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Clin Pharmacol Ther. 2014 Feb;95(2):127-9. doi: 10.1038/clpt.2013.185.

The evolving role of biomarker patents in personalized medicine.

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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.


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.

[Indexed for MEDLINE]

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