我国药品专利强制许可制度的法律规制研究

Research on the Legal Regulation of Compulsory License System For Pharmaceutical Patents in China

面对严峻的公共健康形势,药品专利强制许可制度在平衡专利私权与公众健康权之间实现着有效的动态平衡。通过梳理我国药品专利强制许可立法的演变过程,从政策定位、法理依据和社会需求三个层面对该制度存在的现实基础进行分析,指出我国药品专利强制许可制度之所以处于"零实施"的现状,既有政策负效应的障碍,也在制度模式和立法上存在缺陷。进一步明确该制度的政策定位,通过立法完善制度设计,促进该制度在我国的实践落成和法律完善。

In the face of a serious public health situation,the compulsory license system of pharmaceutical patents has achieved an effective dynamic balance between the private rights of patents and public health rights.Through combing the evolution process of China’s compulsory license system of drug patents legislation,analyzing the actual basis of the system’s existence from the three levels of policy orientation,legal basis and social needs,and pointing out why China’s compulsory license system of drug patents is in a"zero implementation"status,There are not only obstacles to the negative effects of policies,but also defects in the institutional model and legislation.Further clarify the policy positioning of the system,improve the system design through legislation,and promote the implementation of the system in my country and the improvement of the law.