Synergistic Analysis of Chinese Medicine Registration and Patent Protection
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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。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.
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Key words:
- Chinese medicine /
- new drug registration /
- patent protection /
- synergy /
- Lianhua Qingwen series drugs
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[1] 李慧, 宋晓亭. 药品专利审查引入新药注册审查思路的可行性研究[J]. 中国药学杂志, 2017, 52(17): 1563-1568. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGYX201717016.htm [2] 谢伟, 马治国, 张磊. 中国药品专利链接体系化的路径选择研究[J]. 中国科技论坛, 2021(5): 108-117. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGKT202105012.htm [3] 国家药监局综合司国家知识产权局办公室公开征求《药品专利纠纷早期解决机制实施办法(试行)(征求意见稿)》意见[EB/OL]. [2020-09-11]. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhqyj/20200911175-627186.html. [4] 关于药品专利纠纷早期解决机制相关专利信息登记平台公开测试等有关事宜的通知[EB/OL]. [2021-05-18]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=464a59511b09ddfc. [5] 关于就《中药领域发明专利审查指导意见(征求意见稿)》公开征求意见的通知[EB/OL]. [2020-04-08]. https://www.cnipa.gov.cn/art/2020/4/8/art_75_132083.html. [6] 国家药监局综合司公开征求《中药注册管理专门规定(征求意见稿)》等6个文件意见[EB/OL]. [2020-04-30]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200430154501315.html. [7] 王海南. 中药审评审批改革与中药注册分类——2020第四届中国创新药论坛发言[J]. 中国新药杂志, 2021, 30(3): 193-196. https://www.cnki.com.cn/Article/CJFDTOTAL-ZXYZ202103001.htm [8] 鉴往知来, 跟着总书记学历史|传承创新中, 擦亮中医药这块金字招牌[EB/OL]. [2021-05-12]. https://wap.peopleapp.com/article/6198802/6100516. [9] 郑成思, 朱谢群. 信息与知识产权[J]. 西南科技大学学报(哲学社会科学版), 2006, 23(1): 1-14+20. doi: 10.3969/j.issn.51-1660/C.2006.01.001 [10] 马天旗. 高价值专利筛选[M]. 北京: 知识产权出版社, 2018: 7. [11] 以岭药业2020年年度报告[EB/OL]. [2021-04-09]. http://www.szse.cn/disclosure/listed/bulletinDetail/index.html?88c1d8d8-4a9c-4857-8e4e-b8724e2fc1be. [12] 邓晓芒. 《纯粹理性批判》讲演录[M]. 北京: 商务印书馆, 2013: 176. -
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