摘要
药品专利强制许可制度基于平衡药品专利权和公共健康利益而生,是世界各国在TRIPS协定框架下保障仿制药供应、降低药品价格和应对公共健康危机的重要制度供给。在经历三次修订后,我国专利法现已建立了药品专利强制许可制度的主体框架,构造了药品专利强制许可一般制度和药品出口专利强制许可特殊制度两类制度安排,设计了五种实施路径,并初步建立了保障实施的配套制度。法律制度障碍目前仍是阻碍我国药品专利强制许可制度实施的重要因素,主要表现为药品专利强制许可一般制度的可操作性不强、药品出口专利强制许可特殊制度的内容和功能设计不尽合理,以及缺乏部门协作与经济激励等配套制度。建议我国修正《专利法》中专利强制许可章节的结构与条款,完善《专利法实施细则》等行政法规和部门规章的相关内容,并尽快健全基于药品专利强制许可制度的部门协作机制。
Drug patent compulsory license system, based on the balance between the patent rights and public interests, is an important system for many countries to reduce drug prices, improve drug accessibility and respond to public health crisis within the framework of the TRIPS Agreement. After three revisions, China’s patent law has now established the basic framework of compulsory license system for drug patent, constructed two kinds of institutional arrangements: general system for compulsory licensing of drug patents and special system for compulsory licensing of drug export patents, designed five implementation paths, and initially established a supporting system for guaranteeing implementation. Institutional barriers are still the key factors hindering the implementation of compulsory license system for drug patents in china. The main problems are lack of operability on the general compulsory License system of drug patents, unreasonable design of content and function on the special system of compulsory license system of drug export patent, and the absence of supporting systems such as departmental collaboration and economic incentives. It is recommended that China should amend the relevant provisions of the Patent Law, improve the relevant contents of administrative regulations and departmental regulations, and improve the departmental cooperation mechanism based on the compulsory licensing system for drug patent as soon as posible.
出处
《华侨大学学报（哲学社会科学版）》
CSSCI
北大核心
2019年第5期99-110,共12页
Journal of Huaqiao University(Philosophy & Social Sciences)
基金
国家知识产权局横向课题“出口等三种情形下专利强制许可程序实务研究”(k8215008)
关键词
药品专利
强制许可制度
专利法
仿制药
drug patent
compulsory license system
patent law
generic drug
