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.
Facts. The facts (briefly): a category of drug, thiopurines, including 6-MP and AZA, had been used to treat gastrointestinal disorders. When administered to a patient, the patient’s body transformed the thiopurine drug into metabolites (6-MMP and 6-TG).
The patents at issue (‘623 and ‘302) disclosed a correlation between the level of the metabolites in a patient and the efficacy and toxicity of the drug. The correlation could be used to adjust a patient’s dosage of the drug. U.S. Pat. No. 6,355,623; U.S. Pat. No. 6,680,302. USPatNo.6355623 USPatNo6680302
Claims: Administering Drug and Determining Metabolite Level; Indication of Need to Increase or Decrease Drug Level. Claims in the patents recited two steps: first, administering a 6-TP drug to a patient and second, determining the levels of metabolite (6-TG and 6-MMP) in the patient. The claims concluded with a “wherein” clause. The clause provided that the measured level of metabolite “indicated a need” to increase drug dosage to optimize drug efficacy, if the metabolite was above a designated level, or to decrease drug dosage to reduce toxicity, if the metabolite was below a designated level.
Claim 1 was representative:
1. 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 8×10 8 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 8×10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
One claim (46) omitted the administering step, reciting only the “determining” step.
46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×10 8 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 8×10 8 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Original Prometheus; Supreme Court Remand. In the original Prometheus, Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009), vacated and remanded, 130 S. Ct. 3543 (2010), the court held that the claims were directed to patent-eligible subject matter. Applying the Federal Circuit’s exclusive machine-or-transformation (MORT) test, which the Federal Circuit had adopted in its en banc Bilski (2009) decision, the panel held that the claims’ “administering” and “determining” steps were transformative and not merely data-gathering steps. After its Bilski decision, the Supreme Court remanded Prometheus.
Prometheus After Remand. In the rebound Prometheus, the Federal Circuit noted that the Supreme Court’s Bilski decision did not dictate “a wholly different analysis or a different result.” True, the original decision did rely on the MORT test, finding that the claimed methods were transformative as part of body-transforming treatment methods. However, the Supreme Court did not reject the MORT test, only its exclusivity. Thus, transformation was still an important “clue” or “tool.” Also, the original decision addressed the “preemption” concept of Bilski. As the original decision reasoned, the claims here are not “drawn to a natural phenomenon, the patenting of which would entirely preempt its use as in” Gottschalk v. Benson, 409 U.S. 63 (1972); Parker v. Flook, 437 U.S. 584 (1978). The claims recited specific steps of treating a specific disease by administering specific drugs and measuring specific metabolites. The claimed invention was an improvement in a treatment process.
In Prometheus, the Federal Circuit dismissed an accused infringer’s argument that the claims here are similar to those found to be unpatentable in an opinion by three Supreme Court justices. Lab. Corp., 548 U.S. 124 (Breyer, J., dissenting from dismissal of certiorari as improvidently granted). However, the Federal Circuit noted, a dissenting opinion is not controlling law and need not be discussed. The accused infringer argued that two concurrences in Bilski, representing a majority of five Supreme Court justices, cited the Lab. Corp. dissent. However, that citation did not turn a dissent into controlling law. One opinion (by Justice Stevens) cited Lab. Corp. for the proposition that excessive patent protection can retard technological progress, but it did so in arguing for a rule categorically banning business method patents. “[T]his case does not involve business method patents.”
Supreme Court Grant of Certiorari. On June 20, 2011, the Supreme Court granted a petition for certiorari.