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中药注册与专利保护的协同性分析
引用本文:王月茹,谢伟.中药注册与专利保护的协同性分析[J].南京中医药大学学报(社会科学版),2022(1).
作者姓名:王月茹  谢伟
作者单位:陕西国际商贸学院医药学院;西安交通大学法学院
基金项目:陕西省中医药管理局科研项目(2021-PY-009);陕西省知识产权决策咨询研究项目(YJ-202107);陕西省教育厅科研项目(19JK0103);陕西省科技厅社会发展项目(2018SF-275)。
摘    要:在新冠肺炎疫情与人类长期共存的国际共识下,以连花清瘟胶囊(颗粒)为代表的抗疫中药成为践行“传承精华,守正创新”新理念的生动实践。基于现阶段最新的政策情势,目前国内关于中药注册与专利保护协同的专题制度已有所涉及,但是仍存在创新标准不适、专利价值低质量及体系衔接错位脱节等现实困境。因此,通过中药连花清瘟系列药品的新药注册与专利保护协同进路的实证分析,提出了专利创造性专属审查、高价值专利培育及注册与专利保护体系链接之中药注册与专利保护协同的构建对策,希冀为新契机下中药产业的高质量协同发展提供实践参考。

关 键 词:中药  新药注册  专利保护  协同性  连花清瘟系列药品

Synergistic Analysis of Chinese Medicine Registration and Patent Protection
WANG Yue-ru,XIE Wei.Synergistic Analysis of Chinese Medicine Registration and Patent Protection[J].Journal of Nanjing University of Traditional Chinese Medicine(Social Science),2022(1).
Authors:WANG Yue-ru  XIE Wei
Institution:(School of Medicine, Shaanxi Institute of International Trade and Commerce, Xianyang 712046, China;Xi'an Jiaotong University School of Law, Xi'an 710049, China)
Abstract:Under the international consensus that the novel coronavirus pneumonia and human beings coexist for a long time,the anti-epidemic Chinese medicine represented by Lianhua Qingwen has vividly practiced the new concept of"inheriting the essence,keeping the righteousness and innovation".Based on the latest policy situation,the thematic system of registration and patent protection of Chinese medicine has been covered,but there are still some practical dilemmas such as unsuitable innovation standards,low quality of patent value,as well as misalignment and disconnection of the system.Therefore,through the empirical analysis of the synergy between new drug registration and patent protection of Lianhua Qingwen,we propose the countermeasures for the construction of synergy between Chinese medicine registration and patent protection by exclusive examination of patent creativity,cultivation of high-value patents,as well as linkage of registration and patent protection system,hoping to provide practical reference for the high-quality synergy development of Chinese medicine industry with the new opportunity.
Keywords:Chinese medicine  new drug registration  patent protection  synergy  Lianhua Qingwen series drugs
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