Israel’s Teva Pharmaceutical Industries Ltd. has defeated Merck & Co. Inc. in its patent litigation over the brain tumor treatment Temodar.
The US District Court for the District of Delaware ruled that Merck’s patent for Temodar is not enforceable due to prosecution latches and inequitable conduct.
Teva is now 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 the treatment, Teva is eligible to receive 180-day marketing exclusivity for its generic version of the drug.
The Temodar drug has annual sales in the US of $369 million. Merck acquired the drug when it bought out Schering Plough in November 2009. Merck is apparently “very disappointed” by the court ruling, which it intends to appeal.