The impact of Myriad and Mayo: Will advancements in the biological sciences be spurred or disincentivized? (or was biotech patenting not complicated enough?)

Abstract

For years, purified and isolated naturally occurring biological substances of great medical importance—including genes—have been the subject of U.S. patents. Similarly, methods in which the detection of a biological substance (e.g., in a blood sample) dictates subsequent actions, as in disease diagnostics and treatment, have long enjoyed patent protection. However, two recent Supreme Court cases, Association for Molecular Pathology v. Myriad Genetics, Inc. (133 S. Ct. 2107) (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (132 S. Ct. 1289) (2012), have shaken up the status quo of biotech patenting. The highest court in our land unanimously agreed with patent challengers that much of what we took for granted as patentable subjectmatter is not, as amatter of law, eligible for patenting after all. This review discusses the Myriad and Mayo cases, their impact on which biologybased innovationswemayormay not continue to patent, andwhether the altered status quo is benignly corrective or gravely disruptive. Is what happened here a good thing or not?