专利链接制度的竞争风险及法律因应研究—基于美、加、欧、印、澳、韩经验的比较

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摘要 2020年签署的中美经贸协定引入了专利链接制度,但从多个国家移植该制度的经验观察中发现,此种旨在 “链接”仿制药上市审批与原研药专利保护的早期纠纷解决机制具有延迟仿制药市场进入的效应,而充分和及时的仿制药竞争能够平抑药价、保障药品可及性,产生巨大的消费者剩余。作为极为依赖仿制药的国家,中国务必要警惕专利链接蕴含的竞争风险,应借鉴各国反链接垄断的制度移植实践,通过监督药品专利登记、取消仿制药审批自动暂停、增设损害赔偿条款和严查反竞争和解协议等举措,实现药品竞争和创新政策的平衡,促进仿创双方共同发展。

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	孙瑜晨

关键词 ：药品专利, 专利链接, 药品审批, 专利垄断, 专利常青

Abstract：The patent linkage system was introduced into the China-US Economic and Trade Agreement signed in 2020.However,based on the observation of institutional transplantation in many countries,the article finds that this early dispute resolution mechanism,which can link generics’ marketing approval and branded drugs’ patent protection,has the effect of delaying the market entry of generics.Nevertheless,sufficient and timely generics competition can stabilize drug prices,ensure drug availability and produce huge consumer surplus.As a country that relies heavily on generics,China must be alert to the competitive risks in patent linkage.China should learn from other countries’ anti-monopoly system transplantation practice,and achieve a balance between drug competition and innovation policies by supervising drug patents registration,canceling the automatic suspension of generic drug approval,adding damage compensation clauses,and rigorously inspecting anti-competitive settlement agreements.

Key words： Drug patent Patent linkage Drug approval Patent monopoly Patent evergreen

收稿日期: 2020-10-28

PACS:

D923.42

基金资助:中国政法大学青年教师学术创新团队支持计划 (21CXTD08),教育部哲学社会科学重大课题攻关项目 “经济全球化背景下中国反垄断战略研究” (15JZD018)。

作者简介: 孙瑜晨 (1990-),男,云南迪庆人,中国政法大学民商经济法学院讲师、法学博士,研究方向为竞争法、知识产权法。

引用本文:

孙瑜晨. 专利链接制度的竞争风险及法律因应研究—基于美、加、欧、印、澳、韩经验的比较[J]. 中国科技论坛, 2021(9): 163-172.
Sun Yuchen. Research on the Competitive Risk of Patent Linkage System and Legal Response —Comparison Based on the Case Study of the USA and Other Countries. , 2021(9): 163-172.

链接本文:

http://www.zgkjlt.org.cn/CN/Y2021/I9/163

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