Page 12 - 《中国药房》2022年21期

对标国际规则的我国药品专利链接制度实施策略探索 Δ

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王 媛 ，邵 蓉，颜建周（中国药科大学药品监管科学研究院/国家药品监督管理局药品监管创新与评价重点
#
实验室，南京 211100）

中图分类号 R951；D923.42 文献标志码 A 文章编号 1001-0408（2022）21-2566-06
DOI 10.6039/j.issn.1001-0408.2022.21.02

摘 要 目的 从制度设计方面探索我国药品专利链接制度的实施策略，为鼓励药品创新和提升高质量仿制药发展水平提供参
考。方法 梳理我国药品专利链接制度相关政策文件，从制度实施现状出发总结我国药品专利链接制度目前取得的进步和面临的
挑战；在此基础上，总结其他国家的成功经验和教训，结合我国基本国情，为我国药品专利链接制度的落地实施提出建议。结果与
结论 随着2020年修正版《中华人民共和国专利法》的出台，我国已基本完成该制度的顶层设计，但由于部分细则规定尚未完善，
我国尚存在缺乏“拟制侵权”制度、专利信息登记缺乏审查及纠错机制、司法和行政途径链接不畅、等待期时长仍存争议、首仿药市
场独占期制度相关细则不够明确等问题。建议我国建立“拟制侵权”制度和专利无效司法判决程序，调整等待期时长或上市审批
依据，进一步明确首仿药定义及共同挑战专利的情形和市场独占期的消灭事由，同时加强相关部门职能链接程序，落实责任机制。
关键词 药品专利链接制度；专利纠纷早期解决机制；专利法；仿制药

Strategic exploration of the implementation of China’s drug patent linkage system corresponding to
international rules
WANG Yuan，SHAO Rong，YAN Jianzhou（Scientific Research Institute of Drug Administration， China
Pharmaceutical University/Key Laboratory for Drug Regulatory Innovation and Evaluation，National Medical
Products Administration，Nanjing 211100，China）

ABSTRACT OBJECTIVE To explore the implementation strategy of China’s drug patent linkage system from the perspective of
the system design，in order to encourage drug innovation and improve the development level of high-quality generic drugs.
METHODS The current progress and challenges were summarized from the current situation of the implementation of China’s drug
patent linkage system by sorting out the relevant policy documents of the system. On this basis，the successful experience and
lessons of foreign countries were summarized to provide strategic suggestions for the implementation of China’s drug patent linkage
system in combination with China’s basic national conditions. RESULTS & CONCLUSIONS With the introduction of the revised
Patent Law of the People’s Republic of China in 2020，China had basically completed the top-level design of the system，but some
rules and regulations had not been improved. There were still some problems，such as the lack of a“fake infringement”system in
China，the lack of review and correction mechanisms for patent information registration，poor links between judicial and
administrative channels，the dispute over the length of waiting period，and the lack of clarity of relevant rules for the exclusivity
period system of the first generic drug market. It is recommended that China establish a“fake infringement”system and a judicial
decision procedure for patent invalidation，adjust the length of the waiting period or the basis for market approval，further clarify
the definition of the first generic drug，the circumstances of jointly challenging patents and the reasons for the elimination of the
market exclusivity period，and strengthen the functional link procedures of relevant departments and implement the responsibility
mechanism.
KEYWORDS drug patent linkage system；early resolution mechanism for patent disputes；patent law；generic drug

药品作为一种特殊的商品，关乎社会公众的生命健 长周期的特点，故设置专利制度保护创新成果，给予创
康。鼓励新药研发、降低药品价格是提高药品可及性的 新药品更高的利润回报，才能提高企业研发积极性，促
重要途径。由于新药研发具有高技术、高投入、高风险、 进持续创新。仿制药因前期开发投入相对较少，药品价
格相对低廉，对于提高药品可及性、减轻民众用药负担
Δ 基金项目 江 苏 省 研 究 生 科 研 与 实 践 创 新 计 划 项 目（No. 具有重要意义。为平衡创新药企和仿制药企及其所代
SJCX21_0246）；江苏省社科应用研究精品工程课题（No.22SYB-084） 表的社会公众的利益，药品专利链接制度应运而生。药
＊第一作者 硕士研究生。研究方向：医药政策与法规。E-mail： 品专利链接制度是指将仿制药上市批准与创新药品专
cpuwangyuan@163.com
利期满相链接的制度，其通过将可能存在的专利侵权风
# 通信作者 副研究员，博士。研究方向：医药政策与法规。电话：
025-86185193。E-mail：cpuqqyan@163.com 险提前至仿制药上市审批之前识别并解决，从而规避专

·2566· China Pharmacy 2022 Vol. 33 No. 21 中国药房 2022年第33卷第21期