原研药企产品转换行为的反垄断规制——美国与欧盟实践与比较

Anti-monopoly Regulation on Originators' Product Hopping Activities in US and EU

原研药企在一代药品专利基础上申请二代药品专利并申请上市许可从而阻碍仿制药市场进入的产品转换行为成为国际上反垄断法最新关注的一种行为,这种产品转换行为对仿制药企业的市场进入可能存在延迟作用,并对药品消费者选择和药品市场价格竞争产生损害作用。本文通过介绍美国对产品转换的反托拉斯规制近况以及欧盟对产品转换的调查与司法实践,提出对产品转换行为的反垄断分析应采用"合理原则"分析法,并应重视分析产品转换的时机、消费者选择权和仿制药排斥影响等因素,并提出我国反垄断执法机构应对这种有损仿制药价格竞争的产品转换行为有所警惕。

Based on the minor modification of the primary patents, originator companies filed the secondary patents and take the product hopping activities to extend patent protection and exclude generic competitors. So far several competition authorities around the world have enforced antitrust regulation on this kind of practice, which is deemed to be detrimental to the consumer and drug price competition. This article mainly analyzes the administrative enforcement and judicial decisions on product hopping both in U.S. and in EU. And then it draws conclusion that when deciding the legality of the product hopping, rule of reason approach should be applied, with the factors as timing of switching, coercion of consumer and exclusive effect on generic drugs should also be taken into consideration. Chinese antimonopoly agencies should be vigilant to this practice.