1、workshop3Commission on Intellectual Property RightsWorkshop 3: Genetic Resources, Gene-based Inventions and Agriculture19th November 2001Participants: Michael Blakeney (University of London), Linda Brown (DFID), Peter Button (UPOV), John Mugabe (ACTS), Patrick Mulvany (ITDG), Dwijen Rangnekar (Unive
2、rsity of London), Suman Sahai (Gene Campaign), Clive Stannard (FAO), Geoff Tansey (Consultant), Ruchi Tripathi (ActionAid).Commissioners: Sandy Thomas (Chair), Daniel Alexander, Carlos Correa and Ramesh Mashelkar.Secretariat: Charles Clift, Tom Pengelly, Phil Thorpe, Rob Fitter.Summary: The first se
3、ssion of the workshop comprised presentations by the authors of the two study papers commissioned on this topic, followed by a response by a discussant and a general discussion of the paper. The first Paper by Blakeney focused on recommendations regarding TRIPS Article 27.3(b), and prompted a discus
4、sion on the understanding of TRIPS in this context and its relationship with the CBD. The second paper, by Rangnekar, reviewed the evidence available on the impacts of IPRs on agricultural development and initiated a debate on sui generis options for PVP and their access implications. The second ses
5、sion looked into issues such as the flexibilities within TRIPS, sui generis alternatives, food security and the global agricultural system, and technological R&D in the public and private sectors. The third session dealt with the relationships between the various international agreements concerning
6、genetic resources, their implementation and impact on access to the common resource base. Disclosure of origin was a further major topic of debate. The final session drew together the different strands of the workshop discussions, highlighting the most important areas for the commission to concentra
7、te on and suggesting potential recommendation.GlossaryACTS African Centre for Technology StudiesCBD Convention on Biological DiversityCGIAR Consultative Group for International Agricultural ResearchCOFAB Convention of Farmers and BreedersDFID Department for International Development (UK)DUS The crit
8、eria for PVP: Distinctiveness, Uniformity and StabilityEPC European Patent ConventionFAO Food and Agriculture Organisation (UN)GFAR The Global Forum on Agricultural ResearchGM Genetic ModificationGURTS Genetic Use Restriction TechnologiesIP Intellectual PropertyIPR Intellectual Property RightsISNAR
9、International Service for National Agricultural ResearchITDG Intermediate Technology Development GroupITPGR International Treaty on Plant Genetic Resources (FAO)IUPGR International Undertaking on Plant Genetic Resources (FAO)LDC Least developed countryMNC Multi-national companyMTA Material transfer
10、agreementOAU Organisation of African UnityPPP Public Private PartnershipPVP Plant Variety ProtectionR&D Research and DevelopmentTK Traditional KnowledgeTRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO)UPOV Union Internationale pour la Protection des Obtentions Vegetales
11、(International Union for the Protection of New Varieties of Plants)WTO World Trade OrganisationSession 1: Presentation and discussion of the study papersBlakeney PresentationProfessor Blakeney put forward the following propositions as a means to stimulate discussion:The Link Between Article 27.3(b)
12、and DevelopmentRecommendationsa. Review the impact of biotech patents on agricultural research in developing countries.b. Review the breadth of claims permitted in biotech patenting. c. Review the extent of the utilisation of Southern genetic resources and public germplasm collections (e.g. the CGIA
13、R collection).d. Establish an International Institute to provide technical assistance to developing countries on genetic resources management.Technical Issues Relating to Patent and Plant Variety Protection Under Art.27.3(b)Recommendationsa. Preserve the right of any country to exclude plants and an
14、y parts, including gene sequences and fragments, from patentability.b. Adopt clear rules indicating that naturally occurring plant materials, including genes and gene sequences, should not be patentable.c. Define the novelty requirement to exclude from patenting, any subject matter which is availabl
15、e to the public as a written description, used in indigenous communities, or in a germplasm collection.d. Establish commitments by governments not to grant, or to cancel, IPRs on materials obtained from international germplasm collections where such materials are in violation of any Material Transfe
16、r Agreements.e. Define plant varieties under Article 27.3(b) to permit a dual system of protection which includes both modern as well as farmers varieties.f. Allow an exception for experimentation on patented plant materials.Technical Issues Relating to the Sui Generis Protection of Plant VarietiesS
17、ui generis Optionsa. Landraces should be excluded from IP protection.b. Material in germplasm collections should be protected through publication, and collected materials protected by material transfer agreements.c. For medicinal plants, a certificate of novelty should be required for PVP.d. PVP sho
18、uld not be obtained for wild species.e. After purchase the PVP right will be exhausted and any further transactions with the seed will be permissible.Ethical Issues Relating to the Patentability of Life formsRecommendationsa. Consult stakeholders on the ethical impact of IPRs on living materials.b.
19、Develop policy guidelines for IP offices on the balancing of public and private interests in the area of biotechnology.Relationship of Article 27.3(b) to the Conservation and Sustainable Use of Genetic MaterialRecommendationsa. The CBD be granted observer status on the Council for TRIPS.Relationship
20、 of Article 27.3(b) with the Concepts of Traditional Knowledge and Farmers Rights.Recommendationsa. Sui generis possibilities for Farmers Rights legislation (c.f. African Model).b. Develop options for seed saving for different categories of farmers.c. Establish a central fund from which the breeder
21、is paid on the basis of the area grown, and in exchange, farmers are permitted to save, exchange and trade the seed from the protected variety on a non-commercial basis.d. Provide assistance to developing countries in formulating legislation to assist farmers in contributing to the evolution, conser
22、vation, improvement and sustainable use of plant genetic resources for food and agriculture.e. Formulate measures for credit facilities and market provisions governing farmers access to plant genetic resources for enhancing traditional genetic resources, development the exchange systems.DiscussantA
23、potential problem for implementing the Article is that it runs counter to elements of the European Biotechnology Directive and could therefore be difficult for European governments to agree to.In response to many of the recommendations made to the Commission, it was unclear who would be able to unde
24、rtake the extensive reviewing suggested. The Commision has limited time to prepare its report and is unlikely to be able to address these recommendations. Other initiatives, such as the conversion of the International Undertaking to a Treaty, were starting to deal with issues relating article 27.3(b
25、) with development, and ISNAR is developing technical assistance regimes. The Commission should focus on what is can achieve in its time frame.It was recognised that there is little understanding in the international community of the TRIPS 27.3(b), and the Commission could play an important role by
26、explaining clearly the different interpretation options and flexibilities (such as the importance of a research exemption), and the meaning of phrases (such as non-biological processes). Defining terms in the Article needs to be very precise, qualifying terms like plants with as they exist in nature
27、. Questions were raised about the exclusion of landraces in the Article, and the effect this has on the level of protection by IP or from IP (through restricted access). Clarification was recommended.The discussant agreed with the ethical issues raised in the presentation, especially in regard to st
28、akeholder involvement.DiscussionThe relationship between TRIPS and the CBD is thought to be conflicting by some developing countries. However the CBD only refers to IP in a way that does not jeopardise the objectives of the CBD, and the flexibilities in the two agreements mean that they can be imple
29、mented to either complement or conflict, as required. But whatever the interpretation, there must be precision in determining where there are possible conflicts.The use of disclosure of origin of materials as a requirement for IP application could be held by some to conflict with TRIPS, which states
30、 that only the standard three requirements; novelty, non-obviousness and industrial applicability, need be met. And if naturally occurring material is not patentable, why should the isolation of parts of that material be grounds for granting a patent?The FAO International Treaty on Plant Genetic Res
31、ources for Food and Agriculture (ITPGR) is in harmony with the CBD, covering the specific needs of agriculture and holds the middle ground between the CBD (environmental) and TRIPS (trade). Article 9 deals specifically with Farmers Rights.Rangnekar PresentationEvidence from Developed CountriesThere
32、is evidence of only a modest and uneven impact of PVP on R&D investment across crops and companies. Evidence from the US suggests older companies are more successful at accumulating knowledge resources and major market crops are subject to the most intense IP focus.Evidence suggests increases in number of varieties released, but issues concerning varietal quality and planned obsolescence remain. And there seems to be no link between rate of protection of varieties and number rel
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