Biomarkers Unbound - The Supreme Court's Ruling on Diagnostic-Test Patents.

Source

From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (A.S.K.); and the Center for Neuroscience and Society, Alzheimer's Disease Center, Departments of Medicine and Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia (J.K.).

Abstract

In recent decades, biomarkers have become essential in diagnosing disease and assessing patients' responses to therapy. The increasing quantitative rigor and efficiency of these tests have led to the possibility of "personalized medicine." Despite such progress, the way in which a physician uses biomarkers recapitulates an enduring practice of medicine: measure the patient, think about the result, and make a decision. With these advancements, U.S. researchers and companies have also claimed patents on their biomarker discoveries. These patents have generated controversy over whether they hinder the practice of medicine and research by covering not just the actual test but also . . .