[authors: Courtenay C. Brinckerhoff, Jeanne M. Gills, Stephen B. Maebius, Kristel Schorr]
On March 20, 2012, in Mayo Collaborative Services et al. v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012), the Supreme Court held that claims directed to methods of optimizing the dose of specific drugs used in the treatment of specific conditions are invalid under 35 U.S.C. § 101 because they impermissibly claim laws of nature. The Court’s decision reversed the Federal Circuit, which had twice upheld the validity of the claims at issue. Specifically, the Court not only found the claimed methods unpatentable, but also viewed as unpatentable the three additional steps recited in the methods because they were insufficient to transform the nature of the claims. While the opinion provides limited guidance on how to distinguish unpatentable claims reciting laws of natures from patent-eligible claims directed to specific applications of laws of nature, it does make clear that patenting personalized medicine methods will require fact-specific, case-by-case strategies. The full Supreme Court decision is available online.