Page 60 - 《南京医科大学学报社会科学版》2025年第5期

南京医科大学学报（社会科学版）京医科大学学报（社会科学版） 第5期 总第130期
南
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Journal of Nanjing Medical University（Social Sciences）of Nanjing Medical University（Social Sciences） 2025年10月
Journal

Optimization of the drug patent linkage system from the perspective of

interest balancing

LIANG Siyi，FENG Yanyan
School of Intellectual Property，Shandong University of Science and Technology，Qingdao 266590，China
Abstract：From the perspective of interest balancing，this study analyzes key challenges in the theoretical
and practical implementation of core components within the drug patent linkage system， including the
registration system，declaration system，approval waiting period system，and market exclusivity period system.
These challenges include the lack of regulatory mechanisms for patent registration review，unclear account
ability，the prevalence of erroneous patent declarations with ambiguity in supporting regulations，the absence of
effective control against the abuse or disregard of the approval waiting period，and dysfunction of the market
exclusivity period. By drawing upon and analyzing international and practical experiences，specific optimization
measures are proposed to address these issues. The aim is to continuously facilitate the effective implementation
of the drug patent linkage system and reach a tripartite equilibrium among original drug companies，generic
drug manufacturers，and public health by clarifying legal norms，enhancing procedural coordination，and
optimizing the review mechanisms.
Key words：drug patent linkage；principle of interest balancing；patent registration；patent declaration；
approval waiting period；market exclusivity period for the first generic drug