42. The representative of the United States recalled that the United States saw no conflict between the TRIPS Agreement and the CBD. Both agreements could be implemented in a mutually supportive manner and there was no need for an amendment to the TRIPS Agreement. The CBD did not require patent disclosure requirements; it only called upon parties to condition access to genetic resources on prior informed consent and to encourage the equitable sharing of benefits arising upon mutually agreed terms.
43. The most effective means to achieve the objectives of authorized access to genetic resources and the equitable sharing of benefits was through tailored national solutions. New patent disclosure requirements would add uncertainties into the patent system and open a new avenue for litigation and dispute. This would undermine the role of the patent system in promoting innovation and technological development and the economic incentives that patents provide and any potential benefit-sharing that would be derived therefrom.
44. She believed that there was a growing recognition that the new patent disclosure requirements were not enough to guarantee that prior informed consent had been obtained and that benefits were shared in a fair and equitable way. It was obtaining authorized access and not the disclosure of origin in a patent application that manifested prior informed consent. Fair and equitable benefit-sharing was accomplished upon an agreement by entities. The contract-based system was easily adaptable to a country's particular legal system and provided the flexibility to protect traditional knowledge and genetic resources without undermining the economic development incentives of strong intellectual property protection. The proposed patent disclosure requirements would not be effective in preventing erroneously granted patents.
45. Responding to the Peruvian submission, she said that Peru had cited a number of pending published patent applications but, since the patentability of the claimed inventions had not been determined, it would be improper to comment on those. It was not clear whether the mere filing of a patent application could amount to an act of misappropriation. Peru had also discussed the patent applications relating to Maca during the introduction of its paper. Her delegation had reviewed the data base of US patents and located some patents related to Maca, citing literature dating to the 1960's and all the patents had disclosed the country of origin as Peru. Apparently, the inventors had created new, useful and non-obvious inventions from the genetic material that fully met the patenting criteria under US patent law, for example patents pertaining to chemically active isolates, chemical compounds and compositions and not the plant itself. This did not appear to be an example of misappropriation. Her delegation had also reviewed the patents related to the Chancapiedra that Peru had referred to in its paper. They covered novel compositions useful in cosmetics, and that met the statutory requirements for patentability. They listed more than thirty species of plants from which the active ingredients might be derived and that were available from sources throughout the world. They had not identified any examples of misappropriation or biopiracy.
46. She recalled that while some delegations had recognized that contract-based access and benefit-sharing systems were essential, others had continued to argue that patent disclosure requirements were needed to improve compliance with such mechanisms. The United States disagreed with such a policy approach as it was burdensome for the patent system and did not effectively meet the stated goals. Effective enforcement regimes for access and benefit-sharing would be part of civil and criminal codes and might include existing established mechanisms to enforce contracts.
47. She was pleased that the Indian delegation agreed that patenting in itself did not constitute misappropriation. Patents could, in combination with an effective access and benefit-sharing regime, be a valuable tool to generate benefits that could later be shared. If new patent disclosure requirements were adopted and non-compliance was discovered that would invalidate a patent, any benefits from that invention would be greatly diminished.
48. Patent laws were designed to promote the progress of the useful arts by awarding intellectual property rights. They were not designed to regulate all matters relating to those inventions. Restrictions were placed on the use of certain inventions to ensure safety and efficacy, for example the health regulations governing pharmaceuticals, environmental regulations on emissions from automotive engines, or to protect domestic and national security, such as the regulations on firearms. These restrictions were implemented and enforced outside the patent system. The patent system did not condone violation of these other laws and in the same manner, the patent system did not condone misappropriation of genetic resources and violation of a country's access and benefit-sharing requirements. Just as health, safety and environmental regulations applied in their own spheres, a contract-based administrative access and benefit-sharing system could effectively and adequately achieve domestic policy goals related to the conservation and sustainable use of genetic resources. Criminal and civil liability for failure to comply with an access and benefit-sharing system requirement could be included in a country's laws. She said that Members should 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. The Council might also want to consider the work of the IGC on Intellectual Property, Genetic Resources and Folklore at the WIPO.
