Merck & Co., Inc. said that a federal appellate court ruled in its favour in a Temodar patent infringement suit against Barr Laboratories, an affiliate of Teva Pharmaceuticals.
By a 2-1 vote, the appellate court rejected Barr's arguments and reversed a lower court ruling that the US patent was unenforceable.
"The court appropriately ruled that the patent for Temodar in the US 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 US 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 US District Court for the District of Delaware in October 2009.
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