At the request of the Chair, the Secretariat introduced the working document prepared under agenda item 9, namely WIPO/GRTKF/IC/11/8 (a).
The Delegation of Colombia maintained that a disclosure of origin requirement in patent applications should be mandatory. Not only in terms of GRs but also in terms of derived products or derivatives of GRs. It was also necessary to set out coercitive sanctions in case of non-compliance of the disclosure requirement. It stated that, in its legislation, punishment was directly related to the patent application, and to the granting or invalidating of the patent. It pointed out that drawing up an inventory of publications and databases, although a valid alternative, could not be considered the only input or alternative for the purposes of patent examination, as other elements related to GRs and derived products should also be taken into account. It maintained that such provisions on TK relating to GRs should be extensive.
The Delegation of Bolivia (Plurinational State of) stated that a multilateral agreement on GRs linked to the TK of indigenous peoples should not only consider commercial aspects, as proposed in several parts of the document. The claims set out by indigenous peoples in Bolivia went far beyond commercial aspects and in many cases were of a more moral nature. It was important to include references to the moral rights of indigenous peoples. It said that the possibility of patenting plants, animals and microorganisms, that is, life in any of its forms, infringed the moral rights and beliefs of the indigenous peoples of Bolivia and of many other countries. The political constitution of Bolivia expressly prohibited the private possibility of appropriating life in any of its forms including microorganisms. That issue should be included in the discussions with a view to achieving clear definitions and avoiding ambiguities in multilateral legislation on that issue.
The Delegation of El Salvador requested that the document on GRs be also examined or be a working document of the Standing Committee on the Law of Patents, as it was linked to the field of patents and could enrich discussions in that Committee.
The Delegation of Mexico expressed its wish to be informed of the status of document WIPO/GRTKF/IC/11/8(a), in the sense that the mandate of that Committee referred to text-based negotiations and in that document there was only a list of options for consideration. It maintained that the list of options was not exhaustive and that other proposals on the table or others which might arise in the course of the sessions of the Committee and of the Intersessional Working Group should not be put to one side. The options present in the document were not mutually exclusive and could even be complementary.
The Delegation of Sweden, on behalf of the European Union and its 27 Member States, looked forward to participating in continuing discussions regarding relationship between IP and GR, and looked forward to seeing progress in this field. It was highlighted that the renewed mandate would help to refocus the Committee’s work on substance rather than on procedure. The comments on the document WIPO/GRTKF/IC/11/8(A) made by the European Union at the 11th Session in July 2007 were summarized. Three clusters of substantive questions dealing with the relationship between IP and GR were identified, which included (1) the interface between the patent system and GR, (2) IP issues concerning disclosure requirements and (3) IP aspects of access and benefit-sharing contracts. The European Union believed that these three clusters still constituted a good basis for continuing this Committee’s work. As regards the first cluster, document WIPO/GRTKF/IC/11/8(A) listed a range of options to improve the defensive protection of GR and the Delegation listed these. As regard the second cluster, the European Union and its Member states had tabled a proposal for the disclosure of a region or source of GR and associated TK in patent applications. They had a preference for a binding and mandatory disclosure requirement that should be applied to all patent applications. The amendments of Patent Law Treaty (PLT), the Patent Cooperation Treaty (PCT) and, as the case may be, regional agreements such as the European Patent Convention (EPC), would consequently be necessary. The European Union invited all Delegations to revisit its proposal which was contained in document WIPO/GRTKF/IC/8/11. Regarding the third cluster, the Committee had identified a set of draft principles for the development of guide contractual practices or model IP clauses based on which guide contractual practices had been developed as contained in Annex of document WIPO/GRTKF/IC/7/9. The European Union and its Member States had advocated instruments of a non-binding character such as guide practices and model IP clauses and that the Committee should ensure coherence and mutual support with the work of CBD, FAO and WTO. It was believed that there was a need to give the third cluster increased attention. The 9th Conference of the Parties of the CBD had decided to finalize the International Access and Benefit-Sharing Regime and to submit for consideration and adoption at COP 10 in 2010 an instrument or instruments to effectively implement Article 15 and Article 8(j) of the Convention. Paragraph 7 of Article 15 provided that the benefit-sharing should be upon mutually agreed terms. Therefore, there was an actual demand for developing model IP clauses that could be fed into the CBD process. By providing this valuable input, the Committee as a body of IP experts could help ensure coherence with other bodies dealing with GR. Consequently, the European Union and its Member States had a preference for resuming the substantive discussions by addressing the third cluster. The consideration of the issue of GR was an important task for the Committee and the proposal made by the European Union was entitled to an in-depth discussion alongside the proposals of other Member States.
The Delegation of Venezuela (Bolivarian Republic of) supported the statement made by the Delegation of Bolivia, in the sense that, when considering that issue in the Committee, not only commercial values should prevail but also it was necessary to go beyond the commercial, to the moral and beyond the moral to the religious, as religious elements existed for many peoples. It supported the statement made by the Delegation of Colombia, in as much as not only GRs but also derived products should be taken into consideration.
The Delegation of Australia highlighted that there were a number of elements in the List of Options that could usefully be discussed in more detail in the first instance, which were (1) defensive protection of GR, (2) disclosure requirements in patent applications for information related to GR used in the claimed inventions, and (3) IP issues in mutually agreed terms for the fair and equitable sharing of benefits arising from the use of GR. With respect to disclosure requirements per se, there were many issues relating to the impact and implementation of patent disclosure requirements which had not been adequately considered. Work on alternative and complementary mechanisms should be continued, such as the use of TK databases. The papers on the Swiss and the EU proposals could serve as examples to consider such issues relating to the impact and implementation of patent disclosure requirements. The Delegation highlighted there was a need for substantive legal and technical discussion of patent disclosure, in particular the ‘examination of issues’ undertaken by an ad hoc process in June 2005 developing a list of underlying questions that would benefit from further technical consideration. These questions related specifically to the legal technical aspects of the patent system, including such issues as ownership interests and impacts on innovation.
The representative of CONGAF regretted that there was no mention of the United Nations Framework Convention on Climate Change while there were many references to the CBD. He agreed that GRs were a gift of nature and combined with local, community and indigenous human engineering in its use and purpose. He went on to say that GRs had a genetic link to climate change, an inseparable link when interest in product research, use and commercialization centered on a plant. The representative also spoke of the TRIPS Agreement and its dispute settlement mechanism.
The representative of the Center for Peace Building and Poverty Reduction among Indigenous African Peoples (CEPPER) commented on questions of stakeholder engagement and interest and the integration of TK in global fora. He appreciated that there the Committee had achieved much but he also deplored the loss of time and energy. He appreciated democratic engagement. For example, the Chair of the Committee had met with the indigenous caucus and other stakeholders. There was no need for suspicion and mutual mistrust. He believed results would be achieved if the Chair continued in this manner.
The Delegation of the United States of America supported the statement made by the Delegation of Australia that all three clusters should continue to be addressed. The Delegation did not believe that the disclosure requirement would be useful, but there should be an honest and open appraisal of that proposal. In addition, numerous written submissions, oral statements and other positions had been offered with respect to the various proposals, but the objectives and principles for the protection of GR had not been yet established. The Delegation believed that, if the Secretariat could help to create such a document, it would be very useful to have objectives and principles written down in a single document. The objectives and principles were very important because they defined what to do and why. Once they were agreed, further work would be much easier.
The Delegation of Canada supported the interventions made by the Delegation of Australia and USA. The Delegation was ready to talk about the three clusters in document WIPO/GRTKF/IC/11/8(a) and particularly supported any practical way to address the IP aspects of GR, such as any initiatives that would seek to improve prior art searches conducted by patent examiners. One good example was actually to upgrade the access for IP offices to digital libraries. The Delegation also supported the Committee’s renewed mandate with respect to GR and believed that WIPO was the appropriate organization to deal with the IP aspect of GR given its particular expertise. However, there were important linkages of the Committee’s work to the CBD. At the end of March 2010, the 9th working group of the CBD would take place and there would be the final stage of the negotiation of a text on an International Regime on Access and Benefit-sharing. That text included many IP measures that were advocated to ensure compliance with the International Regime. Most notably, it included a proposal for a disclosure requirement of origin of GR to be included in patent applications. The Delegation was of the view that the issue of disclosure of origin should be dealt with at WIPO, in this Committee, as soon as possible because the CBD could make a decision on that in March. The Delegation suggested that perhaps the first intersessional working group should address GR. It also suggested that the intersessional working group should take place as early as possible because it could inform what was going on at the CBD and make sure that a decision on the issue of a disclosure requirement would be taken at WIPO, not at the CBD.
The Delegation of Japan stated that document WIPO/GRTKF/IC/11/8(a) provided a good overview of the development of the discussion on GR and its related issues. Among several options contained in the document, the Delegation suggested focusing on the substantive IP issues concerning the interface between the patent system and GR. At the ninth and eleventh session of the Committee, the Delegation had made proposals on establishing a one-click database to improve the prior search environment concerning GR and TK, thereby preventing so-called erroneous granting of patents. Concern was raised about the access by third parties. Thus, the Delegation suggested taking advantage of existing WIPO website linked to various GR-related national databases of Member States, which were open to the public, and making the website more user-friendly as a portal. The Delegation welcomed the announcement made by the Delegation of India that the Government of India had granted the USPTO examiners access to its Traditional Knowledge Digital Library (TKDL). It was believed that members could learn a lot from the Indian experiences and how those libraries could be developed worldwide. The Japanese Patent Office wished to intensify its internal consultation so that it could join other offices as one of the major users of the TKDL. The Delegation believed the WIPO Secretariat could play an important role in making such databases easily available to examiners around the world in order to make the databases more effective. The Delegation appreciated and supported the suggestions made by the Delegation of Singapore at the thirteenth session of the Committee, when it had indicated several key issues related to technical aspects and the contents of an international database. That proposal was believed to be a good base for further deliberation. The Delegation concluded that the establishment of a powerful search tool, which was easily accessible from all IP Offices around the world, would be worthwhile.
The Delegation of Peru supported the Delegations of Colombia and Venezuela, in as much as not only GRs as such were to be considered but also products so derived, given that the majority of those were of commercial interest and the basis for developing inventions which later would be the subject of patent applications, without taking into account fair and equitable benefit-sharing. It believed it was important to include disclosure requirements as formal requirements of patent applications.
The Delegation of Senegal, on behalf of the African Group, proposed examining the following issues as a matter of priority: developing a range of options on the IP-related aspects of prior informed consent and of access and benefit-sharing arrangements; developing a structured and focused list of options with a view to guiding custodians of GRs to facilitate their decision-making process; developing other proposals for dealing with the link between IP and GRs, as required by the Convention on Biological Diversity; and lastly, developing guidelines and procedures to deal effectively with the IP-related aspects of access and benefit-sharing arrangements. The Delegation agreed that it went without saying that solving such an issue would enable the Committee to make constructive progress in protecting GRs.
The Delegation of Brazil agreed that the negotiations at the CBD needed to be supported and commented on by IP experts. However, the support should be mutual and neither of the processes should be slowed down. The Delegation highlighted that timing was everything. It was time to negotiate at WIPO, taking the interests of all Member States into account, and it was time to be more constructive.
The representative of the Tulalip Tribes of Washington stated that some of the approaches assumed TK and associated GR existed in the public domain. There were still the issue of lack of PIC for historical access to TK and the issue concerning customary law related to TK and associated GR. With regard to the distinction between public domain versus publicly accessible, he stated that if somebody encountered TK, they did not have the right to assume the TK was in the public domain and they needed to check back with the tribes who were the holders of that knowledge. However, some mechanisms were needed. With regard to the disclosure requirement, once something was disclosed in a patent application under existing patent rules, even if an indigenous community had entered into a contract, that knowledge would enter the public domain without special protection within 20 years. He highlighted that indigenous people were trying to solve holistic problems, not just trying to solve a patent problem. Information made available was not only information that could be incorporated into patents, but that could be used by other people to create markets. He suggest being careful of the patent solution or an IP solution which did not address the real problem. With regard to so called embodied TK which led to GR, he questioned what the rights were that indigenous peoples had in those genetic products which they had modified so that their knowledge was embodied in the structure of the crops and so on. Document WIPO/GRTKF/IC/11/8(a) did not reflect such issues.
The Delegation of the Russian Federation supported the work done by the Committee in seeking to elaborate a system for protection of GR in terms of IP and also supported the areas of work that were set out in document WIPO/GRTKF/IC/11/8(a). The further analysis of a disclosure requirement should be a priority, including analyzing information received in response to surveys. Options 4, 8 and 9 were important. As regard to mandatory requirements for disclosure of GR when filing a patent application, the Delegation believed an ultimate decision could be made only after going through all of the studies and all of the work undertaken to date.
The Delegation of Argentina believed it was essential to find in the current forum a swift solution on the issue of misappropriation of GRs. It stated that the mandate given by the General Assembly should be respected and the issues related to GRs, TK and TCEs should be dealt with in parallel. The issue of GRs should not be relegated to the end of discussions, neither in the Committee nor in the Intersessional Working Group meetings. It said that the list of options mentioned in the document was not exhaustive, and that, where the discussions gave rise to proposals which were not included in the list, these should also be taken into account.
The Chair referred to the three types of substantive issues mentioned in the document. It argued that there were different possibilities: exploring the three issues one by one or trying to go deeper into one of them. It recalled that there was a proposal made by the European Union to deal with the third issue in depth and invited slightly more substantive comments to be made on that issue.
The Delegation of Brazil shared its experiences with the fair and equitable sharing of benefits in Brazil. If there was a patent application involving GR, national law required that a letter should be provided indicating where the origins of the GR were. There was a Council under the Ministry of Environment which dealt specifically with the genetic patrimony of Brazil. If TK associated with a GR in a patent application had been obtained from a tribe, the person who applied for the patent first had to show this Council the contract agreed between the applicant and the tribe. This Council would take note of it, without analyzing it, and give a number to the applicant. If the contract was found unfair or against the interests of a third party who had the same GR or TK, the general public attorney of Brazil who defended the interest of the people of Brazil, or the third party, could take legal action against that contract. There were pros and cons with such a system. According to the law of Brazil, the act of granting a patent could be reviewed at any time if it was proved that there had been a fraud, for example, that there was contract or benefit-sharing, or if the third party proved that there was some problem in the contract.
The Delegation of the United States of America appreciated the intervention made by the Delegation of Brazil. It wished to learn more about the perceived pros and cons referred to and how a patent application was treated that originally did not claim a GR but subsequently was amended to claim a GR. The Delegation of the USA questioned whether the application would be reconsidered to determine whether the proof of PIC and MAT would be required. It also asked whether the access contract would no longer be necessary when the application was amended to eliminate claims related to a GR. The Delegation suggested that, within the next three months or so, the Secretariat should collect updated information related to the sharing of national experiences, experiences with contracts and what additional capacity-building was required, and the other items identified in WIPO/GRTKF/IC/11/8(a), and provide the updated information to the next meeting of the Committee.
The Delegation of Venezuela (Bolivarian Republic of) asked the European Union, by way of the Chair, to explain its proposed procedure, and intention, of reversing the third item and making it the first.
The Chair clarified that there was no intention of converting the third item into the first, but an attempt was merely being made to identify issues which would lend themselves to brainstorming.
The Delegation of Australia supported the intervention made by the Delegation of the USA on access and benefit-sharing regimes. Australia had its own ABS regimes. Australia had a national approach to ABS for GR which operated at a State and Commonwealth levels. Because Australia had a Federal System, ABS regimes were operated at both levels and there were consistent guidelines and principles. PIC arrangements and the facilitation of mechanisms were incorporated to negotiate benefit-sharing directly with the indigenous communities.
The representative of the Eurasian Patent Organization (EAPO) said that it dealt directly with the examination of patent applications. Current patent legislation had very strict rules which contained a complex system for determining patentability and the applicant had to go through all the various stages, one by one, in order to obtain a patent. There was a disclosure requirement related to inventions in all areas. In fact, all biotechnological inventions in one way or another were connected with GR. The proposal made by Brazil raised a lot of questions. What would happen if the application was submitted under the PCT system, not on the territory of Brazil? What would the Patent Office of Brazil do if there was an application submitted by the Patent Office of USA dealing with completely different organisms? Would be such an application accepted or not? Thus, the Delegation agreed with the positions expressed by the Delegations of Russian Federation and the USA that first the Committee should concentrate on studying Options 2, 3, 4, 8 and 9. After defining the source or the origin, the disclosure requirement could be discussed. In any case, this requirement could be included in patent legislation but the Delegation was concerned that this might make the work of patent offices even more difficult if this requirement did come into force.
The Delegation of Brazil stated that it would share in detail its experience in written form. The Delegation clarified that, since it had referred to national law, the GR the Delegation had talked about were Brazilian GR.
The Delegation of Peru explained that disclosure of origin was necessary when filing a patent application as that meant that the application included clear and full details. Peru had an access regime for GRs (Decision 391) which established the conditions that had to be met to draw up an access contract for GRs between the State and the interested third party. Bodies other than IP offices dealt with that issue, but the linkage with IP offices was such that it was for such offices to request, as part of the formalities relating to patent application requirements, the access contract for the relevant GRs.
The representative of Tupaj Amaru said that the mandate of the Committee had been and was to examine the issue of GRs in the context of IP, and of sharing the benefits derived from the use of such unprotected resources. It stated that the Committee had not made tangible progress. It recalled the definition of GRs contained in the Convention on Biological Diversity (CBD), in which GRs were understood as genetic material of actual or potential value, and genetic material itself was defined as any material of plant, animal, microbial or other origin containing functional units of heredity. It maintained that it was necessary to protect GRs as their diversity constituted the material and spiritual source of the survival of humanity and in particular of indigenous peoples, that is, the sustenance of all life on Earth. It referred to the preamble of the CBD, which recognized the close and traditional dependence of many local communities and indigenous populations who had traditional ways of life based on biological resources, and the advisability of equitably sharing the benefits derived from the use of TK, innovations and practices appropriate to the preservation of biological diversity and the sustainable use of its parts. It stated that GRs contained an infinite number of living organisms and other forms of life undergoing constant change over the course of millions of years, were an essential part of the heritage of aboriginal nations and local communities, and were a part of humanity’s common heritage. It was vital that the Committee examined genetic resources not only in terms of the market, but also in terms of the spirit of preservation, protection and sustainable development for the survival of humankind. It said that the purpose of the guiding contractual arrangements was to assist parties in drawing up legislative measures, administrative measures or model provisions on access and benefit-sharing and drafting contracts, but that was a far cry from solving biopiracy, which continued with impunity under the protection of the deregulation of everything when everything had a commercial value. In practice, the technical procedures and legal terms were overly complex, and their interpretation and application were inaccessible to indigenous communities. It said that the CBD stipulated sovereign control of biological and genetic resources and the need to regulate access to such resources and benefit-sharing rights derived from their use and exploitation, in as much as the Committee had approved a work plan to draft model non-binding clauses on IP. It maintained that indigenous peoples categorically refused to include human GRs in databases, such as blood or human tissue samples, on ethical grounds and out of respect for human dignity.
The Delegation of Norway strongly supported measures which could better prevent the erroneous granting of patents. It favored an obligation to disclose the origins of both GR and TK in all patent applications. This had been implemented in Norwegian legislation for GR in 2004 and for TK in July of 2009 by amendments to the Patent Law. The Delegation highlighted that all TK should be included, not just TK connected to GR. However, a failure to meet such a disclosure requirement should not affect the validity of a granted patent. After the patent was granted, a failure to fulfill the disclosure requirement should be sanctioned outside the patent system. The Delegation also clarified that the failure to fulfill the disclosure requirement at the time of filing of a patent application did not prejudice the processing of an application.
The representative of the International Chamber of Commerce (ICC) supported the proposal made by the Delegation of the USA that there be an exchange of national experiences. The explanation by the Delegation of Brazil on the disclosure requirement had been very helpful. However, it was clearly a national system, and extending it more broadly might be difficult. Considering not all GR in Brazil were under the control of indigenous peoples, he questioned whether a patent applicant should still provide a contract when he filed a patent application, if he found a useful new micro-organism in his garden in Sao Paolo.
The Delegation of Brazil replied that the GR in the example provided was not associated with the TK of a tribe or of a traditional community, but was a part of the State’s patrimony. Thus, there should be a contract between the State of Sao Paolo or the Brazilian Government.
The representative of the Tulalip Tribes of Washington drew attention to a study that had been commissioned by the Secretariat of the CBD, entitled a “Study on Compliance in Relation to the Customary Law of Indigenous and Local Communities, National Law, across Jurisdictions, and International Law” (document UNEP/CBD/WG/ABS/7INF/5). The study contained the recommendations of three indigenous experts on the development of contracts related to indigenous peoples. He quoted from the study as follow: “Rights recognition is a precondition to contractual negotiations. All users will explicitly recognize and affirm that indigenous peoples have prior rights, including a right to self-determination within their territory. Indigenous decision-making processes will be incorporated into the negotiation of ABS arrangements, the contractual terms themselves and the dispute resolution processes arising from the contract. Indigenous people representatives will be pre-certified as the appropriate representative body. Indigenous customary law will be given equal weight in dispute resolution processes. FPIC will form a substantive part of all ABS arrangements and incorporate Indigenous customary law. All ABS arrangements will serve as positive evidence that FPIC of indigenous peoples has been obtained. All ABS arrangements will provide for a process to withdraw FPIC.” He suggested that the study could be introduced as an information document in the Committee. He also suggested that, when developing contractual approaches, there needed to be a way to address the situation where TK and GR were shared among multiple communities.
The Delegation of Switzerland stated a proper balance should be found when dealing with the three agenda items which were GR, TK, and TCEs, considering they were on an equal footing. Therefore, the present discussions on GR were welcome. The options for continuing the further work listed in paragraph 4 of Document WIPO/GRTKF/IC/11/8(a) included the issue of disclosure requirements. As other delegations, the Delegation agreed that the Committee should continue its work on disclosure requirements under the new mandate. It recalled the proposals which it had submitted on the disclosure of the source of GR and TK in patent applications in document WIPO/GRTKF/IC/11/10, in which the Regulations of the Patent Cooperation Treaty were proposed to be amended. Switzerland had already introduced such a mandatory disclosure requirement at the national level for patent applications in relation to GR and TK. Options 6 to 10 could also be suitable options for continuing the work of the Committee on GR. The Delegation supported the position expressed by the Delegation of Canada with regard to the importance of dealing with GR in the first session of the intersessional working group. It would allow the Committee to provide its constructive input on IP-related matters to the ongoing negotiations in the CBD on an International Regime on ABS, and other relevant international efforts.
The representative of the Instituto Mexicano de la Propiedad Intelectual said that Mexican legislation provided for a requirement to disclose clearly, fully and sufficiently an invention contained in a patent application, but there was no specific requirement to disclose the origin of a GR. The representative expressed its interest in hearing of the more significant experiences of the pros and cons of including a provision in patent law, which would regulate the existence, or not, of a requirement as to the origin of a GR, in order to have a better overview and to amend or not legislation in that regard.
The Delegation of Indonesia supported the proposal made by the Delegation of Senegal to have further a study of the range of options for IP-related aspects of PIC and ABS. The Delegation was of the view that it is not the task of the Committee to provide inputs to the ongoing negotiations in the CBD as it is not the mandate of the IGC. WIPO can provide its inputs to the CBD, if it deems necessary, through the WIPO Secretariat, likewise as the CBD Secretariat is present in the IGC meetings
The Delegation of South Africa supported the intervention made by the Delegation of Senegal. South Africa had made disclosure of origin a requirement under its patent law in 2005. South Africa had put in place a bioprospecting regulatory system that included not only the defensive protection of GR and TK but also the positive protection of TK and GR. The positive part was to balance the rights of researchers and the rights of knowledge holders. In that particular case, the potential for commercialization of TK and associated GR could be pursued in a proactive rather than a defensive mode. It was also indicated that the bioprospecting regulatory system had had some challenge from researchers, leading to an amendment within a short period of time that had established that the benefit-sharing agreement not be signed at the initiation of the contract but later when proof of the potential of the TK and associated GR had been put in place. There had been a slight shift, as part of the process of balancing the rights of knowledge holders and those of researchers. Finally, the Delegation informed that the South African Government had initiated an amendment of all its IP laws. The process was currently in Parliament and its aim was to make all of the IP laws include ABS requirements. The collective ownership of GR and associated TK was the issue that needed to be discussed. A contractual obligation could take care of benefit-sharing.
The Delegation of Sweden, on behalf of the European Union and its 27 Member States, discussed the third cluster because it was an area where WIPO could make progress as a body of experts. A proposal for the disclosure of the source of GR and associated TK in patent applications had been submitted as document WIPO/GRTKF/IC/8/11. According to the proposal, a mandatory requirement should be introduced to disclose the country of origin or source of GR in patent applications. The requirement should apply to all international regional and national patent applications at the earliest stage possible. The applicant should declare the country of origin. If unknown, the source of the specific GR to which the inventor had physical access and which was still known to him should be declared. If the patent applicant failed or refused to declare the required information and continue to do so after being given the opportunity to remedy that omission, the application should not be further processed.
The Delegation of China stated that the disclosure of the source of GR in the patent application would be very useful. In China, the patent law had just been amended and entered into force. A new clause requiring the disclosure of the origin of GR had been added. The Delegation wished to exchange experiences and information with other Member States.
The representative of the Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture of the Food and Agriculture Organization (FAO) stated there were two parts of the International Treaty which related to the work of the Committee. First, Part 4 of the Treaty established a Multilateral System of ABS for plant GR for food and agriculture. The system covered the 64 most important food crops for global food security and it also contained a number of IP related provisions which set out modalities for the acquisition and exercise of IP titles over genetic material. Part 3 of the Treaty related to farmers rights and included a reference to the right of protection of farmers’ TK that was relevant to plant GR. The Multilateral System established a global gene pool which included more than 1.2 million accessions of plant genetic material of the 64 crops. By ratifying the International Treaty, the contracting parties decided to exercise their sovereign rights over plant GR for food and agriculture through the Multilateral System both to facilitate access to plant GR and to equitably share the benefits arising from the use of those resources. The representative highlighted that it would be useful to recognize the Multilateral System of the Treaty in disclosure requirements in patent applications for GR in a claimed invention, if the Committee was to further work on such a requirement. In practical and concrete terms, it meant that if the disclosure requirement required a patent applicant to disclose the source of the genetic material in the claimed invention and if that material had been received by the patent applicant from the Multilateral System, the applicant would indicate the Multilateral System as the source of the GR. In addition, transfers of material within the Multilateral System occurred under a standardized private contract which had been adopted by all the contracting parties of the Treaty, namely the Standard Material Transfer Agreement (SMTA). The SMTA incorporated all standardized conditions for access and the standardized conditions for benefit sharing under the established Multilateral System. The representative briefly introduced a few technical IP related issues from SMTA operations under the Treaty. While facilitating access to food crops for global food security and climate change adaptation in agriculture, the Multilateral System set out four benefit-sharing mechanisms which were (1) exchange of information relating to plant genetic resources, (2) access to and transfer of technology, (3) capacity building for conservation and sustainable use for plant genetic resources, and (4) commercial benefit-sharing. The commercial benefit-sharing mechanism which was directly related to IP required that a certain percentage of net sales of products which included materials from the gene pool of the Treaty and which were not available without restriction for further breeding research and training should be paid to the benefit-sharing fund of the Treaty. Regarding commercial benefit-sharing, Article 13.2(d) the SMTA provided that a recipient of genetic material who commercialized a product that was a plant GR for food and agriculture and that incorporated material accessed from the Multilateral System should pay to the Benefit-Sharing Fund of the Treaty an equitable share of the benefits arising from the commercialization of that product except when such a product was available without restriction to others for further research and breeding. To the application of this provision in the SMTA, the Multilateral System had become the first fully operational global ABS system which implemented ABS all the way from the level of a public international law instrument, the international treaty, down to the level of an individual GR. Because of the length of the plant breeding cycle which took about 7 years at least to get from initial germ plasm to a new plant variety or another commercial product, there was a normal lag time from the start up of the Multilateral System until genetic material received from the system which was a product stage and generated commercial benefits that could be shared through the Treaty’s mechanism. In recognition of this natural inbuilt lag time, several contracting parties of the Treaty had made voluntary contributions to the Benefit-Sharing Fund of the Treaty in 2008. That had led to the launch of the first international multilaterally managed benefit-sharing project in the history of genetic resource law and policy that had been adopted within a binding legal architecture and approved in June of 2009. The representative also highlighted the non-commercial benefit-sharing mechanisms of the Treaty which equally entailed IP aspects and were of equal importance to the Treaty and the work of this Committee. A resolution had been adopted which referred to Article 17 and which had established a global information system on plant GR and provided that this global information system should facilitate non-commercial benefit-sharing. Two interfaces with IP policy and the operation of IP information systems were raised. First, these developments reflected that the Multilateral System addressed not only the material transfers of genetic material within the gene pool of the Treaty but also the intangible information related to the genetic material in the gene pool. The exchange of information was a non-commercial benefit resulting from the operation of the Treaty. The example of the Cassava genome was given. Finally, the representative stated that Article 9 in Part 3 of the Treaty set out recognition of farmers’ rights which included the protection of TK related to plant GR for food and agriculture. In relation to this provision, the contracting parties were invited to provide further information on their national policies and measures to implement Article 9 and to convene regional workshops on farmers’ rights. The representative concluded that it might be appropriate for the work of this Committee to be taken into account in those workshops and it might be appropriate for a report on the work of the Committee to be provided to the international treaty process.
The Delegation of Australia raised some key questions on the source of origin or country of origin, which were (1) how GR access both in situ and ex situ were treated; (2) what was a relationship between GR and TK and the invention; (3) what kind of evidence was required; (4) what was the compliance burden, penalties for non-compliance and effect on rights; and (5) what level of benefit-sharing had occurred as a consequence of these regime if known.
The Delegation of Canada requested the clarification of the status of the documents. The Delegation suggested that perhaps the documents could be renamed as working documents or issued only as revised versions.
The Delegation of South Africa requested that the Secretariat revise and reissue documents WIPO/GRTKF/IC/9/4 and WIPO/GRTKF/IC/9/5.
The representative of the Indigenous Peoples Council on Biocolonialism (IPCB) stated that options and mechanisms had to be consistent with international human rights laws, particularly those that require parties to recognize and protect indigenous peoples’ rights to the GR that originated from their territories, lands and waters, as well as to associated TK. She referred to and quoted from Articles 26 and 31 of the UN Declaration on the Rights of Indigenous Peoples as well as Erica Daes’ “Final Report on Indigenous Peoples’ Permanent Sovereignty over their Natural Resources”. Certificates of origin and disclosure requirements would fall short of protecting indigenous people rights unless there was a clear recognition of their rights to the GR originating in and from indigenous peoples territories. She concluded that instruments such as disclosure of origin in patent applications or any other IP mechanisms must prevent the usurping of their sovereignty and wrongful taking of their biological resources as well as TK.
The Delegation of Brazil appreciated the CBD briefing that had been provided by the Secretariat to the CBD.
The Delegation of Nigeria supported the intervention made by the Delegation of the African Group, particularly the need for further study on ABS and PIC. A thorough study of these issues would require amendments to major WIPO treaties and agreements. Nigeria would support all efforts for such amendments at the appropriated time, either within WIPO or outside WIPO. The Delegation highlighted the importance of following work being carried out in CBD, WTO and other UN and regional organizations.
DECISION ON AGENDA ITEM 9:
GENETIC RESOURCES
The Committee invited Member States and observers to make available to the Secretariat papers describing regional, national and community policies, measures and experiences regarding intellectual property and genetic resources before February 12, 2010, and requested the Secretariat to make these available as information documents for the next session of the Committee. The Committee requested the Secretariat to prepare and distribute, before the end of January 2010, a revised version of working document WIPO/GRTKF/IC/11/8(a), reflecting the proposed amendments and comments made on and questions posed in relation to this document at this session of the Committee. Amendments, comments and questions of observers should be recorded for consideration by Member States. The Secretariat would invite Committee participants to provide written comments on that revised version before the end of February 2010. The Committee invited the Secretariat then to prepare and distribute a further revised version of the document, reflecting the written comments made, as a working document for the next session of the Committee.
Yüklə 0.9 Mb.