论我国中药专利权保护的立法障碍与完善建议

发布时间：2018-04-22 16:34

本文选题：传统中医药 + 专利权保护　；参考：《吉林大学》2017年硕士论文

【摘要】：中药是中华民族为世界人类健康作出的伟大贡献,凝聚着我国古人几千年来的智慧结晶与心血,其拥有悠久的历史和深厚自成体系的理论基础。我国是中药资源大国和中医药发源国,有着丰富的中药品种、广袤的中药材种植基地、浩如烟海的中药经典单方古籍以及独特的诊疗理念。然而,囿于技术条件所限,我国中药专利权难以受到高质量的保护,大量中药资源被发达国家抢注专利变为“洋中药”之后反投到中国市场上高价销售,攫取巨额专利利润。我国中药专利权保护面临一种尴尬的境地,通过设计构建适应我国国情、契合中药自身特点的立法制度来有效地保护中药专利刻不容缓。本文分为引言、正文以及结论三大部分,其中正文又由三部分组成。正文第一部分首先分别从中药学的狭义角度和知识产权法学的广义角度对我国传统中药的内涵定义进行了界定,介绍了中药相对于西药化学物质所独具的本质区别特性;接着通过目前我国对中药各种保护模式的比较得出了对我国中药进行专利权保护是目前公认的保护力度最强、排他性最强的保护模式的结论,阐述了在我国实施中药专利权保护的正当性;之后本文梳理了我国中药专利权保护立法制度的历史沿革,并对专利申请的现状进行介绍,探讨了我国中药专利权保护的立法缺陷和障碍,集中论述了我国中药专利权保护存在的立法缺陷及成因分析。指出了现行专利法规定的充分公开原则及关于专利权审查中新颖性、创造性和实用性的定义标准对我国中药专利权保护的障碍,现有中药行政保护模式与专利保护模式立法上的冲突矛盾对我国中药专利权保护的障碍,并以我国专利权保护法规与中药特质之间存在着的冲突为视角,深入分析了专利侵权判定边界模糊导致认定维权困难的保护障碍。第二部分是对美国、德国、泰国、日本的中药、植物药或汉方药专利权保护制度及专利保护情况进行比对研究,借鉴评析了这几个国家在传统医药专利权保护领域的制度与实践经验。第三部分在前两部分的基础上,通过对我国现有中医药专利权保护制度体系立法上的保护障碍的分析,和对先进国家传统医药专利权保护立法经验的总结借鉴,我对完善我国中药专利权保护的立法制度提出了一些完善建议,笔者提出了以下解决对策:理顺我国中药专利权保护立法体系,解决中药行政保护和专利权保护二者法律法规冲突的问题;引入传统知识来源披露制度和事先知情同意制度,以期发扬我国中药资源的优势,弥补技术申请上的劣势,从而遏制发达国家无偿利用我国中药资源、抢注中药专利的“生物海盗”现状;根据中药自身的特点有针对性地细化完善中药发明专利对“三性”的审查标准,即调整放宽中药专利权新颖性、创造性和实用性标准;规定秘密审查制度防止中药专利申请信息泄露导致被侵权仿制;延长中药专利保护期限以提高企业及个人的专利申请积极性,利于中药专利权保护的良性发展;进一步具体细化中药的专利侵权判定界限,完善中药侵权认定立法制度;建立中药专利保护的链接机制,将我国食品药品监督管理局(简称SFDA)与国家专利局(简称SIPO)这两个行政部门的职能无缝衔接,更有助于中药的专利权查询与保护。本文对我国中药专利权保护的立法障碍与完善建议的探讨涉及到法学与药学两个学科体系的复合型研究。文章的总体遵照:梳理历史沿革——介绍现状——发现问题——分析成因——总结借鉴先进经验——给出完善建议对策的行文脉络进行论述。本文采用立法理论结合实践的方式,为了保证全文的逻辑严密性和规范性,作者主要运用了以下几种研究方法进行论文的撰写:(一)跨学科领域复合研究法:本文涉及到药学、中药学、知识产权法、民法等多个学科体系的知识,作者采用了以知识产权法学研究为主,中药学知识为辅的交叉研究方法。(二)文献分析法:作者阅读参考了大量著作图书、法律法规、网络资料、权威核心期刊文献以及优秀硕博士学位论文等翔实的资料,在前人已有的研究成果基础上加以拓展细化,探寻完善我国中药专利权保护的立法制度完善对策。(三)比较研究法:本文通过对美国、泰国、日本、德国等世界上代表性国家的传统医药专利权保护法律制度进行归纳、评析,再与我国相关对应的法律制度进行比较研究,总结出了各国在传统医药(或植物药)专利权保护立法方面的优劣之处,并选取其中符合我国国情特色的先进经验作为我国立法完善的借鉴。(四)历史研究法:本文开篇对我国中药专利权保护的立法沿革进行了梳理与归纳,追溯了我国各阶段法律规定的立法背景与当时的设计考量,对整个中药专利权保护的立法进程演变进行了总结,为后文的立法缺陷成因分析与完善建议做好铺垫。
[Abstract]:Chinese medicine is the great contribution made by the Chinese nation to the human health of the world. It has condensed the wisdom and blood of the ancient people of our country for thousands of years. It has a long history and a profound theoretical basis. China is a great country of Chinese medicine resources and the origin of traditional Chinese medicine. There are rich varieties of traditional Chinese medicine and a vast planting base of Chinese medicinal materials. However, limited by the technical conditions, the patent rights of Chinese traditional medicine are difficult to be protected by high quality. A large number of Chinese medicine resources have been converted into "foreign medicine" by developed countries and turned into high prices in the Chinese market, and a huge amount of patent profits are grabbed. The right protection is faced with an awkward situation. Through the design and construction of the legislative system adapting to the national conditions of China to fit the characteristics of Chinese medicine, it is divided into three parts: introduction, text and conclusion. The text is composed of three parts. The first part of the text begins with the narrow sense of Chinese materia medica. The definition of the connotation of traditional Chinese medicine is defined in the broad sense of intellectual property law, and the essential distinguishing feature of traditional Chinese medicine relative to western medicine chemicals is introduced. Then, through the comparison of various protection modes of Chinese medicine, the protection of patent rights of Chinese traditional medicine is the most widely recognized protection force at present. The conclusion of the strong and exclusive protection model expounds the legitimacy of the implementation of the patent protection of Chinese medicine in China. After that, this article combs the historical evolution of the legislative system of the patent protection of Chinese medicine, introduces the status of patent application, probes into the legislative defects and obstacles of the protection of Chinese traditional Chinese medicine patent right, and concentrates on me. The legislative defects and causes of the protection of patent rights in Chinese medicine are analyzed. The full public principle of the current patent law and the obstacles to the protection of patent rights of Chinese traditional medicine are discussed, and the conflict spear of the existing traditional Chinese medicine administrative protection mode and the patent protection mode is also discussed. The second part is the patent protection of Chinese medicine, plant medicine or Chinese medicine in the United States, Germany, Thailand, Japan and the patent rights of the United States, Germany, Thailand and Japan. The protection system and patent protection are compared and analyzed, and the system and practice experience of these countries in the field of traditional medicine patent protection are analyzed and analyzed. The third part, based on the first two parts, analyzes the legislative protection barriers of the existing Chinese traditional Chinese medicine patent protection system and the traditional medicine in the advanced countries. As a summary of the legislative experience of patent patent protection, I put forward some suggestions for improving the legislative system of patent protection of Chinese medicine. The author puts forward the following solutions: to straighten out the legislative system of patent protection of Chinese medicine and to solve the conflicts between the two laws and regulations of the administrative protection of Chinese medicine and the patent protection; and the introduction of traditional knowledge. In order to make up the advantages of Chinese traditional Chinese medicine resources and make up for the disadvantages of the technology application, the system of knowledge source disclosure and prior informed consent can be made up to contain the resources of Chinese traditional medicine and the "biological piracy" status of Chinese traditional medicine patents, and to refine the patent of Chinese medicine according to its own special point. " The standard for the review of the "three sex" is to adjust and relax the novelty of patent rights of traditional Chinese medicine, creative and practical standards; to stipulate that the secret censorship system prevents the disclosure of information from patent application of traditional Chinese medicine to be imitated by infringement; to extend the duration of patent protection of traditional Chinese medicine to improve the patent application of enterprises and individuals and to the benign development of patent protection of traditional Chinese medicine; Further refining the limit of patent infringement judgment of Chinese medicine, perfecting the legislative system of Chinese medicine tort identification, establishing the link mechanism of patent protection of Chinese medicine, and connecting the functions of the two administrative departments of the food and Drug Administration of China (SFDA) and the State Patent Office (SIPO), which is more helpful to the inquiry and protection of patent rights of Chinese medicine. The discussion of the legislative obstacles and suggestions for the protection of patent rights of Chinese traditional medicine involves a complex study of the two disciplinary systems of law and pharmacy. The overall compliance of the article is: combing the historical evolution - the introduction of the present situation - the discovery of the problems - the analysis of the causes - the summary of the experience of the first and the suggestions for the improvement of the suggestions In order to ensure the logical and normative of the full text, the author uses the following methods to write the paper: (1) the interdisciplinary research method: This article involves the knowledge of many disciplines, such as pharmacy, Chinese pharmacy, intellectual property law, civil law and so on. The author adopted the cross research method based on intellectual property law research and traditional Chinese medicine knowledge. (two) literature analysis: the author read a lot of books, laws and regulations, network data, authoritative core periodicals and excellent doctorate theory and so on, based on previous research results. To expand and refine the legislative system to perfect the protection of patent rights of Chinese medicine. (three) comparative study method: This article through the United States, Thailand, Japan, Germany and other representative countries of the world's traditional medical patent protection legal system to sum up, evaluation, and the corresponding legal system in China to compare the general research, The advantages and disadvantages of various countries in the patent protection legislation of traditional medicine (or plant medicine) are put forward, and the advanced experience which conforms to the national characteristics of our country is selected as a reference for the perfection of our country's legislation. (four) the historical research law: This article has combed and summed up the legislative evolution of the patent protection of Chinese traditional medicine, and traces back to every order of our country. The legislative background of the paragraph and the design consideration at that time, summarize the evolution of the legislative process of the protection of the patent right for the whole Chinese medicine, and pave the way for the analysis of the causes of the later legislative defects and the suggestions for perfection.

【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D923.42

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