我国创新药企被提专利无效请求风险预警研究

A research on the risk early-warning of patent invalidation requests of innovative pharmaceutical enterprises in China

我国正由仿制药大国向创新药大国加速转型,越来越多的企业由仿制药企业向创新药企业转变。新角色下被提专利权无效宣告请求的风险日益升高,对企业专利管理实践提出新挑战。首次将我国原国家食品药品监督管理总局药品审评中心发布的《中国上市药品目录集》中创新药企业信息,与国家知识产权局专利局复审和无效审理部公布的专利权无效宣告请求案件信息链接。基于法律纠纷理论模型框架,实证分析药品发明专利无效请求发生概率的影响因素。研究表明:专利价值越高、专利法律质量越低、信息不对称程度(或当事人对无效结果的期望分歧)越大,被提无效请求的风险越高。与理论分析不一致的是,与制剂/组合物专利相比,药用化合物和药用生物分子专利被提无效请求的概率更低。研究结论为企业有效开展药品发明专利被提无效请求的风险预警提供有益借鉴。

China is accelerating its transformation from a big country of generic drugs to a big country of innovative drugs,and more and more enterprises are transforming from generic pharmaceutical enterprises to innovative pharmaceutical enterprises.Under the new role,the risk of drug patent invalidation requests is increasing day by day,which poses a new challenge to the enterprise patent management practice.Patents are relied upon more frequently to protect pharmaceutical innovation.The cost of engaging in invalidation over issued drug patents diminishes their value as an incentive to invest in new drug R&D.From the perspective of enterprises,it is of great theoretical value and practical significance to study how to effectively carry out the early warning of the risk of drug patent invalidation requests.In this paper,we examine the characteristics of drug patents involved in invalidation requests and their owners by combining,for the first time,information about"Catalogue of Chinese listed drugs"issued by China Food and Drug Administration(CFDA)with detailed data of case filings from Reexamination and Invalidation Department of the China Patent Office.By comparing filed cases to a control group,we show that there is substantial variation across patents in their exposure to risk of invalidation requests.We use this empirical evidence to examine hypotheses about the determinants of requests for invalidating drug patents.We show empirically that the risk increases with patent value,asymmetric information(or diverging expectations of invalidation outcomes)and low legal quality.In contrast to the theoretical predictions,the empirical findings suggest that formulation patent is challenged more frequently than composition of matter patent.The possible contributions of this paper are as follows:Firstly,it expands and complements the previous studies on the determinants of the probability of occurrence of patent validity challenges,which mainly focus on patent invalidation proceedings in the United States and patent oppositions in the European Patent Office.Secondly,on the theoretical level,it takes the drug invention patent type as the index to measure the patent value from the dimension of protection scope/intensity,reveals the phenomenon that is inconsistent with the theoretical prediction under the actual national conditions,and enriches the understanding of the determinants of the probability of occurrence of patent validity challenges.Finally,at the practical level,it provides empirical evidence and useful reference for Chinese innovative drug enterprises.It is suggested that the ability to associate observable characteristics of drug patents to requests for invalidation risk should be exploited in developing forecasting tools,a classified management system should be established according to risk grade."Patent invalidation insurance"can be insured for important pharmaceutical invention patents with high risk of request for invalidation.Early-warning of potential requests for invalidation risk of pharmaceutical invention patents is helpful to improve the patent management level of Chinese innovative pharmaceutical enterprises.In addition,great importance should be attached to the writing quality of patent application documents including the specification,so as to improve the quality of patent law from the source.Chinese pharmaceutical enterprises still need to further strengthen the innovation of key technologies such as pharmaceutical compounds and medicinal biomolecules.