创新与仿制的平衡与发展——评Hatch-Waxman法案对美国医药产业的贡献

Balance and Win—Win between Innovative Drugs and Generic Drugs:Review on Contribution of Hatch—Waxman Act to U.S. Pharmaceutical Industry

药品关系着人类的生存和发展,实现药品可及性需要兼顾创新药和仿制药的发展。美国Hatch-Waxman法案是平衡创新药产业和仿制药产业利益的典范,从实践效果来看,其实现了激励创新和鼓励仿制的效果。2017年10月,我国也出台了鼓励创新药和仿制药发展的相关政策。本文拟从出台背景、主要内容、制度创新及实施效果四个方面,对该《Hatch-Waxman法案》中有关药品专利保护的内容,特别是与药品专利链接制度相关的内容进行全面介绍,以期为相关制度在我国的落实提供借鉴。

Drugs are closely related to the survival and development of human beings. The realization of accessibility of drugs requires development of both innovative drugs and generic drugs. The Hatch-Waxman Act of the United States is an excellent example of balancing the interests between the innovative industry and the generic industry.Viewing from the perspective of practical effect, it comes out to be both a stimulation of innovative drugs and an encouragement of generic drugs. In October 2017, the General Office of CCCPC has released relevant policies to promote the development of both the innovative and generic industries. The essay tries to provide thorough and detailed introduction of the Hatch Waxman Act regarding the part related to patent protection, particularly with a focus on patent linkage system provided in the Act, from four aspects including the background of the legislation, the main contents, the innovation in the system and the result of implementation, so as to provide reference for the introduction and implementation of the relevant system in China.