POZEN Inc. has announced that the United States District
Court for the Eastern District of Texas has issued a favorable verdict in the
litigation between POZEN and several generic pharmaceutical companies which had
filed Abbreviated New Drug Applications (ANDAs) seeking approval from the FDA
to market generic copies of Treximet(R) (sumatriptan / naproxen sodium).
Treximet is marketed by POZEN’s exclusive U.S. licensee, GlaxoSmithKline. The
District Court ruled U.S. 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., Alphapharm Pty Ltd., and Dr. Reddy’s Laboratories, Inc. A third patent,
U.S. 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
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
favor of POZEN, thus upholding the patents protecting Treximet,” said John
Plachetka, Chairman, President and Chief Executive Officer of POZEN.