TRIPS中的诚信药品专利强制许可:以往疫情案例的经验教训

M. Arifin
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引用次数: 0

摘要

新冠肺炎疫情影响了专利世界,各国正在准备法律框架,以简化强制许可程序。印度和南非等一些国家甚至更进一步,提议暂停抗击新冠肺炎所需的专利,目前仍在讨论中。一种对新冠肺炎有效的专利药物有可能在其专利持有人经营的许多国家获得强制许可。本文通过审查强制许可的合法性、以前的强制许可案例以及国家在强制许可发放案例中的行为,特别是在泰国、巴西和印度的案例中,讨论了为什么强制许可是一个重要问题。这篇文章将探讨针对强制许可的补救方法,包括对条约进行宪法审查的理论可能性。所讨论的补救措施应包括国际和国内补救措施,包括诉讼和替代措施。研究应采用定性研究方法,利用第一和第二法律来源。这篇文章的结果发现,《多哈宣言》的软法律力量和随后的强制许可案件的援引相结合,是强制许可实践的支柱。然而,根据1969年《维也纳条约法公约》和《与贸易有关的知识产权协定》,专利持有人和国家行为者的强制许可做法仍未完全本着诚意执行。因此,这些专利持有人需要熟悉国际和国内补救办法,特别是宪法审查条约补救办法的可能性。
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GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES
The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.
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