浅析药品专利链接制度的基本构成——以美国为例

Analysis of the Basic Composition of the Pharmaceutical Patent Linkage System:A Case Study of the United States

由于制药行业对专利保护具有高度依赖性,而新药研发的高成本又与公众的用药需求相冲突,为解决这个问题,药品专利链接制度应运而生。美国Hatch-Waxman法案作为该制度的起源,对美国乃至全世界的制药行业均具有深远的影响,其通过仿制药简化申请、专利声明、专利挑战等制度保障了仿制药产业的发展,同时也通过专利延长和试验数据保护等方式支持了原研药的创新。

Due to the high dependence of pharmaceutical industry on patent protection and the conflicting nature of high cost of new drug research with public demand for medication,the Pharmaceutical Patent Linkage System has emerged as a solution to solve the increasingly serious issue.The Hatch-Waxman Act in the United States,as the origin of this system,has had far-reaching influence on the pharmaceutical industry both in the United States and the world.It ensures the development of the generic drug through mechanisms such as abbreviated generic drug applications,patent declarations,patent challenges,and so on.At the same time,it also helps support new drug innovation through patent extensions and test data protection.