Teva said that it will vigorously defend its Copaxone intellectual property rights.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has confirmed that it has received the first paragraph IV notice for a generic version of its three-times-a-week Copaxone 40 mg/mL treatment.
The notice was from Dr. Reddy’s Laboratories Inc. and Teva said that it will continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged. Teva said it plans to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of US Food and Drug Administration (FDA) approval of Dr. Reddy’s ANDA.
Teva added that Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030.
Published by Globes [online], Israel business news - www.globes-online.com - on August 10, 2014
© Copyright of Globes Publisher Itonut (1983) Ltd. 2014
Copaxone