药品市场强制许可的历史与实践

K. Sasykin
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引用次数: 0

摘要

在制药行业,一项新发明——一种药物的开发、专利的获得以及开发商将其引入民间流通,都要花费大量的物力和时间资源。在这方面,药品很容易伪造,也有人企图仿造原药品,这需要特别注意保护专利持有人的权利。获得发明专利为其所有人提供了专有权,是国家对确保创新进步的一种感谢,但另一方面,由于专利所有人可能不诚实,这带来了重大威胁,根据作者的说法,考虑到时代的最新挑战,在提供防止滥用的保护机制方面同样需要注意。由于提供药品是国家卫生保健的主要任务之一,提交人提出了在国内法中适用其中一种机制的实际问题,即将药品作为发明颁发强制许可的机制(强制许可)。本文简要概述了国外该类制度适用的历史概况,分析了国内的规制和执法实践,并在此基础上提出了对该类制度进行法律规制的必要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Compulsory Licensing in the Pharmaceutical Market: History and Practice
In the pharmaceutical industry, the development of a new invention – a drug, the acquisition of a patent and the introduction into civil circulation by the developers spend significant resources in material and time. In this regard, drugs are attractive for falsification, and attempts are also being made to reproduce the imitation of original drugs, which requires special attention to the protection of the rights of patent holders. Obtaining a patent for an invention provides an exclusive right to its owner, being a kind of state gratitude for ensuring innovative progress, and, on the other hand, carries significant threats due to the possible dishonesty of patent owners, which, according to the Author, taking into account the latest challenges of the time, requires no less attention in terms of providing protective mechanisms against abuse. Since the availability of medicines is one of the main tasks of national health care, the Author raised the actual problem of applying one of these mechanisms in domestic law, namely the mechanism for issuing compulsory licenses for medicines as inventions (compulsory licensing). The article contains a brief historical outline of the foreign application of such institutions, analyzes domestic regulation and law enforcement practice, on the basis of which theses are put forward on the need for additional legal regulation.
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21 weeks
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