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Feb 1, 2011 (Vol. 31, No. 3)

Patenting Personalized Medicine Methods

Techniques Involving Physiological Processes Can Still Be Legally Protected

  • In 2010, the subject of “patent eligibility” made the headlines in legal circles. While much of the attention was originally focused on “business methods,” biotech and pharmaceutical methods got caught up in the debate with cases like Prometheus Laboratories, Inc. v. Mayo Collaborative Services (personalized medicine method claims, discussed here), Classen Immunotherapies, Inc. v. Biogen Idec (methods of evaluating and improving immunization schedules), and Association for Molecular Pathology v. U.S. PTO (isolated genes; methods of detecting specific genetic mutations).

    In June, the Supreme Court issued its decision in Bilski v. Kappos, and held that the business method claims at issue did not satisfy the requirements for patent-eligibility set forth in 35 U.S.C. § 101. The Court did not provide much concrete guidance for applying the statute to other types of method claims, however, but vacated and remanded the Federal Circuit’s original Prometheus decision.

    On remand, the Federal Circuit reconsidered the patent eligibility of Prometheus’ personalized medicine method claims in view of the Supreme Court Bilski decision, and again held that the claims qualify for patent protection under § 101. In so doing, the court followed a two-part analysis that may provide a framework for analyzing other method claims related to personalized medicine methods or diagnostic methods.

    Prometheus’ claims relate to personalized methods of optimizing the dosing of specific drugs used to treat gastrointestinal autoimmune diseases. A representative claim reads:

    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 x 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 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    (Not all claims require the administration step.)

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