U.S. Supreme Court decision may restrict patentability of diagnostic methods

The United States Supreme Court has unanimously found that methods for determining an effective amount of a drug to be administered to a patient in need thereof are ineligible under 35 U.S.C. § 101; overturning an earlier Federal Circuit decision. The decision in Mayo Collaborative Services v. Prometheus Laboratories handed down last week, specifically found that the patent claims at issue “effectively claim the underlying laws of nature… [and] are consequently invalid” .

Arguments that methods for optimizing therapeutic efficacy for treatment of a disorder satisfy the “machine-or-transformation” test established in Bilski v.  Kappos were also clarified by the Court; specifically, that the test in Bilski provided an “important and useful clue” to patentability, but did not trump the “law of nature” exclusion. The Court held that the claims in question merely provided for administering a drug to a patient in need thereof, determining the level of said drug in the patient and then setting the upper and lower limits of effectiveness; wherein “administering” a drug simply identifies a group of people who would be interested in the drug, “determining” simply tells doctors to engage in an understood routine, and setting upper and lower limits simply tells doctors about relevant, natural laws they should consider in making a decision. In view of this, Court found that the claims did not do “enough… to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.”

In handing down the decision, the Court remanded the controversial Myriad Genetics case to the U.S. Federal Circuit for further consideration. The corresponding Myriad Genetics case in Australia has been heard by the Federal Court, and previously reported here. The judgement is yet to be handed down.