【摘要】：隨著全球范圍內(nèi)知識(shí)經(jīng)濟(jì)的快速發(fā)展,經(jīng)濟(jì)和科技全球化貿(mào)易自由化進(jìn)程加快,知識(shí)產(chǎn)權(quán)可謂是無(wú)處不在,知識(shí)產(chǎn)權(quán)的重要性也被各國(guó)重視起來(lái)。知識(shí)產(chǎn)權(quán)也漸漸成為衡量綜合國(guó)力的一項(xiàng)重要指標(biāo),發(fā)達(dá)國(guó)家更是把知識(shí)產(chǎn)權(quán)作為處理國(guó)際政治和經(jīng)濟(jì)關(guān)系的重要手段。TRIPS協(xié)議成為WTO成員國(guó)都必須遵守的知識(shí)產(chǎn)權(quán)準(zhǔn)則。在生物制藥領(lǐng)域也不例外,生物制藥的知識(shí)產(chǎn)權(quán)保護(hù)和TRIPS協(xié)議成為近年的熱議問(wèn)題,而其中爭(zhēng)議最多的就是生物制藥知識(shí)產(chǎn)權(quán)保護(hù)和公共健康的關(guān)系問(wèn)題。 本文正文部分分為四章：第一章介紹生物制藥知識(shí)產(chǎn)權(quán)保護(hù)和公共健康的現(xiàn)狀,及國(guó)際上與公共健康相關(guān)的藥品知識(shí)產(chǎn)權(quán)保護(hù)立法。公共健康危機(jī)一次次的爆發(fā),專(zhuān)利藥廠(chǎng)商和發(fā)達(dá)國(guó)家在危機(jī)中的表現(xiàn)不盡如人意,引起了全世界人民對(duì)藥品知識(shí)產(chǎn)權(quán)過(guò)度保護(hù)的不滿(mǎn)。第二章著重論述了生物制藥的知識(shí)產(chǎn)權(quán)保護(hù)和公共健康的辯證關(guān)系,具體闡述了知識(shí)產(chǎn)權(quán)保護(hù)對(duì)公共健康的積極促進(jìn)作用,而后本文從三方面論述了藥品知識(shí)產(chǎn)權(quán)保護(hù)和公共健康的矛盾。世界主要知名制藥企業(yè)都是來(lái)自美國(guó)和歐洲,第三章分別介紹了美國(guó)和歐盟平衡藥品知識(shí)產(chǎn)權(quán)保護(hù)和公共健康矛盾的寶貴實(shí)踐經(jīng)驗(yàn)及其主要法律制度及完善過(guò)程。美國(guó)是全世界藥品專(zhuān)利最多的國(guó)家,也是生物制藥產(chǎn)業(yè)最發(fā)達(dá)的國(guó)家,這些繁榮的背后是與之相適應(yīng)的專(zhuān)利保護(hù)制度在支撐著,本文主要介紹了影響美國(guó)生物制藥行業(yè)的美國(guó)Hatch-Waxman法案、仿制藥簡(jiǎn)化申請(qǐng)制度、Bolar例外和《仿制藥實(shí)施法》。歐盟的仿制藥發(fā)展對(duì)降低藥品價(jià)格、保護(hù)公共健康利益和SPC制度對(duì)專(zhuān)利的保護(hù)和補(bǔ)償也是值得我們?nèi)パ芯亢徒梃b的。我國(guó)知識(shí)產(chǎn)權(quán)保護(hù)起步比較晚,但是我國(guó)用20年的時(shí)間走過(guò)了發(fā)達(dá)國(guó)家歷經(jīng)100年的知識(shí)產(chǎn)權(quán)發(fā)展路程。第四章從我國(guó)《專(zhuān)利法》的三次修改對(duì)生物制藥行業(yè)的影響引出我國(guó)藥品知識(shí)產(chǎn)權(quán)保護(hù)和公共健康關(guān)系平衡的探討,面對(duì)不斷發(fā)展變化的國(guó)際國(guó)內(nèi)形勢(shì),如何依法保護(hù)藥品知識(shí)產(chǎn)權(quán)兼顧社會(huì)公共健康利益,促進(jìn)藥品研發(fā)技術(shù)創(chuàng)新和應(yīng)用。作者提出針對(duì)性對(duì)策并最終得出結(jié)論。
[Abstract]:With the rapid development of the global knowledge economy and the acceleration of the trade liberalization process of economic and technological globalization, intellectual property rights are everywhere, and the importance of intellectual property rights has also been attached importance to by all countries. Intellectual property rights have gradually become an important indicator to measure the comprehensive national strength. Developed countries regard intellectual property rights as an important means to deal with international political and economic relations. Trips Agreement has become the intellectual property standards that all WTO member countries must abide by. In the field of biopharmaceuticals, the intellectual property protection and TRIPS agreement of biopharmaceuticals have become a hot issue in recent years, and the most controversial issue is the relationship between intellectual property protection and public health of biopharmaceuticals. The main body of this paper is divided into four chapters: the first chapter introduces the current situation of intellectual property protection and public health of biopharmaceuticals, as well as the international legislation on the protection of pharmaceutical intellectual property rights related to public health. The public health crisis broke out time and again, and the performance of patent drug manufacturers and developed countries in the crisis was unsatisfactory, which caused the people all over the world dissatisfied with the over-protection of intellectual property rights. The second chapter focuses on the dialectical relationship between intellectual property protection and public health of biopharmaceuticals, and expounds the positive role of intellectual property protection in promoting public health. Then this paper discusses the contradiction between intellectual property protection and public health in three aspects. The main famous pharmaceutical enterprises in the world are from the United States and Europe. Chapter three introduces the valuable practical experience of balancing the contradiction between intellectual property protection and public health in the United States and the European Union, as well as the main legal system and the process of perfection. The United States is the country with the largest number of drug patents in the world and the most developed country in the biopharmaceutical industry. Behind these prosperity are the corresponding patent protection systems. This paper mainly introduces the Hatch-Waxman Act of the United States, the simplified application system of generic drugs, the exception of Hatch-Waxman and the implementation of generic drugs Act, which affect the biopharmaceutical industry in the United States. The development of generic drugs in the European Union is also worthy of our study and reference to reduce the price of drugs, protect the public health benefits and the patent protection and compensation of the SPC system. China's intellectual property protection started late, but it took 20 years for China to go through 100 years of intellectual property development in developed countries. Chapter four discusses the balance between the protection of pharmaceutical intellectual property rights and public health from the impact of the three revisions of the Patent Law on the biopharmaceutical industry, and faces the ever-changing international and domestic situation. How to protect the intellectual property rights of drugs according to law and give consideration to the social public health interests and promote the innovation and application of drug research and development technology. The author puts forward targeted countermeasures and finally draws a conclusion.
【學(xué)位授予單位】：中國(guó)政法大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2011
【分類(lèi)號(hào)】：D923.42;D996;R-051

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