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Intellectual Property law Blog
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Biotech Method Claims Remain Patentable
01-19-2011 [Jessica Hauth] [Permalink]Late last year, the Court of Appeals for the Federal Circuit ruled that certain biotechnology method claims as applied to humans are patentable subject matter under 35 U.S.C. §101. In Prometheus Labs. Inc. v. Mayo Collab. Serv., Docket 2008-1403 (Fed. Cir., December 17, 2010), on remand from the United States Supreme Court with instructions to revisit their previous ruling in view of the determination in Bilski, the Federal Circuit affirmed their initial decision that the patent claims at issue are valid and patentable.
The claims at issue recited an “administrating” step and a “determining” step, as demonstrated in sample 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 8x108 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 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Other claims at issue omitted the “administering” step.
The Federal Circuit held that the claims at issue are directed to patentable subject matter because the steps of the claims are transformative and significant to the claimed invention, and are not just data-gathering steps. The “administering” step was deemed to transform the body of the patient to whom the treatment is applied, since the administered drug is metabolized by the body. Separately, the “determining” step was also held to be transformative, since some form of manipulation is required to extract and measure the amount of metabolite present in a bodily sample.
With this decision, the Federal Circuit begins to define the landscape of patentable subject matter, and distinguish it from what constitutes an unpatentable “abstract idea,” in a post-Bilski world. Other biotech patent cases currently pending before the Court, namely Classen Immunotherapies, Inc. v. Biogen Idec and Association for Molecular Pathology v. U.S. Patent and Trademark Office et al. (“Myriad”), will demand the Court further explain the scope of patentable subject matter in the biotech and life sciences fields.
A copy of the opinion can be found here.