Vanda Pharmaceuticals Inc. announced that Judge Gregory M. Sleet of the United States District Court for the District of Delaware ruled that Roxane Laboratories Inc. (Roxane) infringed US patent nos. RE39,198 (the '198 Patent) and 8,586,610 (the '610 Patent) by submitting to the FDA an ANDA seeking permission to market a generic version of Fanapt before the expiration of Vanda's patents.
"We are very pleased that the court found both patents valid, found that Roxane's ANDA infringes the '198 patent and the '610 patent, and accordingly issued an injunction barring Roxane from marketing its product until the expiration of the later expiring '610 patent on November 2, 2027," said Mihael H. Polymeropoulos, M.D., Vanda's president and CEO.