新专利法背景下药品反向支付协议违法性认定研究

Study on the Illegality Judgment of the Drug Reverse Payment Agreement under the New Patent Law

摘要: 经过第四次修改的《中华人民共和国专利法》在第七十六条明确规定了专利链接制度，开启了我国对药品专利链接制度的进一步探索与构建。专利链接制度的相关规定与配套政策为我国反向支付协议提供了合适的生长土壤，未雨绸缪，对反向支付协议的违法性认定标准的确定能够使药品专利链接制度更加顺利地推行。美国对此类协议的主流审查模式为合理原则，立足个案本身进行审查，但审查因素模糊，不确定性较大；欧盟根据《欧洲联盟运行条约》对境内该类协议进行反垄断审查，其底层分析模式与我国反垄断立法模式较为相似，可参考性较高。对我国而言，通过概括禁止的立法方式表达反向支付协议的违法性，但满足一定条件的可以个案豁免的方式可行性更佳。除此之外，食药监管总局也应积极完善自身法案促进医疗健康体系发展。

Abstract: The Patent Law of the People’s Republic of China, which has been amended for the fourth time, clearly stipulates the patent linkage system in Article 76, opens up the further exploration and construction of the patent linkage sys-tem for pharmaceuticals in China. The relevant provisions and supporting policies of the patent linkage system provide a suitable soil for the growth of reverse payment agreements in China, and the determination of the criteria for determining the illegality of reverse payment agreements can make the implementation of the drug patent linkage system more smooth. The mainstream review model of such agreements in the United States is the principle of reasonableness, based on the re-view of the case itself, but the review factors are vague and uncertain; the EU conducts antitrust re-view of such agreements in its territory according to the Treaty on the Functioning of the European Union, and its underlying analysis model is more similar to that of China’s antitrust legislation, which is highly referable. For China, it is more feasible to express the illegality of reverse payment agreements through the legislation of general prohibition, but the exemption can be granted on a case-by-case basis if certain conditions are met. In addition, the FDA should also actively improve its own bill to promote the development of the medical and health care system.