Vanda Loses Hetlioz Patent Case
Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder drug Hetlioz (tasimelteon).
In a Dec. 14 decision, U.S. District Court Judge Colm F. Connelly also invalidated four of Vanda’s patent claims on the medicine, which was approved in 2014 for treatment of non-24-hour sleep-wake disorder — a condition in which the patient’s biological clock fails to synchronize to a 24-hour day.
Both Teva and Apotex were preparing to launch generic tasimelteon for non-24-hour sleep-wake disorder before the patent expired, according to Vanda’s complaint filed in 2018.
Vanda said it “intends to appeal the decision to the United States Court of Appeals for the Federal Circuit and to request a stay of market entry by Teva and Apotex while the appeal is pending.”
Vanda Pharmaceuticals Inc. (Vanda) is a global biopharmaceutical company focused on the development and commercialization of therapies to address high unmet medical needs and improve the lives of patients. Vanda’s commercial portfolio comprised of two products, HETLIOZ and nighttime sleep disturbances, and Fanapt for the treatment of schizophrenia. In addition, the Company has a range of drugs in development, including HETLIOZ (tasimelteon) for the treatment of jet lag disorder, delayed sleep phase disorder (DSPD), symptoms of autism spectrum disorder and pediatric Non-24; Fanapt (iloperidone) for the treatment of bipolar disorder and Parkinson s disease psychosis and a long acting injectable formulation for the treatment of schizophrenia; Tradipitant (VLY-686) for the treatment of gastroparesis, motion sickness, atopic dermatitis, and Covid-19 pneumonia, and VTR-297 for the treatment of hematologic malignancies and with potential use as a treatment for several oncology indications.
December 19, 2022
