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Supreme Court Opinion in Mayo v. Prometheus

Posted Friday, March 23, 2012 by Mike Gibbons

There was a patent law opinion by the U.S. Supreme Court earlier this week in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc. Supreme Court patent law decisions are relatively rare, as we get about one opinion a year issued by the high court. This opinion will be of interest to the biotech community in Seattle, among other areas.

This case turned on patent eligibility, a topic the Supreme Court returned to for the first time since its decision in Bilski v. Kappos in 2010. I blogged about patent eligibility and its distinction from patentability earlier this year (you can read the earlier blog here). To review, “patent eligible” means the invention falls within a category of inventions for which U.S. patent law provides that a patent may be sought. These categories include processes, machines, and compositions of matter, to name a few. That is different from “patentable,” which means that the invention sufficiently novel, non-obvious and adequately described for a patent to issue.

“Inventions” that are not patent eligible would include laws of nature. Albert Einstein’s famous equation E=mc^2 is not patent eligible, for example. Had Einstein filed an application for a patent on E=mc^2 under today’s patent law regime, the claims would have rejected for being drawn to non-patent eligible subject matter. This would be a “101 rejection” in the parlance of patent attorneys and patent agents, after 35 U.S.C. §101, the section of the patent law discussing patent eligibility.

In the Prometheus case, Prometheus Labs had obtained a patent for a process to be used by doctors to treat patients with autoimmune diseases with certain drugs. The claims at issue included steps of administering the drug to a patient, then determining the level of the drug in the patient. The claims also recited a relationship where a certain level of the drug in the blood stream of the patient would indicate a need for more of the drug in future administrations, and a certain higher level of the drug in the blood stream would indicate a need to reduce the amount of the drug in future administrations.

The case has an interesting procedural history. Following issuance of the patent, Prometheus sued Mayo who was using and selling a treatment that Prometheus believed infringed their patent. The trial court found for Mayo and invalidated the patent on the grounds that the claims in the patent were not patent eligible. Specifically, that the patent only recited a natural law, that law being the correlation between the drug and the amount which would be efficacious in a patient.

Prometheus appealed to the Court of Appeals for the Federal Circuit (CAFC), the court with exclusive jurisdiction over patent appeals (read more here). The CAFC reversed the trial court, finding that the steps of “administering” and “determining” rendered the invention patent eligible.

Mayo appealed the judgment to the Supreme Court, who had by that time issued its own patent eligibility opinion in Bilski v. Kappos. The Supreme Court vacated the decision of the CAFC and remanded the case back to the CAFC for further consideration in light of the Bilski case. The CAFC did just that, reconsidering the case and finding again that the Prometheus claims were patent eligible. Mayo appealed again to the Supreme Court.

Upon the return of the case of the Supreme Court, the opinion by Justice Breyer framed the issue as whether the patent claim added enough subject matter to the law of nature recited by the claim (the amount of the drug in the blood stream which would provide efficacious treatment for a patient). The Court found that the steps of “administering” and “determining” did not add enough, and therefore, that the claims were not patent eligible.

“Einstein,” Justice Breyer wrote, “we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa).”

Justice Breyer went on to suggest that the claims merely recite a law of nature and add “well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” With that, the Supreme Court reversed the CAFC a second time, and held the patent invalid.

The opinion is available from the website of the U.S. Supreme Court here.

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