欧盟认定反向支付协议违法性的经验与启示——以GSK案为例

Experience and Inspiration from EU’s Determination of Illegality of Reverse Payment Agreements:Case Study of the GSK

我国首次规定专利链接制度后,最高院近期审结了我国反向支付协议第一案“沙格列汀片”案,并提出了审查反向支付协议违法性的标准,但其中存在不足之处。欧盟与我国在反向支付协议违法性认定同处于探索阶段,文章通过总结比对欧盟委员会对反向支付协议的审查标准和欧洲法院在GSK案中确立的判定反向支付协议违法性的因素,尝试为我国认定反向支付协议违法性的标准提出完善建议。目前我国的协议违法性认定标准不明确,需要进一步简化协议的违法性认定标准以回应实践层面反垄断执法机构的可操作性需求,协议违法性的认定应明确分析方法,即明确适用目的分析或效果分析,使得标准适用统一,专利的无效性预测对违法性认定没有意义,应在协议的违法性认定标准中去除专利的无效性预测要求。

After China established the patent linkage system for the first time,the Supreme Court recently concluded the first case of China’s reverse payment agreement,The Saxagliptin Tablets Case,and proposed standards for reviewing the illegality of reverse payment agreements,but there are still shortcomings.The EU and China are both in the exploratory stage of determining the illegality of reverse payment agreements.This article summarizes and compares the review standards of the European Commission for reverse payment agreements and the factors that determine the illegality of reverse payment agreements established by the European Court of Justice in the GSK case,and attempts to provide suggestions for improving the standards for determining the illegality of reverse payment agreements in China.