Protecting Traditional Knowledge : Is a Sui Generis System an Answer?

Protecting Traditional Knowledge

Is a Sui Generis System an Answer!

Surinder Kaur V E ~ *

I. INTRODUCTION

The protection of the traditional knowledge, innovations and practices (hereinafter referred to as TK) of indigenous/local communities has received increasing international attention since the adoption of the Convention on Biological Diversity (CBD) in 1992.1 The CBD, through its Article 8(j) has broadened the scope and mandate of protection with wider objectives. Since then, such protection has been actively on the agenda of different inter-governmental bodies, including the human rights bodies, namely the World Trade Organization and its Council for TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights), the World Intellectual Property Organization (WIPO) , the United Nations Environment Programme/CBD, the Food and Agriculture Organization (FAo), the United Nations Conference on Trade and Development (UNCTAD), the World Health Organization (WHO), the International Labour Organisation (ILo), the United Nations Human Rights Commission and the UN Permanent Forum on Indigenous Issues.

A number of countries and regional organizations are proposing or have already adopted measures to protect TK in their respective jurisdictions. At the level of inter-governmental bodies, the most extensive work/discussions have taken place in the WIPO, which established an Inter-Governmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (hereinafter referred to as the IGC) in 2000 with the mandate to discuss intellectual property (IP) issues that arise in the context of:

(i) access to genetic resources and benefit-sharing; (ii) protection of TK, whether or not associated with those resources; and (iii) the protection of expressions of folklore.2

* Professor of Law, University of Delhi, Delhi, India; former President (2001-2003), International Association for the Advancement of Teaching and Research in Intellectual Property.

The author may be contacted at: [email protected]. 1 The Convention came into force on 29 December 1993 and currently has 188 parties. The major

* Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO non-party is the United States.

Doc. WO/GA/26/6,25 August 2000, p. 5.

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The IGC mscussions have since led to an understandmg of the technical mmensions involved in the protection of TK and to the clarification of many concepts related thereto.

The discussions at the international fora are centred around numerous legal, economic, policy and scientific issues in TK protection under the IP regime. As the existing IP regme is found to be inadequate to protect the holistic character of TK, a predominant view is emerging towards devising an international sui generis regime for its protection.3 The protection of TK under a sui genevis IP regime, however, raises a number of policy issues:

(i) about the role of communities and the functions of communally held knowledge in traditions that are part of heritage and culture as well as living traditions of habitat preservation and human interactions. TK is an integral part of the indigenous/local communities, closely linked to the land and habitat where they reside, their culture, socio-political and economic systems and institutions. The natural environment has provided sustenance and healing, given an abiding spiritual basis for cultural and artistic expressions and helps in their conservation and growth. The real issue in this context seems to be the protection of the communities as such and preservation of their lifestyles and cultures rather than the protection of TK as a separate and independent subject-matter;

(ii) about the structuring of economic/pecuniary incentives for the protection of TK and the rights and obligations that are anchored in responses and behaviour rather than in resources. For many, their TK holds a sacred value which they would not part with for money. They want to safeguard their knowledge from plunder. Mere digitization of published or known information to ease the work of patent examiners cannot resolve the question of how holders of TK should be rewarded for their care and feeding of ideas. The real issue in this context is their empowerment and capacity-building;

(iii) about the objectives to be reached by TK protection and the measures necessary towards that end. In this context, the issues that need to be examined are: what is to be protected and from whom is it to be protected; for what purpose; for whose benefit (beneficiaries and stakeholders) and in what form; will it be confined to TK in the public domain or will it cover knowledge held as secrets; and this also has sacred/religious aspects;

(iv) as the TK protected under a sui genevis regime would have an economic/pecuniary thrust which would aim at protecting it against unauthorized use rather than promoting and preserving its further use and

3 In the Fifth Session (July 2003) of the IGC, the delegates from developing countries, particularly from Africa, suggested that the ICC should draft and present to the General Assembly of the WIPO a legally binding international instrument to protect genetic resources (GRs), traditional knowledge and folklore; see Chair’s Conclusions, p. 3.

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hffusion, the following issues need to be addressed: when and how the right will accrue; the nature of entitlements and share in benefits; scope of protection, period of protection (indefinite?) and the rights conferred; and the monitoring/administration/enforcement of the TK-related rights;

(v) about the nature of the regime-whether it is to be a legally binding instrument or a voluntary code;

(vi) whether or not a uniform system for the recognition and protection of indigenous peoples’ knowledge w d meet the expectations of this diverse group, for whom diversity is the lifeblood.

This article wdl examine these policy issues in the context of the current efforts to protect TK at international, national and regional levels. It proposes a holistic approach of protection at the national level and a restricted agenda at the international level with a legally enforceable regime.

11. WHY PROTECT TK?

It is now a well-documented fact that TK plays an important role in the global economy and is valuable not only to those who depend on it in their dady lives but also to modern industry and agriculture.4 Most traditional societies depend on this knowledge for their food and healthcare needs.5 There are no reliable estimates of the total contributions of TK associated with trahtional crop varieties (landraces) to the global economy, but the contributions of TK in the development and growth of pharmaceuticals and biotechnology-based industries are widely reported.6A recent study by the Organisation for Economic Co-operation and Development (OECD) has outlined the relative importance of biotechnology patent activity by concluding that the absolute number of biotechnology patents issued by the United States Patent Office and the European Patent Office has grown substantially in comparison with the total number of patents.7

4 For details, see Bruce M.Campbell and Martin K. Luckert, Uncovering the Hidden Harvest: Valuation Methods for Woodland and Forest Resources, Earthscan, London, 2002; International Institute for Environment and Development (IIED), The Hidden Harvest: The Value o f Wild Resources in Agricultural Systems, IIED, London, 1995. See also Marcelin M. Tonye, Sui Generis Systemsfor the Legal Protection o f Traditional Knowledge and Biogenetic Resources in Cameroon and South Africa, 6 J.W.I.P. 5, September 2003, pp. 765774.

5 WHO has reported that countries in Africa, Asia and Latin America use traditional medicine (TM) to help meet society’s primary healthcare needs. In Africa, up to 80 percent of the population uses T M for healthcare; see WHO Fact Sheet No. 134, revised May 2003. In India, this percentage goes up to 70 percent.

6 It is stated that natural-product-derived pharmaceuticals alone contributed an estimated US$ 120 billion, or 40 percent of global pharmaceutical sales in 1997, with global trade in raw botanical materials approximating US$ 8 billion in the same year: see S.A. Laird and K. ten Kate, The Commercial Use ofBiodiversity: Access to Genetic Resources and Benpfit Sharing, Earthscan Pubs., London, 1999, pp. 78-79. See also I?. Principe, Economics and Medicinal Rants, in T.R. Tomlinson and 0. Olayiwola Akerela (eds.), Medicinal Plants: Their Role in Health and Biodiversity, University of Pennsylvania Press, Philadelphia, 1998. A great deal of TK is likely to have cultural or spiritual value that cannot be quantified in any monetary terms: see D.A. Posey (ed.), Cultural and Spiritual Values .f Biodiversity, UNDP and Intermediate Technology Publications, Nairobi and London, 1999.

7 See Biofechnology Statistics in OECD Member Countries: Compendium ofExisting National Statistics, STI Working Paper 2001/6, at p. 10, as stated in Initial Report on the Technical Study on Disclosure Requirements Related to Genetic Resources and Traditional Knowledge, WIPO Doc. WIPO/GRTKF/IC/4/11, 20 November 2002.

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Traditional knowledge associated with a biological resource is an intangible component of the resource itself. TK has the potential of being translated into commercial benefits by providing valuable leads for the development of usefkl products and processes. The valuable leads provided by TK save time, money and investment of modem biotech firms into any research and product development. It is estimated that a hit-rate of 80 percent or more can be achieved in developing medical drugs where the screening of plants is limited to species used by indigenous communities.8

The issue of protection and preservation of TK at the international level has been brought to the fore at the instance of developing countries because of dfferent concerns and perspectives. A large number of countries rich in genetic resources (GRs) and TK and folklore believe that the traditional communities have been deprived of the benefits fiom the use of their knowledge, innovations and practices which have been monopolized and used by others, mainly by major companies, without their authorization and without acknowledging or rewardng them for their knowledge. Consequently, there is a perceivable asymmetry between the benefits obtained by the companies that commercially exploit this knowledge and the lack of benefits for its true holders. Developed countries have a moral obligation to ensure that indigenousAocal peoples receive a fair and equitable share of benefits arising out of the use of their TK and the commercialization of GRs. Moreover, if the knowledge assets of developed countries are to be protected by means of an international agreement (such as the TRIPS Agreement), it is only fair and equitable that the knowledge assets of developing counties also be sirmlarly protected. It is indeed the responsibhty of the international community to create an egahtarian system for the avadabihty, acquisition, maintenance and enforcement of intellectual property rights (IPRS) whch does not, a priori, exclude any section of the society, An international regime would give holders of TK control over the use of their knowledge assets and the capacity to ensure that they are not exploited c~mmercially.~

There has been an increasing number of reported cases of misappropriation (bio-piracy) and commercial exploitation of this knowledge under patents and other I p ~ s . 1 0 In many of these cases, claims in the patents on plants and their genetic resources

8 See J.W. Sheldon, M.J. Balick and S.A. Laird, Medicinal Plants: Can Utilization and Conservation Co-exist! 12 Advances in Economic Botany, 1997, pp. 1-104. According to Vandana Shiva, using TK has increased the eficiency of screening plants for medical properties by more than 40 percent: see Vandana Shiva, Patents: Myths G Reality, Penguin Books, New Delh, 2001, at p. 52. See also, Michael Blakeney, Communal Intellectual Property Rights oflndigenous Peoples in Cultural Expressions, 1 J.W.I.P. 6, November 1998, p. 985.

9 The Protection of Traditional Knowledge and Folklore: Summary oflssues Raised and Points Made, WTO Doc. IP/C/W/370,8 August 2002, at p. 3.

10 There is a large array of reported cases of misappropriation of TK, patents on natural products such as neem, turmeric, Basmati rice, Hoodia cactus, African potato, ayahuasca, may apple, Australian smokebush, periwinkle have been widely reported and commented upon: see Michael Blakeney, The Protection of Traditional Knowledge Under Intellectual Property Law, [ZOOO] EIPR 251, at pp. 253 et seq., for the details of the infiingement ofartistic works of indigenous people in Australia and cases thereto; Bernard O’Connor, Protecting Traditional K n o w l e d g e A n Overview . f a Developing Area oflntellectcral Property Law, 6 J.W.I.P. 5, September 2003, at pp. 677 et seq.; Gerard Bodekar, Traditional Medical Knowledge, Intellectual Property Rights G Benefit Sharing, 11 Cordozo J. Int’l & Comp. Law 785, 2003, at pp. 795 et seq.; Muriel Lightbourne, @Rice and Men: A n Attempt to Assess the Basmati AJair, 6 J.W.I.P. 6, November 2003, pp. 875-894; Ajeet Mathur, W h o Owns Traditional Knowledge, Working Paper No. 96, Indian Council for Research on International Economic Relations, January 2003, pp. 12 et seq.

PROTECTING T W I T I O N A L KNOWLEDGE 769

are not fundamentally different from the practices applied by the traditional Communities in the utilization of these plants as food; cosmetics or traditional medicines.” Some of these cases have been successfully challenged, such as in the cases of neem and turmeric, but others were not, such as in the case of the patent over ayahuasca.12 This raises an important issue of the legal protection of TK.

The protection of TK is important for the conservation and sustainable development of the environment, as much of the world’s crop diversity has been conserved and preserved by indigenousAocal peoples, which has helped in the protection and conservation of biodiversity. Their knowledge is central to the conservation and preservation of GRs and other bio-resources.13 Most of these communities live in areas where the vast majority of the world’s plant genetic resources (PGRS) are found. There is also the danger that the biological resources increasingly subjected to IPRS and patents are likely to be plucked to extinction, which raises concerns over their exhaustibility and loss of habitat besides the loss of lifestyles and livelihoods to inhgenous communities that have nurtured and used these resources for generations. This may also ultimately afTect food security. International recoption and protection of TK would help in the protection/conservation of the environment14 and in the management of biohversity.

The movement of trahtional communities from their natural habitat and their increasing assimilation with modem society has also raised concerns about the protection of TK, lest this movement would lead to its extinction and prejudicially affect biodiversity.15

Lack of motivation in the younger generation to learn the trahtions is another reason cited for the protection of TK. There is a fear that TK wdl suffer extinction with

11 See Tonye, supra, footnote 4, at p. 763. 12 A plant patent on ayahuasca drink, known as the “vme of the soul“ among the Amazon Quechua people,

produced from the bark of the Banisteriopsis cappi plant, used for many medicinal purposes, was granted to a U.S. citizen, Loren Miller, in 1986 (patent no. 5751). Upon a request from the Coordinating Body for the Indigenous Organizations of the Amazon Basin in 1994, the Centre for International Environment Law (CIEL) filed a case before the United States Patents and Trademarks Ofice, which revoked the patent in 1999 on the basis that the drink was not distinguishable from the prior art presented by the CIEL. O n appeal, the patent was reinstated, as it was not covered by the new rules in the United States on interpatfes re-examination, which was introduced in 1999 and was not the part ofpatent law in 1986 on the date ofthe filng of the patent.

13 Paragraph 26(1) of Agenda 21, adopted at the Earth Summit in 1992, accepts the link between indgenous peoples and the world’s need for environmentally sensitive development, and states: “In view of the interrelationship between the natural environment and its sustainable development and the cultural, social, economic and physical well-being of indigenous people, national and international efforts to implement environmentally sound and sustainable development should recognize, accommodate, promote and strengthen the role of indigenous people and their communities.”

14 “Protecting Traditional Knowledge-The International Dimension”, Inrta’s presentation at the International Seminar on Systems of Protection of Traditional Knowledge, organized jointly by the United Nations Conference on Trade and Development and the Department of Commerce of the Government of India, 3-5 April 2002, New Delhi, p. 2.

15 Writing on biodiversity, Gray observes that “the world biodiversity crisis is matched by a world ‘cultural diversity’ crisis. Indigenous peoples live predominantly in areas ofhigh biortversity while at the same time comprise 95 percent ofthe cultural diversity in the world.”: see A. Gray, Betmen the Spice ofLi and the Melting Pot: Biodiversity Conservation and its Impacf on Indigenous Peoples, IWG~A Document 70, International Work Group for Indigenous Main, Copenhagen, 1991.

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the death of the elders of the community. TK is generally viewed with disdain and as being inferior, since it does not conform to the accepted scientific methods of learning in the context of the modern reductionist approach of science.16 Only by concerted efforts to protect it and accord it due respect can this trend be stopped.

There is also a need to enable these communities to harness TK for their economic uplift and growth." Consequently, the demand for an effective protection of TK has gained momentum, either through the application of the traditional IPR system or by means of a new sui generis system such as traditional community rights or community intellectual property rights.'*

Not all of these concerns and perspectives are addressable within IP terms. The intellectual property rights model, in the context of TK, is limited, as it is aimed at excluding the use of protected knowledge by unauthorized parties, and is not concerned with its promotion or diffusion, goals which are fundamental for the sustainability of TK.19 IPRS function on exclusivity and are limited in time, held by an identifiable natural or legal person. At the end of the protection period, they become part of the public domain. O n the other hand, TK is held (owned) collectively and is inherently dynamic, growing/altering in response to changing environmental and social circumstances, while being in continuity with land and habitat, and mostly exists in an unfixed (oral) form. It originates and is preserved and transmitted in a traditional context and is not limited to any specific field of technology or arts.20 The enforcement of IPRS requires the identification and isolation of the protected information, while the challenging aspect of TK is its holistic character. Hence, it is necessary to clarify the identifiable subject-matter of TK in any international regime.21

16 See Intellectual Property Needs and Expectations of Traditional Knowledge Holders, WIPO Report on Factfinding Missions on Intellectual Property and Traditional Knowledge (1998-1999), Geneva, Switzerland, April 2001, pp. 214-215.

17 Gervais opines that one reason for an increasing demand for protection of TK is the new information technology which has made several indigenous communities politically active, vocal and assertive about their rights: see Daniel Gervais, TRIPS, Doha and Troditiorzal Knowledge, 6 J.W.I.P. 3, May 2003, pp. 403-419.

'8 See Thomas Cottier, The Protection of Genetic Resources and Tradional Knowledge: Towards More Spec& Rights and Obligations in World Trade Law, 4 JIEL 561, 1998; Thomas Cottier and Marion Panizzon, Legal Perspectives on Traditional Knowledge: The Casefor Intellectual Property Protection, 7 JIEL 371, 2004; Graham Dutfield, TRIPS-Related Aspects of Traditional Knowledge, 33 Case W. Res. J. lntl L. 240, 2001. According to Wendland, discussions on the uses of TK have linked the protection of IP to such policy objectives as the promotion of free trade, human rights, health, food, environment and biodiversity conservation, and cultural diversity: see, Wend B. Wendland, Intellectual Property, Traditional Knowledge and Folklore: WPO's Explorafoy Program, 33 IIC 485, 2002.

'9 Christopher Heath and Sabine Weidlich, Intellecfual Property: Suitable $r Protecting Traditional Medicine? Intellectual Property Quarterly, No. 1, 69,2003, at p. 76.

2n See Traditional KnowledgvOperat ional Terns and Definitions, Wrro Doc. WIPO/GRTKF/IC/3/9, 20 May 2002; Intellectual Property Needs and Expectations of Traditional Knowledge Holders, supra, footnote 16, at p. 21 1. Attempts to define T K by different international fora/bodies, though they have not resulted in any definition acceptable to all concerned parties, have clarified its certain characteristics. See also Gervais, supra, footnote 17, at p. 405.

21 Intellectual Property Needs and Expectations of Traditional Knowledge Holders, supra, footnote 16, at p. 216, excludes fiom protectable TK subject-matter spiritual beliefs, dispute settlement, processes and methods of governance, languages, human remains, and biological and genetic resources in their natural state. Nor is knowledge per se protectable, unless it is in the form of a trade secret.

PROTECTING T W I T I O N A L KNOWLEDGE 771

Industrialized countries have generally been supportive of the notion that indigenous peoples’ rights are mainly about being permitted to practice their lifestyle and uphold their sense of identity through adhering to expressions of their folkore and culture. This, however, takes away attention from the essential questions of economic rights and the economic value of TK, some of which comes inextricably linked with their habitat and their title or lack of it to livelihood from the resources of their habitat.

111. INTERNATIONAL INITIATIVES FOR PROTECTION OF TRADITIONAL KNOWLEDGE

The first effort to protect TK, specifically folklore, under the IP regime was a joint initiative taken by the WIPO and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1978 whch led to the adoption of the WIPO-UNESCO Model Provisions for National Laws on the Protection of Expressions of Folklore against Ihcit Exploitation and other Prejudlcial Actions in 1982. These Provisions were in the nature of Guidelines to WIPO Members to protect folklore in their jurisdlctions.22 Since then, a number of efforts have been initiated to protect TK by inter-governmental bodies dealing with intellectual property, environment and human rights which are aimed at entrusting legal control to indigenousAocal communities over the exploitation of their TK when such knowledge has special cultural significance.

A. THE INTERNATIONAL LABOUR ORGANISATION CONVENTION NO. 169

The ILO Convention No. 169 of 1989,23 which replaced the earlier ILO Convention No. 107 concerning Indigenous and Tribal Peoples in Independent Countries of 1957, does not directly address the issue of protection of TK, is more human-rights-centric and asserts the right of indigenous and tribal people over their land. It affirms the right of indigenous peoples to self-identification.24 It obliges States to “respect the special importance for the cultures and spiritual values of the peoples concerned of their relationship with the land or territories or both” (Article 13). In this regard, States are to promote “the full realization of the social, economic and cultural rights of these peoples with respect for their social and cultural identity; their customs and tradtions and their institutions” (Article 2(2)). Governments have the responsibihty to develop, “with the participation of the peoples Concerned, co-ordinated and systematic action to protect the rights of these peoples and to guarantee respect for their integrity” (Article 2(1)). Their social, cultural, religious and spiritual values and practices are to be recognized and protected (Article 5).

22 These were initially negotiated for a treaty but subsequently adopted as Model Guidelines: see M. Ficsor, Attempts to Provide International Protection for Folklore by Intellectual Property Rights, paper presented at the UNESCO- WIPO World Forum on the Protection of Folklore, Phuket, Thailand, 8-10 April 1997.

23 The Convention came into force on 5 September 1991; it has been ratified by seventeen countries. 24 For an account of this instrument, see Peter-Tobias Stoll and Anja von Hahn, Indigenous Peoples, Indigenous

Knowledge and Indigenous Resounes in International Law, in Silke von Lewinsky (ed.), Indigenous Heritage and Intellectual Property: Genetic Resources, Traditiotial Knowledge and Folklore, Kluwer Law International, The Hague/London/New York, 2004, at pp. 21-22; Matthias Leistner, Traditional Knowledge, in von Lewinsky, ibid., at p. 109.


Within the context of the Convention, the concept of cultural identity thus provides an important link between cultural rights and cultural heritage, implying the collective right of indigenous peoples to the protection of their own cultural heritage. The Convention, although not defining TK or explicitly mentioning indigenous resources or folklore, nevertheless recognizes the rights of indigenous peoples over natural resources pertaining to their land and to their traditional activities in order to maintain their cultures and economic self-reliance and development, which are to be safeguarded (Articles 15 and 23). More importantly, they can “decide their own priorities for the process of development as it affects their lives, beliefs, institutions and spiritual well-being and the lands they occupy or otherwise use, and to exercise control, to the extent possible, over their own economic, social and cultural development” (Article 7). The Convention clearly accepts the inter-relationship between cultural heritage law, land rights and cultural rights of indigenous peoples in their own trahtions, which includes TK as well. The Convention is important in providing a model definition of indigenous and tribal peoples (Article 1.1).

B. DRAFT UN DECLARATION ON THE RIGHTS OF INDIGENOUS PEOPLES

The draft UN Declaration on the Rghts of Indigenous Peoples, 1994 by the UN Sub-Commission on the Promotion and Protection of Human Rights25 includes human- rights principles which have implications for TK and biodiversity. It accepts the right of self-determination of indgenous peoples (Article 3). It recognizes their “collective right to live in freedom, peace and security as distinct peoples” (Article 6(1)); their right to the full recognition of their laws, traditions and customs (Article 26); and full maintenance, protection and promotion of past, present and future manifestations of their cultures (Article 12). The Declaration demands that States abstain from removing indgenous peoples from their lands or territories (Article lo), respect their traditions and indgenous knowledge (Part 111) and restore and protect the environment (Article 28). Cultural and intellectual property rights are recognized in Article 29, which reads:

“Indigenous peoples are entitled to the recognition of the full ownership, control and protection of their cultural and intellectual property. They have the right to special measures to control, develop and protect their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs and visual and performing arts.”

The provision is thus wide in its implications, establishing a link between cultural property, cultural identity and the collective right to own and control one’s own

25 The draft Declaration was completed in 1993 and is currently the subject of discussion by a Working Group (or Drafting Group) set up by Resolution 1995/32 of the Commission on Human Rights, 3 March 1995; see UN Doc. E/CN.4/sub.2/1993/29/Annex 1, 23 August 1993. See also Sub-Commission Resolution 1994/95, 24 August 1995. The Sub-Commission on the Promotion and Protection of Human Rights replaced the earlier Sub-Commission on Prevention of Discrimination and Protection of Minorities.


cultural property. In this sense it is close to the ILO Convention.26 Indgenous communities have the right to determine and develop priorities and strategies to use their own lands, territories and other resources. This includes the right that States obtain their “fiee and informed consent” before any projects afTecting their lands, territories or resources may be approved, “particularly in connection with the development, utihzation or exploitation of mineral, water or other resources” (Article 30). There is no explicit mention of TK and traditional resources (as is the case with the ILO Convention), but the term “other resources” in Article 30 could be broadly interpreted to cover them. Article 29 does cover them, but the degree of protection to be accorded to them by States has not been specified.

The draft Declaration, if adopted, would be a significant step in protecting the rights of indigenous peoples, including TK, and would be holistic in approach, including cultural and land rights, but it makes formidable demands upon governments for the attainment of a number of objectives with heavy implications for State resources.

c. DECLAFUTIONS OF INDIGENOUS GROUPS AND PEOPLES

As an aftermath of the adoption of the CBD and the growing importance of TK in biotechnological inventions, a number of international/regional conferences were held with the participation of indigenous peoples and groups, highlighting the recognition of their rights in their tradtional knowledge and the need for its protection. They, nevertheless, were more centred in their approach towards intellectual property rights and the current IPR regime. Significant statements on the rights of indigenous peoples came from some of these Conferences.

The Mataatua Declaration on the Cultural and Intellectual Property Rights of Indigenous Peoples, 199327 had a human-rights approach towards TK and asked for a moratorium on any further commerialization of indigenous medical plants and human genetic materials until these communities have developed appropriate protection mechanisms. It also demanded the recognition of their right over their knowledge.28 The Charter of the Indigenous-Tribal Peoples of the Tropical Forests, 1992 declared the willingness of indigenous peoples to share their knowledge with humanity, as determined by them. It demanded a guarantee of rights to intellectual property and control over the development and manipulation of indigenous knowledge.29 The Jalayinbul Statement on Indigenous Property Rights, 1993 emphasized the right of indigenous peoples “to define for themselves their own intellectual property” in

26 See, for details, Leistner, supra, footnote 24, at p. 111; Stoll and von Hahn, supra, footnote 24, at pp. 22-23. 2’ The Conference was convened by the nine Tribes of Mataatua in the Bay of Plenty Region of Aotearoa,

New Zealand in June 1993. 28 See Blakeney, supra, footnote 10, at pp. 258-259; M. Blakeney, Bioprospecting and the Profecfion ofTraditional

Medical Knowledge ofkdigenour Peoples: An Australian Perspective, [1997] EIPR 298, at pp. 301 et seq.; Leistner, supra, footnote 24, at pp. 112-1 13.

29 The Conference was held in February 1992 at Penang, Malaysia: see Blakeney, supra, footnote 10, at p. 258.

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accordance with “Aboriginal Common Law”.3” The statement most critical of the current IPR system for its colonialist approach, however, was made by the International Consultation on Intellectual Property Rights and Biodiversity, organized by the Coordinating Body of the Indigenous Peoples of the Amazon Basin, held at Santa Cruz de la Sierra, Bolivia in September 1994. It also declared patents and other IPRS to life-forms “unacceptable to indigenous peoples”.31 The main premise of these Statements/Declarations, however, is the right of self-determination and independence of these people in relation to their resources and the recognition of these rights.

D. THE CONVENTION O N BIOLOGICAL DIVERSITY

The CBD is the principal international instrument which explicitly acknowledges the role of traditional knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles in biodiversity conservation and its sustainable development.32 The scope of the TK covered by the Convention, however, is confined to genetic materials (GRs). It is a framework convention, setting out general principles that the parties agree to be guided by and work towards in a long-term process. According to Article S(j) of the Convention, each contracting party, subject to its national legislation, is required to:

- respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological resources;

promote the wider application of such knowledge, innovations and practices with the approval and involvement of their holders; and

encourage the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices.

-

-

Apart from Article S(j), however, no other provision of the CBD requires the consent or involvement of indigenousAocal communities in granting access to genetic resources. It, in fact, does not specify who are the stakeholders in issues related to genetic resources but only places binding legal obligations on national governments, parties to the Convention. In giving effect to other provisions of the Convention, however,

30 The Conference was held at Jingarrba, Australia in November 1993. 3’ See Blakeney, [1Y97] EIPR, supra, footnote 28, at p. 302. Another important conference worth mentioning

is the South-Pacific Regional Consultation on Indigenous Peoples’ Knowlcdge and Intellectual Property Rights, held in 1995 in Suva, Fiji, which was also critical of IPR systems, science and modem tcchnology to control and exploit the resources of indigenous peoplcs. It asserted their right over their lands, resources and temtories; see Leistner, suppra, footnote 24, at p. 113.

32 The other instmments accepted along with the CBn at the Earth Summit at Rio de Janeiro, Brazil in 1992 which accepted the importance of indigenous peoples/communities in the maintenance of biological diversity are Principle 22 of the Ria Declaration on Environment and Development, and Para. 26(3)(a) of Agenda 21 of the Ria Summit.


governments have the authority to determine the mechanism for the involvement of these communities and other stakeholders and to specify their roles and responsibilities.

Article 18(4) states that Contracting Parties shall “encourage and develop methods of cooperation for the development and use of technologies, including indigenous and traditional technologies”. Article 15 recognizes the sovereign rights of States over their natural resources and their authority to determine access to genetic resources and provides that access, where granted, shall be on mutually agreed terms and subject to prior informed consent of the provider party (a contracting party). The most controversial provision is Article 16(5), which requires Parties to co-operate to ensure that patents and other IPRS “are supportive of and do not run counter to its [the CBD’S] objectives”.

In furtherance of this framework, TK has been on the agenda of the CBD since 1996, and an extensive and complex work programme has grown around the issue of IPRS and their role in the implementation of the C B D . ~ ~ The Fourth Conference of the Parties to the Convention for Biologcal Diversity (COP-IV), held in Bratislava, Slovakia in 1998, recognizing “the importance of making intellectual-property-related provisions of Article 8(j) and related provisions of the Convention on Biological Diversity and provisions of international agreements relating to intellectual property mutually supportive, and the desirability of undertaking further cooperation and consultation with the World Intellectual Property Organization”, decided to establish an “ad hoc open-ended inter-sessional working gr0up”.~4 The mandate of the working group was to “provide advice on the application and development of legal and other appropriate forms of protection for the knowledge, innovations and practices of indigenous and local communities” and also “to develop a programme of work, based on the structure of the elements in the Madrid report”.35 The mandate of the group was further extended to case studies on the protection of indigenous knowledge.36 The working group since has held three meetings. It will hold one more meeting, and in the meantime the contracting parties are requested to provide status reports on the implementation of Article S(j) .37

The working group is working towards strategies to protect TK based on a combination of approaches and with full respect for customary law and practices, including the use of existing IP mechanisms, the use of contractual arrangements, a

33 See Decision 111/14, Implementation of Article S(j), UNEP Doc. UNEP/CBD/COP/3/38, Annex; Decision IW17, Intellectual Property Rights, available at: cwww.biodiv.org/decisions/default.aspx>.

34 See Decision IV/9, Implementation of Article S(j) and related provisions, available at: www.biodiv.org/ decisions/default.aspx).

35 Madrid Report, UNEP Doc. UNEP/CBD/COP/~/~O/A~~.~. The Madrid Workshop on Traditional Knowledge was held in December 1997 in Madrid, Spain, to discuss issues of TK in general: see UNEP Doc. UNEP/CBD/TKBD/1/3 of 15 December 1997.

36 Decision V/16 of COP-V; available at: <www.biodiv.org/decisions/default.aspx). 3’ See Decision VW16 of C ~ P - W , held in Kuala Lumpur, Malaysia, 9-20 February 2004. It was also decided

to hold four regional workshops in Asia, Africa, Latin America and Eastern Europe in 2005 to prepare composite reports on TK on a regional basis. See the CBD Website at: (www.biodiv.org/decisions/default.aspx).

776 THE JOURNAL OF WORLD INTELLECTUAL. PROPERTY

register of TK and guidelines and a code of practices. It is also considering the suigeneris mode of protection of TK, which may take into account the elements related to the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization (Bonn Guidelines), particularly in terms of how the elements might complete the Guidelines by focusing on the specific needs and interests of indigenous and local communities in the protection, utilization and equitable sharing of benefits when access to their genetic resources are sought.38

In another significant development, the COP-IV took up the matter of access to genetic resources and benefit-sharing39 and the COP-v decided to establish an Ad HOC Open-ended Working Group to develop guidelines and other approaches on the access to GRs and benefit-sharing from their use. Its work led to the adoption of the Bonn Guidelines40 by the COP-vr in 2002, which called upon the parties to use the Guidelines when drafting their laws and policies “on access and benefit-sharing, and contracts and other arrangements under mutually agreed terms for access and benefit-sharing”.41 The Guidelines are voluntary in nature, which the parties may take into account while giving effect to their obligations under the CBD. They provide some background to the discussion on the practical interaction between the IPR system and the CBD. The Guidelines suggest that Material Transfer Agreements (MTAS) on GRs may include conditions under which the user of accessed GRs may seek IPRS, and monetary and non-monetary benefits may include “joint ownership of relevant intellectual property rights”.4* Parties have been invited:

“. . . to encourage the disclosure of the country of origin of genetic resources in applications for intellectual property rights, where the subject matter of the application concerns or makes use of genetic resources in its development, as a possible contribution to tracking compliance with prior informed consent and the mutually agreed terms on which access to those resources was granted.”

They have further been invited “to encourage the disclosure of the origin of the relevant traditional knowledge, innovations and practices of indigenous and local communities”.43 The same approach has been proposed under the WTO, UNCTAD and the Wrp0.44

As means to implement the CBD requirements for mutually agreed terms, the guiding parameters suggested for contractual agreements provide that the “provision

38 See Report of the Third Meeting of the A d Hoc Open-ended Infer-Sessional Working Group on Article 8(j) and Related Provisions on the Convention on Biological Diversity, UNEP Doc. UNEP/CBD/COP/7/7, 12 December 2003, para. 96.

39 See First Meeting ofthe Panel ofEqer ts on Access to Genetic Resources and Benefit-Sharing, Final Report, UNEP DOC. UNEP/CBD/COP/5/8.

40 The Working Group met in Bonn, Germany in October 2001 and proposed the Draft Guidelines; see UNEP Doc. UNEP/CBD/COP/6/6,31 October 2001.

4’ See Decision VI/24 of COP-VI, Access and Benefit-Sharing as related to Genetic Resources; available at: (www. biodiv.org/decisions/default.aspw .

42 See Appendices I and I1 to the Guidelines, as presented in Decision VI/24 of COP-VI, ibid. 43 See Annex to the Guidelines, ibid. 44 See WlPO Doc. WIPO/GRTKF/IC/4/11, supra, footnote 7, at p. 10.


for the use of intellectual property rights include joint research, obligation to implement rights on inventions obtained and to provide licences by common consent” and “the possibility of joint ownership of intellectual property rights according to the degree of contribution”.45 In order to seek compliance with the prior informed consent of the contracting party providing such resources and mutually agreed terms, the countries may take measures to encourage the disclosure of the country of origin of the genetic resources and the origin of TK in applications for I P R s . ~ ~

On some of the more important topics-such as the impact of IPRs on acceduse of GRs and scientific research, the role of customary law, the relationship between disclosure requirements and international legal obligations, the efficacy of disclosure requirements, the feasibility of an internationally recognized certificate of origin system, monitoring, compliance and enforcement, and the role of oral evidence of prior art in granting IPRs-further information and work has been requested. The COP-VII further elaborated on these issues and has invited parties to recognize TK, whether written or oral, as prior art. Parties are to ensure under their domestic law compliance with the requirement of prior informed consent of the indigenous communities and put in place mechanisms to ensure fair and equitable benefit-sharing at the national level with relevant stakeholders and indigenous/local communities. It invites the W r p o to take into account the CBD’S work on these topics and calls for the WIPO’S work to be supportive of the CBD, to address issues on model provisions on disclosure requirements and to devise options for incentive measures for applicants.47 These initiatives to a great extent address the concern of developing countries but do not create any binding legal obligation.

The importance of the Guidelines for developing countries, nevertheless, is that they are a significant step towards the harmonization of the regme of access and benefit- sharing. It is also important to note that in the context of the CBD, emphasizing national sovereignty and the authority of governments to regulate access to GRs cannot rule out bilateral negotiations between the biodiversity-rich but technologcally poor countries and those seeking access to these resources. In other words, the CBD promotes bilateral agreements between the providers and users of resources, whereas a multilateral approach would be mutually beneficial by laying down the framework of fair terms because in bilateral negotiations the biodiversity-rich countries quite often are not in a strong position to negotiate a fair deal.

45 Para. 43(c) and (d) of the Guidelines, as presented in Decision VI/24 of COP-VI, supra, footnote 41. 46 Para. 16(d)(ii) ofthe Guidelines, ibid. 47 See Decision VlI/19, ArLess and Benefrt-Sharing as related to Genetic Resources (Article 1.5). available at:

www.biodiv.org/decisions/default.aspx). This Decision, along with the CBD Decision on Article 8(j), Decision VII/6, were sent to the IGC in order to develop positive and defensive protection of T K see WIPO Doc. W[Po/GRTKF/IC/6/13, 15 March 2004.


E. THE WORLD INTELLECTUAL PROPERTY ORGANIZATION

The WIPO’S direct and positive involvement in the issue of TK started in 1998.48 During 1998-1999, the WIPO embarked on nine fact-finding missions in various parts of the world, exploring the intellectual property aspects of TK protection while bearing in mind the needs and expectations of TK h0lders.4~ In its 26th session, the WIPO General Assembly established the I ~ c . 5 0 The IGC’S actions so far51 have focused on trying to understand the needs and expectations of traditional/local communities, ascertaining the adequacy of current methods for protecting TK and surveying proposals to enhance such protection. It has produced an impressive number of documents,52 including the model clauses for genetic resources contracts,53 a toollut for documentation of TK protection54 and work on elements of a possible suigeneris system of protection for TK.55 Beyond the Committee’s work, the WIPO is also taking steps to enhance the coverage of documented TK in the minimum documentation of the Patent Cooperation Treaty (PCT)56 and to expand the International Patent Classification (IPc) to contain categories for TK subject-matter to provide for more accurate and focused searching for relevant TK during the patent examination process.57

The WIPO’S approach in the matter of TK protection is mainly IP-related. The documents produced acknowledge the general difficulties with protecting TK under IP law. The IGC has centred its activities mainly on solutions that tend to minimize the rigours of IP criteria. The IP solution is sought for TK in the public domain, which is a small part of the vast arena of TK that has strong moorings in cultures and traditions/rituals. etc.58

48 The first joint initiative with UNESCO in 1978 led to the adoption of WIPO-UNESCO Model Provision for National Laws on thc Protection of Expressions of Folklore against Illicit Exploitation and Other Prejudicial Actions, 1982; see Ficsor, supra, footnote 22.

49 See Intellectual Property Needs and Expectations of Traditional Knowledge Holders, supra, footnote 16. In July 1998 and November 1999, WIPO organized two Roundtables to facilitate an exchange of views among policy- makers, indigenous peoples and other holders of TK for an effective protection of TK through IPR systems.

5” See WIPO Doc. WO/GA/26/6, supra, footnote 2. 51 The IGC has so far met in six sessions and the seventh session will be held 1-5 November 2004. The

Committee’s term was extended by the WIPO General Assembly in its 30th session (22 September-1 October 2003) for the next budgetary biennium with the same mandate, and its new work will focus, in particular, on consideration of the international dimension of those issues without prejudice to the work pursued in other fora. No outcome of its work is excluded, including the possible development of an international instrument or instruments; see WIPO Doc. WIPO-SAARC/GRTK/DEL/03/0.1, November 2003.

52 See the IGC Website at: cwww.int/tk/en/igc/documents/issues.html) for the list of documents prepared by the IGC. See also WIPo Doc. WIPO/GRTKF/IC/5/12,3 April 2003.

s3 See WIPO Docs. WIPO/GRTKF/IC/4/10 of 25 March 2002; WIPO/GRTKF/IC/3/4 of 17 May 2002; WIPO/GRTKF/IC/2/3 of 10 September 2001.

54 WIPO Doc. WIPO/GRTKF/IC/4/5 of 20 October 2002. j5 WIPO Docs. WIPO/GRTKF/IC/5/3 of2 May 2003; WIPO/GRTKF/IC/4/8 of 30 September 2002, Efemenfs

. f a Sui Generis System for the Protection of Traditional Knowledge; and WIPO/GRTKF/IC/3/8 of 29 March 2002, Elements o fa Sui Generis System for the Protection of Traditional Knowledge.

sf, See WIPO Docs. PCT/CTC/20/5; PCT/MIA/7/3; and PCT/MIA/7/5. 57 See WIPO Doc. I~c/CE/32/12. The Committee of Experts of the Special Union for the IPC has already

58 See Paul Kuruk, Bridging the G a p between Traditional Knowledge and Intellectual Property Rights-1s Reciprocity started working on this.

an Answer? 7 J.W.I.P. 3, May 2004, at p. 430.


The IGC’S deliberations so far, however, have revealed a clear division of views among the countries regarding the need, scope and nature of legal protection of TK and its format. Despite their strong, polarized positions on these issues, the countries have agreed that the WIPO should produce the elements for a model sui generis system of protection for TK, though the developed countries are of the view that any legally binding international sui generis system at this stage is premature and unnecessary and that attempts should first be made at the national level to determine its feasibility. Developing countries, on the other hand, desire expeditious work to be undertaken on this.59

Views are also divided on whether there should be two separate documents to protect TK and folklore, but the developing countries desire to protect the holistic character of TK. Broadly speaking, the IGC’S work so far has not produced any tangible results other than being a forum for discussion of legal, economic and policy issues related to the protection of TK, includmg the sui generis form of protection of TK. It has, of course, heightened the awareness among the developing countries to safeguard their valuable knowledge assets. To date, the WIPO has proposed a bottom-up approach under which developing countries first assess how existing national mechanisms of IPRs

could be more effectively used to protect TK before introducing protection at the international level.60

F. THE WORLD TRADE ORGANIZATION

Traditional knowledge has come up on the agenda of the WTO under the TRIPS Agreement. The Agreement, as such, deals with the traditional concepts of intellectual property and does not have any specific provision on the protection of TK. Rather, TK is excluded by virtue of Article 70(3), which considers it as a part of the public domain.61 The relevant provisions in this context could be Article 39 (protection of undisclosed information), if the TK is kept as secret knowledge, and Article 22 (protection of geographical indications). Obviously, these Articles are of limited application and are unable to meet the concerns of developing countries.

The issue of protection of TK was brought before the General Council of the WTO in the context of Article 27(3)(b) of the TRIPS Agreement in 1999, which was to be

59 At the Fifth Session of the IGC, on behalf of the Afiican Group, Zambia suggested that the IGC should draft and present to the General Assembly a legally bindtng international instrument to protect T K see Report ofthe F$h Session af the ICC, WIPO Doc. WIPO/GRTKF/IC/5/15, 4 August 2003, and the Chair’s conclusions. The IGC has been urged to expedite its work on a sui generis system. In the Sixth Session, the %can Group submitted a document listing the objectives, principles and elements of an instrument(s) on TK, see Objectives, Principles and Elements af an International Instrument, or Instruments, on Intellectual Property in Relation to Genetic Resources and afthe Protection of Traditional Knowledge and Folklore,Wiro Doc. WIPO/GRTKF/IC/6/12, 15 March 2004.

See Wrro Doc. WIPO/GRTKF/IC/3/8, supra, footnote 55; WIPO Doc. WIPO/GRTKF/IC/4/8, supra, footnote 55; see also Cottier and Panizzon, supra, footnote 18, at p. 387.

61 Article 70.3 of the TRIPS Agreement reads: “There shall be no obligation to restore protection to subject matter which on the date of application of this Agreement for the Member in question has fallen into the public domain.”


reviewed under its terms.62 Article 27(3) (b) requires Members to protect plant varieties “ either by patents or by an effective sui generis system or by any combination thereof ’. While constructing a sui generix regime, a country may take into account the protection of TK because plant genetic resources have a double nature: they are physical material and the carriers of herechary information which is capable of self-replication and, as such, also a part of TK. This double nature gives rise to a conceptual tension between physical property in germplasm on the one hand and the IPRS in intangible elements of GRs (genotype) which constitute inventions, trade secrets or new plant varieties on the other. TK also became an issue in the context of patenting biological inventions, which saw a tremendous surge after the adoption of the TRIPS Agreement, which made micro- organisms, microbiologcal and non-biological processes patentable.

The submission made by Venezuela at the Third Ministerial Conference of the WTO in Seattle asked that the next review of TRIPS, inter a h , should:

“. . . establish on a mandatory basis within the TRIPS Agreement a system for the protection of intellectual property, with an ethical and economic content, applicable to the traditional knowledge of local and indigenous communities, together with the recognition of the need to define the rights of collective holders.”63

A submission by the African Group, two months later, also called for a new mandate dealing with TK in a future round, leading ultimately to establishing a multilateral legal framework.64 Other developing countries also put forward proposals for the substantive review of TRIPS Article 27(3)(b) and called for the harmonization of the TRIPS Agreement and the CBD, the two internationally binding instruments relating to the protection of TK and use of GRs.65

The proposals from developing countries together argued that the exclusions in TRIPS Article 27(3)(b) should be clarified, that life forms should be excluded from patentability, that information relating to the origins of a biological invention should become part of the patent application process and that the principle of prior informed consent under the CBD should be incorporated into the TRIPS Agreement.66 There was heightened concern about the grant of patents and/or other IPRS covering TK to persons other than the indigenous peoples/communities who own and control them when their TK is being used without their authorization and without sharing with them

62 The issue of TK was first brought before the Committee on Trade and Environment (CTE) in the context of the TRIPS Agreement and the CBD to examine the relationship between trade measures and environmental objectives in the context ofTRrPs Article 27(3)(b): see ?Ine Convention on Biological Diversity and its Relation to Trade, WTO Doc. W T / C T E / W / ~ ~ , 29 September 1997.

b3 See WTC-General Council (1999e), Preparationsfor the 1999 Ministetial Conference: Proposals Regarding the TRIPS Agreement (Paragraph 9(a)(ii) 4 the Geneva Ministerial Declaration). CommunicationfrDrn Venezuela, WTO Doc. WT/GC/W/282, 6 August 1999, para. 2.

64 See Communication to the General Council from Bolivia, Colombia, Ecuador, Nicaragua and Peru, WTO Doc. WT/GC/W/362,12 October 1999.

65 WTO Doc. IP/C/M/25, 22 December 1999. 66 For a detailed summary of the various proposals, see Table 1 in Carlos M. Cotrea, Traditional Knowledge and

Intellectual Property, mscussion paper, Quaker United Nations OfXce, Geneva, Switzerland, 2001, pp. 24-25. Most of these proposals were limited to GRs and TK and little was said with respect to folklore.


the benefits that accrue from such use. The United States, on the other hand, argued that the CBD’S objectives on access to GRs and TK could best be acheved through national legislation and contractual arrangements based on the national legislation, which could include commitments on disclosure.67 This submission of the United States, however, does not address the issue of the consequences of non-compliance with the national legislation and the IPRS granted on GRs and TK.

The strong position taken by the developing countries on the protection of TK, nevertheless, led to its inclusion in the Doha Ministerial Declaration in November 2001. The Declaration, in Paragraph 19, has mandated the Council for TRIPS:

“ ... in pursuing its work programme including under the review of Article 27(3)(b), the review of the implementation of the TRIPS Agreement under Article 71.1 ... to examine, inter a h , the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by members pursuant to Article 71.1. In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.”

It has further instructed the Committee on Trade and Environment to give particular attention to three issues in pursuing its work on items on its agenda, including the relevant provisions of the TRIPS Agreement (Para. 32).68 It is, however, to be noted that the TRIPS Agreement does not make any reference to the CBD in its provisions. Though adopted after the CBD, it failed to take note of Article 16(5) of the CBD, which clearly observes that patents and other IPRS may have an influence on the implementation of the CBD and that parties shall ensure that such rights do not run counter to its objectives.

Since the Doha Ministerial Meeting, the discussions before the Council for TRIPS have centred on the relationship between the provisions of the TRIPS Agreement and the CBD and the protection of TK under the mandated review of TRIPS Article 27(3)(b). In order to assist the Council to discharge its mandate, different nations/national groups have made submissions.69 These submissions, once again, have highlighted the contrasting approaches on the issue of protection of TK under the TRIPS Agreement between the industrialized and developing countries. Industrialized countries consider the WIPO the most appropriate forum to tackle the issue of legal protection of TK, and

67 See Communication ofthe United States to the Councilfor TRIPS, WTO Doc. IP/C/W/257, 13 June 2001. 68 WTO Doha Ministerial Meeting, 2001, Ministerial Declaration of 14 November 2001, WTO Doc.

WT/MIN(OI)DEC/~, 20 November 2001, reproduced in 41 I.L.M. 746,2002. 69 See principally the submission by the African Group, WTO Doc. IP/C/W/404,26 June 2003; submission

by Brazil, China, Cuba, the Dominican Republic, Ecuador, India, Pakistan, Peru, Thailand, Venezuela, Zambia and Zimbabwe, WTO Doc. IP/C/W/356; submission by Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, India, Peru, Thailand, Venezuela, WTO Doc. IP/C/W/403, 24 June 2003; 7’he Relationship between the TRIPS Agreement and the Convention on Biological Diversify, submission by Brazil, Cuba, Ecuador, India, Peru, Thailand and Venezuela, WTO Doc. IP/C/W/420, 2 March 2004; EU Concept Paper, WTO Doc. IP/C/W/383, 17 October 2002; submissions by the United States, WTO Docs. IP/C/W/257 of 13 June 2001 and IP/C/W/393 of28 January 2003; submission by Switzerland, WTO Doc. IP/C/W/400,28 May 2003.


feel that once that body has sufficiently clarified conceptual issues and possible options and completed the model national legislation, the WTO should come back to this matter. According to these nations, the WTO is, in fact, not the right place to negotiate a full-fledged system of protection for a complex, and as yet undefined, subject-matter such as TK or folklore.70

The developing countries, on the other hand, do not find the present IP regime adequate to address their concerns in relation to TK. They find the patent system faulty, as it does not take into account TK as prior art nor does it take care of the requirements of benefit-sharing and prior informed consent. They are insisting that the TRIPS Agreement should be suitably amended or provide a mechanism requiring that an applicant for a patent on biological material or TK should, as a condition to acquire patent rights, disclose the source and country of origin of the biological resources and of the traditional knowledge used in the invention and provide evidence of prior informed consent and fair and equitable benefit-sharing under the relevant national regime.

These requirements in patent applications on biologcal inventions, according to these countries, will ensure that national legal regimes for preventing bio-piracy and requiring benefit-sharing are effectively implemented when use or commercialization of TK takes place outside the country. This will also reduce the instances of bad patents and enhance the ability of countries to track down and challenge bad patents.71 The disclosure requirement may also be justified on grounds that it would ensure effective enforcement at the international level and thus complement provisions in national patent laws that permit revocation of patents for failure to disclose material information or for submission of false information with an intent to mislead.72 Other points made by developing countries can be viewed as necessary to improve national compliance with treaty obligations regarding prior informed consent and benefit-sharing found under the CBD (Article 15). They further argue73 that such compliance would be consistent with the objectives of the CBD as well as with Article 7 of the TRIPS Agreement, which provides that:

“The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation ... to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”

They are ofthe view that a suigeneris protection system would provide proprietary rights to ensure that market forces will operate to generate fairness and equity.74

7” WTO Doc. IP/C/W/370, supra, footnote 9, at pp. 4 and 11 (paras. 9, 10 and 27). 71 India’s suggestions at other international fora on this issue are similar, i.e., that the patent applicant must

(i) disclose the source of biological material and TK; and (ii) provide an undertaking that the prevalent laws and practices of the country of origin have been fully respected; see ibid., p. 6, para. 22.

72 Ibid., para. 14. ’3 Ibid., para 8. 74 Ibid., p. 10, para 24.


These deliberations at the WTO/Council for TRIPS clearly reveal that no perceptible achievement has been registered on the issue of protection of TK and that countries are sticking to their stated positions as revealed in the IGC meetings. It is nevertheless to be noted that out of 147 parties to the TRIPS Agreement, three-fourths are developing countries, which are the chief holders of TK, and they want to correct the balance of TRIPS, which, according to them, is heavily tilted towards the interests of industrialized countries. Consequently, they have demanded the inclusion of TK in the TRIPS Agreement to get a fair return on their resources. The WTO may, however, be considered to be the most appropriate forum, with its dispute settlement mechanism and binding obligations and the procedure of negotiation (based mainly on reciprocity). Furthermore, the United States, which is not a party to the CBD so far, would be negotiating on some of the contentious provisions of the CBD in the TRIPS forum.

G. THE FOOD AND AGRICULTURE ORGANIZATION

The FAO, in November 2001, adopted the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA),75 which is based on the FAO’S International Undertakmg, first adopted in 1983. The Treaty is limited to PGRS for food and agriculture. It is much influenced by the CBD but does not encourage IPRS over PGRS and the TK related thereto. The use of PGRs for medical and healthcare purposes is outside its scope (and can be subjected to IPRS). It recognizes the rights of farmers (without defining who is a farmer) and local/indigenous communities, who have been in the centres of origin and diversity, in conserving, improving and making available these resources (Article 9). The implementation of farmers’ rights requires the “protection of traditional knowledge relevant to plant genetic resources for food and agriculture” (Article 9.2). It is the responsibility of national governments to involve farmers equitably in benefit-sharing from the utilization of PGRS (Article 9.2(b)).76 Article 13 details the provisions on benefit-sharing. Access to PGRS shall be provided solely for purposes of utilization and conservation for research, breeding and training for food and agriculture. The transfer of or access to PGRS shall be subject to the multilateral system, according to the terms of standard MTAS (Article 12). The Treaty, however, does not specifically refer to indigenous people, except in relation to States’ responsibility to “promote in situ conservation by supporting, inter alia, the efforts of indigenous and local communities” (Article S.l(d)). The Treaty is limited in its scope, principally aimed at preventing the loss of agro-biodiversity rather than biodiversity in general, and establishes the principle of farmers’ rights and not the rights of local/in&genous communities in general.

’5 The Treaty entered into force on 29 June 2004. 76 The CBD does not talk about the involvement of local/indigenous communities in decision-making.


H. THE UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT

UNCTAD has addressed the issue of protection of TK from the trade and development perspective. It began its work on TK in October-November 2000 by convening an Expert Meeting on Systems and National Experiences for Protecting Traditional Knowledge, Innovations and Practices. Accepting the importance of TK in the sustainable development of national and international economics, the Meeting recommended to UNCTAD further work on its protection. Possible means for the protection of TK were identified, which would include traditionaVcustornary law, modern IPR instruments and sui generis systems. However, as it felt that national sui generis systems by themselves “will not be sufficient to protect traditional knowledge adequately”, it recommended that UNCTAD explore an international mechanism that might include minimum standards of an international sui generis system for TK p r ~ t e c t i o n . ~ ~

Based on the report of the Expert Meeting, UNCTAD’s Commission on Trade in Goods and Services and Commodities made a set of recommendations which emphasized capacity-building in implementing a TK protection regime, fair and equitable sharing of benefits, and encouraging the WTO to continue discussions on the protection of TK and exchange of information on national systems of TK protection.78 At the International Seminar on Systems for the Protection and Commercialization of Traditional Knowledge, jointly organized by the UNCTAD and the Government of India, held in New Delhi in April 2002, participants considered how evolving national systems for the protection of TK could be supported or augmented by international measures. They were of the view that countries supportive of TK protection could enact provisions designed to prevent misappropriation of TK but that such action would not be effective beyond those countries’ borders unless an international system is put into place. Among others, the following measures were listed for the protection of TK:

- local protection of the rights of TK holders under national sui generis regimes, including customary laws;

protection through registers of TK databases to avoid misappropriation of TK;

a procedure whereby the use of TK from one country is allowed, i.e. to devise a system of “certificate of origin” issued by the competent authority, giving details of the source of origin and prior informed consent, including benefit- sharing conditions; and

an internationally agreed instrument that recognizes such national-level

-

-

-

77 See Outcome ofthe Expert Meeting, UNCTAD Doc. T D / B / C O M . ~ / E M . ~ ~ / L . ~ , 9 November 2000, p. 7. 78 See The Sustainable Use of Biological Resources: Systems and National Experiencefor the Protection of Traditional

Knowledge, Innouatious and Practices, Agreed Recommendations, UNCTAD Doc. TD/B/COM. 1 /L. 16, 27 March 2001.


protection. This would not only prevent misappropriation but would also ensure that national-level benefit-sharing mechanisms and laws are respected worldwide.79

I. THE WORLD HEALTH ORGANIZATION

The WHO'S involvement in TK relates to its work on traditional medicine. In that regard, on request from its Members, it held an Inter-Regional Workshop on Intellectual Property Rights in the Context of Traditional Mehcine in Bangkok, Thailand in December 2000. Like all other fora, it also recommended, inter alia, a mi generis model for the protection of traditional medicine and equitable benefit-sharing, documentation of TK which is in the public domain in the form of TK digital libraries and hssemination of such information, and strengthening of customary laws for the protection of traditional medicine knowledge from bio-piracy . It also recommended the promotion of easy access to trahtional medicine for the healthcare needs of developing countries by using the flexibility provided under the TRIPS Agreement.80 Based on the Report issued by this Workshop, further work of the WHO is envisaged in co-operation with the WIPO, UNCTAD and the WHO'S regional offices.81

IV. SUMMARY OF INTERNATIONAL INITIATIVES

So far, no international regime for the protection of TK has emerged, although an incremental progress has been registered through piecemeal efforts, namely the FAO'S ITPGRFA and the CBD'S Bonn Guidelines on access to genetic resources and benefit- sharing. Their scope, however, is limited to access to GRs and benefit-sharing and they thus relate to the physical aspects of these resources rather than their intellectual o r intangble aspects, which are mainly related to TK and are the subject-matter of intellectual property protection. Apart from this, the Strasbourg Convention on the IPC has recently been revised to take better account of TK subject-matter and further work is undenvay.82 Sirmlarly, the minimum documentation specified under the PCT is being expanded to give explicit recognition to TK as prior art.x3

These measures, however, are not comprehensive enough to address the concerns and needs of developing countries, which desire an international mechanism acknowledging the holistic nature of TK and collective rights of indigenousAocal

79 See Report of the International Seminar on Systems for the Protection and Commercialization .f Traditional

80 See Report ofthe Inter-Regional Workshop on Intellectual Property Rights in the Context of Traditional Medicine,

81 See StoU and von Hahn, supra, footnote 24 , at p. 37. 82 The Committee of Experts of the Special Union for International Patent Classification has undertaken the

process; see Wrpo D o c . WtPO/GRTKF/IC/6/6, 30 November 2003, p. 12. $3 Id. See also Manuel Ruiz, The International Debate on Traditional Knowledge as Prior Art in the Potent System:

Issues and Optionsfbr Developing Countries, T.R.A.D.E., Occasional Paper 9, South Centre, Honolulu, Hawaii, October 2002, pp. 10-16.

Knowledge, New Delhi, India, 3-5 Apnl2002.

Bangkok, Thailand, 6-8 December 2000, WHO Doc. WHO/EDM/"RM/2001, at Chapter 9.


communities over it.84 Developing countries would like to see faster progress towards an international regime ofsome kind, and the suigeneris mode, according to them, would be most appropriate to protect the holistic character ofTK and to tackle the problem ofillegal acquisition of GRs.*5 It should reaffirm the principle of national sovereignty over genetic resources, recognize the role of the State in the preservation and protection of TK and expressions of folklore, recognize the economic rights of TK holders and custodians as well as their moral rights against the culturally offensive use of their knowledge, recogruze the role of customary law and protocols in the protection of TK and expressions of folklore, and recognize the complementary nature of defensive and positive measures relating to the protection of GRs, TK and expressions of folklore.86 This is a long and all- encompassive agenda for a regime whose scope has yet to be delineated.

Some views, however, have been expressed against a single, all-encompassing sui generis regme of protection for TK which “may be too specific and not flexible enough to accommodate local needC.87 These views notwithstanding, the demand for a suigeneris system is too strong to be dwnissed, even though at this stage the nature and scope of such an international regime are not clear. The discussions at the Council for TRIPS, however, have distinctly revealed the following two demands of the developing countries, directed mainly to misappropriation of TK:

(i) patent applicants must disclose the country and source of origin of biological material and traditional knowledge; and

patent applicants must provide evidence that the prevalent laws and practices of the country of origin on prior informed consent and benefit-sharing have been fully respected.

(ii)

The developed countries, particulary the United States, on the other hand, have proposed:

(a) bilateral contracts between the users and providers of genetic resources; and

(b) databases and registers of TK to be used by the patent offices in cases of biotechnological inventions.

These demands and counter-proposals require some serious consideration.

84 See Experts Meeting on Inrtifutional Building, Oroft Action Plan, The Group of Like-Minded Megadiverse Countries, Doc. No. GMC/2003KL/F1NA~/021,23 July 2003. The Group of Like-Minded Megadiverse Countries (MDG) was constituted in February 2002 in Cancun, Mexico, and originally had twelve countries as Members: Brazil, China, Colombia, Costa Rica, Ecuador, India, Indonesia, Kenya, Mexico, Peru, South Africa and Venezuela. Since then, Bolivia, Malaysia and The Philippines have also joined the Group. See the MDG Website at: cwww.megadiverse.org. For more on the MDG, see Peter Drahos, Towards an International Frameworkfor the Protection .f Traditional Group Knowledge and Practice, discussion paper, UNCTAD-Commonwealth Secretariat Workshop on “Elements of National Sui Generis Systems for the Preservation, Protection and Promotion of Traditional Knowledge, Innovations and Practices and Options for an International Framework”, Geneva, Switzerland, 4-6 February 2004, p. 17.

85 See the Report ofthe IGC Sixth Session, WIPO Doc. WIPO/GRTKF/IC/6/14, 14 April 2004. 86 See Submission by the Afiican Group, supra, footnote 59. 87 See Commission on Intellectual Property h g h t s (CIPR), Integrafing Intellectual Property Rights and

Development Policy, CIPR, London, 2002, at p. 80. See also in to , footnote 153.


A. DISCLOSURE REQUIREMENT

The issue of disclosure has already become the subject of contested views among nations in the Council for TRIPS.~~ The debate is mainly centred around Article 27xy of the TRIPS Agreement, which applies to all inventions and covers all aspects of patent law, and Article 29,90 which sets out disclosure requirements that shall (read must) and may be imposed upon a patent applicant and, as argued, implicitly precludes any other disclosure requirements being imposed.91 It has generally been contended by industrialized countries, particularly the United States, that provihng additional norms of disclosure would be violative of Article 27(1) of the TRIPS Agreement and dlscriminatory between the fields of technology and would lead to legal and administrative difficulties for patent offices.92 This argument, according to developing Countries, is not in consonance with the current patent regime where already inventions based on micro-organisms are treated differently, for which, in accordance with the Budapest Treaty, specimens have to be deposited prior to grant of patent.93 Asking for sources is already a part of Article 29(2) of the TRIPS.

International intellectual property agreements have, in general, set condltions for the accrual of the right. A disclosure requirement for genetic resources has not been specifically mentioned in the TRIPS Agreement. In this context, however, Para. 2 of Article 29 can come handy,94 or this requirement may be easily covered under Para. 1 of the same Article, in the same manner as the patent laws require the name of the inventor or listing of prior art in a patent application. This is thus a matter of interpretation of existing international treaty obligations. Any other interpretation of Article 29 would require an insertion of suitable wording in the Agreement.

88 See Cynthia M. Ho, Disclosure of Origin and Ptior Informed Consefiffor Applications oflntellectual Property Rights Based on Genetic Resources: A Technical Study of Implemmtalion Issues, UNEP Doc. UNEP/CsD/WG-AsS/2/INF/2, July 2003.

89 TRIPS Article 27(1) reads in relevant part: “ ... patents shall be available for any inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application ... patents shall be available and patent rights enjoyable without discrimination as to place of invention, the field of technology and whether products are imported or locally produced.”

9O TRIPS Article 29(1) reads: “Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.” (emphases added.)

91 Graeme B. Dinwoodie, Towards an Internotional Framework for the Protection of Traditional Knowledge, discussion paper at UNCTAD-Commonwealth Secretariat Workshop, supra, footnote 84, pp. G 7 .

92 See US. submission, supra, footnote 67. 93 In the case of micro-organisms, the nature of the invention demands that the micro-organisms are

deposited prior to the grant of patent with the depository authority. The Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure, 1977, provides the procedure. See WTO Doc. IP/C/W/403, supra, footnote 69. Protection to micro-organisms under the patent regime was initiated without a proper defintion of “micro-organism” in place, an objection usually raised against the protection of TK i.e. the lack of precise definition.

94 TRIPS Article 29(2) states: “Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants.”


It is notable that many countries have already incorporated provisions in this regard into their IP regimes and regional arrangements (such as Brazil, Costa Rica, India and the Andean Community), mahng the dmlosure requirement a conhtion for granting patents for inventions on biological resources. Under the Indian Patents (Amendment) Act, 2002, failing to disclose the source of TK and bio-resources in the patent application for a biological invention would be a ground for refusal/termination of the patent.95 The question may be asked, however, whether such a national requirement should be subjected to the dispute settlement mechanism of the WTO, particularly when the very term “invention” is subject to different approaches.

In this context, the EU Biotechnology Directive is also worth noting. Recital 27 of the Directive provides:

“Whereas if an invention is based on biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, ij known; whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents.” (emphasis added).96

This provision thus encourages disclosure but does not carry any legal consequence for non-disclosure.~7 It is in apparent contradiction to the stipulations under the above-mentioned national laws. Such a provision would also be unable to address the concerns of developing countries about misappropriation. A multilaterally agreed uniform approach would be in the interest of all countries.

B. EVIDENCE OF PRIOR INFORMED CONSENT AND BENEFIT-SHARING

The issue of prior informed consent is not new to the patent regime, which in the case of joint inventors and employees’ inventions requires evidence of their consent for the grant of patent. Making this a condition in the case of biological inventions related to TK, therefore, is not a demand alien to patent law.9* However, making prior informed consent and benefit-sharing conditions of patentability calls for an important threshold question that needs to be addressed: “When would an applicant need to give this evidence?” Could it be at the point of merely according access to the GRs, or when the genetic resources would lead to an inventive contribution to, or form part of, the

95 Patents (Amendment) Act, 2002, Section 64@) and (4. 96 EU Biotechnology Directive 98/44 of the European Parliament and of the Council of 6 July 1998 on the

Legal Protection of Biotechnological Inventions. Recital 26 of the Directive provides: “Whereas if an invention is based on biological material ofhuman origin or ifit uses such material, where a patent application is filed, the person from whose body the material is taken must have an opportunity of expressing free and informed consent thereto, in accordance with national law.”

97 Switzerland, in its submission to the Council for TRIPS, supra, footnote 69, at p. 6, has supported the proposals of disclosure of source of GRs and TK in patent applications and proposed an amendment of Regulations under the PCT in this regard. If the patent application does not contain the required disclosure, national law may provide for non-processing of such an application when it enters the national phase.

98 See Heath and Weidlich, supra, footnote 19, at p. 82.


“technical character” of the patentable invention?99 Further, whose prior informed consent would be relevant for this purpose-that of the appropriate government authority so designated or of the community-needs to be precisely laid down. Prior informed consent of communities also goes hand-in-hand with the capacity-building of the communities, which should be first informed (and be able to comprehend) how their knowledge will be used and developed.

Besides these issues, another important aspect is the extra-territorial application of this requirement as demanded in the proposal of the developing countries. The requirements of prior informed consent and benefit-sharing for TK-related inventions, as construed under a national law, would be taken into account when granting a patent on a biological invention in a foreign jurisdiction. This could be considered not only violative of the principle of territoriality of IPRS but also to create a conflict-of-laws situation.100 However, this is not an insurmountable problem, and already IP law provides precedence of extra-territorial recognition of the rights and the requirements of granting the right. For example, Article 6quinquies(A)(l) of the Paris Convention for the Protection of Industrial Property provides that:

“. . . every trademark duly registered in the country of origin shall be accepted for filing and protected as in the other countries of the Union, subject to the reservations indicated in this Article.”

Likewise, in the case of well-known trademarks, Article 6bis of the Paris Convention states that:

“The countries of the Union undertake, ex oficio if their legislation so permits, or at the request of an interested party, to refuse or to cancel the registration, and to prohibit the use, of a trademark which constitutes a reproduction, an imitation, or a translation, liable to create confusion, of a mark considered by the competent authority of the country of registration or use to be well known in that country as being already the mark of a person entitled to the benefits of this Convention and used for identical or similar goods.”

However, unlike these provisions where the competent legal authorities both make the determinations about the well-known marks and also accept applications for filing, in the case of TK, the country of origin of the TK needs to make determinations about the TK, whether it is a part of prior art if it is oral and, dependmg on the nature of TK, whether it needs automatic international protection and is binding on the patent-granting country. Probably it is a tall order to ask this of countries which are opposed to these requirements. In such a case, this requirement could be subjected to a few well-drafted exceptions, as the resulting international norms would be more acceptable and may not be considered as an intrusion upon national sovereignty.101 It may nevertheless be noted

99 Brad Sherman, Regulating Azas and Use o j Genetic Resources: Itztellectuaf Property Law and Biodiscovery, [ZOO31

100 See Dinwoodie, supra, footnote 91, at p. 8. ‘0’ Article IObis ofthe Paris Convention (on unfair competition), which leaves it to the country concerned to

EIPR 301, at p. 306.

define the meaning ofwhat is uniair competition, can be an example in this regard.


that if the problem of misappropriation of GRs and TK are to be addressed squarely, these condltions need to be made part of patentability,102 with precise contents and legal consequences.103 Voluntary requirements will not produce the desired results.

c. BILATERAL CONTRACTS

In the view of the developed countries, the best way to address the concerns of developing countries on protection of TK and to ward off its misappropriation is through bilateral contracts between the holders of traditional knowledge and the persons or companies wishing to access and use that knowledge. Such a system could be backed up by suitable national or local legislation. Such contracts should spell out in detail the terms and condltions under which access is granted, including the requirements for joint research and development or transfer of technology that might result from the use of GRs to which access was granted. Such a contract system might also include a requirement that a party to which access has been given identi@, in the specification of a patent application it files claiming an invention developed through use of the GRs accessed, the source of those GRs. Any benefits arising out of the commercialization could be shared in accordance with the terms of the contract. While it is possible that a few individuals might ignore the legal requirements laid down in such contracts, that should not negate their value per se, and national laws might provide criminal and civil liabilities for breach of contracts.104

The developing countries, however, do not endorse this approach, as these contracts are not easily enforceable.'"5 They also result from negotiations between unequal parties,l06 as the foreign companies own a wide experience in contracting while the indigenous communities, on the other hand, have little knowledge and experience in commercial practices and negotiating strategies, a fact which is also true in the case of least-developed countries. In most developing countries, the communities wdl depend on governments, and the extent to which the interests of these communities will be defended depends on their institutional capacity and attitude towards the system.

D. DATABASES OF TRADITIONAL KNOWLEDGE

It has been suggested that creating TK databases would be helpful in addressing the issue of "prior art" and would avoid the problem of bad patents, such as those granted

'02 Sherman, supra, footnote 99, at p. 306. '03 The developing countries have submitted a checklist of issues which need to be addressed in giving effect

lO4 WTO Doc. IP/C/W/257, srtpra, foomote 67, pp. 5 4 . '05 The agreements in certain cases have simply being ignored by the powerful party. For example, in an

agreement of benefit-sharing between the Zimbabwe Traditional Healers' Association (Zinatha) and the University of Lausanne (Switzerland) for a compound, despite an agreement to the contrary, the University proceeded with a patent application without prior consultation: see GRAIN, Barcelona, Spain, Press Release of 28 February 2001.

to these requirements: see WTO Doc. IP/C/W/420, supra, footnote 69.

loh WTO Doc. IP/C/W/370, supra, footnote 9, p. 10.

PROTECTING TRADITIONAL KNOWLEDGE 79 1

in the recent past. Often, TK is only transmitted orally and is therefore not documented. As such, it would not be accessible to patent offices. Where it is documented, it may be in languages with which patent authorities are not familiar. Creating organized databases of TK, searchable over the Internet, would be beneficial for determining prior art by patent offices to determine the novelty and inventive step of an invention, as well as being a help to potential licensees.107 Such databases would also be helpful in the preservation of TK and, through that, of cultural diversity.108

Even though many initiatives are underway in this regard, databases have inherent limitations in the context of TK.Io9 Firstly, while they may forestall the grant of inappropriate patents, they are unable to address the problem of the non-accrual to the holders of TK of the economic benefits resulting from the use of that knowledge. Secondly, they wdl mainly contain the TK which is already in the public domain, and in that case prior informed consent is presumed. Thirdly, while documentation may fulfil an important function in defensive protection of TK, its role in positive protection is very much limited. Moreover, databases codifj. TK as it is identified and described at a particular time, which does not take into account its dynamic nature and its continuous evolution through incremental innovation. As such, they are static and rigid and would be useful only if they were systematically updated to keep up with the evolution of knowledge.110 Views have also been expressed that they may fuel further piracy of TK.111

Developing countries thus find bilateral agreements between the provider and the user of TK and TK databases112 to be inadequate and ineffective. Similarly, adopting voluntary guidelines for bio-prospecting companies wdl also be ineffective.113

107 Ibid., pp. 6-7. 108 See, Silke von Lewinski, Final Considerations, in Lewinski (ed.), supra, footnote 24, at p. 394. 109 Examples are the Traditional Chinese Mekcine Patents Database of China, the Health Heritage Database

and the Traditional Knowledge Digital Library of India, the Biozulua Database of Venezuela, and the StoryBase Database of the Tulip Tribes of Washington State, U.S.A.

110 See Carlos M. Correa, Protecting Traditional Knowledge: Lessons from National Experiences, discussion paper, UNCTAD-Commonwealth Secretariat Workshop, supra, footnote 84, p. 23. Traditond knowledge is stated to be dynamic and which evolves all the time: see Yinliang Liu, IPR Protectionfor N e w Traditional Knowledge: With a Case Study of Traditional Chiraese Medicine, [2003] EIPR 194. It has also been opined that creating databases may clash with the interests of indigenous communities to keep their knowledge secret, wdl only serve the government-induced strategy of preventing misappropriation, and would not be a solution to the need for a holistic approach to conservation of T K see Heath and Weidlich, supra, footnote 19, at pp. 75 and 90.

'11 WTO Doc. IP/C/W/370, supra, footnote 9, p. 7. 112 The issue of disclosure of the origin of GRs and TK has also been raised before the ongoing negotiations

under the WIPO on the draft Substantive Patent Law Treaty. Developed countries also have urged at WIPO that the Standing Committee on the Law of Patents (SCP) should not tackle the issue of TK and GRs until the IGC finishes reviewing the matter: see the WIPO Website at: www.wipo.int/patent/law/en/scp.htm). The SCP last met on 10-14 May 2004. The EU has supported the drawing-up of a specific regime on TK that regulates or enforces access to, prohibition of, and rewards for the use of T K see WTO Doc. IP/C/W/254.

113 WTO Doc. IP/C/W/403, supra, footnote 69, p. 10, para. 23.


V. NATIONAL AND REGIONAL INITIATIVES ON PROTECTION OF TRADITIONAL KNOWLEDGE

Since the debate on sui generis protection of TK has heated up and because of the WIPO’S bottom-up approach to the international protection of TK, based on the national experiences, a number of regional and national initiatives have been taken to protect TK under a suigeneris model. As of February 2002, at least twenty-two countries and certain regional integration organizations had made or were in the process of making available a sui generis form of legal protection for TK-related subject-matter.*14 The regional initiatives have come fi-om the Andean C0mmunity,*~5 the Organization of African Unity (OAU; now the Ahcan Union),116 the Central American Commission on Environment and Development,*17 the Association of South-East Asian Nations (AsEAN),”~ and the Pacific Islands Forum.119

These regional regimes, broadly speaking, are the framework for the mechanisms for access to GRs and benefit-sharing from the utilization of those resources. There are, however, certain differences over the extent of these rights enjoyed by the local communities. The Model Law for Africa recognizes “community rights”, introduces community intellectual rights and has specific provisions on farmers’ rights. The Andean common regime accepts the sovereign rights of the Andean States over such resources and, in case ofintangible components of these resources, a fair and equitable distribution of the profits to the respective indigenous, Afro-American or local community from their use needs to be guaranteed. Article 3 of Decision No. 486 of the Andean Community recognizes the right and competence of indigenousAocal communities to decide on matters pertaining to their collective knowledge. Patent applicants must

114 See Rm’ew ofExisting lnfellectual Propeq Protection $Traditional Knowledge, WIPO Doc. WIPO/GRTKF/IC/3/7, 6 May 2002, p p . 6 et seq.; see also Cottier and Panizzon, supra, footnote 18, at p. 380; WTO Doc. IP/C/W/370, supra, footno&-9, para. i 6 , p. 7.

115 The Andean Community consists of Bolivia, Colombia, Ecuador, Peru and Venezuela. It adouted Decision No. 391 ofJuly 1996 on Common Regime on Access to Genetic Resources, and Decision No. 4g6 of 14 September 2000 on Common Intellectual Propety Regime. So far, only Bolivia has passed the implementing regulation on Decision 391.

‘16 The OAU developed a Model Law on the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources (Model Law) in 1998 as the basis of legislation by Membcr countries, which, however, has not so far augumented the adoption of sui generis regimes in African countries; see Johnson A. Ekpere, The African Union Model Lawfor the Protection ofthe Rights ofLocal Communities, Farmers and Breeders, andfor the Regulation o f Access to Biological Resources, in Christophe Bellmann, Graham Dutfield and Recardo Melendez-Ortiz (eds.), Trading in Knowledge, Earthscan, London, 2003.

117 The Central American Commission on Environment and Development, comprised ofBelize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama, has adopted the Central American Regional Protocol on Access to Genetic and Biochemical Resources and Related Traditional Knowledge. This regime is subject to ratification by national parliaments: see Correa, supra, footnote 110, pp. 7-8.

ASEAN prepared a Draft ASEAN Framework Agreement on Access to Genetic Resources in 1998 which is yet to be discussed and adopted. For the text of the Draft Agreement, see the ASEAN Website at: cwww.aseansec.org,, as referred to in Stoll and von Hahn, supra, footnote 24, at p. 39.

119 The Pacific Islands Forum represents Heads of Governments of the independent and self-governing Pacific Island countries: Cook Islands, Federated States of Micronesia, Fiji, Kiribati, Nauru, Niue, Palau, Papua New Guinea, Republic of the Marshall Islands, Samoa, Solomon Islands, Tonga, Tuvalu and Vanuatu, Australia and New Zealand. It introduced the Model Law for the Protection of Traditional Knowledge and Expressions of Culture in 2002; see the text of the model Law at: ~www.wipo.int/documents/en/meetings/2002/igc/pdf/ grtkf-ic-4-inf2a-attach.pdti. See also Correa, supra, footnote 110, at pp. 14-15.


disclose the relevant information and modalities of the access to GRs and TK. The Model Law of the Pacific Islands Forum extends protection to TK in the “public domain” and has retroactive effects regarding moral rights but not economic rights. The draft ASEAN Framework Agreement in its present format merely reiterates the language of the CBD but talks about involving localhndigenous communities in decision-making on access to GRs and benefit-sharing.

Among the notable countries which have enacted specific TK-related laws are Brazil, Costa Rica, Guatemala, Panama, The Philippines, Peru and Portugal. India and Thailand have also enacted new laws protecting TK in specific areas. Bangladesh drafted the Biodwersity and Community Knowledge Act in 1998 which, however, is yet to be enacted.120

The Brazilian strigeneris measure was enacted in 2001 to protect the TK associated with biodiversity.121 It establishes a regime for access to genetic resources, including specific provisions on the protection of associated traditional knowledge. Under this legislation, the State recognizes the right of indigenousAocal communities to decide on the use of their TK associated with the genetic heritage, which includes the cultural heritage of Brazil. The protection of TK is mainly ensured through a bilateral approach, that is, through contracts of access, the purpose of whch is to ensure the sharing of benefits arising from the use of genetic resources and associated TK. Article 9 of the Law is important, as it guarantees the rights of indigenous/local communities that create, develop, hold or preserve TK associated with the genetic heritage to have the origin of the TK mentioned in all publications, uses, exploitation and disclosures; prevent unauthorized third parties from using, exploiting, experimenting, disclosing, transmitting and re-transmitting data and information that integrate or constitute associated TK; and derive profits from economic exploitation by third parties of associated TK in which the rights are owned by the community. The law provides for sanctions including fines, the seizure of illegal material and products embodying unlawfkl material, prohibition of hstribution, invaLdation of patents or registrations, loss of governmental incentives, etc.122

Costa Rica’s Law on Biodiversity is basically aimed at giving effect to the CBD at the national level and thus is not a specific law on TK. It nevertheless recognizes community rights in TK, which does not require any prior declaration, express recognition or official registration and, as such, may include practices which acquire that status.123 The Law contains specific provisions on the protection of intellectual and

1M A detailed summary of the salient features of these counny initiatives is given in Cornea, ibid., pp. 4-17; O’Connor, supra, footnote 10, at pp. 690-693; WlPO Doc. WIPO/GRTKF/IC/3/7, supra, footnote 114. Biodiversity-related legislation of different countries may be found at the GRAIN Website at: cwww.grain.org/brl/ index-eng.cfinn,.

121 Provisional Measure 2.186-16 of23 August 2001.

123 The Ley de Biodiuerridad, or Biodiversity Law (No. 7788), was adopted by the Legislative Assembly of the WIPO DOC. WIPO/GRTKF/IC/3/7, supra, footnote 114, p. 7.

Republic of Costa Rica in April 1998.


industrial property rights, which also include sui generis community intellectual rights (Article 77). The Law provides for an inventory to be drawn up of specific sui generis rights that the communities wish to protect. The registration of these rights shall be voluntary and free of charge (Article 84). The Law also establishes the prior informed consent of local communities as a condition to grant access to genetic res0urces.1~4

The Guatemalan law125 provides for protection of TK from the national cultural- heritage-oriented approach. The protection is accorded to expressions of national culture comprising intangible cultural-heritage expressions, including traditions, medicinal knowledge, music, performances and the like, by means of registration in a Cultural Goods Regstry. They cannot be disposed of by means of contractual arrangements; that is, they cannot be sold and there is no right of remuneration. It has the public-good approach towards TK in the sense that TK is to be identified, recorded and preserved by the State for the benefit of the entire society.

The sui generis regime of Panama to protect TK is very comprehensive.126 Its objective is to protect the collective intellectual property rights and TK of indigenous communities through the registration, promotion, commercialization and marketing of their rights in such a way as to give prominence to indigenous socio-cultural values and cultural identities and for social justice. Another key objective is the protection of the authencity of crafts and other traditional expressions. The scope of the protection is very wide and encompasses customs, traditions, beliefs, spirituality, and folkloric and traditional expressions of indigenousAoca1 communities. TK is protected to the extent it provides for the cultural identification of indigenous peoples and is susceptible to commercial use. Collective intellectual property rights and TK embodied in the creations of indigenous peoples such as inventions, designs and innovations, cultural and historical elements, music, art and traditional artistic expressions are protected. Collective exclusive rights are accorded to registered elements of TK. In order to be protectable, however, the subject-matter must be susceptible to commercial use. If there is no known author and no date of origin of the protectable subject-matter, it will constitute the heritage of an entire indigenous people. These “collective indigenous rights” may also be the basis of opposing unauthorized third-party claims in IPRS. The authority to attribute rights is vested in the Congress or the Traditional Indigenous Authority. Protection is dependent on the registration of the relevant TK. The law also provides for exceptions to rights conferred as well as measures of enforcement. The Executive Decree of 2001 has made clear that the regime covers biodiversity-related TK, thus giving a practical expression to Article S(j) of the CBD in Panama.127

‘24 See Leistner, supra, footnote 24, at pp. 115-118. 125 The Cultural Heritage Protection National Law No. 26-97, as amended in 1998. 12h Special Intellectual Property Regime on Collective Rights of Indigenous Peoples for the Protection and

Defense of their Cultural Identity as their Traditional Knowledge, Law No. 20 of 26 June 2000; and Executive Decree No. 12 of 20 March 2001.

’27 Id.


Peru adopted the Law on the Protection Regime for the Collective Knowledge of Indgenous Peoples in 2002, which recognizes that the TK of the indigenous peoples helps to conserve and make use of the components of biolversity.128 The Law establishes a sui generis regime that recognizes the indigenous peoples’ ownership and associated rights over their TK as well as their right to decide on how it should be used. Prior informed consent of the relevant community is required for access to knowledge not in the public domain, independently of the purposes for which access is sought. The Law also stipulates that indigenous peoples may enter into “knowledge licensing contracts” which specify the terms for the use of their knowledge. Voluntary regstration of protected indigenous knowledge is set up under the Law within the National Institute for the Defense of Competition and the Protection of Intellectual Property. The registration is not a condtion for protection, however. The Law also stipulates that if the collective knowledge has passed into the public domain in the last twenty years, a percentage of the value of the gross sales resulting from the marketing of products developed from t h s knowledge shall be set aside for the Fund for the Development of Indigenous Peoples. The Fund will also receive a minimum 10 percent of gross sales, before taxes, resulting from the marketing of products developed from collective knowledge. 129

The Philippines was one of the first countries to enact law protecting the rights of indigenous peoples. The Indigenous Peoples’ Rights Act of 1997 and its regulation, Executive Order No. 247 of 18 May 1995, protect the rights of indigenous communities in TK in general, including the right to limit the access of researchers in their ancestral domains/lands or territories and to receive royalties from the income derived from any of the researches conducted and from resulting publications. Access to bio-resources and GRs would be subject to prior informed consent obtained in accordance with customary laws of indigenous peoples and to the conclusion of agreements between the bioprospectors and the Philippines government.

Protection of TK in Portugal has been provided within the fi-amework of Decreto-Lei No. 1 19/2000.130 Protection is conferred to the intangible elements associated with the industrial or commercial use of local plant varieties and other local native material of current or potential interest. Protection is conditional upon the identification, description and registration of the TK in the Register of Plant Genetic Resources. Also, it is limited to the knowledge which was not publicly known outside the population or local community where it was obtained on the date of filing.

128 The Congress of Peru approved Law 27811 in August 2002. See also WrPo Doc. WIPo/GRTKF/IC/3/7, rupra, footnote 114, at p. 8.

129 The proposed Biodiversity and Community Knowledge Protection Act of Bangladesh provides that not less than 50 percent of the net monetary gain obtained from a direct or indirect commercial use of biological and genetic resources in which the communities are the common owners or sole custodian be paid to the concerned local community or the group constituted as a community. It recognizes community rights as belonging to thc people of Bangladesh in perpetuity. It establishes an access regime and includes a reciprocity clause. See Correa, supra, footnote 110, at p. 5.

130 Diario da Republica, No. 93, 20 April 2002. See Correa, ibid., at p. 13.


However, the regime also provides protection of confidential TK. Rights in TK are granted to individuals in the nature of other IPRS.

India has not brought out any TK-specific regime, but laws adopted to give effect to its obligations under the TRIPS Agreement, the CBD and the ITPGRFA have reiterated Inda’s stand in different inter-governmental bodes working on the protection of TK. The Patent (Amendment) Act, 2002131 provides that applicants seeking protection for biologcal inventions must disclose in their patent applications the source of origin of the biological material used in the invention.132 It also allows opposition to the patent application to be filed for failure to disclose or wrongly mention the source of origin of the biological material for the invention in the specification.133 A patent application can be rejected or a patent can be revoked for non-disclosure or wrongful disclosure of the source of origin of biological resources or TK in the patent application and prior disclosure of knowledge, oral or othenvise.134

The Protection of Plant Varieties and Farmers’ fights Act, 2001 has provisions protecting farmers’ rights.135 Farmers have the right to save the harvested seeds of protected varieties and to use and sell them so long as they are not branded.136 The Act also has a provision on benefit-sharing which depends on the registration of genetic material by villagers and local communities and on the proof of their right. Once a variety has been registered on that material, benefits will accrue to the community which will first be deposited with the National Gene Fund (Section 41). There wdl, however, be no proprietary rights of the community over the variety.

The Biodiversity Act, 2002 regulates access to genetic resources and associated knowledge. The Act’s main premise is to check bio-piracy. It also has elaborate provisions on benefit-sharing but is weak in prior informed consent. There is no provision for the involvement of communities in decision-making, which is supposed to be taken care of in framing the operational rules for the Act. The Act is very much influenced by the Bonn Guidelines. The National Biodiversity Authority (NBA) is the principal body for granting access to genetic resources and stipulates the conditions therefor. It has laid down elaborate provisions on benefit-sharing (Section 21). Monetary benefits will first be deposited with the National Biodiversity Fund, which will channel its use. Access to genetic resources for research purposes also requires the

131 The Act became effective on 20 May 2003 with the notification of “Operationalisation ofthe Patent Rules

132 Section 10.4(d)(D) of the Act. 133 Section 25(l)(h), (j) and (k) provide that failure to msclose to the Controller any information required

under the Act as provided in Section 8 (which deals in information and underdung regarding foreign applications) or the complete specifications, or to provide the wrong source of the geographical origin of the biological material used for the invention, or knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere, can be grounds for opposition.

2003”.

‘34 Section 64.l(p) and (4. I35 Section 39. Chapter VI of the Act (Sections 39-41) is devoted to farmen’ rights and the rights of traditional

‘36 This has been done in line with the International Convention for the Protection of New Varieties ofPlants, communities.

1961. as amended.


prior approval of the NBA.13’ India has also created digital databases of prior art related to medicinal plants used in the Indan systems of medcines-Ayuweda, Unani and Siddu.138

In Thailand, two specific laws have implications for TK: the Thai Plant Varieties Protection Act (B.E. 2542, 1999); and the Act on the Promotion and Protection of Traditional Thai Medicinal Intelligence. The Plant Varieties Act recognizes communities’ rights when a plant variety only exists in a particular community, and regstration with the local government organization is mandatory to enjoy the right. The right can be held individually as well as jointly with the community which conserved or developed the plant variety. The Traditional Medicinal Intelligence Act categorizes “tradtional formulas” into categories labelled as “national formula”, “private formula” and “general formula”. Whereas the Ministry of Public Health has the authority to announce a certain formula as a national formula, the rights in which belong to the State, the private formula can be used freely by the owner and third parties can use it with his permission. “General formula” applies to well-known tradonal formulas that are fiee for use by any citizen.139

Besides these TK-specific laws of dfferent countries and model regimes proposed at the regional level, many countries are using their existing IP laws to protect TK, namely Australia, Canada, Colombia, Kazakhstan, New Zealand, the Russian Federation, Venezuela and Vietnam.140

A quick review of the stri generis regimes reveals a great dversity in approaches in the scope and modes of protection of TK. Whde some of them are comprehensive and include tangible and intangble elements of TK-such as Panama’s, which includes tradtional cultural expressions-most of them are limited to biodversity and genetic resources, access to those resources and benefit-sharing from their uthzation. There are also elements of extra-territorial application in some of these regimes; Bangladesh’s proposed law, for example, has provisions to reclaim and regain resources deposited in international or national gene banks or in any other private or public ex-situ or in-ritu collections.141 Most of these regimes are concerned with the defensive protection of TK against misappropriation and emphasize control, with no provision for diasion and promotion of TK.l42 In some cases, rights will accrue on registration (Peru, Portugal, Guatemala),143 while in others they belong to the people in perpetuity (Bangladesh) and

I37 Sections 19 and 20 of the Biological Diversity Act. 138 The TKDL CD released on 23 October 2003 contains 36,000 formulations on the knowledge already in the

public domain. In some States in India, preparation of Community Biodiversity Registers at d a g e level to document TK has been undertaken. Some non-governmental organizations (NGOS) are actively involved in this endeavour, such as HoneyBee Network, SRISTI and Kalpavriksh see Protection of Biodiversiry and Traditional KnowledgP--The Indian Experience, WTO Doc. IP/C/W/198, 14 July 2000, pp. 3 et seq.

I39 O’Connor, supra, footnote 10, at p. 693. 140 WIPO Doc. WIPO/GRTKF/IC/3/7, supra, footnote 114, p. 4. 14’ See all works cited supra, footnote 120. 142 See, for example, The Philippines’s Indigenous Peoples’ Rights Act, 1997 and India’s Biological Diversity

Act, 2002. 143 Under Portugal’s Deneto-Lei No. 119/2002, the registration should provide the full description of TK

which should allow third parties to reproduce or utilize the protected TK and obtain “identical results” to those obtained by TK title holders (Article 3.2(b)).


registration is voluntary (the OAU Model Law, Peru). In some cases, TK in the public domain is treated dfferently and/or considered outside protection (Peru, Thailand); in others, it is under the control of local communities (the OAU Model Law) or its exploitation is subject to payment of a specified fee (Bangladesh, Peru).

These laws do not provide any distinct approach towards enforcement of rights or mechanisms and remedies available for the infringement of these rights. Enforcement of rights within a national legal system is an important aspect of any effective regime, a fact which has been overlooked in these national efforts. Enforcement, in turn, is very much dependent upon who are the beneficiaries and in whom the right vests. This again requires a definition (which has not been attempted in these initiatives), preferably inclusive of the indigenous/local communities and the rights conferred. If these communities reside in a particular area, it is easier to identify them as beneficiaries than when they are scattered in different areadcountries. Approaches are different under these laws as to whether the rights will be held collectively (such as in Brazil, Bangladesh, Panama and Peru) or individually (as in Portugal). Legal regimes need to define how the communities will be represented to assert their rights and what are the measures for enforcement of the rights. Enforcement may be based on the formal legal system or on informal customary laws of indigenous/local communities.

These national/regional regimes also do not provide any distinct approach to facilitate access to genetic resources for commercial and scientific purposes for further research and development of TK. In their concern to prevent unauthorized access to GRs for commercial purposes, access has been hindered even for researchers for scientific purposes.144 In fact, the requirements of access permission should serve the purpose of preventing undue exploitation rather than preventing There is also the multiplicity of stakeholders whose consent needs to be acquired. To reap the benefits from the system and not to unduly hinder access by genuine parties, the procedure needs to be transparent and less cumbersome.

Too much emphasis on protection is ignoring the conservation of TK and biodiversity, which needs to pay respect to traditional farming by giving incentives to traditional/local communities to cultivate those traditions rather than shifting to substitute high-yielding varieties, as well as to respect their land rights and habitat. Conservation must become economically more attractive, which should help to reduce the economic pressure to change tradtional ways of living, forced by poverty. Thus the solution must be found through an appropriate system which should eliminate poverty, preserve biological diversity and reward these communities for their indigenous

'44 Scientists in Brazil, The Philippines and the Andean countries have complained that the prior informed consent procedure causes delays in getting acccss to GRs, which is, in turn, constraining research rather than promoting it; see Correa, supra, footnote 110, at p. 24.

'45 Heath and Weidlich, supra, footnote 19, at p. 83 ; see also Jose Maria A. Ochave, The Anficommons in Bioprospecting: Regulation ofAccess to Genetic and Biological Materials in the Philippines, The World Bulletin, Vol. 15, Nos. 1-6, January-December 1999, 150, at 157; Michael Hassemer, Genetic Resources, in Lewinsky (ed.), supra, footnote 24, at p. 162.


knowledge, creativity and innovations.146 Furthermore, all TK cannot be put into marketable goods or services in total disregard to its innate value.

Capacity-building of indigenous/local communities is another area which has not been adequately addressed. These regimes mainly emphasize benefit-sharing and prior informed consent, without at the same time ensuring a transparent system to allocate monetary benefits for the communities concerned. Furthermore, benefit-sharing is an important tool for conservation of TK but not suficiently adequate. Sometimes communities want moral recognition more than an economic compensation, and this can easily be given effect to through proper legislation providing for the disclosure of TK in all publications, uses and exploitation.*47 Contractual arrangements for benefit- sharing may be important in this regard and have been followed in many cases.148 For contractual arrangements and prior informed consent, however, the empowerment of these communities needs to be emphasized. Their involvement in decision-malung is necessary for the effective conservation/promotion and protection of TK. Any formal legal system imposed from above without their involvement will be under suspicion and would be ignored. A system should create trust in the in&genous/local communities by respecting their rights under their own customary laws rather than under legal regimes based on values, principles and methods of enforcement alien to them.149 As a part of capacity-building, commercialization of TK-derived products150 protected under IPRS, as a part of positive protection of TK, deserves consideration. This, however, would require State support.151 Acquiring IPRS is a costly and cumbersome procedure, which will be a constraint for these communities to pursue such rights on their traditional knowledge. Secondly, marketing of these IP-related products will also require specific skills and infrastructure and would be possible only through the State's assistance.

VI. THE WAY AHEAD

This preliminary review of the international initiatives has revealed the polarized positions of countries at this juncture on the desirabhty of an international regime on the protection of TK. Apart &om the two instruments worth mentioning-the Bonn Guidelines on Access and Benefit-sharing and the FAO'S ITPGRFA-no international instrument has been readied so far for the protection of TK that addresses its holistic character. Barring a few efforts undertaken at the human-rights bodes, most of the

'46 h i 1 Gupta, Compensating Local Communitiesfor Consewing Biodiversity: How Much, W h o Will, H o w and When;

147 Brazilian Provisional Measure No. 2.186, Article 9, so mandates. 148 Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore-An Overview,

149 See Correa, supra, footnote 110, at p. 25. 15" Commercialization of TK generally refers to commercialization of a TK-based or TK-derived product,

where T K is the know-how involved in its production. 151 Commercialization is a sensitive subject for some TK holders, who generally oppose it, stress the

conservation of T K and prevent inappropriate commercialization. O n the other hand, IPR systems promote the protection of only marketable technology o r IpR-derived products.

available at: cwww.snsti.org/papers/compensatin~.

WIPO Doc. WIPO/GRTKF/IC/1/3, 16 March 2001, pp. 12 et seq.


inter-governmental bodles working on the protection of TK are simply confined to its protection through/under the IPR regime. The instrument of intellectual property rights may be usefid in a limited manner in providing defensive protection, and positive protection against unauthorized use by third parties, but it will not take into account the continuous evolution of TK nor would IPRS help in the promotion and dfision of TK. Moreover, &om an economic point of view also, it is not clear that a binding regime that propagates a monopoly in knowledge under an IPR regime is desirable &om an efficiency point of view, particularly where the effect of such a system would be to protect knowledge assets that had already been created in the absence of property rights protection. The goal of intellectual property is stated to be the creation of knowledge by giving incentives in the form of monopoly rights for a limited duration, whde TK is already being created without any incentive. There is also uncertainty over the economic value of TK until it is put into a tangible and tradable

It is important to note that knowledge held by the indigenous communities is an integral part of their cultural heritage which is inextricably linked to indigenous socio-political and economic systems and institutions and to the natural environments in which these communities live. The protection of TK in a holistic manner thus requires a broad approach which should not be limited only to controlling the use of such knowledge but should also create conditions and take measures to harness its further development and evolution, and this would require a multi-pronged approach at different levels.

The national and regional regimes examined above suggest a great diversity in approaches, scope, types of rights and modes of implementation. These national/regional sui generis initiatives for the protection of TK have been constructed on the basis of the special needs of individual countries, depending upon their cultural and political conditions. Looking into the disparities revealed in their approaches, it is unlikely that a “one-size-fits-all” model would adequately take these differences into account and would be able to address all the issues to protect and promote TK. A sui generis approach with a specific agenda of marketability of TK alone would not be able to address all the concerns of TK holders. They have also revealed that many areas are yet to be expanded and addressed under these regimes in order to have a holistic approach towards the protection of TK. Most of these attempts are predominantly confined to protect TK through IPRS. Any international regime on the protection of TK has to take into account this diversity, prompted by individual countries’ needs and perceptions towards TK, and also address the more formidable aspects of its enforceability and monitoring.

Against this background, a single all-encompassing sui generis regime of protection of TK, which may not be flexible enough to accommodate the local needs of individual

152 See Drahos, supra, footnote 84, at p. 23.


countries, has not been supported by certain quarters.153 It is also not clear from the deliberations in international bodles whether a single instrument on TK in the broadest sense of the term, encompassing TK in genetic resources as well as the traditional cultural expressions (folklore), should be adopted or whether there should be more than one instrument addressing the different aspects of TK.

The nature of an international regime could also be a contentious issue. Whereas developing countries would like to have a legally binding treaty in this regard, the countries opposing these initiatives would not like to bind themselves with any such instrument. Generally, countries even shy away from endorsing model sets of rules or guidelines on a subject with which they do not agree because even the non-bindmg instruments create international expectations of compliance and may render them far less discretionary in the long run. In the past, a number of treaties were successfully adopted under the IP regime but subsequently failed to enter into force, apparently due to lack ofinterest in ratifying them or uncertainty about their scope or impact. Examples include such treaties on sui generis protection as the Vienna Agreement for the Protection of Type Faces and their International Deposit, 1973 and the Geneva Treaty on the International Recording of Scientific Discoveries, 1978. Even the WIPO-UNESCO Model Provisions for National Laws on the Protection of Expressions of Folklore, 1982 is not a success story.

On the other hand, if the system is made rigid and binding, for example in the nature of a treaty, although this would make the system more real and effective it might end up keeping away the countries that are not convinced of the merits of the protection of TK and thus reduce its reach. At the same time, a system in the nature of a Declaration or Understanding on traditional knowledge may expand its reach at the cost of its effectiveness.154 Furthermore, in an international regime, countries generally agree to lower mandated levels, in this case in the protection of TK, to the point where they will encounter the least problems. As such, given the diversity of views over the details of what should and what should not be protected, how it should be done and by whom, the prospects of successfully negotiating a detailed rule- intensive regime at this juncture appear to be slim. From the point of view of feasibility, the most desirable course for countries backing the adoption of such a regime would be to have a focused approach with a limited agenda to be followed by an all-encompassing regime which should draw upon the national experiences on the protection of TK. Thus, for a holistic protection of TK, measures may be conceived at both the international and national levels.

153 See CIPR, supra, footnote 87. A number ofNGOs have also expressed the view that it is “premature to move forward to negotiations without the development of an informed understanding of what that regime might entail” and “that an internationally binding regime must be approached in an informed and thoughtful manner. An accelerated process would not necessarily produce the strongest instrument for the protection of TK’, asserting further that meaningful and effective participation of indigenous peoples is absolutely imperative for any further work on this matter; see WIPO Doc. WIPO/GRTKF/IC/6/6,30 November 2003, p. 14, para. 35.

154 See Dinwoodie, supra, footnote 91, at p. 15.


A. INTERNATIONAL MEASURES

An international regime should be adopted in the spirit of the CBD and must facilitate access to genetic resources (in the manifestations of both phenotype and genotype) with a secure system of benefit-sharing. An unduly cumbersome procedure would keep companies away from venturing into this field,*55 and they would seek out alternatives. $56 The regime should address the issue of misappropriation of bio-resources squarely. The TRIPS Agreement could be the best forum, with its basic premise of most- favoured-nation treatment and reciprocity as well as its viable dispute settlement mechanism. This may require the re-opening of the TRIPS Agreement for inserting necessary provisions, which do not seem likely to be agreed upon anytime soon.

As an alternative to address this issue, bilateral agreements based on mutual recognition and reciprocity could be adopted as a viable measure. Though the principle of mutual recognition will have a limited application, it appears to be very sound, as it allows recognition of another country’s standards. It, however, pre-supposes some mutually held standards and would also require a State to recogmze the standards set by another country. Taken along with reciprocity, where each country agrees to protect the standards of the other on a reciprocal basis, the protection granted by a country would gain recognition in another country with whom such an arrangement had been agreed. Reciprocity is also a principle long followed by countries in international trade and even in copyright treaties in the 19th century.157 Material reciprocity has always been looked upon as a means to encourage countries which do not provide a certain level of protection to increase their level of protection in cases where diversity of national laws is considerably high.158 More recently, it has been employed in the cases of the Semi-Conductor Chip Protection Act of the United States and the EC Database Directive, 1996, both with concrete consequences.159

By addressing the issue of misappropriation of bio-resources within the context of the TRIPS Agreement, countries might add the conditions of disclosure and evidence of prior informed consent and benefit-sharing to their national laws under TRIPS Article 29, which obligates WTO Members to require an applicant for a patent to “disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art”. This would also not be in conflict with the

155 It has been already noted that the effect of the CBD has led to dampened demand for access to genetic materials. Laird and ten Kate report that one change in business practice as a result of the CBD is a “decrease in corporate collecting” of genetic resources: see Laird and ten Kate, zupra, footnote 6. See also Rachel Wynberg, Bioprospecting Delivers Limited Benefits in South Afica (Opinion), [2004] EIPR 239.

156 Bodekar opines that controversy over IP issues has deterred many companies from pursuing GRs and has led them to shift to marine exploration, as they are not so far subjected there to these constraints; see Bodekar, supra, footnote 10, at p. 793.

157 See Kuruk, supra, footnote 58, at p. 441. 158 See Sike von Lewinski, fntellertuaf Property, Nationality, and Non-Discrimination, WIPO (ed.), InteiZectuai

159 Id. Property and Human Rights, WIPO, Geneva, Switzerland, 1999, p. 175, at p. 190.


TRIPS Agreement, which allows flexibility in having more extensive protection (including procedures) than is required under the Agreement.

States, if they can so agree, might also adopt a binding sui generis regime on TK by drawing on the lessons from the early stages of the adoption of the two most important conventions on intellectual property: the Berne Convention for the Protection of Literary and Artistic Property; and the Paris Convention for the Protection of Industrial Property. These Conventions have reached their present stage through incremental expansion of substantive obligations largely consistent with norms upon which Members had developed consensus through their experience at the national level.161 They also started with a small number of countries as Members and gradually became almost universal in their reach.

B. NATIONAL MEASURES

National measures hold the key for the protection of TK, as the international measures d only be able to protect the economic aspects of TK if it is put into commercial use. Moreover, an international regime would be mainly limited to its protection and not concerned with its further development, diffusion and conservation, tasks which can be met only under national systems. For example, TK is very much specific to the land and habitat in which indigenousAoca1 communities live. If it is to be maintained, the social and economic context in which it has developed must be maintained and land rights must be recognized. Separating it from its surroundings is lulling TK rather than helping in its enhancement or conservation. Land rights can be guaranteed and conferred only by national governments, which can also provide incentives to preserve the habitat. Similarly, respect for the culture of indigenousAocal communities can also be ensured by national measures. In fact, to attain the objectives of preservation, protection and promotion of TK, a pluralistic legal approach is required at the national level and modes may involve customary/traditional laws of these communities, intellectual property rights, common-law concepts (such as “undue enrichment”, where TK has been put to commercial use without the communities’ authorization; “prescriptive right” over their knowledge; etc.) and legal and contractual agreements. A composite ruigeneris system, based on rules of equity and fairness, giving effect to all these aspects, may be another alternative. Together, these measures should be holistic in their approach towards the conservation of TK.

As a first step, governments must construct heritage legislation, recognizing the biological and cultural heritage of the concerned communities and providing

166 TRIPS Article 1, para. 1, provides : “ ... Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Memben shall be fiee to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.”

161 Dinwoodie, supra, footnote 91, at p. 14.


incentives for community self-management initiatives. For indigenous peoples, heritage is a bundle of relationships rather than a bundle of economic rights.162 It is also important to note that the right of the communities to self-determination in relation to their knowledge management will be crucial for the sustainability and further growth of TK. This in turn requires conservation and continued access to the environment upon which their way of life depends. If TK is to be maintained, the social and economic context in which it developed has to be maintained. Traditional knowledge should not be understood merely as a set of information but as an integral part of living and dynamic societies and cultures.

The system of protection should also address the issue of the continuous erosion of TK. By provilng proper incentives, this can be arrested. These communities must be involved in evolving and implementing measures for the conservation and protection of TK. This is also closely related to the capacity-building of these communities in managing their resources and guarding them against misappropriation and extinction. Such capacity-building should be a priority with governments. Ofien, conservation of biological diversity and the knowledge systems related thereto require economic incentives which should be strong enough to weigh against the destruction of these resources, Apart from benefit-sharing, the commercial exploitation of these resources wlll guard against the extinction of both TK and bio-resources. The returns from the efforts of these communities must be adequately ensured. The IPR system can be one mode to realize this goal but, with its limited reach, it would not be appropriate in each case of TK use. National legslation has to be flexible enough to meet the individual instances of TK, such as when it is kept as a secret or when it is in the public domain.

Any regime, to be effective, must have a viable enforcement mechanism, without which it will not meet the desired objectives. There should be a monitoring system to see that it is implemented in the form as laid down. The enforcement of TK rights is closely related to the issues of identifying the stakeholders, how the rights wlll accrue and who will be competent to enforce the rights. In the case of IPRS, the protected information is also to be identified. National legislation needs to address these aspects to make the system exact. This will require the determination of the objectives to be achieved through the protection of TK, for which a proper definition of TK would have to be attempted. AU these aspects together will require a human-rights-centric approach.

VII. CONCLUSION

It has been noted above that despite the involvement of several inter-governmental bodies working on the protection of traditional knowledge and an impressive body of

162 Irene-Erica Daes, Study on the Protection ofthe Cultural and Intellectual Property oflndigenous Peoples. UN Doc. E/CN.4/Sub.2/1993/28, paras. 22 and 26.


literature and documents produced by international, national and non-governmental bodies, the progress achieved in this respect is not very remarkable so far. Any comprehensive system on the subject would in fact be comprised of several components, and any legal system constructed in this direction should address those components while at the same time responding to the needs of the intended beneficiaries.

Looking at the complexity of the subject-matter, a single, all-encompassing sui generis instrument would not be able to address all the concerns of the holders of traditional knowledge. Rather, efforts should be undertaken at both the national and international levels. The international regime should be realistically based on some of the demanding issues in this respect, particularly the economic aspects; the national regimes should be broad-based, addressing all the relevant components significant for the holistic protection of traditional knowledge.

Documents

Protecting Traditional Knowledge : Is a Sui Generis System an Answer?