208. The representative of Zambia said he supported the two statements made by Senegal. Speaking as the focal point for least-developed countries on TRIPS issues, he said that the decision to extend the transitional period for least-developed country Members was being made within a particular context. It was important that Members fully take into account this context to properly appreciate the suggestions and approach which had been taken by least-developed countries on this issue. Paragraph 7 should be read in the context of the entire Declaration and the objectives of the TRIPS Agreement. Apart from affirming that the TRIPS Agreement could and should be interpreted and implemented in a manner supportive of Members' rights to protect public health, the Declaration confirmed that the objectives of the Agreement provided an important context with respect to interpretation and implementation. In determining the scope and effect of the draft Decision under Article 66.1, the TRIPS Council must interpret paragraph 7 of the Declaration to ensure that the Decision fulfil the object and purpose of providing least-developed countries with maximum flexibility in the domestic implementation of laws and regulations in order to protect public health and also to enable them to create a sound and viable technological base.
209. The first part of paragraph 7 was being discussed in the context of the mandate under paragraph 11.2 of the Decision on Implementation Issues and Related Concerns as contained in document WT/MIN(01)/I7). He announced that a separate communication would be submitted by least-developed countries regarding the monitoring mechanism.2 It was the second part of paragraph 7 that the present draft Decision was meant to address. There were three main issues that had immediate relevance in regard to the implementation of paragraph 7 of the Declaration. These were: (i) the applicability of the Decision to pharmaceutical processes and other types of pharmaceutical patents; (ii) clarity that least-developed countries shall still have full rights under Article 66.1 to ask for further extensions not just in respect of the other parts or sections of the TRIPS Agreement not covered by this Decision but also further extensions with respect to the application and implementation of Sections 5 and 7 of Part II of the Agreement; and (iii) whether the obligations under Article 70.8(a) and 70.9 would still apply to least-developed country Members during the period of extension.
210. He further noted that the Declaration referred to "pharmaceutical products" and this was the language that had been used in the draft Decision. This wording might seem to suggest that the envisaged extension would not apply in respect of pharmaceutical process patents or other types of pharmaceutical patents such as use patents. This concern arose from the distinction under Article 27.1 where it was provided, inter alia, that "patents shall be available for any inventions, whether products or processes". Least-developed countries were prepared to accept paragraph 1 of the Decision as drafted by the Secretariat provided that there was a clear understanding that the use of the word "products" was understood to mean all types of processes under Article 27.1 of the TRIPS Agreement.
211. Regarding the entitlement to further extensions in respect of Sections 5 and 7 of Part II of the TRIPS Agreement, he stated that least-developed country Members appreciated that paragraph 2 of the draft Decision might already address this concern. However, for purposes of clarity, least-developed countries wanted to bring to the notice of all Members their understanding of paragraph 2 of the draft Decision. The use of the word "other" should be read to mean extensions in respect of all other sections and parts of the TRIPS Agreement as applicable, as well as further extensions after 2016 in respect of Sections 5 and 7 of Part II of the TRIPS Agreement.
212. As regards the mailbox and exclusive marketing rights, the representative of Zambia said that the provisions of Article 70.8(a) and 70.9 of the TRIPS Agreement generally applied to Members that had patent protection for other products and processes but did not allow patents on pharmaceuticals and agricultural chemicals. The provisions would therefore not apply to least-developed countries that had had no patent systems at all at the time of entry into force of the TRIPS Agreement or those that had already provided patent protection for pharmaceuticals and agricultural chemicals by that time. With respect to least-developed countries that did not fall within the two categories above, if Article 70.8(a) and 70.9 continued to apply, they would erode the benefits of the extension. In particular, exclusive marketing rights had the effect of enforcing a foreign patent and for all intents and purposes had the same effect as the grant of a patent for five years. Least-developed countries considered it critical that an effective solution be found to ensure that the provisions of Article 70.8(a) and 70.9 would not apply during the period of extension. There should be an understanding that the "enforcement of patent rights" referred to in the Declaration included the provisional enforcement through the mailbox and exclusive marketing rights provisions.
213. He explained that the difficulty with addressing this concern through the Decision under Article 66.1 stemmed from the language of Article 70.8(a) and 70.9, which excluded the application of the transitional arrangements under Part VI, including those under Article 66.1, to the mailbox and exclusive marketing rights provisions under Article 70.8(a) and 70.9. The two paragraphs were drafted in the language of "notwithstanding the provisions of Part VI". In this context, it would appear that the powers of the TRIPS Council under Article 66.1 of the TRIPS Agreement did not include powers to suspend and/or postpone the application of the mailbox and the exclusive marketing rights provisions. The Secretariat had prepared a draft waiver to facilitate the suspension of the obligations under Article 70.8(a) and 70.9 for least-developed country Members where applicable until 2016. Having considered the draft waiver, least-developed countries were of the view that the TRIPS Council should approve the draft waiver Decision as it was and recommend that the General Council adopt it to facilitate this process.
