37. The representative of India introduced the paper submitted by Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand and Venezuela (IP/C/W/438). He recalled that a group of Members, including the co-sponsors of the present document, had submitted a checklist of issues for facilitating discussion on the relationship between the TRIPS Agreement and the Convention on Biological Diversity (IP/C/W/420 and Add.1). He also recalled that, at the last TRIPS Council meeting, this group had made a first submission pursuant to the checklist entitled "Elements of the Obligation to Disclose the Source and Country of Origin of Biological Resources and/or Traditional Knowledge Used in an Invention" (IP/C/W/429/Rev.1). That submission had addressed the first set of questions raised in the checklist. The present submission addressed the second set of questions raised in the checklist relating to elements of the obligation to disclose evidence of prior informed consent under the relevant national regimes. He said that the purpose of the present submission was to carry forward the process of facilitating a more focused, structured and results-oriented discussion on the relationship between the TRIPS Agreement and the Convention on Biological Diversity. He said that the group was encouraged by the many constructive comments received on the first paper and noted that both submissions needed to be read together.
38. He stated that the present submission addressed five issues: the first dealt with how furnishing evidence of prior informed consent would facilitate achievement of the objectives of the CBD and would specifically facilitate the monitoring, and along with other laws, the enforcement of the provisions of the CBD. The objectives and principles of the TRIPS Agreement justified the need for evidence of prior informed consent to be available in the patent system, thus establishing a mutually-supportive and harmonious relationship between the CBD and the TRIPS Agreement. The submission also explained why contractual arrangements by themselves would not suffice since there was no obligation to legislate on the issue of prior informed consent in international law, particularly for Members not party to the CBD. While contractual arrangements could have a role to play, the lack of an obligation to enter into or enforce a contract in the first instance made these insufficient both due to the unequal bargaining strength of the parties to a contract as well as due to the need for enforcement of such contracts outside the country of origin of the biological resource and/or associated traditional knowledge.
39. The second and third issues dealt with how the evidence of prior informed consent should be provided for. He said that the submission recommended that this be done by obligating Members to require evidence of prior informed consent as a condition for acquiring patent rights. Such requirements would not only be fully compliant with the TRIPS Agreement, but would be of significant advantage to patent applicants by facilitating future access and reducing costs. The submission recommended further that such an obligation be discharged by a declaration in the patent application accompanied, where relevant, with the evidence of prior informed consent, for example in the form of a certificate issued by a relevant national authority. He said that assuming that a patent applicant adhered to the law applicable to his activities, he would not find it cumbersome to simply fill up another column in his application form and attach a certificate that he already possessed. The fourth issue dealt with the situation where there was no national prior informed consent regime in the country of origin. He said that in such a situation, the applicant would simply state the fact and in cases where consent had been nevertheless obtained from the authority or community in charge of the location where he had accessed the resource and/or traditional knowledge, inform of such consent.
40. The final part of the submission dealt with the legal effect of not providing evidence of prior informed consent. At the stage of processing of the patent application, the legal effect could be that the processing of the application would be delayed until the necessary declaration and evidence of prior informed consent reached the authorities. He said that the type of time-limits that could be introduced and the penalties that would ensue before the application would be deemed to have been withdrawn could be discussed further. However, discovery of the failure to have provided evidence of prior informed consent once the patent had been granted would involve revocation of the patents. Outside the patent system, other administrative, civil or criminal sanctions could also follow. He said that the co-sponsors of the paper were ready to discuss how such legal effects could be further developed and whether judicial review as a mechanism to implement those concepts could be explored. He said that conceptually the objective was that deterrent, compensatory and equitable consequences should flow from any non-adherence to the obligation to obtain prior informed consent or furnish evidence thereof.
41. Turning to other submissions, the representative of India noted the usefulness of documents IP/C/W/433 and IP/C/W/434 and said that his delegation would provide detailed comments on these at the next TRIPS Council meeting. He said that the characterisation of the ultimate objective of the group of developing countries as "new patent disclosure requirements" connoted a disconnect with the existing disclosure requirements in the TRIPS Agreement and this was not the case. He said that it was necessary to clarify which of the stated and commonly agreed objectives were addressed by the existing disclosure provisions and how they could be changed so as to address the balance of objectives. He said that, for the group, an overarching objective was to ensure certainty that their genetic resources were not misappropriated and that their traditional knowledge and art were not usurped.
42. Addressing concerns raised in the paper from the United States (IP/C/W/434), particularly in its paragraph 10, he said that there was an inextricable link between the objectives of the disclosure requirement and that of prior informed consent and access and benefit-sharing. For example, in addressing the prior informed consent issue, the proposal of the group ensured that the act of patenting did not encourage misappropriation, thus making it an effective tool to arrest misappropriation. Similarly, in addressing the benefit-sharing objective, the proposal was a means to avoid monopolies being created where none were envisaged in the patent system, thus allowing the market forces to play their role. He stated that existing disclosure requirements already helped in preventing bad patents by providing means for examiners to investigate issues like inventorship, novelty and non-obviousness, areas clearly within their mandate in any patent system. He said that what was being suggested was additional to what already existed in the TRIPS Agreement. He disagreed with the assertion in document IP/C/W/434 that national systems could and should take care of the objectives. His delegation had already stated that the post-grant opposition or re-examination proceedings were costly and had pointed out that there had been misappropriation cases addressed under the existing patent regime through tortuous, costly, long winded, post-grant revocation proceedings during which time the true right holders of genetic resources or traditional knowledge continued to suffer.
