创新药企专利无效对他人后续创新的影响研究  

Research on the impact of drug patent invalidation of innovative pharmaceutical companies on the follow-on innovation of other innovators

作　　者：李艳[1] 朱雪忠 Li Yan;Zhu Xuezhong(School of Economics and Management,Tongji University,Shanghai 200092,China;Shanghai International College of Intellectual Property,Tongji University,Shanghai 200092,China)

机构地区：[1]同济大学经济与管理学院,上海200092 [2]同济大学上海国际知识产权学院,上海200092

出　　处：《科研管理》2023年第9期152-161,共10页Science Research Management

基　　金：国家社会科学基金重大项目:“国家重大科技产业项目知识产权安全风险监测预警与防控体系”(19ZDA102,2020.01-2023.12)。

摘　　要：“高投入、高风险、长周期”的特点,使医药创新尤为依赖专利保护。我国药品发明专利“授权难、无效易”,是否与专利制度激励创新的目标相匹配?以我国市场上创新药企为研究单元,以其被提过无效请求的药品发明专利为样本,使用2SLS工具变量法回归分析专利无效对其他主体后续创新的影响。结果显示,我国市场上创新药企的药品发明专利被宣告全部无效和部分无效的比例之和高达86%,表明专利无效宣告制度发挥了剔除错误授权的作用。但与基于美欧研究结论非常不同的是,在本土主体创新能力受限的新兴市场环境中,创新药企的药品发明专利权能够发挥“鲶鱼效应”,激发行业内其他主体的后续创新;而被宣告为无效降低了对行业内其他主体后续创新的激励作用,给搭便车进行低水平重复仿制留下了空间。在理论层面上,揭示了专利制度激励创新目标的实现,亦会受原始创新主体与其他主体之间创新能力距离的影响;在实践层面上,启示政策制定者不仅应从专利无效宣告制度控制专利质量的初衷,亦应结合专利制度激励创新目标及原理的视角,综合全面认识专利无效对创新的影响,为优化促进药品创新和仿制药高质量发展相关政策如“药品专利链接制度”提供来自我国现实国情的经验证据。The patent is considered as a key policy instrument to encourage new drug innovation;however,pharmaceutical invention patents present the characteristics of "difficult to authorize but easy to invalidate",the invalidation rate of drug invention patent rights of innovative pharmaceutical companies in China is as high as 86%.What is the effect of drug patent rights invalidation on follow-on innovation? Does it match the patent system′s goal of stimulating innovation? In this paper,we selected enterprises with innovative drug RD ability in China′s market as the research unit,and drug patents of innovative pharmaceutical enterprises that have been requested for invalidation in China were taken as samples.Using the data on requests for invalidating the drug patent rights of innovative pharmaceutical enterprises at the Patent Reexamination and Invalidation Department of the Patent Office,China National Intellectual Property Administration(CNIPA),we studied the causal impact of a drug patent′s invalidation on the follow-on innovations by other innovators.The biggest challenge in our empirical work identifying the causal effect of patent rights invalidation on later innovation is the potential endogeneity of invalidity decisions.For instance,drug technologies with greater commercial values are both more likely to be heavily defended by the patent holders and to be an attractive target for follow-on innovations.To address this potential endogeneity of invalidity decisions,we need an instrument that affects the probability of patent invalidation,but at the same time does not affect follow-on innovation especially citations by other downstream innovators directly,therefore creating exogenous variation in patent invalidation.There is a fortunate institutional fact that the Patent Reexamination and Invalidation Department adopts collegiate examination,cases that are collegially examined by a panel consisting of three or five members,including a chairman,a first member,and one or three second members respectively.The fir

关 键 词：创新药企 药品发明专利 专利无效 后续创新 

分 类 号：G306.0[文化科学]