論生物制藥知識產(chǎn)權(quán)保護(hù)與公共健康的沖突與協(xié)調(diào)
發(fā)布時間：2018-10-08 09:55
【摘要】：隨著全球范圍內(nèi)知識經(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,知識產(chǎn)權(quán)可謂是無處不在,知識產(chǎn)權(quán)的重要性也被各國重視起來。知識產(chǎn)權(quán)也漸漸成為衡量綜合國力的一項重要指標(biāo),發(fā)達(dá)國家更是把知識產(chǎn)權(quán)作為處理國際政治和經(jīng)濟(jì)關(guān)系的重要手段。TRIPS協(xié)議成為WTO成員國都必須遵守的知識產(chǎn)權(quán)準(zhǔn)則。在生物制藥領(lǐng)域也不例外,生物制藥的知識產(chǎn)權(quán)保護(hù)和TRIPS協(xié)議成為近年的熱議問題,而其中爭議最多的就是生物制藥知識產(chǎn)權(quán)保護(hù)和公共健康的關(guān)系問題。 本文正文部分分為四章：第一章介紹生物制藥知識產(chǎn)權(quán)保護(hù)和公共健康的現(xiàn)狀,及國際上與公共健康相關(guān)的藥品知識產(chǎn)權(quán)保護(hù)立法。公共健康危機一次次的爆發(fā),專利藥廠商和發(fā)達(dá)國家在危機中的表現(xiàn)不盡如人意,引起了全世界人民對藥品知識產(chǎn)權(quán)過度保護(hù)的不滿。第二章著重論述了生物制藥的知識產(chǎn)權(quán)保護(hù)和公共健康的辯證關(guān)系,具體闡述了知識產(chǎn)權(quán)保護(hù)對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)都是來自美國和歐洲,第三章分別介紹了美國和歐盟平衡藥品知識產(chǎn)權(quán)保護(hù)和公共健康矛盾的寶貴實踐經(jīng)驗及其主要法律制度及完善過程。美國是全世界藥品專利最多的國家,也是生物制藥產(chǎn)業(yè)最發(fā)達(dá)的國家,這些繁榮的背后是與之相適應(yīng)的專利保護(hù)制度在支撐著,本文主要介紹了影響美國生物制藥行業(yè)的美國Hatch-Waxman法案、仿制藥簡化申請制度、Bolar例外和《仿制藥實施法》。歐盟的仿制藥發(fā)展對降低藥品價格、保護(hù)公共健康利益和SPC制度對專利的保護(hù)和補償也是值得我們?nèi)パ芯亢徒梃b的。我國知識產(chǎn)權(quán)保護(hù)起步比較晚,但是我國用20年的時間走過了發(fā)達(dá)國家歷經(jīng)100年的知識產(chǎn)權(quán)發(fā)展路程。第四章從我國《專利法》的三次修改對生物制藥行業(yè)的影響引出我國藥品知識產(chǎn)權(quán)保護(hù)和公共健康關(guān)系平衡的探討,面對不斷發(fā)展變化的國際國內(nèi)形勢,如何依法保護(hù)藥品知識產(chǎn)權(quán)兼顧社會公共健康利益,促進(jìn)藥品研發(fā)技術(shù)創(chuàng)新和應(yīng)用。作者提出針對性對策并最終得出結(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】：中國政法大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2011
【分類號】：D923.42;D996;R-051
[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】：中國政法大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2011
【分類號】：D923.42;D996;R-051
【相似文獻(xiàn)】
相關(guān)期刊論文 前10條
1 陽賢文;;建立深圳知識產(chǎn)權(quán)交易平臺之探析[J];特區(qū)實踐與理論;2011年03期
2 臧興東;曾t，
本文編號：2256337
本文鏈接：http://sikaile.net/falvlunwen/guojifa/2256337.html
