我国药品专利反向支付协议反垄断审查模式研究

Research on the Anti Monopoly Examination Model of Pharmaceutical Patent Reverse Payment Agreement in China

摘要: 最高院首次在“阿斯利康诉奥赛康”案中对药品专利反向支付协议作出反垄断初步审查，认定其不违反反垄断法的相关规定。我国目前初步建立了药品专利链接制度，已具备达成反向支付协议的条件，但我国对于反向支付协议的反垄断审查标准仍没有统一。本文将从最高法院的审理思路出发，运用从竞争效果分析、专利有效性的审查、豁免条款等角度的混合分析模式，为规制药品专利反向支付协议提出完善建议。

Abstract: For the first time, the Supreme Court conducted a preliminary antitrust examination of the reverse payment agreement for pharmaceutical patents in the case of AstraZeneca v. OtaZeneca, and determined that it did not violate the relevant provisions of antitrust law. China has initially established a pharmaceutical patent linkage system, which meets the conditions for reaching reverse payment agreements. However, there is still no unified antitrust examination standard for reverse payment agreements in China. This article will start from the perspective of the Supreme Court’s trial approach, using a mixed analysis model from the perspectives of competitive effect analysis, patent validity examination, exemption clauses, etc., to propose improvement suggestions for regulating pharmaceutical patent reverse payment agreements.