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Supreme Court Rejection of Prometheus Lab's Claims Bodes Challenges for Biotech Patents

By Patrick A. Doody, Sheridan K. Snedden

Alert

By Patrick A. Doody, Sheridan K. Snedden

03.28.12

On March 20, the Supreme Court reversed the Federal Circuit in the long-awaited Mayo Collaborative Labs v. Prometheus Laboratories, Inc. decision, striking down Prometheus’ patents on the grounds that the claims too broadly preempt the use of natural correlations between levels of drug metabolite and pharmaceutical effect. While the claims were written to include additional steps, such as an administration step, the Court held these steps were insufficiently integrated into the process as a whole and failed to transform the process into an inventive application of a natural phenomenon. The holding in Mayo clarifies the “law of nature” exclusion under a “preemption test” and has broad implications in determining patent-eligible subject matter in the fields of diagnostic testing, personalized medicine, and biotechnology.

Patent law excludes from patent protection laws of nature, natural phenomena, and abstract ideas. Diamond v. Diehr, 450 U. S. 175, 185 (1981). In assessing the “law of nature” exclusion, the Supreme Court articulated a “preemption test” that prohibits patentability of claims under 35 U.S.C. § 101 if they do nothing more than broadly cover the application of a law of nature or natural phenomena and preempt all uses of the natural phenomena. See e.g., Gottschalk v. Benson, 409 U. S. 63, 67-68 (1972). The preemption test considers whether or not the patent claim would “wholly preempt” the idea; that is, whether the patent would effectively preempt scientific exploration by occupying a basic concept or exclude use of the idea itself.

Justice Breyer delivered the opinion for a unanimous Court in Mayo Collaborative Labs v. Prometheus Laboratories, Inc., in which the Court applied this preemption test to the process claims of Prometheus’ patents U.S. 6,355,623 (the “’623 patent”) and U.S. 6,680,302 (the “’302 patent”).1 Claim 1 of the ‘623 patent recited:

  1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    1. administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
    2. 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.

  1. The claims of the ‘623 patent and ‘302 patent are directed to similar processes for optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder using similar claim language and method steps. Although the Court discussed the ‘623 patent in greater detail, the holding is equally applicable to the ’302 patent claims.

Download: Supreme Court Rejection of Prometheus Lab's Claims Bodes Challenges for Biotech Patents

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Intellectual Property
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