Prometheus v. Mayo

Seven amicus briefs were filed in this appeal of a finding by the district court that the claimed method was drawn to non-statutory subject matter. Relying on its Bilski opinion, the Federal Circuit in its opinion discussed the machine-or-transformation test and concluded that the claimed method of treatment was drawn to patent eligible subject matter.

The patents at issue “claim methods that seek to optimize therapeutic efficacy while minimizing toxic side effects,” and include two main steps: administering a drug to a person and determining the levels of the drug’s metabolites in the subject. (p. 2.) The “measured metabolite levels are then compared to pre-determined metabolite levels” to determine whether to adjust them. The court found that the two main steps were transformative and that although the remaining aspects involved only mental steps, this alone did not remove the claims from patent eligible subject matter.

Claims drawn to a fundamental principle are not patent eligible, but those drawn to an application of a fundamental principle are. The court acknowledged that determining “whether a claim is drawn to a fundamental principle or an application of a fundamental principle” is “hardly straightforward.” (p. 8.) It then quoted its “definitive test” from Bilski: “A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” (p. 8.) This machine-or-transformation test can be satisfied for a method claim by showing that a “claim is tied to a particular machine, or by showing that his claim transforms an article.” (p. 8.) In addition, the machine or transformation part of the claim must not be “insignificant extra-solution activity” and must “must impose meaningful limits on the claim’s scope.” (p. 8.) “This transformation must be central to the purpose of the claimed process.”

The court found that the administering and determining steps were transformative. For the administering step, the ”transformation is of the human body following” administration and for the determining step the transformation is “the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined.” (p. 14-15.) Rejecting arguments that the transformations were natural processes, the court stated that methods of treatment “are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” (p. 15.)

Similarly, the court distinguished natural processes from transformations by noting that “quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law. Transformations operate by natural principles. The transformation here, however, is the result of the physical administration of a drug to a subject to transform—i.e., treat—the subject, which is itself not a natural process.” (p. 16.)

The determining step also involved a transformation because “those levels cannot be determined by mere inspection.” Rather, “some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.” (p. 16-17.)

The court distinguished the present case from In re Grams, 888 F.2d 835 (Fed. Cir. 1989), a case which involved “(1) performing a clinical test on individuals and (2) based on the data from that test, determining if an abnormality existed and determining possible causes of any abnormality by using an algorithm.” (p. 18-19.) In that case the process was merely an algorithm combined with a data-gathering step,” unlike here, where “the claims are to transformative methods of treatment, not correlations.” (p. 21.).

Although the court found that the final steps did not meet the machine-or-transformation test, this did not alter the outcome. “A subsequent mental step does not, by itself, negate the transformative nature of prior steps.” (p. 20.)