Unlike Michael Risch (who richly deserved the multiple shout-outs from the Supreme Court), I did not get a citation (even to my brief) in the Mayo v. Prometheus case, having argued for the major points that the Court adopted (with some important differences that I’ll discuss below). Nevertheless, I’m celebrating, and all the more because Michael’s prediction came true (rather than my prediction of an 8-1 affirmance).
Along with Michael, I was pleased that the Court has clearly dealt a serious blow to the “machine-or-transformation” test of eligibility suggested by the Federal Circuit as an exclusive test in Bilski. (I have argued that it is neither a necessary nor a sufficient test, but only the result of applying a different test to cases before the information age.) The claims at issue in Prometheus was held invalid. It contemplated physical administration of physical entities (synthetic drugs) for the purpose of (chemically) transforming physical entities (humans). This “method of treatment” claim (applying a discovered correlation between blood levels of synthetic drug metabolites and safety and efficacy) recited specific structures (the drugs, which were not “machines” but “compositions of matter”) and the claim as a whole achieved physical transformations.
I also was pleased that the Court extended its Bilski (really Flook) approach to the “law of nature” category of excluded subject matter. Because the case did not address an “abstract idea,” the Court did not base its actual holding on “abstractness” (or vague breadth of the claim) but rather on the lack of any meaningful addition to the “law of nature” by adding “conventional or obvious” “[pre]-solution activity” to the claim steps or by “limit[ing] the use of the [discovery] to a particular technological environment.” In doing so, the Court reinforced that a physical application of a law of nature is not enough — “a process that focuses upon the use of a natural law [to be eligible must] also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”
Specifically, the claim at issue was found not to have “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Since such drafting efforts will always limit the scope of application of the law of nature, the Court here suggests that something more is going on than just a concern for overbreadth (the point that Michael “backtracked” to in his terrific article with Mark Lemley, Ted Sichelman, and Polk Wagner — and to which my own article responds). The Court appears to treat the claims as “determine and infer” claims, notwithstanding the prior physical administration step, and to hold that such claims add nothing to the natural discovery. (Here, the Court could have usefully cited to Kevin Collins’ brief in Bilski.) “Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float. What else is there in the claims before us? The process that each claim recites tells doctors interested in the subject about the correlations that the researchers discovered. And since they are steps that must be taken in order to apply the laws in question, the effect is simply to tell doctors to apply the law somehow when treating their patients.” In reaching this result, Justice Breyer read the “administering” a drug limitation to be nothing more than an identification of the relevant “audience” to hear of the discovered correlation, or as an instruction to do what was already being done in the world. Justice Breyer specifically addressed the argument that the combination of steps was the invention, but apparently rejected it based on the necessity of using the steps in any practical application. “[T]o consider the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately…. Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.” Of course, “administering a drug” does amount to more than an instruction to do or communication of information to an audience that may already do so, but Justice Breyer treats this as insignificant (because conventional to do so).
Given the Court’s approach, Michael cuts to the heart of the matter — the decision effectively holds that “a key way to tell whether a claim is unpatentable subject matter is to see how novel and nonobvious it is in its application of the natural principle.” And that is precisely what I argued to the Court (substituting “creativity” for “nonobviousness”) in the brief that the Court did not cite. From the Summary of Argument: “Consistent with the Constitution, the Patent Act since 1790 has been construed to require that there be creativity in the application of any scientific, natural, or abstract discovery in order for a patent eligible ‘invention’ to exist.” Even as an academic, I can say it’s better to win than to be cited. But like Michael, I really would have liked both. And had the Court cited my brief, it might have gone further to supply a theory of sufficient creativity for determining significance (or conventionality) of limitations along the lines that I had also suggested (based on the case law) — “analogousness” of the claimed process to the discovery (that must be treated for eligibility as if it were prior art).
Unfortunately, the Court’s decision will perpetuate confusion. Having adopted a creativity requirement (i.e., non-conventional limitations) for when an invention applying an excluded law of nature is eligible, the Court then sought to justify its new requirement by reverting to overbreadth concerns. By finding the claim limitations (that also limit the scope of application of the discovery) to be insignificant, the Court indicated that the claim was effectively as broad as the discovery itself. (Michael makes the point that this was therefore an easy case, although I don’t agree on this point, without himself accepting that the limitations were in fact insignificant.) The Court then justifies the exclusion for laws of nature on “a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.”
But there is no necessary reason why this concern should be limited to claims that effectively cover the same scope of application as the discovery. More limited, uncreative claims applying an ineligible discovery may also inhibit further discovery, including future use of a law of nature, without conveying any meaningful public benefit. It is either the creativity of the application of the law of nature alone that should justify the claim’s eligibility (which I have argued was the rule adopted in Dolbear, the famous telephone case, which held that a sufficiently creative invention is eligible whatever its scope), or some comparison between the creativity and the scope of exclusion that justifies eligibility (which Michael believes is a question best left to Section 112 criteria).
The Court reinforces reliance on breadth concerns in one phrase in the opinion, qualifying its reliance on the “conventional” nature of the additional “steps” by adding the phrase that the steps are (must be?) “specified at a high level of generality.” Presumably, only such highly general limitations can make the claim appear to be (effectively) as broad as the law of nature it applies. This reinforces that Court’s apparent (sole?) concern for eligibility is the scope of the exclusions for laws of nature (and similarly broad applications), rather than the (lack of) creativity of the applications. But why should a conventional step (that is not creative in combination) convey eligibility merely because it has a narrower scope than an equally conventional (and uncreative) but broader step — and particularly if the Court has rejected artful claim drafting as a means to avoid the law of nature exclusion? In taking this approach, the Court implicitly rejected the argument (that I made in my brief) that the public domain of applications of a natural or abstract discovery should not be constricted piecemeal by many narrow (but uncreative) claimed applications, just as it should not be constricted wholesale by one broad (but uncreative) claim having highly general limits.
In sum, if subsequent courts (and the PTO) pay attention to this phrase, Michael may be relieved to find that the Court will have rendered ineligible only claims that contain both highly general and uncreative limitations applying excluded discoveries (or “easy cases” that will rarely arise). But the Court has simultaneously invited continuous assessment of the conventionality of each limitation before determining whether the scope of the claim should be considered effectively identical to that of the discovery itself. And in doing so, it will be hard to limit the effects of Prometheus to such cases.