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.