论新冠疫情下的药品专利强制许可制度

Compulsory Licensing System for Pharmaceutical Patents under COVID-19

自新型冠状病毒疫情爆发以来,如何获得治疗新冠肺炎药品成为关注的焦点。一些药品制造厂商进行了严密的专利布局,公共健康与知识产权保护产生严重冲突,如何确定药品专利强制许可中的申请理由、申请主体和强制许可费用计算标准成为讨论的焦点。对此《TRIPS协议》和《多哈宣言》制定了示范条款,给予各国具弹性的立法空间。印度则是灵活利用国际条约弹性条款构建符合自身国情的药品专利强制许可制度的典型,其申请理由范围宽泛,并且采用任一申请主体模式。在费用计算标准方面,德国和加拿大利用立法技术灵活化解了利益冲突,制定了明确的费用计算标准。与此相比,我国专利强制许可存在申请理由不明确,申请主体范围过窄以及缺少强制许可费用计算标准等问题。结合我国具体国情和新冠疫情下的紧急情势,我国应充分利用《TRIPS协议》给予的自由决定权利,增加法定申请理由、设立兜底条款以及解释重要概念来拓宽和明确申请理由;借鉴印度立法采用任一申请主体模式以拓宽申请主体范围;结合专利研发成本、我国经济和科技发展水平制定合理的费用标准,以应对新冠疫情的公共健康危机。

Novel coronavirus pneumonia has become the focus of attention since the outbreak of new coronavirus.Some pharmaceutical manufacturers have strict patent protections,and there is a serious conflict between public health and intellectual property protection.How to determine the reasons for application,the application body and the compulsory license fee calculation standard have become the focus of discussion.In this regard,the TRIPS Agreement and the Doha Declaration have formulated exemplary clauses to give countries flexible legislative space.India,on the other hand,is a typical example of using flexible provisions of international treaties to build a compulsory license system for drug patents in line with its own national conditions,with a wide range of application reasons and adopting any application subject mode.In terms of cost calculation standards,Germany and Canada have used legislative technology to defuse the conflict of interest and formulated clear cost calculation standards.In contrast,there are some problems in China’s compulsory license,such as unclear reasons for application,narrow scope of applicants and lack of calculation standard of compulsory license fees.In light of China’s specific national conditions and the urgent situation under COVID-19,China should make full use of the free decision rights granted by the TRIPS agreement,increase the statutory reasons for the application,set up relevant clauses and explain important concepts to widen and clarify the reasons for application.In order to broaden the scope of applicants,we should learn from Indian legislation and adopt any applicant mode.In line with the cost of patent research and development and the level of China’s economic and technological development,we must formulate reasonable cost standards to deal with the public health crisis posed by COVID-19.