‘wild’ landraces, and that in many cases provided information leading to their collection by the CGIAR and other research centres. There are many non-CGIAR gene-banks, herbariums and research institutes around the world with substantial germplasm and biological resource collections where procedural transparency is not yet established. The following cases provide examples of some of the issues faced where non-CGIAR biological resources are transferred to researchers and commercial enterprises.

Peanuts from Malawi

A peanut has been raised as a potential case of biopiracy by McGown (2006). US PVP no. 200000182 was issued to the University of Florida Agricultural Experiment Station on 15 November 2002 for a peanut (Arachis hypogaea) variety named ‘C-99R’. The C-99R peanut variety is registered in the US Department of Agriculture Germplasm Resources Information Network (GRIN) as Plant Introduction (PI) no. 613135. The GRIN database notes the pedigree of the C-99R variety includes crossbreeding with two other peanuts from Malawi and Brazil (USDA, ARS, PI 259785 and PI 203396 respectively), both collected in the 1950s. The accession history also notes the involvement of a local research body in Malawi, whereas the Brazilian variety was collected from a market in Porto Alegre by a USDA ofﬁcial. According to McGown (2006, p22), the Malawi variety bears important disease-resistance characteristics that are present in C-99R. He also notes that C-99R has captured about 5.5 per cent of the peanut seed market in the US and is licensed to the Golden Peanut Company. Although the University of Florida Agricultural Experiment Station has IP details and royalty structures on their website, it seems unlikely under their current arrangements that beneﬁtﬂows would go back to the original donors in Malawi or to authorities in Brazil. Their royalty structures only include direct contributors to the variety’s development.2

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This case highlights remaining issues with regards to germplasm that has been transferred from ex situ environments to foreign gene-banks prior to the ITPGRFA and the CBD. In this case, the plant-breeder’s right appears to be based on a valid and novel crossbred variety according to US PVP laws. The issue here is whether there should be recognition for prior breeding that introduced disease resistance into the new variety. In the GRIN record, the applicants and the USDA have provided sufﬁcient details that the breeding history of this plant variety can be tracked. In many cases the GRIN records are extremely limited and so external users cannot check to determine the past breeding and origins of a variety. Other checks can be made at the Plant-Variety Protection Ofﬁce Scanned Certiﬁcates Database website3 which often has scanned details that indicate the breeding history and origin of the variety – a requirement of registration. However, many certiﬁcates are missing from this database, including PVP no. 200000182. Additionally, the applicants often only trace back the breeding history of their plant varieties to other recent generations of domestic varieties, thus avoiding the possible ire of having to deal with biopiracy complaints. This appears to be the tactic employed by many breeders currently registering for PVP in the US and elsewhere. If there are several generations of breeding between a foreign plant variety that was collected in the past and a protected variety, the original plant characteristics would arguably have been altered by successive breeding. It also means that the contributions of traditional knowledge surrounding the original plant variety donation may be obscured in the documents as indirect to the current novelty of the PVP-registered plant variety. This is occurring despite the fact that many of the disease-, insect- or drought-resistant accessions and donations that occurred during and prior to the Green Revolution were made with the cooperation or involvement of local researchers, ofﬁcials, farmers or indigenous people who knew of, or indeed helped to develop, these distinctive traits.

Habanero Pepper

A new case of interest was identiﬁed in the US PVP Ofﬁce database with PVP no. 200400329 for the ‘TAM Mild Habanero Pepper’. This certiﬁcate was issued on 25 January 2007 to the Texas Agricultural Experiment Station. The main concern in this case is that the pepper (Capsicum chinense) cultivar was bred from a cross between an orange habanero pepper from the Yukatan Peninsula and a pepper (PI 543188) collected from Bolivia. The Texas A&M University System Agriculture Program put out an ‘AgNews’ press release on the pepper on 12 August 2004, describing it as a successfully bred mild version of the infamously hot and piquant habanero pepper. From a ﬁve-year breeding programme the progeny of a cross ‘between a hot Yukatan habanero and a heatless habanero from Bolivia began to show promise’ (Santa Ana III, 2004). Due to the mildness of the normally piquant habaneros, those breeders from the Texas Agricultural Experiment Station have indicated their excitement at the possibility of selling the habaneros to

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salsa companies and as a fresh product at between $3 and $4 per pound; while the comparable jalapeno peppers fetch around 50 cents per pound (Kevin Crosby, cited by Santa Ana III, 2004). However, much of the uniqueness of this mild habanero can probably be put down to the variety collected in Bolivia. The GRIN database record indicates that the variety is ‘not piquant’ and that it is ‘said to be grown locally’. The original variety was purchased by a USDA ofﬁcial from a Brazilian vendor in the Cobija market of Nicolas Suarez Province (Pando Department), which borders Brazil, on 13 November 1988. The plant material was then transferred to the USDA Plant Genetic Resources Conservation Unit in Georgia where the Texan breeders appear to have obtained the germplasm (GRIN PI 5431988). There are a number of documents that indicate the extent of breeding and use of cultivars of the Capsicum chinense species, including the habanero pepper in South and Central America. Pickersgill (1969; 1971) indicates that archaeological excavations have placed sedentary people practising agriculture east of the Andes, possibly as early as 2000 BC, indicating that it was probably these people who ﬁrst domesticated cultivars of the Capsicum chinense species. Articles such as those by McLeod et al. (1982, p36) and Bosland (1996) also indicate that the likely place of origin of the domesticated Capsicum chinense cultivars are the lowland Amazon Basin with a potential range across Central America, South America and the Caribbean. Clement (1999, p210) also predicts the biogeography of Capsicum chinense at the time of colonial ﬁrst contact in 1492 to be centred on the Amazon Basin, particularly the Amazon River. Thus, there is extensive evidence of the domestication and breeding of habanero peppers for use as a food in the region bordering Brazil and Bolivia. There is also evidence of indigenous use of the plant for medicinal purposes (Davis and Yost, 1983; Roys, 1931; Alcorn, 1984). Despite these documents, due to the limited requirements for granting plant-breeders’ rights in the US (and elsewhere) the examiners do not need to consider prior art as a registration criterion in the same way as a patent, and therefore these documents do not invalidate the plant-breeder’s right. In the PBR documents there is some evidence of breeding, although the socalled ‘novel’ non-piquant trait of the ‘TAM Mild Habanero Pepper’ is likely to be a direct result of the breeding by local growers in Northern Bolivia. Because the USDA admits that the original plant was bred locally and found already with this trait, there is a strong case suggesting that the individual breeders at Texas Agricultural Experiment Station should consult with the USDA and local agriculture authorities in Nicolas Suarez Province to establish a process of engagement and beneﬁt-sharing with the original breeders. The genebanks of the USDA should also be much more cognizant of these issues and should be establishing MTAs like those required by the international research centres of the GCIAR, including recognition, consultation and beneﬁt-sharing arrangements with indigenous and local provider groups as well as restrictions on IPRs. That this case is so recent suggests that researchers are still not aware of both the ethical obligations on them with regards to indigenous knowledge of

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plant varieties, and the legal obligations being developed in the international forums already discussed. However, because the US government has not ratiﬁed the CBD or the ITPGRFA, it is essentially legitimizing these sorts of malpractices so long as they comply with the word of the domestic intellectual property laws in question.

Other Cases of Dubious Plant-Breeder Rights

A number of other dubious cases of PBRs sought or granted over plant varieties are worth mentioning, which relate to the subject matter of some of the patents already discussed. These include PBRs on Enola beans, basmati rice and Kakadu plums. In addition to the patent granted to POD-NERS, the Enola bean has been granted a PVP certiﬁcate in the US (PVP No. 9700027). The application was ﬁled on 5 November 1996 and was granted on 30 June 1999, for 20 years protection. While the patent on this plant variety was challenged and eventually invalidated, the PVP certiﬁcate is still valid, meaning that the certiﬁcate-holder could still threaten legal action to inhibit trade in beans such as the Azufrado Peruano 87 bean that researchers have claimed is likely to be the direct parent of the Enola (Pallottini et al., 2004, p968). On 11 December 1995, RiceTec Inc. sought to register for PVP a rice variety named Basmati 867 in the US. This rice variety has PI no. 593021, which has only a partial record in the USDA GRIN database, but is likely to have been acquired originally from India or Pakistan and then ‘developed in Texas’. Under pressure from NGOs and the Indian authorities, the company abandoned this application in July 1997. An application for PBRs on a Kakadu plum variety named ‘DD26’ in Australia was received on 4 March 2004 and provisionally accepted on 25 March 2004. As already discussed, the Kakadu plum is a bushfood traditionally used by indigenous Australians. The title holder for this provisional PBR is Cognis Australia Pty Ltd and Access Business Group International LLC – the latter company holding a process patent on a method for producing Kakadu plum concentrates. A researcher from Cognis Australia indicated that the individual applicant for PBRs has since retired from Cognis and so the application has sat idle since 2004. An ofﬁcial from the PBR Ofﬁce in Australia has indicated that: ‘the applicant has reported a number of logistical issues relating to the siting and ownership of the comparative trial. As a consequence, the agent is currently in the process of conﬁrming their intentions with the possibility of withdrawing the variety from the PBR scheme’. (Jodie Boyd, personal communication, 18 March 2009).4 Some other PBRs are also worth noting for their lack of adequate description. Historically, the US PVP Ofﬁce has granted many certiﬁcates to plant varieties that have very simplistic descriptions about their breeding and/or origin. For example, PVP no. 008200110, granted in 1982, is a barely legible handwritten submission that indicates an orange Cayenne pepper was ‘discovered as a single plant, by me [Tommy Bolack] in a planting ﬁeld of Red Cayenne’. The

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description provides little more evidence or explanation. Similarly, a certiﬁcate for a pak-choi variety granted to a company in California in 1978 and then transferred to Novartis Seeds again provides a poor description of source (PVP no. 007605009). The certiﬁcate indicates that the germplasm was secured from ‘an Oriental Gentleman, now deceased, in Salinas [California]. This seed was, we presume, from the Chinese mainland as both the seed and the source were closely guarded during this man’s lifetime.’ To rectify these vagaries, the US PVP Ofﬁce, much like its Australian equivalent, has improved its standards for checking the breeding and origin of plant varieties so that, in most cases, the direct parental breeding lines can be identiﬁed. Although it can be difﬁcult to trace these lines back further, the details provided sometimes also allow interested parties to determine the earlier origins of the plant varieties. In some cases where there is direct parent germplasm sourced from other countries, there may be a case for the original farmers to seek beneﬁt-sharing arrangements or other retrospective acknowledgement for their input in the breeding process and use of their knowledge. In other cases there may be a more indirect germplasm heritage through several generations of breeding and, thus, the opportunity for the original farmers to seek recognition is more complex and less likely to succeed.

Trademarks as Biopiracy? A number of incidents have also arisen whereby trademark protection has been sought over the name of a plant. There is particular concern from the countries of origin about deception surrounding the origins and qualities of the product. This may be a result of the sheer breadth of scope available for trademarks under TRIPS and through which countries have considerable ﬂexibility to adopt their own standards for registration (see Box 4.2). The scope for protection under Article 15 of TRIPS is very broad. It allows for signs that people could perceive as distinguishing or signalling a particular

BOX 4.2 ARTICLE 15.1 OF THE TRIPS AGREEMENT – PROTECTABLE SUBJECT MATTER OF TRADEMARKS Any sign, or any combination of signs, capable of distinguishing the goods or services of one undertaking from those of other undertakings, shall be capable of constituting a trademark. Such signs, in particular words including personal names, letters, numerals, ﬁgurative elements and combinations of colours as well as any combination of such signs, shall be eligible for registration as trademarks. Where signs are not inherently capable of distinguishing the relevant goods or services, Members may make registrability depend on distinctiveness acquired through use. Members may require, as a condition of registration, that signs be visually perceptible.

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good or service; these signs not only include visual words and designs, but also sounds, scents and colours (or usually as a combination of colours). However, there are restrictions on what can be trademarked. As UNCTAD-ICTSD (2005, pp228–31) notes, trademark law generally permits descriptive terms to acquire trademark status, but in many jurisdictions this depends upon the terms having achieved a level of distinctiveness or recognition associating that good or service with the company in question. They also note that according to general principles of trademark law, ‘generic’ terms may not serve as a trademark for the goods they identify. For example, a generic term is that which is used for a type or class (a ‘genus’) of products or services, such as ‘bed’ or ‘car’ (UNCTAD-ICTSD, 2005, p231). Plant names are also considered to be generic, including their binomial nomenclature (genus and species), plant variety or cultivar name, and their common name.5 Although not explicitly detailed in the TRIPS Agreement and other international laws on trademarks, this restriction on trademarks over plant names has been enforced in various countries. For example, the Australian government body dealing with intellectual property – IP Australia – has issued an information sheet to indicate that applicants seeking trademark registration under Class 31 (agricultural products) of the Trade Marks Act 1995 cannot register a plant name. Where trademarks have been granted over plant names, there are again concerns about traditional knowledge associated with the original products. In cases where plants have been used traditionally for medicinal purposes, or bred and improved as food crops, the traditional users may be concerned that others are misusing a name or freeriding on their knowledge and/or plant variety improvements. More broadly, the countries of origin of speciﬁc biological resources may be concerned about the potential for deception that the trademarks cause regarding the place of origin and/or the quality of the speciﬁc product. As is the case for many long-standing products protected under geographical indications (GI) rules, such as champagne from France or English Stilton cheese, the reputation and quality of those speciﬁc products has a close association with the geographical region in question. These regions may be important because of growing conditions such as climate and soils, but also because of traditional practices and techniques that give the product its unique status to consumers. Thus, many of the complaints that have arisen, particularly (but not solely) from biodiverse developing countries, relate to plants or biological products that have not yet beneﬁted from GI protection (as in the case of many European products) and that have distinctive qualities and/or knowledge associated with their place of origin. In other cases, the use of overly generic trademarks may simply be obstructive and affect other companies that want to use the term to describe their products in a nonproprietary way. To illustrate these issues, the following sections discuss the ‘Jasmati’ trademark, a trademark on rooibos tea and the concerns of the Brazilian government focusing particularly on açaí. These are cases where concern has been expressed about the use of a trademark in a foreign country that may be deceptive about the origins and qualities of the food or biological product in question. These

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circumstances have been inﬂamed to the point where some stakeholders have called the incidents ‘biopiracy’ – particularly in the Jasmati case.

The ‘Jasmati’ Trademark

In 1998 an international network of NGOs informed the Thai NGO BioThai that a US company had registered jasmine rice under the US intellectual property system.6 Scrutiny of the claims reveals that the US company, RiceTec, Inc., had made several attempts to trademark the name ‘Jasmati’ or some similar derivation of the word ‘jasmine’. Ultimately, they succeeded in registering a trademark associated with a rice product called ‘Jasmati’ in 1993 (Robinson, 2010). The concerns were rapidly and widely reported in the Thai press with varying degrees of accuracy.7 Because RiceTec had also successfully registered the US patent on ‘Basmati Rice Lines and Grains’ in 1998, some confusion occurred between the two cases (Rerkasem, 2003). It was widely believed by the Thai public at the time that there was a trademark and a patent on jasmine rice (khao hom mali). In fact, there was only the ‘Jasmati’ trademark (and a process patent that raises some questions, discussed below). DNA ﬁngerprint analysis has since been done comparing the US varieties in question with the most common jasmine rice varieties, revealing that ‘Jasmati’ is genetically unrelated to jasmine rice. Hence the trademarked product does not use Thai jasmine rice genetic material or agricultural traditional knowledge. Rather, it is deceptive to consumers about the origins of the product. There were also notable concerns in India and Pakistan about deceptions that could occur through use of the name ‘Jasmati’ for basmati rice products under a patent at the time owned by the same company (discussed in Chapter 3). With respect to Thailand, it is worth noting that rice represents the largest agricultural export for which khao hom mali makes up a signiﬁcant proportion (approximately 20 to 25 per cent). Furthermore, Thailand’s long history as a rice-growing country whereby rice represents an integral part of its agricultural heritage, emphasize its importance both economically and culturally. For example, the Thai word for ‘food’ is ‘khao’ which literally means ‘rice’. As a consequence of the purported intellectual property over jasmine rice there were a number of protests held throughout the country, including a crowd of about 500 jasmine-rice farmers outside the US Embassy in Bangkok led by Assembly of the Poor leader Weerapol Sopa and Witoon Lianchamroon of BioThai, among others. The group made the following three demands of the US: • •

The US government must revoke the Jasmati patent [trademark] and must refuse to grant any patents on jasmine rice or other indigenous rice varieties from Thailand; It must urgently cancel the trademarks on Jasmine, Jasmati, or other marks that may confuse the public into believing that such rice is jasmine rice;

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It must stop direct and indirect pressures to force developing countries to provide patent protection on life forms. (Tanasugarn, 1998; Lianchamroon, interviews, 2005)

The Thai government was in the midst of dealing with Thailand’s sizeable national economic crisis at the time and therefore they responded slowly to public concerns. Consequently, the King of Thailand, who does not usually become involved in such political matters, granted an audience to executives of IRRI, from whom it was believed that genetic material had been obtained by RiceTec, Inc. IRRI quickly made a public statement that they did not condone the ‘Jasmati’ trademark and believed it may ‘mislead consumers that such rice is Jasmine rice, grown in Thailand, or Basmati rice, grown in other Asian countries’ (Tanasugarn, 1999; Robinson, 2010). The Jasmati trademark has since been approved for renewal in 2003. Only one challenge has been made on the trademark by another US Company, named Sun Lee, Inc., which was a claim over a similar logo graphic used by both companies. The action was dismissed by the US Trial and Appeal Board (USPTO, accessed 2006). The Thai government and Thai companies to date have not challenged the trademark. A representative from the Thai Department of Intellectual Property was somewhat sceptical whether a case for repeal of the trademark would succeed, noted the expense a trial would incur and suggested that political pressure had been seen as a more desirable option at the time. However, it was also suggested that Thai companies could still challenge the trademark (Assawin Tharang Khun, interview, 2005). Another interesting, related US patent has been identiﬁed with Patent No. 5,208,063, assigned to RiceTec. This time the subject is a process patent that yields ﬂuffy and tender cooked rice with similar characteristics to that of jasmine rice (Tanasugarn, 1998). However, the patent does not mention jasmine rice. This does arouse curiosity about whether RiceTec, Inc. was intending to use this process to give the ‘Jasmati’ rice product characteristics more like Thai jasmine rice, thus contributing to further possible deception about their product. It is likely that the combination of this process patent and the ‘Jasmati’ trademark heightened the biopiracy concerns of many Thai stakeholders. The case also highlights a common Thai public concern that plants and animals should be excluded from monopolistic intellectual property protection (see Yuthavong, 2003; Lianchamroon, interview, 2005; Changtavorn, interview, 2005). As Tanasugarn (1998) argues, many Americans who complained that the jasmine rice crisis was blown out of proportion should understand that the Thais’ resentment towards any attempt to monopolize plants is based on their agricultural background and heritage. Since rice is the most important crop culturally and economically for Thailand, the issue became particularly sensitive (Robinson, 2010). As a consequence of the trademark, some Thai authorities have since been considering a self-defensive form of intellectual property protection. The potential for geographical indication of Jasmine rice has been considered to protect its name under the Act on Protection of Geographical Indications B.E.

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2546 (2003). However, Thailand has reportedly been under pressure from the US not to provide such protection, but rather to undertake trademark protection for individual companies that sell and export the rice. US authorities and lobby groups have suggested that the term ‘jasmine rice’ is a generic name for a plant variety and that it is not geographically speciﬁc so as to warrant GI protection (Kuanpoth, 2005). Trademark protection would not necessarily stop similar misuses of the name ‘jasmine rice’ or khao hom mali, but only protect the trading names of individual companies. The most prevalent jasmine rice variety (Khao Dok Mali 105) has its origins in Chonburi province (central region) and was transferred by farmer/ breeders and grown in Chachoensao province, before also being spread throughout the Issan (northeast) region where it is now predominantly grown (Songkran, interview, 2006). Thai farmers and authorities would argue that it is the climate and soil conditions in the dry Thung Kula Ronghai plateau in the northeast and the generations of conventional breeding and selection that have improved the quality of jasmine rice such that it has soft, white, aromatic characteristics. It is also important to note that American rice-breeders have been trying for years to breed and improve Thai rice varieties to match those grown in Thailand, but have been unable to do so (IRRI, 2001). These factors suggest that some variation of Thai/Issan jasmine rice or khao hom mali would in fact be a suitable candidate for GI protection. In summary, the primary concern here is with the misuse of the name ‘jasmine rice’, which is associated with a product of distinct quality and regional origin, and which is also highly regarded in Thai culture. For local NGOs, the rice industry and even Thai authorities this deceptive trademark justiﬁes the label ‘biopiracy’. This issue was further inﬂamed by a ‘misappropriation’ of jasmine rice germplasm by a US breeder, which is discussed in detail in a subsequent section.

Rooibos Tea

Rooibos (Aspalathus linearis, Fabaceae) is a plant that is indigenous only to the Cedarburg Mountain Range near Cape Town, South Africa. Wilson (2005, p140) notes that the mountain-dwelling people of the Khoikhoi tribe were the ﬁrst to use rooibos as a tea and, had it not been for them, rooibos would have probably simply remained an unutilized bush. The name ‘rooibos’ is an Afrikaans word meaning ‘red bush’ for which the plant has been commonly known since at least the 1960s and probably back to the 1940s, and which is perceived as part of the country’s heritage (Cheney and Scholtz, 1963). With the more widespread trading of rooibos tea, many have made claims about its therapeutic effects, particularly relating to the content of antioxidants and minerals such as zinc. Rooibos production now mainly occurs in a region some 200–300km north of Cape Town, with commercial cultivation of the domesticated or ‘Nortier’ tea in farmed land tracts, as well as a range of ‘wild’ varieties collected by local communities (Nel et al., 2007, p117). Local NGOs such as the Environmental

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Monitoring Group, Southern Africa (EMG) have been supporting the activities of local communities, currently organized as the Heiveld Co-operative and the Wupperthal Tea Association for the harvesting of wild rooibos. These organizations have reputedly become the de facto guardians of the remaining wild rooibos genetic stock (Arendse, 2001). Noted threats to rooibos genetic diversity include the replanting of crop monocultures to replace existing communities and wild stocks, as well as potential climate change impacts on the ecology of these mountain plants. On 3 February 1993 a trademark was ﬁled for the term ‘rooibos’ with the USPTO for use with herbal teas, among other things. The trademark was then registered on 22 November 1994 (Reg. No. 1864122) to a South African company called Forever Young. Following this, a company named Burke International then acquired the trademark and reportedly spent over $250,000 attempting to protect it (Amin et al., 2005, p60). In one court case against the trademark, The Republic of Tea, Inc. v. Burke-Watkins, the District Court in Missouri found that ‘“Rooibos” is the word which has consistently been used to denote the speciﬁc shrub from which [the parties’] tea is derived’.8 The court ultimately reached the decision that the term ‘rooibos’ was a generic description of the plant variety. This, and a number of other lawsuits from Rooibos Ltd (South Africa) and Seelect Tea Co. (California), ultimately forced Virginia Burke-Watkins from Burke International to voluntarily surrender the trademark. A number of commentators have since suggested that the USPTO had granted this trademark in error. It appears that the USPTO failed to adequately check to determine the prior use of the term. It also appears that Burke-Watkins and her attorney were either turning a blind eye to the prior use of the term, were attempting to ‘trick’ the trademark system, or were naive about the legal scope of a trademark (Amin et al., 2005, p61). As a consequence of these actions, hundreds of thousands of dollars have been wasted trying to resolve the issue. Notably, the companies that challenged the trademark were large enough to make these challenges – if it was left to smaller cooperatives of farmers, the trademark may still be in existence. Subsequently, both Burke-Watkins and Rooibos Ltd have registered further trademarks for tea products that use the term rooibos in conjunction with a speciﬁc logo (reg. nos 3,232,510 and 3,182,142 respectively). These trademark records contain the disclaimer ‘No claim is made to the exclusive right to use “rooibos” apart from the mark as shown’, to rule out any ambiguity. In this case the main victims were the exporters of rooibos tea to the US, who were forced to confront the trademark in court cases. Approximately 30 per cent of the South African national harvest is exported, while virtually the entire production of the two communities from Heiveld and Wupperthal now reaches international markets. Although it has been reported that the trademark had signiﬁcant impacts on the resource-poor cooperatives, representatives from EMG who work closely with the communities have indicated that, at the time, Heiveld and Wupperthal were not exporting much of their tea product to the

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US market. However, if the trademark were maintained it would have been a signiﬁcant barrier for trade by these communities to the US (Oettle, personal communication, 2009). Fortunately for them, a number of large US tea and coffee companies and the South African company Rooibos Ltd absorbed most of the legal fees (March, 2007). This incident led to the establishment of the Rooibos Council and prompted the South African government and the industry to consider geographical indication protection. A South African Department of Agriculture ofﬁcial has noted that although the GI system for protection of wines and spirits is wellestablished in the country, the system for protecting non-alcoholic products is a mix of trademarks, unfair competition and consumer protection at present (Dirk Trotskie, cited by March, 2007). The South African government is therefore launching collaborative research projects to investigate the potential of GIs to protect products like rooibos, including the potential reform of laws for GI protection.

Açaí and Other Brazilian Cases

The Brazilian government has also responded to trade-related trademark issues by publishing a list of more than 5000 generic terms (from Portuguese) related to Brazilian biological resources. The Brazilian IP authority, Instituto Nacional da Propriedade Industrial, has been pursuing a number of trademark disputes in the US, Japan, Italy and the UK, particularly where companies have used the Brazilian-Portuguese name of a plant or fruit as a trademark (IP-Watch, 2006). This list was submitted to WIPO which noted it in its Standing Committee on Trademarks, Industrial Designs, and Geographical Indications in November 2006, as well as the WTO TRIPS Council. WIPO’s Standing Committee indicated that: Such a list will help to inform would-be trademark applicants as well as trademark registration authorities of the generic nature of these terms in Brazil. Among others, such initiatives are expected to have some impact on avoiding the appropriation, by private parties, of generic terms used for the designation of plant genetic resources. (WIPO Update 281, 21 November 2006) The circulation of this list to international organizations and trademark ofﬁces around the world has sought to discourage registrations of generic names to avoid the costly legal pursuits that have been ongoing. One example is the açaí berry (Euterpe oleracea, Mart.) which is a common name in Brazil for a small dark blue or black fruit that was traditionally used as a food and possibly a medicine in the Amazon (Lévi-Strauss, 1952), but has more recently become a popular health-food item in Brazil and in other countries (IP-Watch, 2006). The fruit has been described as a ‘superfood’ with various claims made over its antioxidant content, mineral content and ability

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to improve sexual performance; it is now commonly used in fruit juices as well as dietary supplements. A search of the US Trademark Electronic Search System for the term ‘açaí’ yields 105 results of which 68 records are live. Many applications have been refused by the Trademark Ofﬁce because they represent a generic use of a plant name, but there are still many others that include the term as part of a trademark for a food or nutritional product. Of these, there is a handful that could conceivably affect Brazilian food exports to the US, if the trademark owners decide to zealously litigate against açaí products. These include trademarks such as Serial No. 78639680 for ‘Acai Plus’, registered 2 May 2006, relating to dietary supplements containing açaí extracts. Other trademark applications, such as the USPTO Serial No. 78053027 for a word mark ‘Acai’ for a fruit-based beverage, appear have been abandoned due to pressures from the Brazilian authorities on the USPTO and trademark applicants. A search of trademark registrations of other popular South American health foods such as maca also reveals many trademark applications and a number of successful registrations, suggesting that other countries such as Peru may also be facing similar battles against deceptive trademarks. The legal effectiveness of publications such as Brazil’s generic list has been questioned and so many countries are considering protections like GIs for some of their more unique agricultural products.

Misappropriations of Biological Resources and Traditional Knowledge In some cases, commercial enterprises have utilized traditional knowledge relating to a plant or other biological resource without the use of a patent or other intellectual property rights. In these cases, the main concern resulting in the depiction of these cases as a ‘misappropriation’ has been where traditional knowledge holders feel they have been exploited. This may be because this knowledge was held outside the public domain, but has been ‘discovered’ by researchers and then commercialized. There may be customary offences that arise as a result of this disclosure to the public domain; the indigenous or local knowledge holders may believe they should be involved in the commercial activity or that they should receive some of the beneﬁts that it yields; or in other cases the community may have some cultural objection to the modiﬁcation or commercialization of the product (as occurred in the Hawai’i taro case). As Carlos Correa has noted: In some cases commercial companies profitably exploit [traditional medicinal] knowledge, which is publicly available, without acquiring IPRs, and without any beneﬁt-sharing with traditional knowledge holders or cultures of origin. Examples include kava-kava from the Paciﬁc Islands, tea tree oil from Aboriginal Australian medicine, Devil’s Claw from Namibia and South Africa, Prunnus [sic] Africana from equatorial Africa and

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many other herbal medicines popular in western markets. (Correa, 2002, p40) These misappropriations are often played down by the collectors or researchers involved because the lack of IPRs means there is no exclusive claim to commercial operations over their product. However, this sort of argument is naive about the issues surrounding the disclosure of indigenous or traditional knowledge in the public domain. It may also be exploitative where companies that export the products return little revenue or proﬁts back into the communities that discovered, developed or conserved the product in the ﬁrst place. The following cases explore some of these issues surrounding misappropriations of biological resources and associated traditional knowledge. Here, misappropriations are depicted as a subset within the typology of biopiracy. In fact, it is important to note that alongside biopiracy cases involving patents on hoodia and kwao krua, the impacts of over cultivation by commercial herbalist operations that have no exclusive rights have often been far more detrimental than the impacts caused by those operations which have exclusive rights (and are usually tightly regulated and monitored). The cases discussed here include the Biotec/University of Portsmouth Marine Fungi case, the Stepwise Program for the Improvement of Jasmine Rice for the US and a bioprospecting incident from Chiang Mai

The Biotec/University of Portsmouth Marine Fungi Case

A collection of more than 200 rare strains of marine fungi were originally collected by researchers from mangrove and coastal areas in southern and eastern Thailand in 1997–8. From interviews with government ofﬁcials it has been asserted that these were just samples collected from driftwood, with no associated traditional knowledge. Intended for the National Center for Genetic Engineering and Biotechnology (Biotec) in Bangkok, the marine fungi specimens were reputedly posted to the UK by a Portsmouth University professor where they could be adequately stored, under collaborative research terms. In 1998 Biotec asked for the specimens back, citing a ‘gentleman’s agreement’ that they would be turned over when requested. Portsmouth University staff then proceeded to give conﬂicting answers to that request for several months (Srethasirote, interview, 2005; Anonymous, interview, 2006). Thai ofﬁcials and academics began to fear that the country could lose the right to develop and beneﬁt from the rare fungi strains if external pharmaceutical ﬁrms discovered and patented any drug potential in them (Kuanpoth, cited by Daoreung, 1998; Robinson, 2006). These concerns are based upon a chronology of confusing replies received from Portsmouth University. In January 1998, Dr Richard Greenwood, head of the university’s School of Biological Sciences, said he would ‘endeavour to repatriate the Thai isolates’ and asked Thailand to contribute to the cost of dispatching the cultures. In February, he wrote back saying that he would not take any action which might have a ‘ﬁnancial or legal repercussion’. Greenwood also indicated in an

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email to Biotec in February that the university was willing to return the fungi specimens, but would ask Biotec to shoulder technical and shipping expenses. Weeks later, he said a number of strains collected from Thailand had already been sold to commercial companies (Anonymous, interviews, 2006, 2007; Daoreung, 1998). Another letter from the university’s business development director, dated 10 August 1998, implied the institution would not return the specimens because the fungi strains had been collected by its own staff and, therefore, legal title to the collection resided with the university. Then, on another occasion, Biotec ofﬁcials were told that the university could not return the strains because they belong to a company which sponsored the fungi strains collection and research in 1997. Yet in August 1998, a Portsmouth University spokesman was quoted in the Independent newspaper as saying the strains ‘are being looked after properly and have not been sold to science’. Finally, on 27 August, Biotec received a reply from John Craven, the university vice-chancellor, saying that his institution had no use or interest in the cultures and would have them returned as soon as possible (Anonymous interviews, 2006, 2007; Daoreung, 1998). This is a case where the unclear contractual deﬁnition of tangible property rights has led to the transfer of genetic materials that are rightfully under the sovereign control of Thailand (according to the CBD).9 Biotec staff have been cited as indicating that the bizarre correspondence between Biotec and the university raised a ‘strong suspicion’ that Portsmouth had sold some of the strains to industry (Daoreung, 1998). Thus, consequential research and commercialization of products based on the material could have further implications and ambiguities if patent rights were sought. Based on anonymous interviews with members of industry (2005–7), it has been suggested that the activities of the main researcher involver – Professor Gareth Jones – were highly suspicious. Professor Jones moved from the University of Portsmouth to Biotec between 1997 and 1998. During this period, he reputedly had close working associations with a company called Cyanamid. According to these sources there is a strong possibility that he transferred or sold the strains to this company for screening to determine the potential pharmaceutical value of the strains. During Biotec’s investigation into the strains they actually hired Gareth Jones, not realizing that he may have been the one withholding the fungi. At this time they had thought that the university had sold the strains to industry. Eventually, some of the fungi were returned to Thailand in 1998 (some were missing and some had died through improper storage) (Dhillion and Ampornpan, 2000; Changtavorn, interview, 2005). Notably, ofﬁcials who were interviewed within the Biotec department would not divulge the speciﬁcs of the case, noting that the NGOs and the National Human Rights Commission of Thailand had been more concerned about it (Changtavorn, interview, 2005). Anonymous sources suggest that Biotec ofﬁcials have adopted a nonconfrontational stance and are merely attempting to ‘save face’ since hiring Gareth Jones, who worked with Biotec until recently, rather than questioning him about the issue (Robinson, 2007).

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Stepwise Program for the Improvement of Jasmine Rice for the US

The ‘Stepwise Program for the Improvement of Jasmine Rice for the US’ has also been the subject of biopiracy (of tangible and intangible property) and competitiveness concerns. The programme has been the subject of debate in numerous meetings in Thailand and has appeared in the press with outraged comments made by NGOs and members of the Thai public (see Nation, 2001). The case echoes some of the problems concerning the RiceTec ‘Jasmati’ case described above. According to the Dale Bumpers National Rice Research Center, Arkansas, the purpose of the programme is to develop jasmine rice that US farmers can grow easily and proﬁtably, and thus compete with Thai imports. As a USDA ofﬁcial has noted, the: popcorn or nutty scent [is] one of the most important sensory traits which distinguishes basmati and Thai jasmine from conventional rices. Both of these rices are imported into the United States, and breeders would like to develop cultivars having these same traits which could be produced domestically. (McClung, 2003, p191) Public concern and news media coverage in Thailand has focused primarily on the partner project run by plant breeder Chris Deren in the University of Florida Everglades Research and Education Center (see for example, Hargrove, 2003; Nation, 2001). The programme uses two methods including induced mutations of jasmine rice using gamma-ray irradiation and using conventional breeding methods (Robinson, 2010). Firstly, this programme has been controversial because there are some moral, cultural or religious concerns in Thailand. Inducing mutation through gamma-ray bombardment could be interpreted by many people as being at odds with popular Theravada Buddhist teachings and ‘Thai values’ of nature that are embedded in folklore and daily mealtime rituals or practices (Laohavanich, 1989; Khanittanan, 1989; Chamarik, interview, 2005). Regarding the conventional method, Deren has been crossbreeding the Thai rice strain Khao Dok Mali 105 and Jasmine 85 with other rice varieties. Scientists selected Jasmine 85 from IRRI, which was originally collected in 1966 from provincial Thailand.10 Thus the Stepwise Programme uses two varieties that originated in Thailand and are now being modiﬁed to suit US conditions. A second main concern is that Thai farmers in the arid Thung Kula Ronghai plateau in the northeast (Issan region) have through generations of conventional breeding and selection improved the quality of jasmine rice (see Figure 4.1). These Issan farmers had never thought of seeking exclusive rights to the fruit of their labour. They freely shared seeds with other farmers. To them, and indeed to many other farmers in the region, rice and other food crops are the ‘common heritage of [hu]mankind’ (Nation, 2001; Robinson, 2010).

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Source: D.F. Robinson, 29 April 2005, Suphan Buri Province, Thailand

Figure 4.1 Plant breeder Daycha Siripat demonstrates the selection of seeds for replanting in the following season resulting in genetic improvements. The rice grain – Suphan Buri 60 – shares a similar history of breeding and development to khao hom mali (jasmine rice) and is now considered a ‘modern’ variety

These varieties were improved by Thai farmers and were generously donated to IRRI – which Thai NGOs and the press believe has betrayed trust. Arguably, US breeders can reduce the need for the US to import jasmine rice products from Thailand and also compete with Thai jasmine rice in international markets. When the germplasm was transferred, the Thai researchers did not perceive that it would be used to compete against the exports of Thai farmers (Suntorn Srihaneon, meeting comments, 2005). In addition, concerns about the potential for a US patent on the rice have been expressed. Chris Deren’s rice is very similar to varieties of Thai jasmine rice such as the parent lines of khao dawk mali, as well as Khao Pathum Thani 1. If Deren were able to patent the varieties that he bred or mutated, there could be considerable consequences for Thai exports, particularly in terms of delays getting the Thai export rice to the US market while the patent is inspected.

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On the 6 November 2001, IRRI issued a press statement in response to concerns in the Thai press. IRRI admitted that in 1995, they shared a sample of khao dawk mali with the Dale Bumpers Rice Research Center, but no material transfer agreement (MTA) was signed because at that stage they were not required by IRRI. Scientists from the Dale Bumpers Rice Research Centre and the University of Florida have since publicly agreed to accept all the terms and conditions in the current IRRI MTA and have issued signed letters saying so (Robinson, 2010). Dr Padolina of IRRI has noted that: It should be clearly understood by all concerned that it would be very difﬁcult for Dr. Deren to patent any results of his research concerning jasmine rice, and he has publicly stated he would not seek any patents. (IRRI, 2001) Irrespective of this, Thai farmers and ofﬁcials are still frustrated about the ‘freeriding’ on their long-bred and improved rice varieties by being modiﬁed or bred to compete with them.

The Blurry Line between Bioprospecting and Misappropriation – An Example from Chiang Mai

There is a considerable history of bioprospecting activities in Thailand. The Forest Herbarium of the National Park, Wildlife and Conservation Department provides a long history of collections by foreign botanists, the bulk having occurred in the twentieth century, but with some going back to as early as 1778 (Royal Forests Department of Thailand, accessed 31 July 2006). Thai authorities, ofﬁcials and locals were often generous hosts to visiting scientists and provided assistance with the collection of plants, herbs and other biological specimens often with useful traditional applications. Usually, these collections were relatively uncontroversial (although they may have been offensive to some minority groups), but changing institutional conditions have recently put Thai authorities, NGOs and many local communities on the defensive. As Hayden (2003a; 2003b) notes, some bioprospecting operations in Latin America have deliberately sought to avoid indigenous or local bioprospecting by establishing solid relationships with national authorities, extracting from established research institutes and even sourcing ‘de-indigenized’ plants and knowledge from urban markets where they are already a commoditized part of the national public domain (see Greene, 2004). This is also the case in Thailand, but Thai research bodies are clearly still conducting ethnobotanical collections which end up in these herbariums or gene-banks (Brockelman, 1998). The typical origins of useful for these domestic bioprospectors are local farming communities and community forest areas. Thus, the biological resources and associated knowledge are being passed on through a sequence of transactions and local prospecting polemics are often being avoided or dismissed by local researchers and authorities.

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The point can be illustrated with a description of my own ﬁeldwork experience in Samoeng district (Chiang Mai Province) of northern Thailand in February 2006. This ﬁeldwork was intended to gain a better understanding of the customs, taboos and rituals associated with the use of traditional herbs and local plants by Karen people (Khon Pga k’nyau). The visit coincided with a bioprospecting activity by the Chiang Mai University Faculty of Pharmacy, just prior to our arrival. Karen people from nearby Mae Lan Kham indicated that researchers from the university had come and taken many herbs from the village and surrounding forest after presenting an ofﬁcial-looking letter (Ka-Le, interview, 2006). Ka-Le, a young Karen farmer, indicated that the Karen people provided the herbs, having little knowledge about formal legal authority relating to herb and plant protection, and assuming that they had little right to say no to the collection. The researchers provided a document to the Karen people from the Northern Research Centre for Medicinal Plants at Chiang Mai University. To investigate further, we contacted an academic at the Northern Research Centre, Mrs Suwanna Wadapikun (interview, 2006), to identify details about the bioprospecting activity. She indicated that she was not sure who the exact researchers were, but that it was common for them to access material in Samoeng district from the local Karen communities and that other universities such as Chulalongkorn and Mahidon (both based in Bangkok, and which have herbariums used for pharmaceutical research) also conduct these activities. She indicated that the Northern Research Centre had a herbarium with extensive collections already taken from the surrounding region, including documentation of traditional medicinal uses by Thai, Karen, Hmong and other minority groups in the north. When research activities were conducted, Mrs Suwanna suggested that the head (Kamnan) of the community, or the elders, were always contacted and shown the purpose of the project. She also indicated that they provided some beneﬁts back to communities in the form of information-sharing and education about traditional medicines. The centre does not yet commercialize any of its research, but Suwanna indicated that if commercialization did take place, then the provider communities should be consulted ﬁrst. This indicates a reputedly common occurrence (Srethasirote, interview, 2006; Bai Mai, interview, 2005) where Thai academic researchers access biological materials and associated traditional knowledge from local communities, but without a transparent access and prior informed consent process. Although there were some limited consultation activities by the researchers from Chiang Mai University, the people who provided the resources were left with many questions and concerns that the materials might be commercialized, misused according to their customary laws and possibly patented to the exclusion of others (Ka-Le, Pathii Ta-Yae and Pathii Dang, Soblan village, interview, 2006). Provision of information about the extraction may not be sufﬁcient if it does not also identify future potential for further transactions – seemingly the main concern of the Karen people in this village. Although verbal consent appears

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to have been given for the extraction, it does not appear to be sufﬁciently informed, nor were the beneﬁts clear for the community (Ka-Le, interview, 2006). This case highlights the uneven bargaining power and power relations between formally educated researchers and local people leading traditional forest-dwelling lifestyles. It also raises concerns about the substitution of values that occur in these transactions: the Karen people interviewed in this area have a close ideological and spiritual afﬁnity with plants and nature, which may be disrupted by substituting plant extraction with training, ‘education’ or other dubious ‘beneﬁts’. Lastly, the extraction of plants and associated knowledge from these local knowledge domains also removes them from the customary norms and laws that surround them, as maintained by the Karen people. Often there is an assumption that because indigenous or local communities do not have written laws on how plants and/or knowledge should be used, such laws do not exist. Because of these assumptions, plant-based knowledge has continually been extracted from indigenous and local communities without adequate respect of their customary norms and without adequate prior informed consent. Some of the direct implications and issues raised by these extractions are discussed in the following chapter.

Notes 1

ICARDA stands for the International Centre for Agricultural Research in the Dry Areas and is a CGIAR research centre. 2 See http://research.ifas.uﬂ.edu/ipitt.asp, accessed on 11 March 2009. 3 See www.ama.usda.gov and specifically http://ams.usda.gov/PVPO/ CertiﬁcateDatabase/pvplist2.asp, accessed on 11 March 2009. 4 No detailed description of the Kakadu plum has yet been listed on the PBR database and so no further information could be obtained. 5 Plant names are subject to scientiﬁc and plant industry name conventions including the International Code of Botanical Nomenclature (Saint Louis Code) 1999 and the International Code of Nomenclature for Cultivated Plants 2004. 6 The ‘Jasmati’ trademark can be found on the USPTO website in its Trademarks Electronic Search System (TESS) at http://tess2.uspto.gov/. It has registration number 1807817 and serial number 74372314. 7 For example the Thai language Matichon newspaper placed an article on the 23 July 1998 entitled ‘Farmers Mob Demand the American Embassy to Revoke the Jasmati Patent’, despite there being no patent on the Jasmati product. The concern and confusion was probably related to the patent on basmati by the same company and to the process patent for ‘ﬂuffy tender-cooked rice’ that was raised by some Thai academics. It was also noted in a number of interviews and meetings that the interviewees and attendees still thought there was a jasmine patent in the US. This is in part probably related to the frequent translation problems – while copyright law has existed in Thailand for a century, patents and trademarks are a relatively new form of IP law and hence are a new concept for many people. In interviews with local farmers, often people confused intellectual property (sap-sin thang-pan-yaa), patent (sitthi-bat), trademark (kruang-maai-gaan-kai) and copyright (lika-sit) as overlapping or the same concept.

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8 The Republic of Tea, Inc. v. Burke-Watkins, Case No. 03-CV 01862 (E.D. Missouri, 2005). 9 Notably Thailand had not yet ratiﬁed the CBD at this point in time. However, this provision is merely a restatement of a longer standing UN General Assembly Resolution on Permanent Sovereignty over Natural Resources (1962). 10 It is likely that this strain of rice was collected in 1950, by Mr Sunthorn Srihaneon, an agricultural ofﬁcial in Chachoengsao province. The collection of various rice strains was part of a project operated with an American geneticist, Dr Henry H. Love, acting as consultant. The qualities of the rice were investigated and then later submitted to IRRI (Lianchamroon and Srethasirote, interviews, 2005).

5

Implications and Ethical Dilemmas – What have the Cases Shown?

A wide range of stakeholder groups are concerned about the implications of biopiracy. However, it is not always clear exactly how these individuals, groups, companies and governments might be affected. Depending upon the circumstances there are usually a number of direct and indirect impacts. For example, some of these impacts can be quantiﬁed in terms of lost income from exports – although this is often difﬁcult to accurately gauge in practice. In other cases the implications are much less obvious, particularly when there are poor cross-cultural exchanges between those that have appropriated traditional knowledge and those groups that have provided it, either willingly or unknowingly. This chapter attempts to synthesize some of the main impacts and implications that have arisen from biopiracy. These ﬁndings are drawn primarily from the cases already discussed, but notably there are likely to be other impacts in cases that have not been reported here. The most commonly recognized impacts include: • • • • •

exclusion of producers from further sale or export, usually through litigious pursuit of competitors; inequities whereby local communities, researchers, companies or government bodies are left out of the commercial development process of products based on biological resources and/or traditional knowledge; cultural affront which is caused when prior informed consent is not sought of local ‘provider’ groups and/or where the commercialization of a particular plant or other biological resource is seen as offensive to these groups; over exploitation of the biological resource, which may occur as a direct or indirect impact of a patent or other intellectual property right, as public interest and demand for related products increases; breakdown of research relationships and trust.

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These implications are discussed in detail, but also noting the limited reliable and quantiﬁable evidence of some of the impacts. Generally, these impacts also need to be read with the long history of colonial exploitation of indigenous groups and of former colonies in mind, for which biopiracy represents yet another abuse.

Exclusion from Further Sale or Export In certain circumstances, individuals or groups may ﬁnd that they are excluded from further sale or export of their products as a result of a patent or a plantbreeder’s right. Although in practice this may not occur as frequently as might be imagined, there is evidence that it can occur through the pursuit of litigation or even the threat of legal action. In such circumstances there are clear economic impacts for producers and exporters associated with this type of biopiracy. With regards to patents on plant varieties and other biological materials, there are some common misconceptions about the restrictions that patent rights pose to other farmers, breeders and exporters. For example, if an applicant is granted a US patent over a plant variety, the patent monopoly rights can only be exercised within the jurisdiction of the US. This means that US importers and foreign exporters could have to demonstrate that royalties have been paid for commercial use of that speciﬁc protected plant variety before it is brought into the US. The onus on ensuring there is compliance from importers and exporters rests with the patent right-holder. However, customs inspection authorities have increasingly been charged with the role of monitoring intellectual property ‘piracy’ in recent years, particularly in the most advanced industrial economies. Consider the case of Roundup Ready soybeans (for which patent and trademark rights are owned by the Monsanto Corporation) in Argentina. Qaim and Traxler (2005, p75) indicate that Argentine legislation does not allow patents on plant varieties, opting instead to allow protection of plant varieties through a seed law modelled on UPOV 1978. Under the national patent law, gene constructs and genetic alteration processes can be patented and, based on these rules, Monsanto applied for a patent in 1995. This appears to have been rejected because the novelty requirements could no longer be met (i.e. the Roundup Ready characteristics were already established in the existing body of knowledge in Argentina). Given these IP conditions, any organization in the country can freely use the available Roundup Ready varieties for further development under the breeders’ exemption. However, some Argentine companies do pay royalties to Monsanto under a voluntary agreement to maintain a good relationship, thus allowing access to future genetic innovations. Qaim and Traxler (2005, p73) indicate that due to the relatively weak IP protection and resultant small technology mark ups in seed prices, Argentine soybean growers receive 90 per cent of the beneﬁts in that country. This suggests that despite the internationalization of ‘trade-related’ IP rules, there are still considerable limitations on the scope of protection. Further, these IP

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protections that do exist are only effective so far as they can be enforced, which has been a challenge for many biotechnology companies. For example, having failed to obtain patents in Argentina to protect its genetically modiﬁed (GM) soya plants, Monsanto has sought to protect its rights by suing the importers of Argentinian soya meal for infringement of its UK, Spanish and Dutch designations of one of its European patents (EP0546090). However, in all three jurisdictions each tribunal has reached the same decision: non-infringement (Royle et al., 2008). In the UK High Court case of Monsanto Technology LLC v. Cargill the judge found that Monsanto had not proved that the DNA as present in the imported soya meal was ‘isolated’ – necessarily resulting in Cargill being found not to infringe the DNA claims of the patent (as per the wording of Claim 1 on an isolated DNA sequence encoding a glyphosateresistant enzyme) (Cohen and Morgan, 2008, p290). These limitations on the scope of patent protections are supported in a study by Binenbaum et al. (2003, p331) which indicates that crop-breeders in developing countries have substantial freedom to operate regarding research on most crops of greatest signiﬁcance for food security. They indicate that IPRs over biotechnologies relevant to agriculture are held mainly in (and are therefore mainly relevant to) developed countries. The main IPR-based impediments exist where farmers from the global south are exporting ‘infringing’ products to northern countries. This latter point is important for cases of biopiracy, where there may be unfair impediments to exports from south to north. In the speciﬁc circumstances of biopiracy where a patent is spurious, overly broad, or is based on traditional knowledge, there may be some serious implications for sale and export of related products. The most commonly cited incident having this kind of effect was the yellow Enola bean patent discussed in Chapter 3. Due to the litigious pursuit of US importers of yellow Mexican beans, trade of related varieties of yellow beans between the two countries virtually halted. Larry Proctor from POD-NERS sought royalty payments and then sued companies that would not comply. One of the companies sued was Tutuli Produce, which has indicated that their customers were notiﬁed that Tutuli beans were illegal, followed by further actions including customs border samples of every load of beans. The company president, Rebecca Gilliland, indicated that this cost her company $300 per load and unpredictable delays. Worse than that, yellow bean production fell from 250,000 tonne to 96,000 in Sinaloa, Mexico, from 1998–99 to 2000–2001. For the 2000–2001 season, the acreage sown in yellow beans in Sinaloa had declined by 76 per cent, which was all sold on the domestic market (Carlsen, 2001). These impacts were obviously felt by US importers who had to ﬁght legal battles as well as incur additional expenses and import restrictions. In this case, the impacts upon Mexican farmers would also have been quite substantial, with farmers forced to change crops or to sell at lower prices. There have been similar concerns about the use and sale of improved crops in relation to the Monsanto (formerly Agracetus) patent EP0301749 on genetically modiﬁed soybeans and the Agracetus patent covering ‘genetic engineering of cotton plants and lines’. In the soybean case, through mergers

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and acquisitions Monsanto essentially has developed a stranglehold over GM soybean research and markets. The European patent on GM soybeans had the potential to further restrict the expansion of research and commercialization by other agri-industries. With the revocation of the EP0301749 patent, there are now slightly greater opportunities for industry to expand into this market. In other cases, the over-inﬂated promotion of a patent beyond its real scope may threaten the production and sale of competing products as witnessed in the kwao krua biopiracy incident. However, these sorts of issues can usually be quickly resolved between the different parties informally or in the courts. The rooibos trademark also warrants another mention here. Due to the vigorous defence of the rooibos trademark by Burke International, South African tea exports to the US were inhibited until court proceedings were completed. Approximately 6000 tons of rooibos tea have been produced each year from 1999–2000, with approximately half of this being exported and foreign earnings worth US$2.4 million of a total US$8.3 million (Arendse, 2001). Most of this export income is from Europe, but in recent years the US market has opened up considerably. Due to the prolonged battle and high legal costs, the US trademark had some signiﬁcant impacts on the South African industry. The tea-producing Heiveld and Wupperthal communities are reported to have not been signiﬁcantly impacted by the trademark dispute, but the tea industry of South Africa and in the US lost an estimated US$1 million (March, 2007). In the case of the ‘Stepwise Program for the Improvement of Jasmine Rice for the US’ concerns about exports were based on two main issues: if a patent was obtained by the US researchers then there would be jasmine rice export restrictions at customs; or even where a patent is not sought, the main intention of the programme is to adapt Jasmine rice to US growing conditions such that it might compete against Thai exports. The ﬁrst concern is hypothetical – no patent was ever sought. If a patent had been obtained, then there would be import delays and restrictions while rice grains were examined (Kuanpoth, 2005, p144). As Binenbaum et al. (2003, p329) note, the use of modern biotechnologies can be discerned in seeds and fruit parts but not necessarily if the crop is shipped in processed form. Polymerase chain-reaction-based diagnostic methods of DNA or protein can discern genetic modiﬁcations of seeds such as rice (but generally not in oils, extracts and other processed mixtures). Thus, rice inspections at US customs could have become a costly exercise for Thai exporters if the US researchers had patented a genetically modiﬁed jasmine rice variety. For a conventionally bred variety there would also be some delays and costs involved, but the procedure could be a more simple analysis of plant and seed characteristics (see Bioversity International, IRRI and WARDA, 2007). While this concern has never really eventuated for Thailand, it was relevant for India and Pakistan in relation to the patent claims over basmati rice lines and grains. But, due to the quick response by NGOs and Indian authorities, the RiceTec patent does not seem to have had a major economic effect.

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Notably, Binenbaum et al. (2003, p331) suggest that freedom-to-operate problems are most likely among staple crops like rice, in which there is a signiﬁcant ongoing research effort in the global north. The second jasmine rice issue mentioned is highly relevant in most recent misappropriation concerns – that the US breeders have been using Thai jasmine rice germplasm, developed over decades or even centuries, for adaptation to US conditions that will reduce the need for US consumers to purchase rice exported from Thailand. However, given the interdependence of countries on crops from around the world, and the lack of a patent on jasmine rice, there is little that Thailand can do about this particular concern. Rather, Thai academics, the rice industry and authorities are considering protection of a geographic designation of jasmine rice through geographical indications. In practice, producers of herbal medicines, crops, cosmetics and other respective products often are able to continue to sell and export their products unimpeded by a patent or other form of IP protection (spurious or not). A more likely and common issue is the extraction, IP protection and sale of a product that will then take up an increasing market share and compete with the original producers (and often the original knowledge-providers or biodiversity custodians). This has occurred in cases such as the plao noi example, whereby a trademarked and patented Japanese product has been developed from Thai traditional knowledge and sold back to the Thai market in direct competition with herbal remedies that use plao noi as a peptic ulcer treatment. The NGO BioThai claims that Kelnac – the patented and trademarked product – has annual sales of 800 million baht (US$20 million) for which the monetary beneﬁts are only received in Japan.

Inequities One of the main concerns of developing countries in relation to biopiracy has been derived from the perceived inequities that they raise. Where there is potential for commercial development of products based on biological resources and/or traditional knowledge, there is now a widely held expectation that the provider groups, including indigenous or local communities and authorities of the provider country, should be involved in that development process and/or compensated. There is recognition of the need for technology transfer in the preambles of the TRIPS Agreement and the CBD, as well as speciﬁc provisions that aim to encourage technology transfer and investment. Developing countries that agreed to the TRIPS Agreement in the Uruguay Round of Multilateral Trade Negotiations generally did so under the impression that by protecting IPRs, they would be encouraging foreign investment and technology transfer. However, concerns like technology transfer have been poorly heeded by most developed countries in these forums. To illustrate this point, a United National Conference on Trade and Development (UNCTAD) ofﬁcial has indicated that many developed countries have regarded the work of the WTO Working Group on Trade and Technology Transfer as a largely academic exercise and appeared completely unwilling

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to move into discussions that might trigger substantive negotiations (Konde, interview, October 2005). Behind the scenes some had even called for a close to the working group.1 These sorts of institutional barriers have helped maintain the impasse on many developmental inequalities. In the CBD Bonn Guidelines, there are detailed access and beneﬁt-sharing provisions. While there has been an emphasis on royalty-sharing so far, there are also other ‘beneﬁts’ that pharmaceutical, cosmetic and agro-biotechnology companies could provide upon the development and commercialization of products derived from biodiversity and traditional knowledge. These beneﬁts may include foreign direct investment (where the company processes and manufactures the products in-country), employment, training, scientific exchanges and other related beneﬁt-ﬂows. When a biological resource (and associated knowledge) is extracted by researchers and then commercialized and monopolized in another country, there is arguably an obligation on the researchers/company to offer something back to the original providers. Otherwise, developing countries will be continually disadvantaged and left out of the scientiﬁc and industrial development process in these ﬁelds. For example, the US PVP certiﬁcate discussed relating to the peanut variety ‘C-99R’ was bred from a variety collected in Malawi with the assistance of local researchers, but appears to have given nothing back to them in the form of training, collaboration or other beneﬁts. In many circumstances, there may be indigenous or local communities that also want to be involved in the research and development process or that believe they deserve some form of compensation arising from the instrumental use of their knowledge. In some cases there may be inequities that arise through beneﬁt-sharing arrangements that speciﬁcally ﬂow to one speciﬁc group at the neglect of other traditional knowledge holders or biodiversity custodians. This is evident in the ‘blight-resistant rice case’ where rice was extracted from Mali, transferred to IRRI and then subsequently a patent was granted on the isolated gene Xa21 which is chieﬂy responsible for the blight-resistance. As discussed, UC Davis established a Genetic Resources Recognition Fund (GRRF) as a mechanism to share beneﬁts back to agriculture students and researchers from Mali once the patented product was commercialized. As Gupta (2004) describes, the local (but itinerant) Bela and Fulani people were dependent on the wild rice for subsistence, as well as for use in some rituals and ceremonies. Arguably these communities were not the conservators of the rice per se – this particular rice variety grew voraciously and was described by local landholders as a ‘weed’. However, they were the principle users of the rice and may have also had knowledge of the blight-resistance, in addition to the local scientists who originally transferred samples of the germplasm. In this case it is not deﬁnitively clear who should receive beneﬁts – the local scientists, or the Bela and Fulani people? In such a circumstance there appear to be rightful claims by both parties. The exclusion of the Bela and Fulani people may be seen to have prioritized the contribution of science over tradition in the development of this particular innovation. This sort of devaluing of traditional knowledge is a recurring issue in biopiracy cases and in many other contexts.

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In other cases there may be competition over who appropriately represents and ‘speaks for’ indigenous or local people with respect to beneﬁt-sharing and prior informed consent. Greene (2004, p211) indicates that the increasing visibility of indigenous movements is often cited as evidence that indigenous peoples have gained a ‘voice’ in international politics: The idea of a ‘voice’ immediately raises the question of who is speaking for whom and to whom, and therefore of central importance to these emergent forms of indigenous mobilization are the issues of indigenous self-representation and the role of persons and organizations that act as mediators between external interests and local constituencies. Greene explores these issues with reference to the bioprospecting initiatives of the International Cooperative Biodiversity Group (ICBG), particularly the ICBG-Aguaruna negotiations. The Aguaruna are a sizeable Amazonian group that inhabits land in Peru’s high jungle region near the Ecuadorian border. Greene (2004, p214) notes a number of issues that arise through relatively ill-deﬁned agreements that were put in place between the ICBG team and an indigenous organization – the Consejo Aguaruna Huambisa – which involved researchers from Washington University and agreements with an industry partner G.D. Searle and Co. (then Monsanto’s pharmaceutical division). Two NGOs were contacted by Consejo, including RAFI, about the arrangement, in particular about the seemingly small royalty payments to the Consejo (despite some milestone payments already made). Distrust of the ICBG team’s bioprospecting activities grew and, due to the negative depictions from RAFI, the Consejo withdrew from the ICBG project. The ICBG team then sought support from another Aguaruna organization – the Organización Central de Comunidades Aguarunas del Alto Marañon (OCCAAM). This then fuelled conﬂict between the two indigenous organizations. A second round of negotiations was made involving further actors including the Confederación de Nacionalidades Amazónicas del Perú (CONAP) – a multiethnic Amazonian indigenous confederation from which OCCAAM is an afﬁliate organization. A deal was struck between the ICBG team, the industry partner, CONAP and their afﬁliates, but it was not particularly different to the original agreement. Notably, the CONAP and afﬁliates grouping accounts for less than half of the Aguaruna population while the Consejo and other nonparticipants constitute a clear majority (Greene, 2004, p218). So, it seems that the manoeuvring of RAFI has sowed seeds of distrust and potentially deprived much of the Aguaruna population of future beneﬁts, if they are forthcoming. The legitimate authority and ‘voice’ of the Aguaruna people is clearly not easily deﬁned or homogeneous. Therefore, this case provides an excellent example of the pitfalls of convenient notions of ‘beneﬁt-sharing’ from bioprospecting. Beneﬁts need to be appropriate to those stakeholders involved as well. In the Chiang Mai bioprospecting incident described in Chapter 4, the collectors from the Chiang Mai University Faculty of Pharmacy indicated that they

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provided information-sharing and education about traditional medicines with local minority communities. It is not clear if this sort of information-sharing was of any consequence since those traditional practitioners involved already have their own complex systems for understanding traditional medicines. For the Karen people involved in this speciﬁc circumstance, these quite limited ‘beneﬁts’ may have not adequately compensated them for their transferral of time-tested knowledge based on generations of experimentation with local herbs. The limited exchange appears to have also been in some contradiction to local customary norms and protocols about plant collection and use. The current negotiations towards an International Regime on Access and Beneﬁt-Sharing are attempting to formalize beneﬁt-sharing systems such as those put forward in the Bonn Guidelines. However, even if the International Regime is developed, it is clear that there are going to be ongoing issues associated with the identiﬁcation of provider groups, appropriate representation of local communities and the appropriateness of beneﬁt-sharing. Some authors have illustrated the more positive aspects of specific bioprospecting or ABS activities (see Laird and Wynberg, 2008). For example, Wynberg (2008b) outlines the relative success in establishing a ten-year ABS agreement for the breeding and development of tef (Eragrostis tef). The agreement was concluded between the Institute for Biodiversity Conservation in Ethiopia, the Ethiopian Agricultural Research Organization, and the small Netherlands-based company Health and Performance Food International in 2004. The company in question is seeking to develop non-traditional tefbased food and beverage products which it will access from the Institute for Biodiversity Conservation, with return royalties to this institute of 30 per cent of the sale of seeds, plus other beneﬁts including the potential for joint ventures with Ethiopian counterparts. This money is already accruing to a designated foundation. Yet this agreement has also encountered some problems with none of the funds yet distributed to Ethiopian farming groups due to a lack of appropriate governance and indecision on the part of the Ethiopian government on how to distribute or spend the funds (Wynberg, 2008b, pp64–8).

Cultural Affront Cultural and spiritual affronts may include a broad range of offences across diverse ethnic and cultural groups, and may include disruption to values of nature embedded in folklore, religion, ideology, ritual and customary norms (Posey, 1999). Quite commonly, these offences have been caused by the frequent assumptions implicit in biotechnological and biopharmaceutical research – that the manipulation of biological genetic material is acceptable and apolitical. It is also often assumed that patent monopolies (and plant-variety protections) are appropriate for innovations on biological products. The idea that these forms of research and protection might be culturally contingent has generally been ignored by those with vested interests in these industries, and by the intellectual property negotiators of the most industrially advanced developed countries. However, there are still many indigenous groups, NGOs and governments

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that strongly argue against patents on life-forms, such as those from Asia that signed the Thammasat Resolution, NGOs like the Third World Network and a number of governments in Africa and South America. Improper disclosure of information is a major issue in relation to biopiracy cases. When indigenous or traditional knowledge is publicly or widely disclosed, the prevailing Euro-American institutions’ surrounding knowledge, such as intellectual property rights, generally imply that it is in the ‘public domain’. In many cases traditional knowledge has been disclosed to people from outside the community without an informed indication of how it will be used. Consequently, many researchers have then published their ﬁndings in journals and in the patent documents themselves where they are widely accessible. This has continually frustrated many indigenous groups and organizations, as a representative of the Indigenous Saami Council has indicated: Indigenous peoples have rarely placed anything in the so called ‘public domain’, a term without meaning to us … the public domain is a construct of the IP system and does not take into account domains established by customary indigenous laws. (WIPO IGC, cited by Taubman, 2005, p544) By generally disregarding the customary knowledge domains of indigenous and local people, the way knowledge is locally held is then often transformed. Consequently this knowledge has been commoditized through the commercialization and intellectual property protection of the plants related to this knowledge. Therefore, the point of knowledge transformation, where local or secret knowledge enters the public domain, should be highlighted as a circumstance that needs to be understood and protected through both formal and informal (customary) mechanisms. This highlights the importance of appropriate prior informed consent procedures for research relating to traditional knowledge. Cultural affront is usually felt in circumstances whereby prior informed consent has not been sought of local or indigenous ‘provider’ groups. It generally occurs where the commercialization of a particular plant or other biological resource is seen as culturally offensive because it breaches customary norms or laws. As indicated in Figure 5.1 below, once knowledge is transferred from private, secret or community knowledge domains into the ‘public domain’, it undergoes a transformation whereby formal regulations, such as intellectual property rules, can then be applied to them. Once in the public domain, local communities lose their traditional forms of control over the knowledge, plants and other biological resources. In some cases, the unauthorized appropriation of resources and knowledge from local communities and healers who may embody and internalize any wrongdoing, may have the potential for detrimental spiritual and health effects for the healer. Interviews with Hmong community members in Thailand revealed the physical internalization of ‘injury’ according to their belief systems:

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Figure 5.1 Knowledge domains and knowledge ﬂows under informal and formal regulatory regimes

It is ﬁne to be treated and to learn about the herbal medicines. But many herbs require kha khruu [a ritual donation] to respect the spirits that protect them. If someone steals the herbs I will get sick because a kha khruu donation wasn’t paid – it is taboo. (Mee Leng, Hmong healer, interview, Baan Khun Khlang, 13 February 2006) The woman interviewed was a Hmong healer. In subsequent interviews with local Thai and Karen healers, some similar sentiments were expressed, suggesting that between different ethnic groups in northern Thailand there are linked beliefs drawn particularly from animism and Buddhism, as illustrated in Figure 5.2. Although this may be considered superstition by some researchers, there are very strong cultural and spiritual views about guardian spirits in many communities in Thailand (and adjoining countries) that derive from rituals, beliefs and folklore (Khanittanan, 1989; Kriengkraipetch, 1989; Laohavanich, 1989; Santasombat, 2003). Throughout the country farmers also erect, maintain and tribute shrines dedicated to Phra-phum (spirit lord of the place/village) or Phii-baan (the spirit protector of the house), or to Mae Phosop (spirit of rice). The customary norms surrounding these rituals and shrines are linked to beliefs such as karma and reincarnation, which cannot easily be reconciled in legal terms. Thus, when a transaction of plants (or other biological resources) and traditional knowledge occurs, a metaphysical transformation takes place that in turn may manifest in the spiritual or physical (corporeal) injury of a traditional healer (Robinson and Kuanpoth, 2009).

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Source: D.F. Robinson, 27 March 2005, Baan Mae Ka Pu, Amphoe Samoeng, Chiang Mai, Thailand

Figure 5.2 Four different customary practices of the Khon Pga k’nyau (Karen) including customs relating to plants

Cultural affront has also been noted in the case of the patents on taro that were held by the University of Hawai’i. Due to the spiritual belief of the indigenous Hawai’ian people, which has been transferred through folklore, particularly the story of Kumulipo, there were local demands against the patent monopoly over taro. The Kumulipo has been described as the Hawai’ian song of creation (Beckwith, 1949) and consists of a chant that is 2100 lines long, broken into 16 sections representing 16 time periods. This epic song describes the creation of all things from the earth and the sea. Taro (or kalo) is a child of the gods Wakea and Hookokukalani whose second born, a man, is charged with looking after the plant. Thus taro is seen as an ancient brother to the Hawai’ian people and it is their kuleana (responsibility) to look after it. In turn, the taro plant, or elder brother, provides food for the Hawai’ian people (Beckwith, 1970; Schlais, 2007). To the Hawai’ian objectors, the patents represented an ‘ownership of their ancestors’ and were deeply offensive. Additionally, other Polynesian groups have similar respect and concern for the taro plant. For example, in Tongan folklore, the gods travelled to Paluto,

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the land of departed spirits and ruled by the fearful goddess Hikulea. They risked their lives for plants – the taro, yam and breadfruit – which were seen as ‘gifts from the gods’, in order to provide food for Tonga (Reed, 1974, pp39– 45). Beyond taro, the cultural signiﬁcance of other plants, for example kava, has also been a point of serious concern in relation to foreign patents on the plant root (see, for example, extract and composition claims in US patents 6,537,592; 6,541,044; and a WIPO PCT patent with publication number WO/2005/067950). Finally, the general trend whereby researchers claim to have made ‘scientiﬁc breakthroughs’ despite being informed by traditional knowledge, and who consistently refuse to acknowledge the contribution of that knowledge, represent the worst kinds of scientiﬁc imperialism. Traditional knowledge, which is typically inextricably linked to language, folklore, culture, place and identity, needs to be valued as a different but no less important knowledge system than scientiﬁc systems for understanding the world. By misusing and undermining the contribution or value of traditional knowledge, these researchers are also denigrating the culture and identity of indigenous people.

Overexploitation of a Biological Resource The overexploitation of plants or other biological resources may occur as a direct or indirect impact of a patent or other intellectual property right. As public interest and demand for the protected products increases, culling and collecting operations have been known to amplify accordingly to meet this demand. In response to the increasing value of the different kwao krua varieties, overcollection is emerging as a problem in recent years. Following the patents on kwao krua in both Thailand and the US, increased publicity about the potential effects of the plant has resulted in increased demand. The cultivation of the herb is already limited in national parks and restricted areas by the speciﬁc laws and regulations that govern them. However, in other areas the quantity allowed for ‘wild harvest’ has been less clear. An institute of the Thai Department of Public Health has since enacted a regulation under the Thai Traditional and Alternative Medicines Act for the protection of the plant from excessive collection (Nation, 18 May 2005). This does not yet exclude harvesting by traditional medicinal practitioners, but limits commercial quantities from being poached or harvested because of the increasing rarity of the herbs. Due to the slow-growing nature of the kwao krua vine, collection in recent years has far exceeded the plant’s growth rate. The hoodia plant is also being overcollected since a patent was granted on the active compounds which cause suppression of appetite and since the subsequent media attention around the patent and licensing agreements. Hoodia species were listed in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) at the13th Conference of the Parties in Bangkok, 2004. The supporting documentation for the inclusion of hoodia noted that multiple factors, including habitat destruction through

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mining and agriculture, have impacted the distribution of the species. It also makes particular mention of the ‘intensive bioprospecting for commercial exploitation in Botswana, as well as reports of collecting or solicitation of collecting in Namibia, and South Africa’ (CITES, 2004). The report notes that since the isolation of the active ingredient in the Hoodia gordonii species and the extensive press coverage, which anticipated that huge ﬁnancial beneﬁts are to be derived from exploiting this species, there has been an increasing interest in the harvest of hoodia species. These harvesting practices involve the cutting of the above-ground part of the plant, making it relatively easy to decimate small populations (CITES, 2004). The destruction and fragmentation of the hoodia populations are likely to have impacts on species resilience and genetic diversity, further threatening its existence. As a result, plant populations are being closely monitored in the Southern African countries where it is endemic, and there are limitations on collection and harvest activities, with some controlled cultivation trials being undertaken. In addition, the listing under CITES requires that all parties must inspect for the issuance of CITES permits or certiﬁcates for the import of hoodia products. The potential for loss of biological resources through misappropriation is also demonstrated by the University of Portsmouth marine fungi case, in which Thai researchers could have lost the ability to research and commercialize a rare biological product that is difﬁcult to locate in the natural environment. The samples, collected from driftwood in mangrove and coastal areas in southern and eastern Thailand in 1997–8, are believed to be quite rare. As discussed, the fungi were transferred out of Thailand to UK-based researchers. It appears that they were screened for potential pharmaceutical applications and some of the fungi strains were lost and/or died, much to the frustration of Biotec staff in Thailand.

Breakdown of Research Relationships and Trust Most critics of bioprospecting would argue that the seeds of distrust have already been sown in recent decades (and often over longer time periods) and that the feasibility of bioprospecting has been heavily hampered as a result. It is also important to note that many indigenous and local groups have never been interested in bioprospecting or beneﬁt-sharing in the ﬁrst place. As Linda Tuhiwai Smith (2005, p1) notes: The word itself, ‘research’, is probably one of the dirtiest words in the indigenous world’s vocabulary. When mentioned in many indigenous contexts, it stirs up silence, it conjures up bad memories, it raises a smile that is knowing and distrustful. In cases where there is some local interest, it is often generated through the raising of expectations to excessive and unlikely levels. Yet there are certainly still optimists that have been continuing to argue the possibilities for ‘fair and equitable’ research partnerships that are underpinned by the CBD Bonn

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Guidelines and, soon, the International Regime on Access and Beneﬁt-Sharing (Laird, 2002; McManis, 2008; Laird and Wynberg, 2008). The demonstration of any bioprospecting successes, both commercially and in terms of local involvement, may in the future raise the interest of local and indigenous communities. Aside from indigenous and local populations, the research implications of unauthorized collection, research and monopoly can be far-reaching for government interests in research and development. The plao noi case is commonly cited by Thai ofﬁcials, academics and NGOs as having caused a distrust of foreign research and collection activities. Following the patenting of the plant there has been little technology transfer or noticeable beneﬁts for Thai researchers. As a result, formal international research collaborations involving in situ collection of biological samples have plummeted, impacting upon the research collaborations of the Royal Forests Department and related government programmes (Bai Mai, interview, 2005; Hutacharern, interview, 2005; Brockelman, 1998). This is likely to have further impacts on training and the scientiﬁc research capacity of Thai researchers who beneﬁt from international collaborations. To deter further distrust, bioprospecting and related research activities need to operate within a more unambiguous ethical framework. Namely, the establishment of well-deﬁned and transparent prior informed consent (PIC) procedures is crucial to the future success of these research activities. In order to develop and maintain these kinds of research relationships, clear expectations and understandings need to be established before the research begins: this should involve all the key stakeholders, such as national authorities, local knowledge holders and the research parties. Besides improved ethical practices on the part of the researchers, national authorities should also have a clear role. For example, a PIC system established at the national level should include, as a minimum: • • • • • •

An access point acting as, or directing to, competent authorities that can grant PIC; Timing and deadlines that ensure that consent is sought sufﬁciently in advance of access and that applications are processed quickly; Speciﬁcation of use requirements, so that consent authorities may consider the validity and necessity of access, and any problems or offence it might cause; Detailed procedures for PIC (detailed below); Mechanisms for the facilitated consultation of relevant stakeholders (including local and indigenous communities); Transparent processes including documentation, permits, licences or similar. (Adapted from the CBD Secretariat, Bonn Guidelines, 2002, Part IV)

In the process of obtaining PIC, sufﬁcient information must be provided by the researchers to the provider party about the legal entity/person seeking access,

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the resources (and associated knowledge where sought), the intended uses of the genetic resources (e.g. education, herbarium storage, research, development, potential commercialization), intellectual property rights, beneﬁt-sharing, project budget and conﬁdentiality, among other things (Robinson, 2007, p38). The Bonn Guidelines also extensively detail basic requirements for mutually agreed terms between parties (Part IV.D). A list of PIC procedures that could be included in templates for access could include: (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) (n) (o)

Legal entity and afﬁliation of the applicant and/or collector and contact person when the applicant is an institution; Type and quantity of genetic resources to which access is sought; Starting date and duration of the activity; Geographical prospecting area; Evaluation of how the access activity may impact on conservation and sustainable use of biodiversity, to determine the relative costs and beneﬁts of granting access; Accurate information regarding intended use (e.g. taxonomy, collection, research, commercialization); Identiﬁcation of where the research and development will take place; Information on how the research and development is to be carried out; Identification of local bodies for collaboration in research and development; Possible third party involvement; Purpose of the collection, research and expected results; Kinds/types of beneﬁts that could come from obtaining access to the resource, including beneﬁts from derivatives and products arising from the commercial and other utilization of the genetic resource; Indication of beneﬁt-sharing arrangements; Budget; Treatment of conﬁdential information. (CBD Secretariat, Bonn Guidelines, 2002, Part IV.C., p11)

Notably, permission to access genetic resources does not necessarily connote access to knowledge associated with those resources. National authorities need to clearly specify distinctions between access to resources and associated knowledge of their uses, particularly where local communities and traditional farming groups are involved. Then, local communities also need to be consulted and their consent, as well as that of the national authority, should be obtained. While dealing with these access and consent activities might be a fairly routine matter for government ofﬁcials, the whole process could be quite invasive for some traditional local or indigenous communities and therefore culturally sensitive approaches and respect of local customs should be observed. For example, Laird and Noejovich (2002, p206) discuss the pros and cons of obtaining a written document of consent. While a written contract can improve clarity, remove uncertainty and legally bind the parties, there are also often

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concerns that written contract documents may be culturally inappropriate, that they represent a Western approach to negotiation and the establishment of agreement, and that they may create division among community members or between communities. These sorts of barriers continue to challenge researchers who are trying to establish trust in foreign countries and in local communities. For example, during research on community attitudes towards bioprospecting in Chiang Mai in 2005 and 2006 some of the Karen people that I interviewed and observed could not read or write and spoke a local dialect. Therefore, a witnessed prior informed consent procedure was undertaken with the use of a translator who had worked with the communities in the past and was also well aware of their customary norms. Increasingly, local regulations are being developed that detail a range of speciﬁc requirements, such as who has authority to provide or deny consent, as well as respect for customary protocols where PIC involves local communities. PIC procedures have been criticized by some researchers for creating a complex process of access that may discourage research. Indeed, some countries that are defensive of their sovereign control over biological resources may be happy to leave the process in a complex state for protective reasons. In many circumstances, though, there are beneﬁts to be drawn from the establishment of transparent procedures nationally. These could include the potential receipt of royalties, technologies, training, research collaborations and the development of useful products. Therefore, national authorities need to carefully consider these aspects of PIC according to whether the ultimate policy goal is to encourage bioprospecting, to defend against biopiracy, or a combination of both.

Note 1

Although no progress was being made in the face of the Hong Kong WTO Ministerial Conference in December 2005, several developing country submissions were trying in vain to reinvigorate discussions (Konde, interview, October 2005).

6

Current Debates and Ways Forward: Internationally and Regionally

Biopiracy inevitably has to be dealt with through actions at various governmental scales. The majority of biopiracy concerns relate to international transfers of biological resources and traditional knowledge, which often leads to their intellectual property protection in foreign jurisdictions. Consequently, it is important to deal with issues of biopiracy at the global scale. Attempts to transparently regulate these international transfers have been made in ongoing discussions surrounding international treaties and conventions like the ITPGRFA and CBD. Additionally, discussions in the TRIPS Council of the WTO and in WIPO are addressing issues relating to intellectual property rights, genetic resources and traditional knowledge. These international mechanisms and tools are likely to play an important role in the prevention of biopiracy in coming years, but may also serve broader roles for the improvement of patent quality, for the promotion of innovations derived from traditional knowledge and potentially for the improved regulation of bioprospecting activities. A number of regional initiatives relating to biological resources and traditional knowledge have been sought to deal with issues of interest to speciﬁc regions or countries. These have been negotiated in areas of shared biogeographical interest, where there are common issues relating to the protection and promotion of traditional knowledge and community rights. These include the Organization for African Unity (now African Union) Model Legislation for the Protection of the Rights of Communities, Farmers and Breeders, and its Regulation of Access to Biological Resources; the Paciﬁc Model Laws on Traditional Knowledge; and the Association of South-East Asian Nations (ASEAN) Draft Framework Agreement on Access to Biological and Genetic Resources and Fair and Equitable Sharing of Beneﬁts. These model laws have been put forward to encourage regional consistency when dealing with issues of bioprospecting and beneﬁt-sharing, and to assist countries in the development of national laws. In the case of the Paciﬁc Model Laws, they have been drafted

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with the intention of establishing a regional body to coordinate intellectual property and traditional knowledge issues.

‘No Life Patents!’ Shortly after the ﬁnalization of the WTO Agreements, including TRIPS, many stakeholders who were not involved in the Uruguay Round of Multilateral Trade Negotiations, as well as those countries that had been marginalized in discussions, began to realize the full implications of TRIPS. The patentability of life-forms has been of considerable concern to many developing and least-developed countries, as well as local farmers, indigenous groups, and environmental and other public interest NGOs. There are a number of important non-legally binding agreements or pacts, made outside the UN framework of international law, which involved indigenous and local peoples as some of the main contributors and expressed their concerns about intellectual property provisions on traditional knowledge and biological resources. These include the Kari-Oca Declaration and the Indigenous Peoples’ Earth Charter (1992), the Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples (1993), the Covenant on Intellectual, Cultural and Scientiﬁc Resources (for full details of these see IUCN Inter-Commission Task Force on Indigenous Peoples, 1997) and the Thammasat Resolution (1997) signed in Bangkok. To give an example, the Thammasat Resolution rejects the understanding of sui generis depicted by the WTO TRIPS Agreement as ‘highly detrimental to peoples’ economies, cultures and livelihoods’. The parties involved made a statement of: opposition to the extension of intellectual property rights to life forms, be it on humans, animals, plants, micro-organisms, or their genes, cells and other parts. We are also adamantly against biopiracy and the monopolization of biodiversity-related knowledge through such IPRs. (Cantuaria Marin, 2002) In partial response to the concerns of these developing countries and indigenous peoples, the Doha Development Round of trade negotiations has broadened the focus of the TRIPS Council’s discussion and review of Article 27.3(b) on the patentability of plants, animals, microorganisms and their products. According to Paragraph 19 of the 2001 Doha Declaration, the TRIPS Council should also look at the relationship between the TRIPS Agreement and the UN Convention on Biological Diversity. In the early stages of the review the African Group made a submission relating to the patentability exceptions on ‘ordre public and morality’ (TRIPS Article 27.2). The African submission used strong language – evidence of their frustration – calling for revision of Article 27.3(b) so as to prohibit the patenting of plants, animals and micro-organisms:

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Patents on life forms are unethical and the TRIPS Agreement should prohibit them, through modifying the requirement to provide for patents on micro-organisms and on non-biological and microbiological processes for the production of plants or animals. Such patents are contrary to the moral and cultural norms of many societies in Members of the WTO. They make the exception in Article 27.2 for protecting ordre public and morality, which Members that consider patents on life forms to be contrary to the fabric of their society and culture, and to be immoral, and which they would otherwise invoke, meaningless in this regard. (African Group, 2003, WTO Doc: IP/C/W/404, p2) In the talks and submissions that followed, the idea that member states might have strong cultural complaints against across-the-board patent (or PVP) requirements for life-forms was barely entertained at all – they were dismissed, ignored, or the subject was left to national interpretation. Dealing with moral and cultural objections is clearly not the strength of trade negotiators and WTO ofﬁcials. Moreover, developed country negotiators had worked hard to secure this standard of protection for their domestic and transnational biotech industries. Subsequent talks were guided by legal positivism and literalism, such that members stuck to the words of the mandated ‘Development Agenda’ review in order to obtain some potential technical resolution to the concerns surrounding TRIPS-CBD mutual supportiveness. Therefore, it seems unlikely that plant and animal patentability will be revoked under TRIPS. Nevertheless, it is important to note the strong moral and cultural complaint about ‘life patents’ and the possibility of countries utilizing the ‘ordre public and morality’ exceptions in their laws and their patent examination processes. For example, Young (2001, pp10–11) presents several arguments that Maori traditional medicines should not be patentable on moral grounds. Thus, she argues that the New Zealand Patents Act could be rewritten, reformed, or made better use of in its current form, so that Maori traditional medicines might be excluded from patentability.

Amendments to the Patent System Related to the broader review of TRIPS Article 27.3(b), some substantial advances have been made towards a patent requirement that members disclose the source and/or origin of genetic resources (and associated traditional knowledge) used in an invention. The main demanders of a disclosure-oforigin requirement have been biodiverse developing countries, which are seeking to reduce the possibility of patent-based biopiracy. A submission to the TRIPS Council by Brazil, Cuba, Ecuador, India, Peru, Thailand and Venezuela indicated that: One of the major concerns expressed is that the TRIPS Agreement allows the granting of patents for inventions that use genetic

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material and associated knowledge without requiring compliance with the provisions of the CBD. To the extent that bio-piracy is today accepted as a major problem, the challenge is to determine what measures need to be taken within the framework of the TRIPS Agreement to prevent misappropriation and to support the objectives and implementation of the CBD. (Brazil et al., 2 March 2004, IP/C/W/420) These countries therefore outlined the core questions surrounding the need to require disclosure of the source and country of origin of the biological resources and of the traditional knowledge used in an invention, as well as evidence of prior informed consent and beneﬁt-sharing as a patent requirement. In a subsequent submission, also including Pakistan, Colombia, Bolivia and the Dominican Republic, the countries explicitly detailed how such an obligation would assist the patent examination process and reduce the chance that ‘bad patents’ would be granted (Brazil et al., IP/C/W/429, 21 September 2004). These countries suggested that failure to disclose this information should mean that the patent should not be granted, but if the patent is granted and then wrongful disclosure is identiﬁed, then the patent could be revoked, have the rights transferred to another entity or have the scope of patent claims narrowed so as to exclude the parts of the claim of concern. They also indicated that the burden of proof should lie with the patent applicant and that the disclosureof-origin requirement should be mandatory. They suggest that this should be included as an amendment of existing provisions or by introducing a new article into the agreement. The US has taken a hard line in these negotiations, arguing that a ‘disclosure requirement’ would cause unnecessary burdens to the patent system and be detrimental to technological development and investment (US, IP/C/W/434, 26 November 2004; IP/C/W/449, 10 June 2005). The US has also argued that the mandated review under the Doha Declaration should not extend to discussions of this nature (i.e. that a disclosure requirement goes beyond considerations of the relationship between the TRIPS Agreement and the CBD). It has indicated that it would prefer to see these issues resolved on a case-by-case basis through contractual agreements under national access and beneﬁt-sharing laws. The US has made assertions that: As the United States has described in previous communications to the TRIPS Council, agencies such as the National Park Service, the National Cancer Institute, the National Institutes of Health, and the Agricultural Research Service of the Department of Agriculture all have adopted measures tailored to ﬁt their speciﬁc sector’s needs that are consistent with the CBD principles of prior informed consent and beneﬁt-sharing on mutually agreed terms. These US guidelines are practical, effective and not burdensome, and operate outside of the intellectual property system. (US, IP/C/ W/449, 10 June 2005, p2)

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Yet in many of the case studies already discussed, we have seen the consistent failure of US agency guidelines and policies, most recently in the cases relating to the Kakadu plum, açaí and habanero pepper. Clearly, the individual negotiation of contracts or agreements by researchers has failed to date, with many researchers having abused the different power relations and inequities between the negotiating parties. The position of the European Communities group (EC) has been more complex. The EC has sought to appear more ﬂexible on the issue, and in the early stages of these negotiations had invited submissions from majority world countries to expand upon their ideas for a disclosure requirement, its necessity and how it would operate (EC, IP/C/W/383, 17 October 2002). But, in the TRIPS Council, EC delegates have reportedly voiced ‘lukewarm’ attitudes towards disclosure-of-origin since they released a communication to the TRIPS Council in 2002 (Developing country WTO delegates, interviews, 2005; anonymous WTO ofﬁcial, personal communication, 2005). The 2002 communication was put forward as a ‘concept paper’ on how to deal with the review of Article 27.3b of TRIPS, including considerations of a disclosure-oforigin requirement. The language of the communication ‘agrees to examine and discuss the possible introduction of such a system’ and ‘see[s] merit’ in the discussions, seeming somewhat positive to the notion of a disclosure system. However, the EC has also indicated that it does not want ‘an additional formal or substantial patentability criterion’, and indicates that ‘legal consequences to the non-respect of the requirement should lie outside the ambit of patent law’ (EC, IP/C/W/383, 17 October 2002). Delegate reports from the TRIPS Council indicate that, during negotiations, the EC wanted to be seen as warming to the concept of a disclosure-of-origin patent requirement, but have been critical of the ﬁne details, wording, enforcement capacity and forum for the requirement (Developing country WTO delegates, interviews, 2005; anonymous WTO ofﬁcial, personal communication, 2005). Instead of seeking a solution in the TRIPS Council, the EC developed its own proposal on disclosure and put it forward at a forum – the 2005 Eighth Session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) at WIPO – which would be more favourable towards its intentions (EC, 2004). In principle, developing-country negotiators were pleased with some movement on the issue from the global north, but they were much less impressed by the change of forum and the actual content of the proposal (Delegates from Asia and Latin America, interviews, 2005). By moving the proposal from the WTO TRIPS forum to WIPO, the EC were seeking a reduced capacity for the main demanders (biodiverse developing countries) to enforce such a requirement. While the WTO has an effective dispute settlement mechanism that allows cross-retaliation (essentially sanctions) in circumstances where one party is non-compliant with WTO rules, WIPO has less forceful and administratively more complex mechanisms for dispute settlement. In short, the EC has shown interest towards a seemingly ﬂexible, southern proposal, but then signalled that it will not concede to strong enforcement of the disclosure requirement. Since

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the 2002 and 2005 communications, the EC delegates have been watching the ensuing negotiations without making many direct contributions until recently. Japan has suggested that the granting of erroneous patents can be resolved by improving databases that document genetic resources and traditional knowledge and which are used by patent examiners to determine prior art (IP/C/W/504, 17 October 2007); the US has also suggested this as an option. However, the developing-country parties see this as only one part of the solution. One issue with the suggestion is that much information has not yet been disclosed so as to be documented in prior-art databases – often due to the secret nature of the information, or due to mistrust. Therefore, if secret traditional knowledge is obtained by bioprospectors or researchers, but it is not already in the database, then it is unlikely to be recognized as prior art. Having a disclosure-of-origin check, including details of PIC, would conﬁrm that materials and knowledge were obtained appropriately. Negotiations have not been split solely along a ‘north–south’ divide, with some northern countries making submissions and statements that were fairly supportive of the biodiverse developing-country submissions. For example, Switzerland made a proposal to the Working Group on Reform of the Patent Cooperation Treaty in WIPO in 2003 that ‘would explicitly enable the Contracting Parties of the PCT to require patent applicants to declare the source of genetic resources and traditional knowledge in patent applications’. This proposal was subsequently tabled in the TRIPS Council. Notably, the proposal would leave it up to the national legislator to decide whether a disclosure requirement is to be introduced in the national patent legislation. Developing countries, which are eager to see a mandatory and enforceable disclosure requirement, had a modest reaction to this proposal (Switzerland, 25 November 2004, TRIPS Council Doc. IP/C/W/433). Norway also authored a sole TRIPS Council submission for a disclosureof-origin requirement (Norway, IP/C/W/473, 14 June 2006, and IP/C/W/491, 7 May 2007). The submission was substantial, suggesting amendments to TRIPS (as Article 29bis), and hence it was in principle well received by WTO developing-country members. However, some ﬁner details of the document were seen as problematic by many countries. The primary objection to the proposal from developing countries was the suggestion by Norway that failure to comply with a disclosure requirement in the grant of a patent would not be grounds for revocation of the patent. Instead, Norway suggested ‘softer’ options of mediation. Due to the recent stalemate in the Doha Development Round Work Programme as reported by the director general of the WTO (WT/GC/W/591 and TN/C/W/50, 9 June 2008), a number of countries have put forward a ‘Draft Modalities’ text to steer negotiations on outstanding implementation issues in the TRIPS Council. Several developing countries, as well as the African, Caribbean and Paciﬁc group, Switzerland and the EC among others, have suggested parallel modality texts and negotiations on: TRIPS, the CBD and the disclosure issue; a register for GIs; and an extension of protection on GIs for products other than wines and spirits (under Article 23 of TRIPS). This

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compromise appears to have been made by ﬁnding mutual ground between the EC’s desire to improve the international protection of GIs and the possibility that GIs might be used to protect product-based traditional knowledge in developing countries. Convincing the EC to move forward on disclosure-oforigin has been a signiﬁcant victory for the developing-country proponents. Some of the speciﬁc details surrounding a disclosure requirement are still yet to be determined. If the disclosure requirement is a simple description of the legal source and country of origins of the materials used, then it seems unlikely that the US claims of detriment to the innovation process are accurate. Ultimately, what may be required is a generic certiﬁcate indicating prior informed consent and/or authorized transfer of genetic resources (and associated traditional knowledge). Again, this could be a fairly simple and short document that researchers are supposed to obtain anyway, as required under most countries’ import and export permits. In terms of prior informed consent for the documentation of traditional knowledge, this is also already usually required by most reputable research organizations in the industrialized world. As the US government notes, many of the government agencies conducting this sort of research have CBD compliant procedures in place – therefore a disclosure requirement only seems likely to inhibit the more dubious research operations that do not seek PIC or sign material transfer agreements. Exactly what form of certiﬁcate might be required is discussed in the following section, but it is likely to beneﬁt all if a harmonized certiﬁcate was developed that would be valid for patent applications (and potentially plant-variety protection certiﬁcates) as well as transfers of biological resources. As some leading ABS commentators have noted: There are already numerous mechanisms which provide means for tracking at least in part the ﬂow of genetic resources, including through bioprospecting, export and import permits, passport data held by collections, ABS agreements, etc. However, there is, as yet, no harmonised system which can provide easily recognisable evidence of the source/origin of resources and/or of the legal right to use such resources. (Tobin et al., 2004, p16) Negotiations on ABS in the CBD have been attempting to resolve this issue of certiﬁcates. Discussions on the speciﬁcs of such a certiﬁcate appear to be advancing slowly but steadily in the CBD, while in the TRIPS Council articulations of the extent of a disclosure-of-origin patent requirement are still under hot debate. Requiring evidence of a beneﬁt-sharing agreement within the disclosure-oforigin rules may be more problematic for researchers. The issue here is that the researchers applying for the patent have not yet commercialized the product, or even determined if it is suitable for public use (i.e. if it is a pharmaceutical it would have to be clinically trialled for human use). Therefore, it is likely that a more preferable option would be to require that the researchers seeking a patent make a commitment to the sharing of beneﬁts via royalties, milestone payments,

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technology transfer and other provisions if the product is commercially viable. Although this provides less certainty to provider groups, it also may prevent the raising of undue expectations. It has generally been argued that the disclosure-of-origin requirement must be mandatory to have any signiﬁcant effect. There is likely to be a reliance on the good faith of the applicant regarding biological resources and/or the traditional knowledge involved, the source and country of origin, and evidence of PIC and beneﬁt-sharing – meaning that the requirement’s effectiveness will be contingent on the honesty of the patent applicants. The disclosure of this information is likely to be conditional to the successful grant of the patent (Vivas-Eugui and Ruiz, 2005). Where an applicant does not disclose this information or partially discloses it, the main developing-country proponents of the requirement have been arguing that the patent should be refused or suspended until such information is provided. In cases where a patent is granted, but it is found to be based on fraudulent information or deliberately omitted information pertaining to the source and country of origin, PIC or beneﬁt-sharing arrangement, then the patent should be revoked. Under this model, proposed by some of those countries most concerned about biopiracy, the relatively strict conditions should act as a deterrent to those seeking to misuse the patent system or acting negligently in terms of their research ethics and obligations. However, a balance must be struck among the negotiating countries between the deterrent of biopiracy and the outright deterrent of research which may well lead to useful foods and medicines based on biological resources and traditional knowledge. A disclosure requirement should not go so far that it is likely to inhibit research of this kind. Therefore, it is important to determine the ‘right’ level of detail that should be made a requirement for patent applicants. Also relevant to this discussion is some work within WIPO for improved patent-examination procedures. Under the WIPO Patent Cooperation Treaty, the minimum documentation that should be taken into account during an international search has been expanded to include a number of traditional knowledge-related information sources including databases and journals, which hopefully means that traditional knowledge will be identiﬁed early in the patent examination process (WIPO, 2002).

Controlling Access and Transfer of Biological Resources and/or Traditional Knowledge In the CBD Ad Hoc Open-Ended Working Group on Access and Beneﬁt-sharing (WG-ABS), there has been an attempt to negotiate and develop an International Regime on Access and Beneﬁt-Sharing (hereafter ‘International Regime’). The regime is intended to ensure that states maintain sovereign control over access to biological/genetic1 resources (and potentially their derivatives), that fair and equitable beneﬁts are shared as a consequence of this access and utilization of biological/genetic resources, and to prevent misappropriation of biological/ genetic resources and/or associated traditional knowledge. This regime is

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intended to be implemented through national ABS frameworks in accordance with national laws. The WG-ABS had their seventh meeting in Paris in April 2009 in which the parties to the CBD continued to negotiate a draft text for the International Regime. The marked (i.e. incomplete) draft text has been developed over a period of years and still has many issues that need resolving between the parties. It is still unclear when (and if) the International Regime will be fully drafted and then adopted. Generally speaking, in the draft working text it appears that the International Regime will likely apply to: • • • •

•

Biological/genetic resources (and their derivatives); Associated traditional knowledge, innovations and practices; Beneﬁts arising from their commercial and other utilization; Continuing beneﬁts from new uses arising from the commercial and other utilization of these resources and knowledge acquired prior to the entry into force of the CBD (but not to resources transferred or acquired before the entry into force of the CBD or the International Regime); All intellectual property rights associated with these.

The draft working text of the International Regime would require that national authorities be established with the responsibility of ensuring that PIC is obtained for access to biological resources and/or traditional knowledge. This requirement for PIC also should be sought of relevant indigenous and local communities in accordance with customary protocols and laws. Beneﬁtsharing would also be established based upon mutually agreed terms between the parties (i.e. the users and providers). The draft text of the International Regime, in its form at the seventh meeting, includes speciﬁc mention of different types of monetary and non-monetary beneﬁts, technology transfer provisions and participation in R&D and/or joint research activities for the provider authorities and also local and indigenous communities. The current text also deals with transboundary situations which are likely to be common given the dynamic nature of biodiversity and the geopolitical delineation of state boundaries. The draft document describes some ‘multilateral beneﬁt-sharing options’, including the establishment of trust funds that could distribute funds to the bilateral or multilateral partners and their communities. The draft also describes requirements for the development of an ‘internationally recognized certiﬁcate issued by a domestic competent authority’. The certiﬁcate would likely include information such as: • • • •

Issuing national authority; Details of the provider; A coded unique alpha numeric identiﬁer; Details of the rights holder of the biological/genetic resources and/or traditional knowledge;

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Details of the user; Subject matter covered by the certiﬁcate; Geographical location of the accession of resources; Prior informed consent of the country of origin/provider country and indigenous and local communities on mutually agreed terms; Uses permitted and restrictions of use; Conditions of transfer to third parties; Date of issuance; Conﬁrmation of compliance with domestic access requirements.

The parties have tentatively included provisions on checkpoints (including customs, intellectual property offices and other registration points) for certiﬁcates relating to commercial and non-commercial uses. The draft working text indicates that these should be linked to searchable certiﬁcate databases and patent-application databases to ensure that IP rights are not granted on utilized biological/genetic resources and/or traditional knowledge without the disclosure of an internationally recognized certiﬁcate of compliance. It makes sense that a ‘certiﬁcate of origin’ developed under the CBD International Regime could also be used as proof of ‘disclosure of source and origin’ for the purposes of obtaining a patent. Ultimately, it would be in the interests of the parties involved to attempt to harmonize the type of certiﬁcate that might be used for ABS with disclosure requirements in the TRIPS Agreement (and assumedly that could be administered under the WIPO Patent Cooperation Treaty), such that these are ‘mutually-supportive’ (Cabrera Medaglia, 2009, pp18–20). Another question comes about when considering the potential applicability of disclosure and certiﬁcate requirements for plantbreeder rights (PBRs) under UPOV. Through the misuse of PBRs, cases of ‘non-patent biopiracy’ are also an issue. If the International Regime goes ahead, parties may want UPOV to be amended so that a certiﬁcate disclosing the source of origin is also required for the granting of PBRs (see Cabrera Medaglia, 2009, p23). For the parties involved, particularly the biodiverse developing countries that have been most adamant about the need for an International Regime on ABS, such a system should hopefully ensure that there are consistent and transparent research and collection practices around the globe. Of course, this would be subject to the parties agreeing to it and implementing it appropriately. In addition, the US has not ratiﬁed the CBD and until it does (if ever), it is not explicitly obliged to comply with the terms of such a regime. Progress in the forum remains fairly slow but steady, with the parties having difﬁculty agreeing upon many of the explicit deﬁnitions, scope and terms of the International Regime. Thus, it remains in a draft format for the near future. Notably, genetic resources listed in Annex I of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) are likely to be excluded from the scope of the CBD International Regime unless they are used beyond the purposes of the ITPGRFA (e.g. if they are used for medicinal rather than agricultural purposes). The genetic resources listed in Annex I are subject to standard material transfer agreements (SMTA) under the ITPGRFA.

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The ITPGRFA (discussed in detail in Chapter 2) has been of major beneﬁt to the clariﬁcation of legal status of germplasm held in IARC genebanks. The ITPGRFA also applies to in situ germplasm related to food and agriculture in the countries that have ratiﬁed the treaty. Now, this germplasm can only be transferred subject to a standard MTA being signed between the provider organization/entity and the user. The agreement limits the use of IPRs on germplasm transferred under the MTA and establishes a detailed system of beneﬁt-sharing. Thus, these resources are now being more transparently regulated with passport data required for the access/transfer process of genetic resources (Article 12.3[c]). But again, the extent of this treaty is limited by its membership. There are 120 signatories to the ITPGRFA but only 55 countries have ratiﬁed the treaty.2

Other Intellectual Property Opportunities Most formal intellectual property rules have not been looked upon positively for the protection of traditional knowledge, and indeed some have suggested that for many indigenous and local groups, intellectual property protections are what they are trying to protect traditional knowledge from. There are a number of factors that suggest that it is unlikely that many indigenous and local communities are seeking to protect their knowledge through patents or UPOVstyle PVP systems. This is probably due to the cost of preparing an application; the formality and bureaucracy involved in the procedure, the possibility that the monopoly may then exclude other indigenous groups or communities; and the fact that it may be difﬁcult to demonstrate novelty. Also, some communities may have an aversion to the idea of monopoly rights over their knowledge and/ or biological resources. As a result, few policy-makers have pursued this idea in great depth. Rather, most have suggested amendments to the patent system to make it less likely that biopiracy could occur, as already discussed. However, there are some exceptions to this, notably in China through the protection of traditional medicines under patent law. China allows the patenting of medicines under their Patent Law, 1992, but Article 25, which speciﬁcally allows patent protection under the subject matter of products, usages and methods, excludes traditional medicinal compositions and herbs (WHO, 2001; Li and Li, 2007). Aside from utilizing patents, the wording of Article 27.3(b) of the TRIPS Agreement allows some ﬂexibility in how countries implement sui generis systems for the protection of plant varieties. While many developing countries have ratiﬁed UPOV or have adopted UPOV-style PVP systems, there are some countries that have bucked this trend. Instead, countries might seek to develop their own non-UPOV sui generis PVP systems that are better suited to local plant-breeding conditions, may protect non-uniform farmers’ varieties, and ensure farmers’ rights are maintained, among other considerations. With a looming deadline for WTO TRIPS implementation by ‘least developed countries’, these countries should be analysing options for sui generis systems that are more suitable to the individual conditions in their own countries. These sorts of non-UPOV PVP systems may be more suitable for the protection

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of plant-related traditional knowledge. Some model systems are discussed in more detail in this chapter and Chapter 7. Aside from the concerns with patents and PVP, there is considerable interest in at least one kind of IPR. Geographical indications are an area of interest because they can protect the name or description of products that have been produced in speciﬁc geographical areas and which are known to have distinct qualities as a result of that speciﬁc environment and/or traditional production techniques. GIs are deﬁned under the TRIPS Agreement (Article 22) as: Indications which identify a good – as originating in the territory of a [WTO] Member [country], or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin. Currently, the TRIPS Agreement provides for the additional protection of GIs for wines and spirits. With recent alignments between the EC and many developing countries in the TRIPS Council, there is a greater possibility that the impasse on outstanding ‘implementation issues’ could be overcome. This means that greater opportunities for the extended GI protection of traditional knowledge-based products could open up in coming meetings of the TRIPS Council. A number of authors have highlighted the potential for GIs to protect traditional knowledge (Downes, 2002, p381; Vivas-Eugui, 2001; Morgan, 2004; Kuanpoth and Robinson, 2009) for a number of reasons. As Downes (2002, p383) notes, GIs are intended to ‘reward goodwill and reputation created or built up by a group of producers over many years, and in some cases over centuries’. GIs also lend themselves better to communal organization than other IPRs, being advantageous in the traditional knowledge context where such knowledge often originates or is held by speciﬁc communities. If a community in a speciﬁc geographical location has maintained methods of production of certain products over time, which gives that product a certain quality, then that community would likely be eligible for GI protection of the product. Geographical indications also have the advantage that they link traditional practices with place and environment, which could be harmonious with the worldview of many indigenous and local groups. As an expert of the French system of appellations of origin has explained: An appellation of origin goes much further than a simple indication of … where a product is obtained or produced. [It also refers to] the further effects wrought upon a product by natural factors speciﬁc to the locality such as micro-climate, soil formation, and so on and also by speciﬁc human factors that pertain to the product such as viniﬁcation procedure, pruning methods, maturation, and so on. The notion involves the interaction between these natural and human factors, speciﬁc and peculiar to the locality, which

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produces the distinctive quality or character of [that region’s] product. (Downes, 2002, p383) Consequently, the concurrence between sociocultural and environmental factors and the fact that they protect community rather than individual interests has meant that for products such as rooibos tea, as well as basmati and jasmine rice, there is growing interest in GI protection. While GIs are unlikely to stop biopiracy in most cases, they may reduce the possibility of deceptive trademarks being granted and also provide a mechanism for the promotion of traditional products to domestic and export markets. There have been case studies of some successful and potential protections of traditional knowledge-based products. Most notably, Rangnekar (2004; 2009) and Srivastava (2005) have examined issues surrounding the protection of Darjeeling tea, which, although it is an enterprise with a colonial history, may still hold some relevance for other ‘traditional’ products. In the case of Darjeeling tea, local producers in very speciﬁc locations in West Bengal at the foothills of the Himalaya have sought to protect their product from outside claims of tea products under the name ‘Darjeeling’. Darjeeling tea is a product of the unique environment in which it is grown, including climatic and soil conditions, as well as methods of local production that have been passed on for generations. A number of trademarks have been registered in countries including Japan and France which use the term ‘Darjeeling’ or ‘Darjeeling Tea’ which the Tea Board of India has subsequently disputed. The Tea Board of India, as well as associations of local tea producers and the government of India have sought to protect Darjeeling tea through foreign registrations as a trademark or certiﬁed trademark, the creation of a speciﬁc logo and ﬁnally through the registration of Darjeeling tea as a GI in India in 2004. These actions have been followed up with enforcement measures including certiﬁcates of origin, investigations and the pursuit of infringements. The Darjeeling tea case thus provides a useful example of how active strategies can be launched to ensure an indication of origin is not rendered generic, and so that the ‘traditional’ knowledge and qualities of a product can be actively protected. Another similar example is provided by Gopalakrishnan et al. (2007, p44) in relation to the production of Ceylon tea in Sri Lanka. Since the right over GIs has no time limit and can exist continuously, the commercial strength of products created by GIs can be prolonged forever. Therefore, the protection of goodwill surrounding a product is likely to provide stronger protection to the traditional knowledge that underpins it than through any other existing proprietary rights (Kuanpoth and Robinson, 2009).

Indigenous Rights and Traditional Knowledge There are also attempts at the international level to ensure that indigenous rights are respected and that this includes appropriate protection and promotion of traditional knowledge. The United Nations Declaration on the Rights of Indigenous Peoples has recently been adopted by the UN General Assembly

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in September 2007 at the 107th plenary meeting and is a major moral and political step forward in the struggle for indigenous rights. The declaration contains important provisions for the protection of human rights, regarding fundamental freedoms, non-discrimination, self-determination, association, cultural rights, land rights, labour rights and economic rights of indigenous peoples and individuals. Although the declaration took almost 25 years of negotiation and is still a non-binding document, it has been celebrated as a signiﬁcant victory for indigenous rights for an estimated 370 million people. Notably, the declaration contains a number of articles explicitly relevant to traditional knowledge and customary norms. Articles 11 and 12 refer to the right to practise and revitalize cultural traditions and customs, as well as spiritual and religious traditions, customs and ceremonies respectively (see also Article 34). These articles also provide for state assistance and redress of these concerns. Article 24 refers to rights to use and conserve traditional medicinal plants, animals and minerals, while Articles 25 to 27 refer to the relationship between indigenous people and their ‘lands, territories, waters and coastal seas, and other [including biological] resources’. Also, Article 31 makes explicit mention that: 1 Indigenous peoples have the right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions, as well as manifestations of their sciences, technologies and cultures, including human and genetic resources, seeds, medicines, knowledge of the properties of fauna and ﬂora, oral traditions, literatures, designs, sports and traditional games and visual and performing arts. They also have the right to maintain, control, protect and develop their intellectual property over such cultural heritage, traditional knowledge, and traditional cultural expressions. 2 In conjunction with indigenous peoples, States shall take effective measures to recognize and protect the exercise of these rights. These provisions on intellectual property, traditional knowledge and related concerns are important statements that should at least act as a moral, if not legal, deterrent to acts such as biopiracy. More generally, the declaration is likely to increase pressure on national governments to recognize the full suite of rights that should be accorded to indigenous people. The adoption of the declaration is not likely to be a panacea for indigenous issues, but may further enhance the moral and political force of indigenous efforts to secure fair and equitable rights. Consequently, if basic respect for the rights of marginalized indigenous people can be attained, they will have greater opportunities to shape their own futures, including the protection of their own knowledge.

Traditional Knowledge, Customary Protocols and Laws The relationship between traditional knowledge and customary protocols and laws are currently being addressed in two fora: WIPO and the CBD. The

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former has been doing so particularly in the international intellectual property context, while the latter has a considerably broader mandate for work on traditional knowledge. WIPO has been working on a number of complementary initiatives relating to traditional knowledge following on from its detailed fact-ﬁnding missions and preliminary meetings of the IGC. WIPO, with the representatives at the IGC, has been working on draft provisions for the enhanced protection of traditional knowledge in one publication and for traditional cultural expressions in another. The former is of most relevance to this discussion, although it is worth noting that often there is signiﬁcant overlap between traditional biodiversity-based knowledge and cultural expressions which may be used to transfer or convey knowledge. The WIPO documents note this overlap, but indicate that the intention is to address speciﬁc legal questions through the draft provisions and therefore argue that it is more practical to deal with them as two separate documents. Despite these imposed separations, the draft provisions provide a useful model set of principles and measures for the protection of traditional knowledge. Even though WIPO has been criticized for having a limited mandate that generally focuses on private rights in IPRs, the objectives and principles of these documents are surprisingly broad in their scope. They cover areas such as the necessity of meeting the actual needs of traditional knowledge holders, promotion and empowering of traditional knowledge holders, support for traditional-knowledge systems, prevention of unfair and inequitable uses, ensuring PIC and beneﬁt-sharing arrangements are appropriate and equitable, and precluding the grant of improper IPRs to unauthorized parties. The core principles respond to a number of these objectives and also include details on the need for respect of customary use and transmission of traditional knowledge. The substantive principles indicate that national authorities should provide for legal protection against misappropriation (which they deﬁne), as well as for PIC and beneﬁt-sharing. Although these principles are still non-binding draft provisions, they set another useful international precedent. The work of WIPO in relation to the IGC has been useful for developing countries and regional bodies in the development of laws on traditional knowledge. For example, the Paciﬁc Islands Forum Secretariat notes that the questions posed in the document Elements of a Sui Generis System for the Protection of Traditional Knowledge, created by WIPO for the IGC, have guided the development of their Model Laws on Traditional Knowledge (Paciﬁc Islands Forum Secretariat, c.2007). Additionally, WIPO has begun a number of consultations, including one on customary law and intellectual property. The IGC has approved work on customary law, including the draft provisions documents discussed, as well as further consultations following the WIPO fact-ﬁnding missions. An issue paper has been put forward as well as a study commissioned by WIPO on customary law in the Andean region in an effort to induce further submissions. The consultation is seeking a broad range of submissions and case studies that can elaborate the relationship between customary law and traditional knowledge,

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the legal status of customary protocols and laws, the way these customary mechanisms protect and maintain traditional knowledge, and other legal or policy issues at the interface between intellectual property and customary law (WIPO, c.2005). This work is important because there is extensive diversity in the world’s indigenous cultures through which customary norms will vary greatly and play different roles with respect to traditional knowledge and in the broader Western legal context of intellectual property. It is important to determine ways that formal Western IP and related laws can effectively recognize and respect the customary norms of indigenous and local communities. The CBD Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions is also an important forum which explicitly deals with traditional knowledge issues. The forum has a broad mandate for the protection and promotion of traditional knowledge and associated local practices. The working group is also mandated to work with the ABS Working Group on an International Regime in order to ensure that work is in compliance with the aims of Article 8(j). It is worth mentioning that the former working group allows direct participation of indigenous and local representatives, but problematically these representatives are only able to participate in the latter working group as observers. This represents another exclusion and division of indigenous and non-indigenous forums, rather than bringing them together. The CBD secretariat has noted that the ABS Working Group is to be ‘closely informed’ by the concerns raised by indigenous representatives in the 8(j) Working Group (see ICTSD, 2005a). One early outcome of the 8(j) Working Group has been a series of Composite Reports (phase two is shortly to be released) from different regions on the status and trends regarding the knowledge, innovation and practices of indigenous and local communities (see for example, Langton and Ma Rhea, 2003, on the Asia region). The reports have documented the loss of traditional knowledge and emphasize the relative scarcity of sui generis examples of measures and initiatives speciﬁcally designed to protect, promote and facilitate the use of traditional knowledge (at least until recently). As a result the working group is now discussing options for sui generis systems of the protection and promotion of local practice and traditional knowledge, with speciﬁc emphasis on the respect of customary laws of local and indigenous peoples. However, such negotiations have been hamstrung by the need to have a framework that is broad enough so as not to limit or exclude the applicability of the wide range of customary laws. The working group has made recent invitations to parties and governments to make submissions in relation to their experiences of development and implementation of sui generis traditional knowledge systems at local, national and regional scales (COP 9 Decision IX/13 part F, 19–30 May 2008). A number of other action items on traditional knowledge have been continued at COP 9 including the development of guidelines for documenting traditional knowledge, a plan of action for the retention of traditional knowledge and draft elements for the development of a code of ethical conduct (Decision IX/13 part C, D, G, respectively, 19–30 May 2008). These actions are largely

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aimed at the broader retention of traditional knowledge which, according to Composite Reports, is in decline in many parts of the world, as well as the ‘defensive’ protection of traditional knowledge from biopiracy and improper research practices. This broader mandate, going beyond the intellectual property aspects of traditional knowledge, represents a crucial difference from the other forums. This means that the indigenous representatives have a much greater control over the direction of initiatives for the maintenance, protection and promotion of traditional knowledge beyond defensive protection from biopiracy. Staff at the CBD Secretariat had also noted that there had been a fairly ‘limited working interaction between them, the Working Group on Indigenous Populations and the Ofﬁce of the UN High Commissioner on Human Rights’ (Scott, personal communication, 2005). The ofﬁcial indicated that while CBD staff had attended workshops of these organizations, the presence of the working group and human rights bodies at CBD meetings (generally) had been limited. There seems to be some disconnection between these forums even though they should be working closely together for indigenous rights. This disconnection is likely to be mandate-driven and due to the focus on state representation in the UN, as well as because of the cost and distance of travelling between the secretariats and ofﬁces. However, there does seem to be close collaboration between the CBD and the UN Permanent Forum on Indigenous Issues as indicated in the Decisions on Article 8(j) and related provisions at COP 9 (Decision IX/13 part I, 19–30 May 2008). Cooperation, such as at the 8(j) forum, should be of assistance in bridging new ideas about potential sui generis systems that can be promoted by indigenous and local advocacy groups, and that interested countries might develop. However, taking on an issue with as great a diversity of stakeholders as this from the top-down is a colossal task. It is evident that further bottomup research and local community capacity building on a country by country, and case by case basis, could help inform this debate – particularly in relation to customary protocols and laws. This is something that WIPO has sought to have researchers provide information on so that it can develop a critical mass of literature and better understand the customary regulation systems that relate to traditional knowledge. The UN Permanent Forum on Indigenous Issues has also held workshops attempting to develop this critical mass of information. Gradually, more investigations are emerging, for example through the IIED project Protecting Community Rights over Traditional Knowledge,3 and the reports of Thom and Bain (2004), and others.

Summary – International Governance With so many international forums working on issues related to biopiracy one might assume that it will become increasingly difﬁcult for it to occur. There are certainly aspects relating to the international transfer of biological resources (and use of traditional knowledge) and the limitations on extraterritorial application of national laws that mean that biopiracy should be dealt with in one or more

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international institutional settings (which each have their advantages and disadvantages). However, there are still signiﬁcant gaps between the mandates of these agreements and forums, issues of implementation into practical and enforceable national regimes, non-ratiﬁcation of international laws by certain countries, and difﬁculties associated with the formal recognition of knowledge and customs that are verbally maintained and transferred, among other issues. These factors make it less likely that these international initiatives will be effective at reducing the prevalence of biopiracy. It is also worth questioning whether such initiatives can really be successfully driven in a ‘top-down’ manner by diplomats, UN delegates and other senior ofﬁcials. Increasingly, the representatives of indigenous and local people are being allowed, invited and even funded to attend meetings and negotiations on the protection of traditional knowledge and biological resources. The secretariats of organizations such as the CBD and WIPO have also been diligently seeking case studies and information from local and national sources to help counter this ‘top-down’ format of decision-making. Despite these efforts, it seems likely that local communities and national governments will also need to continue to maintain and develop their own unique systems for protecting traditional knowledge and biological resources given the heterogeneous nature of indigenous and local cultures, the diversity of biological resources and environments, and the speciﬁc interests and circumstances of the main stakeholders. Certainly, indigenous and local communities, as well as policymakers, should not rely solely upon physically and often conceptually distant negotiations in international forums to resolve local and national issues relating to biopiracy, traditional knowledge and biological resources.

Regional Initiatives on Biological Resources and Traditional Knowledge Although there has been a recent ﬂood of free-trade agreements between bilateral and regional partners, these have generally been driven by the US, EU and Japan. As a result, the opportunity to include elements intended to inhibit biopiracy and to protect biological resources and traditional knowledge has been limited. Most of the regional progress on biological resources and traditional knowledge has been driven from within biodiverse regions concerned about biopiracy, misappropriations, the maintenance of traditional knowledge and related issues. Regional arrangements have some advantage over negotiations in international forums because of the smaller number of parties involved and because the parties usually have some shared interests and features (whether political, cultural, geographical or environmental).

ASEAN Framework Agreement on Access and Beneﬁt-sharing

There are many endemic species to Southeast Asia and to speciﬁc countries or localities within the region. The Center for Conservation Biology (2004) at Mahidol University, for example, cites 12 freshwater ﬁsh species thought

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to be endemic to Thailand and 120 species which are endemic to mainland Southeast Asia. This highlights the importance of interstate cooperation in the region with regards to access and beneﬁt-sharing to species and plant varieties that are found in ecosystems lying across borders. It is probable, to use the example of some plants discussed in this book, that kwao krua and plao noi are found in countries adjacent to Thailand, including Burma and Laos. The ASEAN Framework Agreement on Access to Biological and Genetic Resources and Fair and Equitable Sharing of Beneﬁts has essentially sought to pre-empt potential problems where there may be biological resources shared across borders and attempts to establish some regional unity on these matters. Currently, there are laws relating to biodiversity protection that include elements on ABS in a few ASEAN countries, but not all. The current ASEAN Framework Agreement and surrounding documents are conﬁdential; however, a draft version can be found at the GRAIN website. The draft agreement was presented and approved during the 8th Informal ASEAN Ministerial Meeting on the Environment in October 2004. ASEAN member states have since been undergoing national consultations before clearing the ratiﬁcation and implementation of the Framework Agreement. At the 19th Meeting of the ASEAN Senior Ofﬁcials on the Environment, on 4–6 August 2008, the ASEAN Centre for Biodiversity reiterated the need for countries to ﬁnalize their national consultations and sign the Framework Agreement. In its draft format, the ASEAN Framework Agreement basically applies conditions, derived from the CBD to member states, for cooperation on matters of PIC and ABS where they have more than one national jurisdiction. It also establishes the ASEAN Clearing House Mechanism, which facilitates ‘consolidation, access, analysis and promotion of regional biodiversity information, issues and initiatives of the ASEAN Member States’. To this end, the ASEAN Centre for Biodiversity is in the process of establishing and maintaining a database on the status of biological and genetic resources, as well as access agreements and applications. According to the draft text of the Framework Agreement, the settlement of disputes is to be pursued through dialogue and, failing that, through a suitable arbitration process according to relevant international treaties. A regional common fund is also to be established where beneﬁts arising from the commercialization of genetic resources can be distributed between provider states. Assumedly, this would also be administered through the ASEAN Centre for Biodiversity.

African Model Law

The African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources was adopted in Ouagadougou in 1998 by the Organization for African Unity (OAU – now African Union) member countries. The African Model Law has broader objectives than the ASEAN Framework Agreement as it also seeks to address issues of community rights and farmers’ rights.

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The bulk of work on the African Model Law started in 1997 when the OAU, through its Scientiﬁc, Technical and Research Commission, embarked on a process to assist African countries in fulﬁlling their obligations under both the CBD and the TRIPS Agreement.4 The Model Law was conceived in response to these international agreements and due to a number of important viewpoints on intellectual property, biodiversity and traditional knowledge that were felt across governments in Africa. As Ekpere (2003, p232) notes, the concept of IPRs as expressed in the TRIPS Agreement was seen as alien to African understandings of property and rights, and therefore more appropriate considerations to the African context, such as community rights, traditional knowledge, technology, innovations and practices, were pursued in the Model Law. As a central principle, the OAU Model Law holds that patents on lifeforms are immoral and go against the basic values of African citizens and should therefore be outlawed (Nnadozie, 2004, p15). Additionally, there were concerns about the food-security implications of IPRs on the ability to exchange farm-saved seed and hence there were farmers’ rights provisions included. In relation to their obligations under Article 27.3(b) of the TRIPS Agreement, African countries have been going through the process of adopting several variants of sui generis systems embodying components of the Model Law. These include South Africa, Egypt, Namibia, Zimbabwe, Kenya, Uganda and Nigeria (Ekpere, 2003, p235; GRAIN, accessed May 2009). The Model Law also speciﬁes frameworks for fair and equitable access and beneﬁt-sharing in a similar manner to the CBD. Deriving from this, the national legal frameworks for access to genetic resources and beneﬁt-sharing in Africa have been more ad hoc and sectoral until relatively recently when some countries, such as Ethiopia, South Africa and Kenya, adopted laws and regulations (Nnadozie, 2004, p11). The African Model Law is fairly unique because of its inclusion of speciﬁc details relating to community rights. The recognition of community rights has been sought by many indigenous, minority and local communities, particularly in relation to issues of land ownership, but also with regards to recognition of their customary norms, practices and laws, whether written or orally transmitted. The Project Coordinator of the OAM Scientiﬁc, Technical and Research Commission describes the importance of community rights in the African context: Community rights and responsibilities that govern the use, management and development of biodiversity, as well as the traditional knowledge, innovations and practices relating to them, existed long before private rights over biodiversity emerged, and concepts of individual ownership and property arose. Community rights are thus regarded as natural, inalienable, pre-existing or primary rights. The OAU’s Model Law recognizes this a priori character of rights in its Preamble … The rights of local communities over their biodiversity leads to the formalisation of their existing communal control over biodiversity. This system of rights, which enhances

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the conservation and sustainable use of biological diversity and promotes the use and further development of knowledge and technologies, is absolutely essential for the identity of local communities and for the continuation of their irreplaceable role in the conservation and sustainable use of this biodiversity … Community rights are especially important for Africa’s multi-ethnic nature. The Model Law provides an opportunity to recognize and sustain Africa’s rich cultural heritage and biological resources by recognising the system of pre-existing rights. (Ekpere, 2000, p20) Firstly, the Model Law (Article 1) deﬁnes a ‘local community’ as a human population who lives in a distinct geographical area, ‘with ownership over its biological resources, innovations, practices, knowledge, and technologies governed partially or completely by their own customs, traditions or laws’. Part IV (Articles 16–23) of the Model Law then details the need for states to recognize the rights of local communities with respect to biodiversity and traditional knowledge, as subject to the norms, practices and customary laws of the indigenous and local communities, whether written or not. With regards to access to biological resources and traditional knowledge, the Model Law also requires that PIC be sought of the local communities and that women participate equally in decision-making (Article 18), that communities may refuse consent (Article 19) and that they may withdraw or restrict consent (Article 20). The Model Law also states that communities should receive at least 50 per cent of beneﬁts provided by any successful utilization and commercialization of biological resources and traditional knowledge (Article 22). Thus, the African Model Law can be considered to be a very community-centred law. While countries have been gradually implementing national laws that draw upon the Model Law, there have been difﬁculties associated with their implementation due to limited capacity, skill and expertise in legal-drafting in many countries, as well as difﬁculties matching articles of the Model Law to national priority objectives (Ekpere, 2003, p236). For example, Ethiopia is the closest to recognizing some form of customary rights in its development of a national Proclamation on Access to Genetic Resources and Community Knowledge, and Community Rights (2006). Yet it is still early on in the implementation of this law and so it is unclear to what extent customary systems for regulating traditional knowledge and biological resources will be effective and free from inter-community or intra-community disputes. It is certainly conceivable that different communities, whether based on geographical, ethnic, religious or other differences, might have reason to argue their respective customary rights over the sharing of beneﬁts arising from the use of a speciﬁc biological resource. To take the protection of traditional knowledge and community rights forward, African Union ofﬁcials and representatives have been working on a Draft Consolidated Framework on the Protection of Traditional Knowledge, Intellectual Property, Individual and Community Rights. The idea for this has stemmed from the concern that Africa does not have a formal and

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consolidated framework to guide member states in the protection of inventions and innovations arising from the efforts of traditional communities as well as individuals. In November 2007, this draft framework was put forward as a guide for member states and which provides a sort of template of the types of provisions that member states would want to incorporate in slightly more speciﬁc detail than the Model Law (African Union, 2007).

Regional Biodiversity Strategy for the Tropical Andean Countries

On 17 July 2002, the Andean Community approved a Regional Biodiversity Strategy for the Tropical Andean Countries. The regional strategy is worth raising because it also provides a framework for collaboration within the Andean countries on issues relating to access and beneﬁt-sharing, as well as the protection and promotion of traditional knowledge. With regards to access and beneﬁt-sharing, the strategy attempts to clarify aspects of the operation of the 1996 Andean Community Decision 391 on a ‘Common Regime on Access to Genetic Resources’. Under the regime, competent national authorities are to be established which are authorized to sign access contracts with researchers. Where necessary, the regime also provides for bilateral and multilateral agreements. However, it says very little about consequent beneﬁt-sharing arrangements. Therefore, Objective II of the strategy is ‘To equitably distribute the resulting beneﬁts with due account of a correct economic valuation of the various biodiversity components’, and it outlines the need for common principles for promoting fair and equitable sharing of beneﬁts. As Ruiz (2003, p241) notes, the Andean Community has also attempted to address issues of conﬂict between traditional knowledge and intellectual property through the 2000 Decision 486 on a ‘Common Regime on Industrial Property’. Article 3 of Decision 486 (Biological and Genetic Patrimony and Traditional Knowledge) establishes that: Member States will make sure that protection provided through elements of industrial property [not only patents] is provided safeguarding and respecting their biological and genetic patrimony as well as the traditional knowledge of their indigenous, AfroAmerican and local communities. In this regard, patents concerning materials obtained from this patrimony or knowledge, will be subject to those materials having been obtained in conformity with international, regional and national regulations. Although this is not a self-executing article protecting member states’ interest in genetic resources and traditional knowledge, it puts in place a regional framework which can be elaborated upon in national regulations. The Regional Biodiversity Strategy has slightly broader goals in relation to traditional knowledge, seeking to ensure that it is not lost over time or

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misappropriated. Objective III of the strategy is, ‘To protect and nurture the knowledge, innovations and practices of indigenous, Afro-American and local communities on the basis of the recognition of their individual, communal and collective rights’. It notes the need for a policy to monitor the process of loss and undue appropriation of traditional knowledge, pilot schemes for the protection and nurturing of traditional knowledge on biodiversity, and for the recording of non-conﬁdential knowledge. The Regional Biodiversity Strategy also recommends the training of political leaders and technical personnel of indigenous, Afro-American and local communities in relation to the legal and technical principles governing the protection and nurturing of traditional knowledge, and how this relates to third party access to such knowledge.

Paciﬁc Model Laws

The Paciﬁc Islands Forum Secretariat has developed two model laws for implementation in Paciﬁc Island countries and coordination through a regional body. They have developed a Model Law for the Protection of Traditional Knowledge and Expressions of Culture,5 as well as a Model Law on Traditional Biological Knowledge, Innovations and Practices. The former law deals mostly with the prevention of misuse of traditional cultural expressions, while the latter is relevant to the prevention of biopiracy and related misappropriations. The Model Law on Traditional Biological Knowledge, Innovations and Practices seeks to establish competent national authorities which would then set up databases of traditional biological knowledge, control ABS and PIC procedures, provide protections for economic and cultural rights, and also establish a Traditional Ownership Tribunal. As yet it is not clear if the database would be accessible to patent examiners; national authorities are likely to determine this, subject to local concerns about accessibility of knowledge and customary protocols. In cases where the competent national authority cannot resolve ownership disputes relating to traditional knowledge, the Traditional Ownership Tribunal would mediate between the parties. This mediation is likely to also take into account the customary norms, protocols and laws of local communities. In August 2008 the Paciﬁc Islands Forum Secretariat began a project on the national implementation of laws relating to traditional knowledge based on the model laws, in conjunction with the Secretariat of the Paciﬁc Community, the South Paciﬁc Regional Environment Programme and WIPO. They are also working towards a regional arrangement for reciprocal recognition and enforcement of rights in traditional knowledge and traditional cultural expressions. It is hoped that the model laws would inhibit biopiracy and misappropriations, promote and maintain traditional knowledge and cultural expressions, and also potentially help mediate claims of ownership between different communities in the Paciﬁc.

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Notes 1

The parties of the CBD have not been able to agree upon the use of the broader term, ‘biological’ resources, or to use the narrower term, ‘genetic’ resources. Generally, developing and least-developed countries have preferred the former and developed countries have preferred the latter. 2 As at 19 May 2009. 3 Project details are available from the International Institute for Environment and Development website at www.iied.org/natural-resources/key-issues/biodiversityand-conservation/protecting-community-rights-traditional-knowledge. 4 However, Ekpere (2003, p232) indicates that the OAU Model Law was initially developed as a direct response to the decision taken and a directive given by the OAU Council of Ministers in 1988. 5 This model law can be found at www.forumsec.org.fj/_resources/article/ﬁles/Paciﬁc ModelLaw,ProtectionofTKandExprssnsofCulture2002.pdf.

7

Current Debates and Ways Forward: National and Local Approaches

The defensive protection of genetic resources and traditional knowledge is an extremely complex task for a country such as Peru whose territory has such broad biodiversity. However, such protection is necessary given that bad patents or potential bad patents can have a very detrimental effect on the economic, social and cultural interests of a country such as Peru. (Peru, 19 September 2007, IP/C/W/493, p8) The IP/C/W/493 submission to the TRIPS Council by Peru on 19 September 2007 reﬂects the dissatisfaction of the government with recent international trends of ‘biopiracy’. Here it notes the occurrence of ‘bad patents’ that have had numerous implications for the country. Hence many governments, particularly from biodiverse developing countries, have begun developing their own initiatives for ‘defensive’ and ‘positive’ protection of traditional knowledge and/or biological resources. These initiatives obviously are limited by their territorial scope; however, they may link into broader initiatives and may also provide useful examples that may ultimately be adopted by other countries that have similar concerns. Although many countries have developed plant-variety protection laws required under TRIPS according to the UPOV model, there have been a number of variations to this model and some quite unique non-UPOV plantvariety protection laws. These sui generis laws have attempted to protect local farmers’ varieties and breeding in various ways. Other biodiversity laws and regulations have also sought to regulate the transfer of biological resources, as well as ensuring local and indigenous communities are respected for their knowledge, sustainable use and conservation of biological resources. National registers and databases of biological resources and traditional knowledge have also been developed to maintain this knowledge and also to provide a

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reference list of prior art to ensure that patent examiners and researchers do not improperly seek to monopolize knowledge that is not novel in the broadest sense. Lastly, national authorities have been established, most notably in Peru, to directly identify and challenge biopiracy cases. There are also many activities being undertaken by non-government stakeholders and, in fact, many NGO actions have been a primary stimulus for improved patent and PVP assessment standards and other acts to prevent biopiracy. NGOs have been the main investigators of biopiracy cases, with some exceptions including academic studies and those undertaken by the Peruvian government. These actions have in turn inﬂuenced the codes of conduct and ethics of researchers including bioprospectors, ethnobotanists, ethnopharmacologists and those in other related ﬁelds. Indigenous representative organizations are also undertaking projects for the documentation and protection of traditional knowledge, customary laws and norms at the local scale. Indigenous representatives are also increasingly making their presence felt in international forums, in bioprospecting negotiations and in national policy development.

Peru’s National Anti-Biopiracy Commission National and international recognition of traditional knowledge is an issue of crucial importance to many developing countries and especially Peru, whose geographical setting places it among the ten countries with the most extensive biodiversity in the world, which are known as ‘mega-diverse countries’ because of their range of ecosystems, species, genetic resources and indigenous cultures with valuable knowledge. (Peru, WIPO/GRTKF/IC/8/12, 2005, p1) The government of Peru has developed a law establishing a protection regime for the collective knowledge of indigenous peoples derived from biological resources (Law No. 27811, published on 10 August 2002, see Box 7.1). However, noting the national jurisdictional limitations of this law, they also enacted a law establishing the National Commission for the Protection of Access to Peruvian Biological Diversity and to the Collective Knowledge of the Indigenous Peoples (known as the National Anti-Biopiracy Commission; Law No. 28216 of 1 May 2004). The National Anti-Biopiracy Commission is chaired and coordinated by INDECOPI – the Peruvian national institute for competition and intellectual property protection – and is made up of representatives of a number of other relevant government bodies, NGOs, indigenous peoples and business associations. The commission has the task of ‘developing actions to identify, prevent and avoid acts of biopiracy with the aim of protecting the interests of the Peruvian State’ (Peru, WIPO/GRTKF/ IC/8/12, 2005, p3). Its main functions are to:

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Establish and maintain a register of biological resources and traditional knowledge; Provide protection against acts of biopiracy; Identify and follow up patent applications made or patents granted abroad that relate to Peruvian biological resources or collective knowledge of the indigenous peoples of Peru; Make technical evaluations of the above-mentioned applications and patent grants; Issue reports on the cases studied; Lodge objections or institute actions for annulment concerning the abovementioned patent applications or patent grants; Establish information channels with the main intellectual property ofﬁces around the world; Draw up proposals for the defence of Peru’s interests in different forums.

The National Anti-Biopiracy Commission has been the most directly active of any national organization in the world in terms of documenting and addressing biopiracy. It has actively sought to identify and highlight acts of biopiracy in international forums, including the submissions on maca and camu camu discussed in Chapter 3. By documenting these cases of spurious patents, the commission has sought to pressure inventors to withdraw patents where appropriate and have also put pressure on foreign patent ofﬁces to improve their patent-examination procedures. Furthermore, the cases have been used to support arguments made by Peru and other countries that an international disclosure-of-origin patent requirement would help reduce the likelihood of further biopiracy incidents.

Biodiversity Laws and Regulations The Biological Diversity Act of India (2002) is worth discussing as a number of its components are speciﬁc to the protection of traditional knowledge and biodiversity. The Indian Act regulates access to biological resources and beneﬁt-sharing and sets up Biodiversity Management Committees (under the National Biodiversity Authority), to which funds are then allocated from sources including compensatory arrangements. Chapter II of the Indian law deals with the regulation of biodiversity including access, PIC and beneﬁt-sharing. Prior approvals for access and transfer of biological resources and associated knowledge are controlled though the National Biodiversity Authority. Additionally, the law indicates that application for IPRs must not be made without approval of this authority. Because the primary concern of the Indian government and the public was deemed to be with regard to the extraction of biological resources outside the sovereign domains of the state, the law has different access requirements for foreigners versus Indian nationals. There is consequently a more complex procedure for access to biological resources and associated knowledge for foreigners, than there is for Indians. Sagar (2005, pp388–9) notes that this

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state-based bias means that local genetic resources might be exploited by Indian researchers: local farmers or tribal groups may not be adequately consulted or receive consequent beneﬁts from Indian researchers. However. the application for IPRs via approval of the National Biodiversity Authority applies equally to Indians and other nationals. Under the Indian Biological Diversity Act, the National Biodiversity Authority coordinates local People’s Biodiversity Registers (PeBRs) across the country. At each local area the Biodiversity Management Committee (BMC) (see Chapter X of the Indian Act) must help facilitate the documentation of traditional knowledge related to biodiversity and its many facets. A National Workshop on People’s Biodiversity Registers was held in June 2006 which led to a methodology paper being released for public review and comment in 2008.1 The compiling of PeBRs involves obtaining prior informed consent of local communities. In fact, each community is supposed to be involved in the control of the entire PeBR process, with the assistance of NGOs and the BMCs (National Biodiversity Authority, 2006). Only knowledge that receives consent is shared. It is anticipated that knowledge will be coded differentially depending upon the desire of the communities – some will be kept conﬁdential (where it is considered secret or sacred knowledge) and some will be available to the public. At the discretion of the local communities, the information will be linked to a larger Indian Biodiversity Information System (IBIS) (Robinson, 2007). The BMCs can also charge fees for collecting activities of biodiversity (where approved), which then accrues in Local Biodiversity Funds (administered by individual states which also contribute to the funds) which can then make grants or loans for the purposes of biodiversity conservation and knowledge. The scale of these tasks is enormous, but the PeBRs development process is already at a remarkable level of complexity. During the last few years they have developed sets of rules (under the Biological Diversity Act), processes, technical measures (including development of the nationwide IBIS and incorporating open source People’s Biodiversity Register Information Systems), PeBRs Methodology Manuals for use at the BMC level, Technical Support Groups (including taxonomists and ecologists, expert farmers and computer scientists), among other measures (National Biodiversity Authority, 2006, 2008). The development of the PeBRs system across India will provide important insights for the development of similar projects in other countries. Aside from the Indian Biological Diversity Act, there are many other national biological resource benefit-sharing systems currently under development and/or implementation around the world. They are worth brieﬂy raising in terms of their regulatory controls such as prior informed consent and access mechanisms and the respect of customary protocols or laws. Box 7.1 is not an exhaustive overview, offering a basic outline of some different approaches to the regulation of biological resources. The development and implementation of these laws and regulations provide important lessons for other countries developing regulations on access and beneﬁt-sharing relating to biological resources. The Indian Biological Diversity Act particularly provides some innovative ideas for approaches that countries

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BOX 7.1 NATIONAL SYSTEMS FOR REGULATION OF BIOLOGICAL RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE Peru has established a Regime of Protection of the Collective Knowledge of Indigenous Peoples (2002). Under the regime, indigenous groups may be entitled to compensation by outside parties in the form of 0.5 per cent of the value of sales of any product developed from the knowledge. Ethiopia has developed an Access to Genetic Resources and Community Knowledge and Community Rights Proclamation (2006). The proclamation organizes beneﬁt-sharing on a case-by-case basis according to each speciﬁc access agreement. The Kenyan Environmental Management and Co-ordination (conservation of biological diversity and resources, access to genetic resources and beneﬁt-sharing) Regulations were passed in 2006. The regulations essentially detail beneﬁt-sharing arrangements for contractual access agreements to genetic resources. The Amapa State Law No. 0388/97 in Brazil regulates access to biological diversity through a consent process. However, the law does not allow exploitation or intellectual property rights for proﬁt-making, so there is no beneﬁt-sharing system.2 The Costa Rica Biodiversity Law (1998) and Rules on Access to Biodiversity (2003) allow intellectual property rights on innovations that have been developed using biological material from Costa Rica, subject to a range of conditions. However, in the initial stages, access permits are required under three different categories: basic research, bioprospecting and commercial economic exploitation. These require prior informed consent agreements stipulating benefit-flows including monetary and technology transfers. In February 2008, South Africa gazetted the Commencement of Bio-Prospecting, Access and Beneﬁt-Sharing Regulations. The regulations require agreements between applicants for access permits and ‘stakeholders’ which should provide for sharing in any future beneﬁts that the bioprospecting should bring about. Sources: GRAIN website, www.grain.org/brl; Dutﬁeld (2006); Robinson (2008b).

could adapt for both the ‘defensive’ and ‘positive’ protection of biological resources and traditional knowledge.

Non-UPOV Sui Generis Plant-Variety Protection Laws While most developing countries have acceded to UPOV (either the 1978 or 1991 versions) or adopted and implemented UPOV-style laws, there are some countries that have adopted national sui generis PVP laws. These laws have generally been preferred to the UPOV model because of concerns about farmers’ rights and due to the inadequacy of UPOV for the protection of traditional agricultural knowledge. Discussed here are the Indian and Thai PVP laws.

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The Indian Protection of Plant Varieties and Farmers’ Rights Act (PVPFR) is a sui generis PVP law that differs considerably from the UPOV model in accordance with the public policy interests of the Indian population. It has been developed with unique provisions that are relevant for farmers’ rights and the protection of traditional agricultural knowledge in relation to domestic and farmers’ varieties. The PVPFR law allows farmers, breeders and other stakeholders to register an ‘extant variety’ (existing or domestic variety) or ‘farmers’ variety’ for PVP provided that it conforms to standard UPOV ‘distinctness, uniformity and stability’ (DUS) criteria (Article 15). Despite the good intentions of this rule, there could be some issues. First, farmers’ varieties or landraces are often not entirely uniform and/or stable and so may fail the registration process. Second, it is conceivable that many breeders would be involved in the breeding process of extant varieties of, say, basmati rice. Exactly how this registering entity will be held accountable to all potential contributors in the breeding process is unclear and could be problematic. If the registration is approved by the Registrar of the PVPFR Authority,3 the law allows conferral of an exclusive right over the variety, nearly identical to that offered to new varieties (similar to the protections offered under UPOV), but subject to a range of conditions. As of March 2008 there were over 350 registrations of extant varieties from a number of different approved species.4 Some authors have argued that property rights on extant varieties ironically could cause an ‘anticommons tragedy’ whereby too many parties independently possess the right to exclude others from utilizing the resource (Ramanna and Smale, 2004). This could ultimately lead to disputes between different groups of farmers. Since the extant variety does not necessarily need to be novel, rightholders could hypothetically gain control over a plant variety used by a wide range of other farmers. It is assumed that communities that contributed to the development of the variety would be excluded from having to gain permission or to pay use-fees under Article 41 (discussed below) (Robinson, 2008b). According to this law, ‘farmers’ varieties’ are a subset within the deﬁnition of ‘extant varieties’ but may also mean a variety which has ‘been traditionally cultivated and evolved by the farmers in their ﬁelds; or … is a wild relative or land race of a variety about which the farmers possess the common knowledge’ (Article 2L). These may be protected in a nearly identical manner to extant varieties under the Act. The approach of this component of the law is to allow equal treatment and allocation of rights to each kind of plant variety (farmers’ variety, extant variety and new variety) and to all types of plant breeder (from local farmer to advanced breeder). It is not yet clear whether the system of registration is too formal for farmers, whether it will be misused by parties seeking to exclude others or whether it will cause anticommons issues. Article 41 accords rights to communities to receive compensation if the community is found, by the PVPFR Authority or from registration details, to have made a signiﬁcant contribution to the evolution of a protected variety. This is essentially recognition of the contribution of sub-patentable innovation and traditional knowledge, and is the main mechanism for compensation under the Act. Although the Act is structured in favour of property rights rules, this is an important additional component for compensation of local

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farmers and breeders. The PVPFR Authority established a task force in 2007 for the development of guidelines and formulation of beneﬁt-sharing, and it seems that compensation mechanisms for local farmers and breeders are still being developed.5 Clarifying a number of implementation vagaries, the Ministry of Agriculture passed the PVPFR Regulations in December 2006. The rules detail the extensive duties of the registrar for examination of applications (Article 3, PVPFR Regs); criteria for registration of extant (and presumably farmers’) varieties (Article 6, PVPFR Regs), overseen by an Extant Variety Recommendation Committee which have since established a number of task forces to determine appropriate DUS criteria for different plant species/varieties (now posted on their website); and other administrative matters. The PVPFR Regulations append application forms, including a section requiring details on the use of farmers’ varieties or varieties of common knowledge used in the parental line for propagation of the hybrid. These have requirements for details of: denomination, geographical source, details of attribution (origin) and details of farmer/village community/ institution/organization (Form 1, Part 10b, PVPFR Regs). These origin requirements are quite detailed and may be burdensome for some local farmers and breeders. However, they may reduce disputes and misappropriations of plant varieties in the long term. The form also asks what sort of recognition (including beneﬁt-sharing) is planned for farmers and/or communities where these groups have conserved the genetic resource that has contributed towards variety development (Form 1, Part 10c, PVPFR Regs) (Robinson, 2008b). It is still fairly early in the implementation process of this law. Policymakers from other countries should monitor the experience of authorities and stakeholders in India as registrations are submitted and these rules begin to have tangible effects. Developments should continue in the coming months and it is likely that there will be increasing interest in the full implementation and operation of the Act. Another national non-UPOV sui generis PVP law is the Thai Plant Varieties Protection Act (PVP Act, 1999) which provides different kinds of protection for general domestic and wild varieties, as well as local plant varieties. It was an objective of those that developed the law that all plant varieties within Thailand are subject to state sovereignty and can be protected under one of the speciﬁc categories (new or local varieties) or under one of the general categories (domestic or wild varieties) (Kuanpoth, interviews, 2005, 2006). A range of Thai farmers’ organizations’ representatives, prominent NGO activists, academics and even government ofﬁcials have indicated that a principal concern about the expansion of the IP system into agriculture (and biological diversity more generally) was that it allows for exclusive control of biological materials.6 The exclusive control of plant varieties (and their replicability) often contradicts past customary practices and may offend cultural and ideological beliefs among different groups in Thailand. Rather than attempting to formalize exclusive protection for all varieties, as in India, which has been a fairly controversial undertaking, Thailand has sought to provide other forms of incentives to breeders of domestic and farmers’ varieties.

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For general domestic and wild varieties, the Thai PVP Act (Chapter 5) essentially details access and beneﬁt-sharing rules for collection, use and commercialization but does not allocate exclusive protection like those available in the Indian PVPFR Act. A range of stipulations must be made, including the intentions of those seeking access with regard to IP rights. Government ofﬁcials have noted that local farmers are exempt from Section 52, thus allowing the continued and free use of a variety by farmers and seeking to provide them with beneﬁts via a PVP fund if the germplasm is commercialized. Currently the law requires permission to be granted by government ofﬁcials for collection, use, development and research for commercial interest. Countries that utilize this sort of approach could consider extending authorizations to include the consent of farmers’ groups. The Act indicates that those seeking to conduct a study, experiment or research on a general domestic plant variety or a wild plant variety or any part thereof for a non-commercial purpose must comply with the regulation prescribed by a PVP Commission (S53). In other words, the contract and proﬁt-sharing arrangement is required only when activities are conducted for commercial interests and non-commercial activities only have to comply with the regulations. However, these detailed PVP regulations have not yet been fully developed and passed through the Council of State of Thailand. The Act establishes a PVP fund which accrues income from the collection, use, research or commercialization of general domestic or wild varieties, registration fees and other sources (Chapter 6). The fund is intended to be used to assist in the conservation and development of domestic and wild relatives of plant varieties by communities, as well as to cover other administrative expenses (Robinson, 2008b; Sungkabuan, interview, 2006). The Thai PVP Act gives more speciﬁc and exclusive protection rights for new varieties (similar to UPOV 1978 rules) and registered local community varieties that only exist in a relatively small geographic area (Chapter 4). For the local community protections, the community would then receive exclusive rights to conserve, use, research, sell and commercialize their local variety if so desired, in a similar manner to a new plant variety right. The intention is that local communities can protect their speciﬁc varieties defensively or positively, depending upon their main concerns and interests. While the Thai Ministry of Agriculture has developed new plant-variety protection regulations, the regulations on general domestic, wild and local plant varieties have been held up by deﬁnitional issues and conﬂicting agendas over the scope of these protections. Plant-Variety Protection Division ofﬁcials of the Thai Department of Agriculture have blamed the delays on concerns over the deﬁnition of ‘general domestic plant varieties’. The PVP Act (S.3) uses the deﬁnition: ‘general domestic plant variety’ means a plant variety originating or existing in the country and commonly exploited and shall include a plant variety which is not a new plant variety, a local domestic plant variety or a wild plant variety.

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The term ‘existing’ is most contentious, with departmental ofﬁcials debating the merits of allowing protection for varieties that ‘exist’ in the country (i.e. that may have been introduced in the past). Other organizations, academics and NGOs have blamed government stalling tactics for the delays, suggesting favouritism towards industry through the passing of the PVP regulations for new varieties shortly after the Act was passed (Robinson, 2008b; Siripat, interview, 2005; Yuwaa, interview, 2005). It is possible that the Thai Department of Agriculture will modify the sui generis law in the near future, moving towards an UPOV-style law due to agricultural industry pressures, despite the efforts of many stakeholders to develop this unique law. If, or when, regulations are passed for general domestic and wild varieties, beneﬁts are expected to accrue to various farmers’ groups which have improved plant varieties such as jasmine rice (khao hom mali) through generations of breeding, selection and development. Local farmers’ groups that have been interviewed seem hesitantly interested in the prospects of beneﬁts arising through the PVP fund; however, they were also sceptical that the government could adequately deliver beneﬁts in a timely, fair and equitable manner.7 Similarly, leaders from organizations of farmers such as the Alternative Agriculture Network indicated that they would welcome government compensation for their ongoing conservation of wild relatives of crop varieties.8 However, there were also concerns about the monopolization of plants such as rice – which is linked to daily customs and spiritual folklore – and broader sentiments about the commoditization of living entities such as plants.9 It is cultural concerns such as these that have largely been forgotten in the development of the mainstream legal systems surrounding plant-variety protection and biological resources (Robinson, 2008b). Other countries have developed laws and PVP systems closely based on UPOV 1978 or 1991, but have modiﬁed some of the rules to suit their own national and local interests. For example, in the Plant Varieties Protection Act of Singapore (2004), for the local examination of a plant variety the law requires a description of ‘the origin and breeding of the plant variety concerned’ (Article 17.a.i.). Provisions such as this are not included in the UPOV 1991 text but arguably should be there so as to help deter the grant of spurious PVP certiﬁcates. The Vietnamese Ordinance on Plant Varieties (2004), based on the 1991 UPOV Act, also contains some additional elements relevant to national public policy concerns. Aside from the usual PVP provisions, the law thoroughly details rules for the management and conservation of plant genetic resources (Chapter II), including access rules and authorization required for extraction of genetic resources and rare plants. The law also prohibits ‘destroying or misappropriating plant gene sources, illegally exporting gene sources of precious and rare plants’, which seems an obvious response to biopiracy and misappropriation concerns. Lastly, the Malaysian PVP law (2004, S.14.2) allows for the protection of plant varieties bred or discovered and developed by a farmer, local community or indigenous people, subject to criteria of being ‘new, distinct and identiﬁable’. This is a useful modiﬁcation of the UPOV criteria for protecting more heterogeneous farmers’ varieties that utilize traditional breeding practices and knowledge.

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Sui Generis Traditional Knowledge and Community Rights Laws Recognition of the rights of traditional local communities is probably the most fundamentally important way to ensure the protection of traditional knowledge, practices, languages, customs and culture. Aside from the Peruvian law on the collective knowledge of indigenous peoples and the Ethiopian proclamation that contains some provisions on community rights, there are a few other national examples. The Philippines formally recognized and clariﬁed the rights of indigenous peoples and indigenous cultural communities in its 1997 Act. The law seeks to recognize their economic, social and cultural wellbeing (and in doing so their civil and political rights), and the applicability of their customary laws in relation to property and ancestral domains. There are a range of provisions for community intellectual rights; protection of indigenous culture, traditions and institutions; right to indigenous knowledge systems and practices; access to biological and genetic resources; sustainable agrotechnical development; and other matters. With the ability to determine their own way of life, their livelihoods and their future, indigenous and local communities will be much better placed to protect their own knowledge and resources (Robinson, 2007, p49). In addition, the Philippines has a Traditional and Alternative Medicines Act (1997) that establishes an Institute of Traditional and Alternative Health Care, mandated with a number of roles and responsibilities. The institute focuses primarily on assuring quality standards of traditional and alternative medicine manufacture, as well as providing incentives (such as ‘tax breaks, exemptions and deductions’) to encourage their use and development. The Act also mentions the local regulation of access to traditional medicines and compensation for access. However, no speciﬁc mechanisms are described to assert these rights (Kuanpoth et al., c.2003). With the Act on Protection and Promotion of Traditional Thai Medicinal Intelligence (1999 [BE 2542]), Thailand has also developed a unique law to protect the intangible assets of the Thai public relating to medicines, as well as the medicinal biological resources of the country. The Act allows for the registration of traditional medicinal formulas, texts and patents, as well as providing provisions for the protection of rare and over-collected herbs within ‘herb conservation areas’. Notably, the kwao krua vine is listed as a protected herb under this law (Robinson and Kuanpoth, 2009). Although China allows the patenting of traditional medicines under their Patent Law, 1992, it does not allow protection of medicinal herbs or nonspeciﬁc products outside speciﬁc active chemical compounds. China also has a Regulation on Traditional Chinese Medicine Prescription Protection (1993, amended 2006) that was introduced to protect traditional medicinal compositions which could not be protected under the amended patent law. In particular, the regulation was developed because of the common circumstance where practitioners used multiple herbs for treatments and did not know the precise therapeutically effective chemical compound, nor could they prove

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the inventiveness of their claim. The regulation provides a 30-year protection that has been the subject of considerable debate (Heping, 2007; Vadi, 2007). Reputedly, the regulation protects many very similar products, often for similar treatments, making it difﬁcult to effectively identify where infringements have occurred. This sort of issue is exacerbated in circumstances where knowledge of a treatment is shared among healer networks, but monopoly has been granted to speciﬁc individuals or groups (Robinson and Kuanpoth, 2009).

Databases and Registers Another main protection measure that has been widely discussed is the concept of traditional-knowledge registers and databases. These databases are being developed and populated for a number of reasons, including for the prevention of biopiracy, but also because this knowledge is steadily being lost through changing lifestyles, modernization, the demise of languages because of education requirements in other dominant languages, and through disruptions such as the migration and resettlement of individuals and communities. There are many different efforts and ways to establish databases and registers, but to be effective they should be carefully designed, clearly explained, accessible and, also, sensitive to customary rules. In order to achieve this, the database should document the traditional knowledge, relevant biological resources, its attributes, its distribution (even approximately), as well as the owners of physical property rights, the groups who have traditional knowledge of its uses, groups who act as custodians of biological resources and any customary protocols associated with their use. A detailed and accessible database such as this could be an effective way to prevent misappropriation, but the complexity of any such database may affect the ease with which stakeholders or ofﬁcials could register entries and locate information. It has been suggested by many authors that elements of these registers or databases (which are not ‘closed’ by consent conditions) could potentially be accessible to patent and PVP examiners (and potentially for applicants also) in order to limit misappropriations of traditional knowledge (Alexander et al., 2004; Dutﬁeld, 2000). National authorities and local communities will have to identify whether or not this kind of disclosure of knowledge is appropriate but, linked with disclosure requirements as part of PVP and patent laws, this could help limit misuse and biopiracy of traditional knowledge. Because India has been the subject of a number of biopiracy incidents, including the basmati, neem and turmeric cases, it has led the way in terms of database development. One initiative from India has sought to open up collected and documented information on traditional knowledge to patent examiners so as to prevent biopiracy. The Traditional Knowledge Digital Library (TKDL) has been in development since 1999 and is a collaborative project between the Indian Council for Scientiﬁc and Industrial Research (ICSIR) of the Ministry of Science and Technology, and the Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) of the Ministry of Health and Family Welfare. The aim of TKDL is to provide

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information on the traditional knowledge existing in India in languages and formats that are understandable to patent ofﬁcers at international patent ofﬁces, so as to prevent the grant of ‘wrong patents’ (ICSIR, undated). The data collected from the TKDL is then digitized in ﬁve different languages (English, German, French, Japanese and Spanish) and then classiﬁed corresponding to International Patent Classiﬁcation (IPC) codes relating to medicinal plants, minerals, animal resources, diseases, methods and preparations. This information has been made accessible to the European Patent Office from February 2009 and has also recently been included, through some IPC subgroup classiﬁcations relating to genetic resources, by WIPO for international patent searches on registrations made under the Patent Cooperation Treaty.10 The scale of the TKDL is enormous, with 30 million pages of information, including 64 authoritative textbooks on ayurvedic medicine and nearly 150,000 ayurvedic, unani and siddha medicines (ICSIR, undated; EPO, 2009). The TKDL project is different from the PeBRs project in that it involves documentation of the knowledge available in the public domain from the existing literature relating to ayurveda, unani, siddha and yoga. The PeBRs project documents biological resources and much of the orally transmitted and locally held knowledge that has not previously been documented. The purpose of the TKDL is more directly aimed at preventing biopiracy, while the PeBRs project has broader aims for the collective understanding and conservation of biodiversity. The Indian PeBRs Simpliﬁed Methodology documents provide a good background on the sort of details that should be collected for these purposes (National Biodiversity Authority, 2008). Recently, China has opened up digital archives of their traditional medicinal knowledge as well. In 2008, the Chinese patent ofﬁce (SIPO) granted the EPO access to its 32,000 entry database on traditional Chinese medicine (EPO, accessed 2009). Databases and registers are not solely administered by governments – there are also NGO initiatives. The Indian Honeybee Network database of traditional knowledge has been very successful in its documentations, with more than 10,000 entries.11 A study by the United Nations University Institute of Advanced Studies (UNU-IAS) also notes the Traditional Knowledge Databases of Inuit of Nunavik, Canada, which has now been collected for the past 30 years (Alexander et al., 2004). Databases in other countries, such as Thailand through the Department of Intellectual Property, have had less success, with only a few thousand registrations (Assawin Tharang Khun, interview, 2006). In such cases, the total number of registrations will likely also be a reﬂection upon the complexity of entry requirements, but also the prevailing sense of trust associated with the disclosure of knowledge among local communities. In the case of Thailand, the concept of ‘intellectual property’ is a relatively new one which has been soured by biopiracy incidents. As a result, many farmers, local communities and producers have been hesitant about the registration of their traditional knowledge, cultural expressions and designs.

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In the past few years, the African Regional Intellectual Property Organization (ARIPO) has also been seeking to establish databases on traditional knowledge through national authorities and has been studying the systems of countries such as India and China, developing prototype databases and trialling them. The aims of ARIPO are to mitigate biopiracy, but also to provide positive protection for innovations (in conjunction with other initiatives), to preserve and also educate about/through traditional knowledge. As a consequence, ARIPO is also considering whether to develop a database of formal journal articles and periodicals on traditional knowledge, to inventory existing documented and public domain knowledge, and/or to collect data on uncodiﬁed and non-public domain knowledge. As in other countries or regions, ARIPO has noted the erosion of traditional knowledge, often through the death of elderly knowledge holders, which relates to the broader concern of knowledge transferral or transmission also underpinning the desire to develop traditional knowledge databases. Ultimately, the scope of database content and objectives must be determined on a local, national or regional basis, based on prevailing concerns such as these.

Traditional Knowledge and Customary Laws: Local Contexts Projects could be developed which respectfully document customary protocols and laws. This could have the overall effect of strengthening the customary rights of local communities over land, natural and intellectual resources. The most appropriate way of undertaking this would be for locals themselves to perform the documentation, with appropriate assistance provided by independent researchers, NGOs and anthropologists if required. There are some examples of this currently occurring, for example as discussed by Callies et al. (2005, p43) in places such as Hawai’i, Norway and Greenland. From the WIPO-sponsored study of ‘customary law in the protection of traditional knowledge’ in the Andean countries, we gain some insight into speciﬁc local case studies (de la Cruz, 2006). Box 7.2 examines a Peruvian case study from the Cuzco region. The main issue associated with the documentation of traditional knowledge and customary norms, protocols or laws is that it is likely to be an oversimpliﬁcation of the dynamism inherent in customary systems (as noted in the Andean case studies). These systems are reliant on connections to land and environments, and to culture and identity as embedded in language and transferred through stories, folklore, music, dance and other cultural expressions. With disruptions to any or all of these, the customary structures that regulate their norms, behaviours, practices and knowledge are also likely to be degraded or changed. As WIPO (c.2005) has noted, a customary law system may be regarded as a ‘living law, a law activated and modiﬁed not by specialised practitioners but by those who in their daily lives, practice the law, living out their traditional customs in everyday contexts’. As such, the documentation of customary protocols may only freeze a static version in time and may not be in keeping

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BOX 7.2 KEY CUSTOMARY LAW PRINCIPLES FROM THE LA PAPA PARK IN THE CUZCO REGION, PERU Reciprocity (Ayni) A principle by virtue of which the continuous exchange of goods and services is produced between persons who know each other, institutions and nature itself, in which a particular service and its respective return (understood as payment in positive law) must occur in a speciﬁc period, constituting a compulsory social mechanism owing to the fundamentally economic interdependence generated between the parties which practise it. Other expressions include ‘Mink’anakuy’ and ‘Rakinakuy’.

Duality (Yanantin) The Andean world is always divided into two parts and this implies that each half requires its other half to act as a complement. Thus, as a result of this principle, situations, rights and obligations are generated in favour of two or more parties, the implementation of which is necessary as a complement in order to achieve harmony.

Balance (Chaninchay) A principle which states that Andean man has the obligation to respect and maintain the balance with (i) the other members of the community, (ii) Pachamama and (iii) the sacred world; and so it must be subject to criteria of proportionality in terms of capacities, needs and efforts. Others include ‘Pashminakuy’ and ‘Tupachiy’. Source: de la Cruz (2006).

with evolving practices by local communities. On the other hand, Dutﬁeld (2006) notes that for integration of customary law into national legal systems, the level of in-depth understanding required may only be possible through codiﬁcation. This, then, also raises questions as to what extent customary law would be recognized – in certain contexts would it be given an equal weighting to formal codiﬁed laws? Or would it be referred to within these laws but left less clearly deﬁned? These sorts of questions are challenging the indigenous communities themselves, as well as the policy-makers attempting to appropriately respect and recognize customary laws.

The Role of Non-Government Interest Groups and Stakeholders It is important to note the vital role that non-government organizations and individuals can have on biopiracy. Organizations such as RAFI/ETC Group have had a leading role in promoting the biopiracy discourse and regularly highlight new cases and issues. This sort of monitoring has in many cases

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led to national government responses and challenges against spurious patents or other intellectual property concerns. However, the interventions of NGOs such as RAFI have also had consequences including interference with potential beneﬁt-sharing arrangements, such as in the ICBG Aguaruna case in Peru discussed by Greene (2004). In this same case, issues of appropriate representation of indigenous people (and their knowledge of biological resources) arose, which is an ongoing problem in many parts of the world that will ultimately need to be resolved on a case-by-case basis. Some governments have pre-empted this with regulations, such as the Pacific Model Laws, which have mechanisms for mediation between different communities that may share traditional knowledge over a speciﬁc plant or other biological resource. Among indigenous groups around the world there will clearly be varying concerns and interests surrounding their desires to see traditional knowledge protected, preserved or promoted, and/ or to see it developed and potentially commercialized. Once commercialized there may be very different expectations surrounding beneﬁt-sharing, again differing according to the community’s desires and interests. Conﬂicts between communities are likely to be difﬁcult to mediate and resolve, with reference to customary laws or not, and so it is important that governments develop systems in close consultation with as broad an array of local peoples as possible. Other NGOs and interest groups have played a contrasting role, trying to water down the need to take action on biopiracy. A number of organizations or associations, often posing as NGOs or research centres, which are generally funded by biotechnology industry or pharmaceutical sector interests, are often also present at various negotiations including the working group meetings of the CBD. These organizations have often put forward their own ‘research’ arguing against the need to amend the international patent system or to develop international systems of ABS. More formally, these sorts of industry perspectives have been put forward in papers such as Finston’s ‘industry viewpoint’ (2005) on genetic resources as a senior representative of the Pharmaceutical Research and Manufacturers of America (PhRMA), and those by Oxley (2005) of the Australian APEC Study Centre which also receives funding from PhRMA. While it is clearly important that innovation in areas of biotechnology and pharmaceuticals continues, these industries have already received extensive expansions in the international applicability and scope of rights offered under the ‘trade-related’ intellectual property system (Drahos with Braithwaite, 2002). Typically, these papers have taken a very uncompromising and narrow utilitarian perspective on ‘genetic resources’ and the role of the patent system (as discussed in Chapter 1). Last, but not least, indigenous and local stakeholders have created many of their own new opportunities and the international community has been relatively receptive in recent years. In many countries, these peoples have been granted rights that they were previously deprived of and that will place them in better stead to determine their own futures and to maintain their own cultures. However, these legal rights are only valuable so long as indigenous people are sufﬁciently free and motivated to exercise them. For example, as the

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chairman of the National Human Rights Commission of Thailand (Chamarik, interview, 2005) has noted, although community rights exist in writing, the Thai ‘Constitution does not provide a ready-made respect for the community right, and so people must struggle for its realization’.

Notes 1 The meeting documents can be found online at ww.nbaindia.org/pbr/pbr.htm. 2 A tentative English translation can be found at www.lclark.edu/org/ielp/amapa english.html. 3 Details of the Protection of Plant Varieties and Farmers’ Rights Authority can be found at http://plantauthority.gov.in/index.htm. 4 See current Indian PPV and FRA Ofﬁce registration details of extant varieties at http://plantauthority.gov.in/PDFile/ExtantvarietyAppStatus20Mar2008.pdf. 5 See http://plantauthority.gov.in/announcement.htm. 6 Robinson (2007), pp23–7, note 15. 7 Interviews with various farmers (approximately 25) in Suphan Buri, Prachin Buri, Roi Et, Bangkok and Chiang Mai provinces (2005–6). 8 Interview, Ubon Yuwaa, (Farmer/activist, Alternative Agriculture Network), Roi Et Thailand, 25 April 2005. 9 Described by Thai authors such as S. Nathalang, ‘Conﬂict and Compromise Between the Indigenous Beliefs and Buddhism as Reﬂected in Thai Rice Myths’, in S. Nathalang (ed.) (2004), Thai Folklore: Insights into Thai Culture (2nd edition), Chulalongkorn University Press, Bangkok, pp99–121. 10 207 subgroups were included in the WIPO IPC 8th edition in January 2006. 11 The Honeybee Network is found at the NGO Society for Research and Initiatives for Sustainable Technologies and Institutions’ website at www.sristi.org/honeybee. html.

Conclusions

For many indigenous communities, farmers, groups that maintain traditional practices, and across large populations in the developing world, biopiracy reﬂects the abuses, disregard and neglect that have long been shown by colonial powers and the industrialized ‘West’. Biopiracy may have important implications for local producers and for research in developing countries and remote regions; in terms of cultural impact, it also reﬂects a longer history of colonial maltreatment, albeit through different means. The biopiracy cases illustrate an epistemological hypocrisy, whereby scientists utilize traditional knowledge and innovations while simultaneously denigrating such knowledge as unworthy of recognition. Given the injustices rendered, it is hoped that this book encourages the broader recognition of biopiracy and the formal adoption of a deﬁnition along the lines of the typology proposed in Chapter 1 (see Box 1.2). In addition, biopiracy needs to be adequately addressed in the patent and broader intellectual property system (for the prevention of ‘nonpatent biopiracy’), as well as through appropriate mechanisms for the control and transfer of biodiversity. Alongside technical and legal mechanisms, some re-conceptualizations are also needed, particularly regarding the notion of the ‘public domain’. As Waelde and MacQueen (2007, pxiii) note: since property and intellectual property laws are fundamentally territorial, varying from jurisdiction to jurisdiction, this means … that the scope and content of the public domain so deﬁned is also fundamentally contingent upon the facts of legal geography, and not everywhere the same. In fact, we need to recognize that we have not one but many public domains (Boyle, 2003). In the context of biopiracy we are usually talking of international transactions and thus of an international public domain that is ultimately made up of collections of national public domains. These national public domains are to some extent bounded by limitations of language, but are also shaped by the differing scope of protection under the IP law of national jurisdictions (for example in the biopiracy context, through the US’s national novelty interpretation regarding foreign knowledge or use). They are also partially

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shaped by the implications of the social environment for the application of laws (for example, through exceptions to IP protection on the grounds of morality, public order or social utility) among other inﬂuences (Taubman, 2007, p70). International policy-makers are aware of these differing jurisdictional interpretations of the public domain. For example, the harmonization of patentability criterion (including novelty) is on the agenda of the ongoing work towards a WIPO Substantive Patent Law Treaty, which would ultimately inﬂuence what is considered prior art and public domain. Additionally, priorart databases may help examiners determine if patent applicants are improperly using traditional knowledge that has been interpreted as ‘public domain’ and therefore freely available to use. However, these are limited technical measures that are unlikely to provide more complex interpretations of where there are boundaries on the public domain, what knowledge has been disclosed improperly, or where knowledge is sacred or secret, among other important distinctions. What is really needed is a more culturally informed understanding of manifold knowledge domains (rather than ‘public’ domains) that are regulated both through formal rights and also through customary norms and rules. These knowledge domains are again shaped by territories, but also cultural boundaries or borderlines such as language, beliefs, values, religions and customs. These domains are not neat or clearly deﬁned, and they are not static over time and space. They also do not share boundaries with the biogeographical distributions of plants, animals and other biological resources and so a number of overlapping or adjoining knowledge domains may regulate speciﬁc species and plant varieties. Some knowledge domains and biological resources may be very broad and very ‘public’, whereas others will involve smaller communities and may be held secret by certain groups. Some pieces of knowledge and some plants or animals may also be sacred to certain groups as informed by religion, rituals and folklore. This cultural diversity, as it pertains to knowledge domains, should be valued for the beneﬁts it provides for selfdetermination and identity, societal dynamics, innovation and broader beneﬁts to humankind. As such, indigenous and local communities and those who work with them should strive to maintain and improve understandings of their speciﬁc customary knowledge domains. Making researchers and the public understand customary knowledge domains is not likely to be a simple task. Not only do these customary knowledge domains operate in different ways in different territories and over time and space, they also require re-conceptualizations of scale and jurisdiction. For the most part this book has addressed biopiracy and the protection of biological resources and traditional knowledge through the typical lenses of scale: international, regional, national and local. Customary knowledge domains also operate through other scales and jurisdictions that, for many in the global north, may be hard to envisage, recognize or accept. As noted by a Karen elder in northern Thailand:

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When knowledge of herbs is shared it is often informed by the perception of the character of the person seeking the knowledge as well as based on possible indications from spirits about them. If the knowledge that is shared is used inappropriately, it may adversely affect to spirit of the person who provided the knowledge, in the form of illness or otherwise. (Pathii Ta-Yae, interview. 14 February 2006, Soblan Village, Chiang Mai)1 This is something akin to the way customary regulations operate surrounding knowledge domains on the other side of the globe. A representative of the Tulalip Tribes of Washington indicates that misuse of traditional knowledge can: cause severe physical or spiritual harm to the individual caretakers of the knowledge or their entire tribe from their failure to ensure that the Creator’s gifts were properly used, even if misuse was used by others outside the tribe, or by tribal members who were outside of the control of customary authority. For this reason … misappropriation and misuse [is] not simply a violation of ‘moral rights’ leading to a collective offense, but a matter of cultural survival for many indigenous peoples. (WIPO IGC, 9 July 2003; cited by Taubman, 2007, p66) What we see in both examples is an extension of jurisdiction and authority beyond the typical Western modes of regulation through laws, courts and policing at the local, national or international scale. These customary regulations are instead diverted in (at least) two different trajectories or scales: the intimate and embodied, and the inﬁnite (see Figure 5.1). In both cases the caretaker of the knowledge internalizes or embodies injury in the form of physical and/or spiritual harm when it is misused.2 Legally and metaphysically speaking, it would be difﬁcult to remedy this sort of injury – prevention is the best course of action. In terms of the inﬁnite, the customary regulations surrounding the knowledge domains refer to a higher level of spiritual authority. For example, in the case of the Karen community, remedies to the misuse of knowledge might be sought with reference to karma and reincarnation, or through a combination of animist and Buddhist rituals. These sorts of customary regulations surrounding knowledge domains are not easily reconciled through Western modes of governance or even Western modes of thinking. Thus, a challenge remains for the recognition of customary knowledge domains and for the wider public to better understand the complex systems of regulation at conceptually complex and alternate scales.

Notes 1

Similar sentiments are also described by a Hmong healer from northern Thailand in Chapter 5 and in the Hawai’i taro case described in Chapter 3.

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The formal Western equivalent would see this as a violation of human rights, for example Article 18 of the International Covenant on Civil and Political Rights, 1966.

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Index

ABS (access and beneﬁt-sharing) 36, 38, 106, 155 CBD on 27, 28, 77, 124–126, 132–133 certiﬁcates 125–126 drawbacks of 63 international regime of 108, 120, 123, 124–127 national systems of 143, 145 regional agreements on 117, 134–135, 136, 139 in sui generis systems 147 see also access; beneﬁt-sharing açaí berry 75, 86, 91–92, 121 access 27, 99, 115, 150 see also ABS Access to Biological Resources, Regulation of 117 Aframomum stipulatum 71 Africa 4, 31, 41, 61, 109, 122 database in (ARIPO) 152–153 patent exceptions in 46 property/rights concept in 136 traditional medicines in 11 see also speciﬁc countries African Model Law 40, 117, 135–138 community rights in 136–138 African Union see OAU Agracetus 72, 103–104 see also Monsanto agriculture 2, 12, 14, 102–104 monoculture 30, 35 research in 24, 103 traditional 66–67 see also CGIAR Aguaruna people 13, 107, 154 Aitken, R. 5 Alvarado Vertiz, M.A. 53

Amazon 13, 53, 68–70, 83, 91, 107 Ampornpan, L.A. 64, 65 Andean Community 131, 138–139 Andean nuna bean 71 animals used in medicine 9 animism 110, 159 anticommons tragedy 146 Argentina 102–103 ARIPO (African Regional Intellectual Property Organization) 152–153 Artemisia judaica 59–61 ASEAN (Association of South-East Asian Nations) 117, 134–135 Asia 4, 5, 31, 109, 149 see also India; Pakistan; Thailand Australia 6, 9, 13, 40, 46, 75–76 PBRs in 79–81, 84 Plant Breeder’s Rights Act (1994) 79 ayahuasca (Banisteriopsis caapi) 68–70 Bain, D. 133 Banisteriopsis caapi (ayahuasca) 68–70 Banks, Joseph 6 Barton, J.H. 74 basmati rice 15, 47–49, 84, 87, 151 research in 49 Bela people 66–67, 106 beneﬁt-sharing 13–14, 16, 36, 62, 64–65, 66–67, 77, 107–108, 153 and CBD 26, 27 failures in 65, 66–67, 70, 71 international agreements on 123–124 obligations 75 PBRs/PVP and 81, 83 and trust 114 see also ABS beverages 2, 3, 13 bilateral agreements 40–41

180

CONFRONTING BIOPIRACY

Bilaterals (NGO) 42, 43 Binenbaum, E. 103, 104, 105 binomial nomenclature 6 biodiversity 10, 13–14, 19, 38, 41, 141 depletion of 25 international regulation see CBD and national laws 26, 27, 143–144 trans-boundary nature of 125 biodiversity conservation 13–14, 28 Biodiversity Management Committee see BMC Biodiversity Prospecting (Reid et al) 11, 12 Biological Diversity Convention see CBD biological resources 1, 23–25, 117 as commons 23, 24–25 national registers/databases of 141, 142 privatization of 24–25 and sovereignty 27 Biological Resources, Regulation of Access to 117 biopiracy 3, 14–21 and bioprospecting 10 categories of 20–21, 70 counter-discourse 16–17 deﬁnitions/ambiguities in 17–20, 77, 157 discourse 14–17 impacts of 101–116 and intellectual property piracy 14, 15, 16 local 57 bioprospecting 1, 3, 11–14, 117 and biopiracy 10 and Fair Trade 13 and misappropriation 97–99 origin of term 11 and pharmaceutical companies 11–12, 13 and traditional knowledge 11 see also plant hunting/collecting Biotec 93–94 biotechnology corporations 1, 14–15 and patents 24, 30 BioThai 58, 87, 105 Blakeney, M. 24, 53 blight-resistant varieties 49–51, 66–67, 106 BMC (Biodiversity Management Committee, India) 143–144

Body Shop 13 Bolivia 71, 82–84, 120 Bonn Guidelines (CBD, 2002) 27, 65, 106, 108, 115 Bosland, P.W. 83 botany 2, 5, 6, 97 Botswana 61, 80, 113 Braithwaite, J. 16, 19, 32 Brand, J.C. 75 Brazil 4, 7–9, 81, 91–92, 119–120 Brierley, J.H. 5 Britain (UK) 60, 103 Empire of 5–6, 9 Buddhism 95, 110, 159 Butea superba see kwao krua Callies, D. 153 Cambodia 9 camu camu (Myrciaria dubia) 53–55, 75, 143 Canada 40, 46 cancer drugs 11–12 Cantuaria Marin, P.L. 118 Capsicum chinense see habanero pepper Caribbean 4, 5, 41, 122 case-by-case approach 31, 120, 145, 155 cayenne pepper 85 CBD (Biological Diversity Convention, UN, 1992) 10, 13–14, 18, 25, 26–28, 42, 73, 117, 120 ABS in 27, 28, 77, 124–126, 132–133 and African countries 136 beneﬁt-sharing in 26, 27 Bonn Guidelines 27, 65, 106, 108, 115 challenges in 28 conservation in 28 on customary protocols/laws 130, 132–133 IPRs and 26–27 political use of 16 prior informed consent in 27, 28 and technology transfer 105 US and 26, 74, 84, 126 WG-ABS 124–125 Centre for International Environmental Law (CIEL) 69 CGIAR (Consultative Group on International Agricultural Research) 24, 25, 36, 66, 71, 79

INDEX

MTA of 81, 83 Chen, J. 17 Chiang Mai Province (Thailand) 97–99, 107–108, 116 chickpeas 79 China 2, 6, 40, 127, 150–151, 152 CIAT (International Center for Tropical Agriculture) 52, 71 CIEL (Centre for International Environmental Law) 69 cinnamon 2, 5 CITES (Convention on International Trade in Endangered Species) 62, 113 classiﬁcation of plants 6, 152 Coates, K.S. 10 COICA (Coordinating Body of Indigenous Organizations of the Amazon Basin) 69 Colombia 71, 80, 120 colonialism 3, 4–6, 7, 102 and human rights 9 independence from 10 Columbus, Christopher 4 commons 23, 24–25, 146 community rights 30, 117, 133, 135, 136–137, 149–151, 155 compensation 46, 77, 81, 105, 106, 143, 146 competition 5, 91, 95–97, 142 CONAP (Confederación de Nacionalidades Amazónicas del Perú) 107 Congo 71 Conklin, Harold 7 Consejo Aguaruna Huambisa 107 conservation 9, 13–14, 19, 28, 59, 60–61, 150 copyright 16, 29 Correa, C. 37–38, 92–93 cosmetics industry 13, 14, 106 Costa Rica 12, 13, 145 cotton 72, 103 Cotton, C.M. 4, 7 crossbreeding 48, 50, 51, 81–82, 95–97 Cuba 4, 119–120 cultural ecology 7, 129 customary norms/laws 19, 39, 40, 50–51, 59, 61–62, 99, 130, 142, 149, 153–154

181

and cultural affront 101, 108–112 domains 158–159 international agreements on 130–133 customs controls 52, 102, 104 Dale Bumpers Rice Research Centre (US) 95, 97 Darjeeling tea 129 databases 81–82, 84, 122, 124, 126 traditional knowledge 139, 141, 142, 151–153 Da Vine plant 68–70 Davis, E.W. 6 Davis (UC Davis) 66, 106 defensive patent portfolios 74 Deren, Chris 95, 97 developing countries 17, 29 biopiracy discourse in 15, 28 ITPGRFA and 37–39 ownership/commons status in 24–25 plant/seed exchange in 23–24, 25, 35, 37, 38, 95 resource ﬂow from 14, 16 traditional remedies in 11–12 TRIPS and 78, 119–120, 122 UPOV and 34 WIPO and 31–32, 121 see also speciﬁc countries Development Agenda 30, 119 Devil’s Claw 92 Dhillion, S.S. 64, 65 diabetes 60 diaz bluestem (Digitaria milanjiana) 80 disclosure of origin 16, 31, 119–124, 143, 147 certiﬁcates 126 disease-resistant varieties 49–51, 66–67, 106 distinctness, uniformity and stability see DUS DNA testing 104 documentation of plants 5, 6–7 see also databases Doha Declaration (2001) 118, 122 Donavanik, Jade 57 Downes, D.R. 128–129 Drahos, P. 16, 19, 32, 40 Drake, Sir Francis 5 DUS (distinctness, uniformity and stability) 35, 78, 145–146

182

CONFRONTING BIOPIRACY

Dutch exploration/trade 5–6 Dutﬁeld, G. 15, 16, 18, 19, 51, 68, 73, 153 East India Co. 5, 6 economic partnership agreements see EPAs Ecuador 70, 71, 119–120 education 95, 98, 99, 108, 115, 151 Egypt 136 Ancient 1–2, 3 Ekpere, J.A. 136–137 employment 10, 106 endangered species 9 see also CITES enola beans 51–53, 84, 103 environmental degradation 9, 113 EPAs (economic partnership agreements) 40, 41, 42 Eragrostis tef (tef) 108 ETC (Erosion, Technology and Concentration) Group (formerly RAFI) 14–15, 16, 18, 19, 42, 52–53, 58, 72, 73, 154 on PBRs 79–81 Ethiopia 108, 137, 145, 150 ethnobotany 2, 6–7, 142 ethnology 7 European Commission (EC) 121–123 European Patent Ofﬁce 46, 152 European Union (EU) 16 in bilateral/regional agreements 40 patents/PVP in 29, 31 exclusion of producers 101, 102–105 exports 101, 102–104 extant varieties 146–147 extraterritoriality 27 faba bean (Vicia faba) 80 fairness/equity principle 46–47, 65, 68, 76, 114 fair trade 13 FAO (Food and Agriculture Organization) 24–25, 26, 36, 37 farmers 1, 23–24, 35, 118 exchange of plants/seeds by 23–24, 25, 35, 37, 38, 95 institutionalization of 15 rights 30, 35, 36, 39, 135, 145 farm-saved seed 35, 37

Finston, S.K. 155 folk medicine see medicinal plants food products 12 food security 103, 136 foreign investment 105, 106 Fowler, C. 1–2 France 128–129 free-riding 77, 79, 81 FTAs (free-trade agreements) 40, 41, 42 Fulani people 66, 106 gardens botanic 6 indigenous 5 GATT (General Agreements on Tariffs and Trade) 27 gene-banks 12, 23–24, 39, 73, 79, 98 common heritage status of 24–25, 26 ITPGRFA and 127 MTA for 81 and PBRs/PVP 81–82, 83 generic terms lists 91 genetic databases 81–82, 84, 122 genetic engineering 1, 3, 72 genetic reductionism 15, 17 genetic resources 14, 117 Genetic Resources Recognition Fund see GRRF genetic-use restriction technologies (GURTs) 14–15 Gerhardsen, T. 16 germplasm 78–79 breeding history requirements for 79–81, 84–85 as common heritage 24–25, 95 exchange 23–24, 25, 36 unauthorized use of 70 see also gene-banks ginger 2, 5 GIs (geographical indications) 86, 88–89, 105, 122–123, 128–129 GM (genetically modiﬁed) plants 103–104 Gopalakrishnan, N.S. 129 Gorman, J.T. 75 governance 23, 63, 108, 159 Greene, S. 107, 154 ‘green gold’ 12, 17 Green Revolution 15, 24, 82 Greenwood, Richard 93–94

INDEX

GRIN (Germplasm Resources Information Network) database 81–82, 84 GRRF (Genetic Resources Recognition Fund) 66, 67, 106 Gupta, A.K. 66–67, 106 GURTs (genetic-use restriction technologies) 14–15 habanero pepper (Capsicum chinense) 82–84, 121 Harshberger, John 7 Hatshepsut, Queen 1–2 Hawai’ian Taro 49–51, 92, 112 Hayden, C. 11, 98 health-foods 62, 91–92 herbal medicine see medicinal plants herbariums 64, 81, 97, 98 herb conservation areas 150 Hmong people 109–110 hoodia 61–63, 93, 113 Hooker, Joseph 6 HSCA (Heritage Seed Curators Australia) 79–81 human rights 2, 9–10 international instruments of 39–40 and IPRs 39–40 movement 10 hybrid varieties 24, 49–51 IARCs (International Agricultural Research Centres) 24, 25, 39, 127 ICBG (International Cooperative Biodiversity Group) 13, 107, 153 ICBG Projects 12, 13 identity 19, 39, 112 IGC (Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO) 32–34, 67, 121 criticisms of 33, 34, 68 on customary laws 131–132 ILO (International Labour Ofﬁce) 10 implementation issues 32, 33, 36, 37, 41, 122, 127–128, 134, 137, 147 INBio agreement 12, 13 India 2, 71, 73, 79, 87, 104, 119–120 activism in 15, 84 basmati rice patent in 47–49 Biodiversity Act (2002) 15, 30, 143–144

183

colonial 4, 6 databases/registers in 143–144, 151–152 patent law in 48 PVPFR 145–147 rice research in 49 sui generis system in 145–147 Tea Board 129 traditional medicines in 11 Indigenous Issues, UN Permanent Forum on 133 indigenous knowledge see traditional knowledge indigenous peoples 1, 118 activism/groups of 15, 69, 107, 142 and colonialism 4, 5, 6 consent and see PIC impacts of plant trade on 9–10, 12 inclusion of 13, 39, 66–67, 73, 98–99, 143–144, 155 oppression of 9, 39 overexploitation of 7–9, 101, 112–113 and ownership 12–13, 14, 25, 50–51 rights of 3, 9, 39–40, 129–130, 155 ‘voice’ for 107 see also community rights Indigenous Peoples’ Earth Charter (1992) 39, 118 Indigenous Peoples, Rights of, UN Declaration on 129–130 Indonesia 4, 5 inequities 70, 77, 101, 105–108, 121 information-sharing 108 Intellectual, Cultural and Scientiﬁc Resources, Covenant on 118 intellectual property standards 40 intergovernmental organizations 15 international agreements 3, 23–43, 77–78, 117–134, 155, 158 bilateral see bilateral agreements on biodiversity 13–14 on gene-banks 24–26 on human rights 39–40 indigenous involvement in 39–40 on indigenous rights 10, 39–40 on intellectual property 1, 14 and national governments/laws 27, 36, 117, 131, 133–134 non-legally binding 39, 118

184

CONFRONTING BIOPIRACY

regional see regional agreements research sources for 42–43 US and 26, 74, 84, 120–121 International Center for Tropical Agriculture (CIAT) 52, 71 International Labour Ofﬁce (ILO) 10 International Plant Classiﬁcation (IPC) 152 International Treaty on Plant Genetic Resources for Food and Agriculture see ITPGRFA International Undertaking on Plant Genetic Resources (IUPGR) 24–25 International Union for the Conservation of Nature (IUCN) 9, 118 inventive step requirement 46, 48, 54, 73, 75, 138 IPC (International Plant Classiﬁcation) 152 IPRs (intellectual property rights) 1, 14, 24–26, 83, 102–103, 115, 117, 118 and bilateral/regional agreements 40–41, 136 and biopiracy discourse 14, 15, 16–17, 20, 21 exceptions to 29, 32, 158 expansion of 16, 29 and geographical indications see GI harmonization of 31–32, 34, 41 and human rights 39–40 hypocracy in 14, 16, 17, 157 and national policies see national laws and PBRs/PVP systems 20 and ‘public domain’ 109, 110, 157 research sources for 42–43 and sovereignty 26 and trademarks 87–88 as Western principle 23, 25, 34, 132 WIPO and 31–34, 131 IRRI (International Rice Research Institute) 49, 66, 97, 106 ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) 35–39, 76, 84, 117, 126–127 on access/transfer 126–127 aims of 35–36 criticisms of 37 farmers rights in 35, 37 and gene-banks 127

global information system in 37 impacts of 37–38 membership 127 Multilateral System/MTA 36, 38, 39, 81 IUCN (International Union for the Conservation of Nature) 9, 118 IUPGR (International Undertaking on Plant Genetic Resources) 24–25 Japan 14, 46, 129 patents in 53–55, 63–66, 74, 105, 122 ‘Jasmati’ trademark 87–89 jasmine rice (khao hom mali) 87–88, 95–97, 104, 105, 149 Jeffrey, M.I. 26 Johnson, Martha 10 Jones, Gareth 94 kakadu plum (Terminalia ferdinandiani) 75, 84, 121 Karen people 8, 59, 65, 98–99, 108, 110, 111, 116, 158–159 Kari-Oca Declaration (1992) 39, 118 kava kava 92, 112 Kenya 136, 145 Kew Gardens 6 khao hom mali see jasmine rice knowledge domains/ﬂows 109–110 indigenous see indigenous knowledge ownership of 1 privileging of 46 kwao krua (Pueraria miriﬁca/Butea superba) 55–59, 93, 112–113 Laird, S. 11, 12, 13, 116 land ownership/rights 9, 10, 130 Latham, R. 2 Latin America 4, 13 least developed countries 29–30, 34, 78, 118, 127–128 Lepidium meyenii (maca) 67–68, 143 Libya 60 life-forms, patentability of 109, 118– 119, 136 Linnaeus, Carl 6 lobby groups 16 local community varieties 148

INDEX

maca (Lepidium meyenii) 67–68, 143 McClung, A.M. 95 McGown, Jay 59–61, 81 McLeod, M.J. 83 MacQueen, H. 157 Magellan, Ferdinand 5 Malawi 81–82, 106 Malaysia 149 Mali 66–67 Maori people 119 marine fungi case 93–94, 113 Mary Kay Inc. 75–76 Mataatua Declaration (1993) 39, 118 material transfer agreements see MTAs media 45, 49, 79, 87, 95, 97 medicinal plants 2, 6, 7, 11, 59–61, 64, 68–70, 92–93, 98–99, 107–110 databases of 152 depletion of 9 national laws on 150–151 patentability of 119, 127 in patent-based biopiracy 55–59, 63–66, 67–70 and pharmaceutical companies 11–12, 13 Merck 12, 13 Mexico 51–53, 103 microorganisms 118 milestone payments 123 Miller, Loren 68–70 misappropriations 21, 25, 52, 92–99, 131 and bioprospecting 97–99 jasmine rice case 89, 95–97 marine fungi case 93–94, 113 model laws 40, 117–118, 135–138, 139 monitoring 42, 139 monocultures 30, 35, 78 monopolies 35, 50–51, 77, 87, 106, 114 Monsanto 12, 72, 102–104 Monsanto LLC v. Cargill 103 Mooney, Pat 14.18 MTAs (material transfer agreements) 36, 37, 38, 39, 75, 81, 83, 97, 123 standard (SMTA) 126 Myrciaria dubia see camu camu Namibia 61, 92, 113, 136 national laws 16, 28, 36, 40, 122, 131, 133–134, 157–158

185

ABS 120, 136 disclosure-of-origin 122 farmers rights 37 harmonization of 31–32, 34, 41 and model laws 117, 136, 137 patent/PVP 29–30, 46 sui generis 144–151 on traditional medicine 113, 150–151 see also sovereignty Natural Justice (NGO) 62–63 neem 71, 142 Netherlands 5–6, 103, 108 New Zealand 119 NGOs (non-governmental organizations) 13, 14, 15, 23, 42, 104, 109, 154–155 and patent examination process 142 in patent-related biopiracy cases 45, 47, 49, 57, 58, 61–62, 72, 73 and PVP/PBRs 78, 79 and trademarks 87 see also ETC Noejovich, F. 116 non-infringement 103 non-obviousness criterion 46, 48, 50, 52, 68 non-patent biopiracy 21, 77–99, 126 categories of 77 Norway 31, 122, 153 Novartis 12, 85 novelty 46, 49, 50, 51–52, 54, 58–59, 68, 72, 157 geographical limitation on 48, 52, 71, 78–79 and PBRs 78–79 nutmeg 3, 5 OAU (Organization for African Unity) 117, 135–136 obviousness see non-obviousness criterion OCCAAM (Organización Central de Comunidades Aguarunas del Alto Marañon) 107 Opium Wars (1824/1852) 6 oral tradition 54 orchids 7–9 ordre public and morality 118–119 overexploitation 7–9, 101, 112–113 Oxley, A. 17, 155

186

CONFRONTING BIOPIRACY

Paciﬁc Model Laws 117–118, 139 Paciﬁc region 41, 92, 122, 131 pak-choi 85 Pakistan 6, 47, 48, 87, 104, 120 patentability of life-forms 109, 118–119, 136 patent-based biopiracy cases 21, 45–76, 103–104 Aframomum stipulatum 71 Andean nuna bean 71 Artemisia judaica 59–61 ayahuasca (Banisteriopsis caapi) 68–70 basmati rice 47–49 blight-resistant rice 66–67, 106 camu camu (Myrciaria dubia) 53–55, 75, 143 future of 73–76 Hawai’ian Taro 49–51, 92, 112 hoodia 61–63, 93, 113 Japanese plao noi (genus Croton) 63–66, 105, 114 kwao krua (Pueraria miriﬁca/Butea superba) 55–59, 93, 112–113 neem 71 Peruvian maca (Lepidium meyenii) 67–68 turmeric 71 yellow enola beans 51–53 patent examination process 20, 31, 34, 41, 75 and databases 42, 151, 152 failures of 54, 55, 72–73, 74–75 improvements in 57, 70, 120, 124 NGOs and 142 Patent Law Treaty 16, 31 patents 15, 16, 18, 24, 25, 117 amendments to system 119–124 bad, effect of 141 broad 72 defensive portfolios 74 disclosure of origin in 16, 31, 119–124 exceptions from 29, 41, 46, 55–57, 69, 118–119 and exclusion from sale/export 102–105 for extraction processes 53–57, 60–61, 70 and fairness/equity principle 46–47, 65, 68, 76

geographical limitation on 48, 52 grant rates 74–75 inefﬁciencies/abuses of system 70–73 monitoring 42, 43 novelty and see novelty obtaining, criteria for 45–46, 48, 69–70, 72 and PVP 84 research sources for 42–43 and trademarks 49 transparency 54–55, 68 TRIPS and 29–31 PBRs (plant-breeder rights) 20, 34–35, 78–81 and disclosure of origin 79–81, 82, 83, 84–85, 126 PCT (Patent Cooperation Treaty, WIPO) 31, 46, 122, 124 peanuts 81–82, 106 PeBRs (People’s Biodiversity Registers, India) 143–144, 152 pepper 2, 5 pepper, habanero 82–84, 121 persian clover (Trifolium resupinatum) 80 Peru 13, 71, 92, 119–120, 141–143 Anti-Biopiracy Commission 15 camu camu case in 53–55, 75, 143 customary law principles in 153, 154 indigenous knowledge protection in 142, 145, 150 and ITPGRFA 37–38 maca patent case in 67–68, 143 National Anti-Biopiracy Commission 142–143 and TRIPS 141 and US 41 Peruvian maca (Lepidium meyenii) 67–68, 143 Pﬁzer 12, 62 pharmaceutical corporations 1, 11–13, 60–61, 155 bioprospecting cases 12–13 Phaseolus vulgaris see yellow enola beans Philippines 150 PhRMA (Pharmaceutical Research and Manufacturers of America) 155 Phytopharm 60–63 PIC (prior informed consent) 13, 21, 27, 28, 41, 60, 63, 75–76, 77

INDEX

international agreements on 120, 122, 126, 131, 139 and knowledge transformation 109 national systems of 143, 144 and plant collections 98–99 system/procedures for 115 and trust 114–116 written contract of 116 plant breeding/breeders and patents 23–24 rights see PBRs plant collections 64, 81, 97, 98 plant exchange 23–24, 25, 35 plant genetic resources global information system for 37 transfers 35–36, 39, 77, 141 plant hunting/collecting 1–4, 6–8, 97 in ancient world 1–2 see also bioprospecting plant trade 2–10 and colonialism 3, 4–6, 7, 24 impacts of 3, 7–10 power relations in 24, 27 plant variety protection see PVP plao noi (genus Croton) 63–66, 105, 114 POD-NERS 51–53, 103 Polo, Marco 2–3 polymerase chain reaction 104 Polynesian people 112 Portsmouth University (UK) 93–94, 113 Portugese empire 4–5 Posey, D.A. 9 postcolonialism 10 potatoes 38 poverty 39, 61 power relations 24, 27, 98–99, 121 Powers, Stephen 7 prior art criterion 46, 52, 54, 59, 68, 71, 122 prior informed consent see PIC privatization 1, 24–25, 30, 51 processes, patents for 53–57, 60–61, 70, 104 Proctor, Larry 51–52, 53, 103 production methods 53–57, 60–61, 70, 128–129 public domain 109, 110, 157, 158 public opinion 15 Pueraria miriﬁca see kwao krua

187

Pure World Botanicals 67, 68 PVPFR (Protection of Plant Varieties and Farmers’ Rights Act, India) 145–147 PVP (plant-variety protection) 20, 24, 25, 119, 127–128 as biopiracy 77–85 databases and 82, 84, 151 national systems for 30 and patents 84 and small-scale farmers 35 sui generis systems see sui generis TRIPS and 29–30 see also UPOV Qaim, M. 102 Quillen, C.D. 74 R&D (research and development) 24, 125 RAFI (Rural Advancement Foundation International) see ETC Rangnekar, D. 129 Ray, John 6 recombinant DNA technology see genetic engineering regional agreements 40–41, 117–118, 134–139 African Model Law 40, 117, 135–138 Andean Community 131, 138–139 ASEAN framework 117, 134–135 Paciﬁc Model Laws 117–118, 139 registers see databases regulation of biological resources 3, 15–16, 27, 28, 143–144 CBD 13–14, 16 international see international agreements Reid, W.V. 11, 14 research and development (R&D) 24, 125 resource ﬂow/transfer 14, 16, 73 rice blight-resistant 66–67, 106 International Research Institute (IRRI) 49, 66, 97, 106 jasmine 87–88, 95–97, 104, 105, 149 patent cases 15, 47–49 and trademarks 87–89 see also basmati rice

188

CONFRONTING BIOPIRACY

RiceTec Inc. 47, 48, 84, 87, 104 Rio Earth Summit (1992) 10, 14, 26 rooibos tea 86, 89–91, 104, 129 Roundup Ready soybeans 102–103 royalties 51, 102, 123 Ruiz, M. 138 Saami people 109 SACSIR (South African Council for Scientiﬁc and Industrial Research) 61–62, 63 Sagar, R. 143 sanctions 121 Sankyo Co. 63–64, 65 San people 61–63 Santa Ana III, R. 82 scientiﬁc imperialism 112 seed exchange 23–24, 25, 35, 37, 38, 95 seed industry 12, 24, 35 biopiracy by 51–53, 71 seed prices 102 sexual performance/dysfunction 55, 67–68, 92 Shaman Pharmaceuticals 12, 13, 62 Shiva, Vandana 15, 19–20, 48 Singapore 149 Sinha, R.K. 64 SIPO (Chinese patent ofﬁce) 152 slimming products 62 small-scale farmers 24, 35 SMTAs (standard material transfer agreements) 126 Solander, Daniel 6 South Africa 61–63, 113, 136, 145 rooibos trademark in 89–91, 104 SACSIR 61–62, 63 WIMSA 61–62 South America 4–5, 13, 31, 92, 109 South Centre 15, 42 Southeast Asia 4 sovereignty 16, 23, 26, 27, 38 small-holder 35 soya meal 103 soybeans 72, 102–104 Spain 4, 5, 103 spice routes 2, 3, 4–5 spices 2, 3, 71, 142 spiritual/religious dimension 28, 50, 51, 59, 69, 70, 95, 99 and cultural affront 108, 109–112

Srinivasan, C.S. 24 Srivastava, S.C. 129 Stepwise Program 93, 95–97, 104 sui generis systems 29–30, 41, 118, 127–128, 131, 132, 141, 144–151 beneﬁt-sharing in 146, 147 farmers’/extant varieties in 145–146, 148 Indian 145–147 reasons for adopting 144–145 Thai 147–149 Suthersanen, U. 16 Switzerland 31, 122 Tanasugarn, L. 57, 87 Taubman, A. 109 taxonomies indigenous 7 Linnaean 6 tea 129 see also rooibos tea tree oil 92 technology transfer 65, 66, 105, 124 tef (Eragrostis tef) 108 Terminalia ferdinandiani see kakadu plum terminator technologies 14–15 Texas Agricultural Experiment Station 82–83 textiles 6, 7, 72, 103 Thailand 15, 16, 109–110, 114, 119–120, 155 Chiang Mai Province 97–99, 107– 108, 116 database in 152 Issan region 89, 95 ITPGRFA in 38 ‘Jasmati’ trademark controversy in 87–89 jasmine rice in 87–88, 95–97, 104, 105 kwao krua (Pueraria miriﬁca/Butea superba) cases 55–59, 93, 112–113 misappropriation in 93–99 patent-based biopiracy in 55–59, 63–66 rice growing in 87, 89 sui generis system in 147–149 Traditional and Alternative Medicines Act 113

INDEX

traditional medicine regulation in 113, 150 see also Karen people Thai PVP Act (1999) 147–149 Thammasat Resolution (Thailand, 1997) 15, 39, 109, 118 Thom, B. 133 TKDL (Traditional Knowledge Digital Library, India) 151–152 Tobin, B. 123 Tonga 112 Tordesillas, Treaty of (1494) 4, 5 trade agreements 40–41 inequality in 16 monitoring 42, 43 and trademarks 90–91 trademarks 29, 49, 77, 78, 85–92 açaí berry case 91–92 and generic terms lists 91 and GI rules 86, 88–89, 129 ‘Jasmati’ case 87–89 restrictions on 86 rooibos tea case 89–91, 104 TRIPS on 85–86 Trade-Related Aspects of Intellectual Property Rights see TRIPS traditional knowledge 27, 73, 117, 136 and colonialism 4, 5, 7, 73 and customary norms/laws 99, 109–111, 130–133, 153–154 databases/registers 139, 141, 142, 151–153 deﬁned 18–19 devaluing of 7, 106, 112 ecological 10 ethical principles and 13 and ethnobotany 6–7 geographical indications and see GIs and human rights 39–40, 129–130 and IPRs 14, 25–26, 33–34 misappropriation of 92–99 oral transmission of 54 ownership of 1, 25, 139 and PBRs/PVP 82, 83–84 and pharmaceutical companies 12, 13 protecting 33–34, 37, 38, 127–128, 133–139, 154–155 protecting, challenges of 28 and public domain 109, 110, 157, 158

189

and sui generis systems 149–151 traditional medicine see medicinal plants Traditional Ownership Tribunal (Paciﬁc Islands) 139 training 36, 57, 99, 106, 114, 116, 139 trans-boundary issues 125 transparency 35–36, 39, 81, 115, 117 patent 54–55, 68, 73 and plant collections 98–99 Traxler, G. 102 ‘TRIPS-plus’ actions 40–41 TRIPS (Trade-Related Aspects of Intellectual Property Rights, WTO) 14, 15, 17, 28–31, 32, 117 and African countries 118–119, 136 amendments to 119–121, 122 and disclosure-of-origin 31, 119–120, 122 EC and 121, 122–123 GIs in 122–123, 128 patent exceptions in 46, 118–119 patents/PVP in 29–31, 34, 35, 78 and sui generis systems 29–30, 118, 127 and technology transfer 105 trademarks in 85–86 trust/mistrust 97, 101, 107, 114–116, 122 Tuhiwai Smith, L. 7, 114 Tulalip people 159 turmeric 71, 142 Tutuli beans 103 Tyler-Whittle, M.S. 7–9 UC Davis 66, 106 Unilever 62 United East India Co. (VOC) 5 United Nations (UN) 9–10, 23, 66, 133 Biological Diversity Convention see CBD on human rights 39 on indigenous rights 129–130 Sovereignty over Natural Resources resolution (1962) 23 WIPO see WIPO United States (US) 14, 33, 157 Agriculture Dept. (USDA) 48, 80, 83 bilateral/regional tactic of 40 case-by-case approach of 120–121 and CBD/ITPGRFA 26, 74, 84, 126 and disclosure-of-origin 120–121, 123

190

CONFRONTING BIOPIRACY

IP expansion in 16 misappropriation cases in 89, 95–97 Patent Act 69, 70 and patent-based biopiracy cases 47, 48, 49, 50–53, 67–68, 74–75, 103 patents in 15, 29, 31, 34, 41, 42, 43, 46, 102, 112 Patent and Trademark Ofﬁce see USPTO pharmaceutical companies in 12, 13 PhRMA 155 PVP Ofﬁce 81, 82, 84–85, 106 trademarks in 87–89, 90, 92 UPOV (Union for the Protection of New Varieties of Plants) 29, 34–35, 41, 102, 126, 127, 141 criticisms of 35 DUS requirements in 35, 78, 145–146 and TRIPS 34, 35 Uruguay Round (GATT) 27, 28–29, 105 USDA (US Dept. of Agriculture) 48, 80, 83 USPTO (US Patent and Trademark Ofﬁce) 47, 48, 51, 52, 65, 68–70, 90, 92 shortcomings of 69–70 utilitarian view 16–17

Waelde, C. 157 Webster, O.H. 73 WG-ABS (Working Group on Access and Beneﬁt-sharing, CBD) 124–125 Whatmore, S. 25 wild harvesting 66–67, 113 WIMSA (Working Group on Indigenous Minorities in South Africa) 61–62 wine 3, 91, 122, 128–129 WIPO (World Intellectual Property Organization) 16, 27, 31, 31–34, 42, 46, 73, 91, 112, 117 criticisms of 32, 131 on customary protocols/laws 130– 132, 153 developing countries and 32, 122 IGC see IGC importance of 31, 32 Woods, B. 75 WTO (World Trade Organization) 15–16, 23, 27, 28–29, 31 Dispute Settlement Body 32, 40, 121 EC and 121–122 on intellectual property see TRIPS Working Group on Trade and Technology Transfer 105–106 Wynberg, R. 11, 12, 13, 61, 62, 108

Venice, Republic of 3 Vicia faba (faba bean) 80 Vietnam 9, 149

yellow enola beans (Phaseolus vulgaris) 51–53, 103 Young, S. 119