【摘要】：藥品發(fā)明是高風(fēng)險(xiǎn)、長(zhǎng)周期、大投資的,該領(lǐng)域的發(fā)明對(duì)知識(shí)產(chǎn)權(quán)的依賴性非常高。而藥品作為一類特殊的商品,其質(zhì)量可控性、安全性、有效性只有在藥品監(jiān)督管理部門進(jìn)行全面的檢查后,才可批準(zhǔn)其上市銷售。但是在進(jìn)行上市許可審查的過(guò)程中,如果出現(xiàn)審批藥品涉及其他人的專利,這時(shí)的行政注冊(cè)行為肯定會(huì)影響藥品專利的保護(hù)狀態(tài)。因此，對(duì)于怎樣協(xié)調(diào)藥品注冊(cè)管理與其專利保護(hù)之間的關(guān)系這對(duì)于給予藥品專利權(quán)人的合法權(quán)益、保護(hù)新藥研發(fā)單位的積極性和仿制藥生產(chǎn)商的積極性都有很強(qiáng)的促進(jìn)作用。 本論文采用的主要的研究方法是,歷史研究分析法,分析比較研究法、實(shí)例分析法等。本文一共分為下面5個(gè)部分：第一個(gè)部分從藥品注冊(cè)管理和專利保護(hù)的基本概念入手,主要梳理了我國(guó)藥品注冊(cè)管理制度的變遷回顧和藥品專利保護(hù)的歷史沿革。第二部分首先通過(guò)分析藥品注冊(cè)管理和專利保護(hù)的關(guān)系,闡述了兩者的聯(lián)系、區(qū)別及交叉影響,然后分析了協(xié)調(diào)處理兩者的關(guān)系理念是利益平衡原則。第三部分主要概述了我國(guó)《藥品注冊(cè)管理法》中專利相關(guān)問(wèn)題的規(guī)定,和現(xiàn)有制度與實(shí)際操作中的不足。第四部分詳細(xì)論述了美國(guó)藥品專利鏈接制度和專利期延長(zhǎng)制度,通過(guò)中、美相關(guān)制度的比較研究,提出我國(guó)有必要借鑒國(guó)外的有益經(jīng)驗(yàn),構(gòu)建妥善處理藥品注冊(cè)與專利保護(hù)關(guān)系的制度。第五部分就如何協(xié)調(diào)藥品專利保護(hù)與藥品注冊(cè)審批之間的關(guān)系提出了一些合理的建議,主要包括完善藥品注冊(cè)管理制度,和對(duì)我國(guó)是否建立藥品專利期延長(zhǎng)制度進(jìn)行了思考。
[Abstract]:Pharmaceutical invention is high risk, long-term, large investment, the field of invention is highly dependent on intellectual property rights. As a special kind of commodities, the quality control, safety and effectiveness of drugs can only be approved after the drug supervision and administration departments conduct a comprehensive inspection. However, in the process of listing license examination, if the approval of drugs involves other people's patents, then the administrative registration behavior will definitely affect the state of drug patent protection. Therefore, how to coordinate the relationship between drug registration management and patent protection has a strong role in promoting the legal rights and interests of drug patentees, protecting the enthusiasm of new drug research and development units and the enthusiasm of generic drug manufacturers. The main research methods used in this paper are the historical analysis method, the comparative analysis method, the case analysis method and so on. This paper is divided into the following five parts: the first part starts with the basic concepts of drug registration management and patent protection, mainly combing the changes of drug registration management system and the history of drug patent protection in China. The second part analyzes the relationship between drug registration management and patent protection, expounds the relationship, difference and cross-influence between the two, and then analyzes that the concept of coordinating the relationship between the two is the principle of balance of interests. The third part mainly summarizes the provisions of patent related issues in the Drug Registration and Administration Law of our country, and the deficiencies in the existing system and practice. The fourth part discusses the drug patent link system and patent extension system in the United States in detail. Through the comparative study between China and the United States, the author points out that it is necessary for our country to learn from the beneficial experience of foreign countries. To establish a system to properly handle the relationship between drug registration and patent protection. The fifth part puts forward some reasonable suggestions on how to coordinate the relationship between drug patent protection and drug registration examination and approval, mainly including perfecting the drug registration management system and thinking about whether to establish the drug patent extension system in our country.
【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：R95

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本文編號(hào)：2426691