The US District Court for the Eastern District of Texas has issued a positive judgment in the proceedings of a lawsuit between POZEN Inc. and several generic pharmaceutical companies, announced POZEN. These companies had filed Abbreviated New Drug Applications (ANDAs) seeking FDA marketing approval for generic versions of Treximet(R) (sumatriptan/naproxen sodium).
GlaxoSmithKline, the exclusive US licensee of POZEN, is in charge of marketing Treximet. According to the District Court ruling, Par Pharmaceutical, Inc., Alphapharm Pty Ltd., and Dr. Reddy’s Laboratories, Inc. infringed the US Patent Nos. 6,060,499 (the ‘499 patent) and 6,586,458 (the ‘458 patent) to be valid and enforceable. Further, Par and DRL infringed the US Patent No. 7,332,183 (the ‘183 patent) covering the Treximet formulation to be valid and enforceable. The ‘183 patent was not asserted against Alphapharm.
In April 2010, another defendant in the lawsuit – Teva Pharmaceuticals, USA, Inc – agreed to get into a settlement with POZEN. Although Teva was released from the lawsuit, as maintained by the terms of the agreement, the company obliged to be bound by the outcome. The decision may be challenged by the defendants in the Court of Appeals for the Federal Circuit.
The District Court ruled that the FDA not grant approval for the ANDAs by Par and DRL at least until the ‘183 patent expires on February 2, 2025, and for the ANDA by Alphapharm at least until the ‘499 and ‘458 patents expire on August 14, 2017. If the FDA allows pediatric exclusivity to the petition by GSK, each of the above dates may be extended by six months.
Attorneys from the law firm of Vinson & Elkins L.L.P. represented POZEN in the proceedings of this lawsuit.
Chairperson, President, and Chief Executive Officer of POZEN, John Plachetka, said: “We are pleased that the District Court has ruled in favor of POZEN, thus upholding the patents protecting Treximet.”