The Federal Circuit Court of Appeals has confirmed its earlier decision, rendered before Bilski v. Kappos, 130 S. Ct. 3218 (2010), was decided, and ruled that methods for determining the optimal dosage of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases recite patentable subject matter under § 101. Prometheus Labs. Inc. v. Mayo Collaborative Servs., 2008-1403 (Fed. Cir., decided December 17, 2010). The court initially upheld the patent claims under the machine-or-transformation test, finding that “the ‘administering’ and ‘determining’ steps were transformative and not merely data-gathering steps under the second prong of the test.”
According to the Federal Circuit, Bilski rejected “the machine-or-transformation test as the sole, definitive test for determining patent eligibility of a process under § 101. . . . Instead, the Court declined to adopt any categorical rules outside the well-established exceptions for laws of nature, physical phenomena, and abstract ideas.” The U.S. Supreme Court did not reject the machine-or-transformation test outright, instead characterizing it as “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes.” The Court vacated the Federal Circuit’s ruling upholding the Prometheus Laboratories patent, and remanded for consideration in light of Bilski.
On remand, Prometheus argued that “its asserted claims involve a particular transformation of a patient’s body and bodily sample and use particular machines to determine metabolite concentrations in a bodily sample,” thus taking its claims beyond abstraction and involving “an application of a law of nature, not the law itself.” The Mayo Clinic, which sought to use its own metabolite measuring tests, argued that the claims “are invalid because they preempt all practical use of naturally occurring correlations between metabolite levels and drug efficacy.”
The court determined that (i) “the method claims recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations”; and (ii) “the treatment methods claimed in Prometheus’s patents in suit satisfy the transformation prong of the machine-or-transformation test. . . . The transformation is of the human body and of its components following the administration of a specific class of drugs and the various chemical and physical changes of the drugs’ metabolites that enable their concentrations to be determined.”