药品行业产品跳转行为的反垄断规制

On the Anti-Trust Regulation of Product Hopping in the Pharmaceutical Industry

药品行业的产品跳转行为是一种延缓仿制药入市的反竞争策略,原研药企通过对已有专利技术方案的重新设计获取新的药品专利权,并以欺诈性或胁迫性手段完成市场转换。该行为属于滥用知识产权的垄断行为,损害了仿制药竞争及消费者利益,故引起多个国家的反垄断关注。国际上,欧美国家在反垄断实践中,逐步构建起以消费者选择权为主,兼有竞争者利益、多种社会经济政策综合考量的反垄断审查标准。近年来,我国仿制药质量与疗效一致性评价工作渐入佳境,实现仿制药替代是必然趋势,未来药品行业极有可能出现类似行为,故我国反垄断法学界与实务界有必要总结美国、欧盟、加拿大等国家的反垄断实践经验,从基本原则、审查路径、审查标准等方面构建合适的反垄断分析框架。

In the pharmaceutical industry,product hopping is an anti-competitive strategy to delay the entry of generic drugs.The original drug companies obtain new drug patent through redesigning the existing patent technological solution,and gain market switch by fraudulent or coercive conduct.Such behavior is monopolistic behavior which abuses intellectual prperty,harms generic competition and consumer welfare,arousing concerns from antitrust authorities in many countries.In practices,European and American countries have established the anti-trust review standards mainly featured by consumer choice,also take comprehensively competitor interests and multiple social and economic policies into account.In recent years,the consistency evaluation of the quality and efficacy of generic drugs in China is much improved,generic drug substitution is an inevitable trend,product hopping may also happen in the future Chinese pharmaceutical industry.Therefore,it is necessary for China to draw experiences of anti-trust practices in this field in US,EU countries,Canada,etc.,and construct our own antitrust analysis framework from the perspectives of basic principles,review path,review standards and so on.