18. The Chairperson suggested that, since the practice in the Council's past meetings had been that the delegates address these three agenda items together, the Council again take them up at the same time. She informed the Council that it had just received a new submission from Brazil, India, Pakistan, Peru, Thailand and Venezuela entitled "Elements of the Obligation to Disclose the Source and Country of Origin of Biological Resource and/or Traditional Knowledge Used in an Invention" (IP/C/W/429).2 She also recalled that, at its meeting in June, the Council had agreed to revert at the present meeting to questions raised concerning a paper presented by Switzerland at that meeting (IP/C/W/423). She recalled that, at that meeting, the Chair had reported on his consultation on how future work on these items should be organized. He had said 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. After discussing the matter, the Council had agreed that the Chair should continue these consultations. However, in the absence of a Chair, it had not yet been feasible to pursue these consultations.
20. The first issue dealt with how such an obligation for disclosure would help in better examination of patents and in preventing cases of bad patents. A number of cases had been documented, such as those relating to neem, turmeric, hoodia and ayahuasca, where patents had been issued with respect to genetic resources and products or processes that had been known and used by traditional or local communities for many years and even centuries. These cases, involving various levels of bio-piracy, had raised serious questions about the quality of patent examination. While a number of mechanisms to improve the availability of prior art information with respect to genetic resources and traditional knowledge used in patent examination had been suggested, none of these mechanisms was likely to make available all prior art information in the context of important cultural and religious sensitivities associated in particular with traditional knowledge. Many of these mechanisms were voluntary and provided no guarantee that in fact patent examiners in different countries would consider this information in their prior art search. Consequently, a legally binding obligation to disclose the source and country of origin of biological resources and/or traditional knowledge used in inventions would help ensure that all relevant prior art information is available to the patent examiners. Furthermore, disclosure would help determine whether the claimed invention was excluded from patentability under paragraphs 2 and 3 of Article 27 of the TRIPS Agreement and would serve as part of a process to systematize available information of biological resources and traditional knowledge. Lastly, the disclosure requirements would also be useful in cases of challenges to patent grants, disputes on inventorship or entitlement to a claimed invention and in infringement cases, all of which formed important components of processes to ensure patent quality. He added that disclosure requirements of various types were already an accepted norm in international patent law practice.
21. The second issue concerned the meaning of disclosure of source and country of origin of biological resources and of the traditional knowledge used in the invention. He said that the purpose of disclosure was primarily to prevent bio-piracy, to prevent the granting of bad patents and to curb misappropriation. It could also help in pursuing prior informed consent and benefit-sharing obligations under the appropriate national regimes. Such disclosure obligations would be triggered wherever the biological resources and/or traditional knowledge were used: (a) to form part of the claimed invention; (b) during the process of developing the claimed invention; (c) as a necessary prerequisite for the development of the invention; (d) to facilitate the development of the invention and (d) as necessary background material for the development of the invention. He said that the communication showed that the administrative and cost burden on patent applicants would be minimal as the information to be disclosed would most likely be available to the patent applicant as part of the process of developing an invention.
22. The third issue concerned the legal effects of wrongful disclosure or non-¬disclosure. In this regard, he said, the paper proposed that the disclosure requirement would have both formal and substantive components and implications. The nature of the legal effect of insufficient, wrongful or non-disclosure would depend on whether one was dealing with a formal or substantive component of the disclosure or whether it was at the level of pre- or post-grant. Where such failure to disclose was discovered before the examination or grant of a patent, the legal effect could be that the application would not be processed any further until the necessary information had been submitted. This could be accompanied with penalties and time-limits within which the proper disclosure should be made, failing which the application could be deemed withdrawn. The non-processing of the patent application was justified as such failure to disclose affected the determination of prior art, inventorship or entitlement to the claimed invention, the scope of the claim and/or whether it was necessary for understanding or carrying out the invention. Where such failure to disclose was discovered after the grant of a patent, the legal effect could include revocation of the patent in cases where it was determined that proper disclosure would have led to the refusal to grant the patent, or in cases where there was a fraudulent intention. In addition to revocation, criminal and/or administrative sanctions could be imposed, for example, where such failure to disclose amounted to a false representation. The legal effect could also include full or partial transfer of the rights to the invention where complete disclosure would have shown that another person or community or governmental agency was the inventor or part-inventor, or would otherwise be entitled to all or part of the claimed invention. In addition, the legal effect could include narrowing the scope of the claims where parts of the claims were affected due to lack of novelty or fraudulent intention or where full disclosure would have led to refusal to admit those parts of the claims.
23. He said that the above-mentioned concepts would be further developed when Members reflected on the mechanism to implement such concepts and could include judicial review. While a certain flexibility could be incorporated as to the exact legal effect of each infraction, Members should nevertheless have an obligation to ensure that the effect of such a failure to disclose was effective in terms of its deterrent, compensatory and equity value. He said that, apart from the above, there could be separate and additional legal effects related to enforcing obligations on prior informed consent (PIC) and benefit sharing (BS) which would be introduced in later submissions.
24. Regarding the fourth issue as to who should bear the burden of proof, he said that an application would be deemed prima facie to comply with the disclosure requirement if it contained a declaration in the prescribed form indicating the source and country of origin of the biological resources and/or traditional knowledge. However the applicant would be required to positively discharge the burden of proof that the genetic resources and/or traditional knowledge had been legally and legitimately accessed and that benefit-sharing had taken place or would take place if a patent was granted with respect to the invention covered.
25. The fifth and final issue related to the manner in which the proposed obligation of disclosure should be introduced into the TRIPS Agreement. In this regard he said that a positive obligation to be imposed on patent applicants was envisaged to be introduced into the TRIPS Agreement either by appropriately amending the existing provisions or by introducing a new article into the Agreement and that a number of Members already required patent applicants in their territories to make such disclosures. However, because of the global dimension of bio-piracy, relying on national measures alone was not sufficient to address the problem.
