Federal Circuit Reverses Invalidity of Method of Calibrating Drug Dosages

Yesterday, in Prometheus Labs., Inc. v. Mayo Collaborative Services, the Federal Circuit reversed a district court determination that method claims directed to methods for calibrating the proper dosage of thiopurine drugs by measurement of two metabolites were invalid as not directed to patentable subject matter.

Specifically, claim 1 of U.S. Patent No. 6,355,623 reads as follows:

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 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The district court ruled that the claims had three steps: (1) administer the drug to a subject; (2) determine metabolite levels; and (3) be warned that an adjustment in dosage may be required. The court characterized the first two steps as data gathering steps and the third step as a mental step. The metabolite levels in the body “warn” the doctors to adjust the dosage; this is a natural phenomenon that occurs in the body and thus was not “invented” by the inventors.

The Federal Circuit reversed, holding that the claims meet the transformation prong of the Bilski test.

The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined.

The court went on to make a much broader statement regarding methods of treatment claims:

The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.

This statement seems to indicate that all claims that recite steps that include administration of a drug contain patentable subject matter.

The court also held that the claims that did not include this step also contained patentable subject matter based on the “determining” step. Determining metabolite levels requires a transformation of the substance being analyzed.

The Federal Circuit continued by noting that the district court erred in holding that the first two steps are merely data gathering steps. The Federal Circuit held that these steps are central to the claimed method and are themselves transformative.

A claim that contains patentable subject matter does not become unpatentable simply by adding a mental step to the claim. As long as the claim as a whole is not simply directed to mental steps, the claim is still patentable.

Finally, the district court relied extensively on the reasoning of Justice Breyer in his now infamous dissent from the dismissal in Lab Corp. v. Metabolite Labs. The Federal Circuit dismissed this reliance in a single footnote, noting that “[t]hat dissent is not controlling law and also involved different claims from the ones at issue here.” Hopefully, this will finally put reliance on Lab Corp. to bed.

The Federal Circuit again noted the helpfulness of the various amicus briefs filed supporting each side in this case. They continue to signal a desire to the patent community to file such briefs.

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3 Responses to “Federal Circuit Reverses Invalidity of Method of Calibrating Drug Dosages”

  1. Mayo Asks Supreme Court to Review Another Patentable Subject Matter Case « INVENTIVE STEP Says:

    […] Mayo Asks Supreme Court to Review Another Patentable Subject Matter Case The Mayo Clinic has filed a petition for certiorari to the Supreme Court asking them to review the Federal Circuit’s decision in Prometheus Labs., Inc. v. Mayo Collaborative Services. […]

  2. Bilski Reaction « INVENTIVE STEP Says:

    […] Federal Circuit had previously reversed a district court ruling in this case that a method of calibrating drug dosages was not patentable subject matter.  The […]

  3. Federal Circuit Reconfirms Patentability of Method of Calibrating Drug Dosages « INVENTIVE STEP Says:

    […] By Matt Osenga Last year, prior to the Supreme Court’s decision in Bilski v. Kappos, the Federal Circuit reversed a district court holding that Prometheus’s claims to methods of calibrating drug dosages were […]

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