The Mayo Clinic has filed a petition for certiorari to the Supreme Court asking them to review the Federal Circuit’s decision in Prometheus Labs., Inc. v. Mayo Collaborative Services.
In Prometheus, the Federal Circuit reversed a district court determination that method claims directed to methods for calibrating the proper dosage of thiopurine drugs by measurement of two metabolites were invalid as not directed to patentable subject matter. The Federal Circuit analyzed the claims of the case under the Bilski test and found that they met the transformation prong. The court did use rather broad language that seems to indicate that all claims that recite steps that include admistration of a drug contain patentable subject matter. Further, determining metabolite levels requires a transformation of the substance being analyzed.
Mayo’s petition presents the following question to the Supreme Court:
Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations.
Mayo argues that the Federal Circuit’s new Machine-or-Transformation Test as the sole determinant of patentable subject matter conflicts with Supreme Court precedent. Mayo argues that the Supreme Court has held that when a patent claim preempts all uses of a natural phenomenon, the claim is invalid.
Mayo argues that Prometheus’s patent claims are so broad that they cover a physician’s mental determinations when evaluating a patient who has been given the drug. The claims cover the recognition of a correlation between metabolite level and patient condition following administration of a drug and thus preempt all such recognized correlations. These correlations are natural phenomena. Mayo argues that the simple recognition of such is insufficient to warrant a patent.
Mayo also spends a great deal of time arguing that this case will resolve questions that were left open when the Supreme Court dismissed the LabCorp case after agreeing to hear it.
Will the Supreme Court Hear Two Patentable Subject Matter Cases?
Given that argument in Bilski is set for November 9, it seems unlikely that the Court would hear another subject matter case right on its heels. It is true that the Court has done so in the past, deciding Chakrabarty and Diehr in consecutive terms, and deciding several prosecution history estoppel cases, Warner-Jenkinson and Festo, within a few terms of each other.
In this case, however, it seems more likely that the Court will hold the cert. petition until after it decides Bilski. It seems likely that the Court will change the Federal Circuit’s exclusive Machine-or-Transformation Test in some way (which way is another question). Thus, I would predict that the Court will GVR (grant, vacate, remand) this case after Bilski is decided. This means that the Federal Circuit will have to reconsider the Prometheus case in light of whatever new rule on the issue that the Supreme Court expounds in Bilski.