Next week, the Supreme Court will hear oral arguments in the method patent infringement case of Mayo Collaborative Services v. Prometheus Laboratories, Inc. The question presented is as follows:
“Whether 35 U.S.C. § 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.”
At issue is the legitimacy of Prometheus’ two patents for optimizing patient treatment of certain gastrointestinal autoimmune diseases such as ulcerative colitis by measuring a patient’s metabolite levels and using such measurements to adjust dosage of a thiopurine drug. Mayo has claimed that the Prometheus patents do not involve patentable subject matter, stating that “Prometheus’s patents monopolize every useful implementation of a correlation between particular types of drug treatment and the natural bodily metabolism resulting from that drug treatment.” Depending on the outcome, the decision could have a broad impact on the patentability of diagnostic methods used to establish proper drug dosing and to thereby deliver personalized patient treatment.
Stay tuned for an update following oral arguments.