中药提取物组合物的专利信息分析及专利保护研究

发布时间：2018-04-09 12:28

  本文选题：中药　切入点：提取物组合物　出处：《北京中医药大学》2016年博士论文

【摘要】：目的：通过对中药提取物组合物的专利文献信息进行挖掘和分析,探索此类专利的发展历史、重点防治的疾病领域和权利人分布,明确中药提取物组合物及其专利的内在特点,为促进我国中药提取物组合物的科研创新、推动中药提取物组合物的专利发展和保护提供思路与参考。方法：本研究以国家知识产权局专利数据库、中国专利信息中心、中国知识产权网以及相关知识产权机构作为数据信息来源,检索的时间范围为1995年1月1日至2014年12月31日期间申请的中药提取物组合物的相关发明专利为研究对象,运用Excel、Access、 SPSS等软件,通过简单和高阶统计相结合,理论与实例相结合的方法进行分析。具体如下：1.简单分析与聚类分析相结合,探索中药提取物组合物专利的发展进程、病系研发方向及权利人分布；2.运用频数分析、聚类分析和因子分析相结合的方法,探索重点防治病系的中药提取物组合物的药物及科类的组合规律；3.根据重点防治病系的药用植物科类的频数分析结果,以有效专利中所涉及的高频科类及其所含中药为研究对象,对其药理作用及活性成分进行对比,结合以药性为研究参数的模糊聚类分析结果,探索同科中药的相似性；4.根据权利人分布的研究结果,以高频权利人的中药提取物组合物有效专利为研究对象,对其有效专利的剂型、活性成分结构以及用途等进行简单统计,结合理论分析,为现代中药企业专利网的构建提供借鉴；5.基于对中药提取物组合物的组合规律和特点的分析结果,以理论联系案例的方法探讨此类发明的可专利性判断。结果：1.中药提取物组合物相关创新成果的专利保护发展于近二十年,发展速度于2004年开始具有明显提升；2015年以前国内中药提取物组合物有效发明专利中,职务发明占78.11%；高频专利权人主要包括现代中药企业、高校以及以技术开发、技术转让等为核心经营范围的技术企业；防治内科疾病中的心系病与肝系病的中药提取物组合物有效专利所占比例较大。2.防治心系病的中药提取物组合物涉及高频中药为丹参、人参和三七等,高频科为五加科、豆科、唇形科以及伞形科；常用中药组合单元为人参+麦冬,丹参+降香,人参+五味子等；常用科类组合单元为五加科+百合科,唇形科+豆科,五加科+五味子科等。3.防治肝系病的中药提取物组合物涉及高频中药为丹参、黄芪、川芎等,高频科类为伞形科、唇形科、菊科等；常用中药组合单元为栀子+黄芩、柴胡+甘草、白芍+当归；常用科类组合单元为茜草科+唇形科、伞形科+豆科、毛茛科+伞形科。4.各科均有一些在有效成分及药理作用方面具有相似性的中药,依据模糊聚类分析结果,对各类中药进行对比发现,各科属于同类的中药在药理作用和活性成分上更为接近。5.天士力制药集团股份有限公司含有丹参的中药提取物组合物的专利网基本构建完全,该专利网主要围绕丹参提取物十三七提取物十冰片这一组合物展开,在核心权利获得保护的基础上,通过对组合物单元进行替换、细化组合物配比范围等核心技术的延伸,形成具有更大保护力度和更加稳固的防御体系。结论：1.中药提取物组合物发明专利在近二十年中历经四个增长阶段,整体处于上升趋势,其增长与国家法律法规及重大战略的推动、中药提取物的产业化趋势、近年来丰硕的中药提取物组合物的科研成果等因素密切相关；有效专利的职务发明比例在整个中药复方领域具有明显优势,高频权利人以现代中药企业居多；中药提取物组合物有效专利所述用途,以心系病与肝系病的防治居多。2.根据防治心系病和肝系病的中药提取物组合物的组合规律研究结果,高频中药大多属于高频科类,且常用的中药组合单元与常用科类组合单元基本一致；高频科类及常用科类组合单元对新的中药提取物组合物研发具有一定的提示作用；中药提取物组合物的组合规律研究,在激励自主研发,促进专利申请等方面具有一定应用价值。3.本研究中所涉及的同科中药,药性相似者在化学成分与药理作用方面具有更明显的共性；相关领域科研人员应辨证运用同科中药的相似性,适当绕开热点研发药物,对低频中药的化学成分及药理作用进行深入研究,进而展开新组合物的研究,为促进单位创新成果的产出,构建和完善专利网等方面提供可能。4.现代中药企业应以核心技术的专利权利获取为基础,围绕一类具有相似功效的产品,展开中药提取物组合物的外围研发与专利网构建,同时注重研发方向的多样化,根据不同技术路线有针对性的申请专利,以丰富专利网的构建路线,提高专利网的系统性,促进专利网的可持续发展；重视专利申报质量与申请时机,以提高专利网构建的成功率。5.对中药提取物组合物的可专利性判断应将专利法与中医药理论相结合,主动引用中药领域权威单位的实验室检定数据或专家的意见；我国专利审查标准中应尽快增设专门针对中药领域发明的章节。建议：1.政府层面：以完善适用于中药提取物组合物发明的专利保护政策为主要任务。在现行专利审查标准中,尽快增设专门针对中药领域发明的章节,提高可专利性判断的客观性与准确性；倡导多样化的知识产权激励政策,以促进创新成果的产出。2.企业层面：以完善中药提取物组合物专利战略为主要任务。重视专利研发战略,协助专利战略的制定；围绕核心专利展开自主创新,加强防御性专利战略构建；多样化研发方向,提高专利网的系统性和完整性。3.科研层面：以提高创新成果的可专利性及促进产品转化为主要任务。科研单位应合理利用专利文献信息,结合自身研发领域,加强基础研究,提高创新成果的可专利性；创办专门针对现代中药制剂研发的协同创新发展中心,加强校企合作,构建对现代中药的科学研究及专利申报的全程跟进制度,促进创新成果的产出并及时投入企业生产,实现创新成果快速转化。
[Abstract]:Objective : To explore the development history of the traditional Chinese medicine extract composition , focus on the disease field and the distribution of the rights , clarify the inherent characteristics of the traditional Chinese medicine extract composition and provide the thought and reference for the patent development and protection of the traditional Chinese medicine extract composition . The method is as follows : 1 . The research is based on the combination of simple and high - order statistics , the development process of the traditional Chinese medicine extract composition patent , the development direction of the disease system and the distribution of the right person .
2 . The combination of frequency analysis , cluster analysis and factor analysis was used to explore the combination of medicine and medicine of traditional Chinese medicine extract composition with emphasis on prevention and control of diseases .
3 . Based on the results of the frequency analysis of the medicinal plants of the disease - prevention department , the pharmacology and active ingredients of the high - frequency family and the Chinese medicine contained in the effective patent are compared , and the similarity of the same Chinese medicine is explored with the result of the fuzzy clustering analysis of the drug properties as the research parameters ;
4 . According to the research result of the distribution of the right person , the effective patent of the traditional Chinese medicine extract composition of the high - frequency right person is the research object , the dosage form , the active ingredient structure and the application of the effective patent are simply counted and combined with the theoretical analysis , so as to provide reference for the construction of the patent network of the modern Chinese medicine enterprise ;
5 . Based on the analysis results of the combination rule and characteristics of the traditional Chinese medicine extract composition , the patentability judgment of the invention is discussed by the method of theoretical contact case . The result is that 1 . Patent protection of the related innovative results of the traditional Chinese medicine extract composition is developed in the last two decades , and the development speed is obviously improved in 2004 ;
In the effective inventor ' s patent of Chinese traditional Chinese medicine extract composition before 2015 , the invention occupies 78.11 % ;
The high - frequency patent holder mainly includes modern Chinese medicine enterprises , colleges and technology enterprises with the core business scope such as technology development and technology transfer ;
The traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases relates to a traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases , and relates to a traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases , which relates to a high - frequency traditional Chinese medicine as red sage root , ginseng and notoginseng , etc .
The common Chinese medicinal composition is Ginseng Radix , Radix Ophiopogonis , Saviae Miltiorrhizae Radix , Lignum Dalbergia Odoriferae , Ginseng Radix and Fructus Schisandrae , etc . ;
The traditional Chinese medicine extract composition for preventing and treating hepatic diseases relates to a traditional Chinese medicine extract composition for preventing and treating liver diseases , and relates to a traditional Chinese medicine extract composition for preventing and treating liver diseases , which relates to a high - frequency Chinese medicine as salvia miltiorrhiza , astragalus root , Szechwan rhizome and the like .
The common Chinese medicinal composition comprises Fructus Gardeniae , Scutellariae Radix , Bupleuri Radix , Glycyrrhrizae Radix , Radix Paeoniae Alba and Radix Angelicae Sinensis ;
The invention discloses a traditional Chinese medicine extract composition , which comprises the following components in parts by weight : 1 , the traditional Chinese medicine extract composition has four growth stages , the whole is in an ascending trend , the growth of the traditional Chinese medicine extract composition is promoted by the national laws and regulations and the major strategy , and the industrialization trend of the traditional Chinese medicine extract is closely related ;
The proportion of the job invention of the effective patent has obvious advantages in the whole traditional Chinese medicine compound field , and the high - frequency right person is the most modern Chinese medicine enterprise ;
according to the combination rule of the traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases and liver diseases , the high - frequency traditional Chinese medicine is mostly high - frequency family , and the common traditional Chinese medicine combination unit is basically consistent with the conventional medicine combination unit ;
the high - frequency family and the commonly used medicine combination unit have certain prompting effect on the research and development of the new traditional Chinese medicine extract composition ;
The combination rule of traditional Chinese medicine extract composition has certain application value in stimulating independent R & D , promoting patent application and so on .
In order to promote the output , construct and perfect the patent network , the research of the traditional Chinese medicine should be based on the patent rights of the core technology , and the development direction should be diversified . According to different technical routes , the patent network should be patented , so as to enrich the construction route of the patent network , improve the systematicness of the patent network and promote the sustainable development of patent network .
Pay attention to the quality of the patent application and the timing of the application to improve the success rate of the patent network construction . 5 . The patentability judgment of the traditional Chinese medicine extract composition should combine the patent law with the theory of Chinese medicine to actively refer to the laboratory verification data or expert opinion of the authoritative unit in the field of traditional Chinese medicine ;
in that current patent review standard , a special section specially for the invention in the field of traditional Chinese medicine is added as soon as possible to improve the objectivity and accuracy of the patentability judgment ;
Promote the diversification of intellectual property incentive policies to promote the output of innovative results . 2 . Enterprise level : to improve the patent strategy of traditional Chinese medicine extract composition as the main task . Pay attention to patent development strategy and assist in the formulation of patent strategy ;
Develop independent innovation around core patent , strengthen defensive patent strategy construction ;
In order to improve the systematicness and completeness of the patent network , the scientific research level : to improve the patentability of the innovative results and to promote the transformation of the products into the main tasks . The scientific research units should use patent document information reasonably , strengthen the basic research and improve the patentability of the innovation results in combination with the research and development field .
Establish a collaborative innovation development center specially for the development of modern Chinese medicine preparation , strengthen cooperation of the school and enterprise , construct the whole process follow - up system for scientific research and patent application of modern Chinese medicine , promote the output of innovative results and put into the enterprise production in a timely manner , and realize the rapid transformation of innovative results .

【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R284;G306
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本文编号：1726449