美国和加拿大药品专利链接制度介绍  

Analysis of pharmaceutical patent linkage system in the United States and Canada

作　　者：张帆 温宝书 ZHANG Fan;WEN Bao-shu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国临床药理学杂志》2023年第24期3693-3696,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：药品专利链接制度是指将仿制药审批与药品专利保护相衔接的制度。本文通过介绍美国和加拿大药品专利链接制度的背景及基本内容,为进一步完善我国药品专利纠纷早期解决机制提供参考,以加快推进我国仿制药的发展。The pharmaceutical patent linkage system refer to linking generic drug approval and patent pertaining to pharmaceutical products.Based on the US and Canada pharmaceutical patent linkage system,to analysis and provide reference for domestic pharmaceutical patent linkage system and enhance the development of generic drug.

关 键 词：药品专利 仿制药 专利链接 专利挑战 原研药 

分 类 号：R95[医药卫生—药学]