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…)

Bilski’s Impact On Life Science Patents

Today’s guest post was written by our friends at DLA Piper, Richard Mulloy (Partner in the Patent Litigation practic)  and Lisa Haile (Patent Prosecution partner and the co-chair of DLA Piper’s Global Life Sciences sector).

Two significant developments arose out of Bilski regarding life science patent claims.  First, the Supreme Court’s endorsement of the machine-or-transformation test as one tool to analyze claims under 35 U.S.C. §101 provides some guidance to patent applicants and litigants. Second, the Court’s suggestion that the Federal Circuit develop “other limiting criteria” to analyze claims under §101 provides additional flexibility to develop tests more applicable to the life sciences, where the machine-or-transformation test is not particularly appropriate.

The Federal Circuit will have an opportunity to provide additional guidance in two pending cases: Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403, and Classen Immunotherapies, Inc. v. Biogen IDEC, Nos. 2006-1634 and 2006-1649.  The Prometheus and Classen cases were both remanded to the Federal Circuit for additional consideration in light of Bilski.   (more…)

Bilski v. Kappos: Summary And Implications


Written by Andrea M. Augustine (Partner at Foley & Lardner LLP and faculty member for the upcoming PLI Patent Litigation program) and Kevin J. Malaney (Associate at Foley & Lardner LLP)

On June 28, 2010, the U.S. Supreme Court issued its much anticipated opinion in Bilski v. Kappos.  In Bilski, the Court affirmed the judgment of the Court of Appeals for the Federal Circuit, In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), that the claims in question did not qualify for patent protection.  In doing so, the Court unanimously rejected the Federal Circuit’s determination that the “machine-or-transformation” test was the exclusive test for “process” patent eligibility.  But instead of establishing what test should be applied in future cases, the Court left this question open and simply relied on previous Supreme Court case law and the Patent Act to hold Applicants’ claims ineligible for patent protection.  Despite the uncertainty regarding the appropriate test, Bilski does provides some guidance as to what “process” claims are eligible for patent protection.  Because of the open questions that remain, future cases will be closely watched and studied for clarification and application of the Court’s holdings.  In the meantime, observers, advocates, and pundits will review the fine details and history of In re Bilski in search of guidance on the future of business method patents and patent applications. (more…)