药品专利“反向支付和解协议”反垄断规制的国际比较研究

International Comparative Study on Anti-Monopoly Regulation of Drug Patent "The Reverse-Payment Settlement"

"反向支付和解协议"是指在药品专利侵权纠纷中,专利权人通过支付金钱或其他利益给仿制药企业达成和解,以推迟仿制药上市的协议。无论是创新药产业很发达的美国和欧盟,还是加拿大、韩国、印度等国,其立法和执法机构也都对此类协议极为关注,并通过反垄断执法等措施予以规制。尽管"反向支付和解协议"并非与药品专利链接制度直接相关,但药品专利链接制度在很大程度上提供了滋生这类协议的"温床"。中国药品专利链接制度已提上议事日程,有必要通过完善反垄断执法、完善药品专利链接制度设计等对这类协议进行规制。

The reverse-payment settlement refers to an agreement in which patentees reach a settlement with generic drug companies by paying money or other benefits in a patent infringement dispute to delay the marketing of generic drugs.Whether it is the United States or the European Union,where the innovative pharmaceutical industry is very developed,or Canada,South Korea,India,etc.,its legislative and law enforcement agencies are extremely concerned about such agreements and regulate them through measures such as anti-monopoly enforcement.Although the reverse-payment settlement is not directly related to the pharmaceutical patent linkage system,the pharmaceutical patent linkage system provides a large"hotbed"for such agreements.As China’s pharmaceutical patent linkage system has been put on the agenda,it is necessary to regulate such agreements by improving anti-monopoly law enforcement and improving the design of pharmaceutical patent linkage system.