Earlier this week, the Supreme Court heard oral arguments in Mayo v. Prometheus, an important case that deals with many of the same §101 issues as were present in Bilski earlier this year.
Briefly, Prometheus concerns patents on a method for determining optimal dosage levels for drugs used to treat autoimmune diseases. In the claimed process, a particular drug is administered to a patient, and the levels of the drug's metabolites present in the patient are then determined. The process also includes steps wherein presence of a metabolite at certain levels indicates a need to increase or decrease the amount of drug administered in the future.
This case first came to the Federal Circuit after it had decided In re Bilski, but before the Supreme Court issued its decision in Bilski v. Kappos. As a result, the Federal Circuit applied the machine-or-transformation test as the definitive test under §101, and found the claims to be patent-eligible. According to the Federal Circuit, the administering and determining steps were transformative and therefore satisfied the second prong of the test, and as a result the claims did not wholly preempt the use of the correlations between metabolite levels and therapeutic efficacy or toxicity.
After Bilski v. Kappos, the Supreme Court vacated this case and remanded it to the Federal Circuit for reconsideration, giving that court one of its first opportunities to attempt to apply and interpret Bilski. On remand, the Federal Circuit characterized the central question as whether Prometheus's claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use, or whether the claims are only drawn to a particular application of the phenomenon. Mayo, argued, before the Federal Circuit and again this past week before the Supreme Court, that this was the sole controlling standard, and that Bilski stood for the proposition that, while the machine-or-transformation test is a helpful clue, it cannot be outcome-determinative in this analysis. According to Mayo, even if the claims passed the machine-or-transformation test, more analysis, such as a robust preemption analysis, would be necessary to make a subject-matter eligibility determination. Prometheus, on the other hand, argued that the Bilski ruling only meant that patents which did not satisfy the machine-or-transformation test were not necessarily unpatentable, but did not go so far as to say that some patents that do satisfy the test are unpatentable.
The Federal Circuit ultimately agreed with Prometheus. Does this conception of patent-eligible subject matter comport with the result in Bilski? In Bilski, the Court never mentioned the machine-or-transformation test as anything other than a useful tool, and a helpful clue in patent-eligibility analysis. And, as noted by the Federal Circuit, in Benson the Supreme Court stated that "[t]ransformation and reduction of an article to a 'different state or thing' is the clue to the patentability of a process claim that does not include particular machines." So, while the Supreme Court does support the machine-or-transformation test as useful, it has never explicitly ruled that a claim that passes the test is also per se not preemptive. However, by the same token, it has never explicitly found a claim that does pass the test to be unpatentable. So, while this line of reasoning in Prometheus does extend somewhat beyond current Supreme Court precedent, it is at least not inconsistent with that precedent. It will be interesting to see, when the decision in this case finally comes down, whether the Supreme Court is willing to stretch as far as the Federal Circuit.
