对我国药品专利纠纷早期解决机制的思考

Reflection on early resolution mechanism of drug patent disputes in China

我国专利法第四次修正中新增加第76条,建立药品专利纠纷早期解决机制。其核心是将药品行政上市许可与药品专利相链接,目的是保护药品专利权人合法权益,鼓励新药研究和促进高水平仿制药发展。我国药品专利纠纷早期解决机制的特色,是创新性地给予药品上市许可申请人、有关专利权人或者利害关系人,就“上市申请的仿制药是否在原研药专利权利要求范围之内”提起确认之诉的权利,或者请求行政裁决的权利,从而将药品上市审批程序与药品专利进行衔接,有效实现仿制药上市前解决药品专利纠纷,起到与美国药品专利链接制度规定“拟制侵权”相似的功能。结合2021年7月出台的《药品专利纠纷早期解决机制实施办法(试行)》,从4个方面预测分析我国药品专利纠纷早期解决机制中有待完善的内容。

Article 76 was added in the fourth amendment of the patent law of China,which established an early resolution mechanism for drug patent disputes.The core of it is to link the administrative marketing authorization of drugs with drug patents,so as to protect the legitimate rights and interests of drug patent owners,and encourage the research of new drugs and promote the development of high-level generic drugs.The feature of early resolution mechanism of drug patent disputes in China is that it innovatively grants the right to file a confirmation lawsuit on“whether the generic drug applied for listing is within the scope of the patent claims of the original drug”,or the right to request administrative adjudication,for the drug marketing license applicant,the relevant patentee or interested party.Thus,the drug marketing approval procedure is linked with drug patents,which is effectively realizing the resolution of drug patent disputes before generic drugs are marketed,and plays a similar function to the“fictitious infringement”stipulated by the drug patent linkage system of the United States.Combined with the Implementation Measures for Early Resolution Mechanism of Drug Patent Disputes(Trial Implementation)issued in July 2021,the contents to be improved in the early resolution mechanism of drug patent disputes in China are predicted and analyzed from 4 aspects.