构建合乎国情的药品专利链接制度  

Establishing a national drug patent link system in according to our conditions

作　　者：李红团 LI Hong-tuan(Beijing Sanju Sunshine Intellectual Property Agency Co.,Ltd.,Beijing 100029,China)

机构地区：[1]北京三聚阳光知识产权代理有限公司,北京100029

出　　处：《中国新药杂志》2018年第17期1953-1963,共11页Chinese Journal of New Drugs

摘　　要：我国的医药行业正在经历着产业升级和国际化浪潮的洗礼。本文回顾了美国药品专利链接制度的创建,并通过一些我国国内实际发生的案例,探讨专利链接制度在实现创新和仿创之间的平衡中的作用。平衡不是此消彼长,而是双促进共提高。In China,pharmaceutical industry is experiencing upgrading and globalization. This article indicates the conduct of patent system for pharmaceutical products in the United States,and explores the patent system as the consideration that achieves the balance between novel and generic pharmaceuticals. This balanced relationship is not inversely proportional,but directly proportional.

关 键 词：药品专利链接制度 专利不侵权声明 数据保护 药品注册 BOLAR例外 行政审批不侵权 橙皮书 

分 类 号：R95[医药卫生—药学]