the current law of plant genetic resources and traditional

This paper can be downloaded in PDF format from IELRC’s website athttp://www.ielrc.org/content/a0609.pdf

THE CURRENT LAW OF PLANTGENETIC RESOURCES ANDTRADITIONAL KNOWLEDGE

Susette Biber-Klemm, Thomas Cottier, Philippe Cullet & Danuta Szymura Berglas

Published in: S. Biber-Klemm & T. Cottier eds, Rights to Plant Genetic Resources and TraditionalKnowledge: Basic Issues and Perspectives (Wallingford: CABI, 2006) p. 56-111.

International EnvironmentalLaw Research Centre

International Environmental Law Research [email protected]

2.1 Introduction

This chapter seeks to lay out the main legalfoundations in existing international lawfor the protection of plant genetic resources(PGR) and traditional knowledge (TK). It is,primarily, an exercise of stocktaking, ofproviding a survey and of identifying issuesto be dealt with in successive chapters.

The chapter first introduces the generalprinciples of international law, which,today, are enshrined by the doctrine of per-manent sovereignty over natural resources.While there was a trend to address the her-itage of biological diversity in terms of acommon public good and ascribe it to thelimited domain of common heritage, it iswell established, since the 1992 Rio Confer-ence and subsequent instruments, that thematter does pertain to national sovereigntyand therefore national regulation within thebounds of international law. A survey ofinternational agreements, in particular theConvention on Biodiversity (CBD), affirmsthis view. Equally, a survey of agreementswhich seek to provide an open, multilateral

international system within the Interna-tional Undertaking on Plant GeneticResources (IUPGR) (International Undertak-ing; IU) and the new International Treaty onPlant Genetic Resources for Food and Agri-culture (ITPGRFA), administered by theFood and Agriculture Organization (FAO),confirm the point by way of introducingmutually granted concessions of unim-paired facilitated access to plant geneticresources. Similarly, the efforts within theConsultative Group on International Agri-cultural Research (CGIAR) in supporting anopen system confirm the overall principle.This chapter then provides a short survey ofWorld Trade Organization (WTO) law andseeks to identify its main implications forPGR and TK. Given its comprehensive andcomplex structure, the Agreement onTrade-related Aspects of Intellectual Prop-erty Rights (TRIPS Agreement) will beexamined in detail in subsequent chaptersof this book. The same is true for otherinstruments addressing property rights, inparticular the Union internationale pour laprotection des obtentions vegetales (UPOV)

2 The Current Law of Plant GeneticResources and Traditional Knowledge

Susette Biber-Klemm,a Thomas Cottier,b Philippe Culletc and DanutaSzymura Berglasa

aWorld Trade Institute, University of Berne, and Faculty of Law, University of Basel,Maiengasse 51, CH 4056 Basel, Switzerland; bWorld Trade Institute, University ofBerne, Hallerstrasse 6/8, CH 3012 Berne, Switzerland; cSchool of Law, School of

Oriental and African Studies, University of London, Thornhaugh Street,London WC1 0XG, UK

© The Swiss Agency for Development and Cooperation 2006. Rights to Plant Genetic Resourcesand Traditional Knowledge (eds S. Biber-Klemm and T. Cottier, assoc. ed. D. Szymura Berglas)

56

Convention and the ITPGRFA. Finallythe survey addresses pertinent nationallegislation by way of example. A shortdescription of the European and USintellectual property rights (IPR) systemprovides the necessary background, as abrief introduction to access legislation cur-rently existing or partly enacted in develop-ing countries, under the doctrine ofpermanent sovereignty over naturalresources.

At this stage, it is already clear that theproblem of PGR and TK is formed by a hostof different principles, rules and agree-ments, most of them administered by differ-ent international organizations and fora,and thus also by different national authori-ties and constituencies: from departmentsof the environment, to agriculture, to for-eign trade, human rights, human health,plant and animal health, to intellec-tual property, competition, and perhapsadditional ones. They all face the prob-lem of policy coordination at home,and even more so at the internationallevel. The system is still highly fragmen-ted, organized in different chapters,often without much coordination orinteraction between these. It will beone of the major goals to bring about struc-tures in the field that allow meaningfulinteraction, cooperation and joint decision-making.

2.2 Permanent Sovereignty over PlantGenetic Resources1

State sovereignty remains the fundamentalprinciple around which all inter-state rela-tions are organized.2 In effect, internationallaw is based on the principle that all statesare juridically equal and that there is noauthority superior to states. One of the spe-

cific elements of state sovereignty concernsthe control of the natural, biological andgenetic resources found in areas under theirjurisdiction.

The question of sovereignty over natu-ral resources was the object of intensedebate in the aftermath of decolonization.Newly independent states, after gainingpolitical independence, sought to gain con-trol over resources found under their juris-diction, with a view to gaining control overthe exploitation of economically valuablenatural resources. The recognition of States’Permanent Sovereignty over NaturalResources was first formalized in a UN Gen-eral Assembly Resolution.3 This principlerefers to the right of each state to freelyexploit and develop its natural resources. Itconstitutes the basic principle for allocatingrights and responsibilities in internationallaw in this field. The principle of perma-nent sovereignty has since been reiteratedin numerous treaties and other interna-tional documents. Its binding status ininternational law is unquestioned (Schri-jver, 1997).

One of the attributes of sovereignty isthat states can freely choose to restrict it byway of agreement. In the field of the envi-ronment, the scope of sovereign rights hasslowly been circumscribed. In fact, one ofthe most generally recognized principles ofcustomary international law in the field ofthe environment is Principle 21 of theStockholm Declaration, which providesthat states have

the sovereign right to exploit their ownresources pursuant to their ownenvironmental policies, and theresponsibility to ensure that activitieswithin their jurisdiction or control do notcause damage to the environment of otherStates or of areas beyond the limits ofnational jurisdiction.4

Current Law of PGR and Traditional Knowledge 57

1 Author: Philippe Cullet.2 UN Charter, San Francisco, 26 June 1945 and UN General Assembly Res. 2625 (XXV), Declaration on Prin-ciples of International Law Concerning Friendly Relations and Co-operation among States in Accordancewith the Charter of the United Nations, 24 October 1970, reprinted in 9 ILM 1292 (1970).3 UN General Assembly Resolution 1803 (XVII), 14 December 1962, Permanent Sovereignty over NaturalResources, reprinted in 2 ILM 223 (1963).4 Declaration of the United Nations Conference on the Human Environment, Stockholm, 16 June 1972,reprinted in 11 ILM 1416 (1972).

This basic limitation on states’ rights touse their territories and resources as theysee fit was confirmed in the Rio Declara-tion.5

Further refinements have been addedover time. Specific issues have given rise tospecial principles. In the case of biodiver-sity, states negotiating the CBD found a spe-cific compromise. The convention‘reaffirms’ states’ sovereign rights over theirbiological resources but increases theirresponsibility to conserve and sustainablyuse the resources they control.6 Theresponsibility that states have towards theinternational community is encapsulated inthe principle of ‘common concern’.Common concern implies that the sover-eign rights that are recognized as belongingto states are tempered by the internationalcommunity’s interest in the conservationand sustainable use of a global good (Boyle,1994). In other words, states retain controlover their biological resources but have aduty to cooperate with other states inresolving issues of interest to the interna-tional community.

Apart from the special principle of‘common concern’ devised for biologicalresources, distinct rules have also evolvedin the case of genetic resources. The devel-opment of rules for the control of geneticresources has followed a different trendfrom biological and natural resources foundunder the jurisdiction of states. Plantgenetic resources were traditionally seen asa common heritage of humankind.7 Themain implication of the common heritagestatus in the case of genetic resources wasthat there should be no restriction on avail-ability and, consequently, appropriationunder private right schemes was deemed

inappropriate. This constituted the coreprinciple of the 1983 International Under-taking. The notion of common heritage hasprogressively given way to appropriationunder the guise of both private rights andsovereign rights. First, disagreements overcommon heritage status in the context ofthe International Undertaking have ledstates to adopt interpretations of the Inter-national Undertaking that could beaccepted by all FAO member states. The1989 resolutions maintained the principleof common heritage but intimated that bothplant breeders’ rights and farmers’ rightswere compatible with the principle ofcommon heritage.8 Secondly, the CBD rec-ognized states’ sovereign rights over bothbiological and genetic resources that fallunder their jurisdiction. Since the principleof common heritage had by 1993 becomeredundant, it became necessary to renegoti-ate the International Undertaking to takeinto account the new trends towards appro-priation and benefit sharing. The resultingITPGRFA makes no mention of the princi-ple of common heritage.

The regulation of genetic resourcespresents further difficulties. Given theirnature, a state’s control over its geneticresources is even more difficult to assertthan control over biological resources. Therapid development of genetic engineeringhas led to calls for new rules to regulateaccess to genetic resources. The CBD specif-ically addresses this issue. Article 15 recog-nizes states’ sovereign rights to regulateaccess to their genetic resources. However,it goes on to impose an obligation on statesnot to unduly restrict access by other par-ties. In other words, the CBD gives statesthe authority to ultimately determine con-

58 S. Biber-Klemm et al.

5 Principle 2, Rio Declaration on Environment and Development, 14 June 1992, Rio de Janeiro, reprinted in31 ILM 874 (1992).6 Preamble, Convention on Biological Diversity, Rio de Janeiro, 5 June 1992, reprinted in 31 ILM 818 (1992).7 The concept of common heritage was first developed in the context of the law of the sea concerning deepseabed resources. See, for example, UN General Assembly Res. 2749 (XXV), Declaration of Principles Gov-erning the Seabed and the Ocean floor, and the Subsoil Thereof, Beyond the Limits of National Jurisdiction,17 December 1970, GAOR 25th Session, Supp. 28 (A/8028).8 Res. 4/89, Agreed Interpretation of the International Undertaking, 29 November 1989, Report of the Con-ference of FAO, 25th Session, Rome 11–29 November 1989, Doc. C89/REP and Res. 5/89, Farmers’ Rights,29 November 1989, Report of the Conference of FAO, 25th Session, Rome 11–29 November 1989, Doc.C89/REP.

ditions for access to their resources but atthe same time strongly encourages them notto simply deny access to other contractingparties. While states are asked to provideregulated access to their genetic resources,the CBD makes provision for two importantfactors. First, access must be subject to priorinformed consent. Secondly, the benefitsdirectly or indirectly derived from access-ing genetic resources must be fairly shared.This ensures that while states are stronglyencouraged to provide access to resourcesthat are under their sovereignty, they alsoparticipate in the benefits arising from thislimitation of their sovereign rights.

Finally, the special situation of geneticresources held in the gene banks of theConsultative Group on International Agri-cultural Research (CGIAR) should be men-tioned. These accessions have, in mostcases, been provided voluntarily by statesparty to these ex situ gene banks, on theunderstanding that all designatedgermplasm held by the various Interna-tional Agricultural Research Centres(IARCs) would be freely accessible. TheCGIAR has been under pressure to revise itsintellectual property guidelines in recentyears. The basic principle remains that theIARCs do not apply intellectual propertyprotection to their designated germplasmand require recipients to observe the sameconditions. They also refrain from assertingIPRs over the products of their research. Anexception to this rule is made in case theassertion of IPRs facilitates technologytransfer or otherwise protects developingcountries’ interests. The CGIAR alsoimposes the condition that any IPRs on theIARCs’ output will be assigned to theCentre and not an individual. While theguiding principles on intellectual propertygenerally seek to contain to an extent themonopoly elements of IPRs such as patents,plant breeders’ rights are specifically wel-comed (Consultative Group on Interna-tional Agricultural Research, 1999).Recipients of germplasm can apply forplant breeders’ rights as long as this doesnot prevent others from using the original

materials in their own breeding pro-grammes.

This brief review of the evolution of theconcept of sovereignty in the specific fieldof biological and genetic resources can besummarized as follows. First, at least sincethe 1960s, the principle that states havesovereign rights over their natural and bio-logical resources has been reiterated onnumerous occasions. Secondly, geneticresources that used to be considered acommon heritage of humankind are nowfirmly included in the same category as bio-logical resources. Thirdly, the relativeimportance of the notion of sovereigntyshould not be overestimated, since therehas been a parallel trend towards muchstronger private property rights over biolog-ical and genetic resources, in particularIPRs. Overall, the main trend over the pastfew decades has been towards the appropri-ation of economically valuable resourceseither through sovereign or private propertyrights.

2.3 International Agreements andInstitutions

A number of international agreements con-stitute the law concerning PGR and TK atthe international level. This section high-lights some of the most significant treatiesand institutions dealing with the manage-ment of biological and genetic resources,IPRs and issues surrounding the conserva-tion and use of TK.

2.3.1 The Convention on BiologicalDiversity9

The CBD, even more than most environ-mental treaties, is the result of the progres-sive development of internationalenvironmental law since the early 1970s.Since the 1972 Stockholm Conference,states have signed various regional andinternational agreements designed to dealwith various environmental issues, from


9 Author: Philippe Cullet, with the help of Danuta Szymura Berglas.

the protection of specific species, habitatsor ecosystems, to treaties dealing with theuse and exploitation of environmentalresources, as well as treaties addressingsome of the consequences of industrialactivity, such as air pollution or hazardouswastes. However, before 1992, states hadnot managed to adopt a comprehensivelegal framework for the conservation andmanagement of biological resources. TheCBD fills this gap and provides the firstumbrella agreement addressing both theconservation and use of all biologicalresources.

The CBD was adopted in 1992 inthe form of a binding framework treaty.Its three main goals are the conservationof biological diversity, the sustainableuse of its components,10 and the fair andequitable sharing of the benefits derivedfrom the use of genetic resources (Article 1CBD). The Convention reaffirms the corner-stone principle of state sovereignty overresources that grants states sovereignrights to exploit their own resourcespursuant to their own environmental poli-cies, together with the responsibilityto ensure that activities within theirown jurisdiction or control do not causedamage to the environment of other statesor areas beyond the limits of nationaljurisdiction. The Convention, however,innovates in bringing a new qualificationto the principle of sovereignty. It intro-duces the notion that the conservationof biological diversity is a ‘common con-cern of humankind’, whereby states have aduty to cooperate in the sustainable man-agement of resources found under theirjurisdiction.

The CBD provides a number of generalobligations for member states. In particular,these include a commitment to developnational strategies, plans or programmes forthe conservation and sustainable use of bio-

logical diversity. Member states must alsointegrate, as far as possible, and as appro-priate, the conservation and sustainable useof biological diversity into relevant sectoralor cross-sectoral plans, programmes andpolicies. Generally, member states arerequired to promote the sustainable use ofbiological resources by: integrating consid-eration of the conservation and sustainableuse of biological resources into nationaldecision-making; adopting measures relat-ing to the use of biological resources toavoid or minimize adverse impacts on bio-logical diversity; protecting and encourag-ing customary use of biological resources inaccordance with traditional cultural prac-tices that are compatible with conservationor sustainable use requirements; supportinglocal populations to develop and imple-ment remedial action in degraded areaswhere biological diversity has beenreduced; and encouraging cooperationbetween its governmental authorities andits private sector in developing methods forsustainable use of biological resources(Article 10 CBD).

Conservation under the CBD is tobe achieved in two main ways. First, theConvention emphasizes in situ con-servation which proposes the conserva-tion of genes, species and ecosystems inthe surroundings where they have devel-oped their distinctive properties byestablishing protected areas, rehabilitat-ing degraded ecosystems and adoptinglegislation to protect endangered species.11

In situ conservation implies, among otherthings: the development of guidelinesfor protected areas; the regulation of biolog-ical resources; the promotion of theprotection of ecosystems and natural habi-tats and the maintenance of viable popula-tions of species in natural surroundings; thepromotion of environmentally soundand sustainable development in adjacent


10 Sustainable use is defined under Article 2 of the CBD as the use of components of biological diversity ina way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintainingits potential to meet the needs and aspirations of present and future generations.11 Article 2 of the CBD defines in situ conditions as ‘conditions where genetic resources exist within ecosys-tems and natural habitats, and, in the case of domesticated or cultivated species, in the surroundings wherethey have developed their distinctive properties’.

areas; the rehabilitation and restorationof degraded ecosystems and the promotionof the recovery of threatened species;controlling the risks associated with the useof living modified organisms; controllingalien species; seeking compatibilitybetween present and future use; develop-ing necessary legislation to protectthreatened species or populations; regulat-ing any processes or activities found tohave an adverse impact; and providingfinancial support for in situ conservation,especially to developing countries (Article8 CBD).

Secondly, supplementary ex situ con-servation outside the natural habitats of theprotected biodiversity components is alsoproposed. Ex situ conservation requires theuse of gene banks and zoological and botan-ical gardens to conserve species, which cancontribute to saving endangered species. Exsitu measures are preferably undertaken inthe country of origin. They include a dutyto maintain facilities for the conservationof, and research on, plants, animals andmicroorganisms; to seek the rehabilitationof threatened species and their reintroduc-tion into their natural habitats; to regulatethe collection of biological resources fromnatural habitats for ex situ conservation soas not to unnecessarily threaten ecosystemsand in situ populations of species; and toprovide financial support for ex situ conser-vation, especially to developing countries(Article 9 CBD).

The CBD addresses a number of otherissues of specific interest in the context ofplant genetic resources. It imposes a dutyon all member states to: respect, preserveand maintain knowledge, innovations andpractices of indigenous and local communi-ties embodying traditional lifestyles rele-vant for the conservation and sustainableuse of biological diversity; promote their

wider application with the approval andinvolvement of the holders of such knowl-edge, innovations and practices; andencourage the equitable sharing of the ben-efits arising from the utilization of suchknowledge, innovations and practices (Arti-cle 8(j) CBD). The Conference of the Parties(COP) has addressed the implementation ofArticle 8(j) in different ways. An ad hocopen-ended inter-sessional working groupwas established at COP 4 to give moreimportance to issues related to TK.12 TheWorking Group is mandated with the taskof giving advice on legal and other means ofprotection of the knowledge, innovationsand practices of indigenous and local com-munities embodying traditional lifestylesrelevant to the conservation and sustain-able use of biological diversity. Further,COP 5 adopted a specific programme ofwork which aims at fostering the participa-tion of local and indigenous communitiesin all aspects of the implementation of Arti-cle 8(j).13 Member states are also requestedto protect and encourage customary use ofbiological resources in accordance with tra-ditional cultural practices that are compati-ble with conservation or sustainable userequirements (Article 10 CBD).

The CBD also provides a general legalframework regulating access to biologicalresources and the sharing of benefits arisingfrom their use. The question of access isclosely related to the issue of property rightsand the legal status of biological resourcesunder international law. Access has pro-gressively become a contentious issue as thedevelopment of genetic engineering pro-vides new ways to acquire IPRs over inven-tions derived from biological resources. As aresult, since much of the world’s biodiver-sity is found in developing countries,14 thequestion of access became one of centralimportance in the CBD negotiations.


12 Decision IV/9. Implementation of Article 8(j) and related provisions, in Decisions Adopted by the Confer-ence of the Parties to the Convention on Biological Diversity at its Fourth Meeting, Bratislava, 4–15 May1998, UN Doc. UNEP/CBD/COP/4/27 (1998).13 Programme of Work on the Implementation of Article 8(j) and Related Provisions of the Convention onBiological Diversity, in Decisions Adopted by the Conference of the Parties to the Convention on BiologicalDiversity at its Fifth Meeting, Nairobi, 15–26 May 2000, UN Doc. UNEP/CBD/COP/5/23 (2000).14 An important exception is Australia, which is both developed and ‘megadiverse’.

The Convention attempts to provide aframework which both respects donorcountries’ sovereign rights over theirbiological and genetic resources and facili-tates access by users. Access must thereforebe provided on ‘mutually agreed terms’ andis subject to the ‘prior informed consent’ ofthe country of origin (Article 15 CBD). Fur-ther, the CBD provides that donor countriesof microorganisms, plants or animals usedcommercially have the right to a fair shareof the benefits derived from their use. Ben-efit-sharing, as conceived under the Con-vention and the Bonn Guidelines adoptedin 2002, can take the form of monetary ben-efits, such as access fees; up-front pay-ments; payment of royalties; licence fees incase of commercialization; research fund-ing; and joint ventures. Benefit-sharing canalso take the form of non-monetary benefitssuch as the sharing of research and devel-opment results; collaboration, cooperationand contribution in scientific research anddevelopment programmes; participation inproduct development; admittance to ex situfacilities of genetic resources and to data-bases; training related to genetic resources;and access to scientific information rele-vant to conservation and sustainable use ofbiological diversity (Bonn Guidelines,2002).

The Convention goes further than thegeneral regime provided by Article 15 andspecifically provides for technology transferas an invaluable instrument for the effectiveimplementation of the Convention. In fact,Article 16 specifically recognizes the needto facilitate the transfer of technologies thatare relevant to the conservation and sus-tainable use of biological diversity, or makeuse of genetic resources and do not causesignificant damage to the environment.

The CBD is noteworthy in the contextof international environmental agreementsfor offering a Statement on the relationshipbetween the management of biological andgenetic resources and IPRs. Article 16clearly indicates that IPRs are not to under-mine the working of the Convention. Theactual relationship of the CBD with the

TRIPS Agreement is an issue that has notyet found a specific answer. This is partlydue to the fact that a clear-cut answerto this question would remove some ofthe grey areas that currently allow dif-ferent states to take different views on thismatter.

The agreement reached on the substan-tive provisions of the Convention waspartly dependent on the willingness ofdeveloped countries to provide financialresources to subsidize developing coun-tries’ compliance with the proposedregime. As a result, the Convention requeststhe allocation of ‘new and additional finan-cial resources’ to enable developing coun-tries to meet the ‘agreed full incrementalcosts’ of implementing measures whichfulfil the obligations of this Convention(Article 20 CBD). The importance of finan-cial commitments for developing countriesis illustrated by the fact that developingcountries have the possibility, under theConvention, of making the implementationof their commitments dependent on theeffective implementation by developedcountries of their commitments related tofinancial resources and transfer of technol-ogy. In practice, developed countriesdischarge their financial commitmentsthrough the Global Environment Facility(GEF), which has operated the financialmechanism since the entry into force of theCBD.15

The institutional structure of the CBDincludes a number of bodies. These includethe Conference of the Parties, a SubsidiaryBody on Scientific, Technical and Techno-logical Advice (SBSTTA), and the Secre-tariat. The Conference of the Parties, whichbrings together all member states, is gener-ally mandated with keeping the implemen-tation of the Convention under review.More specifically, it reviews progress underthe Convention, identifies new priorities tobe pursued, sets work plans for members,amends the Convention, creates expertadvisory bodies, reviews progress reportsby member nations and collaborates withother international organizations and agree-


15 See Chapter 6 for further developments on the GEF.

ments. Periodic state reports to the Confer-ence of the Parties constitute one of themain monitoring instruments institutedunder the Convention. State parties mustreport on the means they have adopted toimplement the objectives of the Conventionand the level of success of such measures.The Conference of the Parties has launcheda number of thematic programmes cover-ing, for instance, the biodiversity of inlandwaters, forests, marine and coastal areas,dry lands and agricultural lands, agricul-tural biodiversity, and cross-cutting issuessuch as the control of alien invasivespecies, strengthening the capacity ofmember countries in taxonomy, and thedevelopment of indicators of biodiversityloss.

The SBSTTA has been established toprovide expert advice to other organs of theConvention. It is a multidisciplinary expertbody which has the mandate to: providescientific and technical assessments of thestatus of biological diversity and of theeffects of types of measures taken in accor-dance with the Convention; identify inno-vative, efficient and state-of-the-arttechnologies and know-how relating to theconservation and sustainable use of biolog-ical diversity, and advise on the ways andmeans of promoting development and/ortransferring such technologies; and provideadvice on scientific programmes and inter-national cooperation in research and devel-opment related to conservation andsustainable use of biological diversity. TheCBD functions on a daily basis through aSecretariat situated in Montreal, whichorganizes meetings, drafts documents,assists member governments in the imple-mentation of programmes, and coordinateswith other international organizations tocollect and disseminate information.

The CBD provides for the adoption ofprotocols. To date, only one instrument, theprotocol on biosafety, has been adopted.16

The Cartagena Protocol has been adopted inresponse to concerns over the negativeenvironmental and health effects of somegenetic engineering developments. The Pro-tocol seeks to regulate some aspects of thetransboundary movement of living modi-fied organisms, in particular bio-engineeredagricultural goods. Its aim is to ensure thata sufficient level of protection is achievedso that the transfer of living modified organ-isms does not entail adverse effects on theconservation and use of biodiversity. TheProtocol also recognizes that the risks tohuman health posed by modified organismsare closely related to the risk they pose tobiodiversity. The Protocol is put in practicethrough a procedure for ‘advanced in-formed agreement’.17 This imposes a dutyon the exporter of a living modified organ-ism falling under the scope of the Protocolto provide at least the information listed inAnnex I to the Protocol. In the case of seedsor live animals, importing countries havethe right to restrict imports in order to min-imize possible adverse effects on the con-servation and sustainable use ofbiodiversity.18 One of the most significantelements of the Protocol is that a decision torefuse an import can be taken even in theabsence of full scientific certainty regardingthe extent of the potential adverse effects.In the case of commodities to be used asfood or feed, the procedure is generally lessonerous for the exporter and does notinclude an obligation to notify the import-ing country of each shipment, even thoughthe importing country can generally restrictimportations of a specific commodity.

2.3.2 The International Treaty on PlantGenetic Resources for Food and

Agriculture19

The international legal regime for the con-servation and use of agricultural plant


16 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Montreal, 20 January 2000,reprinted in 39 ILM 1027 (2000).17 Article 7 ff. of the Cartagena Protocol, Note 16 above.18 Article 11 of the Cartagena Protocol, Note 16 above.19 Author: Philippe Cullet, with the help of Danuta Szymura Berglas.

genetic resources has been marked bysignificant changes over the past fewdecades. Traditionally, plant geneticresources for food and agriculture (PGRFA)were freely exchanged on the basis thatPGRFA constituted a common heritage ofhumankind. As a result, PGRFA could notbe appropriated. These principles werereflected in the practice of the CGIAR andwere embodied in the International Under-taking adopted by the FAO Conference in1983 (FAO Resolution 8/83).

It affirmed the principle that plantgenetic resources are a heritage ofhumankind that should be made availablewithout restriction to anyone. This coversnot only traditional cultivars and wildspecies but also varieties developed by sci-entists in laboratories. The InternationalUndertaking was adopted as a non-bindingconference resolution. However, theemphasis on the free availability of PGRFAproved to be unacceptable to some devel-oped countries that already had interests ingenetic engineering. Broader acceptance ofthe International Undertaking was onlyachieved after the FAO Conference passedinterpretative resolutions in 1989 and1991.20 These resolutions affirm the need tobalance the rights of formal innovators asbreeders of commercial varieties and breed-ers’ lines on the one hand, with the rights ofinformal innovators of farmers’ varieties onthe other. Resolution 4/89 recognizes thatplant breeders’ rights, as provided for inUPOV Convention, are not inconsistentwith the Undertaking, and simultaneouslyrecognizes farmers’ rights as defined in Res-olution 5/89. Resolution 3/91 recognizesthe sovereign rights of nations over theirown genetic resources.

Further revision of the InternationalUndertaking has been prompted by thegrowing importance of biological resourcesat the international level. In 1992, Agenda21 called for the strengthening of the FAO

Global System on Plant Genetic Resources,and its adjustment in accordance with theoutcome of negotiations on the CBD. Reso-lution 3 of the Final Act to the CBD recog-nized that certain matters which theConvention had not addressed, such as theissue of access to ex situ collections notacquired in accordance with the Conven-tion, and the realization of farmers’ rights,were to be dealt with by the FAO’s GlobalSystem on Plant Genetic Resources, ofwhich the International Undertaking wasthe cornerstone. The FAO Conference pro-vided the framework for the revision of theInternational Undertaking in its Resolution7/93, which called on member states to gen-erally harmonize the Undertaking with theprovisions of the CBD, to address the issueof access to plant genetic resources, includ-ing the question of ex situ collections notaddressed in the CBD, and specifically toensure that the new instrument wouldfoster the realization of farmers’ rights. Thenegotiations for the revision of the Under-taking in harmony with the Conventionbegan with the First Extraordinary Sessionof the Commission on Plant GeneticResources in November 1994 and contin-ued until the adoption of the Undertakingas a Treaty on 3 November 2001.21

The new Undertaking is now known asthe International Treaty on Plant GeneticResources for Food and Agriculture (ITP-GRFA).22 The Treaty was the object of ardu-ous negotiations that led to a finalconsensus text that was acceptable to all thestates present, apart from the United Statesand Japan, who abstained from voting uponthe text.

The overall objectives of the ITPGRFAare significantly different from those of the1983 Undertaking. The Treaty, reflectingthe new orientation given by the CBD,emphasizes the conservation of PGRFA,their sustainable use and benefit sharing.The guiding principles for these three


20 Res. 4/89, Note 8 above and Res. 5/89, Note 8 above.21 Negotiating documents can be found on the web site of the Commission on Genetic Resources for Foodand Agriculture at http://www.fao.org/ag/cgrfa/default.htm22 International Treaty on Plant Genetic Resources for Food and Agriculture, Rome, 3 November 2001 (here-after ITPGRFA).

http://www.fao.org/ag/cgrfa/default.htm

objectives are the promotion of sustainableagriculture and food security.

The ITPGRFA addresses a number ofissues pertaining to the conservation anduse of plant genetic resources. In otherwords, the Treaty focuses on issues notaddressed in other international treaties,such as farmers’ rights, but it does notdirectly address patents or plant breeders’rights as covered in the TRIPS Agreementand the UPOV Convention, respectively.23

The ITPGRFA is the first treaty providing alegal framework that not only recognizesthe need for conservation and sustainableuse of plant genetic resources for food andagriculture, but also delineates a regime foraccess and benefit sharing (ABS), and inthis process provides direct and indirectlinks to intellectual property right instru-ments. Secondly, it directly links plantgenetic resource conservation, IPRs, sus-tainable agriculture and food security.Thirdly, the ITPGRFA provides the firstmultilateral system of ABS for PGRFA.Fourthly, it includes a section on farmers’rights. The ITPGRFA gives recognition tofarmers’ contribution to conserving andenhancing plant genetic resources for foodand agriculture. It further gives broadguidelines to states concerning the scope ofthe rights to be protected under this head-ing, but overall devolves the responsibilityfor realizing farmers’ rights to memberstates. This includes the protection of TK,farmers’ entitlement to a part of benefit-sharing arrangements and the right to par-ticipate in decision-making regarding themanagement of plant genetic resources.However, the treaty is silent with regard tofarmers’ rights over their landraces. In fact,the ‘recognition’ of farmers’ contribution toplant genetic resource conservation andenhancement does not include any prop-

erty rights. In this context, the only rightsthat are recognized are the residual rights tosave, use, exchange and sell farm-savedseeds.

An important consequence of theTreaty is that guidance concerning the man-agement of CGIAR collections will, in thefuture, come from the Treaty’s GoverningBody.24 This is significant because theCGIAR has historically largely worked onthe basis of the sharing of resources andknowledge. In recent years, following theadoption of the TRIPS Agreement in partic-ular, the CGIAR has progressively modifiedits position with regard to the grant ofIPRs.25 New guiding principles on intellec-tual property were adopted to harmonizeCGIAR’s core principle that designatedgermplasm is held in trust for the worldcommunity with the recognition of variousforms of property rights, including sover-eign rights, farmers’ rights and privaterights.26 In principle, the IARCs do notapply intellectual property protection totheir designated germplasm and requirerecipients to observe the same conditions.They also refrain from asserting IPRs overthe products of their research. An exceptionto this rule is made in cases where the asser-tion of IPRs facilitates technology transfer orotherwise protects developing countries’interests. The CGIAR also requires that anyIPRs on the IARCs’ output should beassigned to the Centre and not an individ-ual. While the guiding principles generallyseek to contain the monopoly elements ofIPRs such as patents, plant breeders’ rightsare specifically welcomed. Recipients ofgermplasm can apply for plant breeders’rights as long as this does not prevent othersfrom using the original materials in theirown breeding programmes.

In practice, the ITPGRFA is of greater


23 On the relationship between the Treaty and intellectual property right instruments, see, for example, Arti-cle 12.3.f of the ITPGRFA, Note 22 above.24 See Article 15 of the ITPGRFA, Note 22 above.25 See, for example, CGIAR, ‘Progress Report on IPR Matters and Proposal for Review of Plant Breeding’,Mid-Term Meeting, 1999, Beijing, CGIAR Doc. MTM/99/20. 26 See CGIAR (1999) CGIAR Center Statements on Genetic Resources, Intellectual Property Rights, andBiotechnology. CGIAR, Washington, DC. Individual IARCs have also adopted intellectual property right poli-cies; see, for example, International Maize and Wheat Improvement Center, Policy on Intellectual Property(2000).

importance for PGRFA covered under theMultilateral System. Concerning theresources covered, member states mustadopt an integrated approach to the explo-ration, conservation and sustainable use ofPGRFA. Their specific obligations includethe need to inventory PGRFA, promotetheir collection, promote farmers’ and localcommunities’ efforts to manage and con-serve their PGRFA on-farm, promote in situconservation of wild-crop relatives andwild plants for food production, and co-operate to promote the development of anefficient and sustainable system of ex situconservation. Further, member states are totake measures to eliminate threats toPGRFA. Alongside conservation obliga-tions, member states must also promote thesustainable use of PGRFA. Measuresinclude the promotion of agricultural poli-cies that foster the development and main-tenance of diverse farming systems; anemphasis on research which enhances andconserves biological diversity by maximiz-ing intra- and inter-specific variation for thebenefit of farmers; the promotion of plantbreeding efforts which strengthen thecapacity to develop varieties particularlyadapted to social, economic and ecologicalconditions; the promotion of the use oflocal and locally adapted crops, varietiesand underutilized species; and the supportof the wider use of diverse varieties andspecies in on-farm management, conserva-tion and sustainable use of crops.

The main institutional innovation ofthe ITPGRFA is found in the novel schemedevised to regulate ABS of PGRFA coveredunder the Treaty. The Multilateral Systemis a consequence of the policy reversal,which has seen PGRFA pass from thedomain of a shared resource to one that isunder the sovereignty of states. This is adirect consequence of the link between theTreaty and the CBD that provides fornational sovereignty over biologicalresources. The underlying reason for theinclusion of a system of facilitated access isthat the sovereign rights of states over theirPGRFA are qualified by the recognition thatthese resources are a common concern ofhumankind and that all countries depend

largely on PGRFA that originated in othercountries. As a result, donor countries havefull control over their PGRFA but there arestrict limitations on their ability to restrictaccess to other states.

Under the Multilateral System, a seriesof crops (listed in Annex I) which accountfor most of – but not all – human nutritionare covered by a provision under whichmember states agree to provide facilitatedaccess. As per the ITPGRFA, access is to beprovided only for the purpose of utilizationand conservation for research, breeding andtraining for food and agriculture. As a resultof the recognition of PGRFA as a commonconcern, access has to be accorded expedi-tiously. Member states must also makeavailable all passport data and, subject toapplicable law, any other associated avail-able non-confidential descriptive informa-tion. Concerning material that is underdevelopment by farmers or breeders at thetime when access is requested, the Treatygives the country of origin the right to delayaccess during the period of development.This was one of the most difficult parts ofthe Treaty negotiations related to the treat-ment of IPRs. The compromise solution isthat recipients of PGRFA cannot claim IPRsthat limit the facilitated access to thePGRFA, or their genetic parts or compo-nents, in the form received from the Multi-lateral System. Further, PGRFA accessedunder the Multilateral System must also bemade available to other interested partiesby the recipient under the conditions laidout by the Treaty. This provision, whichstops the appropriation of isolated compo-nents from material accessed under theMultilateral System, was strongly opposedby some countries that had determined thatthis would stifle innovation. On the otherhand, when intellectual property or otherproperty rights already protect the PGRFAin question, access can only take place inconformity with the treaties regulatingthose particular kinds of property rights. Asis the case with some other treaties, like theBiosafety Protocol, the ITPGRFA refuses toestablish a hierarchy between itself andother related treaties, such as IPRs treaties.This leaves the door open for conflicting


interpretation at the time of implementa-tion.

The question of access is closelyrelated to that of benefit sharing. In fact, thebenefit-sharing regime constitutes anotherpart of the bargaining process that seeks tomake PGRFA a common concern ofhumankind. Access is to be facilitated and,as a result, donors are granted the right toreceive some form of benefits in return. Infact, the Treaty goes one step further inasserting that the premise for benefit shar-ing is, in the first place, the fact that accessto PGRFA constitutes in itself an importantbenefit for recipient countries. Differenttypes of benefit-sharing mechanisms areprovided for under the Treaty: theseinclude the exchange of information, accessto and transfer of technology, capacitybuilding, and the sharing of the benefitsarising from commercialization. Withregard to the sharing of information, theTreaty envisages that member states will,for instance, provide catalogues and inven-tories, information on technologies, and theresults of technical, scientific and socio-economic research. The Treaty provides aspecific information system, the GlobalInformation System, which will generallyserve to provide all member states with rel-evant information concerning crops in theMultilateral System. Concerning technol-ogy transfer, the Treaty only provides a gen-eral obligation to facilitate access totechnologies for the conservation, charac-terization, evaluation and use of PGRFA,which is further qualified by the fact thataccess to such technologies is subject toapplicable property rights. In the case ofdeveloping countries, specific mention ismade of the fact that even technologies pro-tected by IPRs should be transferred under‘fair and most favourable terms’, in particu-lar in the case of technologies for use inconservation as well as technologies for thebenefit of farmers in developing countries.Beyond information and technology trans-fers, benefit sharing can take the form ofcapacity-building measures. These includethe establishment of programmes for scien-tific and technical education and training inconservation and sustainable use of

PGRFA, and the development of facilitiesfor conservation and sustainable use ofPGRFA. Finally, the Treaty provides for thesharing of monetary benefits. Theseinclude, for instance, the involvement ofthe private sector in developing countriesin research and technology development.Further, the standard Material TransferAgreement, through which facilitatedaccess will be implemented, will include arequirement that an equitable share of thebenefits arising from the commercializationof a product that incorporates materialaccessed through the Multilateral Systemwill have to be paid to the Trust Accountset up under the Treaty. The benefits thatarise under the benefit-sharing arrange-ments must be primarily directed to farmerswho conserve and sustainably use PGRFA.

The ITPGRFA deals with a number ofother issues of relevance in the context of themanagement of plant genetic resources.Importantly, the Treaty specifically addressesthe issue of ex situ collections held in trust bythe International Agricultural Research Cen-tres (IARCs) of the CGIAR. The Centres,which have signed agreements with the FAOconcerning their collections, are now invitedto sign new agreements with the Treaty’sGoverning Body. These agreements willdetermine that the access provisions of theITPGRFA will govern the collections of theCentres that are part of the Annex I list. Thiswill, however, only cover materials collectedafter the entry into force of the Treaty andthat fall within its scope. The Centres are alsoobliged to provide preferential treatment tocountries that provide material to their genebanks and are not to request any MaterialTransfer Agreement if a country of originwants to access its own material. Generally,the Centres recognize the authority of theGoverning Body to provide policy guidancerelating to their ex situ collections.

The Governing Body, a body compris-ing all member states, will oversee theimplementation of the ITPGRFA. Its func-tions will generally be to promote the fullimplementation of the Treaty. This willinclude the adoption of plans and pro-grammes for the implementation of thisTreaty, the establishment of subsidiary


bodies as may be necessary and the consid-eration and adoption of amendments – byconsensus – to the Treaty.

Overall, the Treaty, which constitutesthe outcome of many years of negotiations,is noteworthy for providing the first inter-national recognition of farmers’ rights in abinding instrument. The provisions con-cerning ABS, which will constitute themost important part of the Treaty in prac-tice, are largely lacking in specificity. Thisreflects the difficult balancing that the nego-tiators had to provide between the interestsof developed and developing countries, bigprivate seed companies and small farmersand a number of other actors in between.

2.3.3 The law and policy in the World TradeOrganization27

From GATT to the WTO

With the advent of the World Trade Organi-zation (WTO), which succeeded the Gen-eral Agreement on Tariffs and Trade(GATT) 1947, the legal framework bearingon PGR, and indirectly on TK, has signifi-cantly changed by its actual or potentialimplications (Cottier, 1992). The strongerrules governing trade in goods (GATT), theGeneral Agreement on Trade in Services(GATS), and in particular the TRIPS agree-ment set a new context for transactionsinvolving PGR. A relatively well-developeddispute settlement mechanism accords thisframework greater efficacy. However, whiletrade in PGR falls under current WTO law,the protection of TK so far has not beenaddressed in treaty law. It was placed onthe agenda for further discussions underthe TRIPS Agreement at the 2001 DohaMinisterial Conference.28

The WTO system today rests on threemajor pillars: the rules affecting trade ingoods, trade in services and the protectionof IPRs.29 The WTO system is an importantpart of the law on PGR and the protection ofTK. Most of the WTO law potentiallyapplies to goods and services relating tothese subjects. This is true for the GATT1994 and the sectoral agreements, in partic-ular the Agreement on Agriculture and theAgreement on Sanitary and PhytosanitaryMeasures.30 Of paramount importance isthe TRIPS Agreement, as it directlyaddresses intellectual property protectionof PGR.

International trade in PGR has alwaysbeen subject to the multilateral disciplinesof the GATT 1947. In principle, this agree-ment also applied to trade in agriculturalcommodities derived from PGR, and theGATT 1994 continues to do so. The most-favoured nation treatment (Articles I, II)and national treatment (Article III) princi-ples have to be respected. The prohibitionof quantitative import restrictions alsoapplies, with narrowly defined exemptions(Article XI), as well as general exceptions(Articles XX, XI). The rules on importlicensing (Article XIII) and other pertinentprovisions, in particular the disciplines ontariffs (Articles II, VII and XXVIII), transit(Article V), fees and formalities, (ArticleVIII), anti-dumping (Article VI), marks oforigin (Article IX), transparency and judi-cial review (Article X), state trading andmonopolies (Article XVII), and balance ofpayment exemptions (Articles XII, XVIII)all apply to agricultural products. The samewas true of important sectoral agreements,such as the old Agreement on TechnicalBarriers to Trade. However, under GATT1947 there were many exemptions, and dis-ciplines remained weak. Key provisions on


27 Author: Thomas Cottier.28 WTO, Ministerial Declaration, para. 19, WT/MIN(01)/DEC/1 (20 November 2001).29 There are 12 side agreements to the GATT 1994 and no fewer than six understandings, all of which elab-orate further on its provisions. The rules on services trade have been further developed after the UruguayRound to cover the regulation of financial services and telecommunications. There are four plurilateral agree-ments, of which the Agreement on Government Procurement is particularly important. 30 Other agreements not dealt with in this survey may also be of importance, such as the Agreement onImport Licensing Procedures and the Agreement on Safeguards. The GATS is relevant for consulting and otherprofessional services in connection with PGR and TK.

subsidies to agricultural products wereweak.31

The system has witnessed substantialstructural changes since the 1970s, whichaccelerated with the Uruguay Round andwill further evolve with forthcomingrounds of trade liberalization. These are ofimportance in the present context. First,international trade law has progressivelydeveloped beyond market access and begunto increasingly entail harmonization ofdomestic regulations. It has moved towardsa global law of integration. Secondly,WTO law now has a relatively effective dis-pute settlement mechanism which nolonger leaves non-compliance without costsand disadvantages for governments andnations. Both of these aspects place WTOlaw in the forefront of international legaldevelopments. It is worth recallingthese developments before turning to thecontents of WTO law pertinent to PGR andTK.

From tariffs to farm support levels andintellectual property protection

Trade policy in the early post-SecondWorld War era focused on the gradualreduction of tariffs and the elimination ofpreferential systems. The GATT 1947provided, in essence, a framework for agradual process of tariff reduction. Theprovisions of the GATT 1947 were origi-nally designed to accompany this processand to avoid frustration and circum-vention by other means: in particularquantitative restrictions, subsidies, ordiscriminatory taxes on imports. Indeed,the gradual reduction, and even elimina-tion, of tariffs within customs unions andfree trade areas increasingly shifted theemphasis on non-tariff measures. Quantita-tive restrictions, export subsidies, anti-dumping duties, technical standards,balance of payment measures, labelling

requirements, import licensing, rules ongovernment procurement, and ‘voluntary’export restraints (VERs) all became addi-tional and widely used instruments. Withtheir beginnings in the Kennedy Round,such non-tariff barriers became, besides theclassical process of tariff-reduction, themain objects of trade negotiations in theTokyo Round.

A third generation of trade barriers wasbrought in focus during the 1980s. Itencompasses a number of issues, rangingfrom domestic farm support to restrictiveregulation of service industries, of invest-ments and, finally, the protection of intel-lectual property. These subjects stem fromdifferent fields of law, public and private,but have in common that they are allmainly part of the general domestic legalsystem. They are not directly geared to clas-sical international trade relations but theyhave been affecting such relations more andmore in terms of limiting market access.There is a link between the above factorsand some of the great political difficultiesin reaching final agreement in key issues ofthe Uruguay Round, such as reduction ofagricultural support systems, and condi-tions for investment and liberalization oftrade in services. The main difficulties to besettled in the area of TRIPS have similarroots. The issue of patentability of pharma-ceuticals, foodstuffs, or of living matter –namely, the problem of how far exceptionsto patentability should be allowed to go, or,in copyright, how the relationships ofauthors, producers, performers and usersshould be arranged – are perhaps the mostprominent examples in showing how farinternational negotiations and regulationshave penetrated socially, ethically or cul-turally sensitive issues of the domesticpolitical process.

More than ever before, internationaltrade regulation today seeks to provide faircompetition in a globalizing market econ-


31 The USA, for example, benefited from a general waiver. The European Community, in defence of itsCommon Agricultural Policy (CAP), often retaliated by using its veto power on the establishment of disputesettlement panels or on the adoption of reports, leaving them without much consequence in practice.Switzerland enjoyed major benefits in its protocol of accession, making it one of the most protectionist Mem-bers in agriculture, despite a relatively high level of food imports.

omy. Foreign and domestic economicaffairs can no longer be separated; and theincreasing importance and attention paid toforeign policy in general, formerly of realinterest often merely to a few, is a naturaleffect of such developments. This is alsotrue in the context of trade in PGR and theprotection of TK, which entail an inextrica-ble linkage of domestic and foreign policyissues.

International dispute settlement andenforcement

The dispute settlement mechanism of theWTO is a unique and powerful instrumentin international economic relations. TheDispute Settlement Body (DSB) of the WTOhas now developed a substantial jurispru-dence that is unique in a highly fragmentedand decentralized system of internationallaw.32 In a nutshell, the WTO dispute set-tlement mechanism consists of threephases. Upon the filing of a complaint, con-sultations are to be held among the Parties.Failing a successful conclusion by negotia-tions (the result in approximately two-thirds of all disputes), the complainingParty is entitled to ask the DSB for theestablishment of a panel.33

A panel, once established, regularlyconsists of trade officials and/or academicsknowledgeable in the field of law at issue,most commonly economists and lawyers. Itis assisted by the WTO Secretariat (specifi-cally the Legal Affairs Division and theoperational divisions concerned). Partiessubmit legal briefs to the panel and two orthree oral hearings are held at which inter-ested Third Parties may also take part andexpress their legal arguments. Panel pro-ceedings are conducted in a judicialmanner and on the basis of a set of custom-ary and written procedural rules developedover time. The panel may also conduct

hearings with independent experts in thefield. The panel drafts a report which is cir-culated to the Parties for comments before afinal version is submitted to the DSB. If thereport is adopted in the absence of a reverseconsensus, it proceeds to implementation.However, the Parties, in particular thelosing Party, may object and file an appealto the Appellate Body, a standing panel ofseven senior international trade lawyers.Appeals are generally limited to specificpoints, which may also be raised by thewinning Party. The jurisdiction of theAppellate Body is limited to questions oflaw. It does not extend to factual assess-ment and evidence, apart from certainexceptions. The report of the AppellateBody is again submitted to the DSB. Thelosing Party no longer has the right toobject, and the report is adopted unlessthere is consensus (including the winningParty) to reject the report. It goes withoutsaying that this procedure in practicalterms entails automatic adoption of thereport, and the losing Party is obliged tocomply. The entire proceedings from thefiling of the complaint are subject to verytight time limits. Proceedings are usuallycompleted, including the appellate phase,within 18 months. Longer periods havebeen found to be necessary in more com-plex cases, but even those are far shorterthan most domestic, let alone international,judicial proceedings.

The decision forms the basis for imple-mentation. The losing Party, in principle, isobliged to implement the recommendation.However, it has the option to offer compen-sation which is rarely accepted and oftennot of interest to the winning Party. Oftenthe amount of compensation is set by apanel of arbitration – which is normallycomposed of the original panel – in terms ofsurcharge tariffs equivalent to the financiallosses incurred since the unlawful measure


32 From 1995 to the beginning of 2001, 103 disputes were resolved. Of these, 48 or almost half were settledwithout recourse to adjudication (see Duk Park and Umbricht, 2001).33 Importantly, complaints on nullification and impairment of benefits do not entail only violations of treatyprovisions, but may also comprise so-called non-violation complaints. This course of action, albeit rare,envisages the protection of legitimate expectations as to conditions of competition, and bars Members fromtaking measures in bad faith that nullify trade concessions granted in previous negotiations.

was put in place. Failing implementationand compensation, the winning Party mayobtain the right to suspend concessions(retaliation). Countries are free to targetareas not directly linked to the subjectmatter in dispute. Retaliation for failure tocomply with the GATT 1994 and therelated sectoral agreements may thus even-tually result in measures in the field of serv-ices or intellectual property, and vice versa.Targeted goods may also be alternated inorder to increase pressure to comply. TheUSA, for example, operates special carousellegislation to this effect.

The enforcement system benefits largemarkets with retaliatory powers. It is one ofthe weaknesses and inequities of the systemthat it leaves small markets and weakercountries with little power to retaliate. Thesystem has not reached a level of multilat-eral implementation that would encourageall Members to participate in such action. Itis therefore not surprising that large coun-tries rank among the main users. At thesame time, it is important to emphasize thatthe WTO dispute settlement mechanismhas also been used successfully by develop-ing and smaller countries alike, as compli-ance with adopted reports has also provedto be in the long-term interest of largeMembers. Except for three major cases,compliance so far has shown an impressiveand successful record. In difficult cases, thenew system has shown the efficacy of itsnovel features, unheard of so far in interna-tional law: it eliminated veto or exitpowers, and made rulings subject to moni-toring of implementation and effectiveenforcement. It is not a coincidence thattwo of the cases that have proved to bemajor stumbling blocks, the banana dis-pute34 and the dispute on hormone-treatedmeat,35 essentially addressed problems ofproduction and trade in agriculture which –besides services – is one of the most highly

regulated and protected sectors. Tensionswith national or regional law abound. Themandatory nature of the system, and theimposition of substantial surcharge tariffsfollowing denial of implementation by theEuropean Communities, almost broughtabout crises and major trade wars with theUSA. For the first time, problems could nolonger be evaded by veto, and the Partieshad to go through a long and protractedprocess of negotiating a political settle-ment. This exit no longer exists, and thetensions show, more than anything else, thedeep and fundamental changes of the rulesof the game brought about by the advent ofthe WTO.

The system applies to all areas of WTOlaw alike. While panels are barred from cre-ating additional obligations or rights, theprocess of interpretation inherently entailsa refinement of the law. Indeed, in betweentrade rounds, the main emphasis of WTOlegal activities is on dispute settlement andthe development of case law. In the field ofPGR, no cases have so far been decided.Yet, related areas, such as sanitary and phy-tosanitary measures, have been repeatedlyscrutinized and a substantial body of lawhas evolved. This is also true for intellec-tual property protection, which until 1995had never been the subject of mandatorydispute settlement. The DSU fully appliesto the TRIPS Agreement.36 So far, ninerequests for consultations in the field havebeen filed, many of them relating either torules on patent protection for pharmaceuti-cals and agricultural chemical products orenforcement of IPRs.37 In some of thesecases, mutually agreed solutions betweenthe Parties involved were notified (Baracol,2001, pp. 37–41). The relative success ofconsultations may be because the TRIPSprovisions are detailed and provide goodguidance in assessing rights and obliga-tions.


34 European Communities – Regime for the Importation, Sale and Distribution of Bananas, WT/DS27/AB/R(9 September 1997).35 European Communities – Measures Concerning Meat and Meat Products, WT/DS26 and 48/AB/R (16 Jan-uary 1998).36 The only exception concerned so-called non-violation complaints, which were excluded until the year2000.37 Cf. see above, Annex 1, giving an overview of WTO disputes in the field of intellectual property rights.

The panel stage was reached by twodisputes relating to obligations of countriesto provide a so-called mailbox for the filingof patent applications even before the gen-eral transitional period of 10 years elapsed.In India–Patent Protection for Pharmaceuti-cal and Chemical Products,38 the Panel andthe Appellate Body ruled upon a complaintby the USA (and also one by the EuropeanCommunities) that administrative prac-tices, short of a legal basis, did not amountto an adequate compliance with these obli-gations. On substance, important casesaddressed the scope of fair use exceptionsin patent law and in copyright law. A fur-ther case addressed the protection of trade-marks and trade names under US law in thecontext of economic sanctions againstCuba.

The Agreement on Agriculture

The advent of the WTO was accompaniedby a comprehensive Agreement on Agricul-ture, the main feature of which was the reg-ulation of import restrictions (Horber, 1995,p. 51). Member states were obliged, by wayof their tariff schedules, to reduce tariffs inagriculture by 36% on average (at least 15%per tariff line) by 2001. This leaves mostcountries with still very high bound tariffs,the reduction of which will be the subject offurther rounds of negotiations.39 Indepen-dently of tariff protection, a minimummarket access right beginning with 3% ofdomestic consumption and increasing to5% had to be realized by 2001. Domesticsupport by product-related subsidies – for-merly typically a domestic issue – had to bereduced by 20%. Further decreases areto be expected in the Doha Round. Onthe other hand, Members obtained fullautonomy in the use of non-product-related payments (the Green Box), whichhas been mainly used to finance directassistance, and has become the basisof a new agricultural policy in both the

European Communities and Switzerland.The shift from product-related support(often causing excess production) todirect payments has paved the way forecological reforms. Overall, they bearthe potential for sustainable agriculture,which, short of pressures from the globaltrading system, would have been difficult tobring about domestically. Finally, theagreement obliges countries to reduceexport subsidies by 36% (on the basis of1986/1988 rates) on agricultural productsand transformed products (such as choco-lates or biscuits) and a quantitative reduc-tion by 21% of subsidized products. TheDoha Ministerial Declaration of November2001 pledged to work towards furtherreduction, with a view to eliminating allexport subsidies in agriculture, given theiroften detrimental impact on developingcountries.40

The Agreement on the Application of Sanitaryand Phytosanitary Measures

A new Agreement on Sanitary and Phy-tosanitary Measures (SPS Agreement) regu-lating foodstuffs was adopted, replacing theapplication of the Technical Barriers toTrade (TBT) Agreement in this field. It waselaborated during the Uruguay Round andaddresses the problem of excessive foodsstandards that may unreasonably impairtrade in agricultural products. Such stan-dards also exist in the field of geneticresources, in particular seeds. The Agree-ment essentially seeks to encourage the useof international foods standards developedby international bodies, such as the jointCodex Alimentarius Committee of the FAOand the World Health Organization (WHO).However, it allows Members to apply theirown and stricter standards, provided thatthey are in a position to scientificallydemonstrate that such higher standards arerequired in order to respond to the level ofrisk that has been defined. The complex


38 WT/DS50/AB/R (19 December 1997).39 For example, bound agricultural tariffs in the European Communities amount to an average of 17.3% andin Switzerland to 34%. WTO, Trade Policy Review: European Union 2000, xix (2000) and WTO, TradePolicy Review: Switzerland and Liechtenstein, xxi (2000).40 WTO, Ministerial Declaration, para. 13, WT/MIN(01)/DEC/1 (20 November 2001).

agreement allows Members to invoke theprecautionary principle. Since 1995, it hasgiven rise to a number of complex disputeswhich sought to define the proper levels ofprotection and of judicial review of suchmeasures, the Hormones case being themost prominent and controversial. It isimportant to note that it has remainedunclear whether the SPS Agreement alsoapplies to genetically modified organisms(GMOs). Moreover, it may partly overlapand conflict with the Cartagena Protocol onBiosafety which allows trade restrictionsmainly, but not only, for reasons of envi-ronmental protection.

The Agreement on Trade-related Aspects ofIntellectual Property Rights

CHANGING PARADIGMS AND THE ADVENT OF THE

AGREEMENT

While the law of PGR outside trade-relatedmatters has been defined primarily by theinstruments discussed above, in particularthe CBD, the ITPGRFA and the CGIARSystem and its rules and policies, the inclu-sion of intellectual property protection inthe WTO system with the adoption of theTRIPS Agreement has fundamentallyaltered previous equations. New conditionsand incentives for investment have been setin global law, exclusive rights granted, anda new relationship between protected prod-ucts and those pertaining to the publicdomain has emerged.

It is important to note that interna-tional efforts to bring about adequate IPRprotection did not start with the TRIPSAgreement. The international dimension ofintellectual property is not new. In fact, asearly as the 1880s, it ranged among the firstefforts in international economic law to

bring about shared perceptions. The manyagreements and unions, in particular thoseadministered by the World IntellectualProperty Organization (WIPO), provideample evidence of this tradition. Otherorganizations and forums, in particular theOECD and the UN General Assembly, alsoshow a considerable record of work andrecommendations to the extent that IPRsare related to the transfer of technology orto competition.41 Yet, due largely to differ-ing perceptions as to the role of intellectualproperty in the process of economic devel-opment, as well as diverging traditionsamong industrialized countries, substantiveglobal standards, in particular concerningindustrial property, remained largely of anopen and permissive nature. Throughoutthe 1970s and the early 1980s attempts tointroduce more specific norms largelyfailed due to such differences; the unsuc-cessful effort to revise the Paris Conventionis a case in point. Moreover, an effective,swift and simple system of dispute settle-ment is lacking within the WIPO, and nostandards existed in the treaty system onthe effective enforcement of IPRs. Thethrust of worldwide cooperation thereforehas focused mainly on achieving nationaltreatment for foreign nationals and, withthe exception of international copyrightlaw, on the important field of acquisitionand administration of rights, namely byusing effective ways to simplify the interna-tional registration of national trademarks,designs and patents.

The difficulties mentioned in achievingglobal progress in traditional internationalforums have led to the increased linkage ofIPR protection with trade policies, and themarriage has attracted considerable schol-arly attention ever since.42 The negotiations


41 The negotiations on the law of the sea in the 1970s (UNCLOS III) provide a classic example of extensiveefforts to negotiate on intellectual property rights in order to bring about such transfers in the field of deepseabed mining.42 Outside the regional context of the European Communities, such linkages were first established by the 1984US Trade Act, and further reinforced in 1988 with controversial provisions and procedures allowing for retal-iation in market access in goods and services against countries having unfair and distorting regimes on intel-lectual property, whether or not these were in conflict with current international obligations. The IPRprotection–trade linkage in domestic US law, and bilateral and regional efforts, such as the Caribbean BasinInitiative, were certainly a source of inspiration in bringing the subject into the GATT system upon the initia-tive of the US when the Punta del Este Mandate for the Uruguay Round was drafted and agreed upon in 1986.

that led to the adoption of the TRIPS Agree-ment were initiated by the USA.43 The ini-tiative was particularly based upon theestimates made by the USA, whose indus-tries in 1986 suffered losses of some 24 bil-lion dollars due to inadequate protection ofintellectual property and related invest-ments. In the beginning, the European Com-munity was reluctant to commit itself onthe issue, but in the course of the negotia-tions, it gradually became one of the majordemandeurs.

The 7-year negotiations went throughthree phases. A long process of fact-finding,which also worked as a tool for mutual edu-cation, led to comprehensive proposals byvarious Contracting Parties. After the mid-term review of Montreal in December 1989and the April 1990 ministerial decision,intensive negotiations took place. Workwas successfully concluded in December1991, when the draft TRIPS Agreement waswrapped up as part of the ‘Dunkel Text’.During the last phase, efforts were aimed atkeeping the results achieved and at avoid-ing their being jeopardized by counter-productive new proposals in the field ofintellectual property, or by a deadlocking ofnegotiations regarding other issues such asagriculture or audio-visual services. Unlikeduring the first two phases, the last phasewas marked by conflicting interestsbetween the USA and the European Com-munities on copyright issues (culturalaspects, blank tapes levies). The resultsachieved were made possible due to vari-ous factors, many of which are interestingfor the purposes of a general assessment ofthe importance of intellectual property. Toa great extent they exceeded the initialexpectations.

THE SUBJECT MATTER OF THE AGREEMENT

Signed on 15 April 1994, the TRIPS Agree-ment lays down the essential elements for theminimum level of protection that countries

must accord to intellectual achievements. Itcovers all fields of intellectual property:copyright, topographies of integrated cir-cuits, trademarks and service marks, geo-graphical indications, industrial designs,patents for inventions and trade secrets. Itdefines rights and obligations under thesedifferent forms of intellectual property. Gen-erally speaking, such rights include theexclusive right to make, use, sell, offer to sell,and import products protected by IPRs. Inaddition, member states undertake to providedetailed rules guaranteeing the proceduresand remedies that must be available at thenational level for IPRs to be effectivelyenforced. Members had to implement theTRIPS Agreement by the end of the transi-tional period, which ended for developingcountries in 2000. The transition period willend in 2005 for rules on product patents,except for least developed countries. Withthe adoption of the TRIPS Agreement, intel-lectual property is now an integral part of themultilateral trading system.

GENERAL PROVISIONS

The Agreement strengthens the nationaltreatment principle as contained in the rel-evant existing international conventions(Article 3). However, it includes a conceptof trade law that is new in the field of intel-lectual property law: the most-favourednation (MFN) principle (Article 4). A WTOMember must accord automatically to otherWTO Members the same favourable treat-ment it has granted to a third country on abilateral basis. The MFN particularlystrengthens the position of smaller coun-tries vis-à-vis the big trading powers. As aresult of the TRIPS Agreement and its MFNclause, a bilateral agreement concluded, forexample, between the USA and Japan onthe improvement of registration procedureswill also be extended erga omnes so as toavoid any incompatibility with the TRIPSobligations.


43 At the end of the Tokyo Round, the USA and the European Communities unsuccessfully launched a draftAnti-Counterfeit Code. Subsequent work did not materialize due to opposition by developing countries.Eventually, the protection of intellectual property rights was included in the 1986 negotiating mandate ofPunta del Este, and – as a political compromise – limited to its ‘trade-related aspects’.

The TRIPS Agreement contains twogeneral provisions that are of potentialimportance for PGR and TK. First, Article 7states:

The protection and enforcement of intellec-tual property rights should contribute tothe promotion of technological innovationand to the transfer and dissemination oftechnology, to the mutual advantage of pro-ducers and users of technological knowl-edge and in a manner conducive to socialand economic welfare, and to a balance ofrights and obligations.

This general provision was proposedby developing countries and intended tosafeguard the proper balance between pri-vate rights and public goods against one-sided and detrimental effects that IPRs mayhave, and in order to promote their useas incentives for foreign investment andtransfer of technology. The provision is of ahorizontal nature and applies to all provi-sions of the agreement. Given its nature, itis not independently operational but formsthe interpretation of other provisions, inparticular when defining the proper rela-tionship between exclusive rights andpublic goods. We shall return to the impactof the provision on PGR and TK.

Secondly, the TRIPS Agreement alsorecognizes in Article 8 that intellectualproperty regulations do not prevent Mem-bers from adopting measures necessary toprotect public health and nutrition, and topromote the public interest in sectors ofvital importance to their socio-economicdevelopment. Members are equally entitledto take measures against the abuse of IPRsor against practices that unreasonablyrestrain trade or adversely affect the inter-national transfer of technology. The effectsof intellectual property protection mayentail some potential for conflicts withantitrust law. However, Article 8 is con-

strained by the proviso (introduced uponthe motion of industrialized countries) thatsuch measures are required to be consistentwith the other provisions of the TRIPSAgreement. Article 8.1 therefore does notallow deviation from the operational provi-sions of the TRIPS Agreement. As to Article8.2, addressing the abuse of IPRs and com-petition, it is important to note that theauthority of Members to take measures isfurther detailed in Article 40 of the TRIPSAgreement, which preserves the rights ofMembers to take action under their ownnational or regional competition rules. Theissue of restrictive business practices isaddressed in the TRIPS Agreement only interms of the matter being left to nationaljurisdiction. It is expected that it will bebrought into focus again in future negotia-tions, when a fine balance will have to bestruck between protection of investments,exclusive rights resulting from those invest-ments, and the efficient functioning ofglobal competition.44

Article 8, like Article 7, forms interpre-tation and has to be taken into account indefining the scope and impact of rights andobligations under the TRIPS Agreement.The provisions of Article 8.1 played animportant role in recent disputes and dis-cussions relating to compulsory licensingof patents over new essential medicines (forHIV/AIDS). The Ministerial Declarationadopted at Doha confirmed its importance,while leaving operational rules, in particu-lar on compulsory licensing of patents(Article 31), unchanged.45

COPYRIGHT AND RELATED (NEIGHBOURING) RIGHTS

Copyright entails the protection of expres-sions of mental activity not only in the artsand sciences, but also in modern technol-ogy. Its scope is limited and it does not pro-


44 The Doha Ministerial Conference adopted the following work programme on competition in para. 25,without opening negotiations on the subject. ‘In the period until the Fifth Session, further work in the Work-ing Group on the Interaction between Trade and Competition Policy will focus on the clarification of: coreprinciples, including transparency, non-discrimination and procedural fairness, and provisions on hardcorecartels; modalities for voluntary cooperation; and support for progressive reinforcement of competition insti-tutions in developing countries through capacity building. Full account shall be taken of the needs of devel-oping and least-developed country participants and appropriate flexibility provided to address them’. 45 WTO, Ministerial Declaration, para. 17, WT/MIN(01)/DEC/1 (20 November 2001).

tect substance, ideas, procedures and meth-ods (including mathematical concepts). Itinherently does not require a high level oforiginality. The same is true for neighbour-ing rights that address the rights of per-forming artists, film broadcasters andphonogram producers.

Copyright and neighbouring rights pro-tection is important for the protection of TKto the extent that it is expressed. Tradi-tional music and performances are at theforefront. Moreover, it is important for elec-tronic data collections on PGR and for pro-gramming specifically designed for thisfield. It covers books and publications onthe subject. Otherwise, copyright is notsuitable for addressing PGR and knowledgeper se. It is rather by protecting the culturalbackground and its diversity that copyrightindirectly makes a contribution to their val-uation and reward.

The provisions of the TRIPS Agreementon copyright amend the traditional rules ofthe Berne Convention and essentially focuson new technologies: the protection of com-puter programs, including exclusive rentalrights, and of electronic databases (Articles10 and 11); the protection of rights of inter-preters and broadcasting organizationsagainst unauthorized reproduction, theworldwide protection of phonogramsagainst unauthorized copying and reproduc-tion, and the recognition of exclusive rentalrights over phonograms (with the possibilityof preventing the rental in particular of newcopies, subject to existing rules which arelimited to an obligation of equitable remu-neration) (Article 14); and the protection ofcinematographic works to avoid widespreadcopying materially impairing the exclusiveright of reproduction (Article 11). Thehuman rights dimension of copyright wasexplicitly excluded (due to pressure fromthe US film industry), as the TRIPS Agree-ment (and dispute settlement) does notencompass moral rights under Article 6bisof the Berne Convention (Article 9.1).

The agreement prescribes a minimumduration of protection of 50 years (Article

12), except for broadcasters’ rights, forwhich the period is 20 years (Article 14.5)from the end of the calendar year of author-ized publication, making, or broadcasting.In other words, unlike in many nationallaws, there is no post mortem auctoris termof protection.46 The protection of perform-ers’ rights, which was traditionally limitedto European civil law countries, is for thefirst time dealt with in a multilateral treatyof a wider geographical coverage.

TRADEMARKS

Trademark protection is of key importancein identifying and individualizing productsoriginating from PGR and/or based on TK.Seeds and varieties can be sold under trade-marks, and TK can be protected indirectlyby linking it to trade names and supple-mentary qualifications, using terms not inthe public domain.

The function of trademarks consists inidentifying the origin of the product andallowing the consumer to distinguish differ-ent products. For the first time in interna-tional economic law, the TRIPS Agreementprovides a globally uniform definition oftrademarks (for goods and services), includ-ing protection of combinations of colours(but not requiring protection for soundmarks) (Article 15). Protection of interna-tionally well-known trademarks (i.e. with-out registration) applies not only toproducts but also to services. Trademarkscannot be used to bar parallel importsunless there is a risk of confusion for theconsumer (Article 16.1). The term of protec-tion is no less than 7 years, with indefinitepossibility of renewal (Article 18). A possi-bility of cancellation of trademarks existsonly after a minimal time period of non-useof 3 years (Article 19). There is a prohibitionof other requirements for the use of trade-marks (e.g. requirement for use to be only incombination with another trademark), and(unlike in patents) a complete prohibition ofcompulsory licensing (Articles 20, 21). TheTRIPS Agreement entails a significant


46 The provisions are of particular significance for producers of computer programs and phonograms, againstcounterfeiting and piracy.

improvement of trademark and service markprotection in countries other than in West-ern Europe and North America. The protec-tion of internationally well-knowntrademarks is thereby enhanced.

PROTECTION OF GEOGRAPHICAL INDICATIONS

Geographical indications are a primeinstrument for protecting products derivedfrom PGR and TK, as this protection (otherthan trademarks) requires the quality, repu-tation or other characteristic of a product tobe essentially attributable to its geographi-cal origin. This allows the protection notmerely of the uniqueness of the product butalso the uniqueness of its origin and TK atthat place.47

As a general rule, protection is ensuredby an obligation to introduce laws pro-tecting against deception of the consu-mer as to the true geographical origin andquality of the product and against otherforms of unfair competition (Article 22). Thesame rule also applies to the use of names inthe course of trade to the extent that they areused in a manner to mislead the public(Article 24.8). Members are barred from reg-istration of trademarks which mislead thepublic as to the origin of the product (Arti-cle 22.3). Protection thus takes place on acase-by-case basis without prescribing regis-tration in international law.

A higher (absolute) level of protectionwas introduced for wines and spirits (Arti-cle 23). These products enjoy privilegedprotection. The use of geographical namesfor products produced elsewhere is barred,even where the true origin of the product isindicated or where it is accompanied byqualifications such as ‘kind, type, style,imitation’ or the like. However, such pro-

tection does not extend to denominationsin customary use. Homonymous indica-tions, namely similar names for differentorigins, are protected, subject to measuresagainst consumer deceptions. In particular,denominations of wines and spirits con-tinuously using foreign locations, but inuse before 1984 and in good faith, aregrandfathered and cannot be challenged(Article 24.4). Generally, no protectionexists against use of denominations ifthey are in generic use in the common lan-guage of a Member. The same is true forproducts of the vine if they coincide withthe customary name of a grape variety (Arti-cle 24.6).

The TRIPS Agreement contains obliga-tions to further develop protection of geo-graphical indications. An internationalsystem for notification and registration forgeographical indications of wines shouldbe negotiated (Article 23.4). Member statespledged to enter into negotiations in orderto further extend the coverage of protection,in particular to foodstuffs. In this respect,the Council for TRIPS initiated preparatorywork by the end of 1998, but no resultshave been achieved.48 The Doha MinisterialConference reiterated the agreement tonegotiate on the subject of an internationalregistration of wines, but a similarly strongcommitment exists for the further develop-ment of protection for other geographicalindications. The Conference merely notedthat the TRIPS Council would deal withthese issues pursuant to proceduresadopted for implementation issues.49

INDUSTRIAL DESIGNS

The Agreement adopts, for the first time ininternational economic law, a common def-


47 For example: Flocons de Quinoa, ‘Quinoa Real’, a grain cultivated in the Andes (Bolivia) 3000 m abovesea level, which has specific qualities due to cultivation at this altitude.48 See the press release on: http://www.wto.org/wto/new/pu101298.htm49 Doha Ministerial Declaration, para. 18: ‘With a view to completing the work started in the Council forTrade-Related Aspects of Intellectual Property Rights (Council for TRIPS) on the implementation of Arti-cle 23.4, we agree to negotiate the establishment of a multilateral system of notification and registration ofgeographical indications for wines and spirits by the Fifth Session of the Ministerial Conference. We note thatissues related to the extension of the protection of geographical indications provided for in Article 23 to prod-ucts other than wines and spirits will be addressed in the Council for TRIPS pursuant to paragraph 12 of thisDeclaration’.

http://www.wto.org/wto/new/pu101298.htm

inition of industrial designs. However,countries remain free to require either nov-elty or originality (Article 25). There is anobligation for Members to provide for pro-tection of creations in the field of textiles soas to take into account the short life cycle(fashion) of such design creations. The termof protection must be no less than 10 years(Article 26.3). The provision on textiledesigns is of particular importance to thedesign industry. Registration may becomeimportant for traditional crafts and thepreservation of cultural identity and tradi-tion, to the extent that they bring aboutinnovative patterns that qualify, in terms oforiginality, for design protection. Moreover,copyright protection can also be used inmany countries as a possible way to protectdesigns without any registration require-ments.

TOPOGRAPHIES OF INTEGRATED CIRCUITS

The protection of integrated circuits is notof any relevance here except for the fact thatit is an example of sui generis protection,derived for a specific technology. TheTRIPS Agreement, building upon theTreaty on Intellectual Property in Respectof Integrated Circuits (Washington Treaty),grants exclusive rights, including the rightto prevent the importation of goods con-taining the topographies. Limited excep-tions (only stock in hand or ordered beforenotice of an unlawful act) exist in favour ofthe bona fide buyer of counterfeited goods(Articles 36, 37). The term of protectionextends to at least 10 years (Article 38). Itentails a prohibition of reciprocity treat-ment in the national laws of industrializedcountries through the MFN clause.

PATENTS FOR INVENTIONS

The provisions on patents for inventions ofthe TRIPS Agreement define, to a largeextent, the legal conditions applicable togenetic resources and TK. The provisions ofthe TRIPS Agreement considerably enhancethe protection for breeding and genetic

engineering, and have changed the legalrelationship between genetic resources andTK on the one hand, and newly appropri-ated technological advances on the other.They are of considerable significance notonly for the chemical and pharmaceuticalindustries, but also for all other sectors withactive patent-oriented strategies. In the fieldof biotechnology, the limitation ofpatentability to microorganisms reflects theminimal consensus in a worldwide contro-versial discussion, which will continue asthe present state of the law neither satisfiesthe long-term needs of the industry nor ofdeveloping countries.

The TRIPS Agreement establishes theprinciple of non-discrimination as to thefields of technology, the place of invention,and the country of production (Article27.1), thus barring differential treatment ofdifferent fields of technology. Members arenot allowed to apply different rules onpatent protection depending on differentfields of technology: no special rules forgenetic engineering can be adopted. Theminimum term of protection is 20 years(Article 33). The Agreement entails an obli-gation to provide product protection in thefield of pharmaceuticals and foodstuffs.Developing countries are obliged to intro-duce such protection by 2005. In the mean-time, inventions are to be protected byso-called ‘pipeline’ protection, whichamounts to quasi-exclusive rights by meansof administrative measures and marketingapproval until full patent protection takeseffect (Articles 70.8, 70.9).50

The TRIPS Agreement recognizes gen-eral exceptions from patenting in order toprotect the ordre public and morality,including the protection of human, plantand animal life and health or to avoid seri-ous prejudice to the environment. Impor-tantly, exceptions can only operate if at thesame time the Member prohibits commer-cial exploitation of the product. On theother hand, it is not sufficient to precludepatenting only because the law prohibitsthe exploitation of the invention. Beyondthese general exceptions, the TRIPS Agree-


50 The scope of these rules was expounded in India-Patent Protection. WT/DS50/AB/R, 19 December 1997.

ment recognizes special exemptions forwhich Members may qualify. Negotiationson these points were extremely difficult,and they resulted in what was considered aprovisional solution. Plants and animalsother than microorganisms, and essentiallybiological processes for the production ofplants and animals, may be excluded frompatentability. But there is an obligation togrant patent protection of inventions relat-ing to microorganisms and essentially bio-logical processes. It entails an obligation toprovide an effective sui generis protectionfor plant varieties. Members may choose tooperate under the UPOV Convention. Theymay choose to design new and innovativeschemes of protection, taking into accountconsiderations of benefit sharing and accessregulation under the CBD. Finally, theymay, in addition, opt for special or generalpatent protection, either exclusively or inaccumulation. We shall return to these dis-tinctions in a close examination of patent-ing of life forms in different countries (seeSection 2.4).

Article 27.3(b) was meant to be of aprovisional nature and the provision wassubject to a review 4 years after the entryinto force of the TRIPS Agreement in 1995.The review has not produced any substan-tive results. The Doha Ministerial Confer-ence reiterated the mandate to pursue thereview. Importantly, this mandate includesan examination of the relationship of theTRIPS Agreement, the CBD, the protectionof TK and folklore, and other new develop-ments raised by Members:

19. We instruct the Council for TRIPS, inpursuing its work programme includingunder the review of Article 27.3(b), thereview of the implementation of the TRIPSAgreement under Article 71.1 and the workforeseen pursuant to paragraph 12 of thisdeclaration, to examine, inter alia, the rela-tionship between the TRIPS Agreement andthe Convention on Biological Diversity, theprotection of traditional knowledge andfolklore, and other relevant new develop-ments raised by Members pursuant to Arti-cle 71.1. In undertaking this work, theTRIPs Council shall be guided by the objec-

tives and principles set out in Articles 7and 8 of the TRIPS Agreement and shalltake fully into account the developmentdimension.51

This statement implies recognition ofthe fact that the scope of patentabilitycannot be settled independently of otherrelevant instruments and the interests atstake, and of the importance to obtain anoverall balance in accordance with thegoals set forth in Article 7 of the Agreement.

PROTECTION OF TRADE SECRETS (UNDISCLOSED

INFORMATION)Protection of undisclosed information is ofimportance to TK to the extent that thecircle of knowledgeable people isrestricted. This may be of importance tohealers and shamans in the use of geneticresources.

Protection of undisclosed informationwas introduced by the TRIPS Agreementand recognized as an intellectual propertyright (Article 2) going beyond mere protec-tion against unfair competition. The notionof undisclosed information is defined. Asecret is protected if it is not generallyknown or readily accessible to personswithin circles that normally deal with theinformation. It must have commercial valueand is subject to reasonable measures ofprecaution in order to keep the secret (Arti-cle 39). The TRIPS Agreement establishesthe right to take action against infringementof trade secrets, including damages to bepaid by enterprises which knew, or shouldhave known, that the information givenincluded trade secrets (Article 39.2, note10; Article 45). It entails an obligation toprotect test data concerning pharmaceuti-cals or agricultural chemical products thatutilize new chemical entities in the courseof an approval procedure against unfaircommercial use (Article 39.3).

The adoption of provisions on the pro-tection of trade secrets – for the first time ina multilateral treaty – is of particular impor-tance in the light of growing use of tradesecrets by enterprises in various fields. Pro-


51 WTO, Ministerial Declaration, para. 19, WT/MIN(01)/DEC/1 (20 November 2001).

tection of test data against unfair commercialuse will need to be developed in clearerterms (as for example in European Commu-nity law through a 5-year limitation of pro-tection). The provision is likely to result inlicensing of test data and therefore in sharingthe burden ex post of research efforts. Theprotection against further disclosure of testdata by the competent authorities is of par-ticular interest to the agrochemical and phar-maceutical industries, whose products aresubject to marketing approval procedures.

ENFORCEMENT AND TRANSPARENCY

The TRIPS Agreement entails a code ofdetailed rules on enforcement. The right tohave access to review by judicial authori-ties of final administrative decisions isestablished (Articles 42, 41.4, 62.5). TheTRIPS Agreement stipulates the right toobtain injunctions (Article 44), damages(Article 45) and other remedies, includingdestruction of products and means of pro-duction (Articles 46, 59). Protection againstmisuse of procedures by the right holder(harassment) is established (Article 48).

The right to obtain provisional meas-ures (Article 50) and suspension of therelease of prima facie counterfeit or piratedgoods for a period of ten working days, andif need be, against payment of security, isestablished (Articles 51–57). An obligationto make laws and agreements publiclyavailable provides for transparency. In par-ticular, the obligation to publish or makepublicly available final judicial and admin-istrative decisions of general application(precedents) expresses fundamental pre-cepts of the rule of law.

The enforcement provisions requirelegislative amendments, particularly indeveloping countries and in Central andEastern Europe. The adoption and imple-mentation of such provisions are of keyimportance to an effective protection andenforcement of IPRs. From a long-term per-spective, they improve the means by whichto tackle intellectual property problemsthrough judicial channels. Before the adop-

tion of the TRIPS Agreement, only diplo-matic interventions were possible. Therequirement to publish precedents willimprove transparency in many countries,including Western Europe.

WTO law and genetic resources

In conclusion, the law of the WTO is ofparamount importance for geneticresources and TK. The regulatory level andthe effective dispute settlement mechanismplace it at the heart of future developments.The brief survey above indicates that regu-lation of the two areas is affected by anumber of agreements, including the GATT1994, the Agreement on Agriculture, theAgreement on Sanitary and PhytosanitaryMeasures and the TRIPS Agreement. Werealize that the impact of WTO rules is notlimited to the particular problem of intel-lectual property and patenting. It alsoaffects other forms of IPRs. Moreover, otherregulatory areas, in particular tariffs andother trade regulations, such as phytosani-tary measures, affect it too. There is an over-all potential for promoting the use of, andthe protection of, genetic resources and TKin the different policy instruments of theWTO. But there is a potential to render suchprotection and promotion more difficult ifit is not sufficiently taken into account infuture law-making. It will be a matter ofexamining these problems in the fullcontext of other agreements and domesticregulations. The ministerial mandate ofDoha to examine the issue of patenting lifeforms in a wider context, including the pro-tection of TK, is encouraging. It is a neces-sary first step towards a larger coherenceand has to be expanded to all pertinentissues alike.

2.3.4 The International Union for theProtection of New Varieties of Plants

(UPOV)52

The UPOV Convention was first signed in1961 to provide a form of legal protection of


52 Author: Philippe Cullet with the assistance of Danuta Szymura Berglas.

plant varieties for Western European coun-tries.53 It seeks to protect new varieties ofplants both in the interest of agriculturaldevelopment and of plant breeders.Although it did not introduce patents,UPOV sought from the outset to provideincentives to the private sector to engage incommercial plant breeding, by introducingso-called plant breeders’ rights. Despite thedistinction between patents and plantbreeders’ rights, the two share several basiccharacteristics: they provide exclusive com-mercial rights to holders, reward an inven-tive process, and are granted for a limitedperiod of time, after which they pass intothe public domain.

More specifically, UPOV recognizes theexclusive rights of individual plant breed-ers to produce or reproduce protected vari-eties, to condition them for the purpose ofpropagation, to offer them for sale, to com-mercialize them, including exporting andimporting them, and to stock them with aview to production or commercialization(Article 14.1 UPOV). Protection underUPOV is granted for developed or discov-ered plant varieties that are new, distinct,uniform and stable (Article 5 UPOV). Theconcept of novelty under UPOV is notewor-thy because it differs from the approachunder patent law. Under UPOV, a variety isnovel if it has not been sold or otherwisedisposed of for purposes of exploitation ofthe variety. Novelty is thus defined in rela-tion to commercialization and not by thefact that the variety did not previouslyexist. UPOV gives a specific time frame forthe application of novelty. To be novel, avariety must not have been commercializedin the country where the application is filedfor more than a year before the application,and in other member countries for morethan 4 years.54 The criterion of distinctnessrequires that the protected variety shouldbe clearly distinguishable from any othervariety whose existence is a matter ofcommon knowledge at the time of the filing

of the application. Stability is obtained ifthe variety remains true to its descriptionafter repeated reproduction or propagation.Finally, uniformity implies that the varietyremains true to the original in its relevantcharacteristics when propagated.

The UPOV Convention has beenrevised several times since 1961: in 1972,1978 and 1991. At present some states areparties to the 1978 Act and some states areparties to the 1991 Act. Non-member statesthat wish to join the UPOV regime at pres-ent must join under the 1991 Act, but thereis no obligation for existing member statesto ratify the latest version of the conventionif they do not wish to.

The revisions to the Convention havegenerally served to progressively strengthenplant breeders’ rights. The 1991 version, forinstance, extends breeders’ rights to all pro-duction and reproduction of their varietiesand to species as well as general and spe-cific plant varieties. This now also includesso-called ‘essentially derived varieties’(Article 14.5 of UPOV). Protection of anessentially derived variety is obtained if thevariety is predominantly derived from theinitial variety and retains its essential char-acteristics. It must also be clearly distin-guishable from the initial variety whileconforming to the initial variety in theexpression of the essential characteristics.

One of the main distinguishing featuresof the original UPOV regime is that therecognition of plant breeders’ rights is cir-cumscribed by two main exceptions. First,under the 1978 version of the Convention,the so-called ‘farmer’s privilege’ allowsfarmers to re-use propagating material fromthe previous year’s harvest and to freelyexchange seeds of protected varieties withother farmers. Secondly, plant breeders’rights do not extend to acts done privatelyand for non-commercial purposes or forexperimental purposes, and do not extendto the use of the protected variety for thepurpose of breeding other varieties and the


53 Note that this section introduces the UPOV Convention in general. Further developments concerning plantbreeders’ rights can be found in Chapter 3. 54 Article 6 of the UPOV Convention. In the case of other member countries, the relevant timeline is 6 yearsfor trees and vines.

right to commercialize such other varieties.The 1991 version of the Convention, bystrengthening plant breeders’ rights, hasconversely limited existing exceptions. Theremaining exceptions include acts doneprivately and for non-commercial purposes,experiments, and for the breeding andexploitation of other varieties. Breeders arenow granted exclusive rights to harvestedmaterials and the distinction between dis-covery and development of varieties hasbeen eliminated.55 Further, the right to saveseed is no longer guaranteed as the farmer’sprivilege has been made optional.

As noted, plant breeders’ rights werefirst conceived as an alternative to patentrights. As a result, UPOV originally pro-vided that the two kinds of IPRs should bekept separate. Under UPOV-1978, memberstates can, for instance, only offer protec-tion through one form of IPRs. The grant ofa PBR on a given variety implies that noother intellectual property right can begranted to the same variety. This restrictionhas been eliminated under UPOV-1991 anddouble protection is now allowed.

The UPOV Convention was first negoti-ated and ratified mostly by developed coun-tries. It is only since the adoption of theTRIPS Agreement that more developingcountries have progressively joined theConvention.56 Even though developingcountries did not participate in the devel-opment of this legal regime which is tai-lored for mechanized and large-scaleagriculture, the rationale for joining it isthat the UPOV regime is generally held tofulfil the conditions of a sui generis systemas required under Article 27.3(b) of theTRIPS Agreement.57

2.4 Selected Regional and NationalLegal Frameworks58

2.4.1 Developing countries

Developing countries have adopted differ-ent strategies to respond to the need tointroduce IPR frameworks in the field ofplant genetic resources as required by theTRIPS Agreement. This section reviews afew of the initiatives that have been taken atthe broad level of a whole continent (theAfrican Model Legislation), at the regionallevel (Andean Community) and at thenational level (Peru and India). This servesto illustrate different ways in which devel-oping countries have faced the challenge ofintroducing IPR in the field of plant geneticresources.

The African continent: the OAU ModelLegislation59

In the African continent, states have tried torespond individually and collectively tothe challenge that the implementation ofthe TRIPS Agreement presents for most ofthem. Before the adoption of the TRIPSAgreement, most sub-Saharan Africanstates, in particular the least developedones among them, had not invested signifi-cant time and effort in developing IPRregimes in the field of plant geneticresources. The sudden need to implementthe TRIPS Agreement has led African statesto pursue different strategies. Some stateshave tried to develop national frameworkswhile others have tried to cooperate in theframework of existing regional IPR organi-zations.60 Most states realized that the diffi-culties involved in devising a newframework for access and control over plant


55 See, for example, Nijar and Ling (1994, p. 277).56 Overall, as of July 2002, out of 51 member states there were 16 developing country members, an over-whelming majority of them being Latin American countries, and with only four developing country membersaltogether from Africa and Asia.57 See, for example, WTO, Review of Article 27.3(b): The View of Switzerland, WTO Doc. IP/C/W/284(2001).58 Authors: Philippe Cullet, Susette Biber-Klemm and Danuta Szymura Berglas.59 Author: Philippe Cullet.60 See, in particular, Annex 10 of the Agreement to revise the Bangui Agreement on the Creation of an AfricanIntellectual Property Organization of 2 March 1977 and 24 February 1999, Bangui.

genetic resources and related knowledgenecessitated an effort at a broader level. Asa result, the Organization of African Unity(OAU) took on the task of negotiatingamong its member states a model lawadapted to the African region that could berelied upon when introducing nationallegal frameworks concerning plant geneticresources.

The African Model Legislation for theProtection of Rights of Local Communities,Farmers, and Breeders and for the Regula-tion of Access to Biological Resources(Model Legislation) was finally adopted in2000 after a period of consultations andnegotiations. The Model Legislation pur-sues a number of inter-related goals. It gen-erally seeks to ensure the sustainablemanagement of biological resources. Withinthis broad objective, the Model Legislationfocuses on a number of different issues.These include the question of access to bio-logical resources, community rights, farm-ers’ rights and plant breeders’ rights.

The Model Legislation first seeks toreassert countries’ sovereign rights overtheir biological resources and proposes asystem whereby access can only be grantedwith prior and informed consent of thestate of origin of the biological resource, aswell as of concerned communities.61

Among the conditions laid down in theModel Legislation is one specifying thatpatents over life forms are not recognizedon accessed biological resources. As aresult, individuals or legal entities that col-lect biological resources are barred fromapplying for patents over biologicalresources accessed in accordance with theModel Legislation.62

After dealing with the issue of accessand the conditions on which access can begranted, the Model Legislation defines three

types of related property rights. First, it rec-ognizes the collective rights of communitiesto their biological resources and the right tocollectively benefit from their use, rights totheir innovations, practices, knowledge andtechnology as well as the right to benefit col-lectively from their utilization.63 In practice,these rights allow communities to prohibitaccess to their resources and knowledge, butonly in cases where access would be detri-mental to the integrity of their natural orcultural heritage.64 The right to controlaccess is strengthened with a right to receiveat least 50% of the benefits derived from thecommercial use of their resources or knowl-edge. The duty to channel the benefits backto the communities is put on the state.65 TheModel Legislation also provides for therecognition of community IPRs. These rightsinclude the rights of communities to com-munity innovation, practice, knowledge ortechnology.66 Apart from the specific indi-cation that registration is not a condition forthe protection of community IPRs, theModel Legislation does not provide a com-plete framework for community IPRs, a taskthat must be undertaken by individualcountries adopting the Model Legislation.

The Model Legislation goes on todefine farmers’ rights. Farmers’ rightsinclude the protection of TK relevant toplant and animal genetic resources; theright to an equitable share of benefits aris-ing from the use of plant and animal geneticresources; the right to participate in makingdecisions on matters related to the conser-vation and sustainable use of plant andanimal genetic resources; the right to save,use, exchange and sell farm-saved seed orpropagating material; and the right to use acommercial breeder’s variety to developother varieties.67

Besides the recognition of community


61 See Articles 3–8 of the African Model Legislation for the Protection of Rights of Local Communities, Farm-ers and Breeders and for the Regulation of Access to Biological Resources, 2000. 62 Article 9 of the African Model Legislation, note 61 above.63 Articles 17–19 of the African Model Legislation, note 61 above.64 Article 20 of the African Model Legislation, note 61 above.65 Article 23 of the African Model Legislation, note 61 above.66 Article 24 of the African Model Legislation, note 61 above.67 Articles 25–27 of the African Model Legislation, note 61 above.

rights and farmers’ rights, the Model Legis-lation also defines plant breeders’ rightsalong the lines of the model provided by theUPOV Convention. The Model Legislationseeks to provide a comprehensive regimethat includes not only the rights of farmersand communities but also the rights of com-mercial breeders. The underlying reason forincluding plant breeders’ rights in theseprovisions is that the Model Legislationproposes a plant breeders’ rights regimethat is much more balanced than the UPOVversion. The Model Legislation thus pro-vides broad exemptions to the rights ofbreeders and also gives significant latitudeto member states to restrict the rights forreasons of public interest.68

On the whole, the Model Legislationseeks to provide a framework that takes intoaccount the requirements of Article 27.3(b)of the TRIPS Agreement. At the same time,it tries to go further and to recognize thespecific needs of African countries byemphasizing the need for a strict regime onABS, as well as the need for the recognitionof other rights, such as the collective rightsof communities and farmers’ rights. Whilethe Model Legislation constitutes a sourceof inspiration for all states that are develop-ing legal frameworks in this field, it has notbeen widely adopted in the form it receivedat the level of the OAU. This is probablydue, in part, to the fact that while the plantbreeders’ rights regime proposed under theModel Legislation goes some way towardsmeeting the criteria of an ‘effective’ suigeneris system under the TRIPS Agreement,the rather stringent restrictions imposed onthe rights of commercial breeders, and theintroduction of farmers’ rights as well ascommunity rights, make it a rather contro-

versial instrument at the internationallevel. This is the case although it probablyconstitutes an appropriate starting point formost African countries, and is much moreadapted to local circumstances and needsthan a regime solely based on the UPOVConvention.

Andean region69

THE ANDEAN COMMUNITY’S REGIME ON GENETIC

RESOURCES AND TRADITIONAL KNOWLEDGE

The Andean region has been at the forefrontof efforts to introduce legal frameworks toimplement the access and benefit-sharingprovisions of the CBD. This section surveysthe region-wide regime on access to geneticresources and traditional knowledge andgives an overview of its implementation inthe Peruvian legislation.

Two Decisions of the Andean Commu-nity are relevant for its regime on access togenetic resources and TK: the 1996 Deci-sion on a Common Regime on Access toGenetic Resources,70 and Decision 486 onthe Common Intellectual PropertyRegime.71

The 1996 Decision 391 of the CartagenaAgreement,72 established a common regimeon access to genetic resources. Its purpo-ses are: (i) to establish the conditionsfor a just and equitable participation in thebenefits of access; (ii) to lay the foundationsfor the recognition and valuation of thegenetic resources and their by-products,and of their associated intangible compo-nents; (iii) to promote conservation andsustainable use of biological diversity; (iv)to promote the development of scientific,technological and technical capacities at alllevels; and (v) to strengthen the negotiating


68 Articles 43 and 45 of the African Model Legislation, note 61 above.69 Author: Susette Biber-Klemm.70 Andean Community Commission, Decision 391: Common Regime on Access to Genetic Resources, Cara-cas, Venezuela, 2 June 1996 http://www.comunidadandina.org/normativa/dec/D391.htm (English and Span-ish).71 Decision 486: Régimen Común sobre Propiedad Industrial, Lima, Perú, a los catorce días del mes desetiembre del año dos mil.72 The Cartagena Agreement of 1969 (the Andean Subregional Integration Agreement), as revised by the Pro-tocol of Trujillo of 1996, created the Andean Community. The Andean Community aims at the economicand social integration of its members in view of the creation of a Latin American Common Market. The mem-bers of the Andean Community are Bolivia, Colombia, Ecuador, Peru and Venezuela.

http://www.comunidadandina.org/normativa/dec/D391.htm

capacity of the member countries (Article2).

The ‘strategic value’ of the know-how,innovations and practices of the nativeAfro-American and local communities,their historic contribution to the conserva-tion and development of biological diver-sity, and the sustained use of itscomponents are explicitly recognized in thepreamble (paras 5 and 6). The close inter-dependence between the native popula-tions and communities and their biologicalresources, and the need for its reinforce-ment, are acknowledged (para. 7).

The Decision’s subject matter encom-passes the genetic resources, their by-prod-ucts and so-called ‘intangible components’.By-products (Producto derivado) aredefined as ‘a molecule, a combination ormixture of natural molecules, includingcrude extracts of live or dead organisms ofbiological origin that come from the metab-olism of living beings’ (Article 1.7). The‘intangible components’ are defined as allknow-how, innovation or individual or col-lective practice with a real or potentialvalue that is associated with the geneticresource, its by-products or the biologicalresource that contains them, whether or notprotected by intellectual property regimes(Article 1.18). Thus the Decision explicitlyincludes not only genetic, but also bio-chemical information73 and TK.

The Decision is based on the con-cept that genetic resources originating in astate, and their by-products, are goodsbelonging to the heritage of the state. Assuch, they are ‘inalienable, not subject toprescription and not subject to seizure orsimilar measures’. This exclusive right ofthe state is independent of the propertyregimes applicable to the biologicalresources that contain the genetic or bio-

chemical resources, or to the land on whichthey are located (Article 6). The state is theexclusive holder of the property rights overthe genetic resources. This means that thegenetic information contained in domesti-cated plants and crops bred by farmers andindigenous communities falls under theauthority of the state, the individual hold-ers not being allowed to decide about theuse made of the genetic information.74

Farmers and local communities have norights either to the genetic information con-tained in their varieties, or to the biochem-ical information contained in, for instance,medicinal plants.

Neither does the Andean Community’sregulation of Plant Breeders’ Rights recog-nize any rights of farmers to their vari-eties.75 The ‘Common Provisions on theProtection of the Rights of Breeders of NewPlant Varieties’76 closely follows the UPOVregulations. Breeders’ certificates are to begranted to persons who have created new,uniform, distinct and stable plant varieties:the term ‘creation’ meaning ‘the productionof a new variety by the application of scien-tific skills’ (Article 4).

TK, however, remains under theauthority of its authors. Member countriesare obliged to ‘recognize and value therights and the authority of the native, Afro-American and local communities to decideabout their know-how, innovations andtraditional practices associated withgenetic resources and their by-products’(Article 7).

This differentiation of the rights togenetic and biological resources and associ-ated TK leads to a complex system and var-ious ‘layers’ of access contracts in theDecisions ABS regime.77

Access contracts are to be concludedbetween the applicant and the state (Article


73 The question being whether medicinal plants as such (i.e. biological resources) fall under the regulationor not (Ruiz Muller, 2003). 74 As to the consequences of this regime on the rights of grassroot stakeholders in the ABS process, see Biber-Klemm, Chapter 7; similarly, Ruiz Muller (2003) and Rosell (1997).75 A narrow farmers’ privilege for own (non-commercial) use is granted (Article 26).76 Decision 345: Régimen Común de Protección a los derechos de los Obtentores de Variedades Vegetales,Bogotá, Colombia, 21 October 1993.77 As to the problems generated by this system regarding the marketing of the information see Biber-Klemm,Chapter 7; similarly, Ruiz Muller (2003).

32), the latter defining the conditions foraccess (Article 17). In addition, so-calledancillary contracts defining the conditionsfor access have to be concluded betweenthe applicant and the owner of the biologi-cal resource (land owner, possessor, man-ager; ex-situ facility; owner of the biologicalresource [Articles 41–44]). These contractsdo not confer an independent right ofaccess but depend on the main access con-tract with the National Authority (Article42). If ‘intangible components’ are includedin the research, the conditions for accesshave to be negotiated with their respectiveholder and to be included in an annex tothe access contract (Article 35). So, in orderto be allowed to access one resource, vari-ous layers of contracts with various stake-holders in different locations might have tobe negotiated.78

In the case of failure to comply with thestipulations of the annex, the entire accesscontract can be nullified (Article 33).

The national intellectual propertyoffices have to control compliance with theaccess regulations. Sanctions such as fines,confiscation, closing-down of establish-ments or disqualification from applying fornew accesses may be imposed upon unau-thorized access or transactions that are notprotected by corresponding contracts (Arti-cles 46 and 47). IPRs that have beenobtained or developed on the basis of illicitaccess are not to be acknowledged by theMember Countries.

This control is reinforced by Decision486 on the Common Intellectual PropertyRegime,79 which, revising an earlier ver-sion, was adopted in 2000.80 The Decisionis specifically meant to implement theTRIPS Agreement and the CBD. Withrespect to access to genetic resources andtraditional knowledge, the Decision stipu-

lates the following: as in decision 319, themember states recognize the rights and fac-ulties of local, indigenous and Afro-Ameri-can communities to decide over theircollective knowledge (Article 3). It narrowsthe possible scope of patents in excludingnot only life forms, in whole or in part, asthey are found in nature, natural biologicalprocesses and biological material whichexist in nature, but also material that can beisolated from any life form, includinggenomes or germplasm (Article 15).

It provides a certain control of the legit-imacy of access, as any application for apatent on an invention, obtained or devel-oped from genetic resources, their derivedproducts, or from TK shall include a copyof the access contract, or the copy of thedocument that accredits a licence or author-ization of use from the community, respec-tively (Article 26). Patents granted oninventions obtained or developed fromgenetic resources or traditional knowledge,without presentation of a copy of the properaccess contract or licence from the commu-nity, are to be nullified (Article 75), and anymark referring to elements of the cultures ofindigenous, Afro-American or local com-munities shall not be registered without thecommunity’s express consent (Article136).81

THE PERUVIAN REGIME ON ACCESS TO GENETIC

RESOURCES AND TRADITIONAL KNOWLEDGE

In implementing the Andean framework,Peru has issued regulatory instruments onaccess to both genetic resources, and to TK.These are, with regard to the geneticresources, the ‘Law on the Conservationand Sustainable Use of Biological Diver-sity’82 and the ‘Draft Regulation on Accessto Genetic Resources’; with regard to TK,


78 See the enumeration in Ruiz Muller (2003), Box 1.79 Decision 486: Régimen Común sobre Propiedad Industrial, Lima, Perú, a los catorce días del mes desetiembre del año dos mil.80 The following is based on information from GRAIN: Andean Community Adopts New IPR Law, 5 Octo-ber 2000. http://www.mtnforum.org/resources/library/grain00a.htm (23 May 2004).81 See the critical assessment of this decision in the interview with Margarita Florez in the GRAIN informa-tion above, note 80. 82 Ley sobre la conservación y aprovechamiento sostenible de la diversidad biológica, Ley No 26839. Acces-sible in Spanish on: http://www.grain.org/brl/brl-ley-peru-es.cfm

http://www.mtnforum.org/resources/library/grain00a.htm

http://www.grain.org/brl/brl-ley-peru-es.cfm

the ‘Law introducing a Protection Regimefor the Collective Knowledge of IndigenousPeoples derived from BiologicalResources’.83

The Law on Conservation and Sustain-able Use of Biodiversity is the implementa-tion of the Convention on BiologicalDiversity. It is based on the designation inthe constitution (Artículo 66o) of all naturalresources (renewable and non-renewable)as the heritage of the state. It was enacted in1997. The law adopts the Andean Pactregime of the state being owner of thegenetic resources, independently of theownership of the biological resources.Accordingly, the state is party to the accessprocedures (Artículo 27, 28). Access can berestricted or denied for reasons includingconservation of resources and their ecosys-tems, and/or potential negative effects onessential elements of the cultural identityof the peoples involved, and for‘strategic’ genetic resources84 (‘Recursosgenéticos … calificados como estratégicos’)(Article 29).

The ‘Proposal of a Regulation onAccess to Genetic Resources’ establishesthe procedure for gaining access.85 It fixesthe content of the request, determines thecompetent authorities and establishes theperiod of time granted to the authorities for

the individual steps. It further spells out theminimum conditions the agreements mustcontain. As parties to the negotiations, itdetermines a state agency, and for the nego-tiations of the ancillary contracts theprovider of the genetic resource – whichcan be the state, but also, for instance, an exsitu gene-bank or an indigenous people,including landowners or owners of the bio-logical resources – and the purchaser/appli-cant. The conditions of compensation are tobe negotiated with the provider86 of theresource (Article 34). However, the maincontract has to be negotiated with the com-petent state agency. The ancillary contracts‘can’ (podrán) be concluded with the otherinvolved stakeholders, the wording leavingopen whether there is an obligation toinvolve them or not (Article 9). The finan-cial benefits resulting from the access con-tract are to be set aside for a fund for theconservation, investigation and develop-ment of genetic resources. A directive coun-cil administers the fund, encompassingrepresentatives from the involved min-istries, universities teaching genetics, NGOsand indigenous peoples (Article 51). Thefund is meant to support projects for theconservation and use of genetic resources,as well as to improve the scientific capaci-ties of the universities conducting research


83 Ley 27811: Régimen de protección de los conocimientos colectivos de los pueblos indígenas vinculadosa los recursos biológicos (10 August 2002); http://www.concytec.gob.pe/infocyt/ley27811.html;http://www.grain.org/brl/peru-tk-2002–en.cfm. See also the overview in WIPO (without document number),Descriptions of National and Regional Experiences with Existing sui generis Measures and Laws for the Pro-tection of TK; advance copy, WIPO Intergovernmental Committee on Intellectual Property and GeneticResources, Traditional Knowledge and Folklore, Fifth Session, July 7–15, 2003. For medicinal plants there isspecific legislation (Ley 27300 de aprovechamiento sostenible de las plantas medicinales, 8 July 2000).84 The draft regulation on Access on Genetic Resources defines ‘Strategic Genetic Resources’ as: ‘Todorecurso que es nativo o no del Perú o que el Perú es su centro ancestral de diversificaciôn, que serve para-graphsatisfacer al menos una necesidad humana básica, que se sosepcha que tiene un potencial ceonicoinusitado, que es naturalmente escaso a nivel mundial o endémico y natrualmente insustituible. La calida derecurso gehético stratégico es declarado expresamente por el Estado Peruano’ (Article 2.39). However, theinterdiction of the exportation of viable or primarily processed parts of the – commercially interesting – Macaplant (Lepidium meyenil) is based on the argument of the conservation of the national genetic heritage allow-ing exceptions of free trade (Decreto Supremo No 039–2003–AG, 8 December 2003). 85 Propuesta de Reglamento sobre Acceso a los Recursos Geneticos. Version Abril-Julio 2001. Accessibleunder http://www.inrena.gob.pe/divbiol/reglamento-final-06–de-agosto.pdf (23 May 2004). The proposal ispresently (summer 2004) in the parliamentary process; the final version not yet being known (personal infor-mation Begoña Venero, INDECOPI).86 The draft regulations define as provider the person, institution, indigenous people or other facility in theframework of Decision 391 and the present regulations … including the state.

http://www.concytec.gob.pe/infocyt/ley27811.html

http://www.grain.org/brl/peru-tk-2002%E2%80%93en.cfm

http://www.inrena.gob.pe/divbiol/reglamento-final-06%E2%80%93de-agosto.pdf

in genetic resources, but also institutionsthat enable the negotiating capacity of theindigenous people (Article 49).

So, the proposed Peruvian regime onaccess to genetic resources hardly strength-ens the position of local farmers and otherholders of genetic resources and is even arather weak implementation of the partici-patory farmers’ rights as stipulated in theITPGRFA.

In turn, the right of indigenous peoplesto their collective knowledge is explicitlyrecognized and regulated in the ‘Law intro-ducing a Protection Regime for the Collec-tive Knowledge of Indigenous Peoplesderived from Biological Resources’.87 Thislaw is based on a provision in the PeruvianLaw on Intellectual Property that gives theMinistry of Industry, Tourism, Integrationand International Trade the competence to‘establish a regime to protect and possiblyregister the knowledge of native and farm-ing communities’.88 The term ‘indigenouspeoples’ is broadly defined as ‘aboriginalpeoples holding rights that existed prior tothe formation of the Peruvian state, main-taining a culture of their own, occupying aspecific territorial area and recognisingthemselves as such. These include … ruraland native communities’ (Article 2(a)).

The law creates a sui generis rightto the collective knowledge that belongsto the communities of the indigenous peo-ples (and explicitly not to its individualmembers) (Article 10). This collectiveknowledge is considered a part of the cul-tural heritage of the indigenous peoples(Article 11). Therefore the rights of theindigenous peoples to their collectiveknowledge are inalienable and not extin-guishable (Article 12). The present genera-tions preserve, develop and administertheir collective knowledge for their ownbenefit and for that of future generations(Article 9). Consequently, the knowledgecan only be licensed. The licence does notconfer exclusive rights, nor is it able to pre-vent others from using the knowledge or

other licences from being awarded on thesame knowledge. Nor do the licences affectthe right of the peoples to use and furtherdevelop their collective knowledge (Article32).

The regime creates three instruments: asystem to control access to the collectiveknowledge, a system of registers of collec-tive knowledge, and an additional fundingsystem, which is to contribute to the inte-gral development of the indigenous peo-ples.

Access to TK is dependent uponobtaining the prior informed consent of therepresentative organizations of the indige-nous peoples possessing the collectiveknowledge. Other indigenous peoples pos-sessing the same knowledge are to beinformed by the organization. Their inter-ests and concerns are to be taken account ofin the negotiations (Article 6). The lawdefines the obligatory contents of thelicence contracts, such as information onthe intended research, its risks and implica-tions, the statement of the compensationand the obligation of the licensee to inform(Article 27). The contracts are to be regis-tered by the National Intellectual PropertyInstitute (INDECOPI, Instituto Nacional deDefensa de la Competencia y de la Protec-ción de la Propiedad Intelectual), whichverifies the legitimacy of the licence con-tracts. The conditions for gaining access aredifferent for access for scientific and in-dustrial use respectively. In respect ofaccess for scientific use, only the priorinformed consent of the people concernedis needed. In the case of access for com-mercial or industrial application, inaddition, a licence contract has to be con-cluded. This contract has to fix the condi-tions for the payment for access and anequitable distribution of the benefits (Arti-cle 7). Further, the contract of licencemust contain the obligation to periodicallyinform the licensor in general terms aboutthe advances in the investigation, industri-alization and marketing of the products


87 Note 83 above. 88 For the description of the legislation process, in particular in view of the participation of indigenous com-munities, see Tobin and Swiderska (2001).

developed from the collective knowledge(Article 21(e)).

The Fund for the Development ofIndigenous Peoples is meant to support thecomprehensive development of the indige-nous peoples through the financing of proj-ects and other activities (Article 37). Thefund is autonomous and administered byan Administrative Committee which com-prises five members of representativeorganizations of indigenous peoples andtwo members of the National Commissionfor the native peoples. The law statesexplicitly that the Committee shall, to theextent possible, proceed according to thetraditional mechanisms and customs devel-oped by the indigenous peoples for allocat-ing and distributing collectively generatedbenefits.

The fund is made up of a percentage ofthe economic benefits resulting from the mar-keting of goods that have been developed onthe basis of TK; further, of contributions fromthe state budget, international technicalcooperation and donations (Article 41).

An interesting detail is that in caseswhere the collective knowledge has passedinto the public domain within the pre-vious 20 years, a percentage of the bene-fits resulting from the marketing of thegoods developed on the basis of thisknowledge has to be set aside for thefund. Collective knowledge is consideredto be in the public domain either whenit has been made accessible to personsother than the indigenous peoples by masscommunication media, or where it hasbecome extensively known outside theconfines of the indigenous peoples andcommunities (Article 13). The PublicDomain TK is registered in the PublicNational Register.

The registration system consists of threetypes of registers: the Public National Regis-ter, the Confidential National Register andthe Local Registers (Article 15) (for detailssee Biber-Klemm, Chapter 7). The registershave a twofold purpose: on the one handthey are meant as instruments to preservethe collective knowledge of indigenous peo-ples; on the other hand they are intended toserve as a tool to defend the interests of

indigenous peoples regarding their TK (Arti-cle 16).

The registration does not constituterights over TK. All knowledge that is col-lective in nature, developed by indigenouspeoples and which is not in the publicdomain, irrespective of whether it isregistered or not, is protected against dis-closure, acquisition or use without the con-sent of the indigenous peoples who possessit, and against unauthorized disclosureinvolving a breach of a duty of reserve. Sothere is a certain degree of protection butno exclusive rights are conferred (Article42).

THE ANDEAN REGION’S EXPERIENCE IN PERSPECTIVE

The Andean Pact legislation on access togenetic resources and the Peruvian law onsui generis rights to TK have been hailed aslandmarks in the process of implementingthe CBD. In particular, the Peruvian legisla-tion has been at the forefront for the cre-ation of sui generis rights to TK associatedwith genetic resources. The Law 27811 pro-vides a regulatory framework throughwhich indigenous peoples can assert theirrights over their collective knowledge (RuizMuller and Lapeña, undated, p. 15).

Yet, up to now, no access contractshave been concluded on the basis of Peru’sTK legislation, and according to Ruiz, theAndean Pact Decision 391 has had littlepractical impact on the actual conclusion ofaccess contracts (Ruiz Muller, 2003, para.No. 10).

Even if it may be too early to evaluatethe Peruvian legislation, it might be inter-esting at this point to have a closer look atthe possible reasons for this occurrence.

Ruiz Muller (2003) analyses the issuein view of the Andean Pact Decision 391.He identifies the creation of incentives asone of the most important factors to pro-mote research into biodiversity. He consid-ers it as an absolute necessity to create alegal framework that is clear, simple, prac-tical, without inherent contradictions, andclearly promoting bioprospection.

He perceives the following as obsta-cles. First, the system of different layers of


contracts, given by the regime of differenti-ation in ownership described above. Sec-ondly, the fact that the state is the principalnegotiator, and, as a rule, has the lead in thenegotiations in matters concerning scien-tific topics and technical and legal issuesregarding genetic resources; in fact mattersover which specialized institutes havegreater capacity and expertise. Thirdly, thedifferences in access procedures for the dif-ferent resources such as microorganisms,PGRFA and genetic resources for medicinaluse; and finally, the high transaction costs(time, money, effort) the Decision gener-ates, which might be higher than theexpected benefits.

These observations, which in our opin-ion are also at least partly true for othercountries and regions,89 have led to aprocess aiming at evaluating and improvingthe regime in the near future (Ruiz, per-sonal information). Ruiz advocates a pro-active rather than a defensive approach tolegislation in matters of ABS and pleads fora system that is simple, practical and flexi-ble enough to be adapted to the variabilityof real access situations.

India90

India has made significant progress inrecent years towards setting up a legalregime for the management of plantgenetic resources. The proposed regime islaid out in three separate legislative instru-ments. These are: the Protection of PlantVarieties and Farmers’ Rights Act, the Bio-diversity Bill and the Patents (Amendment)Act of 2002. The separation of various ele-ments into three is partly due to India’sinternational legal obligations. The PlantVarieties Protection Act constitutes aresponse to Article 27.3(b) of the TRIPSAgreement,91 the Biodiversity Act consti-

tutes India’s attempt to implement theCBD,92 and the Patents (Amendment) Actseeks to put India in conformity with itsTRIPS obligations in the field of patent pro-tection.93 The proposed regime reflects itsfragmented parentage insofar as there are anumber of inconsistencies or overlapsamong the three bills. Since each instru-ment was drafted separately, they are exam-ined in turn.

THE PLANT VARIETIES PROTECTION AND FARMERS’RIGHTS ACT

The Protection of Plant Varieties and Farm-ers’ Rights Act constitutes the government’sresponse to its obligations under Article27.3(b) of the TRIPS Agreement. The Indiangovernment has chosen not to introducepatents over plant varieties but rather todevise its own system of IPRs. Further, it wasagreed that the UPOV Convention should notbe ratified but that a law suited to the specificconditions of the country should be drafted.In its present form, the Act focuses on theestablishment of plant breeders’ rights andfarmers’ rights. The regime for plant breeders’rights largely follows the model provided byUPOV and the criteria for registration are thesame as those found in UPOV, namely nov-elty, distinctness, uniformity and stability.The Act incorporates elements from the 1978version of UPOV and includes some ele-ments from the more stringent 1991 version,such as the possibility of registering essen-tially derived varieties.

The second main aim of the Act is tointroduce farmers’ rights. At this level, theJoint Parliamentary Committee, to whichthe bill was referred after its introduction inParliament, has proposed substantialchanges.94 While the version of the billoriginally introduced in Parliament onlycontained a short provision on farmers’


89 See Biber-Klemm, ABS, Chapter 6 and Registration, Chapter 7.90 Author: Philippe Cullet.91 Protection of Plant Varieties and Farmers’ Rights Act, 2001.92 Biological Diversity Act, 2002.93 Patents (Amendment) Act, 2002.94 See Joint Committee on the Protection of Plant Varieties and Farmers’ Rights Bill, 1999, Report of the JointCommittee (August 2000).

rights, the Committee decided to add awhole new chapter on farmers’ rights. Asadopted, the Act seeks to put farmers’ rightson a par with breeders’ rights. It provides,for instance, that farmers, like commercialbreeders, can apply to have a variety regis-tered.95 Generally, the Act envisages thatfarmers should be treated like commer-cial breeders and should receive the samekind of protection for the varieties theydevelop.

The Act also provides two avenues forbenefit sharing.96 The first scheme allowsindividuals or organizations to submitclaims concerning the contribution theyhave made to the development of a pro-tected variety. The final decision is taken bythe Authority established under the Act,which determines the amount, taking intoaccount the importance of the contributionin the overall development of the varietyand its commercial potential. The secondbenefit-sharing avenue allows an individualor organization to file a claim on behalf of avillage or local community. The claimrelates to the contribution that the village orcommunity has made to the evolution of avariety.

THE BIODIVERSITY ACT

The Biodiversity Act was drafted inresponse to the CBD. The Act does not aimat providing a general regime for biodiver-sity management but focuses on some spe-cific elements that are of concern at present.The Act thus reflects the government’sstrong reaction to biopiracy.97 The Act isalso partly premised on the desire to avoid

a direct confrontation with WTO obliga-tions in the field of plant genetic resources.

Generally, the Act focuses on thequestion of access to resources.98 Itsresponse to the current challenges is toassert the country’s sovereign rights overnatural resources. It therefore proposes toput stringent limits on access to biologicalresources or related knowledge for all for-eigners. The Act’s insistence on sovereignrights reflects current attempts by variouscountries to assert control over nationalresources or knowledge. While the Actfocuses on preserving India’s interests vis-à-vis other states in rather strong terms, itsmain impact within the country will be toconcentrate power in the hands of the gov-ernment. Indeed, Indian citizens and legalpersons must give prior intimation to thestate biodiversity boards of their intentionto obtain biological resources.99 The Act iseven more stringent in terms of IPRs since itrequires that all inventors obtain the con-sent of the National Biodiversity Authoritybefore applying for such rights.100 Theimpacts of this clause are, however, likelyto be limited since patent applications arecovered by a separate clause.101 Further, theAuthority has no extra-territorial authorityand cannot monitor applications for IPRsoutside India.

Overall, the Biodiversity Act implicitlytakes the position that India cannot do morethan regulate access by foreigners to itsknowledge base. It does, however, attemptto discipline the IPRs system in somerespects. As noted, it requires inventorswho want to apply for IPRs to seek theAuthority’s permission. It also authorizes


95 Section 16.1(d) of the Plant Varieties Act, note 94 above. 96 See Sections 26 and 41 of the Plant Varieties Act, note 94 above.97 See, for example, US Patent No. 5,401,504, Use of Turmeric in Wound Healing, issued 28 March 1995and European Patent No. EP 0436257, Method for Controlling Fungi on Plants by the Aid of a HydrophobicExtracted Neem Oil.98 The only substantive chapter of the Biological Diversity Act – Chapter II – is entitled Regulation of Bio-logical Diversity.99 Section 7 of the Biological Diversity Act, note 95 above.100 Section 6 of the Biological Diversity Act, note 95 above.101 Permission of the National Biodiversity Authority must be obtained before the sealing of the patent butcan be obtained after the acceptance of the patent by the patent authority. See Section 6.1 of the BiologicalDiversity Act, note 95 above.

the Authority to allocate a monopoly rightto more than one actor. Further, the Author-ity is also entitled to oppose the granting ofIPRs outside India.102 The Act also seeks toaddress the question of the rights of holdersof local knowledge by setting up a system ofbenefit sharing. The benefit-sharing schemeis innovative insofar as it provides that theAuthority can decide to grant joint owner-ship of a monopoly intellectual right to theinventor and the Authority or the actualcontributors if they can be identified.103

However, the sharing of IPRs is only one ofthe avenues that the Authority can chooseto discharge its obligation to determine ben-efit sharing. Further, it is in the Authority’spower to allocate rights to itself or to a con-tributor, such as a farmer contributor, andthe latter has no right to demand the alloca-tion of property rights. Other forms of ben-efit sharing include technology transfers,association of benefit claimers withresearch and development, or the locationof production, research and developmentunits in areas where this will facilitatebetter living standards for the benefitclaimants.

PATENTS (AMENDMENT) ACT

The Patents Act adopted in 1970 dealt withpatents in general and was not specificallyrelated to biological resources. However, itaddressed a number of issues that are of rel-evance in the context of PGR management.It rejected, for instance, the patentability ofall methods of agriculture and was gener-

ally much more restrictive than similarlaws in Western countries. TRIPS hasimposed significant alterations to this Act.Thus, where formerly only a process patentcould be obtained for no more than 7 yearsfor food- or medicine-related inventions,104

TRIPS now requires the availability ofproduct and process patents for 20 years.

The Patents (Amendment) Act, 2002generally seeks to modify the Act to allowcompliance with TRIPS. There was notmuch scope for diverging from the ratherprecise TRIPS obligations if India wanted toavoid further confrontation with theWTO.105 The Amendment Act thus bringsthe duration of the rights to a uniform20-year period and also substantially modi-fies the sections concerning the working ofthe patents by, for instance, doing awaywith licences of rights. The provision thatseeks to oblige patentees to manufacturetheir inventions in India was also struck outbecause of the TRIPS requirement thatimports should not be treated differentlyfrom products produced locally.106 Withregard to environmental protection, theAmendment Act includes some of theTRIPS exceptions related to environmentand health. It also addresses the question ofbiopiracy by imposing the disclosure of thesource and geographical origin of biologicalmaterial used in a patented invention. Fur-ther, non-disclosure of the geographicalorigin or the anticipation of the inventionin local or indigenous knowledge consti-tutes grounds for opposing or revoking apatent.


102 Section 18.4 of the Biological Diversity Act, note 95 above.103 Section 21.2(a) of the Biological Diversity Act, note 95 above.104 Section 53 of the Indian Patents Act, 1970. 105 India was taken to the WTO dispute settlement mechanism by both the USA and the EU for its failure toimplement in due time its obligations relating to Exclusive Marketing Rights. For the US complaint, see, forexample, India – Patent Protection for Pharmaceutical and Agricultural Chemical Products (US complaint),Report of the Panel, 5 September 1997, WTO Doc. WT/DS50/R, and India – Patent Protection for Pharma-ceutical and Agricultural Chemical Products (US complaint), Report of the Appellate Body, 19 December1997, WTO Doc. WT/DS50/AB/R.106 Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh, 15 April1994, reprinted in 33 ILM 1125 (1994).

2.4.2 Developed countries

Europe107

European states have sought harmonizationof their intellectual property laws for a longtime, both in the context of the EuropeanUnion (EU) and in broader forums. TheEuropean Patent Convention (EPC) of 1973currently brings together 27 states and pro-vides a general framework for the harmo-nization of patent law throughoutEurope.108 It has become one of the focalpoints of interest in the development ofpatent law in the field of biotechnology. Inthe context of the EU, the most significantinstrument with regard to recent develop-ments in genetic engineering is undoubt-edly the Biotechnology Directive of1998.109

EUROPEAN PATENT CONVENTION

The EPC generally provides a uniformpatent granting procedure that appliesthroughout the member states. In the con-text of the law of plant genetic resources,the EPC is particularly noteworthy withregard to the scope of patentability. Thegeneral conditions for patentability are sub-stantially similar to those of the TRIPSAgreement and include the criteria of nov-elty, inventiveness and industrial applica-bility.110 Some specific exceptions topatentability are provided in Article 53.This generally includes inventions whoseexploitation would be contrary to publicmorality. The notion of public morality has

been interpreted as covering public peaceor social order or serious prejudice to theenvironment.111

The EPC also excludes the patentabil-ity of plant or animal varieties (but notplants and animals in general, as in theTRIPS agreement), or essentially biologicalprocesses for the production of plants oranimals, with the exception of microbiolog-ical processes or their products that arepatentable.112 The exclusion from patent-ability of plant varieties was first inter-preted by the European Patent Office (EPO)as being a consequence of the existence ofnational and international regulations for theprotection of plant breeders’ rights.113 Theconsequence was that only the patenting ofplants or their propagating material in thegenetically fixed form of the plant varietywas prohibited, but not the patentability ofthe plant or the animal itself. Since 1995, theinterpretation of Article 53.b is that claimson plants are not acceptable because trans-genic plants encompass plant varieties.However, plant cells have now been deter-mined as being patentable.114

EUROPEAN UNION BIOTECHNOLOGY DIRECTIVE

The Directive on the Legal Protection ofBiotechnological Inventions is now the cen-tral instrument in the EU context concern-ing the patentability of GMOs.115 It hasbeen one of the most contentious pieces oflegislation to go through the European Par-liament. After lengthy debates it wasadopted in June 1998, and subsequentlyunsuccessfully challenged.116


107 Author: Philippe Cullet.108 Convention on the Grant of European Patents, Munich, 5 October 1973 (hereafter EPC).109 Directive 98/44/EC of the European Parliament and the Council of the European Union on the Legal Pro-tection of Biotechnological Inventions, 6 July 1998, 1998 OJ L 213 (hereafter Biotechnology Directive).110 Article 52.1 of the EPC, note 111 above.111 Plant Genetic Systems vs Greenpeace, EPO Technical Board of Appeal, 21 February 1995 (T 356/93). 112 Article 53.b of the EPC, note 111 above.113 Ciba-Geigy/Propagating Material, EPO Technical Board of Appeal, 26 July 1983 (T49/83), and Lubri-zol/Hybrid Plants, 10 November 1988 (T 320/87).114 See Plant Genetic Systems vs Greenpeace, EPO Technical Board of Appeal, 21 February 1995 (T356/93).115 Biotechnology Directive, note 112 above.116 See Netherlands vs Council of the European Union, Judgment of 9 October 2001 (Case C-377/98).

The Directive is premised on the recog-nition of the importance of biotechnologyand the necessity of providing legal protec-tion to biotechnological inventions in theEuropean Community. It complies withother EU legal instruments and the EPC.The principle is that biotechnologicalinventions are to be protected by patentrights. It specifically excludes thepatentability of plant and animal varieties,and essentially biological processes for theproduction of plants or animals. However,patentability is provided for inventionsconcerning plants or animals if the techni-cal feasibility of the invention is notconfined to a particular plant or animalvariety. This significantly narrows downthe exception concerning plant and animalvarieties.

The Directive follows the EPC andTRIPS in prohibiting patentability in situa-tions where the commercial exploitation ofan invention would be contrary to ordrepublic or morality. It provides specificexamples of inventions deemed to breachthese norms. These include processes forcloning human beings and processes formodifying the genetic identity of animalswhich are likely to cause them sufferingwithout any substantial medical benefit tohuman or animal, and also animals result-ing from such processes.

The scope of protection providedunder the Directive is extremely broad. Apatent on biological material possessingspecific characteristics gives the patentholder rights over any biological materialderived from that biological materialthrough propagation or multiplication in anidentical or divergent form, and possessingthose same characteristics. However, theDirective includes a limited exception inthe case of agricultural use. It provides aform of farmers’ privilege modelled afterthe plant breeders’ rights model, authoriz-ing farmers to use the product of their har-

vest for propagation or multiplication ontheir own farm.117 This exception extendsto protected livestock as well.

Finally, the question of the Directive’srelationship with other internationaltreaties in the field of patents and biodiver-sity must be highlighted. Article 1 specifi-cally indicates that the provisions of theDirective are without prejudice to the obli-gations of the member states pursuant tointernational agreements, and in particularthe TRIPS Agreement and the CBD. In itsruling on the application for annulment ofthe Directive brought by The Netherlands,the European Court of Justice had to give anopinion on the compatibility of the Direc-tive with the CBD. In rejecting The Nether-lands’ contentions, the Court made animportant statement concerning the theo-retical impact of the Directive on the pro-tection of TK. It stated that:

[i]t cannot be assumed, in the absenceof evidence, which is lacking in this case,that the mere protection of biotech-nological inventions by patent wouldresult, as is argued, in deprivingdeveloping countries of the ability to moni-tor their biological resources and to makeuse of their traditional knowledge, anymore than it would result in promotingsingle-crop farming or in discouragingnational and international efforts topreserve biodiversity.118

The Court further dismissed a claimconcerning the absence of benefit-sharingprovisions in the Directive. It noted that theCBD does not specifically impose onmember states the obligation to take intoaccount the interests of the country fromwhich the genetic resources used in thepatented invention originate. However, theCourt also acknowledged that Article 1.2imposes on member states the obligation toimplement the Directive in such a way thatthey do not breach their obligations underthe CBD.


117 See also Council Regulation (EC) No 2100/94 on Community Plant Variety Rights, 27 July 1994, OJ 1994L227/1.118 C-377/98, note 119 above at § 65.

USA119

The USA has been at the forefront of thedevelopment of patent law, in particular inthe fields of plant varieties and geneticengineering. The USA was the first countryto enact a specific Plant Patent Act, in 1930,that provides protection for certain asexu-ally reproduced plants.120 Protection isgranted to whoever invents or discoversand asexually reproduces distinct and newplant varieties. The scope of protection hasbeen the subject of recent litigation. InImazio vs Dania, the Court of Appealsdetermined that the term variety shouldbe understood as providing protection onlyto a specific plant and not to a range ofplants.121

The Plant Patent Act has been sup-plemented by the 1970 Plant Variety Pro-tection Act, which grants protection tonovel varieties of sexually reproducedplants.122 The concept of variety is hereinformed by the definition found in UPOV-1991 and differs from the concept of varietyfound in the Plant Patent Act.123 The rightsgranted under this Act are plant breeders’rights and not patents. One of the main dif-ferences between the two is that farmerscan make use of seeds generated from pro-tected stock, an exception that is not avail-able under the patent regime. The scope ofthe exceptions in favour of farmers has beenthe object of significant debate. In Asgrowvs Winterboer, a seed company sued farm-ers for selling the crop produced from pro-tected stock to other farmers for use asseed.124 The main issue in this case con-

cerned the scope of the farmer’s privilegeunder 7 U.S.C. 2543. This section clearlyprotects farmers who use part of the seedsproduced from protected stocks on theirfarm or who sell them. However, the courtheld that farmers are not protected in caseswhere the saved seed is grown for the pur-pose of sale for replanting because this con-stitutes a violation of 7 U.S.C. 2541(3).125

The privilege under section 2543 is tobe understood exclusively as authorizinga farmer to sell the seed s/he has set asidefor the purpose of replanting his ownacreage.

The lead of the USA in the context ofplant variety protection has been extendedin the past two decades to the field ofgenetic engineering. The USA was the firstcountry to accept the patentability of artifi-cially created life forms, thereby paving theway for the rapid development of the newbiotechnology industry. The decision of theUS Supreme Court in Diamond vsChakrabarty triggered one of the most sig-nificant changes in the patent regime inrecent times.126 The Court was presentedwith the novel case of the ‘invention’ of anartificially created life form. It analysed thecase from the point of view of the distinc-tion between an invention and a discovery.In the balancing act, the Court put moreweight on the fact that the bacterium wasmade by human beings (manufacture) thanon the principle that products of nature didnot constitute patentable subject matterunder US law. The Court found support forits position in the existence of a plantpatent Act that makes a clear distinction


119 Author: Philippe Cullet.120 Plant Patent Act of 1930, 35 U.S.C. 161 ff.121 Imazio Nursery vs Dania Greenhouses, 3 November 1995, Court of Appeals, Federal Circuit, 69 F.3d1560.122 Plant Variety Protection Act of 1970, 7 U.S.C. 2321 ff.123 Imazio Nursery vs Dania Greenhouses, 3 November 1995, Court of Appeals, Federal Circuit, 69 F.3d1560, 1568.124 Asgrow Seed Company vs Denny Winterboer and Becky Winterboer, dba Deebees, 18 January 1995,Supreme Court, 513 U.S. 179. 125 7 U.S.C. 2541: ‘Except as otherwise provided in this subchapter, it shall be an infringement of the rightsof the owner of a protected variety to perform without authority, any of the following acts (…): (3) sexuallymultiply, or propagate by a tuber or a part of a tuber, the variety as a step in marketing (for growing purposes)the variety’.126 Diamond vs Chakrabarty, 16 June 1980, Supreme Court, 447 U.S. 303.

between products of nature and human-made inventions rather than between livingand inanimate things.

The 1980 decision left open the ques-tion of the patentability of plants and livingorganisms. In the 1985 decision Ex parteHibberd, the patentability of plants wasaccepted.127 After significant debates, thePatent and Trademark Office (PTO) grantedin 1998 the first patent for a transgenicanimal.128 In the past decade, there hasbeen a flurry of patent applications fortransgenic plants and animals. Finally, inJ.E.M. vs Pioneer Hi-Bred, the SupremeCourt confirmed the possibility of inventorsof new plant varieties applying for patents.The Court reasoned that the possibility ofprotecting new plant varieties under thePlant Variety Protection Act did not pre-clude protection through patents becausethe application conditions for the latter aremore stringent and the rights granted moreextensive. These developments must beunderstood in the context of further devel-opments concerning the patentability ofgenes. In recent years, patents on genes thatclaim cover on an isolated gene, or con-structs that include the gene, have beenincreasingly often admitted (Barton andBerger, 2001). This has a direct impact ontransformed plants that include such con-structs. In other words, the increasing scopeof patentability in the field of plant varietymust be understood not only with regard topatents on plant varieties themselves butalso with regard to patents on genes thatmake up these varieties.

Australia129

FACTUAL BACKGROUND TO THE AUSTRALIAN

POSITION

Megabiodiversity. Australia is a country –and continent – of tremendous biodiversityor ‘megabiodiversity’, holding about 13% ofthe world’s biodiversity (Voumard, 2000, p.7) and of the estimated 44,000 species ofplants growing there, 88% are found onlyin Australia (Blakeney, 1997, 1999, p. 85).In terms of endemic species, Australia hasthe most mammals and reptiles, the secondmost birds, and fifth most higher plants andamphibians.130

The isolation of the Australian continenthas resulted in the survival of a number ofsimplified plant and animal types whichhave been particularly suitable for geneticmodification, or which have provided avaluable reservoir of characteristics for thegenetic modification of non-Australianplants and animals. For example, thearidity and salinity of the continent hasresulted in the development of organismswith particular resistance to theseconditions (Blakeney, 1999, p. 85).

The value of Australian indigenoustraditional ecological knowledge and theproblem of ‘biopiracy’Duboisia plant. The TK of Australian indige-nous people about the properties of Aus-tralian plants has often been used in thecommercialization of some of thoseplants,131 but not always with adequaterecognition of their contribution. Forinstance, the Duboisia plant, used byQueensland Aborigines for therapeutic pur-poses, was developed by a British surgeonat the end of the nineteenth century as asubstitute for atropine, and later found tocontain hyoscine, used as a sedative in


127 Ex parte Hibberd et al., 18 September 1985, Patent and Trademark Office Board of Patent Appeals andInterferences, 227 U.S.P.Q. 443.128 U.S. Patent No. 4,736,866, Transgenic Non-Human Mammals, 12 April 1988.129 Author: Danuta Szymura Berglas.130 Communication from Australia IP/C/W/310 2, October 2001 point 15.131 ‘A recent examination of plant breeders’ certificates issued by the Plant Breeders’ Rights Office found thatof 36 certificates issued over Australian native plants, 16 had traditional known uses. Two of these certifi-cates issued to Australian Native Produce Industries Pty. Ltd. pertained to traditionally used food species:muntries, Kunzea pumifera (AU 96/031), and sea celery, Apium prostratium (AU 96/026). Allegedly, nobreeding work had been carried out on these species’ (Fourmile-Marrie, 1998, p. 2).

treating motion sickness and as a ‘truthdrug’. According to Blakeney, ‘the cultiva-tion of Duboisia is currently conducted on acommercial scale in Northern New SouthWales and Southern Queensland, but with-out any recompense to indigenous peoples’(Blakeney, 1999, p. 86).

Native bush food. There is increasing interestin Aboriginal knowledge about bush food asa valuable source of nutrition. The Aus-tralian Native Bush Food Industry Commit-tee reported that in 1996 bush food saleswere over AU$14 million and rising (Wood-ley, 1998, p. 329, cited by Fourmile-Marrie,1998, p. 2). In fact, a non-indigenous Aus-tralian, Les Hiddens, known as ‘the BushTucker Man’, has been very successful inbringing the value of Aboriginal knowledgeabout Australian bush food to the minds ofall Australians, through his television pro-grammes, books and CD-ROMs.132 Unfortu-nately, this success has also led to him beingcondemned by some as ‘the very public faceof (biopiracy)’ (Fourmile-Marrie, 1998, p.2).133 Apart from the question of whetherindigenous Australians have been properlycompensated for the commercialization oftheir TK remains the fundamental issue ofwhether they agreed to the commercializa-tion of their knowledge by others in the firstplace.134

Acacias. Aboriginal knowledge about thefood value of acacias was instrumental in arecent study conducted by the AustralianTree Seed Centre of the Commonwealth Sci-entific and Industrial Research Organization(CSIRO) Division of Forestry in severalAfrican dry-land countries (Senegal, Niger,

Burkina Faso, Somalia, Kenya and Zim-babwe) upon the usefulness of planting aca-cias in those countries. ‘With respect to foodpotential, what is currently known aboutthe food value of acacias has been largelythe result of tapping into Aboriginal knowl-edge’ (Devitt, 1991). ‘And yet’, according toFourmile-Marrie, ‘Aboriginal people are notinvolved in the subsequent research, devel-opment and application processes regardingthose overseas projects’, contrary to Aus-tralia’s obligations under the CBD (Four-mile-Marrie, 1998, p. 1).

Smokebush. The endemic plant smokebush(genus Conospermum) provides an interest-ing illustration (Janke, 1999, pp. 24–25).Smokebush grows in the coastal areasbetween Geraldton and Esperance in West-ern Australia, and its healing propertieshave been known and used by indigenousAustralians for a long time. During the1960s the Western Australian governmentgranted the US National Cancer Institute(NCI) a licence to collect plants for screen-ing purposes, and in 1981 specimens weretested for the presence of cancer-fightingproperties. None were found, but the speci-mens were held in storage until the late1980s when they were again tested, thistime in the quest to find a cure for AIDS.Out of 7000 plants screened from aroundthe world, Smokebush was one of only fourplants found to contain the active con-stituent conocurovone, which laboratorytests showed could destroy low concentra-tions of the HIV virus. This ‘discovery’ wassubsequently patented. The US NationalCancer Institute has since awarded Amrad,a pharmaceutical company from Victoria,


132 For instance, Explore Wild Australia with the Bush Tucker Man (1999) ABC Books/Viking, Sydney; CD-ROMs From the Rainforest to Cape York and From Arnhem Land to the Kimberley.133 For Aborigines, ‘reproduction is unreal, while recreation is real. The fixation on the written word hasimplications for the practice of cultural heritage’ (Janke, 1999, p. 7).134 Compare different points of view of indigenous Australians: Les Malzner stated at the Indigenous Refer-ence Group Meeting, September 1997: ‘Indigenous ownership is seen more in terms of responsibility for cul-ture rather than excluding others from its use’, whereas Francis Kelly Jupurrula, spokesperson for the CentralLand Council submitted: ‘We should keep it [knowledge of traditional medicines and bush tucker] for our-selves, not give it away. We are just like giving our land away altogether. I think we should all keep itbecause it’s confidential … We should keep it for our generations’ (speaking at Akarnenhe Well, 14–16October 1997, CLC Submission January 1998) (Janke, 1999, pp. 44 and 46).

an exclusive worldwide licence to developthe patent.

In the early 1990s the Western Aus-tralian government also awarded Amradrights to the smokebush plant in order todevelop an anti-AIDS drug, having powerto grant exclusive rights to Western Aus-tralian flora and forest species for researchpurposes pursuant to amendments made in1985 to both the Conservation and LandManagement Act 1984 (Western Australia)and the National Parks and Wildlife Act(Western Australia). According to Blakeney(1997, p. 196), Amrad paid $1.5 million tothe Government of Western Australia tosecure access to smokebush and relatedspecies, based on projected royalties of$100 million per year by 2002 in the case ofsuccessful commercialization.

The concern of the indigenous Aus-tralians is that they have not received anyacknowledgement, financial or otherwise,for their role in having first discovered thehealing properties of smokebush. Accord-ing to the Centre for Indigenous History andArts (Western Australia):

The current legislation disregards thepotential intellectual property rights thatthe Indigenous peoples in Western Aus-tralia have in flora on their lands. Further-more, multinational drug companies couldbe sold exclusive rights to entire species offlora, preventing anyone from using thosespecies for any other purpose without theconsent of the companies. Indigenous peo-ples in Western Australia now face the pos-sibility of being prevented from using anyof the flora which is the subject of an exclu-sive agreement. It is therefore vital that anyreform of the intellectual and cultural prop-

erty laws include provisions for the recogni-tion of indigenous peoples as the nativetitle owners of all the biological resourcesof the flora and fauna that are on their lands(Centre of Indigenous History and the Arts,submission to Our Culture, Our Future,October 1997 (Janke, 1999)).

In short, it is clear that indigenous Abo-riginal ecological knowledge is valuable,135

but a more just determination of the legalrights to Australia’s biological resourcesand associated TK is still in the process ofdevelopment.

ABORIGINAL INTELLECTUAL PROPERTY

Aboriginal acknowledgement of their IPRs.The Julayinbul Statement on IndigenousIntellectual Property Rights has expresslyacknowledged the existence of ‘Aboriginalintellectual property’ which is found‘within Aboriginal Common Law’, and assuch ‘is an inherent inalienable right whichcannot be terminated, extinguished, ortaken’.136

Clause 5 of the Julayinbul Declara-tion137 includes ‘the right [of indigenouspeople] to control subsequent use of andaccess to the genetic make-up within theflora and fauna of the forests’. Further,indigenous Australians would like to seethe principle of prior informed consent,which applies to sovereign states under theCBD, to be extended to them (claim 7).138

The basis for the Aboriginal definition of theirIPRs. Article 2(viii) of the Convention Estab-lishing the World Intellectual Property Orga-nization, 14 July 1967, defines intellectualproperty as the rights relating to literary,


135 Although the value of indigenous knowledge to the biotechnology industry in Australia has not yet beenestimated (Janke, 1999, p. 15).136 The Julayinbul Conference on Intellectual and Cultural Property, held at Jingarrba, in the Daintree Forestregion of North-Eastern Australia on 27 November, 1993, produced the Julayinbul Statement on IndigenousIntellectual Property Rights and a Declaration Reaffirming the Self-Determination and Intellectual PropertyRights of the Indigenous Nations and Peoples of the Wet Tropics Rainforest Area, cited by Blakeney (1999,pp. 93–95).137 Declaration Reaffirming the Self-Determination and Intellectual Property Rights of the Indigenous Nationsand Peoples of the Wet Tropics Rainforest Area, produced by the Julayinbul Conference on Intellectual andCultural Property, held at Jingarrba, in the Daintree Forest region of North-Eastern Australia on 27 Novem-ber, 1993, cited by Blakeney (1999, pp. 93–95).138 See comprehensive list of indigenous claims in Janke (1999, pp. XX–XXI).

artistic and scientific works; performances ofperforming artists, phonograms and broad-casts; inventions in all fields of humanendeavour; scientific discoveries; industrialdesigns; trademarks, service marks and com-mercial names and designations; protectionagainst unfair competition; and all otherrights resulting from intellectual activity inthe industrial, scientific, literary or artisticfields (emphasis added).

The basis of this definition is ‘intellec-tual activity’, whether it stems from anindigenous or non-indigenous person, andTK – of both indigenous and non-indige-nous people – is one form of intellectualactivity within intellectual property.

The United Nations Special Rappor-teur, Erica Irene Daes, stated in a 1993report ‘all elements of heritage should bemanaged and protected as a single, interre-lated and integrated whole’.139 Accordingto the submissions made to the AustralianGovernment by representatives of Aborigi-nal communities in their comprehensivereport, Our Culture, Our Future (Janke,1999), heritage forms the basis of any dis-cussion on TK and IPRs held by Australianindigenous people. The report states that

[indigenous] heritage consists of the tangi-ble and intangible aspects of the wholebody of cultural practices, resources, andknowledge systems developed, nurturedand refined by Indigenous people andpassed on by them as part of expressingtheir cultural identity. (Janke, 1999, Chap-ter 1, p. 11)

This includes agricultural, scientific,medicinal and ecological knowledge,which are relevant in our context.

The report uses the term, ‘indigenouscultural and intellectual property rights’ torefer to indigenous Australians’ rights to

their heritage, adopting the terminology ofArticle 29 of the Draft Declaration of theRights of Indigenous Peoples, 1994 (Janke,1999, p. 7), which states that:

Indigenous peoples are entitled to therecognition of the full ownership, controland protection of their cultural and intel-lectual property. They have the right tospecial measures to control, develop andprotect their sciences, technologies andcultural manifestations, including humanand other genetic resources, seeds, medi-cines, knowledge of the property of faunaand flora, oral traditions, literatures,designs and visual and performing arts.140

The explanation given by indigenousAustralians for adopting ‘indigenous cul-tural and intellectual property rights’ ratherthan the World Intellectual Property Organi-zation (WIPO) definition is to ‘take intoaccount the apparent distinction between“property”, which suggests commercialisa-tion and the protection of commercial rights,and “heritage”, which implies preservationand maintenance issues’ (Janke, 1999, p. 7).Further, the indigenous Australian defini-tion intends to highlight the apparent dis-tinction between the arts and culture on theone hand and science on the other, a splitlargely attributable to Western thinking.141 Itis not that ‘property’ and ‘heritage’ are mutu-ally exclusive, but that heritage is anotherissue to consider.

Traditional knowledge is regarded ascommon heritage and not as a commodityto be patented for commercial exploitation,perhaps to the exclusion of traditionalowners. As with many other aspects ofindigenous culture, knowledge of differentplants and their healing properties isrestricted to a particular class ofpeople. Knowledge about the therapeutic


139 A Study on the Protection of the Cultural and Intellectual Property of Indigenous Peoples, July 1993,E/CN.4/sub.2/1993/28,28 July 1993, para. 31, p. 9.140 Report of the Sub-Commission on Prevention of Discrimination and Protection of Minorities at its 46thsession, Draft United Nations Declaration on the Rights of Indigenous Peoples, United Nations DocumentsE/CN.4/1995/2 and E/CN.4/Sub.2/1994/56.141 ‘The development of specific legislation in the Australian framework has focused on arts and culturalexpression only and has tended to neglect other areas of heritage, such as biodiversity knowledge, resourcesand scientific and medicinal application of cultural knowledge … This is because western culture tends toseparate arts from science … in indigenous cultures, the division is less distinct’ (Janke, 1999, p. 195).

properties of plants is passed on by wordof mouth. Indigenous people get access tosuch knowledge when they have attainedthe appropriate level of initiation. Just aspractitioners of western medicine muststudy medicine before they can practise it,so a certain degree of knowledge isrequired before a plant can be used safelyin indigenous society (Janke, 1999, p. 24).

Indigenous rights, like TK, are notsomething static, but subject to change.‘How will … [any reforms] meet the needsof artists who no longer belong to a tradi-tional community, or whose communitiescan no longer say they own a particulardesign?’ (Stephen Gray, unpublished,1994). The same may be said for traditionalecological knowledge. ‘Any legislationshould not attempt to freeze Indigenousculture but should aim at allowing both so-called traditional and contemporary rightsto be recognised and protected’ (Janke,1999, p. 186).

The communal nature of Aboriginal knowl-edge and resources. Australian Courts haverecognized that classic intellectual propertylaw is inadequate to deal with the commu-nal nature of indigenous resources andTK.

In Yumbulul vs Reserve Bank of Aus-tralia (1991) 21 Intellectual PropertyReports 481 (cited by Blakeney, 1999, pp.91–92) the trial judge admitted that ‘Aus-tralia’s copyright law does not provide ade-quate recognition of Aboriginal communityclaims to regulate the reproduction and useof works which are essentially communalin origin’ (p. 490). This case involved thereproduction by the Reserve Bank of thedesign of a Morning Star Pole on a com-memorative banknote. The Galpu Clan ofnorth-eastern Australia sought to preventthis on the basis of the communal obliga-tion of the artist as a clan member to pre-vent the design of the pole being used in aculturally offensive manner – the authorityand knowledge to use the design havingbeen obtained through initiation and reve-lation – but the trial judge found that he

had disposed of his IPRs in a legally bind-ing document.

In Milpurrurru vs Indofurn Pty. Ltd(1995) 91–116 CCH Australian IntellectualProperty Cases 39,051 (cited by Blakeney,1999, pp. 91–92) the court was prepared toconsider cultural harm in its assessment ofdamages for breach of copyright awarded toa number of Aboriginal artists whosedesigns were wrongfully reproduced oncarpets. None the less, the idea of also com-pensating the communities of the artistswho were no longer alive was rejected, for‘the statutory remedies [of Australia] do notrecognise the infringement of ownershiprights of the kind which reside under Abo-riginal law in the traditional owners of thedreaming stories’ (at 39,077). This isanother example of Australian courtsattempting to determine the extent to whichAboriginal customary law may be recog-nized under modern Australian law.

The problem is that in seeking to trans-late indigenous TK into modern intellectualproperty terms one has to deal withthe Aborigines’ notion of property, whichis said to be ‘quite different’ (Janke,1999, Chapter 5 and p. XXII). E.I. Daes hasstated

Indigenous peoples do not view their her-itage in terms of property at all … but interms of community and individual respon-sibility. Possessing a song, story or medicalknowledge carries with it certain responsi-bilities to show respect to and maintain areciprocal relationship with the humanbeings, animals, plants and places withwhich the song, story or medicine is con-nected. (Daes, 1993, emphasis added)

It is not that proprietary rights arerejected, but that they do not neces-sarily attach to any given individual,and in any case have certain communalresponsibilities attached to them.142 Abo-riginal intellectual property includes theright to control the disclosure, dissemina-tion, reproduction and recording of indige-nous knowledge, ideas, and innovationsconcerning medicinal plants, biodiversity,and environmental management (claim 16)


142 See list of indigenous claims in Janke (1999, pp. XX–XXI).

– which is similar to Western concepts –and community cultural and intellectualproperty rights (claim 5) – the communalelement being foreign to Western notions ofintellectual property, and so, not takenproperly into account.

A related question is the role of theindividual within the context of communalownership. More correctly said it is ‘a greatnumber of generations [of individuals][who] contribute to the development ofindigenous cultural heritage’. In the caseDeceased Applicant vs Indofurn (1994) 30Intellectual Property Reports 209 (the Car-pets Case) it was held that an individual orgroup is often the custodian or caretaker ofa particular item of heritage. Artists mayhave the authority to depict a traditional,pre-existing design in their artwork byvirtue of their birth or by initiation, but theyhold this knowledge on trust for the rest ofthe clan. Further, sufficient evidence wasfound of individual artistic interpretationeven though the artworks in question fol-lowed pre-existing traditional designs. Thevalue of this case in our study is the explo-ration of the interrelationship between theindividual and the community of which heor she forms a part, and the relationshipbetween individual and community rights.This is fundamental to the discussion onhow TK, which is mostly communal innature, may be better integrated and pro-tected by the largely individualistic systemof Western intellectual property law.

Incidentally, the means of appointingone or more individuals as representativesof their clan is not problematic: BulunBulun and Milpurrurru vs R. and T. Tex-tiles Pty. Ltd. Federal Court of Australia,unreported, 3 September 1998, van Dousa J.(WIPO, 2001, p. 71). In this way one ormore community representatives of adefined indigenous or local communitymay advocate the rights of that communityover its TK in much the same fashion as anindividual would seek protection of his orher rights.

Public domain knowledge versus knowledgevested permanently with its holder. A prob-lem is that, according to classical notions of

intellectual property law, once ethnobiolog-ical information has been published, andpatent or copyright protection has expired,it falls within the public domain (Blakeney,1999, pp. 92–93; see Chapters 1 and 4, thisvolume), contrary to the customary law ofindigenous people, who consider them-selves the custodians of it in perpetuity.Indeed, ‘the establishment of a publicdomain collecting society for indigenousworks is not favoured because this supportsthe current legal assumption that indige-nous cultural and intellectual property outof copyright is in the public domain andfree for all to use and exploit’ (Janke, 1999,pp. XXXIX and 208). Rather, an ‘indigenouscollecting society’ is preferred, which rec-ognizes the custodianship of indigenousand local communities over their TK in per-petuity.

For instance, the book Bush Food(Isaacs, 2000) provides a neat summary ofthe most important Australian biologicalresources known and used by AboriginalAustralians, compiled in collaboration withseveral indigenous Australians, who arephotographed and named and arguablyjoint inventors for the purpose of the bookitself. None the less, it was presumably notintended that this project would bring allthe Aboriginal TK contained in the bookwithin the classic public domain, even ifthe book was first published before theCBD. Indeed, the whole purpose of thistype of book is to bring the value of indige-nous knowledge to the attention of a wideraudience – to educate others about thevalue of Aboriginal ethnobotanical and eth-nobiological knowledge – but without inany way abrogating Aboriginal rights overit.

Henrietta Fourmile-Marrie states that ‘aconsiderable amount of [Aboriginal] TKconcerning [their] use of plant and animalspecies for food and medicine has alreadybeen published with the copyright to suchinformation being held by non-indigenouscollectors and institutions’ (Fourmile-Marrie, 1998, p. 2). Examples includeCribb, A.B. and Cribb, J.W. (1974) WildFood in Australia, Collins, Sydney;Cherikoff V.S. and Isaacs, J. (1989) The


Bush Food Handbook, Ti Tree Press, Bal-main; Low, T. (1988) Wild Food Plants ofAustralia, Angus and Robertson, Sydney;Bindon, P. (1996) Useful Bush Plants, West-ern Australia Museum, Perth (note: only thelast example is post-CBD).143

What is sought is that, first, the right asoriginator, custodian or holder of suchknowledge be recognized; and secondly,that this right be used as a basis for claim-ing a right to compensation, which couldtake the form of some collecting society orcommunal fund, given the communalnature of indigenous TK. The use of regis-ters to document important indigenousknowledge, with or without confidentiality,and perhaps despite prior publication, isanother proposal (Janke, 1999, pp. 140,229).144

AUSTRALIA’S OBLIGATIONS PURSUANT TO NATIONAL

AND INTERNATIONAL LAW

The basis of the Australian legal system.Modern Australia is represented by about200 years of European settlement, superim-posed on an Aboriginal culture more than60,000 years old. The basis is British andAustralian common law, and the develop-ment of a modern democracy within asophisticated social, economic, politicaland legal system.

The common law notion of terra nullius,in which the rights of Aborigines to theirland were not recognized upon European set-tlement, was overturned in an importantHigh Court decision, Mabo vs Queensland(No. 2) 1992 (Commonwealth) 175 CLR 1,which led to the enactment of the NativeTitle Act 1993 (Commonwealth). Mabo heldthat Aboriginal people and Torres StraitIslander ownership of land survived the col-

onization of Australia, and recognized a formof property called ‘native title’ which ‘has itsorigin in and is given its context by the tradi-tional laws acknowledged by and the tradi-tional customs observed by the indigenousinhabitants of a territory’ (Justice Brennan inMabo vs Queensland, p. 58; WIPO, 2001, p.78). This has helped to pave the way forindigenous customs to be recognized bymodern law, which is an ongoing process.

National and international legal obligations.Australia is party to numerous interna-tional conventions, and is at the forefront indeveloping legislation to take betteraccount of the special needs of its indige-nous people. Work is being done on twolevels: the further development of modernlaw, and the coordination of indigenousrights and responsibilities within thatmodern law. Australia has developed adraft legislative model for regulating accessto genetic resources, and considers existinglegal and administrative mechanisms as themost appropriate basis for the protection ofTK (Communication from AustraliaIP/C/W/310 2 October 2001 point 1).

Australia ratified the CBD on 18 June1993, and is party to TRIPS and the Inter-national Treaty on Plant Genetic Resourcesfor Food and Agriculture. The Plant breed-ers’ rights Act 1994 (Commonwealth)145

gives effect to Australia’s obligations ascontracting party to the 1991 text of theInternational Convention for the Protectionof New Varieties of Plants, known as theUPOV Convention, which Australia joinedas a Member on 1 March 1989 and ratifiedon 20 January 2000. Section 17 of the Actrecognizes the ‘farmers’ privilege’, allowingseeds to be saved for replanting.

Further, there is an abundance of Com-


143 Some indigenous Australians believe that indigenous people should receive compensation for aspects ofculture that were applied commercially in the past (Janke, 1999, p. 15).144 ‘Consideration should be given to the establishment of a national register which identifies the owners ofICIP. Any established register should not be a means of evidencing title. The register should only be used toprovide contract details for subsequent users of indigenous material to contact the relevant community forprior consent. The register should be designed, managed and controlled by indigenous people’ (Janke, p. XLIand Chapter 22).145 The Plant breeders’ rights Amendment Bill 2002 (Commonwealth) seeks to clarify the rights of plantbreeders to remuneration regarding public interest restriction and enhance the access of plant breeders to thePlant breeders’ rights Scheme (Bills Digest No. 164 2001–02).

monwealth, State and Territory legislationand policy recommendations relating tothis topic.146 Section 51(xviii) of the Aus-tralian Constitution gives the Common-wealth, meaning Federal Government, thepower to make special laws regarding copy-right, patents or inventions and designs,and trade marks, and the common law pro-vides the remedies of breach of confidenceand passing off. Under Australian law,State and Territory governments (corre-sponding with Canton level) are primarilyresponsible for access to genetic resourcesfound in non-Commonwealth land andwaters, but it becomes a Commonwealthconcern to the extent that federal mattersbecome involved, such as trade and com-merce, corporations, external affairs, exportcontrol and laws for the ‘people of anyrace’. In any case, the State and Territorygovernments are similarly bound by Aus-tralia’s obligations under the CBD pursuantto the external affairs clause in the FederalConstitution (Fourmile-Marrie, 1998, p. 5).

Recommended Action 6.1.7 of theNational Strategy for the Conservationof Australia’s Biological Diversity (an instru-ment of public administrative law) proposesthat within Australia one ought to:

Recognise the value of the traditionalknowledge and practices of Aboriginalpeople and Torres Strait Islanders and inte-grate this knowledge and those practicesinto biological diversity research and con-servation programmes by:

Encouraging the recording (with theapproval and involvement of the indige-nous people concerned) of traditionalknowledge and practices;

Assessing their potential value for nutri-tional and medicinal purposes, wildlifeand protected management and other pur-poses; and

Applying traditional knowledge and prac-tices in ways which ensure the equitable

sharing of the benefits arising from theiruse (National Strategy, 1992, p. 4, cited byBlakeney, 1989, p. 89).

In the Report, Biodiversity. The Role ofProtected Areas (1993), the House of Repre-sentatives Standing Committee on Environ-ment, Recreation and the Arts commentedthat the identification of traditional prac-tices entails more than the gathering ofinformation, as it raises ‘questions ofauthenticity, knowledge and power’. TheCommittee recommended that Action 6.1.7be amended so that indigenous communi-ties are encouraged ‘to undertake or other-wise collaborate in research projects whichutilise TK and practices in the study of bio-diversity and in conservation’ (paras. 4.70and 4.72).147

On ABS: The Environment Protection and Bio-diversity Conservation (EPBC) Act 1999(Commonwealth). The EPBC Act 1999replaces the National Parks and WildlifeConservation Act 1975 (Commonwealth),but does not affect operation of the NativeTitle Act 1993 (Commonwealth), which isdiscussed below.

S301 of the EPBC Act 1999 providesthe mechanism to implement Australia’sinternational and domestic obligations forthe control of access to biological resourcesin Commonwealth areas:

1. The regulations may provide for the con-trol and use of access to biologicalresources in Commonwealth areas.2. Without limiting subsection 1, the regu-lations may contain provisions about all orany of the following:1. (a) the equitable sharing of the benefits

arising from the use of biologicalresources in Commonwealth areas;

1. (b) the facilitation of access to suchresources;

1. (c) the right to deny access to suchresources; and


146 Designs Act 1906; Copyright Act 1968; Circuit Layouts Act 1989; Patents Act 1990; Trade Marks Act1995; Plant Breeders Rights Act 1994 (and Plant breeders’ rights Amendment Bill 2002).147 Also see the discussion paper entitled Access to Australia’s Biological Resources, prepared by the Co-ordination Committee on Science and Technology (CCST), Department of the Prime Minister and Cabinet,Office of the Chief Scientist, AGPS, Canberra, March 1994, pp. 31–32, cited by Blakeney (1999, pp. 89–91).

1. (d) the granting of access to suchresources and the terms and conditionsof such access.

In 2000 a Commonwealth PublicInquiry over access to biological resourcesin Commonwealth areas advised upon ascheme with legal effect that could beimplemented through regulations under s.301 of the EPBC Act 1999 (Voumard, 2000).In essence, the scheme seeks to implementthe CBD goals of the conservation and sus-tainable use of biological resources and theequitable sharing of its benefits, togetherwith the protection of TK, especially thatheld by indigenous people.

Specifically, the scheme provides foran access permit to native biologicalresources found in Commonwealth areas,which may be granted or refused by theGovernment in consultation with the rele-vant Government Agency or landowner,depending on whether the collection ofmaterials would be ecologically sustain-able; and a benefit-sharing contract basedon a model contract developed and agreedupon by governments, industry, indigenousorganizations and other stakeholders. Thebenefit-sharing contract between the partiesmust address prior informed consent,mutually agreed terms, adequate sharing ofany benefits derived and the value and pro-tection of indigenous knowledge and envi-ronmental benefits in the area from whichthe resource was obtained.

Applications for Access Permits maybe made on-line; the Application fee mayonly be ‘moderate’; and ‘as far as possible(subject to concerns about confidentiality),information about access and benefit shar-ing agreements would be made public’ (AGuide to the Draft Amendments to the Envi-ronment Protection and Biodiversity Con-servation Regulations, 2000 – AccessPermits and Benefit Sharing Arrangements,cited in Communication from Australia).The Minister may attach conditions to theAccess Permit, such as the obligation tolodge voucher specimens in Australianpublic collection institutions, or the provi-sion of information about the specimens.

Interestingly, the decision of the tradi-

tional owners of biological resources todeny access to their resources is explicitlynot reviewable (Voumard, 2000, pp. viiiand 21). This is in order to prevent ‘legalbullying’ which may wear down their deci-sion to deny access, but conceivably couldbe a problem if the denial of access conflictswith Australia’s obligations to provideaccess for ‘environmentally sound uses’pursuant to the CBD.

Where biological resources are in aCommonwealth reserve that is not Com-monwealth-owned land, such as Uluru-Kata Tjura (Ayers Rock), Booderee NationalParks (Jervis Bay) and parts of KakaduNational Park, the rights of the land owneras owner of biological resources may be reg-ulated by the EPBC Act or regulations madeunder the Act in relation to Commonwealthreserves (Voumard, 2000, pp. 47, 68 and71). As Commonwealth ‘areas’ under s. 525of the EPBC Act, they are owned by indige-nous Australians and administered byEnvironment Australia under certain leas-ing arrangements. For example, s. 354 (1)(a) requires that a sample of a native speciesbe taken in accordance with a managementplan for the reserve, but this would notaffect the exercise of ‘traditional’ rights touse Aboriginal land in accordance with theAboriginal Land Rights (Northern Territory)Act 1976 (s. 71), or native title rights inaccordance with the Native Title Act 1993.Section 8(2) of the EPBC Act 1999 providesthat the EPBC Act does not affect the oper-ation of those Acts.

In short, after determining who ownsor who is primarily responsible for the(Commonwealth) land upon which the bio-logical resources may be found, the ABSprovisions of the EPBC Act come into play,which themselves do not abrogate theinherent indigenous rights over that landand its resources as recognized by theNative Title Act.

On land rights: The Native Title Act 1993 andNative Title (Amendment) Act 1998 (Com-monwealth). The Native Title Act 1993(Commonwealth), which arose in responseto the Mabo decision mentioned earlier,preserves native land title and associated


rights from confiscation by the govern-ment.

The issue of land rights is clearly ofcentral concern to local and indigenouscommunities as custodians of their biologi-cal resources and related TK. The connec-tion between TK and land rights isrecognized in Section 223(1) of the NativeTitle Act, which defines ‘native title’ as‘the communal, group or individual rightsand interests of Aboriginal peoples orTorres Strait Islanders in relation to land orwaters’ provided that three conditions arefulfilled:

1. The rights and interests must be pos-sessed under the traditional laws acknowl-edged and customs observed by theAboriginal and Torres Strait Islanders.2. The Aboriginal or Torres Strait Islandersmust, by those laws and customs, have aconnection with the land and waters.3. The rights and interests must be recog-nized by the common law of Australia,being the most difficult condition to proveamongst these three (Blakeney, 1999, p.95).148

Section 223(2) refers to ‘hunting, gath-ering or fishing rights and interests’ as beingincluded within Native Title, and has beeninterpreted as meaning that, first, others arenot excluded from also exercising theserights, and secondly, that even where tradi-tional medical remedies might havebecome the subject of a patent or plant vari-ety registration, Aboriginal people wouldstill be permitted to continue to use suchtraditional medical remedies (Blakeney,1999, p. 87).

Furthermore, according to current Aus-tralian legal opinion, native title rights caninclude the right to access and use of bio-logical resources, and to control the right ofothers to access and use of biologicalresources in relation to particular land,including a corresponding denial of access,but native title would not (yet) encompass aright to control all uses of a resource wher-ever it was located (emphasis added)(Voumard, 2000, p. 72). The Aboriginal cus-todians of a plant found on their landwould not be able to extend their rights tothe same plant found growing on someoneelse’s land. Each case of who owns or isprimarily responsible for specific land,upon which certain biological resources arefound, must be considered individually.This is a practical approach, reflecting theattempt in Australia to take into accountcompeting claims based upon different sys-tems of law, meaning both the rights foundunder modern Australian law and indige-nous customary law.

An important element of modern Aus-tralian bioprospecting agreements149 is thatthey are made with both the relevant Stategovernment and indigenous authorities,and that the benefits are shared with theAborigines as custodians of the biologicalresources.150 For instance, Section 14 of theKakadu National Park Management Plan151

reserves the right of the traditional owners,the Bininj/Mungguy, to continue to exer-cise their traditional rights to gather plantsand plant material for food and for makingcultural artefacts.

The Uluru-Kata Tjuta National ParkManagement Plan provides that in respect


148 Mabo was confirmed in the recent High Court decisions of Western Australia vs Ward; Attorney-General(Northern Territory) vs Ward; Ningarmara vs Northern Territory [2002] HCA 28 (8 August 2002) found athttp://www.austlii.edu.au/au/cases/cth/high_ct/2002/28.html, and Members of the Yorta Yorta AboriginalCommunity vs Victoria and Others (M128/2001) http://www.austlii.edu.au, which was also mentioned in theNeue Zürcher Zeitung, 17 December 2002, p. 52.149 For instance, ExGenix Ltd (formerly Amrad Discovery Technologies) has agreed to this (Voumard, 2000,pp. 94–95).150 Although the CSIRO submitted to a Canberra Hearing on 30 May 2000 that the intrinsic value of biolog-ical resources and associated traditional knowledge can be quite limited. The Queensland government com-mented that the chance of discovering a new pharmaceutical may be 1 in 1,000,000 samples screened,costing about AU$100 million, taking 8–15 years to develop. The possible monetary benefits from bio-prospecting agreements are often overestimated (Voumard, 2000, p. 99).151 This has legal effect according to principles of Administrative Law.

http://www.austlii.edu.au/au/cases/cth/high_ct/2002/28.html

http://www.austlii.edu.au

of bioprospecting agreements,152 the agree-ments need not be exclusive; the indige-nous owners may continue to use theirresources and knowledge; the indigenousowners may not be forced to divulge theirknowledge; and ABS may be determined inaccordance with traditional laws and cus-toms (Voumard, 2000, Chapter 6).

The significance of these examples is toshow how rights to traditional geneticresources and related TK may be given legalrecognition through the existing legalsystem (Communication from Australiapoint 29).

The inextricable link between rights over bio-logical resources and TK, including ABS, andrights to land. Perhaps the real difficulty isnot to devise an ABS scheme for biologicalresources in Commonwealth areas, or evento recognize the rights of indigenous Aus-tralians to their TK and resources, but toidentify the true holder of the resourceswhere competing claims are made overthem. ‘Commonwealth areas’ refers by defi-nition to Commonwealth waters and landowned or leased by the Commonwealth andCommonwealth Agencies, and land inexternal territories, which may conflictwith indigenous claims pursuant to theircustomary law. The central issues in litiga-tion have become: who has control over theland upon which the biological resourcesmay be found? Are such land rights exclu-sive? And can they be suspended or extin-guished? This conflict reflects thecompeting claims made by the interactionof modern law with indigenous law. Forinstance, the Commonwealth AboriginalLand Rights (Northern Territory) Act 1976deals with agreements made between theNorthern Territory Government and theAboriginal people to the effect that the com-munities own the land, and in some caseslease it back to the government. Occasion-ally there are disputes between the Aborig-inal people and the State or Territory

government over who owns the biologicalresources or minerals found there (WIPO,2001, p. 78 citing Roundtable, Darwin, Aus-tralia, 15 June 1998, Northern Land CouncilDarwin).

Milirrpum vs Nabalco (1971) 17 FLR141 recognized Aboriginal customary law asa ‘system of law’ within the Australian legalsystem. The fundamental connection whichAborigines have with their land is spiritual(per Blackburn, J. at 167), but neither spiri-tual connection nor cultural knowledgealone is sufficient to constitute native title toland, which also requires a physical pres-ence on the land {s. 223 (1) (b) of the NativeTitle Act; Western Australia vs Ward; Attor-ney-General (NT) vs Ward; Ningarmara vsNorthern Territory (Ward’s case) [2002]HCA (8 August 2002) (Full Court of the HighCourt of Australia) para. [964.6] and [964.8]per Callinen J.}. Abandonment of traditionallifestyle was found to sever the connectionof the Yorta Yorta people to certain land inthe case of Members of the Yorta Yorta Abo-riginal Community vs Victoria and Others(M128/2001), although this decision is notconsidered final.

Ward’s case involved different landtenure including vacant Crown land, pas-toral leases, Crown land in or about thetown of Kununurra, the Ord River irrigationarea, Lake Argyle and the Argyle DiamondProject and the Keep River National Park,and certain waters. Even if native title isfound to exist, it may be partially or whollysuspended or permanently extinguished153

by such things as the granting of pastoralleases or mining leases and the resumptionof land for the carrying on of public works:[453], [454], [468.3] and [468.4]. Pastoralleases may provide exclusive possessionwith a reservation in favour of Aboriginesto enter and enjoy, for subsistence pur-poses. ‘To the extent that rights and inter-ests granted by the pastoral lease were notinconsistent with native title rights andinterests, the rights and interests under the


152 Major companies involved in bioprospecting in Australia include AstraZeneca, ExGenix (formerlyAMRAD), Australian Institute of Marine Science, CSIRO and BioProspect Limited (Voumard, 2000, p. 93).153 Under s 237A ‘extinguishment’ of native title is permanent, otherwise it is a mere suspension of rights thatmay be revived.

lease prevailed over, but did not extinguish,native title rights’ [464] and [468.10]. Con-versely, if exclusive possession is validlygranted then there is no need to considerinconsistency, because by definition, exclu-sive possession is inconsistent with nativetitle: per Callinen J. [964.3]. A lease grantedfor a national park may protect traditionalAborigine use of the land where native titleis not wholly extinguished.

A lease granted in perpetuity may givethe lessee a right of exclusive possessionthat extinguishes all native title: Wilson vsAnderson [2002] HCA 29 8/08/02. Aborig-ines may in some cases simply have theright of occupation to live on the land andseek their subsistence from it – like a lodgerin a house owned and exclusively pos-sessed by another (Ward [555]).

Ward held that ‘[t]he evidence estab-lished no native title right to or interest inany mineral or petroleum. [So] no questionof extinguishment arises’ (Ward [482] and[468.22]), although this view was notshared by Kirby J.

The common law recognizes the con-cept of joint possession. ‘But possessionthat is not exclusive is a contradiction interms, for the right of general control andexclusion is central to the concept of legalpossession’ [477]. In a similar case, WikPeoples vs Queensland (1996) 187 CLR 1,the pastoral leases were not thought toconfer exclusive possession or else did notnecessarily extinguish native title, a contro-versial result which will be limited to itsfacts [473–481].

The attempt to integrate Australianindigenous law into the modern commonlaw legal system is regarded sceptically bysome. In Ward’s case, His Honour CallinenJ. remarked that it would probably be betterto ‘redress the wrongs of dispossessionby a true and unqualified settlement oflands or money than by an ultimatelyfutile or unsatisfactory, in my respectfulopinion, attempt to fold native title rightsinto the common law’ ([970] and [1064]).The Commonwealth Regulations would inany event not alter existing property law inAustralia.

His Honour’s point was that:

this Court and other legal bodies arefounded on a post-dream time legal order.Although some may contend that weshould, we do not in fact recognise Aborig-inal criminal law, tort law or any aspects ofindigenous laws, nor do we pretend to. Thequestion then is why the common law ofproperty, which had been regarded as set-tled for more than a century, should havebeen changed to recognise sui generis inter-ests in land that had no counterpart in ourlegal system. [1064]

This raises the issue of the compatibil-ity – or incompatibility – of maintaining‘two equal and parallel systems of law’, anissue raised by indigenous Australians inJanke (1999).

HOW WOULD ABORIGINAL SUBMISSIONS FIT IN WITH

THE EXISTING AUSTRALIAN LAW?To what extent can ‘Aboriginal intellectualproperty’ and ‘Aboriginal common law’ bereconciled with Western notions of intel-lectual property law and with modern Aus-tralian law in particular? Consideration ofcertain statements and reports reveals afundamental division of opinion about cer-tain key issues.

The Final Statement of the SouthPacific Regional Consultation on Indige-nous Peoples’ Knowledge and IntellectualProperty Rights, held in Suva, Fiji, in April1995, in which indigenous Australians tookpart, accuses the modern IPR system andmodern science and technology of ‘perpet-uat[ing] imperialism … to control andexploit the lands, territories and resourcesof indigenous peoples’. This is clearly arejection of the Western form of IPRs,though not a rejection of IPRs per se. Nonethe less, such thinking led to a call for thePacific Region to be ‘a life forms patent-freezone’ (Article 1), and ‘a moratorium on bio-prospecting in the Pacific’ (Article 2), atleast until ‘appropriate protection mecha-nisms are in place’ (Blakeney, 1999, p. 94).What is alarming is the result that researchand investment in natural biologicalresources will thereby be discouraged, andthe motivation to cultivate such resourcesmay be so reduced as to bring them


into danger of extinction (see Chapter 1on loss of biological resources and relatedTK). The Final Statement also declared‘the right of indigenous peoples of thePacific to self-governance and independ-ence of our lands, territories and resourcesas the basis for the preservation of indige-nous peoples’ knowledge’, the wider ramifi-cations of which fall outside the scope ofthis study.

On Access and Benefit Sharing. IndigenousAustralians consider there to be ‘somethings that cannot be sold, such assecret/sacred objects and information’,and ‘indigenous people should be ableto stop commodification of certain aspectsof their cultures’ (Janke, 1999, p. XIX).In short, they demand the right to con-trol access over their knowledge andresources.

Otherwise, indigenous Australiansmay be interested in benefiting from thecommercialization of some of their knowl-edge and resources.154 The difficulty isassessing the worth of the contribution ofTK to an invention based upon it.

Blakeney notes that ‘it will often bequestionable whether the contribution ofindigenous knowledge from which a phar-maceutical product is developed can beconsidered to be the sort of contributionwhich will allow the indigenous persons tobe considered a joint inventor under patentslaw’ (1999, p. 93). This is because merely‘being the first to observe a useful propertyor effect of an invention’ (Consolidated Alu-minum Corp. vs Foseco Int’l Ltd 10 U.S.P.Q.2d 1143) does not amount to joint inventor-ship, which requires each joint inventor‘working toward the same end and produc-ing an invention by their aggregate efforts’[269 F. Supp. 818 (DDC1967)].

Alternatively, where ethnobiolo-gists work together with local or indigen-ous communities in order to discoverboth the identity of medicinal plants andthe treatments for which they are used,

the contribution of TK to the develop-ment of a plant-based drug is more evident,and accordingly, the demand for a fair shareof the profits is greater (Blakeney, 1999,p. 93).

In fact, a distinction exists between thetraditional use of a plant, known for itshealing purposes, which is or which oughtto remain unaffected, and patent protectionon new inventions stemming from thatplant, such inventions falling outside thescope of TK. Confusion about this is detri-mental to the discussion on the apportion-ment of the benefits derived from the use ofthe plant and the TK related to it.

At any rate,

what is becoming evident … is that Natureis probably not going to produce the next‘blockbuster drug’ directly, but that thechemical structures that Mother Nature pro-vides are the structural leads that chemistswill then modify to produce ‘improvedmolecules’ that no chemist in his or herright mind would have considered makingde novo. (Sub. 39 of a CSIRO report cited inVoumard, 2000, p. 237; also consider theSmokebush example mentioned earlier)

That being so, a case can still be madefor compensating indigenous people to theextent that they point chemists in the rightdirection of the benefits that ‘MotherNature’ has to offer.

The integration of modern law and indigenouslaw. Australian legal thinking on the legalrights to plant genetic resources and relatedTK, especially that which is held by indige-nous Australians, is in a process of evolu-tion and compromise.

Some indigenous Australians wouldlike to see the implementation of ‘two paral-lel and equal systems of law’ within Aus-tralia (Janke, 1999, Part Three of the Reportand p. XXVII). Although there is a certainattractiveness to this idea – recognizingindigenous customs to have equal merit –the notion is rejected for both practical andconceptual reasons (Communication from


154 Claim 9 in the list of indigenous claims (Janke, 1999, pp. XX–XXI). For example, the Aboriginals of Uluru,formerly known as Ayers Rock, now keep part of the proceeds collected from tourists, in recognition of theircustodianship.

Australia points 24–32; 31). First and fore-most, it is not possible for any state to pursuetwo separate systems of law and governmentsimultaneously. Either the notions espousedby indigenous law will be compatible withthose found in modern law, in which casesuch law is superfluous, or else they will con-flict, in which case an order of priority willneed to be determined. This must take intoaccount not only subjective notions of whichlaw is preferable, but also the correct politicaland legal means to effect changes in the law,which is, after all, the law of the land, in thiscase a constitutional democracy for all of itscitizens whether indigenous or not.

The common law view is that thesources of law are to be found in an increas-ing order of importance, and that customarylaw is already included as a source of law,although legislation and case law takeprecedence over it (see any standard legaltext such as Legal Institutions by ProfessorWilliam Morison, Law Book Company,Sydney). ‘Specifically, Australia assessesthe existing legal framework, and then seeksto apply practical measures that accommo-date indigenous concerns in the day to daymanagement and administration of ICIP’(Communication from Australia point 25).‘An entirely new form of statutory protec-tion for ICIP, as envisaged by the Report OurCulture, Our Future is seen by the Aus-tralian government to be a “dramatic step”,introducing a level of unnecessary complex-ity and duplication which the governmentwould rather avoid in favour of developingthe existing legal system’ (Communicationfrom Australia point 31). The Australiangovernment also uses ‘non-legislative means… to accommodate indigenous concerns inthe daily management of intellectual andcultural property’ (point 32), including col-lecting societies (point 33).

If ‘two equal and parallel systems oflaw’ are strictly not possible, what, then, ispossible? A number of decisions155 and

developments have led to the suggestionthat ‘Aboriginal and Torres Strait IslanderIPRs may be recognisable by Australian laweither as part of native title within the scopeof the reasoning in the Mabo decision, or byanalogy with it’ (Gray, 1998, p. 78).

Aboriginal Australians have in turnrecommended that a sui generis legislativeframework be established to protect indige-nous cultural and intellectual propertyrights, including ecological knowledge, andthat ‘any rights granted should ensure thatthere are no time limits on protection andno fixed form requirement for protection tobe given’ (Janke, 1999, p. XXXVI).

Further, ‘the legislation should notinhibit the further cultural development ofmaterials within their originating commu-nities. That is, customary and traditionaluse should not be affected’ (Janke, 1999, p.XXXVI).

CONCLUSIONS

The development by Australia of a ModelContract on Access and Benefit Sharing is avaluable contribution ‘to the global commu-nity … [on] this important issue’ (Commu-nication from Australia point 18). ‘It ishoped that the measures taken by Australiato protect indigenous intellectual and cul-tural property within Australia may be ofuse to other countries’ (point 22).

Clearly, in order to incorporate con-cepts of Aboriginal intellectual propertyinto modern Australian law it is necessaryto think of intellectual property as some-thing more than the protection of commer-cial interests for a given period only. Theremust be a more fundamental recognition ofthe worth of all intellectual activity,whether stemming from indigenous or non-indigenous people. In this way, intellectualproperty may be considered to be part ofcultural heritage, rather than somethingincompatible with it.156


155 Native Title Act (1993) (Commonwealth) – which arose due to Mabo; Wik Peoples vs State of Queens-land (1996) 141 ALR 129; Bulun Bulun vs Nejlam Pty. Ltd. (1989) Federal Court of Australia; Yumbulul vsReserve Bank of Australia (1991) 21 IPR 481; and Milpurrurru vs Infofurn Pty. Ltd. (1995) 30 IPR 209.156 This was suggested by the Office of National Tourism in their submission to Our Culture, Our Future,1997 (Janke, 1999, p. 8).

Furthermore, any effective system forprotecting the legal rights over biologicalresources and related TK must also addressthe issue of rights over the land in whichthey are found. There are features of indige-nous ecological knowledge that are worthy

of special attention, and Australia is at theforefront of attempting to integrate indige-nous customary law into the modern legalsystem. It may be said that Australia is aninteresting example of the process of bring-ing together both North and South interests.


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