The evolving role of biomarker patents in personalized medicine.
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.
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.
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Kesselheim
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.
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Shiu
D015415:Biomarkers; D006801:Humans; D007603:Jurisprudence; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D057285:Precision Medicine / Q000379:methods; D017149:Private Sector / Q000331:legislation & jurisprudence; D014481:United States
D015415:Biomarkers