Minutes - TRIPS Council - View details of the intervention/statement

Ambassador Choi Hyuck (Korea)
C; D; E REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B); RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY; PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE
35. The representative of Brazil said that his delegation shared all the concerns expressed in Peru's submission and looked forward to continuing to work with the delegation of Peru in negotiations on an amendment to the TRIPS Agreement. He said that a number of submissions on the disclosure requirements revealed certain shared objectives and goals. The TRIPS Council had benefited from certain questions and clarifications in these submissions and could now suggest a way forward in this debate. 36. Setting out the basics of the proposal made by a number of developing countries, he said that it was the firm view of these countries that disclosure of source and country of origin of biological resources, evidence of prior informed consent, and evidence of fair and equitable benefit sharing in patent applications would play a significant role in preventing biopiracy and misappropriation, apart from ensuring that all contributors to innovations were adequately rewarded. A mandatory disclosure obligation on patent applicants would, to an extent, operate as a self-policing provision. This approach would have a number of advantages: first, it would be an additional reason why the patent applicant would be encouraged to comply with national laws on access and benefit sharing; second, the onus on the patent applicant was limited to providing information and evidence that was known to him or should have been known to him so that the administrative and cost burden on him would be minimal and the burden on the patent offices would be even less; third, it would increase the capacity of patent offices in examining patent applications that dealt with biological resources and associated traditional knowledge; and fourth, it would serve as a critical tool for biodiversity-rich countries in tracking down the patent applications based on biological resources and related traditional knowledge and enable challenges to specious patents in a less burdensome manner. 37. He said that in the absence of the requirement for the disclosure of source and country of origin, the aggrieved countries would only have the option, under the relevant patent system, of challenging the grant of patents that did not meet the criteria of patentability in the granting country based on their own efforts to collect evidence of use to cite as prior art. These countries would have no recourse where biological resources had been used without having obtained prior informed consent of the countries having the rights over such resources or where the access constituted misappropriation. Pursuing a legal remedy under international law and in multiple jurisdictions was complicated and expensive and was therefore not an economically viable option for many aggrieved countries due to the capacity constraints faced by them. He further said that in cases of inventions based on biological resources and/or associated traditional knowledge, the source of origin of the biological resources and associated traditional knowledge was critical for ascertaining whether the applicant had invented what he claimed or just found the "invention" in nature or obtained it from traditional cultures. This was especially important when the traditional knowledge used in the invention was undocumented and existed in oral form or was documented in a local language. Disclosure of source and country of origin of the resource and traditional knowledge would enable a better assessment by patent examiners of novelty and inventive step involved in the invention. 38. He said that a fundamental premise behind the disclosure requirements was that disclosure of origin would enhance transparency in the context of access to genetic resources and associated traditional knowledge. There was no disagreement on the fact that a researcher or collector needed to know where to go and whom to contact. Even where information on origin in itself might not be sufficient for assessing novelty and inventive step in an invention, it was believed that such disclosure would facilitate a more thorough enquiry by patent examiners into the state of existing traditional knowledge, prior art and the nature of inventive step undertaken by patent applicants in developing inventions. 39. He said that it was acknowledged that the effectiveness of use of any information would be contingent on the extent to which adequate administrative mechanisms were in place to enable effective searches by both patent applicants and patent examiners. While the consolidation of databases, such as India’s Traditional Knowledge Digital Library and China’s Traditional Chinese Medicines Database, was a valuable tool for enabling this, it was not sufficient in itself to cover the entire gamut of biological material and associated traditional knowledge. Disclosing the source of origin would therefore be a fundamental advancement enabling searches that might be outside the scope of such established databases. The actual implementation of such searches could be enhanced through better networks between designated focal points in various countries and clearing house mechanisms established at the international level. The fact that this needed to be done, however, did not dilute the need for the disclosure requirements or negate its fundamental contribution in achieving a better patent system. On the contrary, it would help in achieving a more transparent and effective patent system, in which the number of erroneously granted patents could be substantially reduced. 40. He said that several countries, mostly those providing biological resources, had already enacted laws to put in place an access and benefit-sharing regime. These countries had also provided the terms for benefit sharing on a fair and equitable basis in their domestic legislations. However, this was in itself insufficient to stop biopiracy and misappropriation of biological resources and associated traditional knowledge. It did not achieve one of the central objectives of the disclosure requirements, which was to stall the reward of a patent for knowledge, information or materials misappropriated from another country. Regarding the concern that the expanded disclosure requirements would potentially diminish the benefits of a patent, he said that such requirements would ensure that proprietary rights were not granted to patent applicants who had acted in bad faith. The granting of such patents in the absence of compliance with prior informed consent and benefit-sharing would be tantamount to an unjust reward for a patent applicant. Such a situation would seem to run counter to the objectives and principles of the TRIPS Agreement, in particular those contained in Articles 7 and 8. 41. Regarding the legal effect of failure of meeting the disclosure requirements, he said that it would depend on whether such failure was established before or after the grant of patents. If the non compliance was established before the examination or grant of a patent, the legal effect could be not to process the patent application further until the submission of necessary declaration and evidence. If it was established after the grant of a patent, the legal effect should be revocation or invalidation of the patent. He said that documents IP/C/W/429/Rev.1, IP/C/W/438, IP/C/W/442, and IP/C/W443 enumerated the circumstances where revocation or invalidation would be contemplated. In particular, revocation was proposed where a proper disclosure would have led to the refusal to grant patent on the following grounds: lack of novelty due to the existence of prior art, insufficient, wrongful or no disclosure with fraudulent intention, or violation of ordre public or morality. Revocation or invalidation would also be foreseen in cases where there was failure to disclose evidence of prior informed consent and benefit sharing with fraudulent intention. In such cases, the proposed disclosure requirements also foresaw several alternatives to revocation under certain circumstances, such as criminal and administrative sanctions, and full or partial transfer of rights to the invention, which might be better suited to ensure adequate compensation and to promote fair and equitable benefit sharing. If prior informed consent and benefit sharing had taken place, but was not disclosed or wrongfully disclosed, penalties could be outside the patent system. He said that a calibrated disclosure mechanism with adequate legal sanctions in cases of non-compliance was crucial to ensuring its effectiveness and deterrent effect. In addition to revocation, he said that criminal and/or administrative sanctions might also apply through relevant legal procedures both within and outside the patent system. 42. Turning to the definitions of the terms "biopiracy" and "misappropriation", he said that "biopiracy" and "misappropriation" had been used variously to refer to illegal and/or illegitimate acts with respect to the acquisition and use of genetic resources and traditional knowledge from developing countries. He cited the definition of "piracy" in Black's Law Dictionary as follows: "The unauthorized and illegal reproduction or distribution of materials protected by copyright, patent, or trademark law". He also quoted Eaton S. Drone's understanding of piracy in his book entitled "A Treatise on the Law of Property in Intellectual Productions", as stating "The test of piracy [is] not whether the identical language, the same words, are used, but whether the substance of the production is unlawfully appropriated". He said that the term "biopiracy" was in many ways similar to the term "piracy", and that just as the lack of an agreed WTO definition on the term "piracy" had not stopped Members from including the extensive enforcement provisions into the TRIPS Agreement, the lack of definition of "biopiracy" should not be a precondition for the establishment of the disclosure requirements. 43. Furthermore, he said that the proposed disclosure requirements sought to prevent the application or grant of a patent for an invention, in which genetic resources and/or associated traditional knowledge were used without disclosure of the country of origin and source and without prior informed consent and equitable benefit sharing. The requirements could ensure that contribution of all stakeholders to the invention were duly acknowledged and reworded. Genetic resources and traditional knowledge could be part of a claimed invention, or a prerequisite for the development of an invention, or material or information which facilitated the development of an invention, or necessary background material or information for the development of an invention. In addition, he questioned the actual deterrent effect of a system which did not provide for revocation as a possible sanction for failure of disclosure. 44. In reply to the questions as to how to fulfil the requirement for the disclosure of the country of origin and source and what was the relationship between this requirement and the FAO's International Treaty on Plant Genetic Resources for Food and Agriculture, he said that the proposed disclosure requirement entailed the disclosure of both the country of origin and source which could be the same as or different from each other. This requirement was in line with Article 15 of the CBD. He noted the argument by some Members that the plant genetic resources for food and agriculture covered by the multilateral system under the FAO's Treaty should constitute an exception to the proposed disclosure mechanism. He said that his delegation was still open to considering ways to reflect these concerns in an eventual text. 45. In response to Switzerland's question on the implications of the disclosure requirements for the PCT and the Patent Law Treaty (PLT), he said that the international patent system was made up of a number of treaties and instruments which built on each other and were generally meant to be complementary. The discussion in the TRIPS Council was a discharge of the mandate given to Members under a WTO work programme. The implementation of the disclosure requirements, once agreed and defined under the TRIPS Agreement, could facilitate actions elsewhere. On the other hand, changes made elsewhere without the proposed amendment to the TRIPS Agreement would not be sufficient to address either the mandate Members had or the problems Members wished to address. 46. Responding to the question on the role of patent offices, especially in determining the veracity of the information provided by patent applicants relating to benefit-sharing and prior informed consent, he said that paragraphs 21 and 22 of document IP/C/W/443 had adequately addressed this question and that his delegation welcomed any textual suggestions that provided more precision to the obligation of disclosure.
IP/C/M/48