本文選題：藥品專利 + 強(qiáng)制許可　； 參考：《西南大學(xué)》2014年碩士論文

【摘要】：經(jīng)濟(jì)全球化在推動(dòng)各國(guó)快速發(fā)展的同時(shí),也導(dǎo)致因人口激增和頻繁性跨國(guó)流動(dòng)引起的傳染性疾病跨區(qū)域爆發(fā)。這一現(xiàn)象在缺乏先進(jìn)醫(yī)藥技術(shù)和資金投入的發(fā)展中國(guó)家和最不發(fā)達(dá)國(guó)家表現(xiàn)得尤為突出。我國(guó)作為其中的典型國(guó)家之一,面對(duì)近年來(lái)多次爆發(fā)的公共健康危機(jī),如何讓患者及時(shí)獲取廉價(jià)有效的藥品成為亟待解決的問(wèn)題。然而,制藥企業(yè)技術(shù)水平與資金的有限性,導(dǎo)致發(fā)生公共健康危機(jī)時(shí),我國(guó)不能立刻為患者提供有效的藥品,而其他國(guó)家療效顯著的專利藥品因價(jià)格過(guò)高只能讓患者望而卻步。為提高國(guó)人的藥品可及性,同時(shí)又不損害專利權(quán)人的合法利益,實(shí)施藥品專利強(qiáng)制許可制度成為重要的解決途徑。 自世界貿(mào)易組織(WTO)簽署的《與貿(mào)易有關(guān)的知識(shí)產(chǎn)權(quán)協(xié)定》及之后達(dá)成的一系列協(xié)議給予成員國(guó)實(shí)施藥品專利強(qiáng)制許可的權(quán)利后,一些發(fā)達(dá)國(guó)家和發(fā)展中國(guó)家就已通過(guò)實(shí)施該制度達(dá)到了限制專利權(quán)濫用、保障公共健康的目的。如美國(guó)為對(duì)抗炭疽病毒感染而與德國(guó)拜耳公司進(jìn)行了以實(shí)施強(qiáng)制許可相威脅的談判,最終迫使拜耳公司主動(dòng)降低藥價(jià)；泰國(guó)針對(duì)心臟病的治療藥品簽發(fā)了抗心臟病藥品“波立維”的專利強(qiáng)制許可。兩國(guó)在減輕國(guó)內(nèi)醫(yī)療保險(xiǎn)負(fù)擔(dān)的同時(shí),也滿足了患者對(duì)藥品的需求,降低了因缺乏藥物導(dǎo)致的死亡率。然而,當(dāng)別國(guó)通過(guò)實(shí)施藥品專利強(qiáng)制許可而為保障公共健康作出努力時(shí),我國(guó)仍然對(duì)該制度保持著僅限于紙面的態(tài)度。 從制度層面分析,TRIPS協(xié)定對(duì)實(shí)施專利強(qiáng)制許可的條件、程序、種類等都作出了規(guī)定。作為TRIPS協(xié)定的成員國(guó),我國(guó)在借鑒其規(guī)定的基礎(chǔ)上已初步形成了《專利法》、《專利法實(shí)施細(xì)則》和《專利實(shí)施強(qiáng)制許可辦法》為主的專利強(qiáng)制許可制度體系。從社會(huì)層面分析,近年來(lái)突發(fā)性公共健康危機(jī)的增加,患者對(duì)專利藥品的需求增大,為實(shí)施藥品專利強(qiáng)制許可制度提供了市場(chǎng)基礎(chǔ)。那么導(dǎo)致我國(guó)至今尚未實(shí)施藥品專利強(qiáng)制許可制度的原因到底是什么?通過(guò)哪些途徑可以改善我國(guó)已有的現(xiàn)狀?為應(yīng)對(duì)將來(lái)發(fā)生的公共健康危機(jī)可能引起的藥品供應(yīng)不足,為促使我國(guó)醫(yī)藥企業(yè)能夠更快的學(xué)習(xí)先進(jìn)的醫(yī)藥技術(shù),也為使我國(guó)已有的法律制度得以實(shí)施。本文試圖通過(guò)比較分析國(guó)外與我國(guó)藥品專利強(qiáng)制許可的實(shí)施狀況,探討我國(guó)未實(shí)施該制度的問(wèn)題之所在,從而為完善我國(guó)藥品專利強(qiáng)制許可制度的實(shí)施提出建議。具體研究如下：第一部分,分析藥品專利強(qiáng)制許可制度實(shí)施的相關(guān)概念、國(guó)際國(guó)內(nèi)背景及實(shí)施的必要性；第二部分,分析我國(guó)實(shí)施該制度的現(xiàn)實(shí)困境；第三部分,介紹部分發(fā)達(dá)國(guó)家與發(fā)展中國(guó)家的制度實(shí)施情況并總結(jié)經(jīng)驗(yàn)；第四部分,通過(guò)借鑒國(guó)外制度與具體實(shí)施的經(jīng)驗(yàn),提出推進(jìn)我國(guó)藥品專利強(qiáng)制許可制度實(shí)施的途徑。
[Abstract]:Economic globalization not only promotes the rapid development of countries, but also leads to cross-regional outbreaks of infectious diseases caused by population explosion and frequent transnational mobility. This phenomenon is especially evident in developing countries and least developed countries which lack advanced medical technology and capital investment. As one of the typical countries, in the face of the public health crisis which broke out many times in recent years, how to get cheap and effective drugs in time has become an urgent problem. However, due to the limited technical level and capital of pharmaceutical enterprises, when public health crisis occurs, our country can not provide effective drugs for patients immediately, and other countries can only put off the patients because of the high price of patented drugs with remarkable curative effect. In order to improve the availability of drugs without harming the legitimate interests of the patentee, the enforcement of the compulsory licensing system of drug patents has become an important solution. Since the Agreement on Trade-Related aspects of intellectual property Rights (trips Agreement) signed by the World Trade Organization (WTO) and a series of subsequent agreements giving member States the right to enforce compulsory licensing of pharmaceutical patents, Some developed and developing countries have implemented the system to limit patent abuse and protect public health. For example, in order to combat anthrax infection, the United States and Germany Bayer company to carry out the threat of mandatory licensing negotiations, eventually forced Bayer to take the initiative to reduce drug prices; Thailand has issued a patent enforcement license for the anti-heart drug Polyvir. While reducing the domestic health insurance burden, the two countries also meet patients' demand for drugs and reduce mortality caused by lack of drugs. However, when other countries make efforts to protect public health by enforcing compulsory licensing of drug patents, our country still maintains a paper attitude towards the system. This paper analyzes the conditions, procedures and types of compulsory patent licensing in trips. As a member of trips Agreement, China has formed a patent compulsory licensing system based on the provisions of the trips Agreement, including the Patent Law, the detailed rules for the implementation of the Patent Law and the measures for compulsory Patent Licensing. From the social level, in recent years, with the increase of sudden public health crisis, patients' demand for patented drugs increases, which provides a market basis for the implementation of the compulsory licensing system of drug patents. So what is the reason why China has not yet implemented the compulsory licensing system of drug patents? Through what ways can we improve the existing situation in China? In order to deal with the shortage of medicine supply caused by the public health crisis in the future, to promote the Chinese pharmaceutical enterprises to learn the advanced medicine technology more quickly, and to make the existing legal system of our country carry out. This paper attempts to compare and analyze the implementation of drug patent compulsory licensing in foreign countries and in China, and to discuss the problems that have not been implemented in our country, so as to put forward some suggestions for perfecting the enforcement of compulsory drug patent licensing system in China. The concrete research is as follows: the first part, analyzes the related concept, the international and domestic background and the implementation necessity of the drug patent compulsory license system; the second part, analyzes the realistic predicament of the implementation of this system in our country; the third part, the third part, This paper introduces the implementation of the system in some developed and developing countries and summarizes the experience. The fourth part puts forward the ways to promote the enforcement of compulsory licensing system of drug patents in our country by learning from the experience of foreign institutions and concrete implementation.
【學(xué)位授予單位】：西南大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：D923.42

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本文編號(hào)：2020290