The Protection of Biodiversity and Traditional Knowledge in International Law of Intellectual Property pot

The Protection of Biodiversity andTraditional Knowledge in International Law of Intellectual Property The relationships between international intellectual property treaties,the United Na

The Protection of Biodiversity and

Traditional Knowledge in International

Law of Intellectual Property

The relationships between international intellectual property treaties,the United Nations international environmental treaties (first and fore-most the convention on Biological Diversity), the relevant customarynorms and soft law form a complex network of obligations that some-times conflict with each other The first set of treaties creates privaterights while the latter affirms the sovereignty rights of States over geneticresources and related knowledge and creates international regimes ofexploitation of the same

Jonathan Curci proposes solutions to the conflicts between treatiesthrough the concept of“mutual supportiveness,” including the construc-tion of a national-access and benefit-sharing regime, mandatory contrac-tual provisions in relevant international contracts, a defensive protectionwhen genetic-resource-related traditional knowledge is unjustly patentedthrough the analysis of the concepts of “ordre public and morality,”

“certificate of origin” in the patent application and “novelty-destroyingprior art” and positive protection through existing and sui generis intel-lectual property rights and misappropriation regimes

jonathan curci is the Legal Counsel of Quantam Business Group,Ltd, Israel and Academic Counsel of Touro International University,Rome

As its economic potential has rapidly expanded, intellectual propertyhas become a subject of front-rank legal importance CambridgeIntellectual Property and Information Law is a series of monograph studies

of major current issues in intellectual property Each volume contains amix of international, European, comparative and national law, makingthis a highly significant series for practitioners, judges and academicresearchers in many countries

Judge of the Court of Appeal, England

A list of books in the series can be found at the end of this volume

The Protection of Biodiversity and Traditional Knowledge in International Law of

Intellectual Property

Jonathan Curci

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© Jonathan Curci 2010

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eBook (NetLibrary)Hardback

1 Introduction to legal issues related to genetic resources andtraditional knowledge in the international intellectual

Part II The protection of genetic resources in intellectual

2 The TRIPS Agreement and the patent protection of genetic

2.1 The general principles of the TRIPS Agreement 29

2.2 The patentability of biotechnology 36

2.3 Economic considerations on biotech-patents and their interaction

3 The relationship between the TRIPS Agreement and

treaties protecting genetic resources and traditional

3.1 The impact of the TRIPS Agreement on CBD obligations 51

3.2 The impact of UPOV on the freedom of exchange of seeds 62

3.3 Some international intellectual property aspects of the FAO

v

Part III The protection of traditional knowledge in the

4.1 An intellectual property approach to the concept of traditional

5.1 The CBD mandated access- and bene fit-sharing regime 104

5.2 An access- and bene fit-sharing regime and the contractual solution 105

6 The defensive protection of traditional knowledge in

6.1 The certi ficate on the disclosure of origin/source 132

6.2 Traditional knowledge as prior art 208

6.3 Ordre public and morality as exception to patentability 233

7 Positive protection of traditional knowledge 275

7.1 Positive protection of plant genetic resources and related traditional knowledge in provider countries 275

7.2 Protecting traditional knowledge through the implementation of

7.3 The creation of new intellectual property rights for plant genetic

resources related to traditional knowledge 285

7.4 The protection of traditional knowledge through unfair competition 304

7.6 Applying patent law to traditional knowledge innovation 313

7.7 Overview on the utility of geographical indications and trademarks 315

List of abbreviations

ABS access and benefit sharing

ACP African Caribbean Pacific

AIPLA American Intellectual Property Law AssociationAIPPI Association internationale pour la protection de la

propriété intellectuelleARIPO African Regional Industrial Property OrganizationATRIP International Association for the Advancement of

Teaching and Research in Intellectual PropertyCAF Corporación Andina de Fomento

CBD Convention on Biological Diversity

CBE Convention sur le brevet européen

CFR Code of Federal Regulations

CGIAR Consultative Group on International Agricultural

ResearchCGRFA Commission on Genetic Resources for Food and

AgricultureCHM clearing house mechanism

CIEL Center for International Environmental Law

CIT Court of International Trade

CLR compulsory liability regime

CNRS Centre nationale de la recherche scientifique

COP Conference of the Parties

CPGRFA Commission on Plant Genetic Resources for Food

and AgricultureCRADA Cooperative Research and Development AgreementCSD Commission on Sustainable Development

CSIR Council for Scientific and Industrial ResearchDC/DCs developing country/developing countries

DDAGTF Doha Development Agenda Global Trust FundDNA deoxyribonucleic acid

DSB dispute settlement body

DSU dispute settlement understanding

vii

EC European Community

ECHR European Convention of Human Rights

ECJ European Court of Justice

ECOSOC United Nations Economic and Social CouncilEPC European Patent Convention

EPO European Patent Office

FAO Food and Agriculture Organization

GAOR General Assembly Official Records

GATT General Agreement on Tariffs and Trade

GIs geographical indications

GMO genetically modified organism

GNU general public license

GPA Global Programme of Action for the Protection of the

Marine Environment from Land-based ActivitiesGR/GRs genetic resource(s)

GRAIN Genetic Resources Action International

GRULAC Group of Countries of Latin America and the

CaribbeanHIV human immunodeficiency virus

IAO Instituto Agronomico per l’Oltremare

ICANN Internet Corporation for Assigned Names and

NumbersICESCR International Covenant on Economic, Social and

Cultural RightsICJ International Court of Justice

ICTSD International Centre for Trade and Sustainable

DevelopmentIGC intergovernmental committee

ILA International Law Association

ILC International Law Commission

ILM International Legal Materials

ILO International Labor Organization

INBio Costa Rican National Biodiversity Institute

INDECOPI Instituto Nacional de Defensa de la Competencia y de

la Protección de la Propiedad Intelectual

IPGRI International Plant Genetic Resources Institute

IPGRTKF intellectual property and genetic resources,

traditional knowledge and folkloreIPR intellectual property right

ITPGRFA International Treaty on Plant Genetic Resources for

Food and AgricultureIUCN The World Conservation Union

IUPGR international undertaking on plant genetic resourcesLDC least developed country

MEA multilateral environment agreement

MNC multinational corporation

MTA material transfer agreement

NAFTA North American Free Trade Agreement

NGO non-governmental organization

NIF national innovation fund

OAU Organization of African Unity

OEB Office européen des brevets

OECD Organization for Economic Cooperation and

DevelopmentOSD open source definition

OSI open source initiative

PBR plant breeders’ right

PCIJ Permanent Court of International Justice

PCT Patent Cooperation Treaty

PGM plant genetic material

PGR/PGRs plant genetic resource(s)

PGRFA plant genetic resources for food and agriculturePGS plant genetic systems

PIC prior informed consent

PLO Palestine Liberation Organization

PVP plant variety protection

R&D research and development

RAFI Rural Advancement Foundation International (now

Action Group on Erosion, Technology andConcentration, ETC Group)

RSA Recueil des sentences arbitrales

SAA Round Statement for Administrative Action

SAARC South Asian Association for Regional CooperationSADC Southern Africa Development Community

SCP Standing Committee Law of Patents

SINGER System-wide Information Network for Genetic

ResourcesSPLT Substantive Patent Law Treaty

SPS Sanitary and Phytosanitary Measures

SRISTI Society for Research and Initiatives for Sustainable

Technologies and InstitutionTAK traditional agricultural knowledge

TEK traditional ecological knowledge

TIPR/TIPRs traditional intellectual property right(s)

TKUP traditional knowledge of the uses of plants

TMK traditional medicinal knowledge

TRIPS Agreement on Trade-Related Aspects of Intellectual

PropertyUDHR Universal Declaration on Human Rights

UNCTAD United Nations Conference on Trade and

DevelopmentUNEP United Nations Environment Program

UNESCO United Nations Educational, Scientific and Cultural

OrganizationUNFOF United Nations Forum on Forests

UNHCR United Nations High Commissioner for Human

RightsUNTS United Nations Treaty Series

UPOV Union internationale pour la protection des

obtentions végétales (International Union for theProtection of New Varieties of Plants)

URAA Uruguay Round Agreements Acts

USPTO United States Patent and Trademark Office

VCLT Vienna Convention on the Law of Treaties

WHO World Health Organization

WIPO World Intellectual Property Organization

WIPO IGC on

IPGRTKF

Intergovernmental Committee on IntellectualProperty and Genetic Resources, TraditionalKnowledge and Folklore

WSSD World Summit on Sustainable Development

WTO World Trade Organization

The present work is based on a doctoral dissertation deposited at theLibrary of the Graduate Institute of International and DevelopmentStudies University in Geneva (Switzerland) that is much richer in terms

of footnotes and legal reasoning because broader in scope than the presentbook I thank the University of Torino (Italy) and the Brigham YoungUniversity in Provo, Utah (United States of America) for providing thenecessary education, their libraries and work place to draft this work Iowe a special thanks to the Research Fund of the European Patent Office(EPO) for the grant that has allowed me to carry on this work under morecomfortable conditions

I wish to express my gratitude to the supervisor of the underlyingdoctoral work Marcelo Kohen (Professor of International Law at theGraduate Institute of International Studies in Geneva, Switzerland),Thomas Cottier (Director of the World Trade Institute– WTI – at theUniversity in Berne, Switzerland) and Marco Ricolfi (Professor ofIntellectual Property at the Law School of the University of Turin,Italy) Their extensive expertise in the technical aspects of the new andcutting-edge topic of international trade law and the opportunities each ofthem were able to offer me as a researcher or consultant on projects undertheir direction provided me with invaluable experience, as well as much-needed motivation

I also wholeheartedly thank Dr Anthony Taubman, Acting Directorand Head of the WIPO Global IP Issues Division, and Dr Shakeel Bhatti,former Head of the WIPO Genetic Resource Traditional Knowledge andBiotechnology Section A special thanks to my friends Daniel Stewart(Attorney-at-Law), David Newell and Peter Bradford (Patent Attorney)for having thought, discussed and researched with me related topics in ourprofessional and research projects

A very special thanks for the linguistic insights and corrections byAlison Craig and William Marconi

xi

Part I

The main problems

1 Introduction to legal issues related to genetic

resources and traditional knowledge in the international intellectual property system

In the new millennium, biotechnology is enabling genetic engineering toyield very important breakthroughs, with immense possibilities for novelorganisms to be developed The myriad biotechnological applicationsreleased into the environment for pharmaceutical, agricultural, andmedicinal purposes generate transnational concerns that pose an enor-mous challenge to national and international communities The means ofprotection sought for these types of inventions is the patent Althoughopinions about how much patent systems contribute to long-term eco-nomic growth vary, there can be no dispute that patents are vital to thebusiness models of many companies and are playing an increasing role insociety As human technological prowess has expanded throughout thenatural and human worlds, the patent has followed, not far behind.Questions about the proper place of patents in society, some old andsome new, have found increasing urgency and importance, especially aspatent law extends to societies not accustomed to its peculiarities.Peoples in developing countries (DCs) denounce the patentability ofgenes, which reduces the world’s genetic resources (GRs) down to mereproperty rights, resulting in corporate control over access to food, medic-inal technology, and other resources essential to mankind’s health andwelfare Additionally, potential transnational harm caused by geneticengineering may also arise through the destabilization of regional ecolo-gies via genetic pollution and through an accelerated decline of biologicaldiversity on a global scale Thus, legal control over biodiversity is an issue

of serious international consequence

The present book focuses particularly on the international legal regime

of commercial exploitation and ownership of GRs, on which logical innovation is based At the core of this study lies the problems ofsharing benefits arising from the exercise of intellectual property rights(IPRs) over plant genetic resources (PGRs) and traditional knowledge(TK) under existing treaties and conventions with special attention to thecontractual relations between companies from industrialized countriesand indigenous communities and genetic resource providing countries

biotechno-3

Although this analysis is conducted through an international law approach,

it does not neglect some anthropological and sociological aspects of privateownership of living forms and its interaction with different value systems

1.1 Defining the problems

This chapter starts with general considerations on the problem of ship and patents on PGRs; in a second stage, it observes the interactionamong the international public domain, the States’ sovereign rights overPGRs and private IPRs over the same, and ultimately introduces the newproblem of traditional knowledge (TK)

owner-It lays out the methodological aspects of the analysis and presents a briefoverview of the theories of creation of the sources of international law thatare relevant to this subject-matter and that will be used through thedevelopment of analysis Accordingly, the impact of international law,with particular attention to World Trade Organization (WTO) law, shall

be taken into account in a comparative approach Because the EuropeanUnion (EU) and United States (US) jurisdictions have developed variouslaws, policies and judicial decisions on the relationship between protec-tion of biodiversity and intellectual property they offer broad examples ofimplementation of international law that are worthy to be described anddiscussed when appropriate

1.1.1 Patents and ownership of genetic resources

The patentability of biotechnology took off after the US Supreme Court’slandmark decision in Diamond v Chakrabarty.1By acknowledging that statu-torily patentable subject-matter included“anything under the sun that ismade by man,” the Court encompassed both foreseeable and unforeseeablesubject-matter This Diamond standard encompassed the inventive work ofbiotechnology and gene sequences Consequently, an “imitation effect”rippled from the US to Europe and other jurisdictions, generating a series

of legislative measures to patent living forms In addition, the WTOAgreement on Trade-Related Aspects of Intellectual Property Rights2

1 Diamond v Chakrabarty, 447 United States, 303 –09 (1980), reported also in F Abbott,

T Cottier and F Gurry (eds.), The Intellectual Property System: Commentary and Materials (Kluwer, The Hague, 1999) 25.

2 Agreement on Trade-Related Aspects of Intellectual Property Rights (April 15, 1994) Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round 31–33 International Legal Materials (ILM)

1197 (1994).

(TRIPS) internationalized the patent protection of biotechnologicalpractices.

In industrialized societies, investment and innovative output in thebiotechnology industry has been so conspicuous that the benefits ofinnovation in this field have generally been viewed as outweighing thecosts of the monopolistic restrictions created by patents Now, not onlyplant varieties but also micro-organisms and genetically modified animalsare patentable Genetically altered animals, such as the infamous Onco-Mouse of Harvard University (bred for cancer research), have also beengiven patents Thousands of patent claims have been made and granted

on human genetic material, including material that has arguably beenaltered from its natural state

The patent is the primary IPR that is sought in thefield of biotechnologybecause it is meant to be a right concerning innovations used in new orimproved products or processes Patents enable the holder to excludeimitators from marketing such inventions or processes for a specifiedtime; in exchange, the holder is required to disclose the formula or ideabehind the product or process After a patent is granted, the owner has amonopoly over commercial exploitation of the invention for a limitedperiod The stated purpose of a patent is to stimulate innovation byoffering higher monetary returns than the market otherwise mightprovide.3

There are two problems that patent protection generates The firstconcerns the monopolistic feature of the cost analysis of patent protection

in this field The classical IP scholarship has crafted each protectionaccording to the principle of“allocative efficiency” according to whichthe long-term benefits flowing to society from the protection granted to aparticular class of creators or innovators outweigh the (mainly short-term)costs imposed by the monopolistic structure of the patent grant.4And the

“mainstream legal literature” has applied this standard principle from IPeconomics to the patenting of biotechnology as well.5

The second problem is generated when formal, industrial, patentableknowledge builds upon prior art of informal TK which is in a quasi-commons

3 Abbott et al., The Intellectual Property System, 25.

4

P Torremans and J Holyoak, Intellectual Property Law (Oxford University Press, 2006) 16,

20 N Carvalho, “From the Shaman’s Hut to the Patent Office: How Long and Winding is the Road? ” (1999) 40 Revista da ABPI 3–28 R H Coase, The Firm, the Market and the Law (University of Chicago Press, revised edition, 1990), see chapters 1 and 2 “The Firm, The Market, and The Law” and “The Nature of the Firm.”

5

Which includes, in the European literature in the bibliography quoted in M Ricol fi,

“Biotechnology, Patents and Epistemic Approaches” (2002) Journal of Biolaw & Business, Special Supplement 77 –90.

regime When it comes to the benefit sharing of the profits arising from theexploitation of this knowledge at the international level these problems areamplified.

A vivid example of benefit sharing illustrates the controversy of privateproperty rights in GRs based on TK held by indigenous groups Imagine aplant that produces a natural sweetener and has been preserved for severalmillennia in a local farming micro-culture This sweetener performs itssweetening function without negative dietary or health side effects Aforeign corporation comes along bioprospecting and secures samples ofthe local sweetening plant, maps its genome, and then proceeds to genet-ically engineer a plant that yields sweetener with a potency tenfold that ofthe original The corporation then patents the modified plant, and theworld quickly forgets the original plant as the patented plant is markedlymore productive Consequently, through commercialization, all of theprofits flow to the company patent holder without a farthing going to theindigenous farmers who preserved the plant for millennia Some 6.5percent of all genetic research undertaken in agriculture focuses ongerm plasma derived from wild species and land races (farmer-developedvarieties of crop plants that are adapted to local environmental condi-tions) Thus, the question is posed: is it fair to give the entire pastry to theone who adds thefinal cherry to the pie?6

This tendency has been popularly called biopiracy or biocolonialism Theorigin of the two terms reveals that the context in which they were formed

is the one of political science or sociology These are not legal terms,let alone technical intellectual property terms The term biopiracy wascoined by Mooney as part of a counter-attack strategy on behalf of DCsthat, as already said, are accused by industrialized countries of supportingintellectual piracy, i.e., counterfeiting all types of goods protected in theindustrialized countries by IPRs In turn, DCs feel that they are no morepirates than corporations that acquire resources and TK from their coun-tries, use them in their Research and Development programs, and acquirepatents and other IPRs without compensating the provider countries andcommunities.7 This anti-biopiracy rhetoric adopted by some DC trade

6 Ricol fi, “Biotechnology, Patents and Epistemic Approaches”, 77; T Cottier, “The Protection of Genetic Resources and Traditional Knowledge: Towards More Speci fic Rights and Obligations in World Trade Law ”, in Abbott et al., The Intellectual Property System 1820 –27; M Blakeney, Presentation at the World Intellectual Property Organization (WIPO) – Torino Law School Specialization Course in Intellectual Property, International Property Aspects of Traditional Agricultural Knowledge (TAK)

2 (Nov 22, 2001), unpublished, on file with the author.

7 R Mooney, “Why I Call It Biopiracy”, in H Svarstad and Sh S Dhillion (eds.), Responding to Bioprospecting: From Biodiversity in the South to Medicines in the North

negotiators has not prevented the legalization of this so-called“conquest”through the TRIPS Agreement This treaty extends to all the developingand least developed members of the WTO the obligation to grant IPRs(patents, trademarks, and trade secrets, etc.), and, to some extent, also toinnovations based on GRs, without mandating any compensation to thelocal communities who have bred and preserved these resources At thesame time, some 90 percent of genetic information and related TK arefound in DCs.8

Biocolonialism is another term related to biopiracy and it often refers tothe pattern whereby the industrialized country corporation extracts rawgenetic materials from the DC, patents the genetically modified productsbased on the raw materials without prior informed consent (PIC) andbenefit sharing, and then sells the finished product to the provider country

at unaffordably high prices In addition to these perceptions of injusticeand misappropriation, the wide scope of the exclusive patent rightsgranted in industrialized countries stirs animosity on the part of theconsumers in DCs, especially when the patent itself is based on a GR or

TK preserved by the consumers of the patented product in DCs.Even part of the legal doctrine has been vociferously arguing that IPregimes may jeopardize the freedom of countries or communities tochoose the way in which they want to deal with the use and protection ofbiodiversity and the related TK This issue blatantly arises when the genesare not appropriated by the sovereign State that patents them but by aforeign entity that manipulates and sells the genetically modified product

As a consequence of the double expansion of patent law both frominanimate to animate subject-matter (biotechnological inventions) andfrom a small group of industrialized countries to most of developing andLeast Developed Countries (LDCs), several peoples in DCs are reactingagainst this kind of “piracy” of indigenous and local communityknowledge

These are some of the reasons for which peoples in DCs allege that IPRs

in thefield of biotechnology could prevent the Convention on BiologicalDiversity (CBD) from realizing the full and practical meaning of Article 39

on national sovereignty over their natural resources and Article 8(j)10on

(Spartacus Press, AS., Oslo, 2000) 37; V Shiva, Biopiracy: the Plunder of Nature and Knowledge (South End Press, 1998) 1 –5; A Story, “Biopiracy and the Dangers of Patent Over-protection ”, (1999) 149 New Law Journal 158.

the rights of local and indigenous communities These provisions aim atfairly distributing the benefits resulting from the use of GRs situated in theterritories of the Contracting Parties.

Industrialized countries respond by affirming their effort to developtechnology enabling the modification, the innovation, and the market-ability of raw genetic materials that otherwise would remain unexploitedwithin developing country indigenous communities that do not have suchcapacities The debate is acrimonious and solutions are not easily at hand

1.1.2 International public domain, sovereign rights, and intellectual property

rights over genetic resources

This section moves from the general concept of ownership of GRs to theconflict between a State’s public law regime of exercise of sovereigntyrights upon GRs and then to the private exercise of IPRs upon the same.The international exercise of patent rights has an impact both on theownership regime over the GR per se and on the knowledge of the uses forand the characteristics of plant and animal GRs Biotechnology depends

on biological diversity as the basis of innovation The access to biologicaldiversity in a given country has traditionally been free and open This led

to the basic inequity (already sketched insection 1.1above) consisting ofthe freedom of appropriation of GR and of TK on the part of the inventor

on one side, while on the other the users in the country in question had topurchase the secondary products subjected to proprietary protection.Profits flow into the hands of right-holders in industrialized countriesfor the exploitation of biodiversity and related knowledge in DCs.For example, suppose a researcher were to incorporate into his studies

TK that had been generated by a particular community over hundreds ofyears and not attributable to any particular person As far as the researcher

is concerned, the TK used in his research is, for all intents and purposes,public domain knowledge Suppose further that the researcher subse-quently reports this knowledge with or without acknowledging the intel-lectual contributions of the initial TK holding community Should thatinformation ever prove useful in the creation of a patentable good, i.e thecreation of a drug through use of TK on a particular medicinal plant,the community would be without recourse to claim ownership or rights

in the TK at the heart of the innovation, merely because that TK was

2001) 50 T Taubman, “Genetic Resources” in S Von Lewinski, Indigenous Heritage and Intellectual Property: Genetic Resources, Traditional Knowledge and Folklore (Kluwer, The Hague, 2nd edn, 2008) 192 –216.

within the public domain at the time it was recorded Meanwhile, thecompany owning the patent exclusively reaps all the commercial benefits.

In the systems of protection of IP in industrialized countries, TKrelated to GRs has until recently been considered as international publicdomain because of the confusion of the public domain with the interna-tional legal concept of res communis humanitatis (common heritage ofmankind).11 The assimilation of TK into res communis humanitatis wasnecessary to justify the free accessibility of TK to all private users.12Whilethe concept of res communis humanitatis covers the ocean floor,13

Antarctica,14the moon,15and outer space,16it is doubtful, in my view,whether biodiversity in general should be placed under the concept ofcommon heritage of mankind, stricto sensu.17There is no treaty or custom-ary principle18that places TK and GRs under the concept of res communishumanitatis On the contrary, starting from the colonial era, colonial statesused to transfer GRs to their masters as contributions to their researchcenters.19

The international communityfinally discussed the position of GRs ininternational law during negotiation of the CBD adopted in 1992 At thestart of the negotiations, the legal status of GRs in situ and ex situ was very

15 K Baslar, The Concept of the Common Heritage of Mankind in International Law (Martinus Nijhoff, The Hague, 1998) 307 –13 C Christol, “The Common Heritage of Mankind Provision in the 1979 Agreement Governing the Activities of States on the Moon and Other Celestial Bodies ”, (1980) 14 International Lawyer 429.

16

P P C Hannapel, The Law and Policy of Air Space and Outer Space: a Comparative Approach (Kluwer, The Hague, 2003); L Tennen, “Outer Space: A Preserve for All Humankind ”, (1979) 1 Houston Journal of International Law 145.

17 I Mgbeoji, “Rethinking the Role of International Law in Relation to the Appropriation of Traditional Knowledge of the Uses of Plants ” 132, 139, 148, 150, 159, 161, 163–70, 179,

252, 253 (a dissertation submitted for the Degree of Doctor in the Science of Law, Dalhousie University Halifax, November 2001 Copy on file with author).

18 A D ’Amato, “Trashing Customary International Law in Appraisals of the ICJ’s Decision: Nicaragua v United States ”, (1987) 81 American Journal of International Law 74–75;

M S McDougal, H D Lasswell, and M Reisman, “The World Constitutive Process of Authoritative Decision ”, (1967) 19 Journal of Legal Education 403.

19

I Mgbeoji, “Rethinking the Role”, 163–70.

unclear: few national laws had been enacted for the commercial tion of the GRs in situ and no real international status had been createdfor the gene banks conserving germplasm20 ex situ (see in more detail

exploita-section 4.2.3below) Ex situ collections of GRs could be acquired freely;

no international obligations existed to share the economic benefits to thecommunities that provided and conserved the resources, and only veryfew international breeding programs were set up to develop and distributecrop varieties for use in the DCs.21

The status of GRs in international law started to be clarified with theadoption of a United Nations (UN) General Assembly Resolution 1830(XVII) on 4 December 1962 At that time, the international communityfocused its efforts on the preservation of biological diversity and on itsrelated knowledge under threat of extinction Meanwhile, the slow proc-ess of globalization of IPRs was considered a successful tool in protectingand encouraging the further development of so-called “modern,”

“formal,” or “technological” knowledge applied to GRs (see the relevantdistinctions of TK insection 4.2below) TK holders, especially in DCs,had felt that this knowledge, passed on from generation to generation, hadprogressively become an“economic resource.” The increasing pace ofexploitation of this knowledge through modern technological instrumentsled the international community to shift the focus of its attention from the

“preservation” of GRs to their “utilization.” Rapidly, various tional fora became involved in the regulation of this matter: UnitedNations Environmental Program (UNEP), World Intellectual PropertyOrganization (WIPO), United Nations Educational, Scientific andCultural Organization (UNESCO), International Labour Organization(ILO), United Nations Conference on Trade and Development(UNCTAD), etc.22

interna-One of the most important highlights in the chronological development

of international public policy on this matter occurred in 1989, when theUnited Nations Food and Agriculture Organization (FAO) enacted theInternational Undertaking on Plant Genetics Resources (IUPGRs),which originally defined PGRs as the “heritage of mankind which should

be available without restriction.” In other words it considered the plasm collected ex situ in gene banks as“common heritage of mankind.”

germ-20 Germplasm is genetic material extracted from a plant.

21

M Hassemer, “Genetic Resources” in S Von Lewinski (ed.), Indigenous Heritage and Intellectual Property: Genetic Resources, Traditional Knowledge and Folklore (Kluwer, The Hague, 2004) 159 –60.

22

See Table 1 “The Overview of the Regulatory Framework”, in T Taubman and

M Leistner, “Analysis of Different Areas of Indigenous Resources” in Von Lewinski, Indigenous Heritage and Intellectual Property (2nd edn, 2008) 200 –1.

This concept was maintained in the IUPGRs of the FAO until 2001(seesection 3.3 below) when the international community adopted theFAO International Treaty on Plant Genetic Resources for Food andAgriculture (ITPGRFA) that facilitated access to a database of PGRsheld in trust by a Multilateral System for specific purposes of utilization.23

This treaty thus establishes PGRs in a combination of a regime of Statesovereignty and a regime of multilateral cooperation, although nowhere inthe ITPGRFA is this concept explicitly stated

The legal status of the rest of the biodiversity was defined by the CBDadopted by the UNEP in 1992 In its preamble, it is stated that the preser-vation of biodiversity is a“common concern of humankind,” whereas, in itsArticles 3 and 15.1, it acknowledges the principle of permanent sovereignty

of the States over their natural resources on their territories This means thataccess to GRs has to be regulated by a private law contract, a so-called

“material transfer agreement” (MTA) involving the provider State and prospecting entity (seechapter 5) The international community has movedfrom this bilateral-contractual solution envisaged by the CBD to a clarifica-tion of the concept of“common concern of humankind” as it relates to theconservation and sustainable exploitation of PGRs

bio-Finally, the WIPO General Assembly, in creating in 2000 theIntergovernmental Committee on Intellectual Property and GeneticResources, Traditional Knowledge and Folklore (WIPO IGC onIPGRTKF) has started a new era of diplomatic discussions on the inter-action among IP, GRs and TK This IGC, supported by a Secretariat oftechnical experts in thefield, is paving the way for the negotiation andadoption of a treaty which should clarify the relationship between privaterights of intellectual property and TK

1.1.3 Introduction to the tensions between the exercise of intellectual

property rights and preservation of genetic resources

Six months after the CBD entered into force, WTO Members adopted theTRIPS Agreement in 199424that marked the commencement of a newera of globalization of IPRs.25This treaty mandates minimum standards

of private property protection of all types of“formal” or “modern edge,” including knowledge developed from GRs Since then IP scholarshave intensely studied the ability of TRIPS-mandated IPRs to protect TKrelated to GRs, taking into account the parallel evolution of non-IPtreaties (e.g CBD and ITPGRFA) Indeed States’ obligations under

knowl-23 www.fao.org/Legal/treaties/033t-e.htm, last viewed November 2007 24 TRIPS.

25

As of January 2007 there are 150 Member States in WTO.

non-IP international law drag the patent system into an unprecedentedpublic debate.

Traditionally, the international IP system had been developed on thebasis of common economic values belonging to a restricted number ofindustrialized countries Since IPRs are territorial– i.e their enforcementcan only be effective within the boundaries and according to the laws of agiven nation or region– international conventions were aimed at harmo-nizing the IP aspects of the national legal traditions of contracting parties.One of the globalizing effects of TRIPS Agreement is to extend theserights and obligations to all the DCs’ national legal systems that do nothave the same level of industrial development to let them benefit from theinternational exercise of IPRs DCs are mainly users instead of holders ofIPRs

It has been observed insection 1.1.1above that the international patentsystem has been experiencing a double expansion both sectorial and geo-graphic: (i) from the traditional protection of inanimate matter to themore sophisticated and complex protection of biological matter; (ii)from the small number of Northern industrialized countries to theSouthern developing and least-developed countries This double expan-sion has been generating a three-dimensional hardship: (i) a certaincriticism of the classic patent system as conceived by the initial industrial-ized countries that created it; (ii) an unprecedented disequilibriumbetween the immediate interests of industrialized countries and DCs;(iii) an institutional fragmentation and overlap among various UN agen-cies and other international fora addressing IP, biotechnology, biodiver-sity conservation and utilization, local farmers’ development and the like.These tensions between IP and environment exist mutatis mutandisbetween IP and otherfields (for instance, health, cyberspace, etc.).Major industrialized States have realized the potential gains flowingfrom this new technology for their national economies spurred on byprivate industries Consequently, they are promoting stronger IP stand-ards to be integrated in multilateral and bilateral treaties to which mostDCs are parties At the same time, industrialized countries have beenaccused of watering down the patentability requirements of biotechnologywithin their own national jurisdictions in order to accommodate corporateinterests without precisely and carefully considering the issues involvedand the consequences thereof

In sum, the transnational behavior of subjects of international law inthis field has been regulated by at least two major multilateral treatieswhich are both legally binding: the CBD and TRIPS Agreement Sincethese issues are intrinsically complex and multifaceted, various interna-tional institutions (such as WIPO, FAO, UNESCO, ILO to name only a

few) are becoming eagerly involved in producing guidelines or even newtreaties on the subjects concerned.

With respect to biotechnological inventions, State Parties are bound,under Article 27 of the TRIPS Agreement, to accept: patenting of micro-organisms and “microbiological processes” and providing some

“effective” form of IPRs on plant varieties, either patents or some suigeneris (new) version But, while the TRIPS Agreement requires thatStates grant exclusive private rights over biological material, the CBD,

on the contrary, affirms the sovereign rights of States to biologicalmaterial This is the“epitaph” that utters the core of the dichotomy thatwill be developing throughout my study (see in particularchapter 3).Broadly speaking, tensions between the sovereign rights of States andthe expansion of IPRs to biological subject-matter has to be primarily seen

in the framework of resource allocation at the international level– underthe pressure of science and technological innovation within nationaleconomies In this context, an analogy can be drawn between the expan-sion of sovereignty rights over GRs and the law of the sea.26The evolution

of the law concerning the continental shelf, exclusive economic zones andthe phenomenon of the“State’s creeping jurisdiction” during the last 50years has been due to the invention of the combustion engine, other uses

of oil, gas, and mineral resources, and the advancement offishing nology.27 The codification of the CBD marks the same tendency of

tech-defining the expanding sovereign rights of States over their GRs, evenincluding the information contained therein The expansion of IPRs frominanimate to animate subject-matter has followed the same pattern.However, thefirst difference consists in the fact that the law of the seasets forth the rights of the State whereas the IPRs on biotechnologicalinventions concern essentially private rights A second difference, and amore complex one, is that thefirst kind of conventions deal with physicalfeatures of natural resources (land, airspace,fish, gas, oil), whereas IPRsdeal with appropriation of ubiquitous information: in our case, geneticallyencoded, exclusively in nature and untouched by the genetic alterations ofman in a laboratory

The expansion of IPRs to living matter has to be interpreted also in light

of a basic structural economic problem If traditionally States have takenresponsibility for the development of biodiversity, e.g plant varieties,

27

Cottier, “The Protection of Genetic Resources”, 1823.

governments no longer can take it for granted that this work will befinanced by the tax-payer During the last decade, many States havefostered privatization of many previously State-owned businesses whichhas transferred some of the decision-making power of governments toprofit-driven private companies The repercussions on the internationallaw-making process within international organizations, such as WTO,have been evident: since the scope of IPR protection granted to specificsubject-matters is one of the most important forms of revenue for com-panies, they strongly encouraged their States to include TRIPS as a WTOAgreement to assure the respect of their IPRs also in all DCs willing tobecome members of WTO And IPRs on living matter are no exception

to this trend

While the expansion of IP protection is including living matters, theworld is experiencing an unprecedented loss of biodiversity: one hundredspecies become extinct every day, many more than the creation of newspecies This “biocide” (neologism for “biological extermination”) isaccomplished while few transnational corporations will eventually controlthe world’s food supply because of the disparity of means of research.Indeed biotechnology today is substantially driven by private companyresearch which will be critical in achieving future food security In turn,the incentive for biotechnological inventions is stimulated by afinancialinvestment thatflows only if such an invention is protected by an appro-priate kind of IPR The loss of biodiversity associated with the allegedmisappropriation of TK related to GRs creates worries in many DCswhose sustainable development largely relies upon these two essentialelements

1.1.4 A brief introduction to the concept of traditional knowledge

The terminologies“biodiversity-related TK,” “TK related to GRs,” or

TK tout court signify the same IP protectable subject-matter.Anthropological science generally prefers to use the expression “tradi-tional ecological knowledge.”28

For the purpose of IP protection, TK is the information on GRs thatpeople in a given community, based on experience and adapted to localculture and environment, have developed over time; TK constantlyevolves This knowledge is used to sustain the community and its cultureand to maintain the biological resources necessary for the continuedsurvival of the community The Canadian government’s Royal

28 T Taubman and M Leistner, “Analysis of Different Areas of Indigenous Resources”, in Von Lewinski, Indigenous Heritage and Intellectual Property, 69 –89.

Commission on Aboriginal Peoples views indigenous knowledge“as acumulative body of knowledge and beliefs, handed down through gener-ations by cultural transmission, about the relationship of living beings(including humans) with one another and their environment.”29

Hansen and Vanfleet introduce this basic definition in their handbook:

Traditional knowledge includes mental inventories of local biological resources,animal breeds, local plants, crop and tree species It may include such information

as trees and plants that grow well together and indicator plants such as plants thatshow the soil salinity or that are known toflower at the beginning of the rains Itincludes practices and technologies, such as seed treatment, storage methods andtools used for planting and harvesting Traditional knowledge also encompassesbelief systems that play a fundamental role in a people’s livelihood and in main-taining their health and the environment Traditional Knowledge is dynamic innature and may include experimentation in the integration of new plant or treespecies into existing farming systems or a traditional healer’s tests of new plantmedicines

The term“traditional” – used to describe this knowledge – does not imply thatthis knowledge is old or untechnical in nature, but rather that it is“based ontraditions.” It is traditional simply because it is created in a manner that reflects thetraditions of the communities wherever they may be found In this sense TK iseasily distinguishable from cosmopolitan knowledge, which is drawn from globalexperience and combines“western” scientific discoveries, economic preferencesand philosophies with those of other widespread cultures.30

TK does not relate to the nature of the knowledge itself, but to the way

in which that knowledge is created, preserved, and disseminated.Knowledge typically refers to “information held in human memoriesthat is accessible, by recall and the practice of learned skills, in a usefulway in day-to-day life.”31TK is more broadly defined as wisdom, whichimplies a blend of knowledge and experience integrated with a coherentworld view and value system Within the context of TK, the meaning of

“traditional” implies that such knowledge is handed down from onegeneration to another, and that it has been accumulated by societies inthe course of long experience in a particular place, landscape or ecosys-tem Therefore, TK, in most cases, is usually collective in nature andconsidered the property of the entire community As such, it does notbelong to any single individual within the community; it is rather trans-mitted through specific cultural and traditional information exchange29

Report of the Royal Commission of Aboriginal Peoples, Canada Communications Group 454 (Ottawa, Vol 4, 1996).

30 A Hansen and J Van fleet, Traditional Knowledge and Intellectual Property, http://shr.aaas org/tek/handbook/handbook_1.pdf 13.

31 Knowledge, Innovations and Practices of Indigenous and Local Communities: Implementation of Article 8(j) Doc., UNEP/CBD/COP/3/19 8 –9.

mechanisms Because the relationship between GRs and legal subjectsthat compose TK-based communities is structured under legal schemesthat are different from the concepts of ownership and property rightsunder the common or civil law systems, many in such legal systems areled to conclude that TK is res nullius, the property of nobody until itsdiscovery by explorers, corporate scientists, governments and so on Thisattitude ignores the fact, however, that national or tribal customary laws32recognize forms of ownership separate from those designated by IP law.33

As will be discussed in further detail later, TK ownership is viewed

in traditional communities as a responsibility rather than an exclusiveproperty right This responsibility is often maintained and transmittedorally by elders or specialists (breeders, healers, etc.) and often to only aselect few people within a community This is why these indigenouscommunities are so alarmed when they see their precious and confiden-tially used TK being commercially exploited by private companies with-out their PIC

As Dutfield puts it:

what is traditional about TK is not its antiquity, but the way it is acquired and used

In other words, the social process of learning and sharing knowledge, which isunique to each indigenous culture, lies at the very heart of its‘traditionality.’ Much

of this knowledge is actually quite new, but it has a social meaning, and legalcharacter, entirely unlike the knowledge indigenous people acquire from settlersand industrialized societies.34

It appears from the above description that the IP protection of TK’sholistic nature is fraught with various difficulties Hence, it is warranted

to state at this early stage that current lex lata of IP will only be marginallyable to satisfy the needs and expectations of TK holders Furthermore,because of the anecdotal nature of TK, it is generally viewed as unreliable

by governments attempting to incorporate TK into their various naturalresource management processes Moreover, since it is hard to dissociate

TK from so many other aspects of the cultures of traditional communities,

it can be difficult to qualify TK as legitimate protectable material,because, after all, TK can be anything that TK holders claim it to be.35

32

Taubman and Leistner, “Analysis of Different Areas of Indigenous Resources”, 89–90.

33 C Correa, Traditional Knowledge and Intellectual Property Issues and Options Surrounding the Protection of Traditional Knowledge – A Discussion Paper (Quaker UN Office, Geneva, 2001) 3.

34 G Dut field, Valuing Traditional Knowledge A Review of the Issues, background paper for a seminar at the Rockfeller Foundation (November 7, 2000).

35 A Howard and F Widdowson, Traditional Knowledge Advocates Weave a Tangled Web, Options Politiques (April, 1997) 46 –48.

It goes without saying that economic interests might not constituteeither the only or the most important priority of such communities ofpeople The study of the reasons for which many communities oppose theintegration of their inherent rights over their knowledge in a commercialsystem would require the aid of social sciences and anthropology and liesoutside the scope of the present research This book limits itself to the TKaspects related to intellectual property protection.36

1.2 Some methodological aspects

1.2.1 Objectives

The present study seeks to achieve three major objectives:

Thefirst is to identify the international rules governing access to GRsand the acquisition of IPRs over GRs Part II interprets various IPtreaties and multilateral environmental agreements (MEAs) on the con-servation and sustainable use of biodiversity and related TK

The second objective is to study the methods of domestic tion of internationally mandated obligations on States, both the providersand the recipients of GRs Accordingly, Part III explores the variousoptions that countries or regional intergovernmental organizations canfollow in order to shape a well-balanced IP system related to the protec-tion of GRs and knowledge related to GRs (see chapters 6 and 7),including access- and benefit-sharing (ABS) regimes governing theirGRs IPRs may indeed have a remarkable impact on the attainability ofthe objective of sustainable use of biodiversity at a variety of levels IPRsmay provide either incentives or disincentives for dynamic conservation ofbiodiversity, ex situ or in situ, depending on the factual and institutionalsettings that may prevail inside a country or region and abroad Similarly,IPRs’ design may either promote or discourage benefit sharing betweencountries and communities which make available genetic material andinformation as well as TK, on the one side, and countries and entitieswhich hold IP and technology, on the other side

implementa-The third objective entails the possible adaptation of IP laws to modate“new” claims by TK stakeholders under IP international laws andsystem

accom-In order to achieve these objectives, it is crucial to use the concept of mutualsupportiveness to reconcile the TRIPS Agreement with other relevant IPtreaties, the CBD, the ITPGRFA, and then other relevant multilateral agree-ments and sources of international law, including soft law and customary law

36

Taubman and Leistner, “Analysis of Different Areas of Indigenous Resources”, 71–77.

In a broader economic and political science perspective, this study seeks

to move beyond the recurrent objection to the exercise of IPRs on technology by postulating solutions based on the comparative advantagethat is potentially to be implemented between North and South Thesesolutions are primarily based on the very fact that while industrializedcountries are empowered with technology able to yield important bio-technological inventions, DCs are richly endowed with biological diver-sity which is progressively lacking in industrialized countries From thisperspective, the solutions proposed here mark the transition from an era ofconfrontation to an era of cooperation between developing and industrial-ized countries The international exchange of PGRs and IP protectionrepresents one of the IP global issues that requires much synergyand strong interdependence between technologically advanced and bio-diversity rich countries An international law approach is at the core of thissynergy

bio-1.2.2 An international law approach

The international law approach influences both the structure of this studyand the content thereof The explanation of the structure will unfold thecontent in this international law perspective of the problems at stake.The present work consists of three parts After the explanation of themain problems in Part I, Part II lays out some theoretical elementsforming the international law perspective of this work’s subject-matterand provides an overview of the impact of IPRs on the preservation andexploitation of GRs and related TK It limits the range of observation tothe new relations between IP law and environmental obligations Thecontroversial issue of the alleged inconsistencies arising from the TRIPSAgreement and the CBD coexist with questions about the ethics ofproperty rights in living organisms and concerns about biodiversity indomestic and regional IP systems in industrialized countries In order tounderstand how to apply the relevant international law into the regional IPsystems, it is also important to analyze the approaches adopted by US andEuropean administrative and judicial bodies towards CBD principles intheir decisions on the patentability subject-matter of biotechnologicalinventions

The main legal challenges posed by the two-pronged expansion of IPRs(i) from inanimate to biological matter and (ii) from industrialized coun-tries to developing ones aggravate the underlying paradox that these legalchallenges pose Through the adoption of Article 27 of the TRIPSAgreement, Northern hemisphere countries have embarked on a rapidand spectacular race to engage Southern hemisphere countries in

international obligations on IP protection for biotechnology when theythemselves have yet to define clear guidelines within their own IP systems

in order to assure protection of biodiversity These facts should spur anoverall message of extreme caution in dealing with the delicate question ofmonopolized private ownership of the building blocks of life

Article 27 of the TRIPS Agreement stands at the top of the pyramid as anoverarching international provision from which all the other international,regional and domestic lawsflow This book’s international law approachconsiders international IP law as an area of public international law The

US historically developed the patentability of GRs; the European patentsystem followed this example along with many other industrialized coun-tries An assessment of the differences between US and European methods

of patentability of genes falls outside the scope of the present work.For the sake of grounding this legal analysis in a real world scenario, it isimportant to address the economic rationale behind the forms of protectiongranted under IP laws and policies in order to understand how industrial-ized nations view the proper application of IP laws to GRs (seechapter 3)

At this juncture, the analysis will move towards the dynamics of tection of GRs and TK by applying or adapting existing IPRs as mainlycontained in the TRIPS Agreement These concerns have led me toprimarily focus on the legal relationships between the TRIPSAgreement and the CBD The alleged incompatibility between thesetwo main treaties also involves legal relations with other treaties like theInternational Union for the Protection of New Varieties of Plants(UPOV)37 and the FAO’s ITPGRFA The Patent Cooperation Treaty(PCT) and the Substantive Patent Law Treaty (SPLT), on the one hand,and the relevant soft law,38on the other hand, will fall within the scope ofthis analysis when interpreting these instruments andfinding solutions de

pro-37 The text of all UPOV Acts can be found at www.upov.org (accessed June 20, 2005).

38

For an evaluation of the value of the source of soft law, see G Abi-Saab, “Eloge du ‘droit assourdi ’: Quelques réflexions sur le rôle de la soft law en droit international contempo- rain ” (1993) Mélanges Rigaux 66 M Virally, “La distinction entre textes internationaux

de portée juridique et textes internationaux dépourvus de portée juridique Rapport provisoire ”, (1983) 60 (1) Annuaire de l’institut de droit international 332–33 C Chinkin,

“The Challenge of Soft Law: Development and Change in International Law” (1989) 38 (4) International and Comparative Law Quarterly 851 P Weil, “Toward Relative Normativity in International Law ” (1983) 77 American Journal of International Law 436;

R Baxter, “International Law in ‘Her Infinite Variety’”, (1980) 29 International and Comparative Law Quarterly 550; J Dupuy, “Droit déclaratoire et droit programmatoire:

de la coutume sauvage à la soft law ”, Société francaise pour le droit international, Colloque de Toulouse, L’Elaboration du droit international public (Pédone, Paris, 1975) 385;

Q Nguyen, Droit International Public (6th edn, LGDJ, Paris, 1999) 386; G F.Handl,

et al., “A Hard Look at Soft Law” (1988) 82 Proceedings of the American Society of International Law 372.

lege ferenda (how the law should be) to make the international IP andenvironmental treaties mutually supportive.

The TRIPS Agreement and the CBD are not legally incompatible strictosensu since they do not have the same object and purpose States have theobligation to stretch their thought and comply with both simultaneously.The conflict between TRIPS and CBD lies outside international law,i.e at the crossroads of stark contrasts of opposing perspectives betweenindustrialized and developing countries, or, oversimplifying, betweenNorth and South The debate over IPRs on biological resources is embed-ded in a broad context with so many interconnections and competinginterests The complexity of this political debate is accompanied byintense emotions, as the debate is often framed in terms of a battlebetween“haves” and “have-nots.”39However, the political or social con-troversies are hereby dealt with as far as they are very relevant to the legalissues at stake

While concentrating on how IPRs protect innovations derived from thegenetic pool of biodiversity and how the IPRs in return impact biodiver-sity, this book also identifies the international principles of conservation ofbiodiversity, especially in the context of the interrelations between inter-national IP legal instruments and MEAs

Having ranged from international IP law (that protects the privateproperty of the innovation in this field) to the major international lawinstruments regulating the protection, preservation and conservation ofGRs, Part III moves into the analysis of IP methods of redistribution

of benefits in the international trade context by using the allocative ciency principles

effi-Part IIIidentifies the aspects of TK that are protectable in the tional patent system Therefore, section 4.2 introduces some relevantmethodological distinctions on which the subsequent analysis builds It

interna-is not my intent to analyze rights to TK in a holinterna-istic manner (which wouldinclude natural rights, land claims, etc.), rather only to the extent of itspossible integration in the existing IP system In other words, the scope ofobservation is limited to the IP-related aspects of the exploitation of GRsand TK, even when it is considered along with the human rights protec-tion of TK

Protection of TK can be sought through (i) national or regional“accesslegislation,” to GRs, (seechapter 5); (ii) defensive protection by adaptinginternationally mandated IP laws to prevent misappropriation of GRs

39

J F Badimboli Atibasay, “The International Legal Regime for Biotechnology Patenting:

An Appraisal from the Standpoint of Developing Countries ” (2001) 31 Revue générale de droit 294.

through the introduction of the disclosure of origin (section 6.1below),the patentability exceptions of ordre public and morality (section 6.3

below), the full assessment of the novelty criterion (section 6.2 below);(iii) positive protection of TK through marketing, transferring, and licens-ing aspects of existing IPRs (seechapter 7) This analysis de lege ferenda,shall also expand on positive protection through new types of IPRs orliability regimes

In this respect,Part IIIwill explore the proposals that have been putforward by governments at the relevant fora, the international legaldoctrine, the recommendations of international organizations, States’statements and non-governmental organization (NGO) sponsored stud-ies in order to render the IP system more supportive of the benefit-sharingtreaty provisions analyzed inPart II

The objectives stated insection 1.2.1above lead me to postulate ways inwhich TK holders can seek protection in EU and US law and judicialpractice Of course, the differences between common law and civil lawapproaches and the underlying policy options will be highlighted by resort

to comparative law with a particular emphasis on the European IP legalframework Through the analysis of this system of reference, the othermain industrialized countries’ systems are then compared with the aim offinding the best methods of protection adapted to particular circumstan-ces IP international treaties will serve as an overarching guide, settingforth the fundamental IP principles that are more precisely applied withinnational or regional jurisdictions, thus building upon the existent scholar-ship that identifies and interprets rules governing the IP exploitation ofGRs and TK

The relevant international legal instruments have been adopted by thesame States but within different fora Influential States have beensuccessful in reaching their objectives in one forum and not in another,thus creating various treaties with apparently conflicting provisions Inturn, the applicable international obligations stemming from differenttreaties remain disarticulated, unless they are interpreted in light of theconcept of mutual supportiveness

1.2.3 The concept of mutual supportiveness and the balance of rightsThe concept of mutual supportiveness40indirectly stems from the ViennaConvention on the Law of Treaties (VCLT) and belongs to the handful of40

L Boisson de Chazournes and M Mbengue, “A propos du principe du soutien mutuel – Les relations entre le Protocole de Cartagena et les Accords de l ’OMC” (2008) 4 Revue générale de droit international public 829 –63.

rules of interpretation of treaties If a conflict among two internationaltreaty provisions arises, it should be solved through the classic rules of lexposterior and lex specialis on conflicting treaty norms as provided by Article30.2 of the VCLT:

When a treaty specifies that it is subject to, or that it is not to be considered asincompatible with, an earlier or later treaty, the provisions of that other treatyprevail

Although very important in other instances, the application of this Article

to the relations between the WTO TRIPS Agreement and the provisions

of environmental law treaties would create a hierarchy of norms, a articulated situation, and much confusion for the contracting parties.Avoiding conflicts of norms between the international environmentaland trade regimes is vital for the unity of the international legal system.Therefore, the method of interpretation adopted in this study will relymore predominantly on Article 31.3(c) of the VCLT,41 according towhich a treaty has to be interpreted in light of all the other rules ofinternational treaty and general law applicable to the parties.42The prin-ciple of mutual supportiveness can be also inferred from this treaty pro-vision Finally, this norm avoids placing one set of norms of aninternational organization above another merely because of some chro-nological difference in treaty ratification and it helps avoid conflicts to theutmost extent

dis-International judicial and policy organs increasingly adopt thisapproach in order to avoid creating self-contained legal systems totallyindependent from general norms and from each other The WTO net-work of treaties on trade law and the UN body of treaties on environ-mental law can be considered as separate self-contained systems Themutual supportive concept renders the commercial or environmentalcharacter of the norms irrelevant as regards their objective interpretationand simultaneous application

Accordingly, the concept of mutual supportiveness between tal and trade regimes requires the application of all the relevant normsamong the parties with a presumption of absence of conflict among the

environmen-41 “There shall be taken into account, together with the context: (c) any relevant rules of international law applicable in the relations between the parties, ” Vienna Convention on the Law of Treaties (May 23, 1969) 1155 UNTS 331.

42

G Marceau, “Conflict of Norms and Conflicts of Jurisdiction – The Relationship between the WTO Agreement and MEAs and other Treaties ” (2001) 1081 Journal of World Trade 1109; G R Tarasofsky, “Ensuring the Compatibility Between Multilateral Environmental Agreements and the GATT/WTO ” (1996) 7 Yearbook of International Law 52; F Francioni (ed.), Environment, Human Rights and International Trade (Hart Publishing, Oxford, 2001) especially 22 –24.

norms ipso jure It enables the parties to simultaneously and harmoniouslyapply the two apparently conflicting bodies of international law: trade lawand environmental law.

This concept has already been implemented in the international making process (in declarations, treaties and protocols) It has also beenused since 1994 by the WTO Committee on Trade and Environment thathas been instituted “with the aim of making international trade andenvironmental policies mutually supportive.”43 More recently, section

law-31 of the Doha Declaration of the WTO Ministerial Conference hasrestated its conviction that“the aims of upholding and safeguarding anopen and non-discriminatory multilateral trading system, and acting forthe protection of the environment and the promotion of sustainabledevelopment can and must be mutually supportive” (italics added).44Itgoes without saying that the raison d’être of continuing negotiations involv-ing international trade and the environment is the enhancement of thismutual supportiveness

On the side of environmental law, Article 22.1 of the CBD attempted tomark the superiority of that treaty when it stated that:

the provisions of this Convention shall not affect the rights and obligations of anyContracting Party deriving from any existing international agreement, exceptwhere the exercise of those rights and obligations would cause a serious damage

or threat to biological diversity

The somewhat vague wording of such a safeguard clause could leave roomfor the superiority of environmental law above other bodies of law, thusjeopardizing the international legal order This peril has led to the neces-sity of adopting the Biosafety Protocol to the CBD that has been carefullydrafted so to ensure its mutual supportiveness with the WTO treaties, thusincluding the TRIPS Agreement.45

More recently, a less burdensome technique has been used to realizemutual supportiveness: rules on the relationship between internationallegal instruments are encapsulated in the preamble and not in thesubstantive norms This practice has the advantage of being rapidly nego-tiated but presents the disadvantage of not being incorporated in thesubstantive provision The preamble sets at least the interpretative tools

43 Decision on Trade and Environment, adopted by ministers at the meeting of the Uruguay Round Trade Negotiations Committee in Marrakesh on April 14, 1994, www.wto.org/ English/tratop_e/envir_e/issu5_e.htm.

44 WTO, Ministerial Declaration of November 14, 2001, WT/MIN(01)/DEC/1, 41 ILM

necessary for the implementation of the substantive treaty provision.

A preamble can create mutual supportiveness with other treaties A vant example of this technique is set forth in paragraph 9 of the preamble

rele-of the FAO International Treaty on Plant Genetic Resources for Food andAgriculture (ITPGRFA)46that states that“this Treaty and other interna-tional agreements relevant to this Treaty should be mutually supportivewith a view to sustainable agriculture and food security,” and “nothing inthis Treaty shall be interpreted as implying in any way a change in therights and obligations of the Contracting Parties under other internationalagreements” (preamble paragraph 10), and finally, “the above recital isnot intended to create a hierarchy between this Treaty and other interna-tional agreements.” In spite of the non-substantive character of this word-ing, this preambular language provides some principles of interpretation

of its substantive provisions with the rest of trade law treaties

This concept will be particularly important in reconciling the TRIPSAgreement and the CBD in implementing the concept of PIC and“benefitsharing.” The same is valid when in paragraphs 6 and 7 it is demonstratedhow patent rights and the Plant Variety Protection (PVP) (mandated byArticle 27.3(b) of TRIPS Agreement) in the DCs is compatible with theexigency of protecting“farmers’ rights,” as articulated in the ITPGRFA.The interpretation of relevant international treaties in a mutually suppor-tive way can assist in adapting international patent law so as to accommodatecertain needs and expectations of local and indigenous communities withregard to the defensive protection of their TK (e.g section 6.2 below).Indeed, the mutual supportive principle does not only mean that one treaty

de jure or de facto conflicts with another, but that one body of treaties has to betaken into account to interpret the ordinary meanings of a treaty in anotherarea Therefore the interpreter of the TRIPS Agreement cannot subordinatethe norms of the CBD to those of TRIPS Excluding the CBD from theinterpretation of TRIPS Agreement provisions amounts to subordinatingthe latter to thefirst.47On the very practical side, the concept of mutualsupportiveness leads, in this context, to the indirect applicability of the CBD

in a potential dispute on a TRIPS provision involving the interpretation ofbiodiversity protection issues.48 Indeed, I agree with the reasoning ofPauwelyn who argues for indirect applicability:

46 The FAO International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) (November 3, 2001), http://ext-ftp.fao.org/ag/cgrfa/it/ITPGRe.pdf.

47 Boisson de Chazournes and Mbengue, “A propos du principe du soutien mutuel”, 855.

48

Ibid , 857 See in favor of the indirect applicability Boisson de Chazournes and Mbengue,

“Trade, Environment and Biotechnology: On Coexistence and Coherence”, in T Cottier and D Wüger (eds.), Genetic Engineering and the World Trade System (Cambridge University Press, 2008).

[A]ll international law binding on both parties to a dispute may, in principle, bepart of the applicable law before a WTO panel Non-WTO law is part of thisapplicable law, and may, in particular, provide a defense against violation of WTOlaw (for example, an environmental agreement binding between the disputingparties may, depending on the relevant conflict rules, excuse a violation of GATT,independently of GATT Article XX) While non-WTO law to be referred to wheninterpreting WTO terms ought to be limited to law that reflects the commonintentions of all WTO members, in my view, the applicable law in a partic-ular dispute may also include law binding only between the two disputingparties.49

49 J Pauwelyn, “Bridging Fragmentation and Unity: International Law as a Universe of Inter-connected Islands” (2004) 25 Michigan Journal of International Law 910.