药品专利限制与强制许可——基于国际经验与中国现况的评析

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在国际知识产权保护体系和国际贸易格局中,专利强制许可因其对专利权的限制强度最大,也最为有效,所以处于专利权边界的最前沿阵地。各种知识产权限制措施构成了知识产权保护与不保护的分界线,而这个边界是变动的和发展的。由于承载了药品知识产权、包括健康权在内的人权以及国际法等众多规则和价值目标,在专利强制许可制度的订立和实施等诸多方面也必然包含着发达国家与欠发达国家之间的多种较量。近十余年来强制许可实际实施例数甚少的现状既是前述复杂性的典型体现,也是各国艰难博弈和理性选择的必然结果。国际国内围绕专利强制许可的立法和实践突出体现了法与政策的融合和互动,也因此暗含了各国决策精细化的必要性。中国在处理药品专利强制许可有关问题时,鉴于需要考虑的目标和价值的多元性,以及其在国际上的敏感性和实施时可能面对的压力和复杂局面,应综合考虑改善药物可及性目标的不同强度不同位阶的各种可选措施,还应在限制专利权的同时注意最大程度发挥专利制度的积极作用、促进药品产业健康发展,以及结合中国在国际经济政治格局中的定位和目标,综合选择最优策略。 In the international system of intellectual property protection and the pattern of international trade, the compulsory licensing of patents is at the forefront of patent rights because patent rights are the most restrictive and most effective. Various intellectual property restrictions constitute the dividing line between the protection and the non-protection of intellectual property, and the boundary is changing and developing. Owing to numerous rules and values ​​such as the intellectual property rights of medicines, human rights including the right to health, and international law, many aspects such as the establishment and implementation of the compulsory patent licensing system must also include many kinds between developed and underdeveloped countries Bouts. The status quo of the actual number of compulsory licenses in the past 10 years is not only the typical manifestation of the aforesaid complexity but also the inevitable result of the difficult games and rational choices in various countries. The international and domestic legislation and practice of compulsory licensing of patents have prominently reflected the integration and interaction of law and policy, and therefore implied the necessity of elaborate decision-making in various countries. In tackling the issues related to the compulsory licensing of pharmaceutical patents, China should take into consideration the improvement of the accessibility of medicines in view of the diversity of goals and values ​​that need to be considered, as well as its international sensitivity and the pressures and complexities it may face in its implementation Various measures of different intensity and different orders of the target should be paid attention to maximizing the active role of the patent system while promoting the healthy development of the pharmaceutical industry while restricting the patent right as well as combining with the orientation of China in the international economic and political pattern. Goal, a comprehensive selection of the optimal strategy.
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