我国仿制药与原研药的专利法律适用问题

Application of Patent Law about Generic Drugs with Brand Drug in China

我国仿制药产业正在面对从2014年-2020年的7年时间里,将有2590亿美元的药品专利到期或即将到期。原研药品的开发研发周期长、投入成本大、技术难度高,其成功受制于安全性、有效性、药品注册审批政策以及市场环境,因此,中国的仿制药生产商需要前瞻性的综合评估市场竞争程度、技术开发难度、特别是相关的专利法律法规政策。

China＇s generic drugs industry is facing problem that in the future seven years from 2014-2020, $259 billion drug patents will expire or areabout to expire. The brand drughas a long research and development cycle, high cost, and high technical difficulty, its success is subject to the safety, efficacy, drug registration ap- proval policy and market environment, therefore, generic drug producers in China need to carry out aprospective and comprehensive assessment of the market competition, difficulty of technology development, especially the related patent laws and regulations.