浅谈我国经典名方的专利保护现状及思考

Current situation and consideration of patent protection in classical representative famous prescriptions in China

经典名方是中医药留给现代人的宝贵文化遗产,2018年11月国务院发布《2018年深入实施国家知识产权战略加快建设知识产权强国推进计划》,其中明确提出加强古代经典名方类中药制剂知识产权保护。目前我国经典名方的知识产权保护现状如何,该文从国家药典委员会制定发布的2015年版《中国药典》一部中选取3首已上市的代表性方剂六味地黄丸、生脉散和桂枝茯苓丸进行相关专利分析,折射出我国目前经典名方的专利保护现状为:首先,近几年经典名方的相关专利申请量有所下降,与近几年的药品注册审批政策呈正相关,国家提倡的加大经典名方的知识产权保护的政策红利尚未反映在专利申请上,也许与药品研发周期长有关;其次,与中医药领域专利申请以个人申请为主不同,经典名方的相关专利申请以企业为主,并且在授权专利中,企业的授权率相对最高;第三,在对经典名方的研发中,以改进制备方法和剂型这2种技术主题为主,但这两类授权专利在后续市场运用上有颇多阻力,需要创新主体在经典名方的二次开发利用上寻找新的突破口。

Classical Representative Famous Prescription is the valuable cultural heritage of Chinese medicine. In November 2018,the State Council issued the " Intensive Implementation of the National Intellectual Property Strategy in 2018 to Accelerate the Construction of IP Strong Country",explicitly proposing to strengthen the intellectual property protection of Classical Representative Famous Prescription.How about the current situation of intellectual property protection of lassical Representative Famous Prescription in China? We selected Liuwei Dihuang Pills,Shengmai Powder and Guizhi Fuling Pills( three representative drugs on market) from Chinese Pharmacopoeia2015 Volume I issued by Chinese Pharmacopoeia Commission to analyze their patent layout,reflecting its status quo of patent protection as follows: first,in recent years,the number of related patent applications for Classical Representative Famous Prescriptions has declined,which was positively correlated with the drug registration and approval policies in recent years,but the policy dividend has not been reflected in the patent application,which may be related to the long period of pharmaceutical R&D;secondly,the patent applicant in the field of Chinese medicine is mainly based on individuals,but the applicant of Classical Representative Famous Prescription is mainly of enterprises,and in addition,the company applicants have the highest authorization rate;thirdly,the main technologies are to improve preparation method and the dosage form in the research and development of Classical Representative Famous Prescription,but these two types of authorized patents have much difficulty in further application on the market. Therefore,the innovative entities shall look for a new breakthrough in secondary development and utilization of Classical Representative Famous Prescriptions.