From the perspective of balancing interests, analyze the problems and challenges faced by the registration system, declaration system, approval waiting period system,and market monopoly period system as important components of the drug patent linkage system in theory and practice. These challenges include the lack of regulatory mechanisms for patent registration review, unclear liability for improper registrations, the prevalence of erroneous patent declarations alongside ambiguity in supporting regulations, the lack of effective regulation over the abuse or disregard of the approval waiting period, and the failure of the market exclusivity period.By drawing on and analyzing international and practical experience, 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 research drug companies, generic drug manufacturers, and public health by refining the content and strengthening the interconnections of specific mechanisms, optimizing examination mechanism, and clarifying legal standards.