Federal Circuit Reaffirms Patent Eligibility of Personalized Medicine and Diagnostic Method Claims

Today’s guest post was written by our friends at Foley Lardner, Courtenay C. Brinckerhoff and Antoinette F. Konski.

Last Friday, in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403 (Fed. Cir. 2010), the Federal Circuit affirmed that personalized medicine and medical diagnostic claims are not per se unpatentable for claiming natural phenomena. The Court’s opinion provides guidance on the post-Bilski application of patent-eligibility requirements to claims that define the relationship between a treatment or drug regimen to the presence or absence of a patient-specific clinical marker (in this case, a metabolite of the administered drug).

The patent-eligibility of such claims has been in question since the Supreme Court’s dismissal of the grant of certiorari in Laboratory Corp. of American Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006). Supreme Court Justice Breyer dissented from the dismissal and wrote a non-binding opinion that “detecting” and “correlating” claims were not patent-eligible. More recently, the Supreme Court decision to vacate and remand the Federal Circuit’s 2009 Prometheus decision in view of its decision in Bilski v. Kappos, 130 S.Ct. 3218 (2010), fueled speculation that the patent-eligibility of such methods might not survive scrutiny under Bilski. (more…)