24. The representative of Brazil introduced the submission made by Bolivia, Brazil, Colombia, the Dominican Republic, Ecuador, India, Peru and Thailand on the "Elements of the Obligation to Disclose Evidence of Benefit Sharing under the Relevant National Regime" (IP/C/W/442). He recalled the previous submissions made by the proponents from the TRIPS Council meeting of March 2004 onwards, including the Checklist, which he said had been generally accepted as the basis for pursuing discussions on this issue. The new submission addressed and elaborated the third and final set of issues mentioned in the Checklist, namely the disclosure of evidence of benefit-sharing under the relevant national regime and should be read together with the earlier submissions, as the elements treated therein were closely interlinked.
25. He said that the first section of the new document sought to explain what was meant by evidence of benefit-sharing under the relevant national regime. The disclosure requirement was aimed at ensuring not only that there was benefit-sharing per se, but that such benefit-sharing took place in a fair and equitable manner, taking into account the circumstances of each particular case. It had been argued that there might be no straightforward way of determining the fair and equitable sharing of benefits. There were a number of factors that could be used to make this determination such as, in the case where there had been sufficient prior informed consent, that the shaping of benefits or an arrangement for future sharing of benefits was premised upon mutually agreed terms in the context of Article 15(7) of the CBD. Also, consideration should be given to whether there was a reporting obligation on issues relating to patenting or commercialization, especially where future benefit-sharing was contemplated.
26. Some had argued that a disclosure requirement for benefit-sharing, as well as related disclosure requirements for country of origin and prior informed consent, could not per se transfer benefits and that national level mechanisms for benefit-sharing must be established. He said that the disclosure proposal was not intended as a replacement for national access and benefit-sharing regimes but as supplementary measures and necessary incentives for patent applicants to comply with the prevalent laws and practices of the countries of origin of the genetic resources and/or associated traditional knowledge. Thus, bio-prospectors, researchers and other prospective patent applicants who wished to access genetic resources and associated traditional knowledge in a fully lawful manner had nothing to fear from the proposed disclosure requirements as these would do little other than to ask applicants to supply information to the effect that the resources and knowledge had been accessed lawfully in the countries of origin. There was no reason why such requirements should be found cumbersome by well-meaning patent applicants.
27. He emphasized that "biopiracy" was a global problem, more often than not involving the acquisition of material in one country and the seeking of a patent over that material, or over inventions deriving from or involving that material, in another country. Therefore, to effectively tackle the problem, it would not be sufficient to rely solely on measures and regimes adopted at the national level in the countries of origin of the genetic resources and an international framework of protection was needed. The ability of patent offices and other authorities in a national jurisdiction to curb biopiracy by imposing a disclosure requirement would be limited unless similar actions were also taken by patent offices in other jurisdictions. Disclosure of evidence of benefit-sharing, as well as the disclosure of the country of origin and of evidence of prior informed consent, would enhance the credibility of the patent system by contributing to the realization of the stated objectives and principles of the TRIPS Agreement itself, as enshrined in Articles 7 and 8.
28. Questions had been asked about when the patent applicants would be expected to introduce evidence of benefit-sharing. Some had pointed out that benefit-sharing can only take place after the grant of a patent and the commercialization of the relevant technology. This did not raise a problem with respect to furnishing the evidence of benefit-sharing. In many cases, the very fact of gaining access to genetic resources might trigger a certain level of benefit-sharing. When real benefits could only arise from the patenting and commercialization of the invention, it was still envisaged that the patent applicant would be required to provide evidence of benefit-sharing. The applicant could do so by submitting evidence of the existence of an arrangement for the fair and equitable sharing of benefits arising out of the utilization of the genetic resources, an arrangement that would have been entered into in accordance with the national laws and practices of the country of origin.
29. If there was no national regime in the country of origin, then a similar approach to that taken for prior informed consent, as specified in document IP/C/W/438, would apply. The applicant would merely have to indicate in the relevant declaration that there had been no national access and benefit-sharing regime in the country of origin, but that, in any case, benefit-sharing had or would take place through an arrangement established with the authorities in charge of the location where the resources were accessed.
30. The final section of the new document addressed the question of the legal effects of non-compliance with the requirement to disclose evidence of benefit-sharing. As in the case of the obligation to disclose evidence of prior informed consent, the nature of the legal effects of non-compliance with disclosure of benefit-sharing would depend on whether it is at pre- or post-grant stage. At the pre-grant stage, if no evidence of benefit-sharing was furnished as required before the examination or grant of the patent, then the legal effect could be that the application is not processed any further until the necessary evidence is submitted. This could be accompanied by penalties and time-limits within which the proper declaration and evidence must be provided. Where failure to disclose evidence of benefit-sharing was discovered after the grant of the patent, the legal effects could include revocation of the patent, particularly where it was determined that there was a fraudulent intention behind the failure to provide evidence of benefit-sharing. It could also include full or partial transfer of rights to the invention as a means to promoting fair and equitable benefit-sharing or criminal and/or civil penalties, including the possibility of punitive damages, where it was determined that the patent holder had, in fact, provided benefits but had not provided the evidence in the application.
31. Speaking on behalf of his delegation, he said that Brazil shared the concerns raised by Peru and had faced similar problems. In recent times, a number of similar cases involving resources and/or knowledge which had been taken from the Brazilian Amazon had been also brought to the attention of the authorities. Those were apparent cases of misappropriation involving attempts to take out patent rights over resources and/or traditional knowledge of the Amazon and the indigenous peoples residing in this region, involving a number of important biological materials that are well-known to the Brazilian population. There had been an attempt to steal the name of a well-known fruit and to have it registered as a trademark in the big markets of the North. There was also a very recent case involving the extraction of a substance from the skin of a frog from the Amazon and apparently there had been attempts to take out patent rights over the extracted substances and also involving traditional knowledge used by indigenous peoples in Brazil. These cases were being investigated by the Brazilian authorities.
32. It was clear that the current intellectual property system was inadequate to address the biopiracy problems faced by developing countries. The system was inequitable, since it facilitated the actions of powerful, industrial interests, but there were no safeguards to protect the rights of developing countries and their indigenous communities. This imbalance would be rectified with an amendment to the TRIPS Agreement, including the disclosure of origin obligation. Like the delegation of Peru, Brazil called upon WTO Members to engage constructively in the light of the mandate given by the Ministers and to refrain from engaging in "forum shopping".
