印度药品专利强制许可制度研究

The Drug Patent Compulsory Licensing System in India and Its Empirical Study

依据TRIPS协议，印度于2002年制定了药品专利强制许可制度，极大地提高了民众用药可及性。首先，本文详细介绍了印度药品专利强制许可的申请理由及授予流程；然后，对首个药物专利强制许可的具体过程及实施效果进行梳理和评价；最后，本文作者借鉴印度经验，提出从及时出台药品专利强制许可实施细则、适当放宽药品专利强制许可申请理由、运用专利强制许可进行药品价格谈判三个方面完善我国药品专利强制许可制度的建议，以期提高患者对重大临床需求药品的可及性。

According to the TRIPS Agreement, India established thedrug patentcompulsoryli-censingsystemin 2002, which greatly improved the availability of drugs for the public. This paper analyzes the reasons for the application for compulsory licensing of drugs in India and the granting process. It also summarizes the specific process and implementation effect of the first compulsory licensing of drugs. Finally, it draws on the experience of India and recommends that it promptly publish detailed implementation rules for compulsory licensing of pharmaceuticals, relax the reasons for the application for compulsory patent licenses for drugs and use patent compulsory licenses to negotiate prices for drugs, in order to improve the drug patent compulsory licensing system in China.