基于统计方法模型分析的中药复方专利保护研究

【作者】 杨旭杰；

【导师】 肖诗鹰；

【作者基本信息】 北京中医药大学 ， 中药学， 2012， 博士

【摘要】 专利制度以创造财富为杠杆,寻求着恰当的利益支点,试图一端有效地激发人们创造的热情,另一端把个人的知识财富转化为无尽的社会财富,以高效优质地推动人类物质文明和精神文明的巨大进步。中药复方专利保护是在护卫本土中药资源、促进中药走向世界的进程中应运而生的制度。十多年来,中药复方专利保护制度以其特有的法律保护、科学审查、全面公开、国际交流之特性,在保护和鼓励中药复方研发、促进创新成果的推广应用、推动中医药基础理论和科研进展、建立开放的中医药知识市场、加速中药产业化进程、促进医药经济繁荣、拓展中医药国际交流、引进和利用国外先进技术等诸多领域发挥了无可替代的作用。中药复方专利保护的研究引发了业内学者的高度重视,只是其研究尚属于方兴未艾阶段,系统的定性研究及统计学模型分析还未出现。本课题以跨学科的知识准备和广泛的文献收集作为基础,采用理论研究与实证分析相结合、纵向比较和横向对比相参照的研究方法,结合简单统计与高阶统计,建立统计模型的指标评价体系,旨在深入剖析中药复方专利发展进程中的影响因子及优化方案。在上述研究路线指引下,研究内容涵盖中药复方研发与专利保护的融合、中药复方专利发展进程、区域进展、专利权人分布、中药复方功效与专利获取的关系、中药复方专利质量提升与社会收益的联系、专利维持之影响因素、特定防治领域的专利特点、有效专利用药规律等方面；通过对以上内容科学的统计分析,得出了精确可信的研究结果与结论：中药复方专利保护对于实现社会收益、推进深入研发、促成中药产业化、提升中药国际地位等诸多领域影响深远,虽然在近二十年的时间里经历了三次飞跃,但是区域发展不平衡,职务发明比例偏低,与迅猛发展的中药复方研发无可同日而语；中药复方专利的发展与国家专利法规的健全及专利战略的强化、中医药科研投入的增加和创新水平的提高、世界医药市场的需求加大及中医药国际认可度的提升等因素密切相关,同时,中药复方专利的发展状况与其防治领域具有相关性,如心脑血管中药复方专利的发展强于整体发展态势,对其组方用药规律的研究有助于本领域新的研发与专利获取；长期以来我们以专利的数量来衡量其发展水平存在一定的局限性,而专利的质量是体现其价值的重要指征,提升中药复方专利的质量须从多方面着手；严格复方专利审查是提升其质量的重要环节,严格规制中药复方专利“三性”对于维护民众身心健康、推动中药科技进步、提升中药的国际地位意义重大,同时也是增加社会整体收益、节约社会成本、促进中药新药的创新研发与保护处于良性循环的重要保证。结合研究过程、结果及结论,本论文分别从宏观、中观、微观三个层面给出应对措施：国家可将中药复方研发与专利保护作为建设创新型国家及实施国家知识产权战略的重要组成部分,构建主从协调的中药复方专利战略体系及全方位、多层次的中药复方专利保护规划,同时将中药复方专利指标作为该领域科研立项的重要标尺,促成中药复方研发与专利保护的高效运营机制；行业协会应充分发挥有益补充,协助政府推进新药研发与保护；国家知识产权局要在提升中药复方专利质量领域展现其重要作用；中药企业合理发挥其在中药复方专利保护体系中的主力地位,正确分析并利用中药复方专利信息、实行高效的专利管理制度、合理运用专利策略、制定适宜的专利战略；中医药院校及科研院所通过优选中医药组方作为研发对象,强化科研人员专利意识的培养,成立职责明确的科研成果专利管理机构,促进成果转化,提高专利利用率,促成优质高效的产学研联盟等多方途径发挥其智囊团优势,全面提升中药复方专利质量。本研究首次将聚类分析、回归分析、频数分析等多种统计学方法运用于中药复方专利研究之中,从时间、空间、专利功效、专利权人、专利内涵等多个视角系统剖析了中药复方专利发展的规律性及内在机理；运用西方社会收益理论及经济学模型探讨中药复方专利的“三性”及其价值评价,实现了中药复方研发、专利保护与社会价值实现三者的有机衔接；结合统计学原理与中药复方专利特点,构建了用以评价中药复方专利运行效绩之相对客观、科学的指标体系,结果更具全面性、系统性、客观性,可操作性较强；结合多年的临床实践对照本研究中有关中药复方专利功效聚类分析结果,以心脑血管中药复方专利为例,全面系统地研究了心脑血管中药复方专利的年度发展、专利权人分布、维持有效的影响因素以及有效专利的组方遣药规律,为该领域中不同实力的机构及个人展开新药研发及专利保护提供了针对性较强的指引和参照；采用系统分析与功能分析法,详细论述了中药复方专利质量在整体系统中的权重与价值,在一定程度上纠正了中药复方专利领域对于专利申请量、授权量的重视程度高于专利质量之现状。所有这些全面体现出本研究的创新性,如果研究成果能够在中药复方专利发展进程中发挥助推作用,也即实现了该科研立题的初衷。更多还原

【Abstract】 Chinese herbal compound patents’protection has positive effect in many fields. To begin with, Patents’protection of scientific fruits is a favorable condition for the international status’promotion of Chinese medicine. What’s more, Chinese herbal compound patents are beneficial for the birth of new drugs and well-known trade marks. Moreover, patents’protection is better for the increasing of Chinese medical enterprises’ strength. Finally, Chinese herbal compound patents’protection can irritate the researchers’enthusiasm which impel new research.As far as social profit is concerned, high-quality herbal compound patents are beneficial for social profit. To begin with, patents’protection can bring about Chinese herbal production efficient. In theory, because the patents owner may not be the best producer, he will have to grant his scientific fruits to someone that manufacture the products efficiently by means of business secret’s permission. However, it must take more cost in business secret’s permission than patents’permission, seeing that scientific achievement secrets’protection may take a risk of revelation. Therefore, but for did patents’protection gives full play, the scientific produce will be inefficient. In other words, common patents won’t attract the public attention, only high -quality achievements are worthy of patents’ protection.In view of the important role described above, more and more scholars have attached great importance to Chinese herbal compound patents’research, however, comprehensive study by means of systematic statistics hasn’t appeared. This article has explored the influencing factors during the Chinese herbal compounds’development progress and derived conclusion as well as optimization scheme by means of theoretical study and higher order statistical model analysis.The study contains a lot of content:1 The importance of Chinese herbal compound patentsAs the premise and basis of the whole study, this section has analyzed the importance of Chinese herbal compound patents’protection by exploring the uncoordinated status between Chinese herbal compound patents’protection and its research.2 The development process of Chinese herbal compound patentsThe history of Chinese herbal compound patents’progress has been divided into several time groups by cluster analysis and the influencing factors have been discussed.3 Regional studies of Chinese herbal compound patentsDifferent regions are classified into several groups according to their Chinese herbal compound patents’strength, then the suitable countermeasures are drawn up for every region.4 Study on the effectiveness of Chinese herbal compound patentsThe Chinese herbal compound patents with different function are used as study objects in order to explore the relationship between patents’acquisition and compound efficacy.5 Study on the Chinese herbal compounds’patenteeThis section regards Chinese herbal compound patent agencies as study objects in order to analyze the distribution of domestic patents and ascertain the methods for increasing positional patents.6 The influencing factors for effective Chinese herbal compound patentsThe impact factors of Chinese herbal compound patents with longer maintenance are investigated by means of regression analysis in order to provide useful guidance to Chinese herbal compound patents’quality improvement.7 Research on the value of Chinese herbal compound patentsThis section has analyzed the importance and optimization methods of Chinese herbal compound patents’novelty, creativity and practicality for patents’quality improvement and value realization on the base of western social benefits theory and econometric model.8 Research on the Chinese herbal compound patents’compositionThis section has explored the Chinese herbal ingredients’regularity of Cardiovascular and cerebrovascular valid patents by means of frequency analysis in order to make direction for R&D as well as patent performance enhancement in this field.On the base of statistical analysis, accurate and reliable results have been obtained:1 Chinese herbal compound patents’protection is important for many areas. Although it has experienced three leap in two decades, problems also arise, such as regional development’s unbalance, low proportion of post invention and so on.2 Chinese herbal compound patents’development is connected with multiple factors, such as national patent laws and regulations’strengthening, increase in R&D investments, enhance of traditional Chinese medical international recognition and so on.3 Chinese herbal compound patents’development relates to its effect, for example, Chinese herbal compound patents in treating cardiovascular and cerebrovascular are better than the overall development trend, while the study of prescription drug law is beneficial for research and patents’acquisition in this field.4 Patent’s quality is an important indication to reflect its value while the promotion of Chinese herbal compound patents’quality is complex and difficult.5 It is important for the State Intellectual Property Office to be strict with Chinese herbal compound patents’novelty, creativity and practicality.This study has put forward Optimization scheme in the macro level, meso-level and micro-level based on the study course, results and conclusion.The creativity of this study has reflected in many aspects: 1 It is the first time to use cluster analysis, regression analysis and frequency analysis in Chinese herbal compound patents’research. The regularity and internal mechanism of Chinese herbal compound patents’are analyzed deeply in many perspectives, such as time, space, patents’function, patentee, patent connotation and so on.2 Chinese herbal compound patents’novelty, creativity and practicality have been investigated by means of western social benefits theory and econometric model, which has made the Chinese herbal compounds’research theory, patents’protection theory and social value theory connect organically.3 The objective and scientific index system in evaluating Chinese herbal compound patents’performance has been established according to principles of statistics and Chinese herbal compound patents’character, which has brought about more comprehensive, systematic, objective and operational results.4 The Chinese herbal compound patents in treating Cardiovascular and cerebrovascular have been investigated comprehensively, which will provide better reference for R&D and patents’protection in this fields.5 The importance of Chinese herbal compound patents’quality has been discussed in detail by means of systematic analysis and functional analysis, which may correct the current situation of underrating patents’quality.更多还原