药品产业化背景下的中药商业秘密冲突研究
发布时间：2019-03-16 16:54
【摘要】：近年来，在药品产业化的背景下，我国中药的现代化和产业化进程明显加快，中药产业的产值已占全国药品总产值的近三分之一。与其他知识的应用和发展一样，知识经济背景下的中药产业化也离不开知识产权法律制度的保驾护航，我国已经建立起包括专利、商标、著作权、反不正当竞争法等在内的一整套知识产权法律和行政保护体系。然而由于知识产权制度与西药都是西方的舶来品，受其影响，我国的药品也趋向于采取与西药相同的专利的形式来保护知识产权，相比之下商业秘密这种中药传统的保护形式则没有得到应有的重视。商业秘密保护以其不公开、无期限限制、无需政府部门授权即可受到保护的特点，使得我国民间大量有效的民间偏方和院内制剂得以保存延续，同时保护处于研发阶段、尚未申请专利的中药技术秘密不会泄露。然而中药作为药品的一种，不同于普通商品，需要受到国家药品上市监管部门的审查。药品的上市监管部门在保障药品企业商业秘密的同时，注重审查药品的安全性、有效性和质量可控性及相关情况的公开，以照顾到公众的生命健康权、知情权和价格利益。因此，不难看出，采取商业秘密的形式保护中药必然会面临药品上市监管制度的挑战。中药商业秘密保护与药品上市监管冲突不仅存在于国内，在中药国际化进程中也面临着同样的问题，二者间的冲突得不到妥善解决将直接影响到中药产业的长远发展。本文的目的就是要通过对中药商业秘密保护和药品上市监管制度的研究，探究如何平衡中药产业化、现代化及国际化进程中各方的利益，协调冲突，为我国的中药商业秘密保护以及国际化提供建议。 本文共分为五大部分。引言主要对中药的基本情况予以介绍，并通过介绍云南白药涉嫌泄密一案引出正文。第一章详细阐述了商业秘密的概念及特点，并通过与专利及中药行政保护的对比，，探讨了中药商业秘密保护的选择问题。第二章首先介绍了我国的药品上市监管制度并与美国做了对比，然后论证了中药商业秘密保护与药品上市监管制度之间冲突的实质是与知情权的冲突，之后将冲突的分析进一步引申到中药商业秘密保护国际化上。第三章从整体的角度，在法律制度、体系构建和政治影响三个方面详细论述了冲突的解决方法。最后对全文进行了总结。
[Abstract]:In recent years, under the background of pharmaceutical industrialization, the modernization and industrialization of Chinese traditional medicine has accelerated obviously. The output value of traditional Chinese medicine industry has accounted for nearly 1/3 of the total value of national drug production. Like the application and development of other knowledge, the industrialization of traditional Chinese medicine under the background of knowledge-based economy cannot be separated from the legal system of intellectual property rights. China has established patents, trademarks and copyrights. Anti-unfair competition law, including a set of intellectual property law and administrative protection system. However, due to the fact that the intellectual property system and western medicine are both imported from the West and influenced by them, Chinese medicines tend to adopt the same patent forms as those of western medicines to protect intellectual property rights. In contrast, trade secrets, the traditional form of traditional Chinese medicine protection, have not been given due attention. Trade secret protection can be protected without the authorization of government departments because of its non-disclosure, unlimited time limit and can be protected without the authorization of the government department, so that a large number of effective folk prescription and hospital preparations in our country can be preserved and continued, and at the same time, the protection is in the research and development stage. The technical secrets of Chinese medicine that have not yet been patented will not be leaked. However, as a kind of medicine, traditional Chinese medicine, different from ordinary commodities, needs to be examined by the national drug market supervision department. In order to protect the trade secrets of pharmaceutical enterprises, the drug market supervision departments pay attention to examining the safety, effectiveness and quality controllability of drugs and the disclosure of related information, so as to take into account the public's right to life and health, the right to know and the interest of price. Therefore, it is not difficult to see that the protection of traditional Chinese medicine in the form of trade secrets will inevitably face the challenge of drug listing supervision system. The conflict between traditional Chinese medicine trade secret protection and drug listing supervision not only exists in China, but also faces the same problem in the process of internationalization of traditional Chinese medicine. The conflict between the two will directly affect the long-term development of Chinese medicine industry. The purpose of this paper is to explore how to balance the interests of all parties in the process of industrialization, modernization and internationalization of traditional Chinese medicine and coordinate conflicts through the study of the protection of trade secrets of traditional Chinese medicine and the regulation system of drug listing. It provides suggestions for the protection and internationalization of Chinese traditional medicine trade secrets. This paper is divided into five parts. The introduction mainly introduces the basic situation of traditional Chinese medicine, and through the introduction of Yunnan Baiyao suspected disclosure case leads to the main body. The first chapter expounds the concept and characteristics of trade secret in detail, and discusses the choice of trade secret protection of traditional Chinese medicine by comparing it with patent and administrative protection of traditional Chinese medicine. The second chapter first introduces the regulation system of drug listing in China and makes a comparison with the United States, then demonstrates that the conflict between the trade secret protection of traditional Chinese medicine and the regulation system of drug listing is a conflict with the right to know. After that, the analysis of conflict is further extended to the internationalization of trade secret protection of traditional Chinese medicine. The third chapter discusses in detail the solution to the conflict from the angle of the whole, including the legal system, the construction of the system and the political influence. Finally, the full text is summarized.
【学位授予单位】：烟台大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：D922.16;D923.42
[Abstract]:In recent years, under the background of pharmaceutical industrialization, the modernization and industrialization of Chinese traditional medicine has accelerated obviously. The output value of traditional Chinese medicine industry has accounted for nearly 1/3 of the total value of national drug production. Like the application and development of other knowledge, the industrialization of traditional Chinese medicine under the background of knowledge-based economy cannot be separated from the legal system of intellectual property rights. China has established patents, trademarks and copyrights. Anti-unfair competition law, including a set of intellectual property law and administrative protection system. However, due to the fact that the intellectual property system and western medicine are both imported from the West and influenced by them, Chinese medicines tend to adopt the same patent forms as those of western medicines to protect intellectual property rights. In contrast, trade secrets, the traditional form of traditional Chinese medicine protection, have not been given due attention. Trade secret protection can be protected without the authorization of government departments because of its non-disclosure, unlimited time limit and can be protected without the authorization of the government department, so that a large number of effective folk prescription and hospital preparations in our country can be preserved and continued, and at the same time, the protection is in the research and development stage. The technical secrets of Chinese medicine that have not yet been patented will not be leaked. However, as a kind of medicine, traditional Chinese medicine, different from ordinary commodities, needs to be examined by the national drug market supervision department. In order to protect the trade secrets of pharmaceutical enterprises, the drug market supervision departments pay attention to examining the safety, effectiveness and quality controllability of drugs and the disclosure of related information, so as to take into account the public's right to life and health, the right to know and the interest of price. Therefore, it is not difficult to see that the protection of traditional Chinese medicine in the form of trade secrets will inevitably face the challenge of drug listing supervision system. The conflict between traditional Chinese medicine trade secret protection and drug listing supervision not only exists in China, but also faces the same problem in the process of internationalization of traditional Chinese medicine. The conflict between the two will directly affect the long-term development of Chinese medicine industry. The purpose of this paper is to explore how to balance the interests of all parties in the process of industrialization, modernization and internationalization of traditional Chinese medicine and coordinate conflicts through the study of the protection of trade secrets of traditional Chinese medicine and the regulation system of drug listing. It provides suggestions for the protection and internationalization of Chinese traditional medicine trade secrets. This paper is divided into five parts. The introduction mainly introduces the basic situation of traditional Chinese medicine, and through the introduction of Yunnan Baiyao suspected disclosure case leads to the main body. The first chapter expounds the concept and characteristics of trade secret in detail, and discusses the choice of trade secret protection of traditional Chinese medicine by comparing it with patent and administrative protection of traditional Chinese medicine. The second chapter first introduces the regulation system of drug listing in China and makes a comparison with the United States, then demonstrates that the conflict between the trade secret protection of traditional Chinese medicine and the regulation system of drug listing is a conflict with the right to know. After that, the analysis of conflict is further extended to the internationalization of trade secret protection of traditional Chinese medicine. The third chapter discusses in detail the solution to the conflict from the angle of the whole, including the legal system, the construction of the system and the political influence. Finally, the full text is summarized.
【学位授予单位】：烟台大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：D922.16;D923.42
【参考文献】
相关期刊论文 前10条
1 李中奎;郭永红;;商业秘密与其他知识产权保护方式之对比及结合[J];电子知识产权;2010年02期
2 许俊才;方宁涛;;美国食品药品监督管理局百年发展历程带给我国药品监管体系的启示[J];世界临床药物;2008年07期
3 董妍;;商业秘密保护与公众知情权冲突[J];商业研究;2012年10期
4 文娜;;论商业秘密与公共知情权冲突与协调[J];法制与社会;2011年05期
5 张冬;;中药知识产权国际化保护问题的实效方法论应用——以中美对中药保护最佳路径选择为视角[J];河北法学;2012年01期
6 刘晓慧;;论传统中医药的商业秘密保护[J];市场论坛;2011年12期
7 张红;;浅议知情权及其法律保障[J];理论月刊;2007年05期
8 张涛;;论商业秘密与公众知情权的冲突与解决[J];前沿;2011年08期
9 强美英;;中医药的商业秘密保护及其产业对策初探[J];生产力研究;2009年24期
10 丁晓s
本文编号：2441775
本文链接：https://www.wllwen.com/falvlunwen/zhishichanquanfa/2441775.html
