我国药品专利链接制度的规则漏洞及其修正
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作者单位:

1. 南京理工大学知识产权学院,江苏 南京 210094 ;2. 北京大学法学院,北京 100871 ;3. 北京策略律师事务所,北京 100000

作者简介:

许圣章(2001—),男,广东佛山人,硕士研究生在读,研究方向为知识产权法;

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中图分类号:

D923.4

基金项目:

中国法学会部级课题“CPTPP药品试验数据规制制度的规则构造、场域与中国因应”[(CLS(2025)D59)];江苏省高校哲学社会科学一般项目“CPTPP知识产权章节中‘与药品相关的措施’的解读与应对”(2025SJYB0032);江苏省知识产权局委托项目“江苏省‘十五五’知识产权规划研究”(YC2024-JC301,58)


Rule loopholes and corrections of the drug patent linkage system in China
Author:
Affiliation:

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

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    摘要:

    我国药品专利链接制度以实现社会与经济效益为根本使命,由专利信息登记、专利声明、批准等待期等制度构成。但实证发现,制度运行存在专利信息登记失范与专利声明无序、第一类声明与信息登记衔接失灵、9个月批准等待期设置失衡且易被滥用等法律规则漏洞,有违制度经济效率。为修正上述漏洞,应采取三条路径:一是构建专利信息与声明的事前预防监管机制;二是明确未尽专利声明注意或通知义务的责任规制;三是设立可灵活调整或依申请延长的批准等待期,进而对《药品专利纠纷早期解决机制实施办法(试行)》相关条款作适应性修订。

    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).

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许圣章,潘坤.我国药品专利链接制度的规则漏洞及其修正[J].南京医科大学学报(社会科学版),2026,26(3):295~302

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  • 收稿日期:2025-12-29
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  • 在线发布日期: 2026-06-24
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