基于药品专利的仿制药研发法律促进机制研究  

Research on Legal Promotion Mechanism of Generic Drug Research and Development Based on Drug Patent

作　　者：贾小龙 缪杰 JIA Xiao-long;MIAO Jie(Law School of Lanzhou University of Technology,Lanzhou Gansu 730000,China)

机构地区：[1]兰州理工大学法学院,甘肃兰州730000

出　　处：《卫生经济研究》2021年第2期70-72,共3页

基　　金：甘肃省科技厅软科学项目“‘双创’背景下创新激励机制优化研究”的中期成果(17CX1ZA018)。

摘　　要：目前我国仿制药产业发展"大而不强",面临的主要制度困境是首仿激励不足、研发专利环境不佳。建立仿制药研发法律促进机制,是改善药品可及性的现实选择,是缓解医疗负担的迫切需求,也是建设制药强国的长久之计。应借鉴新药研发专利激励机制的经验,建立仿制药首仿独占期制度,设立仿制药行业协会,完善药品专利强制许可制度,从而在激励新药研发与促进仿制药发展之间实现更好平衡。At present,the development of generic drug industry in China is"big but not strong".The main institutional dilemmas are the lack of incentive for the first imitation and the poor environment for R&D patents.The establishment of a legal promotion mechanism for generic drug research and development is a realistic choice to improve drug accessibility,an urgent need to alleviate medical burden,and a long-term solution to build a powerful nation of pharmacy.Learning from the experience of the patent incentive mechanism of new drug research and development,it is necessary to establish the first imitation exclusive period system of generic drugs,set up generic drug industry associations,and improve the compulsory licensing system of drug patents,so as to achieve a better balance between encouraging new drug research and development and promoting the development of generic drugs.

关 键 词：药品可及性 仿制药 首仿独占期 无效挑战 强制许可 

分 类 号：R95[医药卫生—药学]