仿制藥的專(zhuān)利侵權(quán)風(fēng)險(xiǎn)防范問(wèn)題研究
本文選題:藥品專(zhuān)利 + 仿制藥; 參考:《華中科技大學(xué)》2013年碩士論文
【摘要】:TRIPS協(xié)議將藥品納入了專(zhuān)利保護(hù)范圍之后,仿制藥工業(yè)的知識(shí)產(chǎn)權(quán)風(fēng)險(xiǎn)變得突出,同時(shí)專(zhuān)利藥的價(jià)格上漲,,引起了發(fā)展中國(guó)家的用藥緊張和公共健康危機(jī)。盡管之后的《TRIPS協(xié)議與公共健康多哈宣言》及《關(guān)于TRIPS協(xié)議和公共健康多哈宣言第六段的執(zhí)行決議》提出了發(fā)展中成員要求防止濫用知識(shí)產(chǎn)權(quán)阻礙社會(huì)經(jīng)濟(jì)發(fā)展的愿望,但仍有許多具體適用上的限制性規(guī)定或障礙。在醫(yī)療開(kāi)支居高不下的壓力和大批醫(yī)藥專(zhuān)利即將到期的利好形勢(shì)下,仿制藥已受到包括發(fā)達(dá)國(guó)家和發(fā)展中國(guó)家的重視,近年來(lái)發(fā)展迅速。出于對(duì)本國(guó)大型制藥公司的利益保護(hù),發(fā)達(dá)國(guó)家對(duì)外仍推行高水平的知識(shí)產(chǎn)權(quán)保護(hù)水平,對(duì)于一些發(fā)展中國(guó)家利用TRIPS協(xié)議靈活性條款作出的醫(yī)藥專(zhuān)利強(qiáng)制許可等采取打壓政策。本文就藥品專(zhuān)利與公共健康之間的沖突原因和協(xié)調(diào)途徑進(jìn)行了分析和論證,并對(duì)我國(guó)相關(guān)的藥品專(zhuān)利制度提出建議。 作為人口大國(guó),保障藥品的可及性是我國(guó)面臨的現(xiàn)實(shí)挑戰(zhàn)。我國(guó)目前97%以上的國(guó)產(chǎn)藥為仿制藥。但是很多企業(yè)仍處于低水平重復(fù)仿制的狀態(tài),帶有盲目性和風(fēng)險(xiǎn)性,不能充分掌握知識(shí)產(chǎn)權(quán)規(guī)則。通過(guò)對(duì)藥品仿制過(guò)程中的專(zhuān)利風(fēng)險(xiǎn)進(jìn)行分析與控制,我國(guó)相關(guān)制藥企業(yè)能夠有效防范專(zhuān)利侵權(quán)風(fēng)險(xiǎn),取得經(jīng)濟(jì)效益和社會(huì)效益的最大化,為我國(guó)的公共健康事業(yè)作出貢獻(xiàn)。
[Abstract]:After trips brought the drug into the scope of patent protection, the intellectual property risk of generic medicine industry became prominent, and the price of patent medicine increased, which caused the tension of drug use and public health crisis in developing countries. Although the subsequent Doha Declaration on trips and Public Health and the implementation resolution on trips and paragraph 6 of the Doha Declaration on Public Health set out the aspirations of developing members to prevent the abuse of intellectual property rights from impeding socio-economic development, However, there are still many restrictive provisions or obstacles to their specific application. Under the pressure of high medical expenditure and the favorable situation that a large number of medical patents are about to expire, generic drugs have been attached great importance to by both developed and developing countries, and have developed rapidly in recent years. In order to protect the interests of domestic large pharmaceutical companies, developed countries still implement a high level of intellectual property rights protection, and some developing countries take measures to suppress the compulsory licensing of pharmaceutical patents, which are made by some developing countries using the flexible terms of trips Agreement. This paper analyzes and proves the conflict between drug patent and public health and the ways of coordination, and puts forward some suggestions on the relevant drug patent system in China. As a large country with large population, it is a realistic challenge for our country to guarantee the accessibility of drugs. At present, more than 97% of domestic drugs in China are generic drugs. However, many enterprises are still in the state of low level repeated copying, with blindness and risk, unable to fully grasp the intellectual property rules. By analyzing and controlling the patent risk in the process of drug imitation, the related pharmaceutical enterprises in our country can effectively guard against the risk of patent infringement, maximize the economic and social benefits, and contribute to the public health in our country.
【學(xué)位授予單位】:華中科技大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2013
【分類(lèi)號(hào)】:D923.42
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