PATENT SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. §101

By: Daniel A. Geselowitz, Ph.D.

On April 13, 2018, the U.S. Court of Appeals for the Federal Circuit (hereinafter, “Federal Circuit) issued a ruling in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals holding that the claims of U.S. Patent No. 8,586,610 (hereinafter, “the ‘610 patent”) are not invalid on the grounds of patent subject matter eligibility under 35 U.S.C. §101.

Vanda Pharmaceuticals owns the ‘610 patent and had sued West-Ward Pharmaceuticals for infringement of the patent by a New Drug Application (“NDA”) for a generic version of Vanda’s drug Fanapt®. The district court held that West-Ward induced infringement and that the claims of the ‘610 patent are not invalid. West-Ward appealed to the Federal Circuit and argued that “that the asserted claims are ineligible under [35 U.S.C.] §101 because they are directed to a natural relationship between iloperidone, CYP2D6 metabolism, and QT prolongation, and add nothing inventive to those natural laws and phenomena.” (Note: A “QT” prolongation or interval is the time between the Q and T of a heart rhythm. When corrected for a patient’s heart rate, it is abbreviated “QTc.”)–click here to read more—