23. The representative of the United States, introducing its new submission (IP/C/W/434), said that it was intended to assist progress in discussions pursuant to the mandate given to the TRIPS Council. He said that the his delegation, like a significant number of WTO Members, saw no conflict between the TRIPS Agreement and the CBD and believed that the two Agreements could be implemented in a mutually supportive manner and that no amendment to the TRIPS Agreement was required. He said that his delegation viewed with utmost caution any proposals that would add uncertainties in patent rights and could undermine the role of the patent system in its primary purposes of encouraging innovation, technological progress and economic development. Further, based on recent discussions in the TRIPS Council aimed at fulfilling the Doha Ministerial mandate, and written contributions submitted in that context, Members appeared to share several broad policy objectives. Those objectives included: ensuring authorized access to genetic resources, that is, that prior informed consent was obtained; achieving equitable sharing of benefits arising from use of traditional knowledge and genetic resources; and preventing the issuance of erroneously issued patents.
24. He said that new patent disclosure requirements would not work to guarantee that prior informed consent was obtained. It must be recognized that it was the relevant prior consent agreement itself, usually constituting a contract between two entities, and not a disclosure in a patent application that manifested prior informed consent. A new disclosure requirement in the patent system would not prevent misappropriation since those who had the intent to act in bad faith would not be deterred by disclosure requirements. He stated that a transparent prior informed consent regime was needed to ensure that a researcher or collector knew where to go, who to contact and which persons were authorized to grant approval in order to conduct his or her research and activities in an appropriate manner. He said that the examples of misappropriation that had been cited by proponents of new patent disclosure requirements appeared to relate to the improper collection and/or use of genetic resources or traditional knowledge. Contrary to some assertions, he said that the act of patenting, per se, did not amount to misappropriation and that patent rights could be an effective tool, in conjunction with a benefit-sharing agreement, to transfer benefits.
25. Similarly, a new disclosure requirement in the patent system per se would not ensure that benefits were equitably shared with the provider of the traditional knowledge or genetic resources and that a mechanism to transfer benefits needed to be established. If a new patent disclosure requirement was adopted and a non-compliant disclosure was discovered that would invalidate a patent or prevent a patent from being granted, any benefits from that invention would be greatly diminished. If a patent were issued but later invalidated or if an application were published but a patent never issued, the invention would have been disclosed to the public and third parties that could most likely use and commercialize the knowledge or resources disclosed without any obligation of sharing benefits. Further, if a patent were never issued and the information never published, the patent applicant could still be able to commercialize the invention without disclosing the invention to the public and without any obligation to share benefits. He added that a new disclosure requirement could have further significant, unintended consequences where a patent applicant had entered into a valid benefit-sharing agreement with the custodians of the traditional knowledge or genetic resources but, due to uncertainties in the law, a disclosure could be found invalid. He said that if, for example, there was improper disclosure that resulted in revocation of a patent due to litigation by a third party not affiliated with a traditional knowledge or genetic resources holder, that would actually upset the pre-existing benefit-sharing agreement. A new patent disclosure requirement could fail to address benefit-sharing resulting from commercialization that occurred outside the patent system and could be meaningless if products derived from or based on traditional knowledge or genetic resources were commercialized but not patented.
26. He said that the proposed new patent disclosure requirements would not only be ineffective in achieving the goal of preventing erroneously granted patents but would also undermine an already overburdened patent system as none of the suggested new patent disclosure requirements aimed at ensuring compliance with patentability requirements. Information such as that indicating the country of origin or ex situ collection sites would do little to ensure the ascertainment of appropriate inventorship, novelty or inventive step, because such information did not generally address the considerations underlying the requirements, such as acts of invention or the state of the relevant art.
27. He added that new patent disclosure requirements would add new uncertainties in the patent system, particularly where the sanctions for non-compliance included invalidation of a patent. That would create a "cloud" of uncertainty over the patent right by opening new avenues for litigation and in other ways that would undermine not only the role of the patent system in promoting innovation and technological development but also any potential benefit-sharing.
28. A new patent disclosure requirement could also lead to significant administrative burdens for the patent offices of Members. It did not seem possible that patent examiners could make the relevant determinations with any degree of legal certainty, particularly decisions that involved interpretations of foreign laws to determine the validity of prior informed consent or adequate benefit-sharing according to the custodian country's legal regime, thereby compounding the uncertainties both in granted patent rights and in the process of granting patents. He added that the proponents of a new patent disclosure requirement had also wrongly assumed that it would be an effective monitoring system.
29. Although his delegation shared many of the objectives raised by various Members, it was not convinced that new disclosure requirements in patent applications were an appropriate solution. Rather, the real challenge was how the objectives could most effectively be achieved.
30. With respect to the objective of obtaining appropriate access and benefit-sharing, he said the experience had shown that the most effective means to achieve this was through the development of national laws outside the patent system. It was imperative that governments implemented laws that required prior informed consent from a clearly delineated point of contact, such as the government and/or indigenous representatives, before a party sought to use or collect traditional knowledge or genetic resources. Points of contact could include the persons authorized to provide access to materials. For example, countries could establish permit systems that imposed civil and/or criminal penalties for extracting genetic resources without a permit, where such permits would serve as evidence of prior informed consent.
31. Continuing, the representative of the United States said that a contract-based system could be used to effectively control the collection of resources and ensure the sharing of benefits from their use as this could provide a great deal of flexibility in determining both monetary and non-monetary benefit-sharing and on issues such as choice of law. Contracts could also provide an effective monitoring system by requiring mandatory disclosure to appropriate authorities of any future commercial application utilizing the relevant traditional knowledge or genetic resource, whether patented or not. A contract-based system, such as the kind described by his delegation in previous submissions to the TRIPS Council, could be easily adaptable to other legal systems, and could provide countries the flexibility to protect their traditional knowledge or genetic resources without certain risks that they had mentioned.
32. He noted that many Members had not yet implemented access and benefit-sharing regimes. He said that many proponents of disclosure requirements did not challenge the necessity of an effective, contract-based, access and benefit-sharing regime but argued that patent disclosure requirements were needed to improve compliance with such mechanisms. His delegation disagreed with such a policy approach as it was unnecessarily burdensome to the patent system. Moreover, such a legal regime, if in force, could be adequately enforced without resort to patent law requirements. He said that effective enforcement regimes for access and benefit-sharing should be part of civil and criminal codes specifically designed to enforce access and benefit-sharing laws. Patent law was not designed to regulate or enforce misconduct issues, such as misappropriation of traditional knowledge or genetic resources, but to promote progress of useful arts. He noted that restrictions could be placed and were placed on the use of certain inventions to ensure safety and efficacy, to protect the environment or to protect domestic or national security. He further noted that those restrictions were enforced outside the patent system by separate regulatory mechanisms. He said that the case had not been made as to why a contractual access and benefit-sharing system would not serve the purpose effectively, just as health and safety codes applied to their spheres. As was the case with other distinct regulatory systems, criminal provisions and/or civil liability for failure to comply could be included in the country's laws for those few who took genetic resources without entering into an access agreement with the required party.
33. He said that in order for the TRIPS Council to more fully consider the concerns raised by the proponents of disclosure requirements, Members could more fully examine national experiences with respect to access and benefit-sharing systems currently in place in order to better understand the perceived shortcomings of such existing systems. He suggested that the Council could consider the extensive work that continued in the Intergovernmental Committee on Intellectual Property, Genetic Resources and Folklore of WIPO, which had been specifically created to deal with many of these and related matters.
34. His delegation agreed that it was important to prevent erroneously granted patents and noted that several tools could be, and were being, used to address such concerns. Patent examiners world-wide could use organized, searchable databases of genetic resources and traditional knowledge when examining patent applications. This could help in the discovery of relevant prior art and thereby improve examination of patent applications in the relevant fields. He also said that Members could consider a provision, such as that used by his country, which required patent applicants to disclose any information relevant to patentability. The information was directly related to the questions of patentability and could help examination of patent applications in a manner that disclosure of source and/or origin of genetic resources or traditional knowledge could not.
35. He said that implementation of post-grant opposition or re-examination proceedings could rectify the situations in which patents had been issued erroneously. Those procedures were far less costly than litigation and could alert national patent authorities when new information was discovered that was relevant to the patentability of the invention. He noted that a number of granted patents had been successfully challenged when it was demonstrated, through opposition processes, that they should not have been granted. Those included patents relevant to turmeric and neem in the United States and European patent offices. He said that his delegation was unaware that any of the perceived instances of misappropriation cited in the TRIPS Council involving a wrongful determination of inventorship or prior art which could not have been satisfactorily addressed by any means he had mentioned or that a patent disclosure requirement for source and/or origin would have corrected.
36. He said that the patent system had been and continued to be a highly effective tool for technological and economic development and that the WTO should be wary of upsetting the delicate balance, particularly when it was doubtful that any suggested changes would actually achieve the stated objectives. Rather than focus on proposed new patent disclosure requirements, the TRIPS Council should focus with more precision on what Members were trying to achieve, review past experiences and situations that prompted various concerns and consider any appropriately tailored solutions. As many of the broader objectives were widely shared, his delegation was confident that appropriate solutions could be reached to address the concerns of all Members.
