51. He said that he had responded to 17 questions posed earlier by Members regarding the draft amendment of the TRIPS Agreement, and requested the Secretariat to circulate the responses as a TRIPS Council document.2 Regarding a question from Switzerland about the disclosure of information, he said that there was a clear need to disclose the country providing the resource as well as the source, and that the requirement to disclose the country of origin would be subject to the condition of "reasonable inquiry". Disclosing only the source without indicating the providing country would not achieve the objectives of the amendment. For example, the indication of source as a laboratory of a multinational company would give no clue about who had provided the resource. As the CBD gave the definitions of both "country of origin" and "the providing country", disclosing information on both of them was an essential requisite for the patent system to become supportive of the CBD. Disclosure of information on the providing country and country of origin would address the international dimension of the misappropriation issue; that is, patent rights might be conferred in a country which was different from the country where the resource was obtained.
52. Regarding a question from the EC and the Philippines as to why the term "biological resources" had been used instead of "genetic resources", he said that the CBD recognized that states had the sovereign right to exploit their own resources, in accordance with the Charter of the United Nations and the principles of international law. Thus, the power enjoyed by states was not limited to the regulation of genetic resources. Accordingly, Article 15 of the CBD, which addressed access to genetic resources, should not be interpreted as preventing states from regulating access and benefit sharing relating to biological resources. Furthermore, the use of the term "biological resources", which was broader than the term "genetic resources", was intended to ensure that all possible cases of biopiracy were covered and to keep pace with technological developments, especially with respect to biotechnology. The term "biological resources" was similar to the term "biological material" used in the preambular paragraph 27 of the European Directive on the Legal Protection of Biotechnological Inventions (Directive No. 98/44/EC), which was defined in Article 2 of the Directive. He further said that once Members had reached an agreement on the amendment, the definition of the term should be universal and binding on all Members.
53. Regarding another question from the EC and the Philippines about who would decide the fulfilment of "reasonable inquiry" as contemplated under paragraph 2 of the draft Article 29bis and what "reasonable inquiry" meant, he said that "reasonable inquiry" was similar to the expressions "reasonable efforts", "reasonable ground to know", and "reasonable steps under the circumstances" used in Articles 34, 37 and 39 of the TRIPS Agreement and in Members' national legislations. The applicant would initially determine how to satisfy this requirement, which was generally understood to mean due diligence. The role of patent offices would be limited, in principle, to confirming that patent applications disclosed information in the prescribed form.
54. He responded to several other questions posed by the EC. As to how the three triggers referred to in the draft amendment - that is, "concerns", "derived from" and "developed with" - would work or what they would mean in practice, he said that the three triggers sought to encompass relevant situations in which biological resources and/or associated traditional knowledge had contributed to an invention, while providing the margin of flexibility for national competent authorities where the patent would be sought to decide whether or not the applicant had complied with the rule. The term "concerns" referred to cases where a predominant or substantial part of an invention incorporated genetic resources. This usage would be similar to Article 3.1 of the EC Directive. The term "developed with" meant that an invention might not necessarily incorporate a genetic resource but the resource and/or associated traditional knowledge might be critical in the development of the invention. This would be the case particularly with respect to traditional knowledge as it might be rarely incorporated in the claimed invention but where the knowledge was indispensable in the development of the invention. The term "derived from" was intended to cover derivative inventions. It also appeared in Article 8.1 of the EC Directive referring to propagation or multiplication from original biological material.
55. With respect to whether the word "including" in the second sentence of paragraphs 2 and 3 of the draft Article 29bis meant that there were additional requirements other than the evidence of prior informed consent and access and benefit sharing, he replied in the negative.
56. About the meaning of the term "associated traditional knowledge", he said that the proponents of the draft amendment intended to give the ordinary meaning to this term. The word "associated" was prefixed to traditional knowledge in order to restrict the disclosure requirements to the traditional knowledge that had relevance to the biological resources used in developing the invention or concerning the subject-matter of the invention. In other words, not all forms of traditional knowledge were covered by the proposed disclosure requirements.
57. About the method of publishing the disclosed information, he said that it would be at the discretion of each Member. The information should be published simultaneously with the patent application or the granting of the patent, whichever was first, in the same or a separate document. The supplementary or corrected information required under paragraph 3 of the draft Article 29bis would be published separately.
58. Regarding questions from the EC and Chinese Taipei concerning the concept of "unenforceable" used in paragraph 5 of the draft Article 29bis, he said that unenforceability was presented as an alternative to the revocation of patents. Thus, a patent holder who had failed to comply with the disclosure requirements would not be entitled to go to court to enforce his rights. This was similar to the principle under the common law that the persons with "unclean hands" could not go to a court to demand equity. For example, if a patent holder did not pay the patent renewal fee, he could not go to court to enforce his patent rights.
59. With respect to New Zealand's question on why the substance of the draft text was broader than its title, he said that titles in the TRIPS Agreement, such as those of Articles 30 and 27, usually gave a general sense of the issue, but did not cover all the elements included under them.
60. He responded to several other questions from the Philippines and said that with regard to the transitional period for implementation of the draft amendment, the draft amendment was predominantly in the interest of developing countries and that the problem of biopiracy had not been tackled adequately for ten years since the entry into force of the TRIPS Agreement. Thus, the period between the adoption of the amendment and its ratification would be sufficient to allow countries to make the necessary changes in their laws. This would exclude LDCs, whose general transitional period had been extended to mid 2013 under the TRIPS Agreement, with possible additional extensions.
61. As to whether a declaration of the providing country and the source, together with a declaration that the providing countries did not have prior informed consent and access and benefit-sharing regimes, would suffice, he said that patent applicants should present the evidence of compliance with the applicable legal requirements in the providing country. If the providing country did not have such requirements, a declaration to this effect would suffice. He said that patent offices would not have to assess the validity of such declarations. It would work based on the prima facie assumption that the declaration had been provided correctly and in good faith. However, the patent applicant would still be required to disclose the providing country, from whom in that country the biological resource and/or associated traditional knowledge had been obtained, and, after reasonable inquiry, the country of origin.
62. Regarding another question about the application of the disclosure obligation, he said that it would apply only to patent applications that were submitted after Members' assumption of the obligation under the draft amendment. As to the meaning of "with reasonable grounds to know" used in paragraph 5 of the draft amendment, he said that the phrase was a widely used legal concept and could be found in many legislative provisions, such as Articles 44 and 45 of the TRIPS Agreement. Paragraph 1 of Article 44 provided, inter alia, that Members were not obliged to accord such authority in respect of protected subject-matter acquired or ordered by a person prior to knowing or having reasonable grounds to know that dealing in such subject-matter would entail the infringement of an intellectual property right. Similar language was used in paragraph 1 of Article 45 regarding damages. The words in paragraph 5 of the draft Article 29bis would have a similar meaning to that in Articles 44 and 45. The knowledge of the patent applicant, the resource available to him, and normal business and scientific practices that he would be expected to know should be taken into account. For example, if there was an access and benefit-sharing law in the providing country, the patent applicant would be reasonably expected to know this law and its requirement. It also implied that the applicant was expected to exercise ordinary due diligence and not be reckless or careless.
63. As to whether Members could impose fees on patent applicants to cover the costs associated with the disclosure obligation, he said that it was anticipated that the disclosure obligation would not impose undue burdens and costs on patent applicants, patent holders or patent offices. For this reason, unless demonstrated otherwise, it was not foreseen that additional fees would need to be charged to cover the costs. However, where a Member considered it relevant, it could take this obligation, together with any other considerations, into account in setting fees. In essence, the intention of the proponents of the disclosure requirements was to leave this issue to the discretion of Members, subject to other rules in the TRIPS Agreement or other treaties, such as the Patent Cooperation Treaty.
64. He responded to several other questions from Chinese Taipei. As to whether paragraph 1 of the draft Article 29bis meant that a Member not party to the CBD would have to comply with CBD requirements, he said that paragraph 1 indicated broad objectives that would be served by the proposed TRIPS amendment. Once introduced into the TRIPS Agreement, the disclosure requirements would be a TRIPS and not a CBD obligation, notwithstanding the sought objective of mutual supportiveness between the two treaties. The amendment would not bind non-CBD parties to the provisions of the CBD, as the disclosure obligations would be acquired exclusively under and in accordance with the TRIPS Agreement. This was normal practice, particularly in the case of the TRIPS Agreement, which had transposed several provisions contained in other international treaties into the realm of the WTO. Reference in the TRIPS Agreement to provisions taken from the Paris Convention or other WIPO treaties did not mean that non-WIPO members were obliged to comply with WIPO obligations.
65. As to whether the requirement for correction of information applied only to the pre-grant period or to the post-grant period as well, he said that the requirement would apply to both the pre- and post-grant periods as both the words "applicant" and "patentee" were used in the draft amendment. Since the failure to comply with the disclosure obligation could prevent the further processing of patent applications or result in the revocation of patents, the flexibility for submitting additional information would benefit the patent applicant or the patentee. Therefore, there should be a continuing opportunity for providing supplemental or corrected information.
66. As to with whom benefit-sharing contracts should be negotiated and the benefits be shared, he said that this was up to each WTO Member and that the draft amendment did not intend to impose a uniform approach on WTO Members.
67. In conclusion, he said that the mandate given by Ministers provided a basis for negotiations on all outstanding implementation issues, including the CBD. It did not exclude an amendment to the TRIPS Agreement as an outcome of the Doha Round.
