HOW INTELLECTUAL PROPERTY RIGHTS ENCOURAGE PHARMACEUTICAL INNOVATION

Michael Ryan
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Abstract

With patent laws governments intervene into the marketplace to provide incentives to innovators to invest their know-how, time, and money into the creation of inventions under circumstances of the appropriability problem associated with intangible assets. The intellectual property notion of trade secrecy means specific information that possesses commercial value and that reasonable efforts have been taken to keep it secret. Innovative pharmaceuticals, both radical and incremental, are especially susceptible to the appropriability problem in knowledge-based economic activity, for turning a prospective molecule as identified in the laboratory into a medicine that may be distributed in the public health system requires many years of computer modeling, animal-testing and, finally, clinical trial testing. Clinical trials are performed in three phases and each phase results in a plethora of data. Drug laws specify that such data are kept confidential by health regulatory authorities for a period of 5 years in the United States and for longer periods in most of Europe. Sufficiently strong appropriability regimes facilitate licensing and cross-licensing relationships between and among universities and business. Substantial empirical research supports the utility of the Bayh-Dole model and doubts the existence of a patent anti-commons (editor note: the existence of numerous rights holders frustrates achieving a socially desirable outcome), in the life sciences.
知识产权如何鼓励医药创新
在与无形资产相关的可挪用性问题的情况下,政府通过专利法干预市场,为创新者提供激励,鼓励他们将知识、时间和金钱投入到发明创造中。商业秘密的知识产权概念是指具有商业价值的特定信息,并已采取合理努力对其保密。在以知识为基础的经济活动中,创新药物,无论是激进的还是渐进的,都特别容易受到适当性问题的影响,因为将实验室中确定的潜在分子转化为可能在公共卫生系统中分发的药物需要多年的计算机建模,动物试验,最后是临床试验。临床试验分三个阶段进行,每个阶段都会产生大量的数据。药品法规定,卫生管理当局对此类数据保密的期限在美国为5年,在大多数欧洲国家为更长时间。足够强大的适当性制度促进了大学和企业之间的许可和交叉许可关系。大量的实证研究支持Bayh-Dole模型的效用,并质疑专利反公地的存在(编者注:众多权利持有人的存在阻碍了实现社会期望的结果),在生命科学。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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