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.”