Today, in a short but sweet statement, the Supreme Court granted the petition for certiorari in Prometheus v. Mayo, 628 F.3d 1347 (Fed. Cir. 2010) (finding method claims relevant to personalized medicine patent eligible) (petition for cert. filed March 2011).
As discussed in our previous Personalized Medicine Bulletin post, parties once again petitioned for certiorari in the Prometheus case, after the Federal Circuit addressed this case (for the second time) in light of the Supreme Court’s decision in Bilski v. Kappos (2010). Because of the importance of this case to the personalized medicine industry, claims at issue in Prometheus bear repeating here. Representative claims include:
Claim 1 of U.S. Patent No. 6,355,623:
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 8×108 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.
Claim 46 of the U.S. Patent No. 6,680,302:
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 8×108 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 or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
In its most recent decision, Federal Circuit held that both the “administering” and “determining” steps were transformative and not merely data-gathering steps. Specifically, the method claims recited a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy/toxicity, i.e., the treatment of a specific disease by administering specific drugs and measuring specific metabolites. As noted by the court, “[t]he invention’s purpose to treat the human body is made clear in the specification and the preambles of the asserted claims.” Thus, the method did not wholly preempt all uses of the recited correlations. The methods were not “merely” data-gathering steps or “insignificant extra-solution activity,” but rather were part of treatment regimes, and therefore involved “a significant transformative element.”
The Supreme Court’s decision to grant certiorari here means that the Court may finally provide some additional clarity regarding the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101. That said, it is possible that the Court might determine that the method claims at issue in Prometheus, previously deemed patent eligible by the Federal Circuit, are not patentable at all.
For instance, in the recent Stanford v. Roche case holding that the Bayh-Dole Act does not automatically vest title of federally funded inventions to federal contractors (e.g., universities), Justice Breyer, in a dissenting opinion joined by Justice Ginsburg, expressly referenced his previous dissent in Lab. Corp v. Metabolite, 126 S.Ct. 2921 (2006), suggesting patent ineligibility of certain diagnostic claims. In this context, in his latest dissent in the Stanford v. Roche case, Justice Breyer states:
[P]atents sometimes mean unnecessarily high prices or restricted dissemination; and they sometimes discourage further innovation and competition by requiring costly searches for earlier, related patents or by tying up ideas, which, were they free, would more effectively spur research and development.
It remains to be seen what Justices Breyer and Ginsburg, and the rest of the Justices might do with the claims at issue here in Prometheus. Either way, this case stands to have a large impact on intellectual property in the personalized medicine space.