生物标志物专利在个性化医学中的不断演变的作用。
The evolving role of biomarker patents in personalized medicine.
机构信息
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
出版信息
Clin Pharmacol Ther. 2014 Feb;95(2):127-9. doi: 10.1038/clpt.2013.185.
Patents are commonly granted for the use of biomarkers in making medical decisions. However, the US Supreme Court recently changed the landscape with a unanimous decision that patents cannot cover discoveries of basic correlations in nature, such as those relating biomarkers to particular clinical outcomes. Subsequent court decisions have overturned patents on genetic and other diagnostic methods involving purely mental processes, but processes integrating biomarkers in practical clinical steps can still earn intellectual property protections.
专利通常授予在医疗决策中使用生物标志物的用途。然而，美国最高法院最近通过一项一致裁决改变了这一局面，该裁决认为专利不能涵盖对自然基本相关性的发现，例如将生物标志物与特定临床结果相关联的发现。随后的法院裁决推翻了涉及纯粹心理过程的基因和其他诊断方法的专利，但将生物标志物整合到实际临床步骤中的过程仍可获得知识产权保护。
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