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POZEN Inc.
POZN, a pharmaceutical company committed to transforming
medicines that transform lives, today announced that the United States Court
of Appeals for the Federal Circuit has affirmed the August 5, 2011 decision of
the United States District Court for the Eastern District of Texas that had
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 U.S. Food and Drug Administration (FDA) to
market generic copies of Treximet ^® (sumatriptan / naproxen sodium). Treximet
is marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline (GSK). The
Federal Court of Appeals affirmed the lower court ruling which held that U.S.
Patent Nos. 6,060,499 (the ʼ499 patent) and 6,586,458 (the ʼ458 patent) were
valid, enforceable and infringed by Par Pharmaceutical, Inc. (Par), Alphapharm
Pty Ltd. (Alphapharm), and Dr. Reddy's Laboratories, Inc. (DRL). A third
patent, U.S. Patent No. 7,332,183 (the ʼ183 patent) covering the Treximet
formulation was valid, enforceable and infringed by Par and DRL. The ʼ183
patent was not asserted against Alphapharm.
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