Originally published June 20, 2011
Keywords: patent Law, patentability, exceptions, Bilski, Supreme Court
Federal law allows inventors to patent "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." 35 U.S.C. § 101. There are, however, "three specific exceptions to § 101's broad patent-eligibility principles: laws of nature, physical phenomena, and abstract ideas." Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010). The Supreme Court granted certiorari on June 20, 2011 in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150, in order to examine the scope of the "laws of nature" exception, as it applies to observed medical correlations between blood test results and patient health.
Prometheus's patent claims relate to tests for the efficacy and toxicity of thiopurine drugs used to treat autoimmune diseases, such as Crohn's disease. Prometheus's claims involve administering a thiopurine drug, determining the resulting level of certain metabolites of the drug in the blood, and considering what use, if any, to make of that information. In accordance with this patent, Prometheus markets a metabolite-concentration test. When Mayo announced its intent to market its own metabolite-concentration test, Prometheus brought suit alleging patent infringement.
A federal district court invalidated Prometheus's patent under the natural laws/physical phenomena exceptions. The court held that the first two steps of Prometheus's method were merely "data-gathering" steps, and that the final step was merely a "mental step" in the mind of the treating physician. At its core, according to the district court, Prometheus was attempting to patent the correlation between metabolite-concentration levels and dosages of thiopurine, preempting all uses of that biologic correlation. This correlation, as a natural law or physical phenomenon, was unpatentable.
The Federal Circuit reversed, finding that Prometheus's claims satisfied the "machine-or-transformation" test because both the administering of thiopurine and the subsequent testing of a blood sample were physically "transformative" and not merely "data-gathering" steps. Thus, the Federal Circuit reasoned, Prometheus's claims did not inappropriately "preempt all uses of the natural processes; they utilize them in a series of specific steps." 581 F.3d 1336, 1349 (2009). Mayo sought certiorari, and the Supreme Court granted, vacated, and remanded in light of its decision in Bilski. On remand, the Federal Circuit adopted substantially the same analysis as before.
Mayo again petitioned for certiorari, arguing that the case presented an opportunity to address an issue left unresolved in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006). The LabCorp petition—which was ultimately dismissed as improvidently granted over the dissent of Justices Stevens, Breyer, and Souter—similarly addressed the patentabiliy of a method that focused on a natural medical correlation. In their dissent, the three Justices argued that LabCorp's patent should be invalidated under the "law of nature" exception.
The Mayo Collaborative Services decision will be closely watched by members of the life-sciences and medical industries. At the certiorari stage, the case already attracted significant interest from numerous amici. Absent extensions, amicus briefs on the merits in support of the petitioner will be due on August 11, 2011, and amicus briefs in support of the respondents will be due on September 13, 2011.
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