新时代中国药品专利链接制度的变革

China’s Reform of the Pharmaceutical Patent Linkage System in the New Era

摘要: 2020年《专利法修正案》获得通过，基本落实了中国药品专利链接制度创新的设想。在借鉴各国经验的基础上，中国设计并开始实施“药品专利纠纷早期解决机制”。结合现有案例可以发现，该制度的实施依然存在专利信息登记制度不完善、专利声明与挑战制度规范性不足、司法与行政程序衔接度不畅等问题。还需结合制度实施的产业背景，在利益平衡理论的指引下进行细化和完善。尝试从明晰专利信息登记范围和挑战成功要件，细化专利登记与声明程序以及提供统一的纠纷解决途径与有效衔接行政与司法程序入手，以期促进新时代中国药品专利链接制度的建设。

Abstract: In 2020, China amended its Patent Law and implemented a pharmaceutical Patent Linkage System. Learning from the experience of the “Pharmaceutical Patent Linkage System” of various countries, China designed and started to implement the “Early Settlement Mechanism of Pharmaceutical Patent Disputes”. However, it can find that there are still some problems in the implementation of this system when combined with the existing cases, such as the imperfection of the patent information registration system, the lack of standardization of the patent statement and challenging system, the unclear division of labor and the poor connection between judicial and administrative procedures and so on. It is necessary to combine the industrial background, and to refine and improve it under the guidance of the theory of balance of interests. It is recommended to clarify the scope of patent information registration and the elements of “successful challenges”, refine the procedures of patent registration and statement, and provide a unified dispute resolution way to effectively link administrative and judicial procedures so as to promote the construction of pharmaceutical patent linkage system in China in the new era.