【摘要】：近年來，在藥品產(chǎn)業(yè)化的背景下，我國(guó)中藥的現(xiàn)代化和產(chǎn)業(yè)化進(jìn)程明顯加快，中藥產(chǎn)業(yè)的產(chǎn)值已占全國(guó)藥品總產(chǎn)值的近三分之一。與其他知識(shí)的應(yīng)用和發(fā)展一樣，知識(shí)經(jīng)濟(jì)背景下的中藥產(chǎn)業(yè)化也離不開知識(shí)產(chǎn)權(quán)法律制度的保駕護(hù)航，我國(guó)已經(jīng)建立起包括專利、商標(biāo)、著作權(quán)、反不正當(dāng)競(jìng)爭(zhēng)法等在內(nèi)的一整套知識(shí)產(chǎn)權(quán)法律和行政保護(hù)體系。然而由于知識(shí)產(chǎn)權(quán)制度與西藥都是西方的舶來品，受其影響，我國(guó)的藥品也趨向于采取與西藥相同的專利的形式來保護(hù)知識(shí)產(chǎn)權(quán)，相比之下商業(yè)秘密這種中藥傳統(tǒng)的保護(hù)形式則沒有得到應(yīng)有的重視。商業(yè)秘密保護(hù)以其不公開、無期限限制、無需政府部門授權(quán)即可受到保護(hù)的特點(diǎn)，使得我國(guó)民間大量有效的民間偏方和院內(nèi)制劑得以保存延續(xù)，同時(shí)保護(hù)處于研發(fā)階段、尚未申請(qǐng)專利的中藥技術(shù)秘密不會(huì)泄露。然而中藥作為藥品的一種，不同于普通商品，需要受到國(guó)家藥品上市監(jiān)管部門的審查。藥品的上市監(jiān)管部門在保障藥品企業(yè)商業(yè)秘密的同時(shí)，注重審查藥品的安全性、有效性和質(zhì)量可控性及相關(guān)情況的公開，以照顧到公眾的生命健康權(quán)、知情權(quán)和價(jià)格利益。因此，不難看出，采取商業(yè)秘密的形式保護(hù)中藥必然會(huì)面臨藥品上市監(jiān)管制度的挑戰(zhàn)。中藥商業(yè)秘密保護(hù)與藥品上市監(jiān)管沖突不僅存在于國(guó)內(nèi)，在中藥國(guó)際化進(jìn)程中也面臨著同樣的問題，二者間的沖突得不到妥善解決將直接影響到中藥產(chǎn)業(yè)的長(zhǎng)遠(yuǎn)發(fā)展。本文的目的就是要通過對(duì)中藥商業(yè)秘密保護(hù)和藥品上市監(jiān)管制度的研究，探究如何平衡中藥產(chǎn)業(yè)化、現(xiàn)代化及國(guó)際化進(jìn)程中各方的利益，協(xié)調(diào)沖突，為我國(guó)的中藥商業(yè)秘密保護(hù)以及國(guó)際化提供建議。 本文共分為五大部分。引言主要對(duì)中藥的基本情況予以介紹，并通過介紹云南白藥涉嫌泄密一案引出正文。第一章詳細(xì)闡述了商業(yè)秘密的概念及特點(diǎn)，并通過與專利及中藥行政保護(hù)的對(duì)比，，探討了中藥商業(yè)秘密保護(hù)的選擇問題。第二章首先介紹了我國(guó)的藥品上市監(jiān)管制度并與美國(guó)做了對(duì)比，然后論證了中藥商業(yè)秘密保護(hù)與藥品上市監(jiān)管制度之間沖突的實(shí)質(zhì)是與知情權(quán)的沖突，之后將沖突的分析進(jìn)一步引申到中藥商業(yè)秘密保護(hù)國(guó)際化上。第三章從整體的角度，在法律制度、體系構(gòu)建和政治影響三個(gè)方面詳細(xì)論述了沖突的解決方法。最后對(duì)全文進(jìn)行了總結(jié)。
[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.
【學(xué)位授予單位】：煙臺(tái)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：D922.16;D923.42

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