药品专利反向支付和解协议的反垄断规制

Anti-Monopoly Regulation on Reverse Payment Settlement Agreements of Pharmaceutical Patent

药品专利反向支付和解协议中所涉药品专利期限届满或属于无效专利情形时,反向支付协议就可能损害公共利益和消费者合法权益,产生排除、限制竞争的后果,应当受到反垄断法规制。美国对反向支付协议反垄断规制采用合理分析规则,欧盟采用“禁止+豁免”规则。我国反向支付协议反垄断规制应注重事前预防和事后审查相结合。在反垄断规制的适用方面,要合理划分专利法与反垄断法的规制边界;适用“禁止+豁免”分析规则;进一步完善药品行业竞争政策法规,包括建立药品专利和解协议的备案和监测制度、细化落实药品专利补偿期制度、建立独占期丧失制度和构建药监、专利、反垄断行政部门信息共享和联合执法平台。

When a pharmaceutical patent invalid in case of expiration,the reverse payment agreement may violate the rights and interests of the public and consumers,resulting in the exclusion and restriction of competition,which should be subject to the regulations of anti-monopoly law.For the anti-monopoly regulations of reverse payment agreements,the United States adopts the reasonable analysis rules,and the EU adopts the prohibition and exemption rules.In China,we should focus on the combination of pre-prevention and post-event review.In the application of antimonopoly regulations,it is necessary to reasonably divide the regulatory boundary between the patent law and the antimonopoly law,apply the prohibition and exemption analysis rules,and further improve the competition policies and regulations of the pharmaceutical industry,including establishing a filing and monitoring systems for pharmaceutical patent settlement agreements,detailed implementation of the pharmaceutical patent compensation period systems,the exclusivity loss systems,and the information sharing and joint law enforcement platform for pharmaceutical regulatory,patent,and anti-monopoly administration.