30. The representative of India requested that the communication from Brazil, China, Cuba, India, Pakistan, Peru, Thailand and Tanzania to the General Council and the Trade Negotiations Committee, circulated as document WT/GC/W/564/Rev.1 and TN/C/W/41/Rev.1, also be circulated as a TRIPS Council working document.1 He drew the attention of the Japanese delegation to the several contributions made by developing countries which he said refuted the course of action suggested by Japan.
31. He said that Norway's proposal showed its recognition of the development dimension of the disclosure issue, which was in accordance with the instructions contained in paragraph 3 of the airgram convening the meeting. His delegation was ready to engage in text-based negotiations based on all proposals on the disclosure requirement in the TRIPS Council or other bodies of the WTO. He said that, being put forward by a developed country, the proposal showed growing convergence on the need for mutual supportiveness of the TRIPS Agreement and the CBD, and on a TRIPS amendment being the appropriate solution for the end of July 2006. The proposal recognized the need for a substantive obligation on patent applicants to disclose the source and country of origin of genetic resources and traditional knowledge, evidence of prior informed consent and benefit sharing. The failure to comply with such an obligation would be punished. It also recognized the need for consultations to develop a text for further negotiations.
32. Turning to the US submission (IP/C/W/469), he said that he appreciated the continued US engagement on these issues. He said that he was happy to note that, despite not having ratified the CBD, the United States shared the objectives of the CBD and was ready to take steps to implement such objectives at the national level. He said that the US had asserted that the absence of provisions against misappropriation in the TRIPS Agreement did not indicate conflict with the CBD, that it was not the lack of safeguards in the Agreement that led to erroneous patents but the lack of national systems to regulate the use of genetic resources, and that the disclosure proposal would create legal uncertainty and other negative consequences. He responded that the absence of such provisions against misappropriation in the Agreement promoted the grant of patents based on genetic resources and associated traditional knowledge without recognizing the CBD objectives, highlighting the urgent need for action towards mutual supportiveness of the two instruments in line with the instructions contained in Article 16.4 of the CBD. Unless the CBD objectives were integrated within the patent system, these two instruments would run counter to each other. The objective of ongoing efforts was to establish adequate procedural norms within the TRIPS Agreement to prevent bad patents, to prohibit misappropriation, and to ensure that the private rights created through the Agreement did not trump the benefit-sharing mechanisms set up by governments in implementing their CBD obligations.
33. Article 29 of the Agreement stipulated certain minimum procedural requirements before the grant of patents. Developing countries were demanding that these procedures be supportive of the objectives of the CBD. These demands were in consonance with Article 7 of the Agreement, which called for the protection of intellectual property rights in a manner conducive to enhancing social and economic welfare. He further said that one of the aims of the disclosure requirements was to ensure that patents were only granted over those inventions which fulfilled the criteria of novelty and inventive step. Such requirements gave useful parameters of existing prior art that would help patent offices to establish inventiveness. This objective could be achieved only through incorporating the disclosure requirements in the Agreement, and not through domestic contract-based access and benefit-sharing regimes, as they only governed the conditions of access and benefit sharing. The disclosure requirement would also help patent offices identify the holder of genetic resources or the country of origin and ensure that the knowledge was not misappropriated.
34. Other solutions, such as searchable organized databases, post-grant opposition and re examination procedures as suggested by the United States, were costly, inadequate and ineffective considering the unique nature of inventions based on genetic resources and associated traditional knowledge. Further, given that holders of genetic resources and traditional knowledge were highly dispersed, organized databases were not probable in the short term. Therefore, this was an impractical suggestion. In any case, oral traditional knowledge could not be included in databases in the short term. Post-grant opposition and re examination proceedings were time consuming and unaffordable for the poor and disadvantaged resource holders.
35. He said that he appreciated the US acceptance of a requirement to disclose information material to patentability. An international disclosure obligation would be material to patentability and would help patent examiners in their search of prior art, and would prevent bad patents by adding to existing searchable databases. It would give useful hints to the patent office in ascertaining novelty and non obviousness and indicate the country which needed to benefit from the commercialization of genetic resources. It was important to trace the true existing knowledge taken from the holder of traditional knowledge in order to establish the inventive step and ensure that bad patents were not issued. This would also ensure that due credit and benefits were given to such holders in cases where the new invention was based on the information provided by them. Thus the disclosure requirement was an effective way to ensure the mutual supportiveness of the TRIPS Agreement and the CBD as it provided a means to prevent misappropriation through patents granted without ensuring benefits to the providing country.
36. There might be different ways in which misappropriation of genetic resources and associated traditional knowledge took place. When there was misappropriation through patenting, bypassing the domestic access and benefit-sharing law, it was not possible to provide effective remedies through domestic law to prevent the abuse of the patent system when the use of such resources or knowledge took place beyond the borders of the providing country. Remedies should be found within the patent system of the country which had issued such a patent. The national system could not remedy such patents even through the terms of a contract and the only solution was to introduce the disclosure requirements at the international level.
37. Regarding the enforcement of national access and benefit-sharing provisions, he recalled that his delegation had illustrated the challenges through the "Yahoo!-Nazi" case in document IP/C/W/459. This case suggested that unless there was an international mandate, a country would have no obligation to enforce the terms of a contract or a decision upholding such terms when it was against its domestic laws and public policy. This clearly showed that unless domestic access and benefit-sharing regimes were under an umbrella of an international obligation, the international character and outlook of the national regimes would not help to achieve the desired enforcement.
38. With regard to the US statement that the disclosure requirement could not be justified by its primary aim of preventing bad patents, he said that, if the source and country of origin were disclosed, the patent office could process the patent application on the presumption that the access obtained from the country of origin was legal. This requirement would ensure the flow of benefits to the providing country, thereby recognizing its proprietary rights over genetic resources and associated traditional knowledge.
39. Responding to the US argument that patent examiners might or might not seek additional information based on the "hints" provided by the disclosure requirements in light of their negative consequences, he said that once an international obligation was created, each country would take steps to improve its examination system. Thus, the disclosure requirements would prove to be sufficient to deal with the core concerns of developing countries. It would facilitate the compatibility of the TRIPS Agreement with the CBD and add to the strength, credibility and certainty of the patent system. On the other hand, domestic contract systems, unenforceable in many ways, could not achieve the efficacy of the disclosure requirements.
