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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）
南 第3期 总第134期
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Journal of Nanjing Medical University（Social Sciences）of Nanjing Medical University（Social Sciences） 2026年6月
Journal

Rule loopholes and corrections of the drug patent linkage system in

China

1
XU Shengzhang ，PAN Kun 1，2，3
1. School of Intellectual Property，Nanjing University of Science and Technology，Nanjing 210094；
2. Law School，Peking University，Beijing 100871；3. Beijing Celue Law Firm，Beijing 100000，China
Abstract：China’s drug patent linkage system is fundamentally designed to achieve economic and social
benefits，comprising mechanisms such as patent information registration，patent declarations，and the nine ⁃
month approval waiting period. However，empirical analysis reveals several legal loopholes in the operation of
the system，including irregularities in patent information registration and disorderly patent declarations；a
breakdown in coordination between Type I declarations and information registration；and an imbalanced nine⁃
month approval waiting period that is susceptible to abuse. These loopholes undermine the system’s economic
efficiency. To address these shortcomings，three approaches should be adopted based on an identification of the
affected operational aspects and associated risks. First，establishing a preventive regulatory mechanism for
patent information and declarations. Second，clarifying liability regulations for failure to fulfill the duty of care
or notification regarding patent declarations. Third，creating an approval waiting period that can be flexibly
adjusted or extended upon application. Thereby，these approaches would support adaptive revisions to the
relevant provisions of The Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes
（Trial）.
Key words：drug patent linkage system；rule loopholes；patent information registration；patent declaration；
approval waiting period