Barclay Damon
Barclay Damon

Legal Alert

Satisfaction of the Machine-or-Transformation Test Necessarily Establishes Satisfaction of the Statutory Eligibility Requirements for Processes under 35 U.S.C. § 101

In an early application of the Supreme Court’s decision in Bilski v. Kappos concerning the determination of patent eligibility of a process under 35 U.S.C. § 101, the Federal Circuit, in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, found eligibility for patent claims drawn to methods of performing clinical tests on individuals. More broadly, the Federal Circuit reinforced its precedent that, while the reverse is not necessarily true according to the Supreme Court’s decision in Bilski, satisfaction of the machine-or-transformation test necessarily establishes satisfaction of the statutory eligibility requirements for processes under 35 U.S.C. § 101.

In 2002, Prometheus Laboratories, Inc. (“Prometheus”) began marketing a patented PRO-PredictRx® metabolite test configured to determine concentration of thiopurine drugs used to treat certain autoimmune diseases. When Mayo Collaborative Services and Mayo Clinic Rochester (collectively, “Mayo Clinic”) stopped purchasing Prometheus’s test in 2004, and began using and selling its own test, Prometheus asserted several of the metabolite test patents against Mayo Clinic in the U.S. District Court for the Southern District of California.

The relevant Prometheus patents generally claim methods of administering certain drugs to a subject, determining the level of the drug in the subject, and indicating a need to increase or decrease the amount of administered drug depending on a correlation of the determined level. In 2008, the district court granted Mayo Clinic’s summary judgment motion and invalidated the asserted patents finding the claims drawn to ineligible subject matter under 35 U.S.C. § 101. Specifically, the district court found the administering and determining steps were necessary data gathering steps for any subsequent use of the concentration data. Further, the subsequent use of the data in the indicating step was purely mental as no change in dosage was required based on the correlation results. Moreover, the data acquired in the determining step was found to be the result of a natural body process, based on observations of the toxicity of naturally produced metabolites. Accordingly, the claims were held to be drawn to natural phenomena which have long been held to be outside the scope of patent eligible subject matter under 35 U.S.C. § 101.

In the intervening time, prior to hearing Prometheus’s appeal, the Federal Circuit decided In re Bilski, and held that the “machine-or-transformation” test was the definitive test for determining whether a process is patentable subject matter. Relying on its recent precedent, the Federal Circuit reversed the district court holding that the administering and determining steps of the asserted independent claims were transformative.

Following the Federal Circuit’s reversal, the Supreme Court decided, in the appeal of In re Bilski, that the machine-or-transformation test was not the sole, definitive test for determining patent eligibility of a process under 35 U.S.C. § 101, but that the test provided “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.” In light of this decision, the Supreme Court granted Mayo Clinic’s petition for certiorari, vacated the Federal Circuit’s reversal of the district court, and remanded the case to the Federal Circuit for reconsideration under this new precedent.

However, on remand, the Federal Circuit maintained its earlier holding again finding that the human body is transformed by both the administration of the specific class of drugs and the determining of the metabolite concentration data. In a broad holding, the Federal Circuit found that “[t]he asserted claims are in effect claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” The Federal Circuit explained that the transformation of the human body, following the administration of the specific class of drugs, includes the various chemical and physical changes of the metabolites that enable the determining of metabolite concentration data. Further, the claimed determining step requires the extraction of metabolites from a bodily sample which thereby transforms the sample such that it is no longer human blood or tissue. Accordingly, the Federal Circuit found the transformative steps central to the claims, not merely insignificant extra-solution activity, and part of a therapeutic treatment protocol resulting in transformative clinical tests and therefore patent eligible subject matter under long-standing precedent reaffirmed by the Supreme Court.

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