对不起你问了吗? 梅奥,万亿,以及关于专利资格的战斗
Robert Cook-Deegan1, Janis Geary1, Kara Hapke1
1Consortium on Science, Policy & Outcomes, Arizona State University.
Journal of law and the biosciences
|June 6, 2024
概括
拟议的立法可以恢复遗传检测方法的专利资格,影响分子诊断领域的创新和监管. 本文分析了废除最高法院关于专利法的裁决的潜在后果.
科学领域:
- 知识产权法 知识产权法 知识产权法
- 生物技术是生物技术.
- 遗传学 遗传学是一种遗传学.
背景情况:
- 最高法院在梅奥诉普罗米修斯 (2012) 和密里亚德诉分子病理学协会 (2013) 的裁决中,对基于自然规律和自然发生的DNA序列的方法的专利无效.
- 这些裁决与基因测试的重大转变相吻合,包括多基因测序的进步,更改的补偿政策以及食品和药物管理局 (FDA) 拟议的法规.
- 分子诊断的风险资本资金减少是一个复杂的问题,受专利法以外的因素的影响,例如Theranos案和开放访问数据的增长.
研究的目的:
- 分析拟议立法的潜在后果,旨在废除梅奥和密里亚德最高法院关于遗传测试专利资格的决定.
- 探索恢复专利资格如何影响分子诊断,创新和监管领域.
- 检查专利法,技术进步和基因测试行业市场动态之间的相互作用.
主要方法:
- 审查具有里程碑意义的最高法院案件 (梅奥诉普罗米修斯,2012年;Myriad诉分子病理学协会,2013年) 以及它们对专利法的影响.
- 对基因检测技术,补偿和监管的同时发展的分析.
- 检查影响分子诊断领域风险资本投资的经济因素.
主要成果:
- 梅奥和密里亚德的决定显著改变了基因测试方法和相关技术的可专利性.
- 技术进步 (例如,测序成本下降了1万倍) 和市场变化 (例如,付款人实践的改变,FDA监管前景) 重塑了基因测试领域.
- 恢复专利资格可能会重新对其他可专利性学说 (如显而易见性和启用性) 施加压力,从而可能使创新复杂化.
结论:
- 拟议的废除梅奥和密里亚德决定的立法可能对分子诊断行业产生深远的影响.
- 法律,技术和经济因素的复杂相互作用使得将专利资格对风险投资资金的确切影响隔离起来具有挑战性.
- 任何立法变化都必须考虑基因测试的更广泛的生态系统,包括监管框架和共享知识资源的可用性.
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