With its recent grant of Certiorari in Prometheus Laboratories v. Mayo Collaborative Services, the Supreme Court has again agreed to consider the patent eligibility of diagnostic methods.
Twice before, the Court had granted Certiorari to review this issue and then ducked the issue.
In Lab Corp v. Metabolite Laboratories, the grant of Certiorari was vacated because the issue had not previously been raised in that case. Generally, Lab Corp involved a claimed process for helping to diagnose vitamin deficiencies. It consisted of using any test to measure the level of a specified amino acid in a body fluid and then noticing whether its level is elevated above the norm; if so, a vitamin deficiency was considered to be likely. In a dissent from the decision to vacate the grant, Justice Breyer, joined by two other justices, expressed great doubt as to the eligibility of such diagnostic methods. Regarding the claim at issue, he concluded that the correlation between the amino acid and vitamin deficiency is a “natural phenomenon,” and the description of this natural law at issue in the abstract patent language of a “process” does not render it patentable.
In an earlier stage of Prometheus, the case currently under consideration, the Court remanded the case to the Federal Circuit for that court’s reconsideration of its original decision in view of the Supreme Court’s intervening decision in Bilski v Kappos. Upon reconsideration, the Federal Circuit again concluded that the diagnostic methods at issue did qualify to be patented, this time using the logic laid down by the Supreme Court in Bilski. It is that decision (http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1403.pdf) now to be reviewed pursuant to the Supreme Court’s recent grant of Mayo’s Petition for Certiorari.
In general, Prometheus claimed:
A method of optimizing therapeutic efficacy for treatment of a specific disorder, comprising:
(a) administering a specific type of drug to a patient with that disorder and
(b) determining the level of a specific metabolite of that drug in the patient,
wherein the concentration of that metabolite in the patient’s blood above or below certain levels indicates a need to increase or decrease the amount of said drug subsequently administered to the patient.
In its Petition for Certiorari, Mayo contended that the claims impermissibly preempt all use of a natural phenomena; namely, correlations between drug metabolite levels and the efficacy and toxicity of the drug.
In the Federal Circuit’s second consideration of this case, Judge Lourie, writing for a unanimous panel including (now) Chief Judge Rader and Judge Bryson, commented on the Bilski decision, pointing out that the Supreme Court (1) declined to adopt categorical rules beyond the well-established exceptions from patent eligibility for laws of nature, physical phenomena, and abstract ideas; (2) did not reject the machine-or-transformation test, but rather characterized it as “a useful and important clue” for determining patent eligibility; and (3) established that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Turning to Prometheus’s patents, the Federal Circuit’s decision framed the issue this way: “patent eligibility in this case turns on whether [the] claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use …, or whether the claims are drawn only to a particular application of that phenomenon ….”
The Federal Circuit ultimately held that Prometheus’s method claims do not wholly preempt all uses of the recited correlations; instead, they recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity. In reaching this holding, the Federal Circuit focused on several primary conclusions. First, it concluded that the claims recite specific treatment steps and involve a particular application of natural correlations – the treatment of a specific disease by administering specific drugs and measuring specific metabolites – without preempting all uses of those natural correlations. Second, the Federal Circuit concluded that the treatment steps satisfy the “transformation” prong of the machine-or-transformation test because they transform the human body following the administration of a specific class of drugs and because of the various chemical and physical changes of the drugs’ metabolites that enable their concentrations to be determined. The Federal Circuit’s decision explained that methods of treatment 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 administering step was thus deemed a significant transformative element of the treatment methods, and the determining step was also deemed transformative in view of the manipulation needed to extract metabolites from a bodily sample and determine their concentration.
Despite concluding that Prometheus’s claims are patent eligible, the Federal Circuit commented on the claimed step that involved comparing measured metabolite levels to indicate a need to increase or decrease the level of drug to be administered. Here, the Federal Circuit agreed with the district court that these are mental steps and are thus not patent-eligible per se. Nevertheless, such mental steps did not negate the transformative nature of the prior administering and determining steps.
This issue is now before the Supreme Court to be decided head on. Given Justice Breyer’s dissent in Lab Corp, parties investing in, developing and patenting diagnostic methods look forward to the Supreme Court’s disposition in Prometheus with great interest and justifiable anxiety.