Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has won its patent litigation against Merck & Co. Inc. (NYSE: MRK) over brain tumor treatment Temodar. The US District Court for the District of Delaware yesterday ruled that Merck's patent for Temodar is not enforceable due to prosecution latches and inequitable conduct.
Teva is waiting for the US Food and Drug Administration (FDA) to give final marketing approval for the company's generic version of Temodar. As the first company to file an Abbreviated New Drug Application (ANDA) with paragraph IV certification for Temodar, Teva is eligible to receive 180-day marketing exclusivity for its generic version of the drug. Teva is seeking to market 5, 20, 100, 140, 180, and 250 milligram capsule dosages of generic Temodar.
Merck acquired Temodar when it acquired Schering Plough in November 2009. According to IMS sales data, branded Temodar has $369 million in annual sales in the US.
Merck said in response that it was "very disappointed" by the court ruling, and that it intended to appeal the ruling.
Teva's share closed at $56.99 on Nasdaq yesterday. The share fell 0.4% by midday today on the TASE to NIS 211.20.
Published by Globes [online], Israel business news - www.globes-online.com - on January 27, 2010
© Copyright of Globes Publisher Itonut (1983) Ltd. 2010