我国药品专利期限补偿制度的解析与重构  

Analysis and Reconstruction of China’s Pharmaceutical Patent Term Compensation System

作　　者：李凡 LI Fan(Center for Studies of Intellectual Property Rights,Zhongnan University of Economics and Law,Wuhan 430073)

机构地区：[1]中南财经政法大学知识产权研究中心,武汉430073

出　　处：《中国发明与专利》2023年第8期69-78,共10页China Invention & Patent

基　　金：国家社会科学基金重大项目“总体国家安全观下产业知识产权风险治理现代化研究”(编号:21&ZD203);高等学校学科创新引智计划(编号:B18058)资助。

摘　　要：药品专利保护遵循“长周期”保护方式才能更好实现创新药、仿制药和公共健康利益之间的动态平衡,使原本在统一专利保护期下失衡的利益格局重回正轨。我国药品专利期限补偿制度未正式付诸实施,但制度困境初显,其中难以溯及已上市新药的字面规定对早期积极响应医药创新研发号召的药企来说显失公平,此外,制度在我国宽松专利环境下恐难真正发挥创新激励效应。据此,有必要提出增设“溯及已上市新药”过渡条款的具体方案,并从把控药品专利准入门槛、层级式划分药品创新激励机制、规制不当专利竞争行为等角度明确药品专利期限补偿制度创新激励机制的修正路径。Only by following the“long-term”protection method of drug patent protection can we better achieve the dynamic balance between innovative drugs,generic drugs,and public health interests,and return the unbalanced interest pattern under the unified patent protection period back to the right track.China’s drug patent term compensation system has not been formally implemented,but the institutional dilemma has begun to appear,among which the literal provisions that are difficult to trace new drugs that have already been marketed are unfair to pharmaceutical companies that actively respond to the call for pharmaceutical innovation,and the system may be difficult to truly exert the innovation incentive effect in China’s relaxed patent environment.Accordingly,it is necessary to put forward a specific plan to add a transitional clause for“retroactive new drugs already on the market”,and clarify the revision path of the innovation incentive mechanism of the drug patent term compensation system from the perspectives of controlling the entry threshold of drug patents,dividing the incentive mechanism for drug innovation in a hierarchical manner,and regulating improper patent competition.

关 键 词：药品专利 期限补偿 创新激励 

分 类 号：D923.42[政治法律—民商法学]