美国药品专利期限延长法律制度研究  

A Study on the Legal System of Patent Term Extension for Drugs in the United States

作　　者：高鹏 Gao Peng

机构地区：[1]国家知识产权局条法司

出　　处：《电子知识产权》2024年第2期64-83,共20页Electronics Intellectual Property

摘　　要：药品专利期限延长制度旨在解决药品因上市过程中为满足药品监管部门要求开展的临床试验和行政审批占用的专利保护期限,导致药品上市后因专利保护而实际获得的市场独占期被相对缩短的问题,对药品的相关专利给予一定时间的期限延长,以激励药品研发企业研发新药的积极性,更好地解决公共健康问题。该制度起源于美国,其后,日本、韩国、欧洲、加拿大等国家和地区也先后建立了类似制度。虽然药品专利期限延长制度侧重于保护专利权人或者药品上市许可持有人的相应权利,但是在相关制度设计中,并没有一味追求对相应权利的强保护,而是在一定程度上对仿制药企业和公平利益进行了平衡,以促进原研药产业和仿制药产业的协同发展。The Patent Term Extension for Drugs aims to address the issue of shortened market exclusivity periods due to the time taken for clinical trials and administrative approvals required by regulatory authorities during the drug approval process,which often encroach upon the patent protection period,by providing a certain extension of time for drug-related patents,to encourage drug research and development companies to actively engage in developing new drugs and better address public health issues.This system originated in the United States,similar systems have been established in other countries and regions such as Japan,Korea,Europe,and Canada.Although The Patent Term Extension for Drugs focuses on protecting the rights of patent holders or drug marketing authorization holders,the design of related systems does not solely pursue strong protection of these rights.Instead,it balances,to a certain extent,the interests of generic drug companies and the public,aiming to promote the collaborative development of both the original drug industry and the generic drug industry.

关 键 词：药品 专利期限延长 法律制度 

分 类 号：D971.2[政治法律—法学] DD913