医药专利反向支付协议的反垄断规制问题研究——以“阿斯利康诉奥赛康”案为切入点

Study on the Antitrust Regulation of Pharmaceutical Patent Reverse Payment Agreements——The Case of AstraZeneca v.Ask-pharm as an Entry Point

最高人民法院在“阿斯利康诉奥赛康”案中对医药专利诉讼中的反向支付协议作出了回应,通过初步审查的方式认定其不违反《反垄断法》的相关规定。但目前在反垄断框架下,对于反向支付协议并未有统一的审查标准。在我国初步建立药品专利链接背景下,未来可能存在更多潜在的反向支付协议。本文探讨通过建立事前预防中的强制报告机制、构建事中审查中统一的审查标准、完善事后监督中的中国上市药品专利信息登记平台,以期完善对反向支付协议的反垄断规制。

In Astrazeneca v.Ask-pharm,the Supreme People’s Court responded to the reverse payment agreement in pharmaceutical patent litigation by finding that it did not violate the relevant provisions of the Antimonopoly Law through a preliminary review.However,there is no unified standard for the study of reverse payment agreements under the antitrust framework.In the context of the initial establishment of drug patent linkage in China,there may be more potential reverse payment agreements.This paper explores the establishment of a mandatory reporting mechanism in ex-ante prevention,the construction of uniform review standards in ex-post review,and the improvement of China’s listed drug patent information registration platform in ex-post supervision,to improve the antitrust regulation of reverse payment agreements.