43. The representative of the European Communities recalled that, at the last meeting, his delegation had informed the Council that it was working internally on the issue of disclosure of origin of genetic resources and traditional knowledge in patent applications. He reported that his delegation would submit effective, balanced and realistic proposals for the introduction, at the global level, of a disclosure system to WIPO by the end of the year, as had been announced at the WIPO General Assemblies in September 2004. He said that this proposal built on the concept paper that had been submitted to the TRIPS Council in September 2002 and would be characterized by the principle that disclosure in patent applications of the country of origin of genetic resources should be a mandatory requirement and not an option. Further, the disclosure requirement should apply to all national, regional and international patent applications and the system envisaged should be as simple as possible and not lead to unnecessary administrative burdens for patent offices and applicants. He said that his delegation would keep the Council informed of any new developments.
44. Commenting on document IP/C/W/434, he said that his delegation like that of the United States, believed that there was no conflict between the TRIPS Agreement and the CBD and that both instruments could be, and should be, implemented in a mutually-supportive manner. His delegation supported the three broad policy objectives highlighted in the document and said that his delegation could support several other ideas. For example his delegation believed that sound national regulations on access and benefit-sharing were essential to guarantee legal certainty for all parties involved in order to protect the rights of providers of genetic resources. In this respect contractual arrangements also had an important role to play.
45. He said that while the introduction of new patent disclosure requirements was certainly not the only solution to achieve the stated objectives, it was a tool that could contribute to a solution along with other elements. He understood the concerns in document IP/C/W/434 with regard to the possible negative impact that the introduction of patent disclosure requirements could have on the patent system as a whole and believed, like the United States, that the patent system should continue to be a highly effective tool for technological and economic development. The view of his delegation was that the introduction of patent disclosure requirements would not necessarily be burdensome to the patent system, to patent offices or to applicants. He said that in the proposal his delegation was working on, the patent applicant would be required to declare the country of origin of genetic resources if the applicant was aware of it and that no additional research on the applicant's part would be required. The patent office would not be required to make any assessment on the content of the disclosed information and its role would be limited to examining whether the formal requirements had been fulfilled and whether the applicant who declared that the invention was based on genetic resources had subsequently disclosed the information. In order to facilitate the monitoring of the respect of any benefit-sharing arrangements, patent offices would be required to notify the disclosed information to a centralized body. The introduction of such measures, should not lead to unnecessary administrative burdens for the patent offices.
46. In his delegation's view, issues relating to disclosure of source and origin were prime candidates to move the discussion forward and constituted an area where there were possibilities for convergence of views. He said that document IP/C/W/429/Rev.1 had raised relevant points on which his delegation could comment without prejudice to the outcome of his delegation's internal reflection on the issue and to his delegation's position in a possible formal negotiation process in the WTO or elsewhere. He said that his delegation considered that a disclosure requirement, provided it was properly calibrated, would positively contribute to the mutual supportiveness between the intellectual property systems and access and benefit-sharing regimes. He said it would help the countries providing access to genetic resources to monitor compliance with access and benefit-sharing rules as well as with the contractual arrangements between providers and users of genetic resources as facilitated by information received through foreign patent offices. It would increase confidence among bio-collectors, whether private enterprises or research centres, and biodiversity-rich countries and indigenous communities and would generate less complex or burdensome and more effective access and benefit-sharing regimes, thus creating a win-win situation for both providers and assessors. It would help prevent inappropriate patenting of genetic resources or traditional knowledge by allowing patent offices to establish prior art more accurately by making more focused searches and would act as a strong incentive for patent applicants to comply with domestic rules on access and benefit-sharing, where they exist, and/or contractual arrangements.
47. It was the view of his delegation that to trigger the disclosure obligation, the genetic resource had to form part of the claimed invention or have been necessary for the development resulting in the invention. In other words, the invention would not have been made without the genetic resource. He said that the proposal in document IP/C/W/429/Rev.1 that any use would be sufficient to trigger the disclosure obligation, even cases of incidental use, went too far. Regarding the administrative and cost burdens, he said that document IP/C/W/429/Rev.1 stated that the applicant should have at least employed all reasonable measures to determine the origin of the material. It was the view of his delegation that it could be burdensome for the applicant if he had to carry out further research. He noted that document IP/C/W/429/Rev.1 did not examine the possible impact of the disclosure obligation on the patent office and that it would be interesting to know what the envisaged role of the patent offices would be. For example, how would they verify whether the patent applicant had obtained the relevant material in a way compatible with access and benefit-sharing and prior informed consent rules? He said that it was the view of his delegation that the role of patent offices should be limited to the strict minimum. He said that the applicant should be requested to provide all reasonably available evidence of the source or origin of the genetic resource or traditional knowledge and it should be up to those who wished to contest such disclosure in an administrative procedure or before a court to provide proof of the contrary, in accordance with the usual rules of law on the burden of proof.
48. Regarding the nature of the obligation, he said that the interest of the distinction between substantive and formal requirements lay in the consequences of non-respect of that obligation. Regarding the legal effect of wrongful disclosure or non-disclosure, he noted that several proposals had been made, ranging from far-reaching sanctions within the patent system to sanctions outside the ambit of patent law. His delegation's view was that a requirement could only be effective if its non-respect gave rise to sanctions but that, at this stage, it believed that such sanctions should lie outside the ambit of patent law using, for example, civil or administrative sanctions.
49. Regarding the manner in which the proposed obligation of disclosure of source or origin should be introduced in the TRIPS Agreement, he said that at the present stage his delegation had no views on the issue. However, if the possibility of inserting a disclosure obligation in the TRIPS Agreement were envisaged, such an obligation had to be properly calibrated. As to how and where such a requirement could fit in the TRIPS Agreement, he said that this was a technical issue which his delegation did not consider to be important at the present stage since the answer would depend upon what was agreed on in substance.
