87. The representative of India said that he disagreed with the statement of the US delegation that there was a growing recognition that the disclosure requirement was not an adequate solution. The discussions that had taken place had shown a growing realization that disclosure requirements were an integral component of the eventual recommendation that the TRIPS Council had to make under paragraph 19 of the Doha Ministerial Declaration. The US delegation also said that it appeared there was a growing recognition in favour of the national contract-based approach whereas, in his view, there was a diminishing recognition of the stand-alone contract based approach being an adequate solution to the issue of the relationship between the TRIPS Agreement and the CBD.
88. He agreed that patents per se did not constitute misappropriation, but said that the act of applying for a patent and the acts involving the accrual of rights on patents without proper authorization did in fact constitute misappropriation, as stated in the submission IP/C/W/443. The United States had also stated that there were a wide variety of restrictions on the use of patented products and an example characterized as environmental restrictions had been given but did not pertain to the obligations arising out of the CBD.
89. With respect to criminal or civil liabilities, he said that it was not clear what would happen when the misappropriation involved transboundary activities and was happening outside the jurisdiction of the national enforcement authorities. He concluded that it was clear from the discussion that national systems were important, but not sufficient to resolve the issue that was being discussed.
90. He agreed that prior informed consent and access and benefit-sharing issues had to be responded to as a first step through a national level system of requirements, but he believed that an international recognition of the need for respecting these prior informed consent and access and benefit-sharing requirements was essential to achieve the shared objective of mutual supportiveness of the CBD and the TRIPS Agreement. The mutual supportiveness of the CBD and the TRIPS Agreement would be achieved in part through the national regimes and other international treaties in other bodies, but the linkage with the TRIPS Agreement for the achievement of these objectives had to be addressed in the WTO.
91. In response to the point made by the Australian delegation that the disclosure requirement might undercut the objectives of the patent system, he believed that the TRIPS Agreement provided for a balance between rights and obligations that the society at large would benefit from. With respect to the point on costs and burdens referred to paragraph 5 of document IP/C/W/429/Rev.1, he said that these arose for those who had to use post-grant proceedings to achieve what could have been achieved if there had been adequate knowledge through disclosure of the origin of the biological material and associated traditional knowledge that was used in an invention.
92. In response to the point made by the European Communities on the role of patent offices in the disclosure requirement, he said that their role was to ensure that patent applications were complete and these did not add any burdens. He said that a combination of national level regimes and the international recognition of the disclosure requirements was the minimum required to meet the shared objectives. He said that the definitions sought to be established by the Swiss delegation would be useful when the technical phase of undertaking the amendment of the TRIPS Agreement took place.
93. He referred the delegation of the Philippines to the three papers submitted by his delegation and the cosponsors on the potential legal effects of the disclosure requirements and was ready to discuss any further concerns. He said that he would revert to the technical comments from some delegations. He proposed that in the forthcoming meetings of the TRIPS Council there should be a more technical discussion on the specifics of the amendment to the TRIPS Agreement.
94. He said that the Doha Ministerial Declaration had placed the needs and interests of developing countries at the heart of the work programme it had adopted. Ministers had also strongly reaffirmed their commitment to the objective of sustainable development. They were convinced that the aims of upholding and safeguarding an open and non-discriminatory multilateral trading system and protecting the environment and promoting sustainable development could and must be mutually supportive. This applied to all the agreements administered by the WTO, including the TRIPS Agreement.
95. The mandate of the negotiations in the Doha work programme tellingly started with implementation-related issues and concerns. Paragraph 12 of the Doha Declaration highlighted the "utmost importance" attached to these concerns, a term not used anywhere else in the entire Declaration. It then expressed determination to find appropriate solutions to these issues. Negotiations on outstanding implementation issues were an integral part of the work programme. One needed to keep the outcome mandated in the Declaration and the process of organizing these negotiations in view when proceeding to find appropriate solutions.
96. There were half a dozen TRIPS outstanding implementation issues, most of which related to the relationship between the CBD and the TRIPS Agreement. An outcome on this issue, therefore, was of utmost importance. A number of delegations, including India, had suggested that one part of the solution was to require patent applicants to disclose the country and source or origin of any biological material and/or associated traditional knowledge used in the invention as well as evidence of prior informed consent and benefit-sharing that may have been obtained in accessing the material and/or knowledge. He believed that the consultations should lead to a satisfactory outcome on this "disclosure issue". He was sure that all Members wished an outcome on this issue and thereby to fulfil the mandate given by Ministers. It was clear to India that a satisfactory outcome on this issue was essential for the conclusion of the Doha work programme.
97. The 1 August 2004 Decision by the General Council Decision, in particular the paragraph on "Implementation", had reminded Members that they had not yet progressed enough on issues that were at the heart of the work programme, including implementation issues. The Director-General had been requested by the General Council to continue his consultative process and to report to the TNC and the General Council no later than May 2005 in order to enable the General Council to take appropriate action by July 2005. Efforts needed to be redoubled to find appropriate solutions as a priority. He called upon the Chairman, in his capacity as a Friend of the DG, to structure a substantive, dedicated and inclusive consultation on the disclosure issue. The consultations should lead to a satisfactory outcome on this proposal.
