对标国际规则的我国药品专利链接制度实施策略探索  

Strategic exploration of the implementation of China’s drug patent linkage system corresponding to international rules

作　　者：王媛[1] 邵蓉[1] 颜建周[1] WANG Yuan;SHAO Rong;YAN Jianzhou(Scientific Research Institute of Drug Administration,China Pharmaceutical University/Key Laboratory for Drug Regulatory Innovation and Evaluation,National Medical Products Administration,Nanjing 211100,China)

机构地区：[1]中国药科大学药品监管科学研究院/国家药品监督管理局药品监管创新与评价重点实验室,南京211100

出　　处：《中国药房》2022年第21期2566-2571,共6页China Pharmacy

基　　金：江苏省研究生科研与实践创新计划项目(No.SJCX21_0246);江苏省社科应用研究精品工程课题(No.22SYB-084)。

摘　　要：目的从制度设计方面探索我国药品专利链接制度的实施策略,为鼓励药品创新和提升高质量仿制药发展水平提供参考。方法梳理我国药品专利链接制度相关政策文件,从制度实施现状出发总结我国药品专利链接制度目前取得的进步和面临的挑战;在此基础上,总结其他国家的成功经验和教训,结合我国基本国情,为我国药品专利链接制度的落地实施提出建议。结果与结论随着2020年修正版《中华人民共和国专利法》的出台,我国已基本完成该制度的顶层设计,但由于部分细则规定尚未完善,我国尚存在缺乏“拟制侵权”制度、专利信息登记缺乏审查及纠错机制、司法和行政途径链接不畅、等待期时长仍存争议、首仿药市场独占期制度相关细则不够明确等问题。建议我国建立“拟制侵权”制度和专利无效司法判决程序,调整等待期时长或上市审批依据,进一步明确首仿药定义及共同挑战专利的情形和市场独占期的消灭事由,同时加强相关部门职能链接程序,落实责任机制。OBJECTIVE To explore the implementation strategy of China’s drug patent linkage system from the perspective of the system design,in order to encourage drug innovation and improve the development level of high-quality generic drugs.METHODS The current progress and challenges were summarized from the current situation of the implementation of China’s drug patent linkage system by sorting out the relevant policy documents of the system.On this basis,the successful experience and lessons of foreign countries were summarized to provide strategic suggestions for the implementation of China’s drug patent linkage system in combination with China’s basic national conditions.RESULTS&CONCLUSIONS With the introduction of the revised Patent Law of the People’s Republic of China in 2020,China had basically completed the top-level design of the system,but some rules and regulations had not been improved.There were still some problems,such as the lack of a“fake infringement”system in China,the lack of review and correction mechanisms for patent information registration,poor links between judicial and administrative channels,the dispute over the length of waiting period,and the lack of clarity of relevant rules for the exclusivity period system of the first generic drug market.It is recommended that China establish a“fake infringement”system and a judicial decision procedure for patent invalidation,adjust the length of the waiting period or the basis for market approval,further clarify the definition of the first generic drug,the circumstances of jointly challenging patents and the reasons for the elimination of the market exclusivity period,and strengthen the functional link procedures of relevant departments and implement the responsibility mechanism.

关 键 词：药品专利链接制度 专利纠纷早期解决机制 专利法 仿制药 

分 类 号：R951[医药卫生—药学] D923.42[政治法律—民商法学]