I hope that some of my loyal readers noticed that my last post on CLS was incomplete, since it did not elaborate on the rationale for the decision(s) arrived at by the majority, either directly or by default.
The first 23 pages of the opinion, written by Judge Lourie, joined by Dyk, Prost, Reyna and Wallace, mostly plods down the well-worn legal trail of Benson, Flook, Diehr, Bilski and now, Mayo v. Prometheus. I read it mostly looking for something new, perhaps a hint of what additional material would render a claim reciting a law of nature patentable.
For example, for some time I have wondered in print what feature in Diehr distinguished the patent-eligible curing process from the patent-ineligible one in Flook. In Parker v. Flook, the Supreme Court held: “If a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory.” Slip op. at 12. This is a much finer filter than one might expect , since the Flook process was drawn to the catalytic chemical conversion of hydrocarbons, but the Court tossed it into the dumpster of “abstract ideas” anyway. Judge Lourie noted that the Supreme Court had started from the posture that the case must be treated as though the abstract principle or mathematical formula were well known. If so, then the claim must contain “some other inventive concept in its application.”
The problem is that the rubber curing process at issue in Diehr that used the Arrhenius equation to determine when to open the mold seems unremarkable . Judge Lourie notes: “In contrast [to Flook], in Diehr, the claimed process incorporating [the equation] also called for steps including ‘constantly measuring the actual temperature inside the mold,’ a step that was said to be new in the art.” Judge Lourie’s doubt that this step rose to the level of another inventive concept is palpable.
Discussing Mayo, Judge Lourie at least makes it clear that the claimed regimen fell under the exclusion of a law of nature, not an abstract idea. Judge Lourie states that the Supreme Court found the administering or the measuring/determining steps recited in the claim to be “insufficiently limiting or inventive to confer patent eligibility. Because these additional steps were mere ‘routine, conventional activity previously engaged in by scientists who work in the field,’” the Court concluded that they did not transform the law of nature into a patent-eligible application of that law.
This does not directly inform us practitioners about how to claim a newly discovered “If A, then B” relationship between a biomarker and a diagnostic conclusion, but it gives us a hint. For a diagnostic claim to be patentable, at the least the relationship between the marker and the disorder, disease, etc. must be a discovery first made by the inventor. I know that this is true for 102/103 patentability, but what about for s. 101 eligibility? The steps recited in such a claim at least would not be ones “previously engaged in by scientists who work in the field.” Is the novelty and unobviousness of the diagnosis per se sufficient to transform the law of nature into patent-eligible application of that law?
Let’s hope that the Supreme Court treated Prometheus’ add-on patent with disdain because it felt the claims were drawn to an “old use” (measuring levels of known metabolites) of an “old compound” (AZA was well-known to treat autoimmune disorders). Judge Lourie goes on to recognize the “abiding concern that patents should not be allowed to preempt the fundamental tools of discovery.” If the tool of discovery is the measurement of known metabolite levels of a known drug, perhaps this analysis has some legs. See also Slip op. at 20-21, where Judge Lourie suggests that the steps added in the Prometheus claims had been “previously engaged in by researchers in the field.” Judge Lourie reminds us that this language about “conventional, or routine” steps relates to a preemption analysis and s. 101, not to ss. 101/103 analyses. Slip op. at 22.
But the key question, at least in the diagnostics arena, remains: is a diagnosis, never made before, though based on a natural phenomenon, a “substantive limitation” that adds “significantly more” to the basic principle; or is the diagnosis simply a discredited attempt to “limit the use of the [natural principle] to a particular technological environment” or to add “insignificant post-solution activity”? Judge Lourie goes further and even attempts to define the elusive “inventive concept”: “[I]n the s. 101 context [it] refers to a genuine human contribution to the claimed subject matter.” Slip op. at 19-20. If a new method of diagnosis is not a “particular, useful application of the principle” at issue, or “a product of human ingenuity,” what is? Clearly, this decision is not going to answer that question, but it is a question in which we all have a chance to be on the right side of history.