无数次:专有数据的困境。

John M Conley, Robert Cook-Deegan, Gabriel Lázaro-Muñoz
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引用次数: 0

摘要

在AMP诉Myriad Genetics, Inc.一案中,最高法院的裁决大大缩小了Myriad Genetics在BRCA基因检测方面的长期垄断,并且在未来几年内,随着其许多仍然有效的专利到期,这种垄断将进一步缩小。但这些发展并没有使该公司默许竞争。相反,它对一些实际和潜在的竞争对手发起了诉讼攻势,起诉他们侵犯了许多未过期的专利,这些专利在最高法院的案件中幸存下来。然而,平行战略可能具有更大的长期意义。在宣布扩大在欧洲的业务时,Myriad强调,它将减少对专利的依赖,更多地依靠其庞大的基因突变和相关健康结果的专有数据库——这一策略也可以在美国使用。作为BRCA基因检测领域以专利为基础的垄断者,Myriad多年来建立了这个数据库,但十多年来一直没有与医学界分享。因此,Myriad有独特的能力来解释患者基因突变对健康的影响,特别是在罕见的“未知意义的变异”的情况下。本文回顾了Myriad专利组合的现状,描述了其正在进行的诉讼攻势,然后分析了其专有数据库策略。文章认为,Myriad的策略虽然在法律上可行,但却削弱了医学研究和卫生政策的重要价值和目标。这篇文章指出了研究和卫生保健社区可能进行反击的几种方式,但承认这将是一场艰难的艰苦战斗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
MYRIAD AFTER MYRIAD: THE PROPRIETARY DATA DILEMMA.

Myriad Genetics' long-time monopoly on BRCA gene testing was significantly narrowed by the Supreme Court's decision in AMP v. Myriad Genetics, Inc., and will be further narrowed in the next few years as many of its still-valid patents expire. But these developments have not caused the company to acquiesce in competition. Instead, it has launched a litigation offensive against a number of actual and potential competitors, suing them for infringement of numerous unexpired patents that survived the Supreme Court case. A parallel strategy may have even greater long-term significance, however. In announcing expanded operations in Europe, Myriad has emphasized that it will rely less on patents and more on its huge proprietary database of genetic mutations and associated health outcomes-a strategy that could be used in the United States as well. Myriad has built that database over its many years as a patent-based monopolist in the BRCA testing field, and has not shared it with the medical community for more than a decade. Consequently, Myriad has a unique ability to interpret the health significance of patients' genetic mutations, particularly in the case of rare "variants of unknown significance." This article reviews the current state of Myriad's patent portfolio, describes its ongoing litigation offensive, and then analyzes its proprietary database strategy. The article argues that Myriad's strategy, while legally feasible, undercuts important values and objectives in medical research and health policy. The article identifies several ways in which the research and health care communities might fight back, but acknowledges that it will be a difficult uphill fight.

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