U.S. District Court grants preliminary injunction to POZEN's Treximet patent lawsuit

Apr 15 2011

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction ordering Par Pharmaceutical Inc. (Par) not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan/naproxen sodium that competes with Treximet^® (sumatriptan and naproxen sodium) sold by GlaxoSmithKline in the United States under an exclusive license from the Company.

The order was entered in connection with the patent infringement lawsuit pending among the Company and Par, Alphapharm Pty Ltd. (Alphapharm), Teva Pharmaceuticals USA, Inc. (Teva), and Dr. Reddy's Laboratories, Inc. (DRL) relating to the submission to the U.S. Food and Drug Administration (FDA) of Abbreviated New Drug Applications (ANDAs) by the four generic companies and the generic companies' plans to market sumatriptan and naproxen sodium products pursuant to such ANDAs, which the Company contends infringe three of its patents covering Treximet. Teva was dismissed without prejudice from the consolidated litigation in April 2010. The case against the other three defendants was tried before Judge Leonard Davis in the Eastern District of Texas on October 12-15, 2010. A decision is pending in the case.

For purposes of evaluating POZEN's motion for a preliminary injunction, Judge Davis focused his analysis on two asserted claims of U.S. Patent No. 6,586,458, one of three patents challenged by the defendants in the case. Judge Davis concluded that the Company had shown "that it is likely to succeed against Par on the merits of its infringement claim of the '458 patent." The Court further concluded that POZEN "is likely to succeed against Defendants' invalidity claims" concerning the '458 patent and that it "does not find that Defendants' arguments raise a substantial question regarding the enforceability of the '458 patent."

The injunction will remain in effect until a final decision is issued in the pending patent litigation. The Company continues to believe that its patents covering Treximet are valid and enforceable, and that these beliefs will be upheld by the Court.