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7. The Convention on Biodiversity: Connecting innovation with conservation?
9. Where to go from here?
In the last decade, the application of modern biotechnology for agricultural, ecological and medical purposes has sparked great hopes for the extent to which man can explore and exploit biological resources for his well-being. Simultaneously, the commercial use thereof has led to intense international and multicultural conflicts and debates. These conflicts and debates hinge on the conflicting claims concerning two of the most important 'resources of biotechnology' - genetic material and knowledge. These claims may have a proprietary character, but too often also relate to spiritual, ecological and ethical considerations. The proponents of one or the other claim may be driven primarily by commercial motives, but may equally well be inspired by cultural opinions. The way in which these claims are awarded or rejected determines, to a large extent, the overall freedom of access to and use of genetic material, whether modified or not. Also, it greatly affects the attribution of the benefits that result from its commercial exploitation. Intellectual property law, and particularly patent law, has a profound influence on the manner in which said claims may be awarded. Patents on genetic inventions principally add to the information available for innovation through the disclosure of the invention in the patent application. At the same time, though, they grant exclusionary rights to the patentee in regard to the commercial use of the invention and the genetic material it consists of. Of course, also the benefits deriving from such use are exclusively for the patentee. The manner in which genetic inventions can be patented may be called the internal patent law perspective. It is determined by positive law and has a technically legal character. The consequences of the manner in which patents for genetic inventions are granted may be called the external perspective. The external perspective deals with broader social outlooks, such as the freedom of access and the use of knowledge related to genetic material and the material itself. These perspectives are interconnected and interactive. This is exemplified by the manner in which they are dealt with in the Convention on Biodiversity (CBD) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).(2) The implementation of these treaties determines to a large extent the manner in which the 'global commodity' genetic material, and the knowledge pertaining thereto, can be exploited commercially. Also, it directs the role of the global public domain in innovation, traditional usages of genetic material and sustainable development. This paper briefly highlights some of the mirroring interests in genetic material and related knowledge - 'the resources of life and culture' - and the impact patent law has on the manner in which they could be safeguarded. Furthermore, national and international initiatives that are taken for this purpose are briefly analysed. To conclude, some suggestion are presented on how the seemingly conflicting interests in this field can be reconciled. Also, issues that would need further research and discussion are formulated, in an attempt to identify the steps ahead in this highly dynamic field.
Clearly, the R&D process for a new biopharmaceutical product involves many participants from many disciplines, cultural backgrounds, countries and stages. Briefly stated, it could commence by means of bioprospection in a biodiversity-rich country, with the help of an indigenous community. It would further entail extensive screenings of the material thus collected, modifications and, in the end, clinical trials. After repetitive successful trials, the company involved may apply for approval by the national authorities and, eventually, the biopharmaceutical may be registered and reach the market. In view of the promises of these products, societies would clearly want to stimulate their development. At the same time, the complexity and costliness thereof may scare off potential investors and inventors. What company would be willing to devote its resources to such a project, without being able to earn back the investment after a successful product has been developed? Here patent law comes in.
Two circumstances are supposed to enable the North to conduct its piracy. First, current patent law does not readily allow the recognition of different types of knowledge used in arriving at an invention. Also, the origin of the biological material and the manner in which it was acquired are irrelevant to the patentability of an invention or the rights related to a patent granted. Second, TRIPS has rendered the Northern patent regimes into a global regime, also where biotechnological inventions are concerned.
The second circumstance supposedly enabling the North to conduct its cultural piracy and biopiracy is related to the implementation of the TRIPS. The TRIPS was concluded in 1994, in the course of the establishment of the World Trade Organization (WTO). Ratification of TRIPS is a prerequisite for membership of the WTO. Of course, developing countries practically had no choice but to adhere to TRIPS. Their economic development made it absolutely necessary to join the WTO, which allows them to freely trade their products around the world. Hence, they were forced to implement TRIPS in their national legislations.(38) The North insisted on the connection between TRIPS and the WTO as it would enable it to effectively enforce the intellectual property rights pertaining to some of its most important export products, i.e. technology and artistic creations such as medicines and films.(39) At the same time, it is clear that developing countries do not have the means to participate in the 'race to innovation'. The state of their technological and economic development does not allow them to compete with equal arms.(40) Therefore, the South feels that it is not only confronted with cultural piracy and biopiracy, but that it is even forced to collaborate. It not only finds that its genetic and knowledge resources are appropriated, but that it must even legitimize the 'theft' through granting and enforcing intellectual property rights. In view of this, some of these countries have made national legislation providing measures against the appropriation of those resources through intellectual property law.
Obviously, these statutes violate TRIPS in various manners, most importantly by negating the distinction between the public and the private domain, adding additional requirements to the patentability of inventions and apparently providing for continuous licenses to the transferors by operation of law. However, these statutes seem to correspond more or less with another treaty which existed before the conclusion of TRIPS - the Convention on Biodiversity.
Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.
Article 8(j) is related to Articles 15 and 16 of the CBD, which are generally considered to be the 'heart' of the convention.(44) Article 15(1) and (2) repeat that states have sovereign rights over their biological resources insofar as they are the country of origin or have acquired them in compliance with the CBD. Pursuant to Articles 15(4) and (5), access to biological resources is conditioned upon prior informed consent of the source country. Furthermore, Article 15(7) states that the countries involved should provide for a mechanism that allows fair and equitable sharing of the benefits arising from the commercial and other utilization of genetic resources. Article 16 of the CBD concerns access to and transfer of technology. Article 16(2) states that developing countries are to have access to technology under 'fair and most favourable terms', albeit consistent with the 'adequate and effective protection of intellectual property rights'.
Moreover, Article 31 of TRIPS provides for granting compulsory licenses if the potential licensor has unsuccessfully made reasonable efforts to acquire such a license from the patentee, or a situation of national emergency exists.(46) In my opinion, it is from these ambivalent and unclear interfaces that a fully integrated international bioprospecting regime should be developed.
Several international governmental organizations ('IGOs') have taken initiatives to that extent; however, to discuss them falls outside the scope of this paper. Briefly, the characteristics and aims of the most relevant initiatives - those taken by the World Intellectual Property Organization (WIPO) and the Secretariat of the CBD - will be considered.(47) WIPO and the Secretariat of the CBD - through its working groups and expert panels - work closely together in pursuing to integrate the two instruments and to reconcile some of the interests involved.
WIPO has conducted an extensive fact-finding mission, to inquire into possible means for the protection of the interests of traditional knowledge holders.(48) Clearly, most manifestations of traditional knowledge cannot be protected pursuant to current intellectual property law. Therefore, WIPO suggests to develop of a sui generis regime. Its most important requirements would be that it concerns documented and concrete knowledge with which the applying community has a cultural association. Rightholders would have the right to prevent the reproduction and fixation of literary and artistic expressions, and the exploitation of technical elements.(49) Although sui generis protection for traditional knowledge may solve some of the conflicts, many problems remain, and further study is required. It would be good to clarify the relation of such a regime with existing intellectual property law, delineate the subject matter, develop methods to identify the proper communities, monitor infringements and mechanisms for enforcement and provide sufficient legal certainty given the dynamic nature of the knowledge protected.(50) Also, the proposed sui generis regime would not address non-economic interests in the subject matter, which, as was noted above, is of great importance to the communities involved.
Another part of the WIPO initiative is aimed at allowing patent examiners to consider traditional knowledge when they inquire into the novelty and non-obviousness of inventions.(51) For this purpose, WIPO has started an experiment with the Traditional Knowledge Digital Library, which in the future could be integrated in its Intellectual Property Digital Libraries.(52) The Traditional Knowledge Digital Library is to provide concise, categorized and standardized information on prior traditional knowledge and to allow patent examiners to apply the novelty and non-obviousness requirements accurately. Whilst increasing the chance that appropriation of traditional knowledge will be noticed during patent procedures, this initiative has one important downside. It puts the traditional knowledge concerned in the public domain, disabling the communities concerned even more in their attempt to obtain protection offensively.
Despite the steps made by the promulgation of the Bonn Guidelines, several key problems remain. The competence of indigenous communities and provider countries with respect to the traditional knowledge and genetic material subjected to the Material Transfer Agreements remains uncertain. As indicated above, this uncertainty derives from the diverse origin of both genetic material and traditional knowledge. This will directly affect the validity of the agreements and raises the question whether courts of law will be inclined to uphold and enforce them. Also, the manner in which the ethical interests of communities should be aligned with the enforcement of intellectual property law pursuant to TRIPS remains unclear. Furthermore, although the rights and obligations in regard to the initial knowledge and material may be specified in the agreements, the legal ramifications thereof for derived inventions and products are not articulated. In regard of the purported additional requirements for patentability - prior informed consent and benefit sharing - questions remain as well. What would be the extent of these requirements in view of the indirect relation between initial material and knowledge, and the eventual invention (end product)? When are the rights of the provider countries and communities exhausted? And what is the legal status of these requirements? Are they formal or substantive ones, i.e. affecting the validity of patents?
The manner in which present-day biopharmaceuticals are developed shows that the classical concept of centre and periphery is no longer applicable, neither economically nor culturally. Local, regional and global interests are inherently connected. The globalization of patent law pursuant to TRIPS greatly adds to this interconnection.(58) In my opinion, one should, however, not ignore the monoculturally determined precept of intellectual property law. Patent law is supposed to stimulate certain types of innovation. It is one of the means by which societies, with a certain level of technological development, can strive to arrange economic growth. Conversely, patent law is the 'product' of a cultural arrangement as well. It seems to me that the application of a monocultural legal concept, such as patent law, to a multicultural world, where different countries have different policy aims and economic needs, is problematic. One may doubt whether the rigid application of TRIPS leads to justified outcomes. This doubt may even increase given the particular features of biotechnological inventions. Other than many other types of inventions, such as mechanical or electronic ones, they seem to build on a combination of substantial intellectual and practical contributions. Many of these go unnoticed when the innovator is awarded for his beneficial efforts through the grant of a patent. Hence, indigenous communities have modified biological materials in their environment for thousands of years, but are mostly left empty-handed. The efforts made, for example by WIPO and the Secretariat of the CBD, to provide them with a share in the benefits of exploitation may be inappropriate. They may not correspond with the needs and expectations of these communities, especially because of their differing cultural perspectives on how one could appropriately exploit natural resources. Another complicated matter relates to the claims of biodiversity-rich countries to the genetic resources present in their territories. These claims have been honoured in the CBD, and countries now have sovereign rights over their genetic resources. The actual basis for this sovereignty is, in my opinion, extremely ambiguous. Increasingly, calls are made to treat genetic resources as the common heritage of mankind.(59) Even more so, the legal ramifications of national sovereignty over genetic resources are unclear and may lead to equivocal rights and obligations. It is my opinion that both the CBD and the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization wrongly mix rights and obligations pertaining to tangible objects and intangible ones - intellectual innovations. This conceptual confusion will not facilitate a further integration of the CBD and TRIPS and may diminish the chance that present conflicts will be resolved in the future.
Probably, the reconciliation of the various interests in genetic resources and knowledge, used in the development of biopharmaceuticals, can only occur through a change of conduct of all participants. Patent examiners should pursue to enhance their means of accurately examining the novelty and non-obviousness of inventions. Bioindustry should recognize the contributions of others to the inventions they develop and patent. The North - the developed world - should seek to stimulate its industries in doing so and may find ways of approaching the TRIPS obligations of developing countries with some leniency. The South - the developing world - may want to benefit from its genetic resources, while simultaneously recognizing the difference between 'raw' tangible material and the eventual invention deriving therefrom. Indigenous communities should pursue to protect their interests proactively, either through sui generis regimes or by other means, but should also allow others to continue their activities and recognize that legal uncertainty may have detrimental effects on the interests of bioindustry. Hence, if they participate in global commercial activities, they should also attempt to play by the rules and, for example, organize them in such a manner as to allow others to have legal certainty.
Obviously, it is the rules that complicate the endeavoured change of conduct; and it is the rules, which, in my opinion, do not suit the present situation of bioprospection and commercialization of the products deriving therefrom. Where to go from here? I would suggest the following.
First, attempts to protect the interests of developing countries in reaping some of the benefits obtained through exploitation of their genetic resources should be distinguished from initiatives to protect the interests of indigenous communities. The former may have control over tangible resources, whereas the latter have intellectually contributed to the development thereof. In my opinion, only the claims of indigenous communities may affect the patentability of inventions, because they influence the novelty or non-obviousness thereof. The claims of developing countries are hard to recognize in the realm of patent law - it would open the door to a variety of claims of the 'owners' of tangible objects used in the making of an invention and may therefore blur the distinction between the intangible (intellectual creation) and the tangible (the manifestation of such a creation). The former is subject to intellectual property law, whereas other legal instruments may apply to the latter.
Second, if one concludes that indigenous communities have indeed significantly contributed to the formation of particular genetic resources, one may want to reward these communities. If this cannot be done according to present-day patent law, one should consider changing that regime or develop an alternative instrument. Before initiating this, it is recommended that the actual contributions of the communities concerned be clarified. The same applies to the relevancy of their traditional knowledge for the development of biopharmaceuticals. When becomes the assistant a co-inventor? Subsequently, the standards for patentability - and perhaps the 'technical focus' of that law - may need alteration in order to allow the protection of more types of innovations. A sui generis system may be developed instead. However, given the manner in which the contributions to the actual biotechnological invention may be blurred, one may consider developing such a system for the inventions at hand, instead of for one of its resources, i.e. traditional knowledge; a sui generis regime tailored to, for example, plant biotechnological inventions. The present initiatives to develop a sui generis regime particularly for traditional knowledge may show to be unworkable. How is it to be integrated into the present patent law regime? How should the non-economic cultural considerations be dealt with?
The claim of cultural piracy and biopiracy needs to be analysed. According to Black's Law Dictionary (8th edition), piracy consists in 'the unauthorized and illegal reproduction or distribution of materials protected by copyright, patent or trademark law'. Also, and related to tangible objects, it could mean: 'robbery, kidnapping or other criminal offence committed at sea' or 'the crime of using force or threat to seize control of an aircraft, especially one in flight'. Clearly, these definitions, neither under present general property law nor under intellectual property law, directly apply to genetic resources and traditional knowledge. A clear understanding of the question whether developing countries and indigenous communities have a justified 'proprietary' claim to the resources concerned is necessary - and if so, whether the conduct of certain bioprospectors amounts to piracy.
Extensive analysis of the application of the novelty and non-obvious requirements to the inventions concerned is required. Moreover, a full-blown analysis of the differing concepts and methodologies of 'traditional' and 'modern' science is needed. Also, in the approach suggested cultural perspectives on the exploitation of natural resources, innovation and proprietary concepts would have to be compared. Do the principles underlying patent law necessarily differ from the principles underlying the concepts of guardianship or custodianship, applied in other cultures? Legal-philosophical analysis would offer the insight required, and possibly show that these perspectives, and therefore the claims deriving from them, are not so much in conflict as may seem at the outset.
I would recommend focusing on the potential consequences of any possible change in the manner in which inventions may be protected by patent law. These changes may drastically influence the speed of innovation in the highly promising field of biotechnology. While seeking to shape new concepts, embodying new approaches to innovation and the exploitation of knowledge and genetic resources, one should not ignore the presupposed positive effects of present-day patent law.
1. Centre for Intellectual Property Law, Molengraaff Institute for Private Law, Utrecht University, the Netherlands. This paper is based on a presentation held at the Ius Commune Research School workshop on Intellectual Property at Edinburgh University School of Law, 19-20 June 2003. Reactions are most welcome.
2. Convention on Biodiversity, 1993, available at <http://www.biodiv.org>. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994; Marrakesh Agreement Establishing the World Trade Organization, Annex 1 C, Legal Instruments - Results of the Uruguay Round, available at <http://www.wto.org/english/docs_e/legal_e/final_e.htm>.
3. M. Weatherall, In Search of a Cure: A History of Pharmaceutical Discovery, Oxford University Press, 1990, p. 3. Aboriginals seem to have had modified organisms for at least 100,000 years. See D. Posey, 'Commodification of the Sacred through Intellectual Property Rights', Journal of Ethnopharmacology (83), 2000, p. 6.
4. P. Rabinow, Making PCR: A Story of Biotechnology, Chicago University Press, 1998, p. 20.
5. For the workings of biotechnology and its potential for a variety of goals, see P.J. Russel, I-Genetics, San Francisco: Benjamin Cummings, 2002, pp. 375 ff. In the remainder of this article, for illustrative reasons references are made to medical biotechnological products, particularly pharmaceuticals. Biotechnological pharmaceutical products are generally referred to as 'biopharmaceuticals'.
6. Commission of the European Communities, Life Sciences and Biotechnology - A Strategy for Europe, COM(2002) 27 final, p. 7, available at <http://europa.eu.int/eur-lex/en/com/cnc/2002/com2002_0027en01.pdf>.
7. S. Laird (ed.), Biodiversity and Traditional Knowledge, London [etc.]: Earthscan, 2002, pp. 250 ff. See also the newsletters 'Leading Biotechnology Drugs on the Market' of the e-journal Med Ad News, available at <http://www.medadnews.com/index.asp>. Apart from the end products, also components of the genetically modified organisms concerned could be commercially promising. For example, the biopharmaceutical Vinblastine, used in the treatment of Hodgkin's disease, is one of Eli Lilly & Co's best-selling products. The medicine is derived from the plant 'Cantharanthus Rosus', and the seeds of that plant became highly priced commodities as well. In 1993, the market price for a kilogram of seeds of this plant was worth 5 million US Dollars. See A. Sasson, Biotechnologies in Developing Countries: Present and Future. Volume 2: International Cooperation, Paris: UNESCO, 1998, pp. 228-232.
8. Nuffield Council on Bioethics, The Ethics of Patenting DNA, 2002, p. 14. Please note that these figures are contested from time to time; available at <http://www.nuffieldbioethics.org>.
9. See, e.g., M.H.M. Schellekens and J.E.J. Prins, 'Regulatory Aspects of Genomics, Genetics and Biotechnology: An Orientation on the Positions of Germany, the United Kingdom and the United States', vol. 7.1 EJCL 2003, available at <http://www.ejcl.org/71/art71-2.html>. On other risks involved, see A. Streltzer, 'U.S. Biotechnology Intellectual Property Rights as an Obstacle to the UNCED Convention on Biological Diversity: It Just Doesn't Matter', TRNATLAW (6) 1993, p. 293.
10. See OECD, Biotechnology Statistics in OECD Member Countries: Compendium of Existing and National Statistics, Paris: OECD, 2001, available through <http://www.oecd.org>.
11. See, on the resources of biotechnology, J. Janssen, 'Property Rights on Genetic Resources: Economic Issues', Global Environmental Change (9), 1999, pp. 313-321.
12. WEHAB Working Group, A Framework for Action on Biodiversity and Ecosystem Management, World Summit on Sustainable Development, 2002, pp. 1-17, available at <http://www.johannesburgsummit.org/html/documents/summit_docs/wehab_papers/ wehab_biodiversity.pdf>. See further P. Ehrlich and E. Wilson, 'Biodiversity Studies: Science and Policy', Science (253) 1991, pp. 785-762. It is noted that the progress in biomatics, enabling the selection of recombination of countless genes and their purported functions, seems to diminish the need to work on the 'natural material' itself.
13. See N.A. Campbell and J.B. Reece, Biology, San Francisco: Benjamin Cummings, 2002, pp. 426-709. Genetic change occurs without and by means of human intervention. The former is called natural genetic drift.
14. See Posey, 'Commodification of the Sacred through Intellectual Property Rights', supra note 3, and R. Barsh, 'Taking Indigenous Science Seriously', in: S. Bocking (ed.), Biodiversity in Canada: Ecology, Ideas and Action, Toronto Broadview Press, 1999, pp. 154-166.
15. See, e.g., G.A. Cordell, 'Biodiversity and Drug Discovery: A Symbiotic Relationship', Phytochemistry (55) 2000, pp. 463-480; C. Weiss and T. Eisner, 'Partnerships for Value Added through Bioprospecting', Technology in Society (20) 1998, pp. 483-484.
16. Article 63(2) of the Convention on the Grant of European Patents (European Patent Convention - EPC), 1973, 1065 U.N.T.S. 199.
17. See, generally, P. Drahos, A Philosophy of Intellectual Property, Aldershot: Dartmouth, 1996.
18. See the economic analysis provided in S.J.R. Bostyn, Enabling Biotechnological Inventions in Europe and the United States, Munich, EPOscript, 2001, chapter I, and K.W. McCabe, 'The January 1999 Review of Article 27 of the TRIPS Agreement: Diverging Views of the Developed and Developing Countries Towards the Patentability of Biotechnology', JIPL (6) 1998, pp. 47-49.
19. In 1873, Louis Pasteur was granted a patent on '. . . improvements in the manufacture and in the treatment of yeast and wort, together with apparatus for doing the same . . .', US patent 141, 072 (1873), whilst others were denied patents for inventions working on or consisting of biological materials. See, e.g., D.J. Kevles, A History of Patenting Life in the United States with Comparative Attention to Europe and Canada, European Group on Ethics of Science and New Technologies, 2002, pp. 3-4, available at <http://europa.eu.int/comm/european_group_ethics/docs/study_kevles.pdf>.
20. See, e.g., OECD, Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies, 2002, available at <http://www.oecd.org/dataoecd/42/21/2491084.pdf>. For the application of the requirements of patentability, see, among others, Bostyn, Enabling Biotechnological Inventions in Europe and the United States, supra note 18 (genes and related compounds); G. Van Overwalle, Octrooieerbaarheid van Plantbiotechnologische Uitvindingen [The patentability of plant biotechnological inventions], Brussel: Bruylant, 1996; J. Koopman, 'The Patentability of Transgenic Animals: A Proposal for Harmonization', FIPMELJ (XIII/1) 2002, pp. 103-204 (animals).
21. These debates usually focus on the exclusion of patentability for violation of the ordre public and morality, as incorporated in Art. 53(a) EPC. See, e.g., P. Drahos, 'Biotechnology, Patents and Morality', EIPR 1999, p. 441; Nuffield Council on Bioethics, The Ethics of Patenting DNA, supra note 8. A recent report of the European Commission emphasizes that these issues have not been solved yet; European Commission, Life Sciences and Biotechnology, supra note 6, and the efforts of the European Group on Ethics in Science and New Technologies, see <http://europa.eu.int./comm/european_group_ethics/avis_en.htm>.
22. Articles 52(1) and 83 EPC.
23. Article 52(2)(a) EPC. See, e.g., J. Conley and R. Makowski, 'Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents', J. Pat. & Trademark Off. Soc'y (85) 2003, pp. 301 ff.
24. It seems to concern all types of biotechnological inventions, albeit one category, such as ESTs and SNPs more than any other, for example transgenic plants. See, e.g., WIPO/BIOT/WG/99/1. See also, on different types of biotechnological inventions, Nuffield Council on Bioethics, The Ethics of Patenting DNA, supra note 8; L. Demaine and A. Fellmeth, 'Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent', Stan. L. Rev. (55) 2002, pp. 303-462; D.M. Gritter, 'International Conflicts over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and a Fair Use Exemption', NYU L.R. (76) 2001, pp. 1623-1691, and supra note 18.
25. The term 'biopiracy' was introduced in 1994 by the FAO's Assistant Director-General Obaidullah Khana. 'FAO Official Blasts Western Biopiracy', Reuter, 6 June 1994.
26. See, e.g., <http://web.worldbank.org/WBSITE/EXTERNAL/EXTSITETOOLS/0,,contentMDK: 20062759~menuPK:98409~pagePK:98400~piPK:98424~theSitePK:95474,00.html>, <http://www.colorado.edu/Research/HARC/tradknow.html> and <http://www.nuffic.nl/ciran.ik>.
27. This happened with the notorious neem tree patents of W.R. Grace Inc. It concerned the Indian plant Azadirachta indica, locally known as the Sarva-roga nivarini. This plant has been used by Indian farmers and traditional healers for thousands of years, and seems to have characteristics that are useful both agriculturally and medically. W.R. Grace received several patents on the plant and certain of its compounds and derivative products, and enforced its patent proactively. Several groups of 'traditional users' in India were threatened with infringement suits and ordered to halt the commercial exploitation of the plant. Only after prolonged battles in the media and before the EPO, one of W.R. Grace's European patents (no. EP 436 257 B1) was revoked because of lack of novelty. The corresponding US patent, no. 512,4349, however, was sustained. See hereon G. Dutfield, Intellectual Property Rights, Trade and Biodiversity, London: Earthscan, 2000, pp. 65-67.
28. In Europe, for example through Article 99 EPC, opposition to the patent, among other things for lack of novelty.
29. P. Drahos and J. Braithwaite, 'Intellectual Property, Corporate Strategy, Globalisation: TRIPS in Context', Wis. Int'l L.J. (20) 2002, p. 451. Drahos and Braithwaite analyse the manner in which large Western corporations have become dependent on intellectual property law and tailor their commercial activities and conduct accordingly.
30. On the difficulties of offensively protecting traditional knowledge and related products through patent law, see generally N. Roht-Arriaza, 'Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities', Mich. J. Int'l L. (17), 1996, pp. 919-965 and F.W. Grosheide and J.J. Brinkhof (eds.), Intellectual Property Law: Articles on the Legal Protection of Cultural Expressions and Indigenous Knowledge, Antwerp [etc.]: Intersentia, 2002 (Molengrafica Series, 13).
31. See The Crucible Group II, Seeding Solutions: Options for National Laws governing Access to and Control of Genetic Resources, vol. 2, Rome: IPRC-IPGRI, 2001; J. Boyle, Of Shamans, Software and Spleens ,Cambridge, Mass.: Harvard University Press, 1996; D. Posey and G. Dutfield, Beyond Intellectual Property, Ottawa: International Development Research Centre, 1996. This is also expressed in various statements made by indigenous communities and their representatives. See the Statement from the International Workshop on Indigenous Peoples and Development, 1997; the Sabah Statement on the Protection and Conservation of Indigenous Knowledge, 1995; the Suva Statement on Indigenous Peoples' Knowledge and Intellectual Property Rights, 1995; the Statement from the COICA/UNDP Regional Meeting on Intellectual Property Rights and Biodiversity, 1994; the Julayinbul Statement on Indigenous Intellectual Property Rights, 1993; Kari-Oca Declaration and Indigenous Peoples Earth Charter, 1992; Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples, 1992; the Declaration of Principles of the World Council of Indigenous Peoples, 1984; availabe at <http://users.ox.ac.uk/~wgtrr/decin.htm>. These declarations have in common that they consider knowledge, land and natural resources, such as genetic material, to be inseparable. Indigenous communities have responsibilities for their natural environment which relate to 'guardianship' or 'custodianship' and are not considered to be rights that could be alienated or otherwise exploited for one's individual benefit, like a property right.
32. On the natural exchange between cultures, see R.J. Coombe, 'The Properties of Culture and the Possession of Identity: Postcolonial Struggle and the Legal Imagination' in: B. Ziff and P.V. Rao (eds.), Borrowed Power: Essays on Cultural Appropriation, New Brunswick: Rutgers University Press, pp. 74 ff. Attempts to solve these problems have been made, for example by the establishment of representative organizations, which would be entitled to decide upon transfer and the future commercial use of the knowledge and would divide the proceeds thereof to the communities they represent; supra note 31.
33. See, e.g., Article 27 TRIPS. Patents can be granted for inventions in all areas of technology, and regardless of the location of invention and whether components thereof are imported or not.
34. WIPO/GRTKF/IC/4/11, p. 27; WIPO/BIOT/99/1; WIPO/SCP/3/11, §208.
35. European Council Directive 98/44/EC, 1998 OJ L 213, pp. 13-21.
36. See, e.g., the Convention on the International Trade in Endangered Species of Wild Fauna and Flora, 1973 (CITES). CITES regulates the import and export of endangered species; available at <http://www.cites.org>. On the stance that patent law is not the appropriate instrument to deal with all sorts of societal aspects of inventions, see e.g. R. Crespi, 'Patenting and Ethics: A Dubious Connection', J. Pat. & Trademark Off. Soc'y (85) 2003, p. 47; U. Schatz, 'Patentability of Genetic Engineering Inventions in EPO Practice', Int'l Rev. Indus. Prop. & Copyright L. (1) 1998, p. 2. But see, e.g., Roht-Arriaza, 'Of Seeds and Shamans', supra note 30, pp. 942-944.
37. Cf. J. Vogel, 'The Successful Use of Economic Instruments to Foster Sustainable Use of Biodiversity: Six Case Studies from Latin America and the Caribbean', Biopolicy Journal (2) 1997, pp. 5-7. Vogel analyses among other things the relation between the lack of scarcity of genetic resources and the economic valuation thereof in benefit-sharing agreements.
38. The grace periods that were granted to certain developing countries pursuant to Articles 65 to 67 TRIPS are expired now, or about to expire, or are, for most countries, not applicable given the exclusion of pharmaceuticals in Article 70(8) and (9). The Declaration on the TRIPS Agreement and Public Health ('Doha declaration'), allowing further postponement to 2016, is only applicable to the least developed countries. WT/MIN(01)/DEC/2, 20 November 2001.
39. For an extensive overview of the circumstances leading to the conclusion of TRIPS, see, among others, Drahos and Braithwaite, 'Intellectual Property', supra note 29, and S. Sell, 'Post-TRIPS Developments: The Tension between the Commercial and Social Agendas in the Context of Intellectual Property', Fla. J. Int'l L. (14) 2002, pp. 193 ff.
40. Machlup already concluded that developing countries should not implement intellectual property law regimes. See F. Machlup, An Economic Review of the Patent System, Washington: US Government Printing Office, 1958. See also C. Juma, 'Intellectual Property Rights and Globalisation: Implications for Developing Countries', Center for International Development, Harvard University, 1999 (Science, Technology and Innovation Discussion Paper No. 4), and J. Lerner, 'Patent Policy Innovations: A Clinical Examination, 53 VNLR (53) 200, pp. 1841 ff.
41. Costa Rica implemented the Ley de Biodiversidad, A.L. No. 7788 (1998), available at <http://www.grain.org/brl/costarica-leybiodiversidad-1998.cfm>; Brazil implemented its Ley PM 2.186-16, 2001, available at <http://www.planalto.gov.br>; Peru implemented the Ley sobre la conservación y approvechamiento sotenible de la diversidad biológica, C. no. 26839, 2002, available at <http://www.indecopi.gob.pe>; India implemented the Biological Diversity Act, B. 93/2000, 2002, available at <http://www.nifindia.org>.
42. The Brazilian statute illustrates this. Recently, a German national was suspected of committing biopiracy, and was arrested in Brazil. M. Astor, 'German Man Arrested in Brazil Accused of Biopiracy', Associated Press, 4 September 2003.
44. Given the scope of this paper, only brief references are made to these Articles.
45. See, generally, on the interface between the CBD and TRIPS S.R. King et al., 'Biological Diversity, Indigenous Knowledge, Drug Discovery and Intellectual Property Rights: Creating Reciprocity and Maintaining Relationships', Journal of Ethnopharmacology (51) 1996; Ch. McManis, 'The Interface between International Intellectual Property and Environmental Protection: Biodiversity and Biotechnology', WAULQ (76) 1998, pp. 255-279.
46. Also, the Preamble and Article 8 of TRIPS emphasize the importance of social and public interests and show that this instrument is not narrowly tailored to trade issues only. It is noted, however, that these provisions may factually not offer developing countries means to redress certain effects of TRIPS. Past conflicts about the implementation of TRIPS caused the US to consider the imposition of severe trade sanctions on the developing countries that allegedly were not fulfilling their international obligations, e.g. Argentina, Brazil, Thailand and South Africa. See, e.g., K. Maskus, Intellectual Property Rights in the Global Economy, Institute for International Economics, 2002, p. 178, available at <http://www.iie.com> and E. 't Hoen, 'TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha', Chi. J. Int'l L. (3) 2002, p. 2. The North thus has an effective tool enabling it to force developing countries to comply with its wishes, perhaps sometimes even when the latter do not have to comply strictly pursuant to TRIPS or other international instruments.
47. Other IGOs addressing the issues related to the interface between CBD and TRIPS are (with reports and keywords): WTO (IP/C/W/195; IP/C/W/228; WT/GC/W/233; IP/C/M/32 (§128); IP/C/M/33 (§121); IP/C/W/347/Add.1; IP/C/W/370; trade, medicines); UNCTAD (TD/B/COM.1/EM.13.3 (§17); trade, development); FAO (CPGR/91/12' CPGR-6-95/8; CGRFA-Ex3/96/LIM/2; CGRFA-Ex5/98/inf.1Annex; CGRFA-Ex8/99/8'CPGR-BSP1,2,4 and 8; food, agriculture, genetic resources); UNESCO (CLT-2002/CONF.203/5; CLT-2002/CONF.203/3 (and Rev.); CLT-2002/CONF.205/5; CLT-2003/CONF.205/5; culture, natural sciences, traditional knowledge); WHO (EB111.R12/2003; WHO/EDM/TRM/2002; EB87.R24/1991; WHA41.19/1988; traditional medicine).
48. See WIPO, Report on Fact-Finding Missions on Intellectual Property and Traditional Knowledge (1998-1999), Intellectual Property Needs and Expectations of Traditional Knowledge Holders, Geneva, April 2001. See also UNEP/CBD/WG-ABS/1/4, p. 8.
49. WIPO, Report on Fact-Finding Missions, p. 226.
51. WIPO, Report on Fact-Finding Missions, p. 217.
52. WIPO/GRTKF/IC/2/6, p. 26. The database is available at <http://www.wipo.int/globalissues/databases/tk/index>.
53. See UNEP/CBD/COP/6/20 and COP Decision VI/24, available at <http://www.biodiv.org/decisions/default.asp?m=cop-06&d=24>.
54. For a national initiative to reconcile both treaties in the user country Belgium, see G. Van Overwalle, 'Belgium Goes Its Own Way on Biodiversity and Patents', EIPR 2002, p. 233.
55. Available at <http://www.kew.org/conservation/principles.html>. Botanical gardens from around the world followed these guidelines. Thus far, however, no Dutch botanical garden participates.
56. See <http://www.nih.gov/fic/programs/icbg.html> and J.P. Rosenthal, The International Cooperative Biodiversity Program: A Benefit-Sharing Case Study for the Conference of the Parties to the Convention on Biological Diversity, available at <http://www.biodiv.org./doc/case-studies/default.aspx>.
57. See, e.g., interview with J. Martínez Alier, Deuda ecológico y biopiratería, 2002, available at <http://www.grain.org/sp/publications/biodiv32-5-entrevista.cfm>.
58. See, on the concept of economic and cultural centres and peripheries, F. Lionnet, 'Logiques métisses: Cultural Appropriation and Post-Colonial Representations', College Literature, (10) 1992, p. 116.
59. See, e.g., The International Undertaking on Plant Genetic Resources for Food and Agriculture (FAO, 1983), available at <http://www.fao.org/ag/cgrfa/IU.htm>; the Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), available at <http://www.unesco.org/shs/human_rights/hrbc.htm>. See also D.A. Cleveland and S.C. Murray, 'The World's Genetic Resources and the Rights of Indigenous Farmers', Current Anthropology (38/4) 1997, p. 481; The Council for Responsible Genetics, The Blue Mountain Declaration, available at <http://www.gene-watch.org>. See also <http://hornacek.coa.edu/dave/Reading/patents.html>.
60. Freely translated: 'Friendship should be initiated by us, because we are looking for them, whereas they are not looking for us'; quoted in C.R. Boxer, Zeevarend Nederland en zijn wereldrijk 1600-1800, Amsterdam: Maarten Muntinga, 2002 (Rainbow pockets), p. 322 (original title: The Dutch Seaborne Empire 1600-1800, London: Hutchinson, 1977).

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