Prometheus V. Mayo – Fed. Cir: “We Got It Right The First Time.”

Today, following the vacation and remand of its earlier decision by the Supreme Court post-Bilski, the Federal Circuit again reaffirmed its reversal of the District Court (copy at the end of this post) and held:

“The asserted method claims satisfy the preemption test as well as the transformation prong of the machine-or-transformation test [for patentable subject matter]…..In other words, when asked the critical question, ‘What did the applicant invent?’ Grams, 88 F.2d at 839, the answer is a series of transformative steps that optimize efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.”

The Federal Circuit held that either one of the recited steps of “administering”  a drug that provides 6-TG to a subject or “determining” the levels of the drug’s metabolites in a subject were sufficiently transformative to meet the M or T 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.”

This led the Court to find that claim 46 of the ‘623 patent, which only recites a determining step, also meets the M or T test (and does not bode well for the plaintiffs in Myriad). The Court also reaffirmed that the administering and determining steps were not merely data gathering steps, but were central to the claimed method of optimized therapeutic efficacy.  The Court pointedly, in fn. 2, declined to give weight to the “Metabolite Labs. dissent,” (548 U.S.124), in which Justices Breyer, Souter and Stevens would have found claims to an assay for cobalamin deficiency comprising determining the level of a marker in a fluid of a subject, and comparing it to a benchmark normal,  patent-ineligible as involving “natural correlations and data-gathering steps.”

While the Court agreed that the steps involving comparing the determined level to a benchmark level and concluding that that a need existed to increase or decrease the amount of drug administered (the “warning steps”) were mental steps, and not per se patentable, the Court warned against partitioning a claim into patent-eligible and non-patent eligible steps, and using the presence of patent ineligible steps to exclude the entire claim from further evaluation: “Although the wherein clauses describe the mental processes used to determine the need to change the dosage levels of the drugs, each asserted claims as a whole is drawn to patentable subject matter”.

The Court also found that the claims are not simply directed to a natural phenomenon and specifically held that they do not wholly pre-empt the use of natural phenomena, but rather are drawn to a particular application of naturally occurring correlations. The Court specifically noted that the claims are not an attempt to patent an algorithm, as were the claims in Grams.  The Court cited its opinion in Bilski (545 F.3d at 958): “After all, even though a fundamental principle is not  patent eligible, processes incorporating a fundamental principle may be patent –eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under s. 101.”

While this decision will probably get on the express train to the Supreme Court, let’s go ahead and “fix” Classen in the meantime.


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