药品专利反向支付协议的反垄断规制

Antitrust Regulation of Reverse Payment Agreement for Drug Patents

药品专利反向支付协议是药品行业特有的垄断行为,普遍存在于美国药品专利侵权诉讼中。多年来,美国反垄断机构在规制反向支付问题上积累了丰富的经验,其反垄断规则经历了从本身违法规则到专利范围测试规则、再到快速审查规则、直到合理规则的曲折变迁。随着美国治理逐步取得成效,反向支付现象又蔓延至欧洲。在此背景下,要积极预防和妥善解决未来我国药品领域可能出现的反向支付行为,必须在充分认识域外国家反向支付协议反垄断规制实践的基础上,回归到中国特色反垄断法律体系中和严厉的“禁止+豁免”法律框架下,尽快出台反向支付协议的反垄断规制指南,走出一条真正适合我国国情的反向支付协议反垄断规制道路。

Reverse payment agreement for drug patents is a monopoly practice unique in the drug industry,which is common in drug patent infringement lawsuits in the United States.Over the years,U.S.antimonopoly agencies have accumulated rich experiences in regulating reverse payment.The antitrust rule has developed from per se illegal rule to scope of the patent test,to quick look rule,and finally to rule of reason.Despite the gradual antitrust success in the US,the phenomenon of reverse payment spread to Europe.Against this background,we must be prepared to prevent the reverse payment practice that may occur in pharmaceutic industry in China in the future.To do this,we must first have a clear understanding of the anti-monopoly regulation practice against reverse payment agreements in foreign countries,and practice antitrust regulation in the“prohibition+exemption”framework of China’s the anti-monopoly legal system.