药品专利链接民事案件受理条件的司法检视与完善

Judicial Review and Improvement of the Acceptance Conditions for Civil Cases Concerning Drug Patent Linkage

摘要: 我国药品专利链接制度在司法实践中面临突出的受理条件争议，案件驳回率居高不下，纠纷早期解决功能难以有效发挥。当前制度存在专利登记标准模糊、行政审查缺位、相关专利界定不清、声明程序刚性过强、《专利法》衔接不畅及诉权基础薄弱等问题。为平衡创新激励与药品可及性，应当统一可登记专利范围，构建行政分层审查机制，规范相关专利认定与声明更正程序，确立本土化有限拟制侵权规则，理顺制度衔接逻辑，推动药品专利纠纷实现早期、高效、实质性解决。

Abstract: The drug patent linkage system of China is facing prominent disputes over acceptance conditions in judicial practice, with a high case dismissal rate and ineffective early dispute resolution. The curent system has problems such as ambiguous patent registration standards, absence of administrative review, unclear definition of relevant patents, excessively rigid of declaration procedures, poor connection with the Patent Law, and weak basis for the right of action. To balance innovation incentives and drug accessibility, it is necessary to unify the scope of registrable patents, establish a hierarchical administrative review mechanism, clarify the identification of relevant patents and declaration correction procedures, adopt localized limited constructive infringement rules, and improve institutional connection, so as to promote the early, efficient and substantive resolution of drug patent disputes.