When I was writing my post on INO Therapeutic’s Petition for Cert. on March 16th, I noticed the cite to the “invitation brief in Hikma Pharmaceuticals USA, Inc. v. Vanda Pharmaceuticals Inc., No. 18-817 (U.S. Dec. 6, 2019)(“the brief”). While this brief concluded that the Supreme Court should not grant cert. in this appeal because the Fed. Cir.’s decision was correct, it contains a rigorous analysis of the Mayo v Prometheus decision. Of course, the S. Ct. did not grant cert. in Vanda or in the later Athena case, which the brief argues might be worthy of review. INO cited the brief as evidence that the Supreme Court’s “reconceptualization” of “traditional limitations on Section 101’s affirmative scope as free-standing atextual ‘exceptions’ has given rise to an array of difficult questions.” US Brief 8. This led me to take a second look at the brief.
The Brief gets right to the heart of the Mayo decision, beginning with a reminder that methods of medical treatment are unquestionably patent eligible, citing to the Hatch-Waxman Act and 35 USC 287(c)(1) and (2)(A)(ii), that protect physicians who may practice the ”patented use of a composition of matter in violation of such patent.” But the brief really gets going when it targets the internal inconsistencies of the Mayo decision:
“Consistent with the settled understanding described below [that the claims were not directed to a new way of using an existing drug], the Court thus appeared to take as its premise that methods of medical treatment are patent-eligible. Nevertheless, …it is arguably unclear how the longstanding and entirely correct rule that method-of-treatment claims are patent eligible can be reconciled with [the] mechanical application of [the Mayo/Alice] two-step framework.”
The brief begins by arguing that the Mayo Court “applied a new and capacious understanding of patent-ineligible ‘laws of nature’”. The brief urges the Court to note that the natural law claimed by the patent involved relationship expressed in “precise mathematical terms ‘between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.’” The brief noted that “that articulation of the natural law is significant in two respects”.
The brief then discusses these “respects”. It notes that the Mayo Court “concluded for the first time that a phenomenon can be a law of nature even if it exists because of, not apart from, human intervention. … The Mayo Court departed from that prior usage [that human-made inventions are not natural laws] by describing as ‘laws of nature’ biological responses of the human body to conditions that arise solely from human intervention.” The brief notes that the administered drugs do not occur in nature and that their administration requires human action. The Mayo Court thus gave undue weight to the fact that the drug is metabolized by “entirely natural processes..”
In the second place, the brief observes:
“the Mayo Court defined the natural law it identified at an extremely high level of specificity…. That highly particularized relationship contrasts starkly with laws of nature the Court had previously identified, such as Newton’s ‘law of gravity’…But if mechanical application of Mayo’s approach leads to the conclusion that the metabolizing of a drug, as in Mayo, is an ‘entirely natural process”—merely illustrating a natural law that ‘exists in principle apart from any human action’—the same would arguable be true of the biological reactions involved in Vanda’s process. And if the precise mathematical correlations in Mayo qualify for this propose as ‘laws of nature’, the same would arguably be true of the highly particularized relationships on which Vanda’s treatment method is premised.” (Although the Mayo decision has been placed in a number of definitional buckets, it is worth noting that it was written as a method of optimizing the treatment of patients afflicted with an autoimmune disorder. Justice Breyer referred to the claims as process claims. On the other hand he also wrote that infringement rested on Mayo’s introduction of diagnostic tests, that embody the claimed invention.)
The brief is also critical of the Mayo Court’s finding that purely conventional steps, such as administering the drug or measuring the metabolites “are normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of that law.” The brief gets to the heart of the matter:
“Thus while the process claimed in Vanda’s patent [genotyping followed by a dosage regimen] concludes with a concrete treatment step [of adjusted drug administration], it is unclear whether that step would render the process patent-eligible under the Court’s reasoning in Mayo, or whether that step would instead be discounted as routine, conventional activity because it is not independently new….Indeed, it is arguably unclear whether even a method of treating disease with a newly created drug would be deemed patent eligible under a mechanical application of Mayo’s two part test.”
So the brief was attempting to sound the alarm that so far has gone unanswered by the S. Ct. INO may not be the best case to remedy all of the confusion wrought by Mayo, but at least the “Question Presented” is much broader in scope that the question posed in Athena’s petition for cert. While the INO question focusses on a method of medical treatment in which some patients are treated and some are not—due to the risk of a specific side effect—the Supreme Court could take this opportunity, hopefully, to affirm that methods of medical treatment are patent eligible.