药品创新与可及视角下中药品种保护制度的完善——以欧美药品试验数据保护制度为借鉴  

Improvement of the Protection System for Traditional Chinese Medicines Varieties from the Perspective of Drug Innovation and Accessibility:Take the Data Exclusivity System in EU and US for Reference

作　　者：李慧 宋晓亭 LI Hui;SONG Xiaoting(Shanghai International College of Intellectual Property,Tongji University,Shanghai 200092,China;College of Marxism,Zhejiang Chinese Medical University,Hangzhou 310053,China)

机构地区：[1]同济大学上海国际知识产权学院,上海200092 [2]浙江中医药大学马克思主义学院,浙江杭州310053

出　　处：《中国软科学》2021年第11期10-18,共9页China Soft Science

基　　金：国家社会科学基金重大项目“中医药传统知识保护专门制度研究”(16ZDA236);国家市场监督管理总局项目“中药品种保护制度实施状况的成效研究”(WZ0070420201517);浙江中医药大学教育教学改革项目“医药高等院校知识产权教育研究”(15048)。

摘　　要：《国家药监局关于促进中药传承创新发展的实施意见》指明"将中药品种保护制度与专利保护制度有机衔接".发展为互补于专利制度的中药知识产权特有保护制度应是中药品种保护制度的修订方向.药品试验数据保护制度是欧美用于鼓励药品创新的重要的非专利手段,作为新型知识产权保护机制,它行政色彩浓厚,互补于专利,并为国际社会认可.两者的比较研究应有利于中药品种保护制度发展为中药知识产权特有保护制度的可行性论证及保护策略的完善.The implementation opinions of the National Medical Products Administration on promoting the inheritance and innovation of Traditional Chinese Medicines(TCM)specifies that “the protection system for TCM varieties shall be effectively linked with the patent protection system”.To develop into a sui generis system for TCM knowledge which is complementary to the patent system should be the revision direction of the protection system for TCM varieties.The data exclusivity system is an important non-patent mechanism used in Europe Union and the United States to encourage drug innovation.As a new intellectual property protection mechanism,it is highly administrative,complementary to the patent system,and recognized by the international community.The comparison between the two systems should be conducive to the feasibility demonstration of the development of the protection system for TCM varieties into the sui generis system for TCM knowledge and the improvement of protection strategy.

关 键 词：药品试验数据 中药品种 药品创新 药品可及性 绝对独占权 相对独占权 

分 类 号：D923.4[政治法律—民商法学]