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抱歉,你问了?以及关于专利适格性的争论。

Sorry you asked? , and the battles over patent-eligibility.

作者信息

Cook-Deegan Robert, Geary Janis, Hapke Kara, Skvarkova Zuzana, Filipek Marina, Leaver Jillian

机构信息

Consortium on Science, Policy & Outcomes, Arizona State University.

出版信息

J Law Biosci. 2024 Jun 4;11(1):lsae010. doi: 10.1093/jlb/lsae010. eCollection 2024 Jan-Jun.

Abstract

Genetic testing for inherited cancer risk changed dramatically when the US Supreme Court handed down unanimous rulings in (2012) and (2013). Those decisions struck down claims to methods based on 'laws of nature' () and DNA molecules corresponding to sequences found in nature (). Senators Thom Tillis (R-NC) and Christopher Coons (D-DE) introduced legislation that would abrogate those decisions and specify narrow statutory exclusions to patent-eligibility in §101 of the US Patent Act. What would be the consequences of doing so? The Supreme Court decisions coincided with changes in how genetic tests were performed, reimbursed and regulated. Multi-gene sequencing supplanted oligo-gene testing as the cost of sequencing dropped 10,000-fold. Payers dramatically changed reimbursement practices. Food and Drug Administration regulation was proposed and remains in prospect. Databases for clinical interpretation made data freely available, augmenting a knowledge commons. The spectacular implosion of Theranos tempered investment in molecular diagnostics. These factors all complicate explanations of why venture capital funding for molecular diagnostics dropped relative to other sectors. Restoring patent-eligibility would put renewed pressure on other patent doctrines, such as obviousness, enablement and written description, that were not raised in the Supreme Court cases.

摘要

当美国最高法院在2012年和2013年做出一致裁决时,遗传性癌症风险的基因检测发生了巨大变化。这些裁决驳回了基于“自然法则”以及与自然界中发现的序列相对应的DNA分子的方法专利主张。参议员汤姆·蒂利斯(北卡罗来纳州共和党人)和克里斯托弗·库恩斯(特拉华州民主党人)提出了一项立法,该立法将废除这些裁决,并明确规定美国专利法第101条中专利适格性的狭义法定排除范围。这样做会有什么后果呢?最高法院的裁决与基因检测的执行、报销和监管方式的变化同时发生。随着测序成本下降了1万倍,多基因测序取代了寡基因检测。支付方大幅改变了报销做法。美国食品药品监督管理局提出了监管措施,且仍在推进中。用于临床解释的数据库使数据可免费获取,扩大了知识共享范围。Theranos公司的 spectacular implosion(原文此处拼写有误,推测可能是spectacular implosion,意为“惊人的崩溃”)削弱了对分子诊断的投资。所有这些因素都使得解释为什么分子诊断的风险投资资金相对于其他行业下降变得更加复杂。恢复专利适格性将给其他专利原则,如显而易见性、实施性和书面描述,带来新的压力,而这些原则在最高法院的案件中并未涉及。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3fd/11150977/f8f2f23dbd46/lsae010f1.jpg

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