WASHINGTON, D.C. - (Mealey's) The patentability of medical treatment claims that include steps that are part of a protocol will be decided by the U.S. Supreme Court, which on June 20 granted certiorari for a second time in a dispute over methods for treating certain autoimmune diseases (Mayo Collaborative Science d/b/a Mayo Medical Laboratories, et al. v. Prometheus Laboratories Inc., No. 10-1150, U.S. Sup.).
The high court in June 2010 vacated and remanded respondent Prometheus Laboratories Inc.'s case against petitioner Mayo Medical Laboratories in light of its ruling in Bilski v. Kappos (2010 US LEXIS 5521; 130 S. Ct. 3218; 177 L.Ed. 2d 792; 95 U.S. P.Q.2d (BNA) 1001 ) [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law] in which it rejected the machine-or-transformation test as the sole method for determining patent eligibility under 35 USCS § 101.
On remand, the Federal Circuit U.S. Court of Appeals in December 2010 reaffirmed its earlier holding that the U.S. District Court for the Southern District of California erred in granting summary judgment of invalidity of two Prometheus patents relating to methods for determining optimal dosage of thiopurine drugs used to treat autoimmune diseases. Prometheus asserted infringement after Mayo announced that it would use and sell its own test. The District Court granted summary judgment that Mayo's test literally infringed but found that the patents' steps of administering the drug and measuring the metabolite levels impermissibly claim natural phenomena - the correlation between thiopurine drug metabolite levels and efficacy and toxicity that resulted from a natural body process.
The Federal Circuit in its initial ruling reversed after applying the machine-or-transformation test, under which a claimed process is patent-eligible if it is tied to a particular machine or apparatus or if it transforms a particular article into a different state or thing. The court held that the administering and determining steps were transformative. In its second ruling in the case, the Federal Circuit again upheld the patentability of medical treatment claims that include steps that are "part of a treatment protocol," finding that such steps are transformative and not merely for the purpose of gathering data.
Mayo sought Supreme Court review to determine if a patentee "can monopolize basic, natural biological relationships." Specifically, the latest petition for certiorari asks "whether 35 U.S. [Code Section] 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve 'transformations' of body chemistry."
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