On June 7, 2018 the United States Patent and Trademark Office (USPTO) issued a new Memorandum that clarifies its view of Subject Matter Eligibility, under 35 U.S.C. § 101, regarding the patentability of Personalized Medicine discoveries.
The Memorandum was prompted by the Federal Circuit’s recent Vanda decision, where the Court provided its own insights as to the Subject Matter Eligibility of Personalized Medicine patent claims.  The claims in Vanda recited a method of treating a patient suffering from schizophrenia with the drug, iloperidone, and included specific steps, such as administering iloperidone to the patient in an amount guided by the genotype of the patient, which can predict the rate of drug metabolism. The Court summarized Vanda by stating: “The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship.”