我国中药专利授权异议案件的特征与启示

Characteristics and implications of patent authorization opposition cases of traditional Chinese medicine in China

摘要

通过统计目前中药专利授权异议案件相关专利文件与判决书相关数据,可知目前我国中药专利授权异议案件的总体特征：目前我国中药专利授权异议案件呈现出个人申请人比重偏高、形式争议较多、组合物发明占比与驳回率均较高、代理机构占比低、技术调查官参与少等特征。建议中药专利研发主体调整研发重点、加强研发合作、规范研发过程、加强知识产权管理意识;审查部门应当注意审查规则的引导作用,完善组合物以外的审查规则和中药实验数据审查规则;审判部门应当推动技术调查官参与中药专利授权异议案件的常态化。

Abstract

By analyzing the relevant patent documents and judgment documents of the current patent authorization opposition cases of traditional Chinese medicine, the overall characteristics of such cases in China can be known.The current patent authorization opposition cases of traditional Chinese medicine in China show the following features：a relatively high proportion of individual applicants, more formal disputes, a high proportion of composition inventions and a high rejection rate, a low proportion of patent agencies, and less participation of technical investigators.It is suggested that the research and development entities of traditional Chinese medicine patents should adjust the research and development priorities, strengthen research and development cooperation, standardize the research and development process, and enhance the awareness of intellectual property management. The examination department should pay attention to the guiding role of examination rules, improve the examination rules besides compositions, and improve the examination rules for experimental data of traditional Chinese medicine. The judicial department should promote the regular participation of technical investigators in patent authorization opposition cases of traditional Chinese medicine.

关键词

中药专利 / 授权异议诉讼 / 职务发明 / 中药组合物 / 技术调查官

Key words

patent of traditional Chinese medicine / litigation regarding authorization objections / service invention / traditional Chinese medicine composition / technical investigator

[1] 国家知识产权局.国家知识产权局2024年度报告[EB/OL].(2025-08-27)[2025-09-09].https://www.cnipa.gov.cn/col/col3562/index.html.
[2] 国家知识产权局.国家知识产权局2022年度报告[EB/OL].(2023-06-05)[2025-09-09].https://www.cnipa.gov.cn/col/col3249/index.html.
[3] 国家知识产权局.国家知识产权局2023年度报告[EB/OL].(2024-09-03)[2025-09-09].https://www.cnipa.gov.cn/col/col3430/index.html.
[4] 王春丽,李子艳.我国中药创新发展现状与趋势[J].中国新药杂志,2023,32 (20):2013-2021.
[5] LI X.Influencing factors,evolution,and strategies for improving the quality of traditional Chinese medicine patents:an empirical study based on patent invalidation cases[J].Ann Med,2024, 56 (1):2422571.
[6] 张朝磊,赵良,卞志家,等.我国中药专利涉及创造性法条的司法判例分析[J].中国新药杂志,2018,27 (2):129-133.
[7] 栾鑫,黄敏,柯博文,等.源于临床有效中药活性成分的创新药物研发策略与挑战[J].中国中药杂志,2023,48 (7): 1705-1710.
[8] XIA N.Intellectual property protection for traditional medical knowledge in China＇s context:a round peg in a square hole?[J].Med Law Rev,2023,31 (3):358-390.
[9] SYED T.Does pharma need patents?[J].Yale Law J,2025, 134 (6):2038-2121.
[10] 邹玥,尤瑾,乔志伟,等.医药化学领域发明专利现有技术适格性判断路径研究[J].科技管理研究,2023,43 (1):132-136.
[11] 马一德,汪婷.现代化中医药专利保护的制度困境与出路——基于对中医药特点与专利保护适应性的反思[J].科技与法律 (中英文),2024,1 (4):1-10.
[12] LIU HB,WANG YF,HUANG JL,et al.Analysis on patents of health care products with substances of medicine food homology in China[J].Chin Herb Med,2024,16 (3):412-421.
[13] 黄姗姗. 技术调查官制度研究[J].学海,2021,1 (1): 167-173.
[14] 邹享球. 技术调查官制度的理论设计及现实困惑[J].知识产权,2021,1 (4):45-57.
[15] 杨秀清. 我国知识产权诉讼中技术调查官制度的完善[J].法商研究,2020,37 (6):166-180.
[16] 管荣齐. 法院审查专利有效性的制度要素[J].学术论坛,2022,45 (2):28-41.
[17] 丁丽曼.丹杞颗粒在制备降低血糖药物中的应用:中国,201210044062.3[P].2012-07-04.
[18] 谢伟. 中药国际化竞争中专利价值实现的困境与进路——以新冠肺炎疫情、中美贸易摩擦、高价值内需为新契机[J].科技进步与对策,2022,39 (3):69-76.
[19] 陕西东泰制药有限公司.一种用于淤血阻滞、脉管不通的中药制剂及其制备方法:中国,200810146980.0[P].2009-01-14.
[20] 北京亚东生物制药有限公司.治疗乳腺增生性疾病的药物组合物及其制备方法:中国,200510000429.1[P].2005-08-31.
[21] 广州白云山和记黄埔中药有限公司.治疗口腔炎症的中药制剂及其制备方法:中国,200710151989.6[P].2008-02-27.
[22] 赵虹,龚韩湘,王羿升,等.知识产权保护视阈下我国中药专利研究现状及发展对策[J].科技管理研究,2021,41 (12):187-191.
[23] 朱雪忠,李艳.我国中药发明专利质量提升路径——基于专利委托代理视角的实证研究[J].科学学与科学技术管理,2021,42 (7):87-105.

基金资助

国家社会科学基金资助项目(24CTY014)