Mayo Collaborative Services et al. v. Promethus Laboratories, Inc.


U.S. Supreme Court Docket No. 10-1150

Opinion delivered by J. Breyer
March 20, 2012

Brief summary: This decision reversed the FC reversal of a DC decision that the claims of Prometheus’ exclusively licensed patents were directed to unpatentable subject matter. It also set aside the 2011 Federal Circuit “Myriad” decision for further review in light of this decision.

Summary: This decision reversed the FC reversal of a DC decision that the claims of Prometheus’ exclusively licensed patents were directed to unpatentable subject matter. The decision considered claim 1 of the ‘623 patent as “typical” which was directed to ““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 8×108 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 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.” The FC held that the claim was patentable in view of the Bilski “machine or transformation test” because the process involves “transforming the human body by administering a thiopurine drug and transforming the blood by analyzing it to determine metabolite levels.” However, this decision concluded that “the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations” (“inform a relevant audience about certain laws of nature”), and “any additional steps consist of well understood, routine, conventional activity”. Thus, the Court concluded, “those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” It found this case more closely resembles Flook (unpatenable method for adjusting alarm limits, “a[n unpatentable] formulafor computing an updated alarm limit” (US, 1978)) than Diehr (patentable process because “additional [non-conventional] steps [installing rubber in a press, closing the mold, etc.] of the process integrated the equation into the process as a whole” (US, 1981)). The Court also stated that these patents could “tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations” and “inhibit the development of more refined treatment recommendations (like that embodied in Mayo’s test)” but also that it “need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.” In another decision (No. 11-725), the Federal Circuit’s 2011 “Myriad” decision was set aside and sent back for review in view of this decision (originally upholding patentability of cDNAs and some therapeutic screening methods).

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