合理原则之下——刺破反向支付协议的面纱

Piercing the Veil of Reverse Payment Agreement under the Principle of Reasonableness

仿制药市场中反向支付协议的大量出现让我们看到专利制度与反垄断制度之间存在的冲突,究竟适用何种原则对反向支付协议进行规制也是两种制度之间进行价值博弈的表现。通过对美国相关案例的考察,目前,本身违法原则、专利权排他范围测试规则、推定违法原则等不同程度地存在着漏洞,结合目前反向支付协议形式与内容愈来愈复杂多样的现实,适用合理原则对于反向支付协议进行规制提供了一种更加全面、合理的视角,应将合理原则确立为规制反向支付协议的主要原则,综合考量多种因素最终认定反向支付协议的性质,维护仿制药市场的自由竞争秩序,同时缓和专利制度与反垄断制度之间的矛盾,保持两种制度的价值平衡,既保护专利人的研发热情,又维护正常的市场竞争秩序。

The emergence of a large number of reverse payment agreements in the generic drug market makes us see the conflict between the patent system and the anti-monopoly system.What principle should be applied to regulate the reverse payment agreement is also the performance of the value game between the two systems.Through the investigation of the relevant cases in the United States,there are loopholes in the existing principles of its own violation,exclusive scope test rules of patent rights,presumption of illegality principle,etc.combined with the reality that the form and content of reverse payment agreement are becoming more and more complex,the application of the principle of reasonableness provides a more comprehensive and reasonable perspective for the regulation of reverse payment agreement The reasonable principle is established as the main principle to regulate the reverse payment agreement,and the nature of the reverse payment agreement is determined after considering various factors.At the same time,the contradiction between the patent system and the anti-monopoly system is eased,and the value balance of the two systems is maintained,which not only protects the enthusiasm of the patentee in research and development,but also maintains the normal market competition order.