Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome.
Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome.
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DOI：
10.1097/gim.0b013e3181d68293
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发表时间：
2010-04
期刊：
影响因子：
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通讯作者：
Cook-Deegan R
中科院分区：
文献类型：
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作者：
Angrist M;Chandrasekharan S;Heaney C;Cook-Deegan R
长QT综合征（LQTS）的基因检测证明了专利和独家许可在不同时间有不同的结果。犹他州大学的独家许可将LQTS测试的商业模式从单一提供商变为两家美国提供商。LQTS与许多基因的突变有关，其中10个基因现在由美国两家竞争公司PGxHealth和GeneDx进行测试。在2009年之前，PGxHealth是唯一的供应商，主要基于对犹他州大学和其他学术机构专利的独家权利。犹他州大学的专利最初被授权给DNA科学公司，后者的专利权被Gennaissance收购，然后被临床数据公司收购，拥有PGxHealth的公司2002年，DNA科学公司通过向提供LQTS基因检测的大学和参考实验室发送停止和终止专利执行信件来“清理市场”。在一至两年的时间里，市场上没有测试。从2005年到2008年，大多数LQTS相关专利由Clinical Data，Inc.控制，及其子公司PGxHealth。BioReference Laboratories，Inc.，从2006年开始，同样来自犹他州大学的公司获得了反补贴的独家专利权，并在2009年初打破了PGxHealth的垄断，在美国建立了基因检测的双寡头垄断，并将商业检测的基因数量从5个增加到10个。
Genetic testing for Long QT syndrome (LQTS) exemplifies patenting and exclusive licensing with different outcomes at different times. Exclusive licensing from the University of Utah changed the business model from sole provider to two US providers of LQTS testing. LQTS is associated with mutations in many genes, ten of which are now tested by two competing firms in the United States, PGxHealth and GeneDx. Until 2009, PGxHealth was sole provider, based largely on exclusive rights to patents from the University of Utah and other academic institutions. University of Utah patents were initially licensed to DNA Sciences, whose patent rights were acquired by Gennaissance, and then by Clinical Data, Inc., which owns PGxHealth. In 2002, DNA Sciences “cleared the market” by sending cease and desist patent enforcement letters to university and reference laboratories offering LQTS genetic testing. There was no test on the market for a one- to two-year period. From 2005-2008, most LQTS-related patents were controlled by Clinical Data, Inc., and its subsidiary PGxHealth. BioReference Laboratories, Inc., secured countervailing exclusive patent rights starting in 2006, also from the University of Utah, and broke the PGxHealth monopoly in early 2009, creating a duopoly for genetic testing in the United States, and expanding the number of genes for which commercial testing is available from five to ten.