药品专利反向支付协议反垄断规制的正当性及其实现路径

The Legitimacy and Realization Path of the Anti-monopoly Regulation of Drug Patent Reverse Payment Agreement

反向支付协议作为药品专利创新保护与医药市场自由竞争博弈的产物,在实施过程中极易造成市场垄断。为提高药品可及性,推动仿制药生产与销售,应对药品反向支付协议进行反垄断审查,以发挥市场自由竞争机制的效用。基于此,有必要以财产理论检视药品专利制度限制的正当性基础,为药品反向支付协议反垄断规制提供理论前提,并在考察域外相关反垄断规制经验的基础上,综合运用以合理性原则为基础的审查规则,辅以和解公布机制与惩罚性赔偿机制,构建我国药品专利反向支付协议反垄断规制的多元价值均衡考量路径。

The drug patent reverse payment agreement as drug patent innovation protection and the product of free pharmaceutical market competition game,in the implementation process of easily cause market monopoly,to improve drug accessibility,promote the purpose of generic drug production and sales,so it should be antitrust regulation,to play to the necessary role of market free competition mechanism.To achieve this goal,in the introduction of related property theory drug reverse payment agreement under the premise of the legitimacy of antitrust regulation,through the investigation of European and American antitrust regulation experience,the integrated use on the basis of rationality principle of review rules,supplemented by settlement mechanism and punitive damages mechanism,realize multiple value equilibrium consideration antitrust regulation path.