Prometheus Bound: Supreme Court Muddles the Meaning of Patentable Subject Matter ...Again

April 2012

Patentable Subject Matter in the U.S.

The nominal scope of patentable subject matter is defined in Section 101 of the Patent Act, which states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor….” 35 U.S.C. § 101.

Manifestly, Section 101’s language is sweeping. It is also not very helpful in any exercise to distinguish between statutory and non-statutory subject matter in the post-industrial age. Even the definitions of the preceding Section 100 add little flesh to these meager bones, specifying, somewhat circularly, that a process is a “process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.” 35 U.S.C. § 100 (emphasis added). Prior case law has rounded out the meaning of Section 101 by exclusion, identifying “laws of nature, natural phenomena, [and] abstract ideas” as categories of unpatentable subject matter. See Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Before the age of business methods, the most prevalent obstacles to patentability were defined by Sections 102 (anticipation) and 103 (obviousness). As inventions have become less tethered to physical structure, however, there has been a renewed focus on the scope and application of Section 101. Last month, the Supreme Court tried once again to define the scope of patentable subject matter. The case, Mayo v. Prometheus, 566 U.S. (2012), was aptly named. For just like the eponymous Titan in Aeschylus’s play, Prometheus was punished for “stealing fire” in the form of the “natural laws” claimed by its asserted patents.

Bilski v. Kappos: A Transformation in the Analysis

The Court last waded into the murky waters of patentable subject matter just two years ago in Bilski v. Kappos, 130 S.Ct. 3218 (2010). Bilski presented the Court with the question of whether claims directed to a business method “for buyers and sellers of commodities in the energy market to hedge against the risk of price changes” comprehended patentable subject matter. It also required the Court to consider whether a Section 101 analysis could be exclusively conducted with the so-called “machine or transformation” test enunciated by the Federal Circuit at the appellate level. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). Under this test, a process must either be tied to a particular machine or apparatus or must transform a particular article into a different state or thing.

Though finding that Section 101 does not categorically exclude claims to business methods, the Court deemed Bilski’s claims to fall in line with its precedent disallowing the patentability of inventions drawn to “abstract ideas”. In the Court’s view, “[a]llowing petitioners to patent risk hedging would pre-empt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.” In the process of reaching this conclusion, the Court rejected exclusive application of the “machine or transformation test,” relegating it instead to the role of “a useful and important clue, an investigative tool, for deciding whether some claimed inventions are processes under Section 101.”

Mayo v. Prometheus: Stealing Fire

Prometheus sued Mayo on two patents, U.S. Pat. 6,355,623 and U.S. Pat. 6,680,302. The following claim from the 623 patent is exemplary:

“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”

Mayo convinced the district court on summary judgment that Prometheus’ patents claimed unpatentable subject matter under Section 101. Prometheus appealed and the Federal Circuit reversed, finding that the claims satisfied the “machine or transformation test” it articulated in In re Bilski. On Mayo’s petition for certiorari, the Supreme
Court vacated and remanded in light of the Court’s intervening decision in Bilski v. Kappos. On remand, the Federal Circuit again found the claims to satisfy the “machine or transformation” test -- even if that test now offered only “a useful and important clue” as to the existence of patentable subject matter -- noting that the claims comprehend “the transformation of the human body and of its components following administration of a specific class of drugs.” Consistent with the statements of Supreme Court precedent, the appellate court also noted that the claims do “not wholly preempt all uses of the cited correlations,” but instead “recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity.” Mayo again petitioned the Supreme Court.

As its earlier remand foretold, the Supreme Court punished Prometheus for “stealing fire,” holding that the claims were indeed directed to unpatentable subject matter:

“Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm…While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.” (emphasis added.)

Why Are Prometheus’ Patent Claims Unpatentable?

The Court answered this question most directly by addressing the language of the exemplary claim and, more particularly, what it failed, in the Court’s view, to add to the putative natural law:

“First, the ‘administering’ step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs. That audience is a pre-existing audience; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims.”

“Second, the ‘wherein’ clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient....”

“Third, the ‘determining’ step tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use...Thus, this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field.”

“The upshot” of the foregoing, the Court concluded, “is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of wellunderstood, routine, conventional activity already engaged in by the scientific community...For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”

What Is a “Law of Nature”?

The closest the Court comes to articulating why Prometheus’ claims comprehend a “natural law” is to state that “[t]he relation [‘between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm,” is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.” (emphasis added).

Demise of the “Machine or Transformation” Test?

Relying on the Court’s own language in Bilski v. Kappos that the “machine or transformation” test is an “important and useful clue” to patentability, the Federal Circuit concluded that the claims resulted in a transformation of the human body by administering thiopurine and transforming the blood by analyzing it to determine metabolite levels. The Prometheus Court rejected this conclusion, in part because it placed unwarranted importance on the “machine or transformation” test:

“[T]he Federal Circuit, in upholding the patent eligibility of the claims before us, relied on this Court’s determination that ‘[t] ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.’ Benson, supra, at 70–71 (emphasis added); see also Bilski, supra, at (slip op., at 6–7); Diehr, 450 U. S. at 184; Flook, supra, at 588, n. 9; Cochrane v. Deener, 94 U. S. 780, 788 (1877)…Regardless, in stating that the ‘machineor-
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...That being so, the test fails here.” (emphasis added).

Conclusions

Undoubtedly, Mayo has the very immediate impact of casting doubt about the validity of numerous medical treatment patents cast in language like Prometheus’ patents. More broadly speaking, Mayo seems certain -- ironically -- to create uncertainty over the scope of patentable subject matter in the post-industrial age, at least where processes and, perhaps, even entirely natural products (e.g., isolated proteins and nucleic acids) are concerned. At least this much can be inferred from the Court’s equating “entirely natural processes” with “natural laws.”

No less disturbing than this turn of events is the rejection of the Federal Circuit’s positive application of the “machine or transformation” test. Though it may stand to reason that the “machine or transformation” test, being only “an important and useful clue,” cannot necessarily establish satisfaction of Section 101, the Court’s dismissal of the Federal Circuit leaves patent applicants at sea when it comes to preparing claims calculated to hit the increasingly amorphous target of patent eligible subject matter. For a while, after Bilski v. Kappos and its Federal Circuit and Board of Patent Appeals progeny, it appeared that meeting the “machine or transformation” test was sufficient to satisfy Section 101, it is clear in at least the immediate wake of Prometheus that drafting patent claims to this test provides no such assurances anymore.

As much as ever, informed guidance and educated insight is needed in evaluating inventions for possible patent protection and crafting patent claims optimized to articulate patentable subject matter. Dickinson Wright’s intellectual property attorneys have the technical expertise and legal knowledge to help you navigate this challenging and ever-changing landscape.

FOR MORE INFORMATION CONTACT:

Chris Mitchell, is a member in Dickinson Wright’s Ann
Arbor office. He can be reached at 734.623.1906 or
cmitchell@dickinsonwright.com.

Stephen M. Parks Ph.D., is of Counsel in Dickinson
Wright’s Lansing office. He can be reached at 517.487.4780
or sparks@dickinsonwright.com.