Pozen Inc., a pharmaceutical company committed to transforming medicines that transform lives, announced that the United States District Court for the Eastern District of Texas has issued a favourable verdict in the litigation between Pozen and several generic pharmaceutical companies which had filed Abbreviated New Drug Applications (ANDAs) seeking approval from the US Food and Drug Administration (FDA) to market generic copies of Treximet (sumatriptan/naproxen sodium).
Treximet is marketed by Pozen's exclusive US licensee, GlaxoSmithKline (GSK). The District Court ruled US Patent Nos. 6,060,499 (the '499 patent) and 6,586,458 (the '458 patent) to be valid, enforceable and infringed by Par Pharmaceutical, Inc. (Par), Alphapharm Pty Ltd. (Alphapharm), and Dr Reddy's Laboratories, Inc. (DRL). A third patent, US Patent No. 7,332,183 (the '183 patent) covering the Treximet formulation was held to be valid, enforceable and infringed by Par and DRL. The '183 patent was not asserted against Alphapharm.
Teva Pharmaceuticals, USA, Inc., another defendant in the litigation, entered into a settlement agreement with the company in April 2010 under which it was dismissed from the litigation, but agreed to be bound by the outcome. The defendants have the right to appeal the decision to the Court of Appeals for the Federal Circuit.
The District Court also ordered that defendants' ANDAs not be approved by the FDA until, with respect to Par and DRL, at least the expiration of the '183 patent on February 2, 2025, and with respect to Alphapharm, the expiration of the '499 and '458 patents on August 14, 2017. Each of the above dates may be extended by six months if the FDA grants GSK's petition for paediatric exclusivity.
Pozen was represented in this matter by attorneys from the law firm of Vinson & Elkins L.L.P.
“We are pleased that the District Court has ruled in favour of Pozen, thus upholding the patents protecting Treximet,” said John Plachetka, chairman, president and chief executive officer of Pozen.
Pozen Inc. is a progressive pharmaceutical company that is transforming the healthcare industry to meet medical needs. By utilizing a unique in-source model and a focus on integrated therapies, Pozen has successfully developed and obtained FDA approval of two self-invented products in two years - something almost no other small pharmaceutical company has done.
Treximet (sumatriptan/naproxen sodium)was approved by the US Food and Drug Administration (FDA) in April 2008 for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with Pozen's patented technology of combining a triptan with a Non-Steroidal Anti-Inflammatory Drug (NSAID) and GlaxoSmithKline's (GSK) RT Technology.