中国药品专利链接制度设计的内涵、现状及其应对

The Connotation,Current Situation,and Response of China’s Drug Patent Linkage System Design

对中国药品专利链接制度设计进行研究,其目的在于全面了解该制度的设计理念、运行机制、实施现状以及当前制度设计对各个权利主体的影响,并以此为药品行政主管或监管部门和行业利益相关方提供指引,进一步完善和优化中国药品专利链接体系。着眼于我国药品专利链接制度的法律、法规和政策框架,一方面,我国当前药品专利链接制度存在诸多可改进之处;另一方面,原研药企需要借助药品专利制度对自身利益予以保护。因此需要基于我国药品专利链接制度的现状予以应对,通过完善专利信息载体,细化专利争议解决机制和填补法律规定的空白,以实现原研药企和仿制药企之间的利益平衡,达成药品专利链接制度最初的设计目标。

The research on the connotation,current situation,and response to China’s drug patent linkage system aims to comprehensively understand the system’s design purpose,operating mechanism,implementation status,and impact on various subject of right.The findings of this research can provide guidance to drug administration or supervision departments and industry stakeholders in improving and optimizing China’s drug patent linkage system.The research focuses on the legal,regulatory,and policy framework of China’s drug patent linkage system,with the recognition that there is room for improvement in the current system.It also acknowledges that original drug companies have a vested interest in utilizing the drug patent system to protect their rights.Therefore,it is necessary to respond to the current situation of China’s drug patent linkage system by achieving a balance of interests between original drug companies and generic drug companies.This can be achieved through measures such as improving patent information carrier,refining patent dispute resolution mechanisms,filling legal gaps,and aligning the system with its original design goals.