中药发明专利侵权诉讼困境分析与纾困路径研究

Analysis of dilemmas and research on relief paths in infringement litigation of invention patents for traditional Chinese medicine

摘要

目的: 本文旨在通过对中药专利侵权诉讼进行系统性分析,总结其共性问题,并提炼其背后的深层原因,据此提出针对性的改进建议。方法: 主要采用实证分析法,并辅之以案例分析法,结合统计数据与相关立法,对中药专利侵权诉讼从审理层级、终审改判率、案件主体结构、诉讼形态等方面进行分析。结果: 研究发现,中药专利侵权诉讼呈现以下特征。（1）从审级分布看,案件的终审层级相对较高,大多数经历了二审乃至再审程序。（2）从终审改判率来看,中药专利侵权案件终审改判率较高。（3）从主体结构看,原被告双方多为法人主体。（4）在诉讼形态上,中药专利侵权案件往往伴随行政诉讼程序,呈现民事与行政交织的特点。结论: 中药专利侵权诉讼面临着相关立法不够健全、诉讼时间长、侵权认定难度大的困境,对此,应当从行政司法协同机制的构建与落实、地方立法的积极推动、中药成果创新转化平台的搭建、药品专利链接制度的灵活使用、企业专利申请战略布局的规划以及中药法制人才的培养等多个层面形成合力,推进我国中药产业的发展。

Abstract

Objective: To conduct a systematic analysis of patent infringement litigation involving traditional Chinese medicine（TCM）,summarize its common problems,explore the underlying causes,and propose targeted improvement strategies. Methods: The research primarily adopted an empirical analysis approach,supplemented by case studies.By integrating statistical data and relevant legislation,TCM patent infringement cases were examined from multiple dimensions,including judicial levels,final judgment reversal rates,litigation parties,and litigation patterns. Results: Several characteristics of TCM patent infringement litigation were indicated：first,in terms of judicial hierarchy,cases tended to reach higher levels of adjudication,with most undergoing second-instance or retrial procedures;second,the reversal rate in final judgments was relatively high;third,regarding party structure, both plaintiffs and defendants were predominantly legal entities;and fourth,in terms of litigation patterns,TCM patent infringement cases were often accompanied by administrative litigation,showing an intertwined relationship between civil and administrative proceedings. Conclusion: TCM patent infringement litigation faces several challenges, including incomplete legislation,prolonged judicial processes,and difficulties in determining infringement.To address these issues,efforts should be made to strengthen administrative-judicial coordination mechanisms,promote local legislation,establish platforms for innovation and transformation of TCM achievements,apply the drug patent linkage system flexibly,develop strategic patent layout planning for enterprises,and cultivate specialized legal professionals in the TCM field,thereby fostering the sustainable development of China's TCM industry.

关键词

中药专利 / 侵权案件 / 实证分析 / 司法保护 / 产业发展

Key words

traditional Chinese medicine patents / infringement cases / empirical analysis / judicial protection / industrial development

[1] 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.
[2] 谢裕颖,单乐天,单臻,等.浙江省中药创新发展与专利保护现状研究[J].中国发明与专利,2025,22(9):80-88.
[3] 张婷,卢岩,陈娟,等.我国生物医药领域技术创新态势研究[J].中国新药杂志,2020,29(22):2521-2527.
[4] 李奕瑾,曹丽荣.我国药品专利侵权案件实证分析[J].中国新药杂志,2023,32(3):224-230.
[5] 王琪. 《民间借贷规定》第17条之反思与修正[J].司法改革论评,2017(1):113-127.
[6] 李晓秋,余晨.论新《专利法》中药品专利链接制度的确立及完善[J].中国科技论坛,2022(1):131-138, 160.
[7] 满田雪. 生物药品专利纠纷早期解决机制研究[D].济南:山东大学,2024.
[8] 鲁昱,赵万一.我国院前医疗急救医疗纠纷的困境与纾解:基于150份判决书的实证分析[J].卫生法学,2025,33(5):63-74.
[9] 陶凯元. 国家层面知识产权案件上诉审理机制改革的实践探索与未来展望[J].法律适用,2024(4):3-11.
[10] 耿露,丁锦希,邵蓉,等.我国创新药物专利司法保护的量化分析:基于药品专利案件裁判文书的实证研究[J].中国卫生法制,2011,19(3):15-18.
[11] 王艳翚,姚峥嵘.中药专利保护的困境及出路:以知识产权制度的协作为契机[J].中国卫生法制,2021,29(5):1-6, 37.
[12] 杨显滨,陈雨,苏喆.论中药复方专利的侵权认定[J].江西财经大学学报,2010(2):111-116.
[13] 重庆知识产权.知识产权强市建设典型案例1创新＂快调+速裁+精审＂专利纠纷化解机制提高知识产权纠纷处理效能[EB/OL].(2025-08-25)[2025 -10-12].
[14] 技术转移研究院.中医药成果转移转化协作平台在四川成都成立[EB/OL].(2025-09-24)[2025-10-12].
[15] 姜月. 基于专利情报分析的中药企业发展战略研究[D].哈尔滨:黑龙江大学,2023.
[16] 赵静雪,何梅孜.中药复方专利申请文件撰写[J].中国科技信息,2021(9):24-26,12.
[17] 姚冲,贾良权,杨富,等.医疗机构中药制剂创新和持续发展能力评价研究[J].中国现代应用药学,2024,41(10):1415-1421.