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AA.review of the provisions of article 27.3(b)


1.The Chairperson recalled that, at its last meeting, the Council had received three new contributions, namely from the European Communities and their member States, Peru and the United States (documents IP/C/W/254, 246 and 257, respectively), in addition to the documents the Council already had had before it from Brazil, India, Japan, Mauritius (on behalf of the African Group), Singapore and the United States (documents IP/C/W/164, 161, 236 and 206, JOB(00)/7583 and IP/C/W/209, respectively). Members had continued their discussion on both a number of substantive issues and a number of procedural questions relating to how the Council should handle its further work on this matter. The Council also had had a discussion about the extent to which all the issues that had been raised under Article 27.3(b) should be pursued in that context or whether some might more suitably form part of the items to be taken up in the context of the review of the implementation of the TRIPS Agreement under Article 71.1. The Council had agreed that the Secretariat should re-issue the illustrative list of questions it had circulated in December 1998 upon a request from the Council and invited Members who had not yet done so to provide responses, in particular developing countries. He informed the Council that the Secretariat had re-issued this list of questions as document IP/C/W/273, which also contained the synoptic tables that had been prepared in May 1999 reflecting the responses to the questionnaire received by that time. The Secretariat had received one new response to this questionnaire, namely from Estonia, which had been circulated in document IP/C/W/125/Add.20. New papers had been received from Switzerland and Norway (circulated in documents IP/C/W/284 and IP/C/W/293, respectively).

2.The representative of Switzerland introduced his delegation's communication (document IP/C/W/284). In the view of his delegation, the review of Article 27.3(b) should focus on the scope of the exclusions from patentability as set forth in sentence one of this provision and on the sui generis system of protection of plant varieties as set forth in sentence two of this provision. Other Members had expressed their views on additional issues that Switzerland considered to be beyond the issues to be dealt with in the review of Article 27.3(b) as such but, where these additional issues had been linked to this review, they were also addressed in his delegation's communication. In the view of Switzerland, the review should first focus on the first sentence of Article 27.3(b), which had major implications on the scope of protection of biotechnological inventions. These inventions deserved the same patent protection as was accorded to inventions in other areas of technology. Therefore, the review should not lead to any lowering of intellectual property protection of biotechnological innovation. His delegation was not advocating the deletion of the first sentence of Article 27.3(b) because, as part of an agreement which established minimum standards at the multilateral level, it was a balanced provision that preserved Members' flexibility to decide whether or not to exclude from patentability plants and animals in light of their specific national interests and needs. Second, the review should focus on the sui generis protection of plant varieties. The UPOV system was in the foreground as an effective sui generis system of protection for plant varieties, but he agreed that there may be others that met the requirements of that provision, including sui generis systems of protection for farmers' varieties. Concerns had been expressed about the impact of the UPOV system on farmers and plant breeders especially in developing countries, but his delegation considered the UPOV system to be flexible enough to allowed Members to adequately address these concerns. Farmers' privilege and breeders' exemption were two important features of the UPOV system. He referred to paragraphs 26 and 27 of his communication in this respect.



3.Regarding genetic resources and related traditional knowledge in the context of patenting of biotechnological inventions, he referred to discussions in several international fora, in which Switzerland was actively participating. For example, there was the idea of a database on traditional knowledge related to genetic resources. Such a database might be of crucial importance when determining the novelty and inventive step of an invention that drew upon traditional knowledge related to genetic resources. One of the major problems that patent-granting and judicial authorities faced was the accessibility of prior art regarding this knowledge. Often, this form of knowledge was only transmitted orally and was not accessible at all by these authorities. If it was documented in writing, it might be in languages that these authorities were not familiar with. A database of traditional knowledge could substantially improve this situation. In paragraph 17 of its paper (document IP/C/W/284), his delegation had enumerated several features that such a database on traditional knowledge could have. For example: the database should be established at the international level, as only this would ensure that all, national, regional and international patent authorities and relevant judicial authorities had adequate access to information on traditional knowledge; given that the recording of traditional knowledge in a single international database would likely be a very costly endeavour, it would seem preferable to link electronically existing regional, national and local databases and create a gateway to these other databases rather than record the knowledge in a single database; such an international database should be established and administered by WIPO because it had ongoing similar automation projects; the recording of traditional knowledge in the database should be voluntary; the knowledge recorded in this database should be organized in standardized classifications; and finally, the traditional knowledge should be regularly updated to ensure that it was always recorded in its latest form. Such an international database would allow the effective integration of traditional knowledge documentation into searches of prior art, and could be an important measure to address the issues arising in the context of access to traditional knowledge related to genetic resources and sharing of the benefits arising from its use. It should complement other measures such as the Draft Guidelines proposed by Switzerland in the CBD as only a comprehensive set of measures taken by the competent international fora would ensure that the issues arising could be properly addressed. Switzerland intended to pursue this idea further in the WIPO.

4.The representative of Norway provided an outline of Norway's paper concerning the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) (document IP/C/W/293). Several WTO Members had expressed concern as to whether there was any conflict between the objectives of the TRIPS Agreement and the CBD and Norway, as a party to both agreements, had an interest in the outcome of such an analysis. The CBD recognized the fact that patents may be granted on genetic resources which the CBD was intended to protect. The wording of Article 16.5 of the CBD was a clear recognition of the fact that IPRs, including patents, might have an influence on efforts to achieve the objectives of the CBD. Therefore, Article 16.5 included an obligation for contracting parties to cooperate in order to ensure that IPRs were supportive of the objectives of the CBD. Since patents gave the owner the exclusive right to exploit patents commercially for a limited time-period, it had been claimed that these exclusive rights in certain cases may reduce access to genetic resources, for example to agricultural plant genetic resources. He said that it had also been claimed that patents might undermine attempts to ensure effective conservation and sustainable use of biological diversity, which were the two main objectives of the CBD. Specifically, it had been argued that developing countries might attach less importance to the conservation of their own genetic resources if IPR regimes allowed for the patenting of genetic resources and knowledge derived from them. This might particularly be the case if mechanisms were not in place to ensure the equitable and fair sharing of benefits arising from the use of these resources. These were the allegations, which it might be difficult to substantiate, although Norway did not reject them outright. These issues, and the fact that the two agreements dealt with genetic resources in different ways, did not in themselves indicate that there was a legal conflict between the two agreements. Nevertheless, there was a potential for conflict between the two agreements and the question of safeguarding biodiversity, including the issues of access, transfer and benefit sharing, versus the question of intellectual property rights was a complex one. There seemed to be nothing in the two agreements that would prevent each from being implemented in a way that was compatible with the other. Although the TRIPS Agreement set minimum standards, the relevant provisions of both agreements were worded in a way that made it possible to ensure consistency through flexible interpretation. However, the parties should be aware of the principles underlying the two agreements in order to ensure mutually supportive implementation in national law. Nevertheless, patents might in certain ways enhance transparency and thereby contribute to benefit sharing. When a patent was applied for, the information would eventually be made available to the public. This enabled others to benefit from the invention, for example, through further research. He referred to the submission by the European Communities and their member States (document IP/C/W/254), which had pointed out several useful aspects of patent protection of genetic resources. In Norway's opinion, the key element in ensuring consistency between the two agreements would be mutually supportive implementation of the CBD and the TRIPS Agreement. To this effect, compliance with the relevant CBD provisions should be ensured through effective implementation in the national legislation of the parties. His delegation believed that the implementation of one agreement might have a bearing on the implementation of the other. It was important that countries were aware of this when implementing the two agreements. As yet, not many parties had implemented both agreements fully. It was therefore important that sufficient priority was given to implementing both agreements in national legislation. It was especially important to implement effective measures to achieve fair and equitable sharing of the benefits from the accessed and transferred materials. In this regard, he would like to mention that Norway was framing a plan of action to implement the CBD. In addition, a committee had been appointed to propose legislation on biological diversity.

5.Regarding the relationship between TRIPS and plant genetic resources for food and agriculture ("PGRFA"), he said that it was important to note that different sectors might need different regimes for access and benefit sharing. Although the CBD set out certain basic conditions for such regimes, there was a high degree of flexibility. "Mutually agreed terms" as stipulated in the CBD did not necessarily have to mean bilateral terms. In the field of agricultural biodiversity, in particular, PGRFA, bilateral agreements for the exchange of genetic resources would be highly impractical. This was because there was a high degree of interdependence between countries with regard to such material. Consequently, a multilateral system was needed for access to, and exchange of, PGRFA, which was the reason for the ongoing negotiations in the FAO to revise the International Undertaking.



6.Regarding the option available to Members to establish an effective sui generis system for the protection of plant varieties, as an alternative to patents, there was a need to secure a sufficiently flexible interpretation of the "effective sui generis" option. Regarding a requirement to disclose the origin of genetic resources in patent applications, according to the CBD, all states that provided genetic resources had the right to make access to these resources subject to prior informed consent. However, the TRIPS Agreement had no provisions making prior informed consent a condition for achieving patent protection. An obligation under the TRIPS Agreement to disclose the origin of genetic resources when applying for patent protection could ensure transparency as regards the origin of biological materials that were to be patented and could make it easier for parties to enforce their rights to their own genetic resources when they were the subject of a patent application. An obligation of this kind could be an appropriate step towards giving effect to the provision of Article 16.5 of the CBD. The introduction of such an obligation should therefore be discussed and further analysed. He recalled Norway's reference to this question in its earlier communication (document IP/C/W/167), and that the European Communities had indicated their willingness to discuss this issue (document IP/C/W/254).

7.The representative of Brazil welcomed the circulation of communications by the European Communities and their member States, Norway, Switzerland and the United States which demonstrated a willingness by those delegations to engage in a constructive debate in the review of Article 27.3(b). Regarding the United States' communication (document IP/C/W/257), his delegation hoped that it might be a sign that the United States would soon become a Contracting Party of the CBD. He believed that the United States' interest in the relationship between TRIPS and the CBD contradicted its opposition to the consensus among other Members to grant observer status to the CBD Secretariat in the Council. The United States' general approach to implementation of the CBD seemed to be that contracts would be the most adequate way of regulating access to genetic resources and ensuring benefit-sharing between the owners and users of genetic resources. However, the CBD was clear as regarded the need to ensure that access to genetic resources was regulated by national legislation, rather than merely through bilateral contracts, in order to ensure that the objectives of benefit-sharing and prior informed consent of the CBD would be actually fulfilled. The United States had expressed its concern with the objective of clarifying rights and obligations on access to genetic resources and providing clear rules to avoid misunderstanding and confusion. Brazil had proposed, in document IP/C/W/228, to incorporate in Article 27.3(b) the following requirements: (a) the identification of the source of the genetic material; (b) the related traditional knowledge used to obtain that material; (c) evidence of fair and equitable benefit-sharing; and (d) evidence of prior informed consent from the Government or the traditional community for the exploitation of the subject-matter of the patent. Brazil had said in that document, "The proposed amendment would have the clear benefit of providing a predictable environment for governments, investors, traditional communities and researchers. As a consequence, research and development in biotechnology in developing countries would be encouraged, which would be in line with the objectives of the TRIPS Agreement to promote technological innovation and the transfer and dissemination of technology." Modification of Article 27.3(b) in this respect could address concerns on predictability, such as the one addressed by the United States, and promote biotechnology together with benefit sharing. Further, in the second paragraph of page 6 of its communication, the United States had mentioned that "It is possible that a few individuals could ignore the legal requirements and simply put a herb in their pocket, in the same way that individuals counterfeit trademarks or pirate copyrighted works…" Besides being an apparent recognition of the notion of bio-piracy, this example appeared to contradict the United States' own arguments. International and national legislation required that both biological resources and IPRs must be protected, and that such protection must be enforced by governments. There was no reason to believe that genetic resources should deserve lower levels of protection and enforcement than those provided to IPRs. The other side of the United States' analogy would be to accept that IPRs, such as patents and trademarks, could be protected and enforced merely through bilateral contracts, without the need for specific protection provided by national legislation. The United States had also referred to Article 19 of the CBD on "Handling of Biotechnology and Distribution of its Benefits", and said that "these obligations also are better met through contractual arrangements". This appeared to ignore the letter and spirit of Article 19, which stated that "each Contracting Party shall take legislative, administrative or policy measures, as appropriate, to provide for the effective participation in biotechnological research activities by those Contracting Parties, especially developing countries which provide the genetic resources for such research, and where feasible in such Contracting Parties". This went beyond the mere establishment of contractual arrangements. Additionally, the United States had ignored the fact that the provision mandated effective participation by developing countries in in situ biotechnological research activities.

8.Regarding the European Communities and their member States' paper (document IP/C/W/254), Brazil appreciated its flexible approach, although it contained a number of disappointing elements from the perspective of ensuring that TRIPS and the CBD were mutually supportive. For example, the European Communities had stated that "the main objectives of the TRIPS Agreement are to set minimum standards of intellectual property protection within WTO Members and to ensure that states make available to right holders judicial and/or administrative procedures to enforce their intellectual property rights". However, Article 7 of the TRIPS Agreement provided that the objectives of the TRIPS Agreement were "the promotion of technological innovation", "the transfer and dissemination of technology", "the mutual advantage of producers and users of technological knowledge in a manner conducive to social and economic welfare", and the "balance of rights and obligations". The European Communities' misunderstanding of the objectives of TRIPS had affected its general approach towards the relationship between TRIPS and the CBD. When Article 7 of the TRIPS Agreement was read together with Article 1 of the CBD, which set out the objectives of the CBD, it became clear that both agreements had several elements in common. Transfer and dissemination of technology was one of the objectives of the TRIPS Agreement and, according to the CBD, transfer of technology was one of the means of ensure fair and equitable sharing of benefits. The objective of a "balance of rights and obligations" in TRIPS was closely related to the objective of benefit-sharing. More importantly, such provisions demonstrated that TRIPS and the CBD could be mutually supportive. The Council should ensure that, at the implementation level, they must fulfill this mutually supportive relationship. His delegation disagreed with the reference in paragraph 11 of the EC's paper, according to which "the TRIPS Agreement does not directly refer to the subject-matter of the CBD. However, the Preamble of Article 8 refers to principles such as developmental objectives, and Article 66.2 refers to transfer of technology". This overlooked the objectives contained in Article 7 of the TRIPS Agreement. Moreover, the subject matter of Article 27.3(b) was plants, animals and microorganisms, which comprised the universe of "genetic resources". Consequently, the subject matters of Article 27.3(b) and the CBD were very close, if not the same in many cases. His delegation generally agreed with the analysis contained in paragraph 14 of the EC's paper, concerning the interaction between patents over inventions developed on the basis of a biological resource and benefit-sharing. It also agreed that the Council needed to grant the CBD Secretariat ad hoc observer status. Regarding disclosure requirements, paragraph 14 of the EC paper said that IPRs did not aim to regulate the access and use of genetic resources, the terms and conditions for bio prospecting or the commercialization of IPR-protected goods and services. Certainly, these were not objectives of the TRIPS Agreement. However, his delegation agreed with Norway that IPRs might have negative or positive effects on the sustainable access and use of genetic resources. Brazil was concerned that, in the absence of disclosure requirements, IPRs could negatively affect the protection of biodiversity, since biological resources could be unduly used in inventions patented in another country. The introduction of disclosure requirements in Article 27.3(b), as suggested by Brazil, would be an appropriate solution to ensure that IPRs had a positive effect on the access and sustainable use of genetic resources. Disclosure requirements were not a "burden" to patent holders. Patent rights needed to be properly exercised, in light of the objective of the TRIPS Agreement to strike a "balance of rights and obligations", which was closely related to the CBD's objectives. In the absence of such requirements, the real burden would fall on countries that had limited means to prevent their plants, animals and microorganisms being unduly patented outside their country.

9.Regarding the establishment of databases to protect traditional knowledge, which had been raised in the communications from the European Communities, Switzerland and the United States (documents IP/C/W/254, 284 and 257, respectively), Brazil agreed that databases could be a useful way of protecting traditional knowledge, provided that the use of the knowledge contained in such databases was properly managed. In no way should the use of such information facilitate bio-piracy. In any event, the mere gathering of information would not represent fulfilment of the objectives of Article 8(j) of the CBD, as it would not result in the "sharing of benefits arising from the utilisation of traditional knowledge, innovation and practices", as was mandated by that provision. The documentation should be backed up by specific means governing the use of such knowledge. Brazil agreed with the United States that "the provisions of Article 8(j) of the CBD and the provisions of the TRIPS Agreement, when appropriately implemented are, therefore, mutually supportive". However, it was not certain that the way in which the United States had described its views on implementation of Article 8(j) would be consistent even with the CBD's objectives.

10.The representative of the United States said that, after a preliminary review of Switzerland's paper (document IP/C/W/284), his delegation was likely to associate itself with the majority of its conclusions. He wanted to study Norway's paper (document IP/C/W/293) more closely and took note of certain observations that it contained. He hoped that Members of the Council agreed with Norway's observation that the CBD recognized that patents may be granted on genetic resources which the CBD was intended to protect. His delegation agreed with Norway that there was no conflict between the CBD and the TRIPS Agreement. With respect to benefit-sharing and the disclosure of the source of genetic resources, he referred all Members of the Council to the United States' paper introduced at the previous meeting (document IP/C/W/257), which suggested that a system to accomplish that objective could be established through contractual arrangements. He said that he might elaborate further at the next meeting on why his delegation did not believe that the patent system was a practical means of accomplishing this objective, nor of fulfilling the goals of its proponents. Responding to Brazil, he said that the United States believed that a benefit-sharing arrangement through contracts was more appropriate than legislation but it did not suggest a less effective means of protecting genetic resources than intellectual property. In fact, to establish a legal system of contracts for access to genetic resources and traditional knowledge, the United States envisaged national legislation establishing a legal framework which would indicate what provisions must be included in each contract. Countries would be free to determine what obligations parties would have to undertake if they were given access to countries' genetic resources or the traditional knowledge of their indigenous communities. He had referred to the possibility of individuals placing genetic resources in their pockets because the United States recognized that bio-piracy, and activities generally associated with that term, did in fact take place. The question was what was the best means of addressing them.

11.The representative of Peru said that the number of documents and statements from developing and developed countries demonstrated the growing interest of WTO Members in this subject. Regarding the European Communities' paper (document IP/C/W/254), Peru considered that this was a valuable contribution to the Council's debate on that issue and agreed with some of the positions it contained. Peru agreed that the legal nature and the objectives of the TRIPS Agreement and the CBD were rather different. Nevertheless, because of the interaction of these two agreements, it was necessary to ensure that the implementation of intellectual property rights, particularly the granting of patents derived from genetic resources or based on traditional knowledge, was consistent with the CBD. In this regard, Peru agreed with the European Communities that the Council should grant ad hoc observer status to the Secretariat of the CBD and strengthen the links between the WTO and CBD Secretariats. With respect to the requirements to include in patent applications a copy of the contract granting access to genetic resources and/or a copy of the licence to use traditional knowledge for inventions that incorporated traditional knowledge, Peru believed that these were valid modalities that governments could use to implement certain provisions of the CBD. Her delegation appreciated the EC's offer of assistance to developing countries to bring into force effective and appropriate legislation to facilitate access to genetic resources. This assistance should not be confined to matters exclusively concerning access to genetic resources but also extend to the protection of traditional knowledge and the establishment of databases which would facilitate its protection and avoid undue use.

12.Regarding the United States' paper (document IP/C/W/257), she offered some comments and posed some questions. The United States said that those seeking information about traditional knowledge must necessarily request permission and assistance of the local and indigenous communities possessing such traditional knowledge. However, this did not always occur in practice. The United States' paper said that "Seeking such information would also provide an opportunity to educate any communities that are unfamiliar with the basics of negotiations, contracting, various forms of intellectual property, etc., that might be relevant to them in marketing their knowledge, innovations, and practices for use by those outside their communities, and for obtaining an equitable share of the benefits arising from the utilisation of their knowledge, innovations and practices." She asked how this objective could effectively be achieved when, in many cases, those seeking information from communities were the very companies conducting research, whose purpose was to obtain the best economic and commercial terms and who did not take into account the interests of the holders of this traditional knowledge. Peru considered that fair and equitable sharing of benefits should be an obligation and not a voluntary matter. The United States' paper said that "Suitable national or local legislation or regulations could establish the legal basis for such contractual arrangements between those seeking to develop knowledge, innovations and practices into commercial products and those providing the knowledge, innovations and practices." Whilst this might be so, national legislation did not provide the international legal framework necessary for its implementation. The United States' paper minimized the problem of undue or unauthorized use of traditional knowledge but this was a great concern to developing countries. She reiterated Peru's view that the Council should evaluate the possibility of protecting traditional knowledge either through existing intellectual property regimes or through some sort of sui generis system.

13.The representative of Indonesia commented on the submissions that had been received. Regarding Peru's paper (document IP/C/W/246), Indonesia shared many of Peru's views on the protection of traditional knowledge and access to genetic resources. Indonesia was a mega centre of biodiversity, with more than 30,000 plant families and 940 species having therapeutic properties, but only 100 species being used by national industries. These potential resources tended to be under utilised and under valued. Ignorance of intellectual property by stakeholders in Indonesia led to the use of traditional knowledge without authorization from the holders. As a consequence, commercial use of traditional knowledge did not provide equitable benefit sharing. Recognizing the potential of its natural resources, Indonesia attached great importance to promoting the protection of genetic resources from misappropriation and unauthorized exploitation. Indonesia saw merit in establishing a regime of protection for genetic resources, both at the national and regional levels. Such protection might not be sufficient without an international arrangement to give effect to the intellectual property rights of local and indigenous communities, and to regulate access to genetic resources. In this context, Indonesia was interested in increasing protection for traditional medicine derived from traditional knowledge. International recognition of traditional knowledge would limit misappropriation and unauthorized exploitation of this traditional medicine. Although the protection would not be in the form of patent, it might be equal to what had been provided in Article 28.1 of the Agreement, i.e. it would prevent third parties not having the owner's consent from acts of making, using, offering for sale, or importing for these purposes that product or process, respectively. It was important to develop a regime of protection for traditional knowledge, including traditional medicinal knowledge and traditional medicine, by applying a sui generis system, new IPR regulations or an appropriate use of the existing intellectual property mechanism.



14.Regarding the papers submitted by the European Communities and their member States, Norway and the United States (documents IP/C/W/254, 293 and 257, respectively), Indonesia appreciated that those delegations had clarified their respective positions on the relationship between the CBD and the TRIPS Agreement. She welcomed the European Communities' positive views on implementation of both the CBD and the TRIPS Agreement, and their recognition of the need to protect traditional knowledge. She agreed with Norway that there should be sufficient flexibility in the implementation of sui generis plant variety protection to allow effective benefit sharing with indigenous and local farming communities. With the establishment of the CBD, it had been recognized that local and indigenous communities who had nurtured biological diversity and depended on it, had a share in promoting conservation and sustainable use of biodiversity. The CBD was a legally binding commitment to prevent over exploitation and secure the conservation and sustainable use of this biological diversity. In Indonesia's view, the relationship between CBD and the TRIPS Agreement should be mutually supportive. The implementation of the TRIPS Agreement should not prevent the implementation of the CBD ensuring conservation and sustainable use of biodiversity. In order to ensure their compatibility, further thought was required to clarify the following issues in the process of implementing both agreements. First, the implementation of Article 27.3(b) of the TRIPS Agreement in relation to biodiversity would justify individual private property rights. The TRIPS Agreement could provide rights to those who claimed that they had invented new plants, animals, microorganisms or a use for them. On the other hand, the CBD recognized national sovereignty over biological resources, which subsequently acknowledged the inherent rights of indigenous and local communities. Second, under the CBD, the use or exploitation of biological resources and traditional knowledge gave rise to equitably shared benefits, whilst under the TRIPS Agreement, patents had to be provided in all fields of technology, so that the use or exploitation of biological resources and traditional knowledge must be protected by IPRs, without any requirement to have a mechanism for benefit sharing. Third, the CBD recognized that access to biological resources required the prior informed consent of the country of origin. The TRIPS Agreement had no provision requiring prior informed consent for access to biological resources. Implementation of both the CBD and the TRIPS Agreement should be carried out in a comprehensive manner taking into account coherency among related international organizations, in order to promote their compatibility and avoid potential conflicts.

15.The representative of Venezuela recalled that her country had enormous genetic resources and traditional knowledge. It was a Member of both the CBD and the TRIPS Agreement and had common legislation with other members of the Andean Community in the areas of intellectual property, traditional knowledge and genetic resources. Venezuela's Constitution guaranteed and protected the collective intellectual property in traditional knowledge and innovations of indigenous peoples. All activities related to genetic resources and traditional knowledge were subject to benefit sharing. Traditional knowledge was essential for the discovery, preservation and use of biological diversity. It was associated with modern biotechnology and the increase in the use of genetic resources for trade purposes. The means of protection of traditional knowledge had not been particularly effective and in the majority of the cases it had been utilised without a corresponding return of benefits to the communities possessing such traditional knowledge. The Council should search for mechanisms which made it possible to prevent the illegal use of genetic resources and to share benefits. Venezuela supported Peru's proposal in paragraphs 28 and 29 of its paper (document IP/C/W/246). Venezuela's national legislation was very close to what had been proposed and it also had Andean legislation. Turning to the EC's paper (document IP/C/W/254), paragraph 4 said that the CBD and the TRIPS Agreement were "of a different legal nature". Venezuela believed that, if that were the case, then it was necessary to find common ground to ensure that both instruments were mutually supportive. Paragraph 8 dealt with the protection of genetic resources; Venezuela sought protection for genetic resources both in their natural state and those used in the production of other products. Paragraph 9 dealt with benefit sharing; Venezuela believed that there should be mutually agreed mechanisms. Progress had been made in the search for adequate forms of protection. Paragraph 12 said that "the CBD did not prohibit patents on inventions using genetic material", but she recalled that the CBD indicated the need for prior informed consent to access to resources on the basis of national legislation. Venezuela welcomed the EC's support in paragraph 14 for granting the CBD Secretariat ad hoc observer status in the TRIPS Council. Paragraph 30 referred to the role that geographical indications could play in the protection of traditional products; Venezuela agreed that this was one possible instrument for protecting traditional knowledge, and another could be a database, as Switzerland had said in its paper (document IP/C/W/284). Access to such a database had to be restricted since the inappropriate use of such knowledge had to be prohibited. Venezuela was aware that a database was extremely costly as it had considerable experience in this matter. Keeping the database up-to-date also required enormous financial efforts but was a necessary feature. Regarding Norway's paper (document IP/C/W/293), she would comment on it at the next meeting. She limited herself to observing that under the CBD genetic resources for food and agriculture deserved special and differential treatment because of the interdependence among countries in relation to them. It was important to keep up to date about this and follow the negotiations on the FAO International Undertaking. However, issues of scope, access and farmers' rights were still under negotiation and the future legal status of the International Undertaking was still unclear. Venezuela agreed with Norway that it should be binding.

16.The representative of European Communities, referring to the re-issuance by the Secretariat of the illustrative list of questions (document IP/C/W/273), urged the Chairperson to repeat his request that developing country Members provide responses to the Council because it would be extremely useful for this exercise. He welcomed Switzerland's paper (IP/C/W/284). He drew attention to its Section II, which contained useful elements with respect to the definition of the scope of the exclusions from patentability in Article 27.3(b), first sentence, and agreed on the need to protect biotechnological inventions adequately. Paragraph 4 listed some examples where biotechnology might be of use, including in the development of new pharmaceuticals necessary to treat illnesses, which was relevant to agenda item N – "Intellectual Property and Access to Medicines". Section III referred to access and benefit sharing and traditional knowledge and prior art. These were very relevant issues, which his delegation had discussed in its own paper (document IP/C/W/254). The proposal for a database of traditional knowledge was not a completely new idea. Switzerland's suggested parameters for consideration of such a database were useful, if such database were considered beneficial. It would not provide a level of protection, but might be a useful instrument in combatting bio-piracy, in particular when the information in the database were available to patent examiners. Section IV, which dealt with the protection of plant varieties, was a very useful elaboration on some key elements which had been underlined earlier in discussions under this agenda item, particularly at the beginning of the review two years earlier when the Council had discussed the scope of Article 27.3(b). His delegation agreed with Switzerland that the UPOV Convention provided an effective sui generis system. Turning to Norway's paper (document IP/C/W/293), much of it was in parallel with the views expressed by his delegation in its own paper (document IP/C/W/254), particularly with respect to the relationship between the TRIPS Agreement and the CBD. Section 3 of Norway's paper referred to national implementation and suggestions as to what countries could do within their own legal sphere. In the absence of international rules it was certainly useful that those countries who believed that it was important to provide protection should start providing it within their national legislation. Section 4 dealt with the relationship between plant genetic resources for food and agriculture and the TRIPS Agreement. It referred to the ongoing negotiations within FAO to review or revise the International Undertaking. This was an important piece of work. The negotiations had not yet been concluded, but his delegation would insist that their results be fully TRIPS-compatible. Section 6 referred to the question of requiring the disclosure of origin of genetic resources in patent applications. His delegation had already explained its position on this issue in a balanced manner. Further work was indispensable in this area and he wanted to come back to that issue when the results of that further work were available.

17.Responding to Brazil's comments on paragraph 5 of his delegation's paper (document IP/C/W/254), he saw absolutely no contradiction between the objectives of the TRIPS Agreement that it listed and those set out in Article 7 of the Agreement. His delegation's paper had emphasized some particular aspects but they did not contradict Article 7. He took note of the positive comments made by Brazil, Indonesia and Peru on several aspects of the paper. He also took note of Brazil's comment that Switzerland's ideas with respect to a database merited exploration. His delegation was certainly ready to work with these delegations in order to see whether they could make further progress. As Peru had highlighted, the European Communities were willing to work with countries interested in obtaining technical assistance, and to discuss what sort of technical assistance could be provided. Their expression of interest should not be interpreted in a narrow manner.



18.The representative of Singapore referring to his delegation's non-paper on this issue (JOB(00)/7583) said that there appeared to be a general feeling that the TRIPS Agreement and the CBD should be looked at in a harmonious fashion, and that the Council should look at how to make them work together. Norway's paper (document IP/C/W/293) had made the point that the link between the two instruments was in the area of patents. Obviously, Article 27.3(b) of the TRIPS Agreement was an important provision. His delegation believed that it should be maintained and that there should be no lowering of standards of protection of biotechnology. Another very important issue for countries with large amounts of biodiversity and genetic resources, was that there should be benefit sharing, which was basically mentioned by the CBD. Singapore was a party to both agreements. There were important ideas to explore further to see how both instruments could be implemented in a way which was mutually supportive, that tried to protect biotechnology but at the same time ensured an equitable system of benefit sharing to the countries of origin of these resources. As to the question of requiring the disclosure of origin of genetic resources in patent applications, Singapore wanted time to study it further.

19.The representative of Korea recalled that his delegation, at earlier meetings, had touched on the relationship between the TRIPS Agreement and the CBD in general terms. At the present meeting he wanted to address some related issues. First, on the issue of genetic resources and benefit sharing, he said that these notions seemed to combine together to constitute essential elements for sustainable use and continue the development of the biotechnology industry. It was important to ensure that intellectual property rights, such as patents, should be based upon a legitimate use of genetic resources and that the benefit deriving from such intellectual property rights should be shared with providers of these genetic resources. Preventive measures against the possible abuse or misuse of genetic resources by unauthorized persons should be put in place in order to protect the rights and benefits of holders of these resources. All of these efforts required cooperation among Members and relevant international organizations. It was vital to collect and share as widely as possible legal, administrative and policy measures or regulations related to access to genetic resources and benefit sharing which were in force in each Member. In this way, the Council could aim to respect both the rights of holders of genetic resources and those of inventors, and work out optimal ways at the international level of facilitating access to genetic resources and benefit sharing which could be acceptable to all Members. With regard to technical issues related to patent protection, such as definitions of microorganism and patentable subject-matter, he said that the distinction between plants, animals and microorganisms was well established under many international conventions including CBD. The definition of microorganism seemed to be properly interpreted in light of objectives and intentions. On the question of requiring the disclosure of origin of genetic resources in patent applications, whilst it could ensure transparency and benefit sharing, it would impose an additional burden on patent applicants and necessitate a readjustment of the balance of interests established in the TRIPS Agreement among applicants and other interested parties. Therefore, further detailed study was needed in view of these positive and negative aspects. Regarding protection of plant varieties, he noted that the Secretariat summary paper (document IP/C/W/273) indicated that most Members who had responded to the checklist fulfilled the requirements of the UPOV Convention. Regarding traditional knowledge, the concept set out in Article 8(j) of the CBD was clear but it was not easy to apply in practice. The question of its scope should be given priority, as well as enhancing Members' understanding of specific cases of the protection of traditional knowledge. Korea believed that it was useful for the Council to have information on national systems and experience in the protection of traditional knowledge. Documentation and establishment of a database of traditional knowledge would give patent examiners easier access to related prior art and enhance the quality of patent examinations.

20.The representative of Zimbabwe said that the African Group was still studying comments it had received from other delegations on its paper dealing with, among other issues, the relationship between the CBD and the TRIPS Agreement and the provision in Article 27.3(b) of the TRIPS Agreement (document IP/C/W/206). The African Group would provide a detailed response to those comments and also comment on papers submitted by other Members in due course. He also reiterated the following points. First, his delegation was convinced that the distinction between plants and animals and microorganisms for the purposes of patentability in Article 27.3(b) was unscientific and that Article 27.3(b) should be amended in the manner suggested in its paper. There was currently an African Model Law on plant variety protection which the Group considered effective and they welcomed alternatives to the currently available international instruments providing for sui generis plant variety protection. Second, his delegation remained convinced that the TRIPS Agreement, especially the criteria for patentability, contradicted and frustrated the provisions of the CBD, particularly as regarded the exploitation of genetic and biological resources. A more detailed exploration and elaboration of these ideas would soon be available.

21.The representative of Japan commented on the papers presented by Switzerland and Norway. The views and the positions expressed by Switzerland in its paper (IP/C/W/284) seemed to be in line with those expressed by Japan in its paper (IP/C/W/236). Japan agreed with Switzerland that the review of Article 27.3(b) should focus on the two issues set out in the first and second sentences of the provision, and that some of the discussion under this agenda item was outside the mandate of the review. Japan agreed with Switzerland regarding the need for adequate patent protection for biotechnology and opposed any lowering of the level of protection. Regarding the international database of traditional knowledge related to genetic resources, Japan agreed with Switzerland that such a database could improve the current situation. Oral traditional knowledge was not easily accessible by patent-granting authorities. The database should primarily be for the purpose of conducting searches of prior art, but it should not constitute a prerequisite for the existence of any rights regarding traditional knowledge nor should it provide any legal basis for benefit sharing. Regarding standardized classification within the database, as suggested by Switzerland, Japan considered that this should be handled at the relevant sub-forum of WIPO, which had already studied this in preliminary discussions. Various options should be explored by experts in order to determine how best such a database could be standardized. Turning to Norway's paper (document IP/C/W/293), he made some preliminary observations. First, Japan agreed with Norway that there was no legal conflict between the CBD and the TRIPS Agreement, although some interactions existed between them. Japan also agreed that the consistency between the two agreements must be ensured at the level of national legislation and practice. Regarding the disclosure of the origin of genetic resources, Japan did not favour inserting a provision in the TRIPS Agreement obliging patent applicants to disclose the origin of genetic resources. He reiterated the view expressed in his delegation's paper that this kind of obligation would go beyond the existing TRIPS obligations and implied a rewriting of the Agreement. Members should be cautious about rewriting the Agreement because the current provisions struck an appropriate balance between rights and obligations of inventors or applicants and third parties, which was the result of a long negotiation in the Uruguay Round.

22.The representative of Malaysia said that the new contributions by the European Communities and their member States, Norway and Switzerland represented those delegations' interest in addressing issues that had been raised under this agenda item. In particular, Malaysia noted the interest expressed in the area of patentability of biotechnology. Switzerland's paper (document IP/C/W/284) had also raised this issue. While they recognized the need to retain the flexibility regarding patentability of plants and animals in Article 27.3(b), there was also a need to apply the criteria of patentability in Article 27.1. These criteria determined whether something could be patented. In the area of biotechnology, the Council needed to continue deliberations to have a clearer understanding of the issues, for example regarding what stages of "development" of genetic resources, genetic parts and components constituted "discoveries" and what were "inventions". The EC paper (document IP/C/W/254) said that genetic resources must be isolated from their natural environment or produced by means of a technical process to satisfy the criteria of patentability. She asked whether this was a new version of the criteria of patentability or whether it was consistent with those set out in Article 27.1. Regarding the study of the relationship between the CBD and the TRIPS Agreement, this had been proposed mainly as an approach to address the issue of bio-piracy and the protection of traditional knowledge. Some delegations believed that these issues could be addressed to a large extent by inclusion of procedures recognized in the CBD in patent procedures, such as disclosure requirements, prior informed consent and benefit sharing. Other delegations had proposed that these requirements be incorporated in national legislation. Another approach was a database, as set out in Switzerland's paper. She invited delegations to express their views on how effective these approaches could be toward regulating access to genetic resources and protecting traditional knowledge.

23.The Council took note of the statements made and agreed to revert to this matter at its next meeting.

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