Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) (Breyer, J. for unanimous Court).  For the slip opinion, click here: Mayo03202012.USSC

SUMMARY:  CLAIM TO “LAW OF NATURE”; PROCESS STEPS NOT SUFFICIENT TO TRANSFORM CLAIM INTO A PATENT-ELIGIBLE APPLICATION OF A LAW OF NATURE; WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL STEPS PREVIOUSLY USED BY RESEARCHERS IN FIELD; CLAIM TYING UP USE OF UNDERLYING NATURAL LAW AND INHIBITING ITS USE FOR FURTHER DISCOVERY. A patent concerned thiopurine drugs, which are used to treat immune-mediated gastrointestinal disorders. When a thiopurine drug is administered to a patient with the disorder, the patient develops metabolites, including G-TG and 6-MMP. The patent reports the named inventors’ discovery of precise correlations between the level of the metabolites in the patient’s blood and the drug’s efficacy and toxicity. The correlations are useful to physicians for adjusting the drug dosage up or down for a particular patient. The claim at issue recites two steps: (1) administering the drug to a patient with an immune-mediated gastrointestinal disorder and (2) determining the level of the 6-TG metabolite, together with two “wherein” clauses, which recite that a concentration below one specified level (230 pmol) “indicate[s] a need to increase” drug dosage and a concentration above another level (400 pmol) indicates a need to decrease the dosage. A district court held the claim invalid as a “law of nature. The Federal Circuit reversed. HELD: the Federal Circuit erred. The claim is invalid as drawn to a “law of nature,” that is, the relationship between metabolite concentration in blood and thiopurine drug efficacy and toxicity. The recited steps of administering the drug, determining the metabolite level together with the “wherein” indications of a need for dosage adjustment, do not transform the claim into a patent-eligible application of a law of nature because (1) “the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field,” and (2) “upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”

COMMENTARY.  For a critical commentary on Mayo, see below. Read CPLRG™ 0079

Cybersource Corp. v. Retailed Decisions, Inc., 2011 U.S. App. LEXIS 16871 (Fed. Cir. 2011) (DYK, Bryson & Prost). Cybersource08162011

Major issues: mental steps as unpatentable methods; Section 101; Bilski; claims to computer readable medium with executable programs instructions; Beauregard claims

A Federal Circuit panel, in an opinion by Judge Dyk, held that method claims to a credit card fraud prevention system, which could be carried out by a human mentally or with the aid of pencil, were unpatentably abstract in the Bilski sense.  The panel also held claims to “computer reaable medium” for carrying out the methods to be unpatentable.

Cross Reference. For a discussion of the “mental steps” doctrine, see Chisum on Patents Sec. 1.03[6]. Read CPLRG™ 0074

Ass’n for Molecular Pathology v. United States Patent and Trademark Office, 2011 U.S. App. LEXIS 15649 (Fed. Cir. July 29, 2011) (LOURIE, MOORE, concurring in part; BRYSON, concurring in part and dissenting in part)  MyriadGenetics07292011.fc

Major issues:  claims to isolated genes; claims to comparing gene sequences to detect cancer; Bilski; patent eligible subject matter

In a much-watched case, known generally by the name of the patent owner, Myriad Genetics, a Federal Circuit panel addressed Section 101 issues concerning claims to isolated DNA and to methods of screening for cancer by DNA testing.  The panel also addressed the issue whether the plaintiffs, “an assortment of medical organizations, researchers, genetic counselors, and patients” had “standing under the Declaratory Judgment Act to challenge Myriad’s patents.”
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On standing, the Federal Circuit held that “at least one plaintiff,” a doctor, had standing.  On the merits, the majority distinguished between claims to isolated genes and screening by cell growth rates and claims to methods of comparing DNA sequences.  The former but not the latter were for patent eligible subject matter.

Pertinent to this decision is the Supreme Courts June 20, 2011 grant of certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, CPLRG 0071 (Fed. Cir. 2010), which involves Section 101 issues on patent claims concerning medical diagnostics.

UPDATE: The Supreme Court reversed in the Prometheus case.  See CPLR 0079.    On March 26, 2012, the Supreme Court remanded the Myriad Genetics case.  Thereafter, on August 16, 2012, the Federal Circuit, in a divided panel decision, affirmed its prior approach.  Myriad2012.fc Thus, applying Mayo, the majority held that the “composition claims to `isolated” DNA molecules” did not “cover patent-ineligible products of nature under § 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter.”  It also held that the “method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells” as not “directed to a patent-ineligible scientific principle.”  However, it held that the “method claims directed to `comparing’ or `analyzing’ DNA sequences are patent ineligible” because the “claims include no transformative steps and cover only patent-ineligible abstract, mental steps.”

Read CPLRG™ 0073

Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010) (LOURIE, Rader & Bryson), on remand from 130 S. Ct. 3543 (2010), cert. granted, 180 L. Ed. 2d 844 (June 20, 2011). PrometheusLabMayo12172010.fc

MAJOR ISSUES: Section 101 patent eligible subject matter; Bilski; medical diagnostic claims

In 2009, before the Supreme Court’s Bilski decision on patent eligible subject matter and abstract ideas, see Bilski v. Kappos, 130 S. Ct. 3218, CPLRG 0015 (2010), the Federal Circuit held that medical diagnostic claims were to patent eligible subject matter. The Supreme Court remanded the case for reconsideration in light of Bilski.  The Federal Circuit reaffirmed its prior decision.  On June 20, 2011, the Supreme Court granted review, indicating the Supreme Court’s intent to address again issues on what constitutes patent eligible subject matter under Section 101, this time in regard to biomedical subject matter. Read CPLRG™ 0071

Research Corp. Technologies, Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010) (RADER, Newman & Plager) ResearchCorp12082010

In an early response to Bilski v. Kappos, 130 S. Ct. 3218, CPLRG 0015 (2010), the Federal Circuit, in an opinion by Chief Judge Rader, rebuffed a Section 101 challenge to claims in two patents to methods of “digital image halftoning.”  The court indicated a reluctance to find the kind of abstractness that the Supreme Court relied upon in Bilski to reject claims as ineligible subject matter under Section 101.  The court suggested that it would be more fruitful to apply specific standards of patentability, such as indefiniteness and lack of written description under 35 U.S.C. Section 112.

The struggle to make sense out of Bilski continued in subsequent Federal Circuit decisions.  See, e.g., Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, CPLRG 0071 (Fed. Cir. 2010), on remand from 130 S. Ct. 3543 (2010), cert. granted, 180 L. Ed. 2d 844 (June 20, 2011); Ass’n for Molecular Pathology v. United States Patent and Trademark Office, CPLRG 0073 (Fed. Cir. July 29, 2011); Cybersource Corp. v. Retailed Decisions, Inc., CPLRG 0074 (Fed. Cir. Aug. 16, 2011). Read CPLRG™ 0072