Faculteit Rechtsgeleerdheid

Universiteit Gent

Academiejaar 2012-13

Biopiracy

Masterproef van de opleiding

‘Master in de rechten’

Ingediend door

Saskia Lemeire

(studentennr. 00803054)

Promotor: Professor Frank Maes

Commissaris: Hendrik Schoukens

!

Acknowledgment

I would like to express my sincere gratitude to some people, without whose help, support and patienceit would not have been possible to complete the process of writing this master thesis.

First and foremost, I want to thank my kind parents, my mother for her patience and presence andmy father for always posing critical questions. They have not only given me the freedom and trust tomake my own choices in life and in my education, but have supported me every step of the way.

Secondly, a special thanks is preserved for François Grossmann who has calmly endured everymoment of despair. Without his support and help this thesis would not look the same.

Thirdly, I would like to thank Sigrid Heirbrant for always believing in me, Toby De Backer forgiving me a push when I need it and both of them for their friendship that I value very high.

And last but not least, a special acknowledgement is preserved for Professor Frank Maes, for hisenthusiasm on the subject I chose for this thesis, and to Hendrik Schoukens, for giving me the freedomto develop this dissertation in my own way.

Contents

Introduction 1

I Situating the Problem, Pirates or Heroes? 3

1 De!ning the Concept, What is Biopiracy? 51.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51.2 De!nition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61.3 Putting it in the Right Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81.4 Why is it a Problem? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2 History 12

3 Case Law 163.1 The Neem Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163.2 Enola Bean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183.3 European Patent O"ce versus US Patent and Trademark O"ce . . . . . . . . . . . . . . 19

4 Preliminary Conclusion 20

II Analysis of the Existing Legal Framework 21

5 Patent Law and Patentable Subject Matter 235.1 World Intellectual Property Organization . . . . . . . . . . . . . . . . . . . . . . . . . . 245.2 TRIPS Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

5.2.1 Minimum Standard of Patentability . . . . . . . . . . . . . . . . . . . . . . . . . 275.2.2 Exceptions to Patentability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

5.3 EU Directive on the Legal Protection of Biotechnological Inventions . . . . . . . . . . . 30

6 Convention on Biological Diversity 336.1 Protecting the Knowledge and Innovations of Indigenous Communities . . . . . . . . . 386.2 Access and Bene!t Sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386.3 Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

7 The Interface between the TRIPS Agreement and the Convention on Biological Diver-sity 417.1 Current Status of Plant Genetic Resources . . . . . . . . . . . . . . . . . . . . . . . . . 427.2 Adapting the TRIPS Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

8 Nagoya Protocol 458.1 The Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 468.2 Assessment of the Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

II

9 Preliminary Conclusion 51

III Towards a Solution 53

10 Rhetoric 56

11 European Union Initiatives 59

12 Using Patent Law to Protect Traditional Knowledge 6312.1 A Mandatory Disclosure Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

12.1.1 National Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6512.1.2 Disclosure outside Patent Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6612.1.3 Disclosure as a TRIPS Obligation . . . . . . . . . . . . . . . . . . . . . . . . . . 6612.1.4 Disclosure through the WIPO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

12.2 Prior Art and Digital Databases of Traditional Knowledge . . . . . . . . . . . . . . . . . 70

13 Alternatives 71

14 Preliminary Conclusion 73

Conclusion 75

Bibliography 78

Annex I: Summary Table of Membership of the Treaties Administeredby WIPO 86

Annex II : Nederlandstalige Samenvatting 91

III

List of Abbreviations

ABS Access and Bene!t SharingCBD Convention on Biological DiversityCGIAR Consultative Group on International Agricultural ResearchCGRFA Commission on Genetic Resources for Food and AgricultureCOP Conference of the Parties (Convention on Biological Diversity)EPO European Patent O"ceFAO Food and Agriculture Organization of the United NationsIGC Intergovernmental Committee on Intellectual Property and Genetic

Resources, Traditional Knowledge and Folklore (WIPO)IPR Intellectual Property RightsLDC Least Developed CountryMTA Material Transfer AgreementNGO Non-governmental OrganizationPBR’s Plant Breeders’ RightsPCT Patent Cooperation TreatyPVP Plant Variety ProtectionSPTL Substantive Patent Law TreatyTRIPS Trade Related Aspects of Intellectual Property Rights (in GATT)UPOV International Union for the Protection of New Varieties of PlantsUSPTO United States Patent and Trademark O"ceWHO World Health OrganizationWIPO World Intellectual Property OrganizationWTO World Trade Organization

IV

Introduction

“ Knowledge is power ” 1

Sir F. Bacon

The end of the twentieth century has been the dawn of a new age, the age of knowledge. Therapid advances made in science and technology have made knowledge a valuable commodity. For ex-ample, internet has brought a revolutionary change. Similarly, genetic sequencing is mind-bending inits implications for bioscience.2 The increased importance of knowledge explains why the economyof intellectual property is much more of a political concern now than it was two decades ago. TheWTO Agreement on Trade-Related Aspects of Intellectual Property Rights has created a globalizedsystem of broad patentability. These technological changes and their legal protection have produced awidespread concern about biodiversity. This concern has been expressed through campaigns againstthe ‘plunder of nature’.3 Biopiracy is one of the detrimental side e#ects generated by the expandingvalue and protection of intellectual property.

Biopiracy is the unauthorized or uncompensated use of biological resources and traditional knowl-edge adhering to other (often developing) countries and their local and indigenous communities. Itfeels morally unjust that farmers from developing countries should pay for seeds that are developedfrom varieties which originally came from their territories. Neither does it feel fair to appropriate thetraditional knowledge of an indigenous community about the uses of a plant to develop a product andmake pro!t of it without that community receiving any compensation in return. One example is theraging public opinion on Monsanto cases. Monsanto is a biotech giant that regularly appears in themedia with protests against its ‘seed oligarchy’ and its unfair treatment of small farmers.4 This is onlyone company. In the pursuit of pro!t, morality is often forgotten.

This unjust phenomenon started out as a story of dominant developed countries that imposed theirdemands on weaker developing countries. However, that story has gotten a lot more complicated.Biopiracy is generated by a complex regime of legislation. Activists often use a one-sided discourseof ruthless multinationals exploiting the poor population of developing countries. This dissertationstrives to put biopiracy in the right context, give an insight to the key issues and take on the searchfor a remedy. The following paragraphs will set out the structure of this dissertation by brie$y takinga peak into each of its three parts.

1“Sciencia potentia est”, Sir Francis Bacon, Religious Meditations, Of Heresies, 1597.2D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship

Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 363.

3C. MAY, World Intellectual Property Organization (WIPO): Resurgence and the Development Agenda, Abingdon, Taylor &Francis, 2006, 1-2.

4RT, “Monsanto protests scheduled in 36 countries”, 9 May 2013, http://rt.com/usa/monsanto-march-protests-world-069/.RT, “Monsanto takes home $23mln from small farmers, seeks to maintain ‘seed oligarchy”’, 13 February 2013,http://rt.com/usa/monsanto-seeds-trial-bowman-123/.The Guardian, “Monsanto-the black stain on the biotech industry”, 11 August 2011,http://www.guardian.co.uk/commentisfree/2011/aug/11/monsanto-biotech-industry-monoculture.

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Firstly, the phenomenon of biopiracy will be situated in its context. Since the problem is notwidely known, the !rst part of this dissertation will explain what biopiracy exactly is and why it is aproblem. For a full understanding of the current international negotiations and more speci!cally itsdi"culties, it is important to know the history leading to the emergence of biopiracy. That is why theauthor provides an overview of the evolution of intellectual property law and biodiversity protection.Additionally, two cases concerning biopiracy will be discussed to assess how the EU and US patentauthorities handle claims of biopiracy.

Secondly, an analysis of the current legal framework concerning biopiracy is made. The two inter-national agreements with the biggest impact in this respect are the WTO Agreement on Trade-RelatedAspects of Intellectual Property Rights and the UN Convention on Biological Diversity. To a certainextent these regimes are incompatible and in reality this gap condones biopiracy. Part two of thisdissertation will highlight the controversial provisions in both of these agreements and the con$ict inthe interface between them. In 2010 the Nagoya Protocol was adopted to adjust some of the existingimplementation problems of the Convention on Biological Diversity. The author will look at the ob-jectives of the protocol and assess whether it is likely to realize those.

Lastly, the third part of this dissertation considers the possible options to remedy the negative ef-fects of biopiracy. On the international level there are many discussions taking place, covering a widearray of possible measures. To remain within the scope of this dissertation, the author has limited thispart to the most realistic and e#ective measures discussed for a remedy.

Throughout the pages of this dissertation the international discussion on biopiracy will be studiedin all its aspects, but also suggestions will be made for a workable remedy that is realistic in light ofthe current status of discussion. Biopiracy is only one of the various topics of con$ict that cause theimpasse in WTO negotiations. It is a very clear example of how di"cult a solution can be reachedwhen there is a substantial con$ict between the claims of di#erent states. Biopiracy tends to stir upemotions and heavy moral judgement, but this dissertation o#ers a legal view on the topic taking intoaccount the perspectives from the di#erent stakeholders. It is the author’s aspiration that the extensivelegal inquiry of this dissertation can o#er the reader a new understanding of the problems surroundingbiopiracy.

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Part I

Situating the Problem, Pirates orHeroes?

The !rst part of this dissertation strives to o#er an elaborate overview on the controversy sur-rounding biopiracy, before conducting an analysis of the legal framework in the second part and sug-gesting a remedy in the third part. Although biopiracy is a highly debated issue, it is not widely known.Therefore an introductory chapter will start by providing the reader with a de!nition of the concept.As there is no harmonized understanding of what biopiracy exactly is, it is important to discuss thekey elements of the de!nition and the points under debate. This chapter will further put the problemin its context by giving voice to counter arguments and explain why biopiracy is a problem that is inneed of a solution.

The second chapter will look at the historical evolution of the biopiracy controversy. During thelast decades, science and industry have changed quite a lot. A thorough knowledge of the internationallegal actions those changes triggered will make for a better understanding of the current legal situa-tion. This knowledge will be a sound base to assess the current regulation that applies to biopiracy inpart two of this dissertation.

Throughout the third chapter the judicial assessment of biopiracy will be illustrated through a ren-dition of two ‘textbook’ biopiracy cases. By looking at the approach of the European Patent O"ce inone case and the reasoning of the United States court in another, the most important di#erences be-tween these two in$uential patent regulators will become clear. Looking at two concrete examples ofbiopiracy will further clarify the impact of biopiracy. The di#erentiating views of the European PatentO"ce and the US Patent and Trademark O"ce are an important element to consider when presentinga workable solution for the problem in part three.

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Chapter 1

De!ning the Concept, What isBiopiracy?

1.1 IntroductionThroughout the ages, humans have been hunting and collecting plants, seeds and other natural ele-ments. Recorded explorations of foreign natural elements trace back to Ancient Egypt, when QueenHatshepsut sent her army out on a search for a speci!c tree.5 One of the !rst in$uential ethnob-otanical works was written in AD 77 by the Greek physician Dioscorides. His De Materia Medica de-scribes nearly 600 plants and their medicinal uses.6 During colonial times many explorers and colonistsbrought back plants, minerals and observations of the practices of local communities to the metropoli-tan state. In 1474 the Republic of Venice enacted the !rst known general patent statute as an incentiveto create or import new technologies.7 Whether for food, science, economic pro!t or medicinal use, abroad range of players have been and are making use of biological resources.8

Up to the present day, genetic resources9 and traditional knowledge associated with those resourcesplay a signi!cant role in di#erent sectors of industry (in plant and animal breeding, biocontrol, foodand beverage, horticulture, industrial biotechnology10, pharmaceutical industry and cosmetics). Manyof these industries use biological resources for research and development. For example, over the last30 years 26% of all new approved drugs are natural products or have been developed from a naturalelement.11 In the agricultural industry a lot of research is dedicated to enhance the resistance of plantsthrough research on di#erent types of seeds and genetic manipulation. This process of research anddevelopment is encouraged through patent protection.

5D. F. ROBINSON, Confronting Biopiracy: Challenges, Cases and International Debates, Abingdon, Earthscan, 2010, 1.(further referred to as ‘D. F. ROBINSON, Confronting Biopiracy’)

6Encyclopædia Britannica, Pedanius Dioscorides (retrieved 28 March 2013),http://www.britannica.com/EBchecked/topic/164412/Pedanius-Dioscorides.

7D. F. ROBINSON, Confronting Biopiracy, supra 5, 3.C. A. NARD and A. P. MORRISS, “Constitutionalizing Patents: From Venice to Philadelphia”, Review of Law and Economics,2006, 234.

8Throughout this dissertation the term ‘biological resources’ is used as de!ned in the UN Convention on BiologicalDiversity meaning “including genetic resources, organisms or parts thereof, or any other biotic component of ecosystemswith actual or potential use or value for humanity”. (UN CBD Art. 2)

9Throughout this dissertation the term ‘genetic resources’ is used as de!ned in the UN Convention on Biological Diversitymeaning ‘genetic material of actual or potential value’. (UN CBD Art. 2)

10Throughout this dissertation the term ‘biotechnology’ is used as de!ned in the UN Convention on Biological Diversitymeaning ‘any technological application that uses biological systems, living organisms, or derivates thereof, to make or modifyproducts or processes for speci!c use’. (UN CBD Art. 2)

11Proposal for a Regulation, COM/2012/0576 !nal, 4 October 2012, Proposal for a regulation of the European Parliamentand of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising from their Utiliza-tion in the Union, 2, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.

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The UN Convention on Biological Diversity declares that in accordance with principles of inter-national law, states have the sovereign right over the resources within their national jurisdiction andthe authority to determine access to those resources. Furthermore the Convention obliges the con-tracting parties to share in a fair and equitable way the results and bene!ts arising from researchand development based upon genetic resources with the party providing these resources.12 However,some countries claim a violation of their sovereign rights by companies which don’t comply with theseobligations. This is called biopiracy.

1.2 De!nitionBiopiracy is a phenomenon that only recently started getting international attention. An o"cial de!-nition of the concept does not exist. The term itself is relatively new, being only used for the !rst timein the early 1990s. It is closely related to the term bioprospecting which also stems from the 1990s.Bioprospecting or bio(diversity) prospecting is de!ned in the Oxford Dictionary as “the search for plantand animal species from which medicinal drugs and other commercially valuable compounds can be ob-tained”.13 The term is widely used for “any program that endeavours to collect genetic material and/orthe knowledge of its uses, usually from areas with high concentrations of biodiversity”.14

The term ’bioprospecting’ originates from the 1993 book Biodiversity Prospecting: Using GeneticResources for Sustainable Development by Reid et al. from the World Resources Institute. In the bookbioprospecting is de!ned as “the exploration of biodiversity for commercially valuable genetic and bio-chemical resources”.15 The authors aimed to promote the preservation of biodiversity and the sharingof its bene!ts by stressing its economic potential. Although the terminology might be new, the practiceof collecting biological material is not. Multiple examples from history, not in the least from colonialhistory, show that this is an old practice. Anthropology Professor Cori Hayden states that bioprospect-ing is a new name for an old practice. Its novelty lies in ethical considerations which have establishedthat the taking of biological resources now comes with a mandate to give back.16

The !rst use of the term biopiracy is usually attributed to activist Pat Mooney, Executive Directorof the Canada-based NGO Action Group on Erosion, Technology and Concentration (ETC Group).17 Itwas used as a way to raise questions about the practice of bioprospecting due to growing frustrationsabout the appropriation and monopolization of resources and traditional knowledge.18

12Articles 3, 15 and 19, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.13“bioprospecting”, Oxford Dictionaries, Oxford University Press,

http://oxforddictionaries.com/de!nition/english/bioprospecting.14C. HAMILTON, “Biodiversity, biopiracy and bene!ts: what allegations of biopiracy tell us about intellectual property.”

Developing world bioethics, 2006, Vol. 6(3), 159. (further referred to as ‘C. HAMILTON, “Biodiversity, biopiracy and bene!ts”’)15The authors cite the previous use of the term ’chemical prospecting’ by Thomas Eisner between 1989 and 1992.

W. V. REID et al., Biodiversity Prospecting: Using Genetic Resources for Sustainable Development, Baltimore, World ResourcesInstitute Publications, 1993, 2-3.

16C. HAYDEN, When Nature goes Public : The Making and Unmaking of Bioprospecting in Mexico, Princeton, PrincetonUniversity Press, 2003, 2.

17Before 2001 the ETC Group was named the Rural Advancement Foundation International (RAFI).18“The terms ‘traditional knowledge’ and ‘indigenous knowledge’ refer to knowledge that is held collectively (at the com-

munity or national level), has been used for generations by local communities and has contributed to the development ofcrop varieties, food security and medicines, as well as the emergence and continuation of artistic work in the form of music,handicrafts and artisanship.”L. R. HELFER, “Regime Shifting”, infra 48, 29.

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As mentioned earlier, biopiracy is not a term with an accepted legal meaning, nor is there a consen-sus on what the term exactly comprises. Scholars, activists and politicians each give a slightly di#erentde!nition. However, before looking in depth at the issue, it is important to understand its meaning andthe debate surrounding it. By analysing the de!nitions given by a number of sources, I will attempt too#er a clear description of biopiracy.

Only in recent years included, the Oxford Dictionary de!nes it as:

“the practice of commercially exploiting naturally occurring biochemical or genetic material,especially by obtaining patents that restrict its future use, while failing to pay fair compensa-tion to the community from which it originates”.19

This de!nition limits the object of biopiracy to ‘biochemical and genetic material’, while giving a broaddescription of the practice as ‘commercially exploiting, especially by obtaining patents’. It explicitlymentions the lack of fair compensation.

The ETC Group, which originally coined the term, gives the following de!nition:

“Biopiracy [...] refers to the appropriation of the knowledge and genetic resources of farm-ing and indigenous communities by individuals or institutions that seek exclusive monopolycontrol (patents or intellectual property) over these resources and knowledge.” 20

Here the object is more extensive and includes both genetic resources and associated knowledge. Sec-ondly, a focus is placed on ‘farming and indigenous communities’. Thirdly, compared to the OxfordDictionary de!nition the scope is somewhat more limited to cases where patents or intellectual prop-erty are used to seek control.21

One of the most known activists against biopiracy is the Indian scientist Vandana Shiva. Sheinterprets the term the following way:

“Biopiracy refers to the use of intellectual property systems to legitimize the exclusive own-ership and control over biological resources and biological products and processes that havebeen used over centuries in non-industrialized cultures.” 22

With regard to the object of biopiracy, there is no reference to associated knowledge. However, com-pared to the previous de!nition, she broadens the victimized group from ‘farming and indigenouscommunities’ to ‘non-industrialized cultures’. Just like most authors, Vandana Shiva targets intellec-tual property systems.

While most descriptions of biopiracy only include intellectual property systems of control, somescholars say this is not fully complete. The unauthorized collection and use of biological resourcesand associated knowledge, not implicating intellectual property, is also labelled biopiracy by them.This practice is often referred to as the misappropriation of biological resources and/or traditionalknowledge.23 This is re$ected in professor Graham Dut!eld’s de!nition of the term:

“[...] it normally refers either to the unauthorized extraction of biological resources and/orassociated traditional knowledge from developing countries, or to the patenting of spurious‘inventions’ based on such knowledge or resources without compensation.” 24

19“biopiracy”, Oxford Dictionaries, Oxford University Press, http://oxforddictionaries.com/de!nition/english/biopiracy.20Action Group on Erosion, Technology and Concentration (ETCGroup), http://www.etcgroup.org/issues/patents-biopiracy.21D. F. ROBINSON, Confronting Biopiracy, supra 5, 18.22V. SHIVA, Protect or Plunder? Understanding Intellectual Property Rights, London, Zed Books, 2001, 49.23D. F. ROBINSON, Confronting Biopiracy, supra 5, 20-21.24G. DUTFIELD, Intellectual Property, Biogenetic Resources, and Traditional Knowledge, Earthscan, 2004, 52.

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Quite some de!nitions narrow the scope of biopiracy to patenting. However, various authors alsonote the impact of other intellectual property systems. More speci!cally plant breeders’ rights (PBRs)established through plant variety protection are known to constitute biopiracy as well.25 Plant varietyprotection is a patent-like system. It allows a plant breeder to prohibit speci!c unauthorized uses of anew plant variety.26

Based on the aforementioned descriptions by actors and authors of importance, I have developed ade!nition of biopiracy that adequately summarizes the problem. Biopiracy refers to the appropriationof biological resources and/or associated traditional knowledge and to the use of intellectual prop-erty systems to legitimize the exclusive ownership and control over these resources and/or associatedtraditional knowledge, without adequate authorization and bene!t-sharing from other (usually devel-oping) countries, indigenous or local communities. This broad de!nition emphasizes the problem andits larger questions of equity.27

In order to respect the scope of this dissertation, I will refrain from going into detail on this mis-appropriation of knowledge. This dissertation will rather treat biopiracy from a legal perspective. Theemphasize will be on intellectual property protection as the legal aspect of biopiracy is a story of con-$icting rights over intellectual property and conservation of biological resources. Within intellectualproperty protection there are di#erent regimes to protect intellectual property. Because patent protec-tion is the most used of those to claim exclusivity over biological resources and thus poses the biggestproblem for biopiracy, the focus will be on patent regulation. More speci!cally, I will focus on howthe current patent legislation makes biopiracy possible and what should be altered to prevent biopiracy.

As the issue of biopiracy is highly controversial, it is no surprise that the terminology is equallycontested. Being a derogatory term, biopiracy is often replaced by terms as ‘unauthorized access’ and‘misappropriation’.28 That is how de!nitions of these terms are increasingly entangled, yet de!ned dif-ferently by every actor. The result of this confusing rhetoric is the existing vague terminology. Manyactors involved avoid even using the word. One does not even have to be an attentive reader to noticethat the word ‘biopiracy’ is nowhere to be found in the Nagoya Protocol, which essence is to tacklebiopiracy by providing a transparent legal framework for the fair and equitable sharing of bene!tsarising out of genetic resources (infra Part II, Chapter 8). Even in a recent proposal for a regulationconcerning biopiracy by the Greens in the European Parliament, the term biopiracy is used very cau-tiously.

1.3 Putting it in the Right PerspectiveMany critics say that there is no such thing as biopiracy. They argue that most corporations simplyact in accordance with existing international property law. Legal scholar Jim Chen points to local gov-ernments, instead of foreign bioprospectors, as being primarily responsible for environmental damagecaused by the collection of biological specimens. This criticism points out correctly that “the idea ofsovereignty over natural resources and biodiversity not only provides nations with rights but also imposes

25D. F. ROBINSON, Confronting Biopiracy, supra 5, 20-21.26W. H. LESSER, “Plant Breeders’ Rights: An Introduction” in A. KRATTIGER, R. T. MAHONEY, L. NELSEN, et al (eds.),

Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, Oxford, MIHR andDavis, PIPRA, 2007, 381, www.ipHandbook.org.

27T. J. KIM, “Expanding the Arsenal Against Biopiracy: Application of the Concession Agreement Framework to PreventMisappropriation of Biodiversity”, SMU Science and Technology Law Review, 2010-2011, Vol. XIV, 79.

28Report prepared for IUCN-Canada and distributed at the Fourth Meeting of the ABS Working Group,T. YOUNG, “An Analysis of Claims of Unauthorized Access and Misappropriation of Genetic Resourcesand Associated Traditional Knowledge”, Granada, 2006, document UNEP/CBD/WG-ABS/4/INF/6, SCBD,http://data.iucn.org/dbtw-wpd/html/EPLP-067-5/section17.html.

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some important obligations, which countries sometimes forget”. As a consequence, governments shouldblame themselves for the failure to protect their biodiversity and for not putting limits on the researchon and appropriation of biological resources. These arguments are very harsh towards developingcountries, but they do present some rational points. Therefore they deserve some consideration.29

Taking the United States as an example, one can understand the point of these critics. Various lawshave been enacted to protect biodiversity, such as the Endangered Species Act or the Marine MammalProtection Act, and are being e#ectively enforced. The United States has an e#ective conservationprogram in force. However, a large part of the world’s biodiversity is found in developing countriesand many of these countries do not have the !nancial means needed to implement a qualitative biodi-versity protection.

Bioprospecting and biopiracy seem to be two sides of the same coin. As unfair and negative asthe practice of biopiracy may sound, critics are right to say that bioprospecting is of essential impor-tance to some sectors of industry, not in the least to the pharmaceutical and agricultural industry. Itneeds to be noted that bioprospecting has made important contributions to science, for example ele-ments of rosy periwinkle have produced anti-cancer medication.30 Research into indigenous peoples’knowledge of biological resources and their use is a since long recognized drug discovery strategy.Globalization and biotechnology have led to the identi!cation and development of drugs in every po-tential environment.31

World agriculture depends on the crossbreeding of plants in hope of uniting the best features of aplant and creating a new variety that is stronger and more resistant.32 By improving the resistance ofplants and growing stronger varieties, farmers and companies raise the probability of having a goodharvest. Scientists working with genetically modi!ed plants argue that these nutritionally enhancedcrops could help alleviate Third World hunger.33 It is a fact that the world population is growing andclimate is changing, possibly making fertile grounds unusable in a couple of decades. Modi!cationof plant varieties could soon prove to be essential in securing the world’s food supply. Because plantbreeding is expensive and demands a high level of technology, it is mainly conducted by large compa-nies in developed countries.

The goal of the intellectual property rights system is to give incentive to create and to encouragetechnological advancement. Research and development is very money and time consuming. In order tomake this pro!table for companies, they are awarded the exclusive rights over their creation for a cer-tain amount of time. However, by the time a product is released on the market usually a company onlyhas left a couple of years (or sometimes months) of exclusivity to make pro!t out of their development.The average cost to research and develop each successful drug was estimated to be e1,059 billion in2005 (including the cost of the thousands of failures). It takes 10 to 15 years to bring a new medicineon the market.34 The complete process of crossbreeding plants from germplasm to a commercially vi-

29M. V. GUBAREV, “Misappropriation and patenting of traditional ethnobotanical knowledge and genetic resources”, Jour-nal of Food Law and Policy, 2012, 72.

30V. TEJERA, “Tripping over Property Rights: Is it Possible to reconcile the Convention on Biological Diversity with article27 of the TRIPS Agreement?”, New England Law Review, 1999, Vol. 33, 971.

31B. A. LIANG, “Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,Journal of Commercial Biotechnology, 2011, Vol. 17(3), 249.

32H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,Ecology Law Quarterly, 1985, Vol. 12(4), 1055.

33M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Tech-nology, 2002, Vol. 13, 126.

34Innovation.org, “Drug Discovery and Development: Understanding the R&D Process”, Pharmaceutical Research andManufacturers of America, 2007, http://www.innovation.org/drug_discovery/objects/pdf/RD_Brochure.pdf. European Fed-eration of Pharmaceutical Industries and Associations, “The Pharmaceutical Industry in Figures: Key Data 2012”, 6,http://www.efpia.eu/sites/www.efpia.eu/!les/EFPIA_Figures_2012_Final-20120622-003-EN-v1.pdf.

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able plant variety takes ten to !fteen years.35 Knowing that most patent regulations award exclusivityrights for a period of 20 years, not so much time is left to generate su"cient revenues to cover the costs.

Many activists deliberately simplify the scienti!c process and the intellectual property rights sys-tem in their protest. Biopiracy is not simply a claim of theft or misallocation of bene!ts, it is rather aconcept that raises broader questions about the intellectual property rights system itself.

1.4 Why is it a Problem?Biopiracy is mainly a problem of lesser developed countries. They are often rich in biodiversity andgenetic resources, but have a lack of technology. In what are now developed countries many plant va-rieties were destroyed during the ice ages due to glaciation, therefore countries with a tropical climatehave the biggest biological diversity.36 Developed countries house the companies that have the knowl-edge and capital needed for technological advancement. These companies then go to the biologicallyrich developing countries for a prospection of useful elements. The TRIPS-Agreement that is supposedto provide protection of intellectual property is the legal basis which makes biopiracy possible.

The companies that face claims of biopiracy are mainly pharmaceutical and agricultural compa-nies. Modern agriculture depends on plant breeding to improve the quality of plants. When a companydevelops a new plant variety, it takes a patent on it and sells the seed to farmers. However, the seedproduced by a hybrid plant (the o#spring of crossbreeding) is not suitable for planting. A hybrid isproduced by crossing two compatible plants in such a way that the result combines the best of both‘parents’. To get the seed for this hybrid, the ‘parent plants’ (known as in-bred lines) have to be com-bined in the same way again. The seed of the hybrid itself will result in a di#erent plant than thehybrid. Only if farmers would have access to the in-bred lines, they would be able to produce thehybrid seed on their own. However, most companies protect this knowledge as a trade secret.37 Hav-ing to buy seed from a company year after year often means a swift economical death for little localfarmers.

Nowadays, there are almost 1000 patents issued for genetically modi!ed versions of !ve big crops:rice, wheat, maize, soybeans and sorghum. Almost 70% of these patents belong to only six companies:Sano! (previously called Aventis), Dow, DuPont, Mitsui, Monsanto and Syngenta. All these companiesare based in the EU, the US or Japan and together they are in control of 30% of the global seed market.38

A second threat caused by modern agriculture is genetic erosion. The widespread cultivation ofimproved plant varieties has led to more genetically uniform plants. Due to this increasing uniformitymultiple plant varieties have gone extinct. This loss of plant genetic diversity is called genetic erosion.This increases the vulnerability of agriculture. The more similar the genetics of crops are, the moresimilar they will react to environmental forces and the larger the impact of a natural disaster can be.39

Biological diversity is not only important for research and development, it also provides a higher re-35H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,

Ecology Law Quarterly, 1985, Vol. 12(4), 1055.36H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,

Ecology Law Quarterly, 1985, Vol. 12(4), 1054-1058.37H. J. BORDWIN, ‘The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,

Ecology Law Quarterly, 1985, Vol. 12(4), 1064.38M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Tech-

nology, 2002, Vol. 13, 136.39H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,

Ecology Law Quarterly, 1985, Vol. 12(4), 1056-1057.

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sistance to climatological changes and natural disasters.

The pharmaceutical industry is involved because a substantial part of drug development is based onnatural elements and their derivatives. In 2011 the world pharmaceutical market was worth e614,583billion, 41,8% of it belonging to the US and Canada, 26,8% to Europe and 12% to Japan. In that same yearthe US pharmaceutical industry spent $ 38,5 billion (approximately e29,5 billion) on R&D followed bythe European expense of e27,5 billion on R&D.40 The world commercial seed market is estimated tobe worth $ 45 billion (approximately e34,5 billion). The US seed market was worth $ 12 billion in2011 (approximately e9,2 billion).41 The size of these markets and their budgets for R&D clearly showthe importance of these industries. That is why this dissertation will focus on the agricultural andpharmaceutical industry in examining the phenomenon of biopiracy.

Companies are not the only ones responsible. National governments are to blame too. The in-digenous communities have not always been protected by their own governments. In some instances,national authorities have taken unilateral actions that leave indigenous peoples and their resourcesoutside bene!ts sharing arrangements. In developing countries the lifestyle of a lot of indigenous orlocal communities is dependent on their biological environment. Therefore an e#ective biodiversitymanagement is essential for their livelihood. The economic pressures of the 1990s forced developingcountries to ‘sell’ and deplete their resources.42 Nowadays too, economic pro!t often prevails overconservation of biological diversity for developing countries.

40European Federation of Pharmaceutical Industries and Associations, “The Pharmaceutical Industry in Figures: Key Data2012”, 5 and 14, http://www.efpia.eu/sites/www.efpia.eu/!les/EFPIA_Figures_2012_Final-20120622-003-EN-v1.pdf.

41International Seed Federation, “Estimated Value of the Domestic Seed Market in Selected Countries for the year 2011”.http://www.worldseed.org/isf/seed_statistics.html.

42B. A. LIANG, “Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,Journal of Commercial Biotechnology, 2011, Vol. 17(3), 249.

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Chapter 2

History

For a thorough understanding of the controversy surrounding biopiracy, it is essential to take a closerlook at the historical evolutions leading up to the emergence of the problem. In order to understand thebiopiracy discourse, two historical developments are important. Firstly, the current intellectual prop-erty system is a result of the globalization of Euro-American intellectual property regimes, particularlythrough the World Trade Organisation’s (WTO) Agreement on Trade Related Aspects of IntellectualProperty. Secondly, through the Convention on Biological Diversity biodiversity has been recognizedas a category of resources and biological resources have become a commodity.43 This chapter o#ersan overview of the historical events and international instruments that have led to the adoption of theWTO Agreement on Trade Related Aspects of Intellectual Property and the Convention of BiologicalDiversity.

Until the 1930s patent protection did not extend to biological life forms. Plant varieties were notconsidered inventions and were consequently excluded from intellectual property protection. In the1930s the method of crossbreeding plants to produce a ‘hybrid’ that is stronger became a widespreadpractice in industrialized countries. Seed companies then used their growing in$uence to obtain plantbreeders’ rights legislation.44 In the US the Plant Patent Act was enacted in 1930, allowing to patentthe phenotype (entire plant) for asexually reproduced plants. The 1970 Plant Variety Protection Actprovides intellectual property protection for varieties that are new, distinct, uniform and stable.45 Thisgreatly expanded patentability and had as a consequence that even seeds could be patented under someconditions.46

Before modern methods of plant breeding existed, patent protection was not considered an e#ectivesystem for the protection of newly developed plant varieties. Crossbreeding plants was a rather obvi-ous method to any farmer and consequently didn’t meet the non-obviousness requirement of patentprotection. Neither comprised the breeding an inventive step. Modern biotechnology brought plantbreeding to laboratories. The extension of patent protection to modern plant breeding methods andthe resulting products increases the signi!cance of patents in plant variety protection. A patent has theadvantage of o#ering a broader protection. Plant variety protection only relates to the speci!c varietyconcerned and the scope of the protection is limited by reference to the physical material itself.47

43C. HAMILTON, “Biodiversity, biopiracy and bene!ts”, supra 14, 160.44J. R. KLOPPENBURG, “Seeds, Sovereignty, and the Vía Campesina: Plants, Property, and the Promise of Open Source

Biology”, Paper prepared for the Workshop on Food Sovereignty University of Saskatchewan, 2008, 4.45K. AOKI, “Food Forethought: Intergenerational Equity and Global Food Supply ? Past, Present and Future”, Wisconsin

Law Review, 2011, 425.46E.K., “North and South: The WTO, TRIPS, and the Scourge of Biopiracy”, Tulsa Journal of Comparative and International

Law, 2003-2004, 288.47M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E.

EVENSON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 41.

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Mid-twentieth century a number of international research gene-banks was established to conserveplant genetic resources in the form of raw germplasm and to provide samples of these materials foragriculture, plant breeding and research. These gene-banks became part of the International Agricul-tural Research Centres and the Consultative Group on International Agricultural Research (CGIAR).48

The research of the Consultative Group is dedicated to food security and poverty eradication in devel-oping countries. These evolutions heralded a new era of plant ownership. Coming from a period offree exchange of plant germplasm and limited exclusive ownership rights over plants, research becameincreasingly globalized in the form of gene-banks and companies pushed for legal protection of theresults of their research.

The !rst international attribution of intellectual property rights for plant genetic resources wasthe 1961 International Convention for the Protection of New Varieties of Plants (UPOV Convention).The convention provides a framework for intellectual property protection of plant varieties. Theseplant variety rights are often referred to as ‘plant breeders’ rights’ (PBRs). PBRs are property rightsfor intentionally bred new plant varieties. PBRs are a weak form of IPR protection compared to theprotection a patent o#ers, but they are easier to obtain. The UPOV Convention was primarily to theadvantage of industrialized countries where plant breeders were concentrated. Although it was possi-ble to claim the possession of modi!ed plant genetic resources as of then, raw plant genetic resourceswere still seen as common heritage.49

In 1983 the UN Food and Agriculture Organization (FAO) adopted the International Undertakingon Plant Genetic Resources (the Undertaking), a non-binding agreement dealing with the conservationand exchange of plant genetic resources for food and agriculture. This agreement stirred up discus-sion on whether plant germplasm should be considered as a ‘common heritage of mankind’ and thusavailable to anyone without restriction.50 This was part of the so called ‘seed wars’ of the 1980s, aninternational controversy over the access to, control over and preservation of plant genetic resources.This discussion was fought over at various international meetings during the 1970s and 1980s, theprincipal arena for the con$ict being the FAO. Like so many debates within the United Nations, in thecontroversy surrounding plant germplasm developed and developing countries were and are still onopposite sides.

The International Undertaking established the Commission on Genetic Resources for Food andAgriculture. The Commission is the only permanent forum that deals with issues related to plant ge-netic resources. It o#ers a place for government discussions and negotiations concerning biologicaldiversity that are relevant for food and agriculture.51 With regard to the International Undertaking onPlant Genetic Resources, the primary concern was exactly this ‘common heritage’ principle. In prac-tice plant genetic resources were freely collected in developing countries, but when sold back by seedcompanies the seed varieties developed from those resources were IPR protected. The Undertakinglabelled all plant genetic resources ‘common heritage’, including special genetic stocks (elite breedinglines and hybrid parents). This label barred intellectual property protection of natural materials.52

48D. F. ROBINSON, Confronting biopiracy, supra 5, 24.L. R. HELFER, “Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmak-ing”, The Yale Journal of International Law, 2004, Vol. 29(1), 38. (further referred to as ‘L. R. HELFER, “Regime Shifting”’)

49K. RAUSTIALA and D. G. VICTOR, “The Regime Complex for Plant Genetic Resources”, International Organization, 2004,Vol. 58(2), 286.

50D. F. ROBINSON, Confronting biopiracy, supra 5, 25.51Food and Agriculture Organization of the United Nations, Commission on Genetic Resources for Food and Agriculture,

History, http://www.fao.org/nr/cgrfa/cgrfa-about/cgrfa-history/en/.52C. HAMILTON, “Biodiversity, biopiracy and bene!ts”, supra 14, 160.

H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”, EcologyLaw Quarterly, 1985, Vol. 12(4), 1063-1064.J. R. KLOPPENBURG, Seeds and Sovereignty: The Use and control of Plant Genetic Resources, Duke University Press, 1988, 8.

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Freely sharing those broadly de!ned plant genetic resources would radically undermine the prop-erty rights breeding companies possess. Therefore the Undertaking was opposed by the US and di#er-ent European countries. Industrialized states argued that the application of the International Under-taking on cultivated plant varieties con$icted with the UPOV Convention. After some negotiations andlobbying the Undertaking was revised and the Agreed Interpretation of the International Undertakingwas issued in 1989. This interpretation recognised that plant breeders’ rights (as protected under theUPOV Convention) were not incompatible with the International Undertaking. The Commission onPlant Genetic Resources for Food and Agriculture simultaneously adopted Resolution 5/89 on farm-ers’ rights. Traditional farmers make important contributions to the conservation and improvementof plant materials, farmers’ rights are attributed as an acknowledgement for these contributions. Theadoption of the interpretation and the resolution was an attempt of the Commission to achieve abalance between the rights of breeders (formal innovators) and the rights of farmers (informal innova-tors).53

After seven years of negotiation in the Commission, the International Undertaking has been re-viewed and in 2001 replaced by the International Treaty on Plant Genetic Resources for Food andAgriculture, popularly known as the International Seed Treaty. Unlike the International Undertaking,the treaty is a binding legal instrument. The soft law provisions developed in the Commission werenow put into ‘hard law’ rules. The treaty recognizes farmer’s rights and establishes a multilateral sys-tem to facilitate access and equitable bene!t sharing.54

The growing antagonism between developed and developing countries has led to the enactment oftwo treaties that are of crucial importance for this dissertation: the 1992 UN Convention on BiologicalDiversity and the 1994 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPSAgreement). The Convention on Biological Diversity has been referred to as ‘the grand bargain’ be-cause it tries to !nd a balance between facilitated access to genetic resources and bene!t-sharing. TheConvention is especially important because it deals with biodiversity as genetic resources over whichnations have sovereign rights. In doing so, the convention concluded the ‘seed wars’ discussion and asa consequence genetic resources could no longer be seen as common heritage.

The Uruguay Round constituted the !rst multilateral negotiations on intellectual property rightsand concluded in the TRIPS Agreement and the establishment of theWorld Trade Organisation (WTO).The TRIPS Agreement is the most comprehensive international instrument on intellectual propertyrights (IPRs). The Agreement created an obligation for all WTO members to implement a minimumlevel of protection for 7 categories of intellectual property. Of these categories one is crucial for thetopic of biopiracy: the regulation on patents.. It increased the standards of protection for IPRs consid-erably. Although developing countries were reluctant in the negotiations to reform their intellectualproperty legislation, they made important concessions without receiving any concession back fromdeveloped countries.

As technology became more and more important for international competition, industrializedcountries wanted to protect their technological advancement through IPRs. Especially the US supremacyin technology had been eroded by counterfeiting by Japan and some other Asian industrializing coun-tries. Apart from protection for new technology, multinational companies lobbied for the eliminationor reduction of trade barriers in developing countries to get unrestricted access to those markets. Theestablishment of the TRIPS Agreement shows the importance and in$uence of the industry and mainlyof the pharmaceutical, agricultural biotechnology and software industry. Industrialized countries have

53L. R. HELFER, “Regime Shifting”, supra 48, 36-37.Food and Agriculture Organization of the United Nations, Commission on Genetic Resources for Food and Agriculture,History, http://www.fao.org/nr/cgrfa/cgrfa-about/cgrfa-history/en/.

54L. R. HELFER, “Regime Shifting”, supra 48, 39-40.

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defended the TRIPS Agreement as part of a WTO deal of intellectual property rights for developedcountries and free market-access for developing countries.55 However, this globalization of the Euro-American notions of patentability only aggravated the already existing problems concerning IPRs.56

One of the most controversial points of the TRIPS Agreement was and still is the high minimumstandard of patentability included in article 27. This article is crucial for the issue of biopiracy be-cause it protects the biopirates. The general international approach to recognise the possibility topatent a living organism is a consequence of US case law. 57 In the landmark decision of Diamond v.Chakrabarty the US Supreme Court decided:

“[...] the patentee has produced a new bacterium with markedly di!erent characteristics fromany found in nature and one having the potential for signi"cant utility. His discovery is notnature’s handiwork, but his own; accordingly it is patentable subject matter under §101.” 58

Five years later the US Patent Court upheld a patent granted for an entire corn plant, including theseed, in the Ex parte Hibberd case. Due to this jurisprudence companies can legally oblige farmers tobuy new seed every year instead of replanting seed generated by their own plants. Now this viewis adopted by many developed countries, it is generally conceived possible to patent manmade livingorganisms under certain circumstances.59

At this period in history (early 1990s) the discourse of biopiracy emerged. Activists from all overthe world raised their voices against the TRIPS Agreement as it was so heavily in$uenced by industri-alized countries. As Walden Bello puts it, “TRIPS has paved the way for the private ownership of productsdeveloped from the traditional knowledge of communities in the South”.60 Especially in developing coun-tries, NGO’s started to campaign against biopiracy. For example in India farmers started the ‘Neemcampaign’ (infra Chapter 3). In the 1990s the !rst biopiracy cases were tried in court as activists chal-lenged patents of multinational companies.

55L. R. HELFER,“Regime Shifting”, supra 48, 3.56C. M. CORREA, Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options,

Zed Books, 2000, 2-5.57C. HAMILTON, “Biodiversity, biopiracy and bene!ts”, supra 18, 161.58U.S. Supreme Court 1980, 447 U.S. 303, Diamond v. Chakrabarty, 310.59E.K. BENDER, “North and South: The WTO, TRIPS, and the Scourge of Biopiracy”, Tulsa Journal of Comparative and

International Law, 2003-2004, 289 and 297.60W. BELLO, “Building an Iron Cage: The Bretton Woods Institutions, the WTO and the South” in S. ANDERSON (ed.),

Views from the South: The E!ects of Globalization and the WTO on Third World Countries, Food First Books and the Interna-tional Forum on Globalization, 2000, 77.

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Chapter 3

Case Law

This chapter will look at two ’textbook’ biopiracy cases. Both the Neem Tree case and the Enola Beancase have generated a lot of protest and media attention as there was in both cases a clear abuse ofmultinational companies towards local communities or farmers. These cases provide concrete exam-ples of biopiracy and show that in some cases judicial authorities can provide a solution. However,these cases are expensive and lengthy. In both cases discussed, the proceedings took up to ten yearsafter which the patent is anyway almost outdated. Therefore it is still essential to amend the existinglegal structure allowing biopiracy to occur.

I have chosen to take a closer look at these two cases because they both provide a clear exampleof what biopiracy is and what its e#ects are. Complementary, as the Neem Tree case was tried bythe European Patent O"ce and the Enola bean case was judged before the US Patent and TrademarkO"ce, the cases touch upon some important di#erences between European and US Patent Law. TheEuropean Union and the United States together form the biggest block of industrialized countries andthus have had a lot of in$uence on the current legal framework for patents.

3.1 The Neem TreeThe neem tree is native to India and Burma, but has been exported to Africa in the 20th century andnow also $ourishes in several West-African countries. In its native environment the tree is well knownfor its medicinal qualities and has been used widely for a whole range of purposes, from a teeth cleanerto a fungicide.61 In the early 1990s research of pesticides turned to nature for !nding solutions. Dueto its exportation to Africa and subsequently to other regions in the world, the tree captured interna-tional attention. Enthusiasm was great because of the few side e#ects. Neem products are unique inthe sense that they do not kill, but rather repel insects.62

In 1990 W. R. Grace and Co., a multinational chemicals and materials company based in the US,and the United States Department of Agriculture !led a European Patent Application. After a long ex-amination procedure the European Patent O"ce granted the requested patent on a fungicide derivedfrom a neem seed extract in 1994. In 1996 the patent was transferred to Thermo Trilogy, a formera"liate of W. R. Grace. The patent was challenged by a team of three people: Vandana Shiva, direc-tor of the New Delhi based Research Foundation for Science, Technology and Ecology; Linda Bullard,then vice-president of the International Foundation of Organic Agriculture Movements (IFOAM); andMagda Aelvoet, then president of the Green Group in the European Parliament. The patent chal-

61A fungicide is a chemical used to destroy fungus or inhibit the growth of it. Fungus can cause serious damage inagriculture.

62Report of an Ad Hoc Panel of the Board on Science and Technology for International Development National ResearchCouncil, “Neem: A Tree for Solving Global Problems”,Washington National Academy Press, 1992, 3-5.

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lenge was part of the larger Neem Campaign of India, a campaign launched in 1993 by Indian farmerswho feared the patent protection of the increasing foreign control over their recourses and traditionalknowledge.63

The patent was opposed on the grounds of lack of novelty, lack of inventive step, insu"ciency ofdisclosure and for being contrary to morality. In 2000 the European Patent O"ce (EPO) decided torevoke in its entirety the patent on a fungicide based on neem seed. The patent was judged to lacknovelty and an inventive step.64 One of the main arguments on which the EPO based its decision wasthe article ’E#ect of Volatiles of Some Plant Extracts and their Oils on Conidia of Erysiphe PolygoniDC’ published in 1981 by H. B. Singh and U. P. Singh. With this article it is obvious for a skilled personto come to the same result as the patentee, as states the decision. Therefore the patent was not novel,not inventive. In March 2005 the Technical Board of Appeals upheld this decision. In its judgementthe Board of Appeal stated that the invention was novel (contrary to the decision of 2000), but lackedan inventive step.65

The case has been called a landmark victory in the world’s !rst case against biopiracy. However,once again the term ‘biopiracy’ was only uttered outside of the proceedings. The opponents did claimthe invalidity (among others) on the ground of article 53(a) of the European Patent Convention. Para-graph (a) dictates an exception to patentability when an invention is contrary to morality and ordrepublic. In the oral proceedings the opponents explained that the patent would threaten the livelihood ofmillions of gatherers of the neem tree as large quantities of neem seed are exported for the productionof the fungicide, leading to a reduction in the natural resources. When a company starts developing anatural product, supply becomes more restricted. Secondly, upholding this patent would have deprivedthe Indian people of their cultural heritage and natural resources. The denial of the existence of priorart would violate the rights of these people as the community to which the resource and knowledgebelonged would be denied its use. In its decision the EPO did not address these objections, but insteadconsidered it as a question of prior public use. Relying heavily on the testimony of Mr. Abhay D.Phadke and the previously published scienti!c article by Mr. Singh and Singh, the EPO decided therewas in fact prior use and consequently revoked the patent.66

The Neem Tree case was the !rst case of biopiracy in which the European Patent O"ce revoked apatent. It was heralded by many activists as an importance legal precedent. Since then other biopiracycases have been concluded with the revocation of the patent, for example the Maca case and thePelargonium case both concluded in 2010.

The neem patent concerned in this case is only one of many patents granted on inventions derivedfrom the neem tree. The European Patent O"ce and the United States Patent and Trademark O"cehave granted multiple neem patents. Unlike the EPO, the United States Patent and Trademark O"cehas not revoked any of its neem-based patents due to a lack of written proof. Under US Patent law,

63C. HAMILTON, “Biodiversity, biopiracy and bene!ts”, supra 14, 165-166.L. BULLARD, “Freeing the Free Tree: A Brie!ng Paper on the First Legal Defeat of a Biopiracy Patent: The Neem Case”, Inter-national Federation of Organic Agriculture Movements, 2005, 1-3, http://www.ifoam.org/press/press/pdfs/Brie!ng_Neem.pdf.

64European Patent O"ce, Opposition Division 13 February 2001, Application No. 90 250 319.2, Method for control-ling fungi on plants by the aid of a hydrophobic extracted neem oil, Grounds for the Decision, EPO online register.https://register.epo.org/espacenet/application?documentId=EFIVPD4GMNBAK03&number=EP90250319&lng=en&npl=false.

65Article 53, European Patent Convention, 5 October 1973. European Patent O"ce, Technical Board of Appeal 4 May 2005,Application No. 90 250 319.2, Method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil, Decisionof 8 March 2005, EPO online register.

66European Patent O"ce, Opposition Division 13 February 2001, Application No. 90 250 319.2, Method for controllingfungi on plants by the aid of a hydrophobic extracted neem oil, Minutes of the Oral Proceedings and Hearing of Witness Mr.Abhay D. Phadke, EPO online register.

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prior art outside of the US has to be proven by written or published documents.67

3.2 Enola BeanAnother ’textbook’ biopiracy case is the case before the United States Patent and Trademark O"ce(USPTO) concerning the yellow enola bean. In 1999 Larry Proctor was granted Patent no. 5,894,079 fora yellow bean originally from Mexico, which he called the ‘Enola bean’ after his wife. Larry Proctor, aUS citizen, had bought a package of beans in Mexico, planted those beans several years and detecteda new strain of the bean that was yellow the whole year round. In addition to the patent, he wasalso granted a Plant Variety Protection (PVP) certi!cate for the new variety of the bean.68 That gaveProctor and his company, Pod-Ners, the exclusive right to commercialize the Enola bean.

Proctor used the patent and PVP certi!cate to block the import of all similar beans from Mexicothrough the US Customs Service. In order to import similar beans to the US, Mexican farmers andtraders were required to obtain a license from Pod-Ners and pay royalties of six cents per pound ofbeans sold. Knowing that the average price in Los-Angeles was twenty-seven cents per pound, it isclear that Mexican import was heavily disadvantaged on the market. As a consequence the yellowbean production in Mexico fell from 250 000 tons to 96 000 tons in the 2000-2001 season.69

The International Center for Tropical Agriculture (CIAT), a Columbia-based research and devel-opment organization, !led a petition for re-examination of the Enola bean patent with the USPTOin 2000 with support of the FAO. Not only had Mexican farmers been cultivating the Enola bean forcenturies, there was even written evidence that US farmers had grown similar yellow beans since the1930s. Moreover, CIAT had a gene bank containing 260 varieties of yellow beans of which six showedstriking similarities with the Enola bean described in the patent. Therefore its novelty was challenged.However, Proctor claimed that the Enola bean was never cultivated in the US before and that its dis-tinct colour made it novel.70

The USPTO Board of Appeals re-examined the patent and after an appeal of the patent owner !-nally rejected the patent in 2008. Firstly, Proctor’s invention was obvious as every person of ordinaryskill in the art would have done the same as him. Secondly, the board found the evidence to prove therewas prior art (the invention was known before). The Enola bean was found to have an identical genetic!ngerprint compared to the well known Azufrado Peruano bean. Therefore the burden of proof wasshifted and Proctor was required to show the di#erence between the prior art and his product, whathe failed to do. That is why the USPTO rejected the patent for obviousness and lack of novelty.71 Ina last attempt to overturn the ruling rejecting the Enola bean patent, Larry Proctor turned to the USCourt of Appeals for the Federal Circuit. The court a"rmed the decision of the USPTO with a short

67D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 332.

68M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,Journal of Food Law and Policy, 2012, Vol. 8, 86-89.

69E. DONOVAN, “Beans, Beans, the Patented Fruit: the Growing International Con$ict over the Ownership of Life”, Loyolaof Los Angeles International and Comparative Law Review, 2002, 121-122.

70E. DONOVAN, “Beans, Beans, the Patented Fruit: the Growing International Con$ict over the Ownership of Life”, Loyolaof Los Angeles International and Comparative Law Review, 2002, 125-126.G. N. RATTRAY, “Patents & Technology: Recent Article: The Enola Bean Patent Controversy: Biopiracy, Novelty and Fish-and-Chips”, Duke Law & Technology Review, 2002, Vol. 1(1), 5.

71United States Patent and Trademark O"ce, Board of Patent Appeals and Interferences 29 April 2008, Appeal 2007-3938,Ex Parte POD-NERS, L.L.C., 30-31.

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and clear judgement and an appeal to ‘common sense’.72

This case proves the importance of written evidence of prior art to challenge a patent under USlaw. The Board of Patent Appeals based its decision on published articles and written evidence of priorart.

3.3 European Patent O"ce versus US Patent and Trademark O"ceThe European Patent Convention contains an exception for ordre public or morality in article 53(a).Inventions that are contrary to ordre public or morality are excluded from patentability. The EPO isstringent on this requirement and assesses every invention before granting a patent. The US has neverhad a similar exception in its patent law, but in case law a doctrine of morality was developed. TheUSPTO has used morality as a ground for refusing patents on gambling machines and later to assesscontroversial biotechnology inventions. However, few examples of its application are available.73

One of the main requirements for a patent is novelty. In a patent application process patent o"cesalways search for prior art, “the entire body of knowledge which was available to the public before the"ling or, if priority is claimed, before the priority date, of a patent application”.74 The European PatentConvention works with a standard of absolute novelty. An invention cannot form part of the prior artand prior art is de!ned broadly as “[...] everything made available to the public by means of a written ororal description [...]”.75 Similarly, the Japanese Patent Act includes oral testimonies in prior art withoutgeographical limitations.76 Unlike the European Patent Convention and the Japanese Patent Act, theUS Patent Act upholds a lower standard of relative novelty. All written materials documenting priorknowledge or use of the invention will be an obstacle for granting a patent. As for the invention beingknown or used by others without written documentation of it, only the knowledge and use that hastaken place in the US will be taken into account.77

The previously considered cases o#er an illustration. We can clearly see that in the Enola Beancase where the USPTO relied only on published evidence that this speci!c variety of bean was alreadyknown in Mexico. The neem patents are a good example of this di#erent approach adopted by the EPOand the USPTO. A change is desirable. This requirement in US Patent Law is becoming anachronisticin our increasingly globalized world.78

72ETC Group, “Enola Patent Ruled Invalid: Haven’t we Bean here before? (Yes, yes, yes, yes and yes.)”, News Release, 14July 2009.http://www.etcgroup.org/sites/www.etcgroup.org/!les/publication/pdf_!le/etcnr_enola_14july09.pdf.United States Court of Appeals, Federal Circuit, 10 July 2009, 2008-1492, In Re Pod-Ners, L.L.C.

73K. CHOUDHARY, “Ordre Public and Morality Exclusions from Patentability”, Indian Legal Impetus, 2012, Vol. V (IX),22-24. http://singhassociates.in/UploadImg/NewsImages/Vo%20V%20Issue%20IX.pdf.

74Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore,“Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore: An Overview”, 16March 2001, WIPO/GRTKF/IC/1/3, para 78.European Patent O"ce, “What is prior art?”, http://www.epo.org/learning-events/materials/inventors-handbook/novelty/prior-art.html.

75Article 54, European Patent Convention, 5 October 1973.76M. V. GUBAREV, “Misappropriation and patenting of traditional ethnobotanical knowledge and genetic resources”, Jour-

nal of Food Law and Policy, 2012, 83.77US Patent Act, 35 U.S.C. §102.

P. DRAHOS, The Global Governance of Knowledge: Patent O#ces and their Clients, Cambridge University Press, 2010, 146.78D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship

Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 332.

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Chapter 4

Preliminary Conclusion

It is important to realize that biopiracy is not a legal concept. It is a term often used by activists, tendingto build the symbolic image of rich multinationals abusing poor farmers and indigenous communities.It is dangerous to get carried away by this rhetoric and strand in a one-sided discourse oversimplifyingthe complex issue of biopiracy. To avoid this, I have given an overview of di#erent understandings ofthe concept and the main counterarguments.

For a better understanding of the legal framework and a possible remedy, this part has anchoredthe legal issue posed by biopiracy in its problematic reality. Although many still deny it, biopiracydoes exist and it poses a real problem. Biopiracy threatens the livelihood of local communities andconstitutes an imminent danger to biodiversity. The biggest obstacle to realizing a solution will beexactly what caused all the controversy: the contraposition of developed and developing countries.Money must $ow in today’s economy and biological resources happen to be extremely valuable.

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Part II

Analysis of the Existing LegalFramework

This dissertation aims to develop a realistic and workable legal solution for the problem posed bybiopiracy. Before a solution can be developed, one has to know where exactly the problem lies. Thatis why this part will answer the question of which legal regimes a#ect the issue of biopiracy and howthey interact. Most importantly, this section will determine the de!ciencies of the current legal frame-work.

The !rst chapter will handle the legal regime of patentability. The most authoritative instrumenton the international level is without doubt the TRIPS Agreement. Especially its article 27 has stirredup quite some controversy. First of all, it obliges the WTO members to adopt a very broad interpre-tation of patentable subject matter. Secondly, it contains a (limited) obligation to adopt intellectualproperty protection for life forms. Although the TRIPS Agreement is later of date than the Conventionon Biological Diversity, we will !rst look at the intellectual property regime it establishes. These twoagreements are interrelated to a certain extent because the negotiations leading to their adoption oc-curred in the same time. For a good understanding it will be easier to !rst assess the TRIPS Agreementand only then look at the Convention on Biological Diversity.

After looking at the legal framework for intellectual property, the second chapter will take a betterlook at the Convention on Biological Diversity. This convention was established out of concerns forthe diminishing biodiversity. We will look at how the rules of the Convention on Biological Diversitya#ect biopiracy. What are the objectives of the convention? Even more importantly, does the conven-tion succeed in realizing her objectives? The convention has faced quite some criticism for not aiminghigh enough and for its lack of an e#ective enforcement. Where are the weak spots in the convention?

Intellectual property protection and environmental protection are widely seen as promoting pro-foundly con$icting visions. The two key international conventions in these matters, the TRIPS Agree-ment and the UN Convention on Biological Diversity, appear to be incompatible to many scholars.While the TRIPS Agreement stimulates international economic development by strengthening intellec-tual property protection, The Convention on Biological Diversity is designed to preserve biodiversityand traditional agrarian knowledge and promotes sustainable development.79 The third chapter strivesto clarify the entangled discourses of intellectual property and biological diversity and see where theyclash.

The most recent international instrument concerning biopiracy is the Nagoya Protocol. It is a pro-tocol supplementary to the Convention on Biological Diversity. The protocol o#ers a more e#ectivelegal framework for access and bene!t sharing. However, it has not entered into force yet and will notdo so until it has su"cient rati!cations. Since it has no real legal power yet, it is hard to assess thee#ects the protocol will have. Nevertheless, chapter four will take on a critical review of its text andsee if there are any loopholes.

79C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversityand Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 255.

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Chapter 5

Patent Law and Patentable SubjectMatter

In order to fully understand the phenomenon of biopiracy and its origin, this chapter will examine theessence of the problem: the patent. More speci!cally it will look into the patentability of biologicalresources and traditional knowledge. As intellectual property law (among which patent law) is the toolused to abuse of these resources and knowledge it is important to determine what exactly is patentablebefore !nding legal mechanisms of protection.

The purpose of the patent system is to stimulate technological innovation. To reach this goal, aninventor is attributed the exclusive right over his invention for a limited period of time. The patentsystem separates knowledge that can be appropriated and patented from public knowledge that is notviable for patenting. Genetic resources present a challenge in this divide as it is not always clearwhether a biotechnological invention is merely a discovery in nature or a patentable innovation. Thecondition of an inventive step can already be ful!lled by the simple isolation, puri!cation or applica-tion of a biological recourse. The current intellectual property regime permits and even promotes thepatenting of inventions derived from genetic resources.

The customary legal systems of indigenous communities are incompatible with the western in-tellectual property regime. The clash of these two incompatible legal frameworks lies at the heart ofbiopiracy. It is the origin of the problematic inequality in bene!t distribution and ownership of patentsderived from genetic resources or traditional knowledge. Their incompatibility makes it di"cult to!nd a suitable compromise. The intellectual property regime allows ’biopirates’ to monopolize geneticresources without sharing the bene!ts with the local community. To address the injustice of biopiracy,the rights of indigenous communities need to be e#ectively recognized.80

At present, no such thing as a supranational patent o"ce exists that can grant a globally applicablepatent. Neither are there internationally harmonised standards that determine which inventions canbe subject for patent protection. Up to today, there is no international treaty nor an international bodythat has set out a binding standard for patentability. As there is no international law on patentability,this matter is left to the discretion of national states. Many scholars agree that novelty, inventive stepand industrial applicability are common international standards on patentability, but in reality there islittle consensus among the di#erent national approaches. This substantive amount of national discre-tion is why biopiracy is not such an easy issue to resolve. Not only is there a clash between developed

80T. J. KIM, “Expanding the Arsenal Against Biopiracy: Application of the Concession Agreement Framework to PreventMisappropriation of Biodiversity”, SMU Science and Technology Law Review, 2010-2011, Vol. XIV, 80-82.

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and developing countries, regulation is subject to domestic politics and interests.81

5.1 World Intellectual Property OrganizationThe World Intellectual Property Organisation (WIPO) is one of the specialized agencies of the UN. Astheir site states, it is their mission is to “promote innovation and creativity for the economic, social andcultural development of all countries, through a balanced and e!ective international intellectual propertysystem.” 82 The WIPO was created in 1967, but its origins trace back to the late 19th century. Theorganization has 185 members (over 90% of the countries of the world). WIPO administers 25 treatiesand provides dispute settlement services. It provides information and training to its member states,especially to developing countries.83 The WIPO General Assembly has created standing, expert andintergovernmental committees to conduct studies on speci!c intellectual property topics. These com-mittees develop soft law guidelines and recommendations.84 The WIPO presents itself as a merelytechnical agency, but in reality its agenda is highly politicized. Due to its external perception of tech-nical agency, the importance of the organization is often underestimated. 85

The WIPO used to be the principal intergovernmental organization in the intellectual property!eld, but the enactment of the TRIPS Agreement has cost the WIPO quite some of its power. Al-though the WIPO is often overlooked in the shadow of the WTO, the organization should not beunderestimated. Even though the TRIPS Agreement was established at the expense of WIPO’s policydominance, the organization has re-established its role and is again an important actor in the globalgovernance of intellectual property. The WTO focusses on enforcement and dispute settlement. WIPOprovides assistance to developing countries and is a forum for studies and soft law creation. Whereasthe activities of the WTO have been dominated by developed countries, WIPO has not clearly chosenthe side of either industrialized or developing countries. Therefore WIPO is an important forum forintellectual property policy setting in the post-TRIPS environment.86

Under the auspices of the WIPO, the Patent Cooperation Treaty was concluded in 1970. Nowadaysthe treaty has 146 members, including all the highly in$uential industrialized countries. The mostnotable absent countries include Saudi-Arabia, Argentina and Iran. The Patent Cooperation Treaty(PCT) has created an international patent application system with uniform formal requirements. Al-though the application procedure is internationally harmonized under this treaty, this doesn’t result inan international patent. The international patent application merely o#ers a preliminary examinationby one of the international authorities, which issues a non-binding opinion on whether the inventionappears to meet the patentability criteria. Article 33 PCT stipulates that an invention has “to be novel,to involve an inventive step (to be non-obvious) and to be industrially applicable”. However, a de!nitionof these terms is largely left to the discretion of national states. Moreover, paragraph 5 of article 33 andarticle 27 clarify that contracting states are free to apply additional or di#erent criteria for obtaininga national patent.87 After this international procedure, the inventor needs to apply to every nationalpatent authority of the countries where he wishes to pursue a patent.

81M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,Journal of Food Law and Policy, 2012 (8), 73-74.

82World Intellectual Property Organization, “What is WIPO?”, http://www.wipo.int/about-wipo/en/.83L. R. HELFER, “Regime Shifting”, supra 48, 12.84L. R. HELFER, “Regime Shifting”, supra 48, 12.85C. MAY, World Intellectual Property Organization (WIPO): Resurgence and the Development Agenda, Abingdon, Taylor &

Francis, 2006, 3.86D. F. ROBINSON, Confronting Biopiracy, supra 5, 31-32.L. R. HELFER, “Regime Shifting”, supra 48, 25-26.

87Article 27 and 33, Patent Cooperation Treaty, 19 June 1970 (last amended 1 April 2002).

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Why then go through the international procedure? The PCT procedure has great advantages, thebiggest advantage certainly being the internationally recognized !ling date and its consequences forprior art searches. In the patent application, the inventor can designate a number of member states.Once a patent application is !led under the PCT, that !ling date will be regarded as the national !lingdate in every of the designated states. This means that any prior art that becomes known in one of thedesignated countries, can’t be used against the application from the !ling date before the PCT forth.88

In 2000 the harmonization process driven by the WIPO was taken a step further with the adoptionof the Patent Law Treaty. This treaty aims to harmonize the formal aspects of national and regionalpatent procedures to make them more user-friendly. Unlike the Patent Cooperation Treaty, the PatentLaw Treaty only has a small amount of parties with its 32 member states. However, 38 countries (orregional organizations) have signed, but not yet rati!ed the treaty. Among those are the United Statesand the European Patent Organization (EPO).89

Developing states proposed the adoption of a disclosure requirement for patents derived from ge-netic resources in the Patent Law Treaty. That would oblige a patent applicant to prove he has obtainedpermission from the country of origin to access genetic resources. Developed countries argued that theprocedural Patent Law Treaty was no place for such a substantive law matter. The WIPO Secretariatdid create an intergovernmental committee for further discussion. That is how the IntergovernmentalCommittee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)was established in 2000. The committee was instructed to address the intellectual property aspects ofgenetic resources and traditional knowledge.90

In its !rst sessions, the IGC has set out a wide-ranging work program. The committee is workingon model contractual clauses for access and bene!t sharing, the creation of a database for traditionalknowledge, the prior art status of traditional knowledge, legal protection of traditional knowledge,[...]In 2003 theWIPO General Assembly extended the Committee’s mandate and allowed it to develop newinternational instruments.91 However, decisions of the Committee are not binding, they serve only asrecommendations to the WIPO members.92 While the ICG continues to develop soft law, these topicsare also discussed in hard law negotiations over the Substantive Patent Law Treaty.

Logically, the next step in internationally harmonizing patent law is going beyond formalities. In2001 WIPO’s Standing Committee on the Law of Patents discussed a !rst draft of the SubstantivePatent Law Treaty. In 2004 the United States, Japan and the EPO !led a joint proposal to make thede!nition of prior art, grace period, novelty and inventive step a priority discussion point. Duringinformal consultations the subjects su"ciency of disclosure and genetic resources have been put for-ward as priority issues as well. The negotiations on the Substantive Patent Law Treaty were put onhold in 2006 because the Standing Committee deemed it premature to reach an agreement between thedi#erent parties. However, the committee is continuing its e#orts to harmonize patent law.93

88World Intellectual Property Organization, “Patent Cooperation Treaty (PCT) (1970)”,http://www.wipo.int/pct/en/treaty/about.html.Patent Lens, “There is no such Thing as an International Patent”, http://www.patentlens.net/daisy/RiceGenome/g2/3544.html.

89World Intellectual Property Organization, “Patent Law Treaty (2000)”, http://www.wipo.int/treaties/en/ip/plt/summary_plt.htmland http://www.wipo.int/treaties/en/statistics/details.jsp?treaty_id=4.

90L. R. HELFER, “Regime Shifting”, supra 48, 69-70.91L. R. HELFER, “Human Rights and Intellectual Property: Con$ict or Coexistence?”, Minnesota Intellectual Property Re-

view, 2003, Vol. 5(1), 60.92 M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,

Journal of Food Law and Policy, 2012 (8), 75-77.93World Intellectual Property Organization, “Draft Substantive Patent Law Treaty”,

http://www.wipo.int/patent-law/en/harmonization.htm.

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5.2 TRIPS AgreementThe TRIPS Agreement was the !rst comprehensive international instrument dealing with intellectualproperty rights (IPRs). There have been other intellectual property agreements before, but the TRIPSAgreement is the !rst that has teeth. Infringements of the agreement can be brought before the dis-pute settlement body. Non-compliance with the rulings of the WTO panels can be punished with tradesanctions.94 The agreement obliges each member to provide a relatively high minimum standard ofintellectual property protection.

The negotiations leading to the adoption of the agreement have been heavily in$uenced by de-veloped countries that wanted to see their technology protected against counterfeiting activities. Theresult is a strong intellectual property protection that disadvantages the countries of the South whichare rather agriculture-based. India is one of the countries with the loudest voice against the inequali-ties created by the TRIPS Agreement. In 1993 the Neem campaign was launched as protest against theincreasing patent protection (supra Part I, Chapter 3). In many developing countries there have beenprotests against the coming into force of the TRIPS Agreement.95

The goal of the TRIPS Agreement is to reduce barriers to international trade and to promote e#ec-tive and adequate protection of intellectual property rights. Article 7 of the Agreement formulates theobjective in the following terms:

“The protection and enforcement of intellectual property rights should contribute to the pro-motion of technological innovation and to the transfer and dissemination of technology, tothe mutual advantage of producers and users of technological knowledge and in a mannerconducive to social and economic welfare, and to a balance of rights and obligations.” 96

The article vaguely requires a balancing of interests, which in itself can be interpreted both infavour and against biopiracy. 97 The relationship between the TRIPS Agreement and the human rightsto health and food has also been questioned.98

A number of developing countries have expressed their concern on the di"culties faced by de-veloping countries to gain access to foreign technology. Therefore, a !ve-year transition period wasgranted to developing countries to comply with TRIPS obligations (until 2000). Least-developed coun-tries (LDCs) were given time until end 2005, but this period has already been extended to 2013. In aWTO meeting in March 2013 the members accepted the possibility to extend this deadline even fur-ther.99

Now the transition period to adopt the necessary legislation has ended, developing countries feelthe consequences of the TRIPS Agreement. For many developing countries the adjustment (or evencreation) of their laws and institutions in order to comply with TRIPS obligations has been a costly

94L. R. HELFER, “Human Rights and Intellectual Property: Con$ict or Coexistence?”, Minnesota Intellectual Property Re-view, 2003, Vol. 5(1), 54.

95C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversityand Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 257.

96Preamble and article 7, Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 April 1994, MarrakechAgreement Establishing the World Trade Organization, Annex 1C.

97M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,Journal of Food Law and Policy, 2012 (8), 74.

98M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E.EVENSON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 37.

99WTO, “Poorest Countries’ Extended Intellectual Property Transition: Time!Limited or Inde!nite?”,http://www.wto.org/english/news_e/news13_e/trip_05mar13_e.htm.The WTO members are still undecided on whether to set a new deadline or grant each country the time it needs. However,this transition period does not mean that LDCs are entirely exempted from compliance with the TRIPS Agreement. Formore detail, see the link to the WTO website cited above.

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project. The United Nations Development Programme has criticized the agreement for not taking intoaccount the di#erent level of development of developing countries, nor their economic circumstances.Equally contested are the bilateral ‘TRIPS-plus’ agreements. ‘TRIPS-plus’ is a reference to bilateraltreaties concluded between a developed and a developing state which contain rules on intellectualproperty protection that are stricter than the TRIPS obligations. These TRIPS-plus agreements oftenensure an earlier deadline for implementation of the TRIPS obligations then agreed in the WTO agree-ment and include the obligation to implement the 1991 UPOV Convention.100 In general, the criticismagainst the TRIPS Agreement has focussed on its e#ects on public health, human rights, biodiversityand plant genetic resources.101

The article that is most important to the issue of biopiracy is article 27 concerning patentablesubject matter. Article 27 has generated the greatest controversy between developed and developingcountries. This article has proved so controversial because it contains a limited obligation to grantintellectual property protection for life forms.102

“Article 27: Patentable Subject Matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any in-ventions, whether products or processes, in all "elds of technology, provided that theyare new, involve an inventive step and are capable of industrial application. Subject toparagraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article,patents shall be available and patent rights enjoyable without discrimination as to theplace of invention, the "eld of technology and whether products are imported or locallyproduced.

2. Members may exclude from patentability inventions, the prevention within their ter-ritory of the commercial exploitation of which is necessary to protect ordre public ormorality, including to protect human, animal or plant life or health or to avoid seriousprejudice to the environment, provided that such exclusion is not made merely becausethe exploitation is prohibited by their law.

3. Members may also exclude from patentability:(a) diagnostic, therapeutic and surgical methods for the treatment of humans or ani-

mals;(b) plants and animals other than micro-organisms, and essentially biological processes

for the production of plants or animals other than non-biological processes. How-ever, Members shall provide for the protection of plant varieties either by patents orby an e!ective sui generis system or by any combination thereof. The provisions ofthis subparagraph shall be reviewed four years after the date of entry into force ofthe WTO Agreement.” 103

5.2.1 Minimum Standard of PatentabilityThe !rst paragraph of article 27 establishes a minimum standard of patentability. It determines thatpatents shall be available for any invention in all !elds of technology, which is a very broad conceptionof patentability. In paragraph 3 it is explicitly clari!ed that micro-organisms and non-biological andmicrobiological processes for producing plants and animals are not to be excluded from patentability.

100 G. K. ROSENDAL, “The Convention on Biological Diversity: Tensions with the WTO TRIPS Agreement over Access toGenetic Resources and the Sharing of Bene!ts” in S. OBERTH’́UR and T. GEHRING (eds.), Institutional Interaction in GlobalEnvironmental Governance, Cambridge and London, MIT Press, 2006, 91.

101L. R. HELFER, “Regime Shifting”, supra 48, 3-4.United Nations Development Programme, Making Global Trade Work for People, Earthscan, 2003, 220-221 and 226.

102L. R. HELFER, “Regime Shifting”, supra 48, 63.103Article 27, Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C to the Marrakech Agreement

Establishing the World Trade Organization, 15 April 1994 (further referred to as TRIPS Agreement).

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The TRIPS Agreement has managed to set a harmonized minimum standard. However, countries arefree to instate stronger protection and commonly accepted understandings of the terms ‘new’, ‘inven-tive step’, ‘micro-organisms’ or ‘plant variety’ are nowhere to be found. Ultimately, patent protectionis to a substantial extent dependent on national implementation.

Intellectual property courts try to make a distinction between patentable inventions and the dis-covery of non-patentable material in nature. Since the case of Diamond vs. Chakrabarty it has beenestablished in US case law that it is possible to patent “anything under the sun that is made by man”104 (supra Part I, Chapter 2). This means that genetically modi!ed organisms, processes to create andproducts derived from plant genetic resources can be patented, in short: all manmade living organismsexcept for human beings.105 Since the 1980s it is possible to patent genes and gene sequences in the US,the EU, Japan and many other countries.106 Even the possibility to patent human genes already existsfor over 30 years, proving the high standard of patentability upheld in industrialized countries. Thegeneral approach is that gene sequences are inventions when they have been isolated and puri!ed.107

Hence, patenting plant genetic resources has become a piece of cake in the liberal patent regimes ofdeveloped countries.

Countries are free to decide that genes and gene sequences are a mere discovery and thus notpatentable. The TRIPS Agreement doesn’t include an obligation to make genetic materials patentable.For example Mexico has excluded the patentability of genetic materials. There is no commonly ac-cepted de!nition of micro-organisms either in science or in patent practice. However, a restrictiveinterpretation of the term would not help developing countries to shield their genetic resources frompatentability. A company still can collect a plant sample and take it to a country where patenting it ispossible. 108

Why do developing countries abide by these rigorous standards implemented by developed coun-tries? Developed countries can exercise a lot of pressure on developing countries. For example theUS and the EU have a lot of leverage because their consumer markets are the largest in the world.109

Developing countries economically as well as politically can’t a#ord cutting ties.

5.2.2 Exceptions to PatentabilityParagraphs 2 and 3 comprise three exceptions to the general rule on patentability. Only in these threesituations an exclusion of certain inventions from patent law is allowed. Firstly an exception can bemade when necessary to protect ordre public or morality, including to protect human, animal or plantlife or health. The interpretation of the concepts ‘ordre public’ and ‘morality’ can vary signi!cantly,resulting in very di#erent national outcomes.110 The second exception provided in paragraph 3(a) is

104U.S. Supreme Court 1980, 447 U.S. 303, Diamond v. Chakrabarty, 309.105V. TEJERA, “Tripping over Property Rights: Is it Possible to reconcile the Convention on Biological Diversity with article

27 of the TRIPS Agreement?”, New England Law Review, 1999, Vol. 33, 980.106E. J. ROGERS, “Can You Patent Genes? Yes and No”, Journal of the Patent and Trademark O#ce Society, 2011, Vol. 93(1),

19-20.Although patent on human genes have been granted for over 30 years by now, the matter is still surroundedby controversy. See BBC News, “Human Genome: US Supreme Court hears Patents Case”, 15 April 2013,http://www.bbc.co.uk/news/world-us-canada-22157410.

107M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E.EVENSON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 37.

108E.K. BENDER, “North and South: The WTO, TRIPS, and the Scourge of Biopiracy”, Tulsa Journal of Comparative andInternational Law, 2003-2004, 310-311.M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E. EVEN-SON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 39-40.

109L. R. HELFER, “Regime Shifting”, supra 48, 21.110M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,

Journal of Food Law and Policy, 2012 (8), 74-75.

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of no importance to the subject of this dissertation. However, the third exception is highly relevant tobiopiracy.

Article 27.3(b) allows an exemption from patentability for plants and animals and the biologicalprocesses for their production. At !rst glance this seems to give developing countries some leeway.However, paragraph 3 states that micro-organisms, non-biological and microbiological processes andplants can’t be excluded from patentability. Any country excluding plant varieties from patent pro-tection is obliged to provide an e#ective sui generis system of protection. In the end, WTO membersare obliged to create patent protection for micro-organisms, for non-biological and microbiologicalprocesses for the production of plants or animals and patent and/or sui generis protection for plantvarieties.

In order to establish a sui generis system, it is essential to know what a plant variety is. As men-tioned earlier, there is no internationally accepted de!nition of what constitutes a plant variety. Theonly relevant debate attempted to distinguish between a patentable plant and a non-patentable plantvariety. This has resulted in an agreement among European patent o"ces that what is protectable bya plant variety right under the UPOV Convention is not patentable and everything outside the scopeof the UPOV Convention is patentable. In the UPOV there have been many discussions on the conceptof plant variety. In the end it comes down to the national legislator to determine a legal understandingof the term.111

The TRIPS Agreement doesn’t provide a de!nition of an e#ective sui generis system. The $exi-bility of this sui generis option could be used to create a protection system that limits the possibilityof biopiracy.112 However, the WTO pushes to adopt the already existing UPOV Convention whenchoosing for the sui generis option of protection. The UPOV Convention has 2 negative e#ects. Theconvention protects plant varieties by granting rights to plant breeders. This ownership of plants bybreeders puts legal and economic restrictions on farmers. Originally, farmers are the main source ofseed supply in developing countries. Certain new technologies prevent the reuse of seed, thus putting aheavy burden on farmers. Secondly, the UPOV framework favours industrialization of plant breeding.The highly marketed plant varieties tend to replace nature’s less predictable varieties. These increas-ingly uniform plants diminish biodiversity.113 The African Group has proposed to add a footnote toparagraph 3(b) de!ning sui generis as to incorporate farmers’ and indigenous peoples’ rights.114 Be-cause of the controversy surrounding subparagraph 3(b), a review was planned.

Article 27.3(b) contains a clause that demands a review of the provisions contained therein fouryears after its entry into force. This review began at the WTO Conference in Seattle in 1999. Duringthis review, developing countries started their e#orts to harmonize the TRIPS Agreement with otherinternational instruments (for example the Convention on Biological Diversity). In 2001 the WTOmembers adopted the Doha Declaration. Paragraph 19 of that declaration instructs the TRIPS Councilto examine the relationship between the TRIPS Agreement and the CBD and the protection of tradi-tional knowledge and folklore.115

111M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E.EVENSON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 41.

112D. F. ROBINSON, Confronting Biopiracy, supra 5, 29-30.113Genetic Resources Action International (GRAIN), “TRIPS versus Biodiversity: What to do with the 1999 Review of Article

27.3(b)”, 1999, 2, http://www.grain.org/article/entries/11-trips-versus-biodiversity-what-to-do-with-the-1999-review-of-article-27-3-b.114E.K. BENDER, “North and South: The WTO, TRIPS, and the Scourge of Biopiracy”, Tulsa Journal of Comparative and

International Law, 2003-2004, 317.115M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,

Journal of Food Law and Policy, 2012, Vol. 8, 75.L. R. HELFER, “Regime Shifting”, supra 48, 63-65 and 67.

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Although the TRIPS Agreement has resulted in a fairly high standard of intellectual property pro-tection, there are de!nitely some gaps in the regulatory framework it has set up. The TRIPS Agreementdoes not provide intellectual property protection for the traditional knowledge of indigenous commu-nities. Nor does it include a requirement to consider unwritten traditional knowledge as a form ofprior art. Thus it is actually possible to patent traditional knowledge in its original form (see supraPart I, Chapter 3, 3.3). The agreement doesn’t require the disclosure of the origin of genetic resources,neither does it require any sharing of bene!ts. The way intellectual property protection is organizedby the WTO is to the detriment of developing countries. 116

5.3 EU Directive on the Legal Protection of Biotechnological Inven-tions

In 1998 the EU Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (the BiotechPatent Directive) was adopted after 10 years of negotiation. During the negotiation process there wasan intense con$ict between the provisions of the TRIPS Agreement and those of the Convention onBiological Diversity. Several EU member states, environmental and farmer’s groups and the EuropeanParliament tried to include the obligations of the Convention on Biological Diversity in the PatentDirective. However, the !nal text of the Patent Directive is more inspired by TRIPS obligations. TheDirective gave patent protection to plant varieties and pharmaceutical products and didn’t include anymechanism of bene!t-sharing for genetic resources.117

The Biotech Patent Directive was adopted to clarify what is patentable and what is not and toharmonize the EU member states’ regulation on biotechnological patents. Most of the EU memberstates were given until 2000 to transpose the directive into domestic legislation. Article 27 of theTRIPS Agreement was of big in$uence on the !nal text of the directive. Article 3.2 of the directiverecognizes the general patentability of biological material: “biological material which is isolated fromits natural environment or produced by means of a technical process may be the subject of an inventioneven if it previously occurred in nature”.118 The exception to patentability of article 27.2 was alreadyincorporated in the European Patent Convention’s exception for ordre public and morality in article53(a). The controversial article 27.3(b) resulted in article 4 of the directive:

“Article 4

1. The following shall not be patentable:a) Plant and animal varietiesb) Essentially biological processes for the production of plants or animals.

2. Inventions which concern plants or animals shall be patentable if the technical feasibilityof the invention is not con"ned to a particular plant or animal variety.

3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which con-cern a microbiological or other technical process or a product obtained by means of sucha process.” 119

116 L. R. HELFER, “Regime Shifting”, supra 48, 29-30.117G. K. ROSENDAL, “The Convention on Biological Diversity: Tensions with the WTO TRIPS Agreement over Access to

Genetic Resources and the Sharing of Bene!ts” in S. OBERTHÜR and T. GEHRING (eds.), Institutional Interaction in GlobalEnvironmental Governance, Cambridge and London, MIT Press, 2006, 91.

118Article 3.2, Directive 98/44/EC of the European Parliament and Council on the Legal Protection of BiotechnologicalInventions (6 July 1998), OJ. L, 30 July 1998, No 213, 13.

119Article 4, Directive 98/44/EC of the European Parliament and Council on the Legal Protection of Biotechnological Inven-tions (6 July 1998), OJ. L, 30 July 1998, No 213, 13.

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Thus, the EU legislation concerning patentability of biological material is an almost literal copy of ar-ticle 27 TRIPS with its possible exceptions implemented.

Proposals to include a provision on prior informed consent and a disclosure of origin requirementwere not successful. Although these two issues did not make it into the legal provisions of the directive,they were both included in as formal statements in the preliminary considerations of the directive.They were mentioned as following:

“(26) Whereas if an invention is based on biological material of human origin or if it uses suchmaterial, where a patent application is "led, the person from whose body the material is takenmust have had an opportunity of expressing free and informed consent thereto, in accordancewith national law;(27) Whereas if an invention is based on biological material of plant or animal origin or if ituses such material, the patent application should, where appropriate, include information onthe geographical origin of such material, if known; whereas this is without prejudice to theprocessing of patent applications or the validity of rights arising from granted patents;” 120

Of course these recitals are not binding. They are just a re$ection of the discussion regarding the textof the directive. The fact that the considerations of the directive do make reference of prior informedconsent and a disclosure of origin requirement proves that these issues have been seriously consideredand discussed. Questions were raised on whether the directive was compliant with the Convention onBiological Diversity. All the EU member states and the European Union are members of the conven-tion. Nevertheless, the European Court of Justice ruled that the Biotech Patent Directive is compliantwith the obligations under the Convention on Biological Diversity.121

EU members Belgium and Denmark have made amendments to their national patent legislationto incorporate the objectives of the Convention on Biological Diversity and the Bonn Guidelines (seeinfra Part II, Chapter 6). Denmark was the !rst to do so. Danish patent law requires that a patentapplication includes information on the geographical origin of the genetic material. In case of non-compliance the penal code applies. Norway has adopted similar legislation. Switzerland has also madedisclosure of the source of genetic material or traditional knowledge mandatory, punishable with apenalty of CHF 100 000 (approximately 81 000 euro). However, it is doubtful whether this punishmentis severe enough to discourage misappropriation, especially for large companies. Belgium has takena di#erent approach by proposing an amendment to its domestic patent legislation. According to theproposal an invention developed in breach of the Convention on Biological Diversity is contrary toordre public and morality and would be banned from patentability, consequently a patent for this in-vention could be revoked.122

120Recitals 26 and 27, Directive 98/44/EC of the European Parliament and Council on the Legal Protection of Biotechnolog-ical Inventions (6 July 1998), OJ. L, 30 July 1998, No 213, 13.

121J. CURCI, The Protection of Biodiversity and Traditional Knowledge in International Law of Intellectual Property, CambridgeUniversity Press, 2010, 145.

122J. CURCI, The Protection of Biodiversity and Traditional Knowledge in International Law of Intellectual Property, CambridgeUniversity Press, 2010, 143.

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The proposed amendment to Belgian patent legislation inserted the non-binding recitals 26 and 27of the EU Directive as full legal provisions, thus giving the EU Directive a maximalist transpositioninto national law. The draft text proposed to add 6) to the existing article 15 §1 of the Belgian patentlaw.

“Art. 15. - §1. De octrooiaanvraag moet bevatten:

1. een tot de Minister gericht verzoek tot verlening van een octrooi;

2. een beschrijving van de uitvinding;

3. één of meer conclusies;

4. de tekeningen waarnaar de beschrijving of de conclusies verwijzen;

5. een uittreksel;

6. een vermelding van de geogra"sche oorsprong van het biologisch materiaal van plan-taardige of dierlijke oorsprong op basis waarvan de uitvinding ontwikkeld werd, indiendeze bekend is. De Koning kan de toepasselijke voorwaarden en uitvoeringsmaatregelenvastleggen.” 123

This new point 6 requires the disclosure of origin in a patent application of the biological materialof plants or animals of which the invention is developed. The proposal also envisioned to introduce theinformed consent requirement of recital 26 of the EU Directive into the Belgian patent law. However,the Council of State (Belgium’s supreme administrative court) was of the opinion that the adoption ofthis new provision would lead to inconsistencies between the EU member states. Therefore the Coun-cil of State rejected the informed consent provision and only a requirement of origin disclosure wasadopted.124

The !nal amendment did introduce the requirement of origin disclosure in Belgian legislation asproposed, but rejected the harsh sanction for non-compliance of the proposal. Instead of revoking thepatent, a more moderate sanction would be sought in the spirit of the Swiss, Norwegian and Danishapproach.125 However, this provision won’t have much e#ects since the Belgian patent o"ce is not asearch authority and does not check compliance.126 So the Belgian disclosure of origin requirement isnot very e#ectively enforced.

123Wetsontwerp tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de octrooibaarheid vanbiotechnologische uitvindingen, Parl.St. Kamer, 2004-51, nr. 1348/001, 51.

124Wetsontwerp tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de octrooibaarheid vanbiotechnologische uitvindingen, Parl.St. Kamer, 2004-51, nr. 1348/001, 13-14.Wetsontwerp en Wetsvoorstel tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de oc-trooibaarheid van biotechnologische uitvindingen, Verslag namens the Commissie voor het bedrijfsleven, het wetenschaps-beleid, het onderwijs, de nationale wetenschappelijke en culturele instellingen, de middenstand en de landbouw, Parl.St.Kamer, 2005-51, nr. 1348/006, 24.

125Artikel 15 §1(6), Wet van 28 maart 1984 op de uitvindingsoctrooien, BS 9 maart 1985.Wetsontwerp en Wetsvoorstel tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de oc-trooibaarheid van biotechnologische uitvindingen, Verslag, Parl.St. Kamer, 2005-51, nr. 1348/006, 25.

126KAMAU, E. C., “Disclosure Requirement ! A Critical Appraisal” in KAMAU, E. C. and WINTER, G., (eds.), GeneticResources, Traditional Knowledge and the Law: Solutions for Access and Bene"t Sharing, Earthscan, 2009, 408.

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Chapter 6

Convention on Biological Diversity

The growing international awareness of the disappearance of biodiversity resulted in the adoption ofthe Convention on Biological Diversity (CBD) in 1992. Due to economic pressure, developing countrieswere forced to make money out of their biological resources. This led to a depletion of their resourcesand diminishing biodiversity.127 The CBD is the biodiversity regime’s foundational agreement. Itis a compromise to the competing claims of developed and developing countries. On the one hand,biodiversity-rich but biotechnology-poor developing countries wanted !nancial bene!ts and technol-ogy transfers to promote conservation rather than exploitation of the genetic resources within theirterritory. On the other hand, biodiversity-poor but biotechnology-rich industrialized states lobbied tominimize bene!ts and transfers while maximizing access to those resources.128 By recognizing intel-lectual property rights, a compromise was sought between the claims of industrialized and developingcountries.

The parties of the CBD have not been able to reach a compromise on the use of the broader term‘biological’ resources, or to use the narrower term, ‘genetic’ resources. Generally, developing andleast-developed countries have preferred ‘biological’ and developed countries have preferred ‘genetic’resources.129 Therefore both terms are used in an almost interchangeable way in the convention andin the coming pages of this dissertation.

The CBD uses economic incentives to encourage a high valuation of biological resources. Withmarket-based strategies the convention makes the conservation of biodiversity economically moreinteresting. The main goal of the Convention on Biological Diversity is to protect biodiversity indeveloping nations.130 The means used to reach that goal are economic. The CBD is the !rst inter-national agreement that addresses “the endangered partnership between indigenous communities withspecial knowledge of their environment and conservation of the natural resources which these populationsrely on to maintain their traditional lifestyles”.131 Through promoting bene!t-sharing and technologytransfers the Convention tries to make the conservation of biodiversity more economically bene!cialthan its exploitation.

The Convention has three objectives: the conservation of biological diversity, the sustainable useof the components of biological diversity and access to genetic resources and fair and equitable sharing

127B. A. LIANG, “ Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,Journal of Commercial Biotechnology, 2011, Vol. 17(3), 249.

128L. R. HELFER, “Regime Shifting”, supra 48, 28-29.129D. F. ROBINSON, Confronting Biopiracy, supra 5, note 1, 140.130D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship

Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 349.

131M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Tech-nology 2002, Vol. 13, 133.

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of bene!ts arising from their utilisation.132 Articles 6 through 14 includes measures to realize the !rstand second objective of the convention, promoting the conservation and sustainable use of biodiver-sity. Articles 15 through 21 address the third objective, the fair and equitable sharing of bene!ts.133

Article 8(j) is one of the key provisions related to intellectual property in the CBD. It requires stateparties to:

“[. . . ] respect, preserve and maintain knowledge, innovations and practices of indigenous andlocal communities embodying traditional lifestyles relevant for the conservation and sustain-able use of biological diversity and promote their wider application with the approval andinvolvement of the holders of such knowledge, innovations and practices and encourage theequitable sharing of the bene"ts arising from the utilization of such knowledge, innovationsand practices.” 134

The combination of the term ‘traditional’ with the terms ‘knowledge’, ‘innovation’ and ‘practice’ issigni!cant. This article recognizes that traditional knowledge is not static, but that it, to the contrary,can bring innovation. The formulation ‘holders of such knowledge’ implies ownership, or at the leastthe existence of legal entitlements. This article seems to say that indigenous and local communitieshave rights over their knowledge, innovations and practices, even though they are not protected byIPRs under the TRIPS Agreement.135

While everyone agrees that biodiversity needs to be preserved, the ‘fair and equitable sharing ofthe bene!ts’ arising from the use of biological resources is a more controversial objective. Articles 15through 21 of the CBD contain the necessary elements for system of fair and equitable bene!t sharing.Among these articles, article 15 and 16 are the most controversial. Article 15 recognizes the sovereignright of a state over its genetic resources and requires prior informed consent. Article 16 creates anobligation to provide and facilitate transfer of technologies. These two articles together are at the heartof the controversy between developed and developing countries and therefore deserve a closer look.136

In order to protect biodiversity, article 15 of the CBD makes countries the gatekeeper of their ownresources. It speci!es that states have the sovereign rights over and a responsibility to conserve naturalresources located within their boundaries. National governments can determine the conditions to gainaccess to genetic resources. These conditions for access and bene!t-sharing as well as restrictionson the use of genetic resource need to be de!ned in national laws or in Material Transfer Agreements(MTAs).137 In any way, this access shall be on mutually agreed terms and subject to the CBD provisions.Paragraph 5 of article 15 requires that this access to genetic resources shall also be subject to priorinformed consent (PIC) of the state providing such resources, unless otherwise determined by thatstate.138 Thus, the CBD emphasizes in situ preservation (the preservation on the original location)

132Article 1, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.133 C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity

and Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 260.134Art 8(j), UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.135G. DUTFIELD, Intellectual Property Rights, Trade and Biodiversity: Seeds and Plant Varieties, Earthscan, 2000, 35.136G. K. VENBRUX, “When Two Worlds Collide: Ownership of Genetic Resources Under the Convention on Biological

Diversity and the Agreement on Trade-Related Aspects of Intellectual Property Rights”, University of Pittsburgh Journal ofTechnology Law and Policy, 2005, Vol. 6, 10.

137L. R. HELFER, “Regime Shifting”, supra 48, 31.Material Transfer Agreements (MTAs) “sometimes referred to as biodiversity prospecting contracts, are agreements between, onthe one hand, national governments or indigenous peoples that own or control access to biodiversity resources and, on the other,the commercial entity that seeks access to those resources”.L. R. HELFER, “Intellectual Property Rights in Plant Varieties: An Overview with Options for National Governments”, FAOLegal Papers Online, 2002 (31), 10.

138D. F. ROBINSON, Confronting Biopiracy, supra 5, 27-28.

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of both biodiversity and the traditional knowledge systems and cultures associated with developingcountries. 139

“Article 15. Access to Genetic Resources

1. Recognizing the sovereign rights of States over their natural resources, the authority todetermine access to genetic resources rests with the national governments and is subjectto national legislation.

2. Each Contracting Party shall endeavour to create conditions to facilitate access to geneticresources for environmentally sound uses by other Contracting Parties and not to imposerestrictions that run counter to the objectives of this Convention.

3. For the purpose of this Convention, the genetic resources being provided by a ContractingParty, as referred to in this Article and Articles 16 and 19, are only those that are providedby Contracting Parties that are countries of origin of such resources or by the Parties thathave acquired the genetic resources in accordance with this Convention.

4. Access, where granted, shall be on mutually agreed terms and subject to the provisionsof this Article.

5. Access to genetic resources shall be subject to prior informed consent of the ContractiongParty providing such resources, unless otherwise determined by that Party.

6. Each Contracting Party shall endeavour to develop and carry out scienti"c researchbased on genetic resources provided by other Contracting Parties with the full partic-ipation of, and where possible in, such Contracting Parties.

7. Each Contracting Party shall take legislative, administrative or policy measures, as ap-propriate, and in accordance with Articles 16 and 19 and, where necessary, through the"nancial mechanism established by Articles 20 and 21 with the aim of sharing in a fairand equitable way the results of research and development and the bene"ts arising fromthe commercial and other utilization of genetic resources with the Contracting Partyprociding such resources. Such sharing shall be upon mutually agreed terms.” 140

Article 15 determines that genetic resources and traditional knowledge are national resources, butgovernments have not always protected the indigenous and local communities from who that knowl-edge originates. Sometimes communities that are rich in the knowledge of biodiversity have a tenuousrelationship with the government of the state in which they live.141 There are cases known wherethe state closed a deal without considering the indigenous people and their knowledge.142 Becauseof these concerns about the bene!ts of biodiversity reaching the right bene!ciaries, the CBD containssome provisions on how states should treat their indigenous communities. The Convention encouragescooperation, equitable bene!t-sharing and respect for indigenous lifestyles that promote the sustain-able use of biological resources.143 Article 16 is the article most related with the interface betweenintellectual property and biodiversity. It explains what constitutes appropriate access to and transferof technology.144

139D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 349.

140Article 15, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.141C. HAMILTON, “Biodiversity, biopiracy and bene!ts”, supra 14, 162.142B. A. LIANG, “Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,

Journal of Commercial Biotechnology, 2011, Vol. 17(3), 249.143Article 8 and 10, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.144C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity

and Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 261-264.

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“Article 16. Access to and Transfer of Technology

1. Each Contracting Party, recognizing that technology includes biotechnology, and thatboth access to and transfer of technology among Contracting Parties are essential ele-ments for the attainment of the objectives of this Convention, undertakes subject to theprovisions of this Article to provide and/or facilitate accessfor and transfer to other Contracting Parties of technologies that are relevantto the conservation and sustainable use of biological diversity or make use ofgenetic resources and do not cause signi"cant damage to the environment.

2. Access to and transfer of technology referred to in paragraph 1 above to developing coun-tries shall be provided and/or facilitated under fair and most favourable terms, includingon concessional and preferential terms where mutually agreed, and, where necessary, inaccordance with the "nancial mechanism established by Articles 20 and 21. In the caseof technology subject to patents and other intel-lectual property rights, such access and transfer shall be provided on terms whichrecognise and are consistent with the adequate and e!ective protection of intel-lectual property rights. The application of this paragraph shall be consistent with para-graphs 3, 4 and 5 below.

3. Each Contracting Party shall take legislative, administrative or policy measures, as ap-propriate, with the aim that Contracting Parties, in particular those that are developingcountries, which provide genetic resources are provided access toand transfer of technology which makes use of those resources, on mutually agreed terms,including technology protected by patents and other intellectual propertyrights, where necessary, through the provisions of Articles 20 and 21 and in accordancewith international law and consistent with paragraphs 4 and 5 below.

4. Each Contracting Party shall take legislative, administrative or policy measures, as ap-propriate, with the aim that the private sector facilitates access to, joint developmentand transfer of technology referred to in paragraph 1 above for the bene"t of both gov-ernmental institutions and the private sector of developing countries and in this regardshall abide by the obligations included in paragraphs 1, 2 and 3 above.

5. The Contracting Parties, recognizing that patents and other intellectual propertyrights may have an in$uence on the implementation of the Convention, shall cooperatein the regard subject to national legislation and international law in order to ensurethat such rights are supportive of and do not run counter to its objectives.145

To promote equitable bene!t-sharing, paragraph 3 of article 16 requires those who develop a tech-nology based on genetic resources to provide access to and transfer of that technology to the develop-ing country which has provided these resources. Of course biotechnology companies are reluctant tosimply give developing countries access to their technologies. That would help create their competi-tion. The governments of developed countries are equally reluctant to weaken their control over IPRsand institute such legislation that is detrimental to the companies based within their territory.146

Paragraph 5 of the article speci!es that the contracting states must “ensure that such rights [in-tellectual property rights] are supportive of and do not run counter to the Convention’s objectives”.The meeting documents of the negotiations show that this paragraph was a compromise between theperspective of intellectual property rights essential for technology on the one hand, and the primacyof environmental protection over IPRs on the other hand.147 It doesn’t give a clear indication of the

145Article 16, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992, (emphasis added by the author of thisdissertation).

146L. R. HELFER, “Regime Shifting”, supra 48, 32.147Article 15, para 4, Second Revised Draft Convention on Biological Diversity, UNEP/Bio.Div/N4-INC.2/2, 1991.

Report of the Intergovernmental Negotiating Committee for a Convention on Biological Diversity on the Work of its Fourth

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relationship between the provisions of the convention and intellectual property rights. This is an ex-ample of the compromised and often ambiguous language of the Convention on Biological Diversity.The competing claims of developed and developing countries have resulted in various concessions andas a consequence the convention doesn’t meet the expectation of either negotiating block.148

One example of the result article 16 aims at is the agreement between Costa Rica’s Instituto Na-cional de Biodiversidad (INBio) and the US based pharmaceutical company Merck & Company, Ltd.(Merck). INBio is a private, non-pro!t organization closely linked to the Costa Rican government. In1991 INBio agreed to collect and prepare samples from Costa Rican plants, insects and micro-organismsfor Merck in exchange for $ 1 135 000 (approximately 869 000 euro) and royalties on any commercialproduct derived from those samples. INBio decided to give 10% of the initial bene!ts and 50% of theroyalties to the Costa Rican authorities in charge of managing the country’s national parks. This biodi-versity prospecting cooperation is a good example of the constructive approach the CBD envisions.149

Every two years there is a Conference of the Parties (COP), a meeting of all the CBD members, todetermine how the Convention should be applied and implemented. Through the COP the approachto intellectual property has evolved over the years. The harmonization of the intellectual propertyrights in the TRIPS Agreement and the CBD’s objectives has become increasingly important. Withregard to intellectual property, the COP has focused on two issues. Firstly, the COP is trying to protectthe traditional knowledge of indigenous communities. Secondly, they advocate a disclosure of originrequirement for intellectual property rights applications. That means that a patent applicant shoulddisclose information on where the genetic resources or traditional knowledge which form the basisof the application come from. Both of these issues are seen as injustices of the TRIPS Agreement bydeveloping countries and NGOs.150

Negotiating Session, UNEP/Bio.Div/N4-INC.2/5, 1991, 16, para 102.Article 15, para 4, Third Revised Draft Convention on Biological Diversity, UNEP/Bio.Div/N5-INC.3/2, 1991.Report of the Intergovernmental Negotiating Committee for a Convention on Biological Diversity on the Work of its SixthNegotiating Session, UNEP/Bio.Div/N6-INC.4/4, 1992, 15, para 10.C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity andBiotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 264.

148L. GLOWKA, et al., A Guide to the Convention on Biological Diversity, IUCN, Gland and Cambridge, 1994, 84.G. K. VENBRUX, “When TwoWorlds Collide: Ownership of Genetic Resources Under the Convention on Biological Diversityand the Agreement on Trade-Related Aspects of Intellectual Property Rights”, University of Pittsburgh Journal of TechnologyLaw and Policy, 2005, Vol. 6, 13.

149H. SVARSTAD, “Analysing Conservation ? Development Discourses: The Story of a Biopiracy Narrative”, Forum forDevelopment Studies, 2002, Vol. 29(1), 77-79.C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity andBiotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 270-271.

150L. R. HELFER, “Regime Shifting”, supra 48, 28-29.

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6.1 Protecting the Knowledge and Innovations of Indigenous Com-munities

The Convention on Biological Diversity recognizes the importance of traditional knowledge of indige-nous communities. Therefore the contracting parties take up the commitment to respect, preserve andmaintain the knowledge, innovations and practices of indigenous communities in article 8(j). In 1998the COP established the Working Group on Article 8(j) to “implement the commitments of article 8(j)of the Convention and to enhance the role and involvement of indigenous and local communities in theachievement of the objectives of the Convention”.151 One of its tasks is to provide advice on the legalprotection of the knowledge and innovations of indigenous and local communities.152

The ad hoc working group monitors the implementation of article 8(j) by the member nations andhas recommended various measures to protect traditional knowledge. On the topic of access to geneticresources and the equitable sharing of bene!ts arising from their utilization the ad hoc working grouphas contributed to the adoption of the Nagoya Protocol (see infra Part II, Chapter 8). The workinggroup has further recommended the use of sui generis systems, the use of contractual agreements, theestablishment of registers of traditional knowledge and the development of guidelines and codes ofconduct for researchers.153 By promoting and monitoring this wide range of measures, the workinggroup tries to protect traditional knowledge.

6.2 Access and Bene!t SharingOut of the Convention on Biological Diversity a Working Group on Access and Bene!t Sharing wasestablished in 2000. Its mission was to develop guidelines for the implementation of the access andbene!t sharing-provisions of the convention.154 The ad hoc working group was equally asked to de-velop guidelines addressing the relationship between intellectual property rights and the CBD’s accessand bene!t sharing rules. In 2001 de working group presented draft guidelines which were adopted bythe COP in 2002: the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharingof the Bene!ts Arising out of their Utilization (Bonn Guidelines).155

The most important feature of the Bonn Guidelines is that it encourages countries to use disclosurerequirements to monitor whether applicants comply with the CBD provisions. The guidelines stressthe importance of prior informed consent, the prior consent of a state and/or indigenous communityfrom which genetic resources are sought. Through an obligation to disclose certain information ina patent application, countries could control whether prior informed consent was obtained, which isthe country of origin of the genetic resources or traditional knowledge used, whether the condition of

151Convention on Biological Diversity, “Working Group on Article 8(j)”, http://www.cbd.int/convention/wg8j.shtml.152L. R. HELFER, “Regime Shifting”, supra 48, 33.153Executive Secretary of the Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of

the Convention on Biological Diversity, “Legal and Other Appropriate Forms of Protection for the Knowledge, Innovationsand Practices of Indigenous and Local Communities Embodying Traditional Lifestyles Relevant for the Conservation andSustainable Use of Biological Diversity”, UNEP/CBD/WG8J/1/2, 2000.Report of the Ad How Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of the Conventionon Biological Diversity on the Work of Its Second Meeting, Conference of the Parties to the Convention on BiologicalDiversity, Sixth Meeting, UNEP/CBD/COP/6/7, 2002, 21.Executive Secretary of the Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of theConvention on Biological Diversity, “Progress in the Implementation of Article 8(j) and Related Provisions and Its IntegrationInto the Various Areas of Work Under the Convention and Through the National Reports”, UNEP/CBD/WG8J/7/2, 2011, 2.

154Convention on Biological Diversity, “Working Group on Access and Bene!t Sharing”, http://www.cbd.int/abs/wgabs/.155L. R. HELFER, “Regime Shifting”, supra 48, 33-34.

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access to the resources have been respected,...156

In 2004 the working group was given a new mandate to negotiate an international instrument incooperation with the Ad Hoc Working Group on Article 8(j) and related provisions. The goal wasto create an “international regime on access to genetic resources and bene"t-sharing with the aim ofadopting an instrument/instruments to e!ectively implement the provisions in Article 15 and Article 8(j)of the Convention and the three objectives of the Convention”.157 After several years of negotiation, aprotocol on ’Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity’ was adopted in Nagoya, Japan, in 2010 (seeinfra Part II, Chapter 8).

6.3 ImplementationThe Convention on Biological Diversity is a binding international treaty, but it has no enforcementmechanisms other than public opinion. Whereas the TRIPS Agreement has a very e#ective enforce-ment mechanism, the CBD is a convention without teeth. Therefore it relies heavily on its implemen-tation by national governments. Not only relies the convention to a great extent on the willingness ofits member states, its language is compromised and often ambiguous.158 As a result of the many com-promises made between the di#erent wishes of developed and developing countries, the convention isformulated in a way that is open for di#erent interpretations.

The language of the CBD doesn’t assure a strong willingness to !ght for biodiversity. In the Con-vention itself we !nd provisions that leave space for escaping from a strong protection regime. Article20 prioritizes economic and social development as well as eradication of poverty for developing coun-tries. It speci!es that these objectives override the objectives of the convention. This means thatbiological diversity in theory can be put aside if economic or social goals require to do so.159 Neitherdoes the convention take a !rm stand against intellectual property rights threatening biodiversity. Dueto its ambiguous language and lack of enforcement mechanism, the convention has failed to meet theexpectations of both developed and developing countries.

Although the main goal of the Convention on Biological Diversity is to protect biodiversity, theconvention doesn’t contain a substantive obligation to do so. Instead of explicitly adopting an obli-gation to protect, the convention determines that sovereign states have the sovereign right to exploittheir own resources. Neither does the CBD recognise that biodiversity is the natural heritage of hu-mankind. A label of natural heritage of humankind would imply an obligation to protect and preservesuch a heritage. However, the Convention only mentions that biodiversity is a common ‘concern’ ofhumankind.160 This use of soft language is exactly why the convention disappoints.

A big blow for the value of the Convention on Biological Diversity is the absence of the UnitedStates. Already during the negotiations leading to the adoption of the CBD, the US announced thatit would not sign the CBD. Signing the convention would impair the American intellectual property

156Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Bene!ts Aris-ing out of their Utilization, Secretariat of the Convention on Biological Diversity, 2002, para?s 16 and 53,http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf.

157Convention on Biological Diversity, “Working Group on Access and Bene!t Sharing”, http://www.cbd.int/abs/wgabs/.158D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship

Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 349.

159Article 20, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.L. D. GURUSWAMY, “The Convention on Biological Diversity: Exposing the Flawed Foundations”, Environmental Conserva-tion, 1999, Vol. 26(2), 79-80.

160L. D. GURUSWAMY, “The Convention on Biological Diversity: Exposing the Flawed Foundations”, Environmental Con-servation, 1999, Vol. 26(2), 81.

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protection system. In June 1993 the Clinton administration eventually did sign the CBD. It only did sobecause a number of pharmaceutical and biotechnology companies that previously were against theconvention changed their opinion. These companies feared to miss out on lucrative bioprospectingopportunities if they stayed away from the CBD completely. Although the US signed the CBD, it neverrati!ed the convention and is thus not a party.161

Activist groups against biopiracy heavily criticized the CBD. An alliance of di#erent action groups,among which the ETC Group (NGO that coined the term ‘biopiracy’, see supra Part I, Chapter 1), hasbaptized itself into the ‘Coalition Against Biopiracy’. Between 2002 and 2008 this coalition has held anaward ceremony every two years. The ‘Captain Hook Awards’ were given to companies or institutionsthat had commited biopiracy. There were also ‘Cog Awards’ for opposing biopiracy (a ‘cog’ is a shipdesigned to repel pirate attacks). These award ceremonies were each time held simultaneously withthe Conferences of the Parties to the Convention on Biological Diversity.162 This display of symbolismshows how much displeasure the CBD stirred up among activists.

161C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversityand Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 256.

162H. SVARSTAD, “Analysing Conservation & Development Discourses: The Story of a Biopiracy Narrative”, Forum forDevelopment Studies, 2002, Vol. 29(1), 73.Captain Hook Awards and Cog Awards, http://www.captainhookawards.org/.

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Chapter 7

The Interface between the TRIPSAgreement and the Convention onBiological Diversity

The TRIPS Agreement and the Convention on Biological Diversity appear to be incompatible to a cer-tain extent. The TRIPS Agreement promotes intellectual property protection to stimulate internationaltrade. The goal of the CBD is to protect biodiversity and foster sustainable development. How can in-tellectual property protection and environmental protection merge? Can the TRIPS Agreement andthe Convention on Biological Diversity coexist without con$icting? Is there any con$ict at all betweenthe TRIPS Agreement and the CBD? Looking at the reaction of various states on this question thereare mainly three di#erent opinions.

A !rst group of states is of the opinion that the TRIPS Agreement and the Convention on BiologicalDiversity can be implemented in a mutually supportive way and consequently that there is no con$ictat all. A second group of countries reaches the conclusion that there is no inherent con$ict, but thatthe international community has to monitor and if needed intervene to ensure the two agreementsare mutually supportive. The third and most debated view is that the TRIPS Agreement and the CBDare not supportive. This last group thinks that there are a number of con$icting issues on substan-tive provisions. The proposed amendments to the TRIPS Agreement generally require that in a patentapplication information has to be disclosed about the source and country of origin of any biologicalmaterial or traditional knowledge used in the invention. Another demand is the obligation for patentapplicants to obtain prior informed consent from the community or country where they access biolog-ical material and a bene!t-sharing agreement with this community or country.163

Intellectual property protection and environmental protection are widely seen as promoting pro-foundly con$icting visions. On the one hand, the TRIPS Agreement stimulates international economicdevelopment by strengthening intellectual property protection. On the other hand, the Conventionon Biological Diversity is designed to preserve biodiversity and promote sustainable development.164

The goals these agreements pursue are miles apart from each other. Protecting biodiversity may putbarriers to intellectual property protection and thus to the economic development the TRIPS Agree-ment pursues. But then again, patenting could indirectly reduce biological diversity.165 As the seedindustry is dominated by only a handful of multinational companies that have the means to promote

163J. CARR, “Agreements That Divide: TRIPS vs. CBD and Proposals for Mandatory Disclosure of Source and Origin ofGenetic Resources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 139.

164C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversityand Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 255.

165G. K. ROSENDAL, “The Convention on Biological Diversity: Tensions with the WTO TRIPS Agreement over Access toGenetic Resources and the Sharing of Bene!ts” in S. OBERTHÜR and T. GEHRING (eds.), Institutional Interaction in GlobalEnvironmental Governance, Cambridge and London, MIT Press, 2006, 90.

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their products, developing countries don’t have so much incentive to preserve their biological diversity.

Article 27 of the TRIPS Agreement mentions the main criteria of patentability (novelty, inventivestep and industrial application). Any disclosure requirement concerning access to genetic resources,prior informed consent or bene!t-sharing as the CBD promotes, would be an extra requirement ontop of the TRIPS criteria. It is not clear if this would be compatible with the TRIPS Agreement. Somestates argue that disclosure requirements for patent applications would be an obstacle to technologicaladvancement based on genetic materials. That would be contrary to the TRIPS Agreement.166 TheTRIPS agreement doesn’t include any disclosure requirement regarding the country of origin of anybiological materials. It awards full protection to the patentee for his invention and does not consideror provide bene!t-sharing for any origin of the invention. According to activists, the way the TRIPSagreement is construed condones and facilitates biopiracy.167

Traditional knowledge is treated fundamentally di#erent under the CBD and the TRIPS Agreement.Article 8(j) of the CBD explicitly recognizes the importance of traditional knowledge of indigenouscommunities. It is one of the central elements of the CBD. On the contrary, traditional knowledgeis expressly not protected under the TRIPS provisions that only protect ‘new’ inventions. There isa gap between the attitudes of both instruments. Intellectual property protection gives incentive toand rewards individual authorship and technological research. Such a culture inevitably clashes withmore traditional lifestyles protected by the CBD. Some cultures consider it immoral to privatize livingorganisms and commonly useful human knowledge.168

7.1 Current Status of Plant Genetic ResourcesThroughout history the international rules governing plant genetic resources have evolved and splitthose resources into three di#erent categories subject to di#erent rules (see Part I, Chapter 2). The!rst category of raw plan genetic resource is nowadays under the sovereignty of the state in whichterritory they are located. The second category is made up of plant genetic resources ‘worked’ by man.These are eligible for intellectual property protection. Plant materials in international seed banks, thethird category, are seen as common heritage and thus available to anyone.169

7.2 Adapting the TRIPS AgreementThe 1999 review of article 27.3(b) of the TRIPS Agreement was the !rst step on a long road of debate.The initial debate focused on the morality of patenting life forms. Over years of discussion, the focushas shifted to patentability requirements. Developing countries want to instate disclosure of originas evidence of prior informed consent and bene!t sharing as a patent requirement. Proposals of de-veloping countries to amend the TRIPS Agreement have mainly requested to (1) harmonize IPRs withthe rules of the CBD, (2) deny patent protection to inventions inconsistent with the CBD, (3) protecttraditional knowledge and (4) ensure the TRIPS-compatibility of national farmers’ rights.170 Where

166G. K. ROSENDAL, “The Convention on Biological Diversity: Tensions with the WTO TRIPS Agreement over Access toGenetic Resources and the Sharing of Bene!ts” in S. OBERTHÜR and T. GEHRING (eds.), Institutional Interaction in GlobalEnvironmental Governance, Cambridge and London, MIT Press, 2006, 92.

167Genetic Resources Action International (GRAIN), “TRIPS versus Biodiversity: What to do with the 1999 Review of Article27.3(b)”, 1999, 2,http://www.grain.org/article/entries/11-trips-versus-biodiversity-what-to-do-with-the-1999-review-of-article-27-3-b.

168D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 351.

169L. R. HELFER, “Regime Shifting”, supra 48, 35.170L. R. HELFER, “Regime Shifting”, supra 48, 64.

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WTO Conferences were originally occupied with moral issues, they currently address technical topics.

In recent years, the WTO has adopted a couple of non-binding declarations that emphasize theneed to compromise the TRIPS Agreement with other international treaties. These interpretive state-ments were answering the criticism against the TRIPS Agreement.171 Various UN human rights bodieshave stated that the intellectual property rules of the TRIPS Agreement are a threat to economic, socialand cultural rights. Di#erent NGOs, developing countries and the World Health Organization (WHO)expressed their concern over intellectual property rights on pharmaceuticals. The organization madea distinction between essential drugs and other drugs that are commodities. The WHO has questionedwhether intellectual property incentives are adequate to ensure investment in medication needed bythe poor.172

In November 2001 the Fourth WTO Ministerial Conference was held in Doha to launch the DohaRound, a round of WTO negotiations to reform the international trading system. An important objec-tive of the Doha Round was to improve the trading conditions for developing countries. At the DohaConference, on the agenda was the e#ect of the international intellectual property policy on developedand developing countries. That would have been a good opportunity to discuss the issue of biopiracy,but the debate over third world access to patented medicines overshadowed the discussion.173 Theconference resulted in the adoption of the Declaration on the TRIPS Agreement and Public Health(Public Health Declaration) and the Doha Ministerial Declaration.174

The Public Health Declaration adopted at the Doha Conference is an answer to the protests ofdeveloping nations, human rights NGO’s and o"cials of intergovernmental organizations concerningthe issue of access to patented medicines. Some developing states were combatting a HIV/AIDS crisis,but the much needed patented pharmaceuticals were too expensive. The Public Health Declarationrea"rms the principle of balanced IPRs. With regard to e#ective measures, the declaration extends thetransition period for least-developed countries until 1 January 2016 to implement TRIPS obligationsconcerning patents and undisclosed information relating to pharmaceutical products.175

The second result of the Doha Conference was the Doha Ministerial Declaration. Paragraph 19 ofthe declaration instructed the TRIPS Council to “examine, inter alia, the relationship between the TRIPSAgreement and the Convention on Biological Diversity, the protection of traditional knowledge and folkloreand other relevant new developments raised by members [...] and shall take fully into account the develop-ment dimension”.176 This approach shows the growing concern over the negative e#ects of the TRIPSAgreement for developing countries. However, up until today the US has blocked the request of theCBD’s Executive Secretary to obtain observer status in the Council. The (already renewed) application

171L. R. HELFER, “Regime Shifting”, supra 48, 46.172L. R. HELFER, “Regime Shifting”, supra 48, 44.173WTO, “The Doha Round”, http://www.wto.org/english/tratop_e/dda_e/dda_e.htm.

M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Technology,2002, Vol. 13, 134.

174L. R. HELFER, “Human Rights and Intellectual Property: Con$ict or Coexistence?”, Minnesota Intellectual PropertyReview, 2003, Vol. 5(1), 60-61.

175The search for an answer to the growing global HIV/AIDS crisis continued in further negotiations, which led to theadoption of an interpretive statement. The decision “allows developing countries that lack su#cient domestic manufacturingcapacity to meet their public health needs by importing generic drugs from other WTO members without restriction as to type ofdisease or type of emergency”.L. R. HELFER, “Regime Shifting”, supra 48, 5 and 67.Declaration on the TRIPS Agreement and Public Health, World Trade Organization, 14 November 2001, para 7.

176WTO, Doha Ministerial Declaration, WT/MIN(01)/DEC/1, 14 November 2001, para 19.Convention on Biological Diversity, “Cooperation with WTO”, http://www.cbd.int/incentives/coop-wto.shtml.

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submitted by the Secretariat is still pending.177

Invoking the Bonn Guidelines and paragraph 19 of the Doha Declaration, a group of developingcountries proposed the creation of additional patent disclosure rules. In order to obtain a patent relatedto plant materials or traditional knowledge, the applicant would have to provide certain information.These proposed rules are stricter in comparison with the current regulation as disclosure of originis not mandatory yet, it is left to the discretion of national governments. Initially, developed coun-tries opposed the proposal, but the EU and Switzerland countered the proposition with a compromise.However, developing countries rejected this compromise and continued to advocate a strong protec-tion of genetic resources and traditional knowledge. Whether these talks will result in a breakthroughis doubtful now trade negotiations have collapsed at the WTO Cancún Conference.178

At the 2003 WTO Conference in Cancún, developing countries sought to limit patent protectionfor biotechnology, while industrialized countries lobbied for the WTO to adopt the UPOV Convention.The UPOV Convention o#ers plant variety protection, but hardly considers third world farmers.179 Onthe contrary, plant variety protection comes with a potential danger of concentrating technology own-ership and restricting the free exchange of seed between farmers.180 In Cancún developing countrieswere far better organized than at previous WTO conferences. A new negotiating block saw the light.The G-20 was formed by developing states to strengthen their position in WTO negotiations.181 Thebreakdown of talks in Cancún shows that developed and developing countries are still on oppositepositions. Finding a compromise will be hard.182

177Convention on Biological Diversity, “Cooperation with WTO”, http://www.cbd.int/incentives/coop-wto.shtml.L. R. HELFER, “Human Rights and Intellectual Property: Con$ict or Coexistence?”, Minnesota Intellectual Property Review,2003, Vol. 5(1), 60-61.

178L. R. HELFER, “Regime Shifting”, supra 48, 67-68.179M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Tech-

nology, 2002, Vol. 13, 134.180R. TRIPP, N. LOUWAARS and D. EATON, “Plant Variety Protection in Developing Countries. A Report from the Field”,

Food Policy, 2007, Vol. 32, 355.181The G-20 quickly included more than 20 countries, but its name refers to its date of creation. Originally the members of

the G-20 were: Argentina, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, El Salvador, Guatemala,India, Mexico, Pakistan, Paraguay, Peru, Philippines, South Africa, Thailand and Venezuela. Since the creation of the group,it has had quite some changes of members.L. R. HELFER, “Regime Shifting”, supra 48, 68.N. BULLARD, “G20: Their Power is Not Ours”, Focus on Trade, 2004 (98), 7-10.P. M. VEIGA, “Brazil and the G-20 Group of Developing Countries”, WTO,http://www.wto.org/english/res_e/booksp_e/casestudies_e/case7_e.htm.

182L. R. HELFER, “Human Rights and Intellectual Property: Con$ict or Coexistence?”, Minnesota Intellectual Property Re-view, 2003, Vol. 5(1), 60-61.

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Chapter 8

Nagoya Protocol

In 2010 the United Nations adopted the Nagoya Protocol on Access to Genetic Resources and the Fairand Equitable Sharing of Bene!ts Arising from their Utilization. The Protocol was supplementary tothe Convention on Biological Diversity and intended to correct the $aws of the CBD. In 2004 theWork-ing Group on Access and Bene!t Sharing and theWorking Group on Article 8(j) and Related Provisionswere instructed to create an international regime for access and bene!t-sharing (ABS). After severalyears of negotiation the Nagoya Protocol was adopted. To become e#ective it needs to be rati!ed by50 countries. The protocol will enter into force 90 days after the deposit of the !ftieth instrument ofrati!cation. In May 2013 the protocol had 92 signatories and was rati!ed by 16 countries.183

The CBD Secretariat expects the Nagoya Protocol will enter into force by 2015. India and SouthAfrica have already rati!ed the treaty and Brazil has signed and showed its satisfaction with the pro-tocol. The United States has not made any move towards signing yet and probably will not do so,regarding its absence from the CBD. The European Union and most of its member states have signed,but not yet rati!ed the protocol. France has already made a lot of requests for changes. Some NGOshave expressed discontent about the protocol. In short, there are mixed reactions towards the proto-col.184

In Nagoya three instruments were adopted. The 173 present states did not only create the NagoyaProtocol, but also a strategic action plan with 20 objectives to 2020 and a !nancial mechanism forthe implementation of the convention.185 This strategic plan is supposed to help realize the !rst twoobjectives of the CBD: conservation and sustainable use of biodiversity. However, the action plan isnon-binding and not precise.

Despite the CBD and the Bonn Guidelines, there are almost no e"ciently functioning regimes foraccess and bene!t sharing (ABS). Only a few countries have created an ABS system in their nationallegislation. Most of those are states providing genetic resources and not the ones using the resources.186

The most relevant framework already in place for ABS is o#ered by the Bonn Guidelines. However,those guidelines are non-binding and thus only have e#ect if a country converts its provisions in na-

183The countries that have already rati!ed the treaty are: Albania, Botswana, Ethiopia, Fiji, Gabon, India, Jordan, LaoPeople’s Democratic Republic, Mauritius, Mexico, Micronesia, Panama, Rwanda, Seychelles, South Africa and the SyrianArab Republic.Nagoya Protocol, “Status of Signature and Rati!cation, Acceptance, Approval or Accession”,http://www.cbd.int/abs/nagoya-protocol/signatories/default.shtml.

184C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 61.

185C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 52 and 62.

186E. C. KAMAU, B. FEDDER and G. WINTER, “The Nagoya Protocol on Access to Genetic Resources and Bene!t Shar-ing: What is New and What are the Implications for Provider and User Countries and the Scienti!c Community?”, Law,Environment and Development Journal, 2010, Vol. 6(3), 248.

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tional laws. A protocol, on the contrary, is a stronger, binding commitment for nations. All the actorsinvolved had a strong desire to reach a solution on the ABS issue and one that would lead to the ac-tual establishment of ABS. Indigenous communities and developing nations wanted a solution for theabuse of biopiracy. Companies, researchers and developed nations could use a clear legal frameworkto protect themselves from the claims of biopiracy.187 For all the stakeholders, the adoption of thebinding Nagoya Protocol on ABS was a victory.

The con$ict over some issues made the !nal adoption of the protocol uncertain until the last mo-ment. The countries didn’t easily !nd an agreement on the scope of the protocol, compliance mea-sures and the balance of rights and obligations of provider- and user-countries.188 The majority ofthe present states could not reach an agreement. Therefore, Japan brought together a small group ofin$uential nations (the EU, Brazil, Norway and the African Group) in a secret meeting which couldcreate a consensus-based text.189 A result had to be reached. After years of troubled negotiations andcontinuing erosion of biodiversity, no one wanted this e#ort to fail. Moreover, the countries that wereboth users and suppliers of biological material also had interests in other international negotiations(for example in the WTO and WIPO). Those countries didn’t want the CBD to interfere with theseother talks, so they had an interest to clarify some of the CBD issues through the Nagoya Protocol.190

A lot of e#ort was done to !nally reach a result, failure was not an option.

8.1 The TextThe preamble of the protocol refers to articles 15 and 8(j) of the CBD and states the third objectiveof the CBD to be its goal: the fair and equitable sharing of bene!ts. It a"rms the link between thisobjective and the other two CBD objectives, the conservation and sustainable use of biodiversity. Thepreamble further refers to some of the di"culties in the implementation of the CBD. Article 6 of theprotocol repeats that access to genetic resources shall be on mutually agreed terms and subject to theprior informed consent of the providing party. The protocol is very elaborate on the procedure of ac-cess and does a lot of e#ort to facilitate this access procedure.191 The compliance with these rules shallbe monitored by national checkpoints that every member state has to create and the ABS ClearingHouse Mechanism. This Clearing House Mechanism will monitor and share information related to ac-cess and bene!t-sharing.192 The Nagoya Protocol o#ers an elaborate set of rules on access procedure,mutually agreed terms and prior informed consent.

In articles 6 and 7, a distinction is made between access to genetic resources dealt with by theformer article and access to traditional knowledge associated with genetic resources dealt with in thelatter. Article 7 requires states to ensure that traditional knowledge associated with genetic resourcesheld by indigenous and local communities has been accessed with the prior informed consent of these

187C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 54 and 56.

188K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Bene!t-Sharing for Indigenousand Local Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 525.

189International Institute for Sustainable Development, “Summary of the Tenth Conference of the Parties to the Conventionon Biological Diversity: 18-29 October 2010”, Earth Negotiations Bulletin, 2010, Vol. 9(544), 26.

190C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 57.

191K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Bene!t-Sharing for Indigenousand Local Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 524-526.

192E. C. KAMAU, B. FEDDER and G. WINTER, “The Nagoya Protocol on Access to Genetic Resources and Bene!t Shar-ing: What is New and What are the Implications for Provider and User Countries and the Scienti!c Community?”, Law,Environment and Development Journal, 2010, Vol. 6(3), 252.

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communities.193 The application !eld of the protocol doesn’t include human genetic resources andgenetic resources that are not subject to the sovereign rights of states (for example in internationalwaters). Genetic resources dealt with by other ABS instruments such as the FAO instruments are alsonot included in the scope of the Nagoya Protocol. Raw genetic resources (meaning not adapted or usedfor research) used for food or farming are not either subject to the protocol.194 A lot of institutions andinternational instruments deal with genetic resources. The negotiations towards the Nagoya Protocolhave brought a degree of order to this overlap by trying to de!ne the !eld of application of the protocol.

Bene!t-sharing is required for every utilization of genetic resources. Then de!ning what a utiliza-tion is, is crucial to know when bene!t-sharing is due. Article 2 de!nes it as following:

“Utilization of genetic resources means to conduct research and development on the geneticand/or biochemical composition of genetic resources, including through the application ofbiotechnology as de"ned in Article 2 of the Convention” 195

During the negotiations a list of kinds of research and development was made. This list was notincluded in the protocol, but can still be used as an indication. It is important that R&D on the bio-chemical composition of genetic resources is explicitly mentioned. Drugs based on the extraction ofchemicals from biological resources clearly fall within the scope of the protocol. The lack of clarity hasalways been a big problem in the instruments adopted concerning genetic resources and this de!nitionbrings a bit more clarity.196

The compliance measures set out by the Nagoya Protocol are rather complicated. Articles 15 and16 of the protocol instruct each member state to take measures to ensure that genetic resources andtraditional knowledge used within its jurisdiction have been accessed with prior informed consent andon mutually agreed terms. The divide between genetic resources and traditional knowledge is upheldin these provisions. Article 15 deals with compliance with legislation for genetic resources and article16 with compliance for traditional knowledge. This obligation is meant for user states: the state inwhich the resources or knowledge is utilized is made responsible for controlling whether their nation-als have respected the domestic law and the law of the state providing the resources. A system of dualcontrol is created. Not only the provider state, but also the user state watches over compliance withthe treaty. In practical terms, this is quite complicated. States will have to cooperate to establish adouble control system.197

Article 17 obliges parties to enhance transparency and monitor the utilization of genetic resources.Where articles 15 and 16 leave it primarily to the discretion of national authorities to decide whichmeasures should be taken to realize compliance, article 17 provides clear guidelines for establishinga monitoring mechanism. Monitoring would happen through checkpoints which submit informationto the ABS Clearing-House Mechanism. One important formulation of article 17 needs mentioning.The protocol draws a clear distinction between genetic resources and traditional knowledge, as seenin the previous articles. It is peculiar that article 17 only mentions “monitoring the utilization of ge-netic resources”. Any similar monitoring mechanism explicitly designed for traditional knowledge is

193Articles 6 and 7, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arisingfrom their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.

194C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 59.

195Article 2(c), Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.

196E. C. KAMAU, B. FEDDER and G. WINTER, “The Nagoya Protocol on Access to Genetic Resources and Bene!t Shar-ing: What is New and What are the Implications for Provider and User Countries and the Scienti!c Community?”, Law,Environment and Development Journal, 2010, Vol. 6(3), 251-252.

197Articles 15 and 16, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!tsArising from their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 57-58.

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not spoken of. Considering the clear distinction of the protocol in many other articles, this lack ofmentioning traditional knowledge could have far-reaching consequences.198

Article 18 aims at achieving compliance with mutually agreed terms by ensuring contract en-forcement. Each member state must encourage providers and users of genetic resources to includeprovisions regarding dispute resolution in their mutually agreed terms. This article makes clear thatbene!t-sharing is a contractual issue and its enforcement is thus an issue of contract enforcement.Consequently, the Nagoya protocol entails no obligation for user states to ensure bene!t-sharing.They only have to make sure that bene!t-sharing can be enforced through the justice system. Theenforcement of bene!t-sharing is a contractual issue and this come with di"culties of forum, liti-gation costs,. . .Many provider states were disappointed that the protocol didn’t provide a strongerenforcement of bene!t-sharing. Paragraph 4 explicitly foresees a review of the e#ectiveness of article18.199

Already during the negotiations on the Nagoya Protocol, states realized the challenges of the newcompliance system enshrined in the protocol. Therefore they considered a pioneering option in inter-national environmental law: the establishment of an international ombudsperson to “support develop-ing countries and indigenous and local communities to identify breaches of rights and to provide technicaland legal support in ensuring e!ective redress of such breaches”.200 This would have resulted in a crosslevel compliance mechanism operating on the local and national level while connecting to the interna-tional level. Eventually this was not included in the protocol, but of course the member countries canstill establish an ombudsman in the future through the Conference of the Parties.201

8.2 Assessment of the ProtocolCompromise, the word used to describe all the aforementioned international e#orts for preservingbiodiversity in this dissertation, applies again for the Nagoya Protocol. On the one hand the protocolbroadens the !eld of application of the Convention on Biological Diversity. On the other hand thedisputed issues of retroactivity and derivatives have been sidestepped. States managed to agree onbalancing the responsibilities in exchange of avoiding controversial concepts.

Article 3 regarding the scope of the protocol was one of the most disputed articles during the ne-gotiations. The article determines that the protocol shall apply to genetic resources and traditionalknowledge within the scope of Article 15 of the Convention and to the bene!ts arising from the uti-lization of such resources and knowledge. The African Group wanted the protocol to apply to geneticresources accessed prior to the adoption of the Nagoya Protocol and prior to the adoption of theConvention on Biological Diversity. That would mean that the protocol applies to already existing col-lections of genetic resources and that bene!t-sharing is required for new and continuing uses of thesealready accessed materials. However, industrialized countries opposed this proposal. They argued that

198Article 17, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.E. C. KAMAU, B. FEDDER and G. WINTER, “The Nagoya Protocol on Access to Genetic Resources and Bene!t Sharing: Whatis New and What are the Implications for Provider and User Countries and the Scienti!c Community?”, Law, Environmentand Development Journal, 2010, Vol. 6(3), 253.

199Article 18, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Bene!t-Sharing for Indigenous andLocal Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 531.

200Article 14bis, Draft Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts arising fromtheir Utilization to the Convention on Biological Diversity, Annex I, UNEP/CBD/COP/10/5/Add. 5, 2010.

201E. MORGERA, “Bilateralism at the Service of Community Interests? Non-Judicial Enforcement of Global Public Goodsin the Context of Global Environmental Law”, European Journal of International Law, 2012, Vol. 23, 761.

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it would go against legal clarity and legal certainty. Eventually, the Nagoya Protocol doesn’t includeany reference to its temporal scope or to retroactivity.202

Another controversial question during the negotiations was whether the protocol would coverderivatives of genetic resources. A derivative is a biochemical compound derived from a genetic re-source, in other words, a small natural element extracted from genetic material. Often it is a derivativeof plant material that constitutes a useful, commercially viable, product for a company either in itspure form or developed. Obviously industrialized countries wanted to limit the protocol’s application!eld as much as possible. Thus, they opposed the mentioning of derivatives. Article 2 of the protocolo#ers a rather broad de!nition of the term, but the term ‘derivatives’ does not appear anywhere elsein the protocol.203 The parties have kept the de!nition in the protocol, but in reality the reference toderivatives has little e#ect. Developed countries are satis!ed that the scope of the Nagoya protocol inreality doesn’t include derivatives.204

A reform of patent legislation hasn’t been addressed in the negotiations leading to the adoption ofthe Nagoya Protocol. Many developing countries want to include mandatory disclosure requirementsin patent applications for a biotechnological invention. Then the applicant would have to provideproof that the biological material at the origin of the innovation has been required with prior in-formed consent and sharing of the bene!ts. The certi!cate referred to in article 17 of the protocolis not a certi!cate of origin to comply with a disclosure requirement. It is only a certi!cate contain-ing information. It is not mandatory and will only be used for informational purposes in the ABSClearing-House Mechanism. Negotiations on a reform of patent legislation can probably only be heldin the WIPO forum discussing the Substantive Patent Law Treaty (see supra Part II, Chapter 5).205

The protocol doesn’t provide much improvement for the rights of indigenous and local communi-ties to their resources and knowledge. The protocol does recognize that these communities have rightsboth to the traditional knowledge they hold and the genetic resources located in their territory.206

The Nagoya protocol also enacts the principle of dual prior informed consent. That mean that boththe national authorities and (when necessary) the local community need the give their prior informedconsent before access to genetic resources or traditional knowledge can be granted. However, theprotocol recognizes that indigenous communities have rights, but doesn’t de!ne these rights. Whatthis protocol will really mean to local and indigenous communities depends on the implementation bystates.

The Nagoya Protocol is again weak on some crucial points. The Protocol avoids speci!cs on drugaccess and equitable compensation for indigenous peoples. Neither does it deal with biodiversitymanagement planning nor with the implementation. The Nagoya Protocol still heavily relies on im-

202Article 3, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 59.K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Bene!t-Sharing for Indigenous andLocal Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 527-528.

203“Derivative means a naturally occurring biochemical compound resulting from the genetic expression or metabolism ofbiological or genetic resources, even if it does not contain functional units of heredity.”Article 2(e), Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.

204International Institute for Sustainable Development, “Summary of the Tenth Conference of the Parties to the Conventionon Biological Diversity: 18-29 October 2010”, Earth Negotiations Bulletin, 2010, Vol. 9(544), 4 and 26.

205C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 58.

206Articles 6 and 7, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arisingfrom their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.

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plementation by the state itself, but that can be a problem in poor countries.207 Article 25 simplyrefers to article 20 of the Convention on Biological Resources with regard to !nancial resources forthe implementation of the protocol. That article determines that “the developed country Parties shallprovide new and additional "nancial resources to enable developing country Parties to meet the agreedfull incremental costs to them of implementing measures which ful"l the obligations of this Convention[. . . ]”. In a further paragraph the drafting states have recognized that the extent to which developingparties will e#ectively implement their commitments under the convention will depend on the e#ec-tive implementation by developed countries of their commitment to !nancial resources and transfer oftechnology.208 Thus, the Nagoya Protocol doesn’t bring more !nancial support for developing coun-tries.

The Nagoya Protocol is a compromise text. User states were made responsible for their nationalsand a monitoring mechanism was created. In exchange the notions of derivatives and temporal scopewere not mentioned. Many deemed the !nal draft of the Nagoya protocol a masterpiece in creativeambiguity. The compromise text didn’t manage to resolve all the outstanding issues. Instead, the dis-puted issues were either removed from the text or replaced by a more general formulation open forinterpretation.209 However, this $exibility in interpretation might prove to be too $exible for an e#ec-tive implementation of the protocol.

At the Conference of the Parties in Nagoya the present states had to recognize that they had failedto meet the 2010 biodiversity target.210 However, it was not this failure, the continuing erosion ofbiodiversity despite 18 years of international negotiations, that the 10th Conference of the Parties isremembered for, but the success of the Nagoya Protocol. The protocol was received as a victory forbiodiversity, although it is not sure if it will result in a substantial improvement. The protocol clari!essome of the issues that were left unclear by the CBD, but will probably only provide minor changes inreality. It was more important to the negotiating parties not to fail, than to really succeed. The negoti-ations have ended with a concrete result and the framework for negotiations has been preserved. Thatis the real victory of the 10th COP, not the changes the Nagoya Protocol envisions.211

The success or failure of the Nagoya Protocol depends on the adoption of strong national legisla-tion by the member states. The protocol is created to provide more legal certainty and transparencyfor the providers and users of genetic resources. On the one hand it tries to make conditions for accessmore predictable and on the other hand the protocol ensures bene!t-sharing even when the geneticmaterials are taken outside of the provider state. At least in theory, this protocol is a great e#ort toprevent biopiracy. Contractual ABS agreements could deliver the economic resources needed for theconservation of biodiversity and a compensation for traditional knowledge. An ABS regime wouldadjust the lack of protection of indigenous communities and developing countries under intellectualproperty law. However, the Nagoya Protocol will only know success if its parties make bene!t-sharinga reality.212

207B. A. LIANG, “Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,Journal of Commercial Biotechnology, 2011, Vol. 17(3), 250.

208Article 25, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010. Article 20, UN Convention on BiologicalDiversity, Rio de Janeiro, 5 June 1992.

209International Institute for Sustainable Development, “Summary of the Tenth Conference of the Parties to the Conventionon Biological Diversity: 18-29 October 2010”, Earth Negotiations Bulletin, 2010, Vol. 9(544), 26.

210International Institute for Sustainable Development, “Summary of the Tenth Conference of the Parties to the Conventionon Biological Diversity: 18-29 October 2010”, Earth Negotiations Bulletin, 2010, Vol. 9(544), 3.

211C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 52 and 62.

212V. DANLEY, “Biopiracy in the Brazilian Amazon: Learning from International and Comparative Law Successes andShortcomings to Help Promote Biodiversity Conservation in Brazil”, Florida A&M University Review, 2012, Vol. 7, 305-306.

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Chapter 9

Preliminary Conclusion

“ The contemporary law of intellectual property routinely falls short of its stated ideal ofadvancing the progress of science and the useful arts. ” 213

J. Chen

Developing countries have two main complaints about the e#orts of industrialized countries tostrengthen international intellectual property protection. Firstly, raw genetic resources and traditionalknowledge originating from developing countries can freely be transferred to industrialized countries,while the commercial products and technology derived from these resources are very expensive be-cause of the intellectual property protection. Secondly, developing nations feel that intellectual prop-erty protection is constructed in favor of the technological innovation of industrialized nations.

Through the WIPO and the WTO the minimum standards of patent law have been globally harmo-nized. The TRIPS Agreement is constructed in the disadvantage of farmers and indigenous communi-ties of developing countries. Farmers who have preserved and improved plant varieties for generationsdo not get any recognition under the WTO regime. Traditional agricultural innovation and traditionalknowledge of indigenous communities do not !t into the TRIPS Agreement and are consequently de-prived of protection although this knowledge is a form of intellectual property.214 The establishmentof such a strong intellectual property protection worldwide has been realized under dominance of in-dustrialized countries.

The rapid disappearance of biodiversity has spurred the international community to take actionand that has resulted in the Convention on Biological Diversity. The Convention essentially makes thenational government of biodiversity-rich states their own gatekeeper. Each state has sovereignty overthe genetic resources located within its territory and determines the conditions of access to them. Thisaccess shall be on mutually agreed terms and subject to prior informed consent and bene!t-sharing.These conditions for access and bene!t-sharing as well as restrictions on the use of genetic resourceneed to be de!ned in national laws.215 The Convention has very good intentions, but no teeth. Itse#ects in reality are thus a lot more insigni!cant than those of the TRIPS Agreement.

213J. CHEN, “Parable of the Seeds: Interpreting the Plant Variety Protection Act in Furtherance of Innovation Policy”, NotreDame Law Review, 2005, Vol. 81, 115.

214C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversityand Biotechnology”,Washington University Law Quarterly, 1998, Vol. 76(1), 268-269.

215L. R. HELFER, “Regime Shifting”, supra 48, 31.L. R. HELFER, “Intellectual Property Rights in Plant Varieties: An Overview with Options for National Governments”, FAOLegal Papers Online, 2002 (31), 10.

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Although some countries assert that the TRIPS Agreement and the CBD are mutually supportive,there is de!nitely a !eld of tension between these agreements. This !eld of tension is where the opin-ions of developed and developing countries clash. During the last two decades the WTO membershave tried in several WTO conferences to reach consensus on amending the TRIPS Agreement so ittakes the development conditions of less developed states more into account. Small amendments havebeen made, but no consensus has been found on major controversial issues such as biopiracy.

In 2010 the Conference of the Parties adopted the Nagoya Protocol as part of the realization ofthe CBD objectives. The protocol aims to create an e#ective access and bene!t-sharing system buthasn’t entered into force yet. There is a market for genetic resources. The Nagoya protocol aims toregulate this economy based on knowledge and biotechnology. The incomes it generates would have topromote the preservation of biodiversity.216 The protocol is a promising commitment of its signatories,but lacks clarity. Whether it will really create a more e#ective ABS regime and thus limit biopiracywill have to be assessed in the future.

216 L. R. HELFER, “Regime Shifting”, supra 48, 52.

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Part III

Towards a Solution

“ So what went out free, would return with a price tag. ” 217

D. E. Schmidt

Morally, it doesn’t feel right that farmers from developing countries should pay seed that is devel-oped from plant varieties which originally came from their territories and which they have cultivatedfor over centuries. Morally, it doesn’t feel right either to appropriate the traditional knowledge of an in-digenous community to develop a product and make pro!t of it without that community receiving anycompensation in return. On those moral principles the whole international community agrees. Thoseprinciples are even enshrined as objectives, goals and considerations, but the international communitydoesn’t manage to agree on hard law rules that are enforceable and will provide a solution to biopiracy.

During the last decade a real biodiplomacy has emerged. Some developing countries have gotten alot of political weight. Where industrialized countries still managed to dominate the WTO during thenegotiation of the TRIPS Agreement, these new political actors put a lot of pressure to realize their owndemands now. On the 10th COP Brazil demanded one billion dollars annually to protect its biodiversityuntil 2020.218 This is just one example. Developing countries have much more political leverage nowthan they had 20 years ago. As the demands of developed and developing countries con$ict on manyof the substantive issues, negotiations are to a large extent blocked. How can a solution be reached?What would a good solution look like?

A !rst step towards !nding a solution would be to adopt a new rhetoric. Until now activists andeven developing countries have used a rhetoric with a negative connotation that accuses industrializedcountries. That is not a good basis for constructive discussion. Chapter ten will look at the rhetoriccurrently used and assess why it is detrimental to the ongoing negotiations. It will look at the changesnecessary for a better rhetoric. An essential !rst step towards result is creating a more constructiveenvironment for discussion.

Recently, a proposal was submitted to the European Parliament to implement the Nagoya Protocolin the European Union. In this post-TRIPS lawmaking environment, the big division between Northand South that was present during the Uruguay Round is slowly disappearing. Developing countriesdon’t all agree on intellectual property issues anymore and some developed countries start to supportreform proposals. Other powerful countries such as the US continue to oppose a reform of intellectualproperty law, but that becomes more di"cult now these new alliances emerge.219 Especially the Euro-pean Union and its member states seem determined to bring the TRIPS Agreement more in line withthe CBD. What is the EU’s position towards biopiracy today? Chapter eleven will look at the steps theEU is currently taking to adapt their patent regime. What approach does the EU take to work towardsa solution and are its commitments sincere?

The most obvious way to bring about change is using patent law to protect genetic resources andtraditional knowledge. The high minimum standards of patent law allow a broad interpretation ofpatentability and omit to protect developing countries and indigenous communities. It is only logicalto search for a solution at the origin of the problem. Most WTO andWIPO members are of the opinionthat the solution has to be found in changing the patent law. However, there is a lot of disagreementon which venue is appropriate to accomplish a change and how that change should look like. Chaptertwelve strives to o#er an overview of the view of di#erent countries and the most realistic solutions

217D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 334-335.

218C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an EndlessDiscussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 53.

219L. R. HELFER, “Regime Shifting”, supra 48, 62-63.

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discussed. Of course changing patent law is not the only solution possible. There are alternatives.Chapter thirteen will discuss other possibilities that are suggested and applied.

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Chapter 10

Rhetoric

Activist groups often bring the simpli!ed story of the rich multinational company that steals theknowledge or resources of a local community and makes big pro!t out of it. In this story the multi-national companies are called biopirates, often along with the developed countries where these com-panies are located. There is a lot of symbolic language used. This rhetoric of ‘piracy’ is probablyunhelpful and maybe even counterproductive. This chapter will look into the rhetoric used by advo-cates for indigenous rights and will assess whether it is in need of a change. Speci!cally two scholarswill be discussed, Paul Heald and Cynthia Ho, who have made some interesting remarks on the rhetoricused for biopiracy.

At this point of the dissertation it has become crystal clear that biopiracy is a controversial issuethat is subject of an intense political debate. Everyone would like to see social justice for indigenouspeople and protection for biodiversity. Just like everyone wants to see medical progress and treatmentsfor diseases. Similarly every farmer wants a good harvest and every consumer wants good vegetablesin the supermarkets. There is wide agreement that these are desirable end-goals, but the means toreach those are in dispute.220 In politics, diplomacy and negotiations, how something is said is almostjust as important as what is said. Calling someone a pirate is maybe not the best strategy to get whatyou want.

The vocabulary used against biopiracy is primarily framed in terms of moral obligation, unjust en-richment and free-riding. Scholar Paul Heald judges this rhetoric to be ine#ective. He calls the call forprotection by the advocates of indigenous communities a rhetorical disaster. There is a wide consensusamong intellectuals that current intellectual property rights are too broad.221 Arguments based on jus-tice will better serve the protection of bio-prospectors than that of indigenous communities. Advocatesfor indigenous communities essentially want the same as bio-prospecting companies (conservation ofbiodiversity and the traditional knowledge of local communities about plants) and thus should avoidmaking them into opponents by calling them pirates.222

During the last two decades, large multinational companies of the pharmaceutical, agribusinessand biotechnological industry have managed to expand intellectual property protection. Nowadays awide variety of inventions qualify for protection, sometimes even through sui generis protection. Onthe one hand, these companies aren’t interested in more rights or better protection for indigenous

220D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 351.

221P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11,521-522.

222D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 352.

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communities as having to compensate them would raise their research costs. On the other hand, thereis a lot of corporate interest in the vast potential of biodiversity. Genetic resources are an importantsource for drug development and new agricultural products, so the ‘biopirates’ lose potential income asbiodiversity disappears and it is disappearing at an alarming rate. It has even been suggested that, un-der certain circumstances, “the bioprospecting value of certain genetic resources could be large enough tosupport market-based conservation of biodiversity”. Therefore, indigenous communities would be muchmore e#ective in their !ght against the destruction of their territory and resources with the biopirateson their side.223

If one side possesses the !nancial and political resources and the other side possesses knowledgeand resources, then why haven’t they cooperated yet to protect biodiversity? Heald has identi!ed anumber of factors that have driven these two groups apart: high transaction costs, a lack of informationfor indigenous communities, corrupt governments, a lack of trust, a threat to the cultural integrity ofindigenous communities and the economic interest for poor countries in selling biodiversity.224 Thus,it is important to build a new bridge between indigenous communities and companies in need of re-sources. The !rst step towards cooperation is adopting a new rhetoric.

There is a need to align the interests of developing nations, their indigenous communities and bio-prospecting companies. Cynthia Ho, a legal scholar, agrees with Heald that the claims of biopiracyhaven’t had much e#ect in protecting the rights of indigenous communities. The WTO is dominatedby developed countries. Claims of piracy and theft made by developing nations that have much lessbargaining power in the WTO don’t have positive e#ect. Developed countries don’t want to comeacross as immoral thieves and consequently won’t engage in a discussion based on claims of piracy.These developed countries have always argued that the TRIPS Agreement is su"ciently $exible. How-ever, they close numerous TRIPS-plus agreements with developing countries which are economicallypressured into cooperation.225

Industrialized countries might be more inclined to listen to a discourse of national sovereigntythan to accusations of piracy. State sovereignty is an widely recognized principle of international law.As all states recognize each other’s right to sovereignty, it is a rhetoric that is easily understood byboth authorities and a state’s population. This strategy has proven to be successful in the interna-tional controversy surrounding HIV/AIDS drugs. The US has reconsidered the enforcement of patenton HIV/AIDS drugs for example in Brazil and South Africa through claims of national sovereigntybacked up with a negative public opinion.226 As for companies, a lot of multinational pharmaceuticalcompanies and recently more and more agricultural companies have serious image problems. Theirbusiness often goes at the cost of the poor and thus, they have an image of being greedy. Engaging inenvironmental preservation could lift their image to a better level.227

Ho proposes to introduce an internet-based commentary system hyperlinked to patents. That wayeveryone who wants can comment on a speci!c patent and the patent holder can enter in discussion.It’s a system to enhance communication and transparency. She says that a di#erent rhetoric is only astart. Complementary to that, communication between the opposite sides should be improved. Sec-

223P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11,530-534.

224P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11, 535.225C. M. HO, “Biopiracy and Beyond: A Consideration of Socio-Cultural Con$icts with Global Patent Policies”, University

of Michigan Journal of Law Reform, 2006, Vol. 39, 504 and 511.D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 353.

226C. M. HO, “Biopiracy and Beyond: A Consideration of Socio-Cultural Con$icts with Global Patent Policies”, Universityof Michigan Journal of Law Reform, 2006, Vol. 39, 507-509.

227P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11, 541.

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ondly, the trend to patent everything that comes out of a laboratory should be put to a halt. Patentingevery result of research could limit research instead of promoting it. Thirdly, the biopiracy campaign-ers can de!nitely !nd allies in developed countries in the debate on whether living organisms shouldbe patentable. There is much variation among industrialized countries on this topic as it is still highlycontroversial.228

228C. M. HO, “Biopiracy and Beyond: A Consideration of Socio-Cultural Con$icts with Global Patent Policies”, Universityof Michigan Journal of Law Reform, 2006, Vol. 39, 517-520 and 532-534.D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the RelationshipBetween Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 352-354.

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Chapter 11

European Union Initiatives

As mentioned before, the North-South divide (developed countries vs. developing countries) is slowlyeroding. Among industrialized countries especially the European Union is doing e#orts to reform itslaw and bring it more in line with the CBD. The European Union is not only member of the CBD, it alsosigned the Nagoya Protocol on 23 June 2011. Currently the EU is working on the legislative processto implement the protocol. The EU implementation of the protocol is planned to be completed in late2014/early 2015.229

In 2011 and 2012 a consultation was held, an impact study conducted and then !nally a draftproposal released. End 2011, after signing the protocol, a public consultation was held among EUstakeholders to explore the possible e#ects of the protocol.230 Then the Institute for European Envi-ronmental Policy conducted a study to analyse legal and economic aspects of implementing the NagoyaProtocol in the EU. The !nal report of the study was presented on 10 August 2012.231 On 4 October2012 a ‘Proposal for a Regulation of the European Parliament and of the Council on Access to GeneticResources and the Fair and Equitable Sharing of Bene!ts Arising from their Utilization in the Union’was submitted to the European Commission.

In July 2012 Catherine Grèze, responsible of the Development Committee, submitted a report onthe development aspects of intellectual property rights on genetic resources and more speci!cally theimpact IPRs have on poverty reduction in developing countries. After a discussion and voting pro-cedure in the committee and in the European Parliament, the parliament adopted the report in theform of a resolution on 15 January 2013.232 Although a resolution is merely a non-binding politicalstatement, the adopted resolution was welcomed as a strong signal of the EU’s commitment to tacklebiopiracy.

The resolution recalls the link between the protection of biodiversity and the realization of theMillennium Development Goals, speci!cally the goal focused on the eradication of extreme povertyand hunger. The resolution further “stresses the challenges that intellectual property rights over geneticresources and traditional knowledge raise in developing countries in terms of access to medicine, produc-tion of generic drugs and farmers’ access to seeds”. The EU and its member states are urged to ratify theNagoya Protocol as a !rst step in addressing the problem of biopiracy. The resolution acknowledges

229European Commission, “Communication on the EU Strategy for Implementation of the Interna-tional Regime on Access to Genetic Resources and Bene!t-Sharing (Nagoya Protocol)”, July 2011,http://ec.europa.eu/governance/impact/planned_ia/docs/2012_env_002_communication_abs_en.pdf.

230European Commission, Environment, “Consultation”, http://ec.europa.eu/environment/consultations/abs_en.htm.231Institute for European Environmental Policy, Ecologic and GHK, “Executive Summary of the Final report for the Euro-

pean Commission, DG Environment”, Study to analyse legal and economic aspects of implementing the Nagoya Protocol on ABSin the European Union, Brussels and London, Institute for European Environmental Policy, 2012, 1-2.

232European Parliament Legislative Observatory, 2012/2135(INI), Development aspects of intellectual property rights ongenetic resources: the impact on poverty reduction in developing countries.

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that there is no generally acceptable de!nition of the term ’biopiracy’, but refers to misappropriatingand/or illicitly bene!ting commercially from the use of traditional knowledge and genetic resources.To conclude the resolution suggests two measures necessary to tackle biopiracy: improving disclosurerequirements related to genetic resources and traditional knowledge and working towards a coherentglobal governance system.233

The legislative proposal concerning implementation of the Nagoya Protocol is still awaiting its !rstreading in the parliament. The proposal is now referred to the Economic and Social Committee andthe Committee of the Regions. On 10 July 2013 there is a vote scheduled in the committees and 22October 2013 is set as an indicative plenary sitting date.234 The proposal aims to protect the rights ofindigenous communities and (mostly developing) countries that provide genetic resources and tradi-tional knowledge, while giving European researchers and companies improved access to resources atlow cost with more legal certainty.235

The legislative proposal strives for an e#ective implementation of the Nagoya Protocol through aset of rules for the users of genetic resources and associated traditional knowledge. Article 4 sets outthe main obligation for users.

“Article 4. Obligations of users.1. They shall exercise due diligence to ascertain that genetic resources and traditional knowl-edge associated with genetic resources used were accessed in accordance with applicable accessand bene"t-sharing legislation or regulatory requirements and that, where relevant, bene"tsare fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, andtransfer to subsequent users information relevant for access and bene"t-sharing.” 236

Given the diversity of users within the EU, the proposal doesn’t oblige all users to take the samemeasures for exercising due diligence. Minimum features of due diligence measures are set out andmore speci!c measures are guided through the recognition of best practices.

The proposal further wants to establish an internet-based register of Union trusted collections.Collections of genetic resources are major suppliers of genetic resources and traditional knowledge.This register of collections would only include collections that supply samples which are legally ac-quired with the establishment of mutually agreed terms. The system of Union trusted collectionsshould lower the risk that illegally acquired genetic resources are used in the EU and give the users ofresources more legal certainty.237

The success or failure of legal instruments is dependent on its enforcement. Article 7 of the pro-posal sets out a system for monitoring compliance.

“Article 7. Monitoring user compliance.1. Member States and the Commission shall request all recipients of public research funding

233European Parliament resolution, 2012/2135(INI), 15 January 2013, Resolution on development aspects of intellectualproperty rights on genetic resources: the impact on poverty reduction in developing countries.

234European Parliament Legislative Observatory, 2012/0278(COD), Access to Genetic Resources and the Fair and EquitableSharing of Bene!ts Arising from their Utilization (Nagoya Protocol): Union Implementation and Rati!cation.

235European Commission Press Release, “Environment: Commission Proposes Measures to Tackle ’Biopiracy’ and FacilitateNature-Based Research”, 4 October 2012, http://europa.eu/rapid/press-release_IP-12-1063_en.htm.

236Article 4 and recital 14, Proposal for a Regulation, COM/2012/0576 !nal, 4 October 2012, Pro-posal for a regulation of the European Parliament and of the Council on Access to Genetic Re-sources and the Fair and Equitable Sharing of Bene!ts Arising from their Utilization in the Union, 2,http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.

237Article 5 and recital 19, Proposal for a Regulation, COM/2012/0576 !nal, 4 October 2012, Pro-posal for a regulation of the European Parliament and of the Council on Access to Genetic Re-sources and the Fair and Equitable Sharing of Bene!ts Arising from their Utilization in the Union, 2,http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.

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involving uses of genetic resources and traditional knowledge associated with genetic resourcesto declare that they will exercise due diligence in accordance with Article 4.2. Users shall declare to the competent authorities established under Article 6(1) that theyexercised due diligence in accordance with Article 4 on the occasion of requesting marketapproval for a product developed on the basis of genetic resources or traditional knowledgeassociated with such resources, or at the time of commercialisation where a market approvalis not required. [. . . ]” 238

Article 9 states that competent authorities will carry out checks to verify if users comply with therequirements set out in articles 4 and 7. Member states must provide rules on the penalties applicableto breaches of articles 4 and 7 of the proposal, but have the discretion to determine what penaltieswill apply. Article 11 proposes !nes, immediate suspension of speci!c use activities or con!scation ofillegally acquired genetic resources. Any punishment must be e#ective, proportionate and dissuasive.Article 15 confers the power to implement this proposal to the Commission.239

Prior informed consent is not mentioned very often. Users need to comply with the applicableaccess and bene!t-sharing legislation, which will often include prior informed consent, but it doesn’tmake a strong case for prior informed consent. The proposal follows the spirit of the Nagoya pro-tocol in leaving the member states the discretion to decide on whether they wish to regulate accessand require prior informed consent and bene!t-sharing to get access to genetic resources or not. Theproposal clari!es that it only applies to resources accessed after the entering into force of the NagoyaProtocol. As the protocol is silent on its temporal scope, the EU proposal makes an explicit choice tolimit its temporal scope.240 The use of the term Ôdue diligenceÕ is slightly alarming. It only refersto the intention of a user instead of imposing a strong obligation, but then again the proposal listsrequirements and compliance measures that nonetheless can make the regime a valuable ABS-regime.

On 20 March 2013 the Economic and Social Committee has given its opinion on the draft proposaland on the 6th of May Committee on the Environment, Public Health and Food Safety has submit-ted its report on the proposal. The Economic and Social Committee has noted that the proposal onlyapplies to genetic resources and traditional knowledge required after the entering into force of theNagoya Protocol. The committee regrets the failure to develop rules that apply to current use of ge-netic resources and traditional knowledge which have already reached the EU without ABS treaties.The Committee on the Environment, Public Health and Food Safety has proposed many amendmentsto the proposal. It has stressed the importance of mentioning prior informed consent in the articles ofthe regulation and to speci!cally prohibit biopiracy in its considerations. The report even suggests toadapt the Directive to protect the environment through criminal law to include biopiracy as a criminalo#ence, if committed intentionally or with serious negligence.241

238Article 7, Proposal for a Regulation, COM/2012/0576 !nal, 4 October 2012, Proposal for a regulation of the EuropeanParliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising fromtheir Utilization in the Union, 2, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.

239Articles 9, 11 and 15, Proposal for a Regulation, COM/2012/0576 !nal, 4 October 2012, Proposal for a regulation of the Eu-ropean Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arisingfrom their Utilization in the Union, 2, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.

240Explanatory memorandum, Proposal for a Regulation, COM/2012/0576 !nal, 4 October 2012, Pro-posal for a regulation of the European Parliament and of the Council on Access to Genetic Re-sources and the Fair and Equitable Sharing of Bene!ts Arising from their Utilization in the Union, 2,http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.

241Opinion of the European Economic and Social Committee, CES2314/2012, 20 March 2013, Opinion of the EuropeanEconomic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council on Accessto Genetic Resources and the Fair and Equitable Sharing of Bene!ts Arising from their Utilization in the Union.Draft Report of the Committee on the Environment, Public Health and Food Safety, PE508.195, 6 May 2013, Draft Report onthe proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair andEquitable Sharing of Bene!ts Arising from their Utilization in the Union, 11, 28 and 34.

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The real consequences this legislative proposal will have, will only become clear further down theroad. There are already quite some amendments proposed to the draft text and the proposal still needsto make it through the parliament and council. Will lobby groups manage to impede the realizationof a law as happened so many times before on the international level? Will the increasingly negativepublic opinion, spurred by examples as the practices of Monsanto, will be convincing enough to getthis proposal through the legislative proposal? It seems like the EU is committed to take serious actionagainst biopiracy. The proposal is a very promising step forward. However, it is necessary to remaincautious. Time will tell if the EU is in it for real this time.

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Chapter 12

Using Patent Law to Protect TraditionalKnowledge

This chapter will look at an approach to resolve the problem of biopiracy from within the internationalpatent system. A limited group believes that biopiracy will eventually be prohibited under interna-tional customary law as a form of regular piracy. However, that view is not supported by internationalpractice, nor is biopiracy recognized as a crime by international law.242 At the international level amuch better approach would be to work within the international patent system. This chapter willexamine how the language and concepts of the international patent regime could be used to achievethe goals of the CBD.243 International intellectual property law is an important tool of political econ-omy. The existence of multiple institutions dealing with it is an advantage to achieve changes. Thepossibility to work in di#erent forums exists, so one just has to !nd the most e#ective way to reach aresult.244

Currently major industrialized states (and regions) such as the US and EU apply a low thresholdfor protection on intellectual property. That means that their patent o"ces easily grant patents andcourts are becoming the arbiters of patentability. In the last two decades there have been many casessuch as the ones concerning the neem tree and the enola bean (see supra Part I, Chapter 3). Putting thethreshold for intellectual property protection higher can be justi!ed on the ground of more certaintyfor the biotechnology sector.245

The resources of indigenous communities are usually existing plant material or traditional knowl-edge about plants, but the current intellectual property regime only protects new inventions. That iswhy the IPR system o#ers little help for biopiracy. Some IPR tools could potentially protect the rightsof indigenous communities. Copyright protection applies to writing and artwork so it could protecttraditional cultural elements, but a copyright is attributed to an individual (not to groups) and is limitedin time. Trade secret law is a good option to protect the cultural heritage and traditional knowledge ofindigenous communities if the community is able to conceal its knowledge. If knowledge is communal,and thus not secret anymore, it is not protectable as a trade secret. The IPR regime o#ers no protectionfor most of the existing knowledge and resources of indigenous communities.246

242M. V. GUBAREV, “Misappropriation and patenting of traditional ethnobotanical knowledge and genetic resources”, Jour-nal of Food Law and Policy 2012, 85.

243I. MGBEOJI, “Patents and Traditional Knowledge of the Uses of Plants: Is a Communal Patent Regime Part of the Solutionto the Scourge of Bio Piracy?”, Indiana Journal of Global Legal Studies, 2001-2002, Vol. 9, 165.

244L. R. HELFER, “Regime Shifting”, supra 48, 8.245M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E.

EVENSON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 40.246P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11, 522.

D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship

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Working fromwithin the intellectual property regime, two categories of protection can be awarded.A !rst category, defensive protection, creates new intellectual property rights for the holders of tradi-tional knowledge and genetic resources. Indigenous communities can then enforce these intellectualproperty rights against others trying to use their knowledge or resources. However, as some scholarshave remarked, imposing western notions of property on indigenous communities might not servetheir best interests.247 Indigenous communities might have a di#erent notion of property. Moreover,many of them won’t have the means to enforce their intellectual property rights, nor the knowledgeon how to !ght a breach of their IPRs. A second, more appropriate, form of protection is positive pro-tection. Positive protection awards holders of traditional knowledge and genetic resources the bene!tsfrom the commercialization of their knowledge. The following pages of this chapter will explore thepossibilities to award indigenous communities the bene!ts of their resources and knowledge.248

12.1 A Mandatory Disclosure RequirementIntroducing a mandatory disclosure requirement to protect the rights of indigenous communities is oneof the most controversial intellectual property-related measures against biopiracy. This requirementwould make the disclosure of certain information a condition to obtain a patent. A patent applicantwould then be obliged to give this information. The establishment of a mandatory disclosure require-ment would provide a mechanism to ensure compliance with the provisions of the Convention onBiological Diversity, speci!cally with the national sovereignty principle, prior informed consent re-quirement and the sharing of bene!ts.249

Not all the proposals of a mandatory disclosure requirement envision the same goal. In general, adisclosure requirement is suggested with one of these three di#erent functions:

! A !rst disclosure requirement that has been proposed obliges to disclose any genetic resource ortraditional knowledge used in the development of an invention. This way the requirement has adescriptive or transparency function.

! A more comprehensive obligation demands disclosure of prior informed consent, access onmutually agreed terms or bene!t-sharing agreements. These more extensive disclosure re-quirements are seen as a possibility to monitor compliance with the Convention on BiologicalDiversity. Understood like this, the requirement has a compliance function. It can be used tooblige patent applicants to give evidence that they complied with the governing rules.

! The most commonly discussed requirement entails the disclosure of the geographical origin ofthe genetic resources or traditional knowledge. This can be aimed at the country, but also at amore speci!c location. This ensures that genetic resources can be accessed to reproduce the in-vention, but also reveals the source of knowledge or resources for bene!t-sharing or determiningthe jurisdiction which applies to the resources.250

Developing countries have since long advocated for disclosure requirement to realize the goals ofthe Convention on Biological Diversity. The Bonn Guidelines adopted by the CBD’s Conference of theParties in 2002 recommended to use patent applications to monitor compliance with the access and

Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 339-340.

247P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11, 529.248M. V. GUBAREV, “Misappropriation and patenting of traditional ethnobotanical knowledge and genetic resources”, Jour-

nal of Food Law and Policy 2012, 85.249B. LU, "Disclosure Requirements for Patent Application: Article 29 of the TRIPS Agreement and a Dimensional Explo-

ration", European Intellectual Property Review, 2012, Vol. 34(5), 341-342.250WIPO, “Technical Study on Disclosure Requirements Related to Genetic Resources and Traditional Knowledge”,

UNEP/CBD/COP/1/INF/17, 2003, 4.

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prior informed consent rules of the CBD.251 However, until now industrialized countries have alwaysopposed the introduction of a mandatory disclosure requirement. Various proposals have been submit-ted, mainly to the WTO and the WIPO, and the discussion is ongoing in multiple international forums.Until now the negotiating countries haven’t managed to reach a consensus.

There are four ways through which a disclosure requirement can be introduced. A !rst possibilityis to leave it to the discretion of national authorities. A second possibility is to introduce a disclosurerequirement, but realize its enforcement outside the scope of patent law. The third and fourth pathboth seek to introduce a disclosure requirement in international patent law. The current internationalregime concerning intellectual property protection already has some provisions that ask for the disclo-sure of origin. However, these have limited e#ects or are not mandatory. On the regional and nationallevel there are some disclosure provisions as well, but they vary greatly. Some are mandatory, some arejust an encouragement and nothing more.252 Some countries seek to establish a disclosure requirementthrough the WTO, others address the WIPO.

12.1.1 National LegislationIndustrialized countries generally prefer the use of national legislation to determine patent applica-tion requirements. This is far from surprising. These countries are not in favour of introducing newrequirements and in domestic law they are free to do as they please. Rather than disclosure require-ments, they propose contracts to enter into bene!t-sharing agreements and realize the goals of theCBD. The US has argued that the best approach to realize the CBD’s objectives is through nationallaws and contracts which include a commitment on disclosure.253

To ensure the enforcement of a disclosure requirement, grave consequences need to be linked toviolations. The most e#ective measures are the rejection or revocation of a patent in case of non-compliance. Currently, the Andean Pact, Costa Rica, Brazil and India refuse to grant a patent if thegeographical origin and/or prior informed consent are not disclosed.254 However, other regimes con-nect less discouraging consequences to disclosure requirements or merely encourage disclosure (thecurrent European regime). In short, there is much variety among national laws concerning disclosurerequirements.

The di#erence among the applicable laws on genetic resources is big and this creates a complexregime. Often resources are used transboundary. Then the country providing the resources has to relyon the country in which the resources are used to take measures to ensure that its laws are followed.As a national law is only applicable on the territory of the country, transnational actions are com-plicated and companies and researchers face a complex labyrinth of requirements.255 The complexityof enforcement of disclosure requirements de!ned di#erently in every country is a major obstacle.Therefore national law is not an e#ective tool to establish a mandatory disclosure requirement.

251L. R. HELFER, “Regime Shifting”, supra 48, 67.252H. BAUM!LLER and D. VIVAS-EUGUI, “Towards E#ective Disclosure of Origin ! The Role of the International ABS

Regime”, ICTSD Bridges, 2004, No. 4, 21.253World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation:

The Debate”, http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.254E. C. KAMAU, “Disclosure Requirement ! A Critical Appraisal” in E. C. KAMAU and G. WINTER (eds.), Genetic Re-

sources, Traditional Knowledge and the Law: Solutions for Access and Bene"t Sharing, Earthscan, 2009, 408-409.255H. BAUM!LLER and D. VIVAS-EUGUI, “Towards E#ective Disclosure of Origin — The Role of the International ABS

Regime”, ICTSD Bridges, 2004, No. 4, 21.

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12.1.2 Disclosure outside Patent LawCurrently, the EU regime dealing with patent on biotechnological inventions merely encourages thedisclosure of origin. The proposal to implement the Nagoya Protocol will establish a mandatory disclo-sure requirement. A user of genetic resources or traditional knowledge will be obliged to disclose theorigin of the resources and to declare that due diligence was exercised to access the resources and thatwhere relevant bene!ts were shared. The legal consequences of non-compliance with this disclosurerequirement are outside the scope of patent law. The proposal leaves discretion to national authoritiesto determine the applicable penalty, but proposes !nes, suspension of activity or con!scation of theillegally acquired resources. None of the measures relates to the patent procedure.256

The problem is that consequences outside the scope of patent law will have much less e#ect. Ifobtaining and keeping a patent is made conditional of ful!lling a disclosure requirement the incentivefor compliance is big. Penalties not relating to the patent will oblige patent applicants way less to com-ply. If a !ne is less expensive than acquiring legal access and prior informed consent to resources andentering into a bene!t-sharing agreement, there is even an economic incentive to continue committingbiopiracy. In a resolution adopted in January 2013 the European Parliament has stated it “considers itcrucial to establish mandatory requirements on disclosing the origin of genetic resources during patentproceedings”. The parliament encourages an amendment of the TRIPS Agreement or a WIPO treatyto establish an international mandatory disclosure requirement. When such a requirement will beintroduced, its e#ectiveness will depend on its compliance measures. The most e#ective compliancemeasures are the ones relating to the granting of a patent.257

12.1.3 Disclosure as a TRIPS ObligationIncorporation of a disclosure requirement in the TRIPS Agreement would ensure compliance with theprovisions of the Convention on Biological Diversity. The big advantage of the TRIPS Agreement isthat it is a binding agreement with a very e#ective enforcement mechanism (its dispute settlement sys-tem that can issue trade sanctions). However, the WTO also comes with a substantive obstacle. In theWTO industrialized countries have an important in$uence and these countries generally don’t wantthe establishment of extra patent requirements. This makes an amendment of the TRIPS Agreementthe most interesting option to establish a change, but also the most di"cult to realize.

The negotiation of a disclosure requirement for genetic resources in patent applications is one ofthe main issues in international intellectual property law and in the WTO negotiations. Since theDoha Round the WTO negotiations have been blocked to a large extent due to the con$icting demandsof developed and developing countries. Although there are serious obstacles, the unresolved issuessuch as a disclosure requirement for genetic resources are still on the WTO agenda. The members infavour of a disclosure requirement have proposed the disclosure of the origin of biological resourcesand knowledge used, evidence of prior informed consent and evidence of bene!t-sharing. Other mem-bers such as the US, Canada and Japan oppose the use of a disclosure requirement to realize the goalsof the Convention on Biological Diversity.258

In 2005 a group of developing countries has showed its desire to include a mandatory disclosurerequirement in the TRIPS Agreement. The group was represented by Brazil and India and included Bo-livia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand and had the support of the Africangroups and some other developing countries. They wanted a patent application to disclose three things:

256World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation:The Debate”, http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.

257European Parliament resolution, 2012/2135(INI), 15 January 2013, Resolution on development aspects of intellectualproperty rights on genetic resources: the impact on poverty reduction in developing countries.

258B. LU, "Disclosure Requirements for Patent Application: Article 29 of the TRIPS Agreement and a Dimensional Explo-ration", European Intellectual Property Review, 2012, Vol. 34(5), 341-342.

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the origin of the genetic resources or traditional knowledge used, evidence of prior informed consentand evidence of fair and equitable bene!t-sharing.259 The disclosure of origin requirement disclosesinformation relevant to prior art and is used this way to combat biopiracy. Requiring evidence of priorinformed consent and bene!t-sharing is meant to ensure compliance with the Convention on Biologi-cal Diversity.260 In July 2008 a group of WTO members submitted a proposal to discuss the disclosurerequirement together with two geographical indications issues.261 So the issue is still on the WTOagenda, but the member states have not managed to reach a consensus on it yet.

Three options have been proposed to amend the TRIPS Agreement. The !rst suggestion is to addan exception to the existing exceptions of patentability under article 27. The new exception wouldcome under paragraph 3:

3. “Members may also exclude from patentability:

c) products or processes which directly or indirectly include genetic resources or traditionalknowledge obtained in the absence of compliance with international and national leg-islation on the subject, including failure to obtain the prior informed consent of thecountry of origin or the community concerned and failure to reach agreement on condi-tions for the fair and equitable sharing of bene"ts arising from their use. Nothing in theTRIPS shall prevent Members from adopting enforcement measures in their domestic leg-islation, in accordance with the principles and obligations enshrined in the Conventionon Biological Diversity.” 262

According to some scholars article 29 of the TRIPS Agreement would be the most appropriate articleto introduce a disclosure of origin requirement.

“Article 29: Conditions on Patent Applicants

1. Members shall require that an applicant for a patent shall disclose the invention in amanner su#ciently clear and complete for the invention to be carried out by a personskilled in the art and may require the applicant to indicate the best mode for carryingout the invention known to the inventor at the "ling date or, where priority is claimed,at the priority date of the application.

2. Members may require an applicant for a patent to provide information concerning theapplicant’s corresponding foreign applications and grants.” 263

Developing countries have proposed to insert a new article 29bis for the disclosure of origin. TheEuropean Parliament has expressed its support for this request in the resolution adopted in January

259Council for Trade-Related Aspects of Intellectual Property Rights, Submission from Bolivia et al., “The Relationship Be-tween the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge,Elements of the Obligation to Disclose Evidence of Bene!t-Sharing under the Relevant National Regime”, IP/C/W/442, 18March 2005.World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation: TheDebate”,http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.

260 C. M. HO, “Biopiracy and Beyond: A Consideration of Socio-Cultural Con$icts with Global Patent Policies”, Universityof Michigan Journal of Law Reform, 2006, Vol. 39, 488-490.

261World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation:The Debate”, http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.

262Council for Trade-Related Aspects of Intellectual Property Rights, Communication from Peru, “Article 27.3(b), Relation-ship Between the TRIPS Agreement and the CBD and the Protection of Traditional Knowledge and Folklore”, IP/C/W/447, 8June 2005.J. CARR, “Agreements That Divide: TRIPS vs. CBD and Proposals for Mandatory Disclosure of Source and Origin of GeneticResources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 140-141.

263Article 29, Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C to the Marrakech AgreementEstablishing the World Trade Organization, 15 April 1994.

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2013.264 Another option proposed is to issue an authoritative interpretation of article 29 TRIPS.265 Var-ious options are possible, but it is clear that articles 27 and 29 are the articles best suited to introducea disclosure requirement.

The introduction of a disclosure requirement in the TRIPS Agreement is a controversial issue bothamong scholars and states. Some even argue that the TRIPS Agreement sets out minimum standardsand thus, no additional requirements are allowed. The US has stated that an additional substantive re-quirement of patentability would be incompatible with the TRIPS Agreement. Industrialized countrieshave also argued that a the proposed disclosure requirement is not su"ciently linked to the inven-tion to be of importance for patentability. The obligation to disclose information on all the geneticresources simply used at a certain point in the development would create an unproportional admin-istrative burden on patent o"ces. Some countries such as the US advocate the use of contracts forbene!t-sharing. However, developing countries judge this to be an incomplete solution.266 It doesn’tlook like a consensus is soon to be reached.

12.1.4 Disclosure through the WIPOAnother often suggested way to introduce a disclosure requirement is through the World Intellec-tual Property Organization. Even within the WIPO di#erent places for discussion have been proposed.Some see WIPO’s Patent Cooperation Treaty (PCT) !t for the introduction of a disclosure requirement.Others prefer the discussion to be held in the Intergovernmental Committee on Intellectual Propertyand Genetic Resources, Traditional Knowledge and Folklore (IGC). Again others think the negotiationson the Substantive Patent Law Treaty (SPTL) are the most appropriate venue for a disclosure require-ment.

Cuba is strongly in favour of an amendment to WIPO’s Patent Cooperation Treaty (PCT). Thedisclosure requirement proposed would be similar to the proposed change in the TRIPS Agreement.Switzerland has proposed that the amendment would allow optional participation so national authori-ties can decide to slowly incorporate the obligation in domestic law for. Switzerland has also asked thedisclosure to be a formal requirement for the patent application, but not a substantive one. A grantedpatent would then only be revoked if a failure to disclose was based on fraudulent intent. The proposalfor a disclosure requirement in the PCT would only apply to inventions directly based on a speci!c ge-netic resource. Thus, disclosure for every biological resource used somewhere along the developmentprocedure would not be required.267

264European Parliament resolution, 2012/2135(INI), 15 January 2013, Resolution on development aspects of intellectualproperty rights on genetic resources: the impact on poverty reduction in developing countries.

265B. LU, "Disclosure Requirements for Patent Application: Article 29 of the TRIPS Agreement and a Dimensional Explo-ration", European Intellectual Property Review, 2012, Vol. 34(5), 341-342.

266C. M. HO, “Biopiracy and Beyond: A Consideration of Socio-Cultural Con$icts with Global Patent Policies”, Universityof Michigan Journal of Law Reform, 2006, Vol. 39, 488-490.

267World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation:The Debate”, http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.J. CARR, “Agreements That Divide: TRIPS vs. CBD and Proposals for Mandatory Disclosure of Source and Origin of GeneticResources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 142.

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Some countries think the IGC is a more appropriate venue to discuss the establishment of a disclo-sure requirement. The proposal submitted in the IGC is essentially the same as the one submitted toamend the PCT. Since 2001 a new international legal instrument is being negotiated in the WIPO, theSubstantive Patent Law Treaty (SPTL). This could prove a good opportunity to establish a mandatorydisclosure requirement. In the draft text of the SPTL a disclosure requirement for patents is allowed,but it is not mandatory for countries to ensure disclosure. However, the last SPTL negotiations havefailed in 2006 and since then the creation and even further negotiations of the SPTL have been put onhold until further notice.268

In June 2009 the African group submitted a proposal to WIPO’s IGC to give a new incentive fordiscussion and break the stagnant situation. The proposal was submitted to the 14th session of the IGC.The African group !rst gave a summary of the general views of the WIPO members and mentionedthe unresolved issues such as a de!nition of traditional knowledge, who should be the bene!ciaryof protection and whether an international instrument is really needed. The African group furtherproposed to work toward a legally binding international instrument for the protection of traditionalknowledge.269

The issue of a disclosure requirement is still being discussed in the IGC. In 2002 the Conferenceof the Parties of the Convention on Biological Diversity asked the IGC to conduct a study on methodswithin the patent system for requiring disclosure.270 Many countries have already submitted propos-als and remarks. From a recent document it is clear that the IGC is still working on draft articles forintroducing a disclosure requirement.271 However, so far no real progress has been made.

The proposals to introduce a mandatory disclosure requirement are quite popular taken into ac-count all the CBD,WTO andWIPOmembers. However, caution is necessary. The goal of the disclosurerequirement is to introduce an ABS regime into patent law, while the essence of ABS lies outside thescope of a patent. If a disclosure requirement would be introduced, it will be of crucial importancethat the requirement is very clear and has a clearly de!ned scope of application. If not, it could createuncertainties in the patent system, reduce the value of patents and ultimately discourage research anddevelopment. The proposals to introduce a disclosure requirement need to be studied from a tech-nical perspective outside of the political debate. A disclosure requirement would only truly create abetter ABS regime and prevent biopiracy if it is complemented by e#ective national systems and theuse of contractual bene!t-sharing agreements.272 A mandatory disclosure requirement would mean animportant step forward, but only if done in a correct way.

268European Parliament resolution, 2012/2135(INI), 15 January 2013, Resolution on development aspects of intellectualproperty rights on genetic resources: the impact on poverty reduction in developing countries.J. CARR, “Agreements That Divide: TRIPS vs. CBD and Proposals for Mandatory Disclosure of Source and Origin of GeneticResources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 143.

269J. J. OSEITUTU, “A Sui Generis Regime for Traditional Knowledge: The Cultural Divide in Intellectual Property Law”,Marquette Intellectual Property Law Review, 2011, Vol. 15, 173.

270World Intellectual Property Organization, “WIPO Process Regarding an Invitation by the Convention on Bi-ological Diversity on Access to Genetic Resources and Disclosure Requirements in IP Rights Applications”,http://www.wipo.int/tk/en/genetic/proposals/.

271WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folk-lore, “Consolidated Document Relating to Intellectual Property and Genetic Resources, Rev. 2”, 8 February 2013,http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_23/wipo_grtkf_ic_23_www_230222.pdf.

272D. KEATING, “Access to Genetic Resources and Equitable Bene!t Sharing Through a New Disclosure Requirement inthe Patent System: an Issue in Search of a Forum”, Journal of the Patent and Trademark O#ce Society, 2005, Vol. 87, 530-531.

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12.2 Prior Art and Digital Databases of Traditional KnowledgeTraditional knowledge of indigenous communities is very dispersed. Often it is di"cult to identifythe owner of speci!c knowledge and to assign the rights over speci!c knowledge within or betweengroups.273 Sometimes there is intangible, but real cultural harm in patenting traditional knowledgewithout consent. Patent law is a system based on private ownership of knowledge. However, somecultures forbid private ownership of knowledge that is of importance for the community.274 A databaseof traditional knowledge would facilitate access and bene!t-sharing considerably and prevent the er-roneous granting of patents.

In order to be viable for a patent, an invention must be novel and non-obvious. That is why patento"ces do a prior art search. If prior art exists, then almost automatically a lack of novelty and obvi-ousness are presumed. There is a tight correlation between those three concepts.275 The existence of adatabase would facilitate the search for prior art and thus prevent that patents are granted erroneously.The only international database for traditional knowledge is the Indigenous Knowledge Database com-piled by the World Bank.276 Both India and the Republic of Korea have a national digital database oftraditional knowledge. The WIPO has a portal of online databases and registries of traditional knowl-edge and genetic resources.277 National patent o"ces can easily search for the existence of prior artthis way.

On this matter, the interpretation of prior art used by the US needs to be mentioned. The USdoesn’t consider prior art from outside the US if it is not proven by written documentation (supra PartI, Chapter 3). Considering the world is more and more globalized, this is an anachronistic interpre-tation. Out of fairness a broader interpretation should be adopted. Of course the establishment ofdatabases provides more written documentation and will also help to resolve this unfair element in theUS patent application process.

For genetic resources there is an extensive digital database compiled by the Consultative Group onInternational Agricultural Research (CGIAR). The database gives all the available information on thegenetic resources stored in the gene banks of the CGIAR. This is especially helpful for research anddevelopment.278 In March 2013 Canada, Japan, the Republic of Korea and the US submitted a recom-mendation to the IGC of the WIPO on the use of databases. The recommendation requests that everyWIPO member would possess a searchable database of genetic resources and traditional knowledge.The requesting countries state that this would facilitate prior art searches and consequently addressthe erroneous granting of patents.279

273P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11, 524.274D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship

Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-mental Law, 2008, Vol. 38, 333.

275M. V. GUBAREV, “Misappropriation and patenting of traditional ethnobotanical knowledge and genetic resources”, Jour-nal of Food Law and Policy 2012, 86.

276World Bank, Database of Indigenous Knowledge and Practices, http://www.worldbank.org/afr/ik/datab.htm.277World Intellectual Property Organization, “Portal of Online Databases and Registries of Traditional Knowledge and Ge-

netic Resources, http://www.wipo.int/tk/en/databases/tkportal/.Council of Scienti!c and Industrial Research, Traditional Knowledge Digital Library (TKDL) of Ayurveda,http://www.csir.res.in/External/Utilities/Frames/career/main_page1.asp?a=tkdl_topframe.htm&b=tkdl_left.htm&c=../../../Heads/TKDL/main.htm.Korean Traditional Knowledge Portal, http://www.koreantk.com/en/JZ0100.jsp.

278Consultative Group on International Agricultural Research (CGIAR), System-wide Informational Network for GeneticResources (SINGER), http://www.genesys-pgr.org/.

279WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folk-lore, Submission of Canada, Japan, the Republic of Korea and the United States of America, “Joint Recommendation on theUse of Databases for the Defensive Protection of Genetic Resources and Traditional Knowledge Associated with GeneticResources”, WIPO/GRTKF/IC/24/7, 28 March 2013.

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Chapter 13

Alternatives

Of course patent law is not the only option to search for a solution to biopiracy, there are alternatives.In reality companies don’t start to search nature randomly to !nd useful resources. They work withresearch leads that signi!cantly reduce the amount of time and money for searching. Those researchleads are often provided by local or indigenous communities.280 Maybe a solution for the fair and eq-uitable sharing of bene!ts can be found by bringing these two actors together, not necessarily throughpatent law obligations.

Public-private partnerships could provide a solution for the problems arising from bioprospectingand biopiracy. If corporations act ethically and provide compensation for the traditional knowledge ornatural resources used as part of a partnership with an indigenous community, these indigenous com-munities will bene!t economically. If their economic position improves, they can be a possible marketfor the company to sell their manufactured products. Hence the investment can pay o#. Corporationscan provide education and infrastructure to local communities which can result in closer relationships.To assure that this all happens fairly, it is important that there is a third partner involved from thecivil society or academic world.281 A very good example is the partnership between Merck and INBio(supra Part II, Chapter 6).

However, it seems that private corporations will need stronger incentives to start a more ethicalway of gathering their resources. More transparency can possibly provide incentives for good be-haviour and voluntary cooperation. Transparency alone won’t do the trick, an e#ective system ofaccountability is needed too. Punishment for non-compliance to the rules is exactly what the existingconventions and protocols lack.282

Academic Peter Drahos has proposed a creative non-intellectual property solution, the creation ofa global bio-collecting society. It would be a private organization outside the context of any treatynegotiation. He argues that an international organization will most likely serve the interests of indige-nous groups better than state organizations. The global biocollecting society would be funded by theWorld Bank. The society would act as a repository for community registers of indigenous knowledgeand provide assistance in contractual negotiations between indigenous communities and a third party.The society would also have a monitoring service for the use of indigenous knowledge and a disputeresolution system. This would give companies legal certainty over the use of genetic resources and it

280P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11,533-534.

281B. A. LIANG, “Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,Journal of Commercial Biotechnology, 2011, Vol. 17(3), 250-251.

282T. A. KURSAR, “What are the Implications of the Nagoya Protocol for Research on Biodiversity?”, BioScience, 2011, Vol.61(4), 257.

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would help resolve the free-riding behavior that now causes biopiracy.283

The question is: what will companies be willing to pay to receive knowledge from this institution?Drahos has designed a complex mechanism of compensation for those who contribute knowledge tothe global bio-collecting society.284 It is a quite complicated construction and probably companieswill be more inclined to enter in a public-private partnership than to cooperate with this society.Nevertheless it is an interesting thinking exercise.

283 DRAHOS, P., “Indigenous Kowledge, Intellectual Property and Biopiracy: Is a Global Biocollecting Society the Answer?”,EIPR 2000, Vol. 22 (6), 248-250.

284P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11,539-540.

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Chapter 14

Preliminary Conclusion

The objective of this part of the dissertation has been to seek a way out of the current impasse in inter-national negotiations towards a better protection of the genetic resources and traditional knowledgeof developing countries and indigenous communities. International negotiations are taking place atvarious venues and those discussions are not focused on !nding a remedy for biopiracy, but addressa wide array of issues. Therefore it was necessary to limit this section to the discussions the authorof this dissertation believes to be key elements on the road to a remedy. This section has strived too#er an overview of the current status of discussion on these key issues and the way they should moveforward. To address the problem of biopiracy in an adequate manner certain measures should be taken.

First of all, a more constructive rhetoric should be adopted. Even the name of the phenomenon,biopiracy, is a very negative term. Although what is happening doesn’t feel morally correct, thereare always two sides to a story. The issue of biopiracy is more complex than what some activists aredescribing. On a politically sensitive matter it is not a good idea to turn the other party into an ad-versary from the start. The blaming of industrialized countries’ government should stop and a moreconstructive discussion should be started. That can be done by focusing on the importance of preserv-ing biodiversity and the cooperation that is possible. A di#erent vocabulary sure won’t be a magicsolution for the problems, but it could ease the negotiations.

Secondly, the implementation of the Nagoya Protocol is an important step forward. The EuropeanUnion is currently debating a legislative proposal to do so. Not only is it important to implementthe protocol in domestic law, the way it is done is even more important. Just like all the previousinternational instruments, the Nagoya Protocol heavily relies on strong implementation by national(or regional in the case of the EU) authorities. The EU’s implementation is a very interesting exam-ple since it consists of developed countries and only relatively recent started to support a reform ofits patent law. The EU seems to have taken up a strong commitment, but there are already someimprovements suggested for the legislative proposal. Imposing strong obligations is key, as historyhas shown that soft law guidelines and recommendation haven’t realized much. As for the EU, it willbe interesting to see the !nal text of the legislation and see how the result of implementation turns out.

Thirdly, certain changes to patent law could provide a substantial change. The European proposalestablishes a mandatory disclosure requirement. Many states agree that this is the way to proceed. Adisclosure requirement can be used to monitor if access legislation and prior informed consent were re-spected and if bene!ts are shared in a fair and equitable way. The EU has connected a failure to discloseto consequences outside patent law (!nes, con!scation of resources). The most e#ective enforcementwould be to make disclosure a condition for obtaining a patent. However, many states disagree onwhich consequences to connect to failure to disclose and on where to negotiate such an obligation.

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Although a mandatory disclosure requirement is indeed a very good approach to monitor compli-ance and remedy biopiracy, not just any disclosure requirement will do that. It is essential to study thepossible implications for research and development and to develop a regulation that would not impedescience or only in the most limited form possible. A disclosure requirement could have negative e#ectson technological advancement and that should be prevented. True progress on this issue should comefrom a combination of an e#ective mandatory disclosure requirement and public-private partnershipssupported with databases on genetic resources and traditional knowledge. Public-private partnershipsprovide an mutually bene!cial cooperation between indigenous communities and companies when ef-fected good. Biopiracy is a very complex problem, so its remedy won’t be easy. It is mainly a questionof e#ective international legislation so national governments will be obliged to implement e#ectiveobligations and provide incentives for technological companies to cooperate with developing nationsand their local communities. A combination of disclosure requirements and mutually bene!cial con-tractual agreements will bring a remedy much closer.

74

Conclusion

This dissertation has strived to provide the reader with a nuanced context for the problem of biopiracy,a full legal analysis of its legal framework and suggestions for a remedy. Currently the legal instru-ments protecting the holders of genetic resources and traditional knowledge are not e"ciently imple-mented and as a consequence have little e#ect. That is why biopiracy continues to happen.

In the !rst and introductory part of this dissertation, the concept of biopiracy was explained andput into a nuanced context by giving voice to the di#erent perspectives on the issue. Not only is therecontroversy on how to address the problem of biopiracy, there is not even a consensus on the exis-tence of the problem and on a de!nition for the term. Within the scope of this thesis biopiracy can bede!ned as the use of intellectual property systems (mostly through patents) to legitimize the exclusiveownership and control over biological resources and/or associated traditional knowledge appropriatedwithout adequate authorization and/or bene!t-sharing from other (usually developing) countries andindigenous or local communities.

History shows that the growing expansion of technology was pushed by developed countries toprotect their technological knowledge and culminated in the adoption of minimum standards for patentlaw in the WTO TRIPS Agreement. E#orts of the much weaker developing nations to address the neg-ative e#ects of IPRs on developing countries and their biodiversity have been much less e#ective.However, the tide is turning. The neem tree case provided the !rst victory in a biopiracy case beforethe European Patent O"ce in 2005. Although the European Union seems to have taken up the commit-ment to adjust the negative side e#ects of international patent law, this attitude can’t be generalizedfor all industrialized countries. For example the US continues to oppose reforms of international intel-lectual property law strongly. The di#erence of mentality of the European and the American patentauthorities can clearly be spotted in case law.

The !rst part being an introductory section, the focal point of this dissertation resides in its secondand third part. The second part has o#ered an extensive inquiry on the international legal agreementsthat a#ect biopiracy, the two main instruments being the TRIPS Agreement and the Convention on Bi-ological Diversity. The third part then builds upon the second part by providing suggestions to remedythe current impasse in international negotiations and address the problem of biopiracy by e#ectivelyprotecting the holders of genetic resources and traditional knowledge.

The two most in$uential international institutions in the !eld of patent law are the WIPO andthe WTO. WIPO has done a great deal of work in harmonizing the formal procedure of patent appli-cations. However, its e#orts to harmonize substantive issue by developing a Substantive Patent LawTreaty have been put on hold since 2006 due to a lack of consensus. The WTO has managed to im-plement minimum standards of intellectual property protection through the TRIPS Agreement. Non-compliance can result in trade sanctions so countries prefer to abide by its provisions. Especially itsarticle 27 is very controversial because it establishes a very broad interpretation of what is patentablethat extends to living organisms and obliges countries to provide intellectual property protection formicro-organisms, non-biological processes and plant varieties.

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The growing concern for the disappearance of biodiversity has resulted in the adoption of theConvention on Biological Diversity. The convention aims to promote the conservation of biologicaldiversity, the sustainable use of the components of biological diversity and access to genetic resourcesand fair and equitable sharing of bene!ts arising from their utilisation. Its text truly proves that theestablishment of the CBD was a compromise to the competing claims of developed and developingcountries. As a result the convention has no teeth. It is plagued by vague concepts and soft law rec-ommendations. It is not surprising that the convention has not brought about big changes in reality.Nonetheless, it has marked a shift in mentality and provides a base for developing countries to backup their demands.

The TRIPS Agreement and CBD promote objectives that are on opposite sides of a spectrum. Inmany WTO Conferences and Conferences of the Parties to the CBD, states have tried to align theirinterests and change the existing agreements to make them more mutually supportive. However, apartfrom some small accomplishments and a lot of good intentions, no real changes have been realized.The TRIPS Agreement has teeth and the CBD lacks compliance mechanisms so intellectual propertyhas primacy over biodiversity and biopiracy concerns. In 2010 the Nagoya Protocol was adopted toestablish a more e#ective access and bene!t-sharing regime. The protocol has not entered into forceyet, so only time can tell what its real consequences will be. However, the protocol relies heavily onimplementation of national authorities just like the CBD. It is questionable whether a lot of states willcommit themselves to e#ectively enforce the Nagoya Protocol.

In the third and !nal part, suggestions have been made to remedy the negative e#ects of biopiracy.From a diplomatic point of view, the current rhetoric used to negotiate a solution for biopiracy is notsuch a good strategy. The practice of blaming should be abandoned and common grounds shouldbe sought to create a constructive atmosphere for further negotiations. For an e#ective remedy tobiopiracy, the last part of this dissertation suggests three measures that would bring about progress:a mandatory disclosure requirement, more extensive databases of genetic resources and traditionalknowledge and public-private agreements.

A mandatory disclosure requirement could be used to monitor compliance with the CBD and rem-edy biopiracy. However, it is important to study its e#ects on technological research and developmentand consider thoroughly the scope of the disclosure requirement. The best way to enforce a disclosurerequirement e#ectively is to make it a condition for obtaining a patent. The possible revocation of apatent is su"ciently discouraging for patent applicants to comply with the requirement. The secondtool for a remedy, databases of genetic resources and traditional knowledge, would make a prior artsearch much easier for patent o"ces. The better prior art searches can be conducted, the less patentswill be granted erroneously. The third measure suggested is promoting public-private agreements be-tween companies and developing nations or indigenous communities. Whereas a mandatory disclosurerequirement prevents abuse and databases prevent the erroneous granting of patents, bene!t-sharingagreements o#er the solution for the core of the problem. Through mutually bene!cial contracts be-tween companies and indigenous communities, these communities would !nally get the compensationthey deserve and implicitly give their authorization to a company. The combination of these three mea-sures could provide real progress.

In conclusion, this dissertation has aimed to provide a legal perspective on the issue of biopiracyand suggest measures to remedy the problem. Biopiracy is a complex issue and it is the author’sbelief that a consensus in the international community is still far away. This thesis has undertaken anattempt to provide the reader with a better understanding of the clash between intellectual propertyon the one hand and biodiversity and local communities on the other hand. It is the author’s hope thatthis dissertation has shed a new light on the topic of biopiracy and has given the reader some food forthought.

76

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Summary Table of Membership of the World Intellectual Property Organization (WIPO) and the

Treaties Administered by WIPO, plus UPOV, WTO and UN

STATES W P B PCT PLT MI MM MP H GH N LI RO LO IPC PH VC BP S NOS TLT W CT W PPT WAS SG BEIJING

UN U W TO

Afghanistan X 1 X Albania X X X X X X X X X X X X X X X X 16 X X X

Algeria X X X X X X X X X X 10 X Andorra X X X X 4 X Angola X X X 3 X X

Antigua and

Barbuda X X X X X 5 X X

Argentina X X X X X X X X X X X 11 X X X

Armenia X X X X X X X X X X X X X X X X X X 18 X X

Australia X X X X X X X X X X X X X X X X 16 X X X

Austria X X X X X X X X X X X X X X X X 16 X X X

Azerbaijan X X X X X X X X X X X X X X X X X 17 X X Bahamas X X X 3 X Bahrain X X X X X X X X X X X X X 13 X X

Bangladesh X X X 3 X X

Barbados X X X X X X X X 8 X X

Belarus X X X X X X X X X X X X X X X 15 X X Belgium X X X X X X X X X X X X X X X 15 X X X

Belize X X X X X 5 X X

Benin X X X X X X X X X 9 X X

Bhutan X X X X X 5 X Bolivia

(Plurinational

State of)

X X X X X 5 X X X

Bosnia and

Herzegovina X X X X X X X X X X X X X X X X X X X X X X X 23 X

Botswana X X X X X X X X X 9 X X

Brazil X X X X X X X X X 9 X X X

Brunei

Darussalam X X X X X 5 X X

Bulgaria X X X X X X X X X X X X X X X X X X X X X 21 X X X

Burkina Faso X X X X X X X X X X 10 X X

Burundi X X 2 X X

Cambodia X X 2 X X

Cameroon X X X X 4 X X

Canada X X X X X X X 7 X X X

Cape Verde X X X 3 X X

Central

African

Republic

X X X X 4 X X

Chad X X X X 4 X X

Chile X X X X X X X X X X X X 12 X X X

China X X X X X X X X X X X X X 13 X X X

Colombia X X X X X X X X X X 10 X X X

Comoros X X X X 4 X Congo X X X X X X X 7 X X

Costa Rica X X X X X X X X X X X X 12 X X X

Croatia X X X X X X X X X X X X X X X X X X X X X X 22 X X X

Cuba X X X X X X X X X X X X X X 14 X X

Cyprus X X X X X X X X X X X X 12 X X

Czech

Republic X X X X X X X X X X X X X X X X X 17 X X X

Côte d'Ivoire X X X X X 5 X X

Democratic

People's

Republic of

Korea

X X X X X X X X X X X X 12 X

Democratic

Republic of

the Congo

X X X X 4 X X

Denmark X X X X X X X X X X X X X X X X X X 18 X X X

Djibouti X X X 3 X X

Dominica X X X X

X

X

6 X

X

Dominican

Republic X X X X X X X X X X 10 X X X

Ecuador X X X X X X X X 8 X X X

Egypt X X X X X X X X X X X X X X X 15 X X

El Salvador X X X X X X X X X X X X 12 X X

Equatorial

Guinea X X X X X 5 X

Eritrea X 1 X Estonia X X X X X X X X X X X X X X X X X X X 19 X X X

Ethiopia X X 2 X Fiji X X X X 4 X X

Finland X X X X X X X X X X X X X X X X 16 X X X

France X X X X X X X X X X X X X X X X X X X X X X 22 X X X

Gabon X X X X X X X X 8 X X

Gambia X X X X 4 X X

Georgia X X X X X X X X X X X X X 13 X X X

Germany X X X X X X X X X X X X X X X X X X X 19 X X X

Ghana X X X X X X X X X 9 X X

Greece X X X X X X X X X X X X X X X X 16 X X

Grenada X X X X 4 X X

Guatemala X X X X X X X X X X 10 X X

Guinea X X X X X X X X X X X 11 X X

Guinea-

Bissau X X X X 4 X X

Guyana X X X 3 X X

Haiti X X X X 4 X X

Holy See X X X X 4 Honduras X X X X X X X X X X X 11 X X

Hungary X X X X X X X X X X X X X X X X X X X X 20 X X X

Iceland X X X X X X X X X X X X 12 X X X

India X X X X X X X 7 X X

Indonesia X X X X X X X 7 X X

Iran (Islamic

Republic of) X X X X X X 6 X

Iraq X X 2 X Ireland X X X X X X X X X X X X X X X 15 X X X

Israel X X X X X X X X X X X X 12 X X X

Italy X X X X X X X X X X X X X X X X X X X X X 21 X X X

Jamaica X X X X X X X X X X X 11 X X

Japan X X X X X X X X X X X X X X 14 X X X

Jordan X X X X X X X X 8 X X X

Kazakhstan X X X X X X X X X X X X X X X X X 17 X Kenya X X X X X X X X X 9 X X X

Kiribati 0 X Kuwait X 1 X X

Kyrgyzstan X X X X X X X X X X X X X X X X X X X X X 21 X X X

Lao People's

Democratic

Republic

X X X X 4 X X

Latvia X X X X X X X X X X X X X X X X X X 18 X X X

Lebanon X X X X X X 6 X Lesotho X X X X X X X 7 X X

Liberia X X X X X X X X 8 X Libya X X X X 4 X Liechtenstein X X X X X X X X X X X X X X X X X X 18 X X

Lithuania X X X X X X X X X X X X X X X 15 X X X

Luxembourg X X X X X X X X X X X X X X X X 16 X X

Madagascar X X X X X 5 X X

Malawi X X X X X X X 7 X X

Malaysia X X X X X X X X 8 X X

Maldives X 1 X X

Mali X X X X X X X X 8 X X

Malta X X X X X X 6 X X

Marshall

Islands 0 X

Mauritania X X X X 4 X X

Mauritius X X X 3 X X

Mexico X X X X

X

X X X X X X X X X X

X X

17 X X X

Micronesia

(Federated

States of)

X 1 X

Monaco X X X X X X X X X X X X X X X 15 X Mongolia X X X X X X X X X X X X X X X 15 X X

Montenegro X X X X X X X X X X X X X X X X X X X X X X X 23 X X

Morocco X X X X X X X X X X X X X X X 15 X X X

Mozambique X X X X X X 6 X X

Myanmar X 1 X X

Namibia X X X X X X X X 8 X X

Nauru 0 X Nepal X X X 3 X X

Netherlands X X X X X X X X X X X X X X X X X X X 19 X X X

New Zealand X X X X X X X X 8 X X X

Nicaragua X X X X X X X X X X X X 12 X X X

Niger X X X X X X 6 X X

Nigeria X X X X X X 6 X X

Norway X X X X X X X X X X X X X 13 X X X

Oman X X X X X X X X X X X X X X 14 X X X

Pakistan X X X 3 X X

Palau 0 X Panama X X X X X X X X X X X 11 X X X

Papua New

Guinea X X X 3 X X

Paraguay X X X X X X X 7 X X X

Peru X X X X X X X X X X X X 12 X X X

Philippines X X X X X X X X X 9 X X

Poland X X X X X X X X X X X X X X X X X X 18 X X X

Portugal X X X X X X X X X X X X X X X 15 X X X

Qatar X X X X X X X 7 X X

Republic of

Korea X X X X X X X X X X X X X X X 15 X X X

Republic of

Moldova X X X X X X X X X X X X X X X X X X X X X X X X 24 X X X

Romania X X X X X X X X X X X X X X X X X X X X X 21 X X X

Russian

Federation X X X X X X X X X X X X X X X X X X X 19 X X X

Rwanda X X X X X X X 7 X X

Saint Kitts

and Nevis X X X X X 5 X X

Saint Lucia X X X X X X X X X X X 11 X X

Saint Vincent

and the

Grenadines

X X X X X 5 X X

Samoa X X 2 X X

San Marino X X X X X X X 7 X Sao Tome

and Principe X X X X X X 6 X

Saudi Arabia X X X 3 X X

Senegal X X X X X X X X 8 X X

Serbia X X X X X X X X X X X X X X X X X X X X X X X X 24 X X Seychelles X X X 3 X Sierra Leone X X X X X 5 X X

Singapore X X X X X X X X X X X X X 13 X X X

Slovakia X X X X X X X X X X X X X X X X X X X 19 X X X

Slovenia X X X X X X X X X X X X X X X X X X X X X 21 X X X

Solomon

Islands 0 X X

Somalia X 1 X South Africa X X X X X 5 X X X

South Sudan 0 X Spain X X X X X X X X X X X X X X X X X X X 19 X X X

Sri Lanka X X X X X X X 7 X X

Sudan X X X X X X 6 X Suriname X X X X X X 6 X X

Swaziland X X X X X X 6 X X

Sweden X X X X X X X X X X X X X X X X X 17 X X X

Switzerland X X X X X X X X X X X X X X X X X X X X X 21 X X X

Syrian Arab

Republic X X X X

X X X X X X

X

X

X 13 X

Tajikistan X X X X X X X X X X X X X X X X X 17 X X

Thailand X X X X 4 X X

Timor-Leste 0 X Togo X X X X X X X X X X X 11 X X

Tonga X X X 3 X X

Trinidad and

Tobago X X X X X X X X X X X X X X 14 X X X

Tunisia X X X X X X X X X X X X 12 X X X

Turkey X X X X X X X X X X X X X X X X X 17 X X X

Turkmenistan X X X X X X X X 8 X Tuvalu 0 X Uganda X X X X 4 X X

Ukraine X X X X X X X X X X X X X X X X X X X X X 21 X X X

United Arab

Emirates X X X X X X X 7 X X

United

Kingdom X X X X X X X X X X X X X X X X X 17 X X X

United

Republic of

Tanzania

X X X X X 5 X X

United States

of America X X X X X X X X X X X X X X 14 X X X

Uruguay X X X X X X X X X X X X 12 X X X

Uzbekistan X X X X X X X X X X X 11 X X Vanuatu X X 2 X X

Venezuela

(Bolivarian

Republic of)

X X X X X 5 X X

Viet Nam X X X X X X X X X 9 X X X

Yemen X X X 3 X Zambia X X X X X 5 X X

Zimbabwe X X X X 4 X X

the former

Yugoslav

Republic of

Macedonia

X X X X X X X X X X X X X X X X X X X X X 21 X X X

OTHER ENTITIES

W P B PCT PLT MI MM MP H GH N LI RO LO IPC PH VC BP S NOS TLT W CT W PPT WAS SG BEIJING UN U W TO

African

Intellectual

Property

Organization

(OAPI)

X X 2

European

Union (EU) X X X X X 5 X X

Hong Kong,

China 0 X

Macao,

China 0 X

Taiwan,

Province of

China

0 X

TOTAL 185 174 166 146 32 36 56 88 60 45 83 27 91 52 62 78 31 78 35 50 55 90 91 3 31 1 193 71 159

W WIPO Convention P Paris Convention B Berne Convention PCT Patent Cooperation Treaty

PLT Patent Law Treaty MI Madrid Agreement (Indications of

Source) MM Madrid Agreement (Marks) MP Madrid Protocol

H Hague Agreement GH Geneva Act of Hague N Nice Agreement LI Lisbon Agreement

RO Rome Convention LO Locarno Agreement IPC Strasbourg Agreement PH Phonograms Convention

V C Vienna Agreement BP Budapest Treaty S Brussels Convention NOS Nairobi Treaty

TLT Trademark Law Treaty WCT WIPO Copyright Treaty WPPT WIPO Performances and

Phonograms Treaty WAS Washington Treaty

SG Singapore Treaty BEIJING Beijing Treaty on Audiovisual

Performances UN United Nations (UN) U UPOV Convention

WTO Agreement establishing the World

Trade Organization (WTO)

Annex II: NederlandstaligeSamenvatting

De masterproef ‘Biopiracy’ biedt een juridische analyse van het internationale rechtskader waarinbiopiracy ontstaan is en onderzoekt maatregelen die een oplossing kunnen bieden. Deze masterproefis onderverdeeld in drie delen: een inleidend deel waarin het fenomeen biopiracy gekaderd wordt entwee uitgebreidere delen die de hoofdzaak van deze thesis uitmaken.

In het eerste onderdeel wordt biopiracy in zijn context geplaatst. Niet alleen is biopiracy een politiekcontroversieel onderwerp, er bestaat zelfs geen eensgezindheid over een de!nitie voor de term. In hetlicht van deze masterproef kan biopiracy gede!nieerd worden als het gebruik van intellectuele eigen-domsbescherming (meestal octrooien) om het exclusieve bezit te legitimeren van biologische grond-sto#en en/of daarmee geassocieerde traditionele kennis die verworven zijn zonder toestemming ofcompensatie van andere (meestal ontwikkelings-) landen en lokale of inheemse gemeenschappen. Heteerste onderdeel geeft verder een overzicht van de historische evoluties en bespreekt via twee recht-szaken het verschil in mentaliteit tussen de Europese en Amerikaanse octrooi verlenende autoriteiten.

In het tweede onderdeel wordt een juridische analyse gemaakt van de internationale akkoorden dieeen e#ect hebben op biopiracy. De twee belangrijkste instrumenten zijn in dit opzicht het TRIPS akko-ord van de Wereldhandelsorganisatie en het VN Biodiversiteitsverdrag. Deze twee akkoorden hebbenelk een zeer verschillend doel voor ogen. Niet nakoming wordt door het TRIPS akkoord zwaar be-straft via handelssancties, vandaar is er e#ectief een wereldwijde minimum standaard aan intellectueleeigendomsbescherming. Het biodiversiteitsverdrag is echter heel wat minder krachtig. Daardoor kanbiopiracy blijven voortbestaan. Er zijn verschillende (grotendeels) vruchteloze pogingen ondernomenom het TRIPS akkoord aan te passen. In 2010 is het Nagoya Protocol aangenomen dat tracht een ef-fectiever regime tot stand te brengen om voordelen van biologische middelen en traditionele kennis teverdelen. Of dit protocol werkelijk iets zal veranderen, zal pas duidelijk worden na zijn inwerkingtred-ing.

Het derde en laatste onderdeel tracht enkele suggesties te geven om tot een oplossing te komenvoor het probleem van biopiracy. Eerst en vooral zou een meer diplomatische retoriek aangenomenmoeten worden om een betere atmosfeer tot stand te brengen voor verdere onderhandelingen. Er volgteen pleidooi voor het aannemen van drie maatregelen die tot een oplossing zouden kunnen leiden: eeninformatieverplichting in een octrooiaanvraag, databanken voor biologische middelen en traditionelekennis en publiek-private akkoorden. De huidige impasse in internationale gesprekken met betrekkingtot biopiracy geven echter niet veel hoop op een spoedige oplossing.

Samenvattend bevat deze masterproef een analyse van de zwakke punten in het huidige interna-tionale rechtskader rond biopiracy en suggesties om deze aan te pakken.

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