WORLD TRADE

ORGANIZATION

RESTRICTED

IP/C/M/44

19 July 2004

(04-3099)

Council for Trade-Related Aspects

of Intellectual Property Rights

MINUTES OF MEETING

Held in the Centre William Rappard

on 16 June 2004

Chairman: Mr. Joshua C.K. Law (Hong Kong, China)

The present document contains the record of the discussion which took place during the TRIPS Council meeting held on 16 June 2004.

Subjects discussed Page nos.

A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT 2

B. REVIEW OF NATIONAL IMPLEMENTING LEGISLATION 3

C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 4

D. RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY 4

E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE 4

F. REVIEW OF IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1 10

G. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 11

H. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 12

I. REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT 23

J. TECHNICAL COOPERATION AND CAPACITY-BUILDING 24

K. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 25

L. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS 25

M. OTHER BUSINESS 26

A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT

1. The Chairman drew attention to the latest Secretariat note reflecting the status of the notifications of laws and regulations under Article 63.2 received from Members whose transitional periods under Article 65.2 or 65.3 had expired on 1 January 2000 or who had acceded to the WTO after that date (JOB(04)/68). The note showed from which of the Members in question notifications had been received by 3 June 2004. Since the Council's meeting in March 2004, Swaziland had notified its TRIPS implementing legislation. Among the 81 Members in question, there remained three who had not yet submitted any notification concerning their implementing legislation, namely Papua New Guinea; Saint Kitts and Nevis; and Saint Vincent and the Grenadines. He recalled that in the previous year, as requested by the Council at its meeting in February 2003, his predecessor had written to the Members that had not been represented at that meeting and which had unfilled notification obligations under Article 63.2. Since then, the Secretariat has had informal contacts with the three delegations that had not yet submitted any notification. He suggested that the Chair once again write to these three Members concerning the notification of their TRIPS implementing legislation.

2. Informing the Council about the supplements and updates to earlier notifications of laws and regulations that had been received since the March meeting, the Chairman said that the Czech Republic had notified a new Trademark Law and an Act on Courts and Judges; El Salvador had notified its "Law on Marks and Other Distinctive Signs"; Georgia had notified a list of geographical indications for wine, alcoholic beverages and mineral water; Germany had notified a "Law to Strengthen the Contractual Position of Authors and Performing Artists" and provisions of certain other laws in the area of enforcement; Hong Kong, China had notified recent amendments to its laws and regulations in the area of patents, designs and trademarks together with explanatory notes; Japan had notified an updated text of its "Customs Tariff Law"; Mexico had notified certain amendments to its industrial property laws and regulations; Panama had notified amendments relating to its criminal and judicial codes; Saint Lucia had notified legislation enacted or amended since the review of its legislation in 2001; and Tunisia had notified that it had ratified the Budapest Treaty. These notifications were being circulated in the IP/N/1/- series of documents. Furthermore, Armenia had provided its responses to the Checklist of Issues on Enforcement (IP/N/6/ARM/1).

3. The Chairman urged those Members whose initial notification remained incomplete to submit the outstanding material without delay. He also reminded Members of their obligation to notify any subsequent amendments of their laws and regulations without delay after their entry into force.

4. As regards notifications of contact points under Article 69, he said that, since the March meeting, notifications of new contact points had been received from Latvia and Swaziland. Furthermore, an updated notification of a contact point had been received from Angola. These notifications had been circulated in document IP/N/3/Add.7. There were now 120 Members who had notified contact points under Article 69.

5. The Council took note of the information provided and agreed to proceed as suggested by the Chair.

B. REVIEW OF NATIONAL IMPLEMENTING LEGISLATION

(i) Follow-up to reviews already undertaken

6. The Chairman said that the Secretariat had updated its informal note that listed all the outstanding material required to complete the reviews that the Council had already undertaken (JOB(04)/67). The table attached to the note listed the 15 Members whose reviews had been initiated at the Council's meetings since April 2001 but which remained on the Council's agenda. The table referred to submissions, including both responses and follow-up questions, received by 7 June 2004.

7. He recalled that, at its last meeting, the Council had initiated the review of national implementing legislation of the Former Yugoslav Republic of Macedonia. Since that meeting, Switzerland had posed one follow-up question to the Former Yugoslav Republic of Macedonia (IP/C/W/419/Add.1).

8. The Chairman turned to the remaining 14 Members, namely Congo; Cuba; Egypt; Fiji; Grenada; Mauritius; Nigeria; Pakistan; Qatar; Saint Kitts and Nevis; Saint Vincent and the Grenadines; Suriname; Swaziland; and Zimbabwe.

9. The representative of Cuba said that she had nothing new to add to what her delegation had said in the last Council meeting with regard to Cuba's pending legislation. Her delegation intended to notify the laws, currently pending before the Council of the State, as soon as they had been adopted.

10. The representative of Egypt regretted that her delegation had not yet been able to submit responses to the outstanding questions and hoped to be able to do so in the near future.

11. The representative of Nigeria said that his delegation would provide responses to the outstanding questions before the next Council meeting.

12. The representative of Pakistan said that his capital had assured him that a response to the one outstanding question would be submitted before the next Council meeting.

13. The Chairman said that the Secretariat note also listed seven Members whose reviews had already been deleted from the Council's agenda on the understanding that any delegation should feel free to revert to any matter stemming from the review at any time. In this connection, certain questions had been raised with regard to the implementing legislation of these countries. Since the circulation of the note, China and Malaysia had provided responses to the follow-up questions that Japan had posed to them in relation to the responses that they had provided in the context of their regular reviews (documents IP/Q/CHN/1/Add.2 and IP/Q/MYS/1/Add.1, respectively).

14. The representative of Argentina said that responses to the pending questions would be communicated as soon as her delegation had received them from her capital.

15. The representative of Japan said that he appreciated the efforts made by China to reply to the questions posed by Japan. His delegation was examining these responses, and wished to reserve its right to put additional and follow-up questions to China, if necessary.

16. The Chairman noted that, since its last meeting, the Council had made very little progress in receiving the remaining outstanding material and thus completing the follow-up to the last pending reviews. He once again urged the delegations concerned to provide the outstanding material, so as to allow the Council to complete the follow-up to these reviews. He suggested that the Council request the Secretariat to update its note on pending reviews before the next meeting.

17. The Council took note of the statements made and agreed to proceed as suggested by the Chair.

(ii) Review of legislation of Armenia

18. The Chairman recalled that, at its meeting in June 2003, the Council had agreed to review the legislation of Armenia, a newly acceded Member, at its meeting in March 2004. However, at that meeting, the Council, upon a request from the Government of Armenia, had decided to postpone the review to the present meeting. Armenia's notification of its TRIPS laws and regulations had been circulated in document IP/N/1/ARM/1, and the texts of the notified laws in the relevant law series of documents. Its responses to the Checklist of Issues on Enforcement had been circulated in IP/N/6/ARM/1. Armenia had received questions from Switzerland (IP/C/W/419). Its responses to these questions had been circulated in document IP/C/W/422.

19. In accordance with the standard procedures, the delegation of Armenia provided a brief introductory overview of the structure of its legislation in the areas covered by the TRIPS Agreement and of the changes that it had had to bring about in order to make the legislation compatible with the Agreement. The record of the introductory statement as well as the questions put to it and the responses given (including responses to any follow-up questions posed after the meeting) would be circulated in a document with the following symbols: IP/Q/ARM/1, IP/Q2/ARM/1, IP/Q3/ARM/1 and IP/Q4/ARM/1.

20. The representative of Switzerland commended Armenia for its efforts to bring its legislation into conformity with the TRIPS Agreement and other international agreements. He thanked Armenia for its responses to the questions posed by Switzerland. The responses to these questions contained the information his delegation had been seeking. He indicated that he would submit two follow-up questions to Armenia.

21. The Chairman requested that written copies of these follow-up questions be provided to the delegation of Armenia and the Secretariat. In accordance with the standard procedures, responses to them should be provided within eight weeks of the meeting. He suggested that the Council take note of the statements made and revert to the matter at its next meeting.

22. The Council so agreed.

C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(b)

D. RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY

E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE

23. The Chairman suggested that, since the practice in the Council's past meetings had been that delegates address these three agenda items together, the Council again take them up at the same time. He informed the Council that it had received a communication from Switzerland (IP/C/W/423), which contained additional comments by it on its proposals submitted to WIPO regarding the declaration of the source of genetic resources and traditional knowledge in patent applications.

24. Reporting on the consultations he had held on these three agenda items, he recalled that, at its meeting in March 2004, the Council had had extensive discussion on how future work on these three agenda items should be organized. At that meeting, the Chair had concluded that it might be necessary for his successor to hold consultations before the present meeting on this matter. Accordingly, he had held a series of consultations on this subject. These consultations had confirmed that there was a common view that it would be useful to find a way of having a more structured and focused discussion in the TRIPS Council on these matters. A number of options for how this could be done had been put forward and discussed. He had detected some signs of flexibility and a broad willingness to engage in a process of identifying areas of convergence in regard to the provisions of Article 27.3(b), as had been suggested by the African Group. However, he regretted that, despite the efforts made by all parties, the consultations had not developed to a point where he would have been able to put a set of suggestions to the Council at this meeting.

25. The representative of Switzerland said that document IP/C/W/423 contained additional comments on the Swiss proposals to amend the Regulations of the Patent Cooperation Treaty (PCT), which had also been submitted to the sixth session of WIPO's Working Group on Reform of the PCT in May 2004. He recalled that the proposals would explicitly enable national patent legislation to require patent applicants to declare the source of genetic resources and traditional knowledge in patent applications, if their inventions were based on such resources or knowledge. The additional comments on the proposals concerned the use of terms, the concept of the source of genetic resources and traditional knowledge, the scope of the obligation to declare the source in patent applications, and possible legal sanctions for the failure to disclose or the wrongful disclosure of the source. By submitting the additional comments to the TRIPS Council, Switzerland aimed at informing the TRIPS Council of its efforts in the WIPO's Working Group on Reform of the PCT. He noted that the latest communication contained in document IP/C/W/423 complemented the two previous communications contained in documents IP/C/W/284 and IP/C/W/400/Rev.1.

26. With regard to the disclosure requirements under patent law, he said that paragraph 8 of Decision VII/19, adopted by the seventh meeting of the Conference of the Parties of the CBD in February 2004, invited WIPO to address issues regarding the interrelation between access to genetic resources and disclosure requirements in intellectual property rights applications. It was his delegation's view that WIPO should make significant progress on these issues and report the result of its work to the CBD in time. By submitting the additional comments on its proposals to the sixth session of the Working Group on Reform of the PCT, Switzerland intended to actively contribute to the work of WIPO in this regard. He said that the work of the TRIPS Council in the context of paragraph 19 of the Doha Ministerial Declaration should benefit and draw upon the relevant work being carried out by WIPO. This would help avoid duplication of efforts and prevent conflicting outcomes.

27. The representative of India welcomed the Chair's efforts in undertaking the informal consultations to structure the discussion on the basis of the checklist of issues identified by a group of developing countries to pursue their proposal on the disclosure of the source of genetic material and associated traditional knowledge and evidence of benefit-sharing. He said that this group of countries remained committed to pursue their proposal. They were encouraged by the widespread support received for the checklist, although consensus could not be reached on structuring the Council's work on the basis of the checklist. He reiterated his delegation's openness to incorporating other related issues in the checklist or exploring different ways which could help the Council focus its discussion in a result-oriented manner. Regarding the new submission by Switzerland, he said that it would help the Council address the concerns relating to the procedural issues involved in patent applications and the disclosure of the source of origin of biological materials.

28. The representative of the European Communities said that further discussions on the three agenda items should be guided by three principles: first, WTO Members should be faithful to the mandate under paragraph 19 of the Doha Ministerial Declaration; second, discussions should be conducted in a result-oriented manner to ensure that the implementation of the TRIPS Agreement and the CBD were mutually supportive, for which it was important that WTO Members, especially the demandeurs should clarify what result they wished to obtain; third, Members must focus discussions on a limited number of issues instead of continuing to have philosophical discussion on all the issues related to intellectual property and the CBD. He said that the issues of the disclosure of origin, farmers' exceptions and the protection of plant varieties were good candidates for such a focused discussion. With regard to traditional knowledge and folklore, he said that Members could deal with certain disclosure issues related to traditional knowledge and folklore, but that it was difficult to start discussions on setting up an international regime for the protection of traditional knowledge. Since Members seemed to have reached an agreement to have a focused discussion, he urged Members to start identifying the issues they should focus on. Referring to the Swiss proposals which had been submitted to WIPO's Working Group on Reform of the PCT, he said that his delegation would come back to them at the Working Group's next meeting in November 2004.

29. He then said that he would make preliminary comments on the checklist of issues contained in document IP/C/W/420, without prejudging the outcome and without prejudice to the EC's positions in possible formal negotiating processes in the WTO or elsewhere. Regarding how an obligation for the disclosure of country and source of origin of the biological resource and associated traditional knowledge used in the invention would help in better examination of patents and in preventing cases of bad patents and what the meaning of disclosure of source and country of origin of the biological resource and of the traditional knowledge used in the invention was, he said that it was the view of his delegation that "disclosure of source or origin" referred to a requirement that a patent applicant should submit certain information to the patent office as regards the source and/or geographical origin of the genetic resource or traditional knowledge used in his biotechnological invention. This requirement could be calibrated in various ways according to the scope of the requirement, the type of information required and the legal consequence of non-respect of the requirement. He said that such a requirement should be sufficiently flexible to take account of the fact that the patent applicant might not reasonably know the geographical origin of the genetic resources used in the invention. For this reason, his delegation preferred to use the term "disclosure of source of genetic resources". He said that, in principle, all applicants should know the source of genetic resources or traditional knowledge. However, in certain circumstances it might be impossible or unreasonably burdensome for the applicant to investigate the entire chain backwards to the origin. An applicant should only be requested in good faith to reveal the best information available or known to him.

30. Regarding the advantage of the disclosure requirement, he said that this requirement, provided it was properly calibrated, would contribute to mutual supportiveness between intellectual property systems and access and benefit-sharing regimes for several reasons. First, the disclosure requirement would help the country who provided access to genetic resources to monitor and keep track of compliance with access and benefit-sharing rules, as well as with contractual arrangements between providers and users of genetic resources. Source countries would be informed of the patent application which incorporated genetic resources or traditional knowledge through foreign patent offices. This would enable them to check whether patent applicants respected national rules and contracts on access and benefit-sharing and to detect commercial benefits from the use of genetic resources. Second, the disclosure requirement would increase confidence among bio-collectors and biodiversity rich countries and indigenous communities. These countries or communities would generate less complex or burdensome but more effective national access and benefit-sharing regimes, thus creating a win-win situation for both providers and accessors. Third, the disclosure requirement would help to prevent inappropriate patenting of genetic resources or traditional knowledge because patent offices could establish more accurate prior art through more focused search. Lastly, the disclosure requirement would act as a strong incentive for patent applicants to comply with domestic rules on access and benefit-sharing, if they existed, and/or contractual arrangements. In sum, he said that the disclosure requirement would act as a supportive measure to biodiversity law at the national level to ensure transparency and to enable source states to check whether their national rules had been respected. It would also contribute to the effective implementation of the CBD. Furthermore, he said that an essential complementary measure to make the disclosure requirement effective would be the introduction of a simple notification procedure in patent offices. When a patent office received information on the source of genetic resources or traditional knowledge, it could notify this information to the clearing-house mechanism under the CBD. The information would therefore be available to all CBD parties as well as to the public. The introduction of such a procedure should not lead to an unnecessary administrative burden for the patent office.

31. As regards what the legal effect of wrongful disclosure or non-disclosure would be, he said that the effect could lie both within and outside patent systems, such as the one suggested by the Swiss proposal. He said that a requirement would be effective only if non-respect of it was sanctioned. However, at this stage, it was the European Communities' view that such sanction should lie outside patent law or should be self-standing, such as civil law or administrative sanctions. He informed the Council that this issue was at present under further internal discussion as a consequence of the European Commission's Communication of December 2003 on the implementation of the Bonn guidelines.

32. As regards the question of on whom the burden of proof should lie, he said that applicants should be requested to provide all reasonably available evidence of the source and/or geographical origin of genetic resources and traditional knowledge. It was up to those who might wish to contest such disclosure in an administrative procedure or before a court to provide contrary proof according to usual rules.

33. Regarding the inclusion of the proposed obligation of disclosure of source and country of origin and associated traditional knowledge in the TRIPS Agreement, he said that his delegation did not exclude the possibility of inserting such an obligation in the TRIPS Agreement, provided it was properly calibrated. However, he thought that, at this stage, it might be premature to start discussions on how and where such a requirement should be set in the TRIPS Agreement. The answer to this question would depend on what substance could be agreed on. There were many options, such as inserting a new article or a new obligation to the existing articles of the TRIPS Agreement.

34. Turning to the disclosure of the evidence of prior informed consent and benefit-sharing under relevant national regimes, he said that, at this stage, his delegation saw serious problems with the introduction of a system whereby patent applicants were required to provide such evidence. First, it was difficult for patent offices to judge whether foreign country legislation on access and benefit-sharing had been complied with. The main function of patent offices was to ensure that patentability requirements were met, which was a difficult task, especially in the field of biotechnology. Requesting patent offices to verify whether patent applicants had respected all legal rules related to the material used in their inventions would seriously overburden patent offices and create legal interpretation problems. He said that the patent office was not required to check whether the applicant had paid VAT on the lab material used for the invention or whether he had respected the legal requirement for the stockpiling of the chemicals used in the research activity although this requirement was important to ordre public. Therefore, he said that although it would be reasonable to entrust patent offices with the task of collecting information on the source of genetic resources or traditional knowledge and transmitting it to a clearing-house mechanism, checking compliance with foreign access and benefit-sharing rules would be one step too far at this stage. Second, he said that many countries did not yet have national legislation on access and benefit-sharing and were not in the position to deliver the certificate of origin, which made the requirement of the disclosure of the evidence of access and benefit-sharing more difficult, if not impossible, to manage.

35. With respect to how furnishing the evidence of prior informed consent would facilitate achieving the objectives of the CBD of ensuring prior informed consent and a harmonious relationship between the CBD and the TRIPS Agreement and whether contractual arrangements for ensuring prior informed consent and benefit-sharing could suffice to achieve the objectives of the CBD in this regard, he said that effective implementation of the CBD resided in a combination of legislative, regulatory and contractual approaches.

36. Regarding how the evidence of prior informed consent through approval of authorities under the relevant national regime should be provided for, he said that a uniform approach in the form of uniform certificates as proposed by several countries and non-state actors could be a solution. He said that proposals to this effect had been made inter Le fichier est trop volumineux pour cette option. Seul les 30000 premiers charactères seront affichés.