Federal appellate court rules in favor of Merck in TEMODAR patent infringement suit

Merck & Co., Inc. said today that a federal appellate court ruled in its favor in a TEMODAR patent infringement suit against Barr Laboratories, an affiliate of Teva Pharmaceuticals.

“We invest heavily in R&D to discover innovative medicines like TEMODAR, and we will vigorously defend our intellectual property rights.”

By a 2-1 vote, the appellate court rejected Barr's arguments and reversed a lower court ruling that the U.S. patent was unenforceable.

"The court appropriately ruled that the patent for TEMODAR in the U.S. is enforceable," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We invest heavily in R&D to discover innovative medicines like TEMODAR, and we will vigorously defend our intellectual property rights."

Teva had been seeking FDA approval to sell a generic version of the 5, 20, 100, 140, 180 and 250 mg capsules of TEMODAR. In connection with Teva's prior agreement not to launch during the appeal, Merck agreed that it will not object to Teva's launch of a generic version of TEMODAR in August 2013. The U.S. patent and exclusivity periods otherwise will expire on February 2014.

Schering Corporation filed the patent infringement lawsuit against Barr in July 2007. A trial was held in U.S. District Court for the District of Delaware in October 2009.