[originally posted 4/2/2012]
By Douglas "Doug" D. Salyers, James Moore Bollinger, Robert A. Angle, Daniel A. Ladow and George B. Snyder
The Supreme Court's recent holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc. [enhanced version available to lexis.com subscribers], invalidating patent claims involving a "law of nature" not eligible for patent protection, may signal a course change in its jurisprudence on patent eligibility issues. Clearly, there has been a shift away from the "machine or transformation" formulation (a process is patent-eligible if tied to a particular machine or apparatus, or transformative of a particular article into a different thing or state), which was ostensibly recognized as a "safe harbor" in Bilski v. Kappos [enhanced version available to lexis.com subscribers]. Eclipsing that formulation is a more basic test - i.e., whether there are elements in the claim beyond the "law of nature" that themselves are sufficiently innovative to qualify for patent consideration.
Prometheus is directed to a detailed exploration of where the dividing line lies between patent-eligible and patent-ineligible subject matter in the life sciences field. In the Court's own words:
The case before us . . . concerns patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. We must determine whether the claimed processes have transformed these unpatentable natural laws.
The facts of Prometheus were fairly straightforward. The patent claims in issue boiled down to three steps, namely, (i) administering a thiopurine drug to a human that causes the production of certain metabolites in the blood stream, (ii) determining the concentration of those metabolites in the blood stream, and (iii) in effect, taking note of whether the metabolite concentration "indicates a need to increase [or decrease] the amount of said drug subsequently administered". The Court started from the premise that "While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation to a particular person, the relation itself exists in principle apart from any human action . . . [and] is a consequence of the ways in which thiopurine compounds are metabolized by the body - entirely natural processes." In that light, the Court identified the key to deciding if subject matter is patent-eligible as being:
whether ... the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws [presumably treating the administering step as part and parcel of the manifest natural law and not an application of it].
The crucial inquiry therefore was whether, beyond just a statement of natural law, a patent claim also includes one or more additional steps that are themselves innovative. Put another way, the Court asked whether apart from the "natural law" in question the additional step or steps recited in the claim, viewed either individually or collectively, were anything more than "purely conventional or obvious." Because it found that "the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations," the Court concluded:
[T]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Thus, the claims were deemed invalid. Pursuant to this holding, the perceived "safe harbor" provision of Bilski - the idea that a patentee's conforming to the so-called "machine or transformation" formulation confers patent-eligibility on a claimed invention - was vitiated or at least subordinated:
[I]n stating that the "machine-or-transformation" test is an "important and useful clue" to patentability, we have neither said nor implied that the test trumps the "law of nature" exclusion.
And indeed, in Prometheus the Court specifically held that the patents in suit were invalid without regard to whether they satisfied the machine-or-transformation test. Rather, the "bottom line" was:
A process that focuses upon the use of a natural law 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.
That this implicates notions of novelty and nonobviousness is irrelevant. The Court ruled that other sections of the Patent Statute - e.g., Sections 102, 103 and 112 - do not reliably disqualify natural law from patentability, such that Section 101 is the best choice even if the analysis overlaps other Sections of the Statute
Ultimately, whether the invention at issue is a diagnostics or other life sciences development, or a software-based business method, the only sure path to patent-eligibility is to incorporate one or more elements (steps) in addition to a recitation of the involved "natural law." These elements or steps must be significant and, individually or in some combination, neither conventional nor routine, but novel and nonobvious. The "machine-or-transformation" standard, seemingly endorsed in Bilski, is not a panacea after all.
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