我国药品专利链接争议解决机制的困境与对策  

Dilemma and countermeasures of the dispute resolution mechanism for pharmaceutical patent linkage in China

作　　者：吴克 郭斯伦[1] WU Ke;GUO Silun(School of Humanities,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学人文学院,北京100029

出　　处：《卫生软科学》2024年第9期46-49,64,共5页Soft Science of Health

摘　　要：我国现行药品专利链接争议解决机制构建了确认是否落入专利权保护范围的司法裁决和行政裁决模式。文章通过梳理我国药品专利链接制度相关法律及政策文件的具体规定,分析了行政裁决与民事诉讼的并行困境,以及这二者与专利无效宣告程序和专利侵权诉讼之间的潜在困境,究其原因是未将仿制药申请上市行为定性为侵权并遵循了传统专利侵权双轨制解决模式和专利确权行政解决模式,并从确立以“拟制侵权”为核心的纠纷解决机制、择一适用行政和司法程序、探索引入专利权无效抗辩事由等角度提出解决对策。China's current dispute resolution mechanism for pharmaceutical patent linkage has established a judicial and administrative ruling model to confirm whether it falls into the scope of patent protection.By combing through the specific provisions of relevant laws and policy documents of China's pharmaceutical patent linkage system,this paper analyzes the parallel dilemma of administrative ruling and civil litigation,as well as the potential dilemma between them and patent invalidation procedures and patent infringement litigation.The reason is that the application for listing of generic drugs has not been classified as infringement,and it follows the traditional dual track solution model for patent infringement and the administrative solution model for patent confirmation.The solutions are put forward from the perspectives of establishing a dispute resolution mechanism with“artificial act of infringement”as the core,selecting appropriate administrative and judicial procedures,and exploring the introduction of patent invalidation defense.

关 键 词：药品专利链接制度 争议解决机制 司法行政双轨制 专利无效宣告 拟制侵权 

分 类 号：R951[医药卫生—药学]