'No-One Is Safe until Everyone Is Safe' – Patent Waiver, Compulsory Licensing and COVID-19
'No-One Is Safe until Everyone Is Safe' – Patent Waiver, Compulsory Licensing and COVID-19
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“在所有人都安全之前，没有人是安全的”——专利放弃、强制许可和 COVID-19
DOI：
10.21552/eplr/2021/2/4
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
J. Wested
中科院分区：
文献类型：
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作者：
B. Kianzad;J. Wested
近几个月来，全球呼吁放弃COVID-19相关疫苗、治疗方法和相关产品的知识产权。辩论的一方将知识产权提升为阻碍全球迅速获得负担得起的疫苗和治疗方法的障碍，而辩论的另一方则指出现有的《与贸易有关的知识产权协定》的灵活性，如强制许可、知识产权对未来创新的必要性，以及制造能力和专有技术等更为重要的其他因素。这种二元论的做法有可能忽视知识产权法和健康权以及创新和卫生政策相互交叉所固有的多种法律、经济和政策的细微差别。需要采取一种平衡的办法，以现实世界有关药物创新的法律和经济学指标、强制许可的程序可行性和知识产权豁免的法律适用性为指导。因此，理解当前辩论的关键在于对知识产权、创新政策和卫生政策的法律进行整体比较。垄断权利的创新诱导方面，以及相互关联的垄断利润，需要与公共政策理由（如健康权）相平衡，也需要与注重社会福利最大化的知识产权比例法律相平衡。在介绍了全球不公平获取COVID-19疫苗和治疗的背景，为当前关于专利放弃和强制许可的辩论铺平了道路之后，该条继续如下。第二节从法律和政策角度简要概述了关于健康权和知识产权的辩论的主要轮廓。第三节详细介绍了《与贸易有关的知识产权协定》框架下国际专利编纂和强制许可文书的法律、历史和程序背景，以及2019冠状病毒病期间强制许可的一些实例。第四节详述了TRIPS理事会的专利豁免提案以及支持和反对该提案的论据。第五节总结了关于平衡健康权、知识产权和创新政策的一些法律和政策思考。©2021,lexion Verlagsgesellschaft mbH。版权所有。
Recentmonths have seen intensified global calls for an intellectual propertywaiver of COVID-19 related vaccines, treatments and related products.Where one side of the debate elevates Intellectual Property Rights as on obstacle to affordable and expeditious global access to vaccines and treatments, the other side of the debate points to the existing TRIPS flexibilities such as compulsory licensing, the necessity of Intellectual Property Rights for future innovation as well as other factors such as manufacturing capacity and know-how being of greater importance. This dualistic approach risk ignoring the manifold law, economics, and policy nuances inherent in the intersection of intellectual property law and Right-to-Health, as well as innovation and health policy. A balanced approach guided by real world indicators regarding law and economics of pharmaceutical innovation, procedural feasibility of compulsory licensing and legal applicability of an IPR waiver is needed. Thus, the key to understanding the current debates lies in a holistic approach to ratio legis of intellectual property rights, innovation policy and health policy. The innovation inducing facets of monopoly rights, and interconnected monopoly profits, need to be balanced against public policy rationales such as Right-to-Health, but also against the ratio legis of IPRs, which focuses on maximizing societal welfare. After the introduction framing the background regarding unequitable global access to COVID-19 vaccines and treatments paving the way to the current debates on patent waiver and compulsory licensing, the Article proceeds as follows. Section II briefly sketches the main contours of the debate on right-to-health and intellectual property rights from a law and policy perspective. Section III details the legal, historical and procedural background of international codification of patents and the compulsory licensing instrument within the TRIPS agreement, as well some instances of compulsory licensing during COVID-19. Section IV recounts the patent waiver proposal at TRIPS Council and the arguments for and against the proposal. Section V concludes with some law and policy reflections on the balance between Right-to-Health, intellectual property rights and innovation policy. © 2021, Lexxion Verlagsgesellschaft mbH. All rights reserved.