Merck wins Temodar patent lawsuit on appeal
Has agreed to allow Teva to launch generic version in 2013
Merck & Co says a federal appeals court ruled in its favour in a patent dispute over cancer drug Temodar with Barr Laboratories.
Barr is a part of generics drugs developer Teva Pharmaceuticals Industries.
Merck said an appellate court rejected, by a 2-1 vote, Barr's arguments and reversed a lower court ruling that the US patent was unenforceable.
Barr had been seeking US FDA approval to sell a generic version of the 5, 20, 100, 140, 180 and 250mg capsules of Temodar.
‘The court appropriately ruled that the patent for Temodar in the US is enforceable,’ said Bruce 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.’
The lawsuit has been ongoing since July 2007, when Schering-Plough, the developer of Temodar, filed a patent infringement lawsuit against Barr. Schering-Plough is now part of Merck.
Teva agreed in March this year that it would not launch a generic version of Temodar during the appeal.
Merck agreed to allow Teva to launch a generic version of Temodar in August 2013 if the patent was upheld. Merck said otherwise the US patent and exclusivity periods would expire in February 2014.