Labopharm comments on the outcome of patent-infringement litigation related to Ultram ER

Jun 4 2010

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today commented on the outcome of the appeal by Purdue Pharma Products L.P. and the cross-appeal by Par Pharmaceutical Companies, Inc. of the decision of the United States District Court for the District of Delaware (the Court) in August 2009 on patent-infringement litigation initiated by Purdue against Par relating to Ultram(R) ER (tramadol hydrochloride extended-release tablets).

In its decision of August 2009, the Court entered judgment in favor of Purdue and against Par on the issue of infringement and rejected Par's claim that the patents were unenforceable for inequitable conduct. The Court, however, entered judgment in favor of Par and against Purdue on the issue of validity, citing obviousness. On June 3, 2010, the United States Court of Appeals for the Federal Circuit entered judgment upholding the lower court's original decision.

The August 2009 judgment permitted Par to market its generic formulation of Ultram ER in the U.S. following receipt of final regulatory approval from the U.S. Food and Drug Administration. Labopharm's once-daily tramadol product, RYZOLT(TM), is marketed in the U.S. by Purdue, however, Ultram(R) ER, and therefore any generic version of it, is not therapeutically equivalent (A/B rated) to RYZOLT(TM), and cannot be substituted for RYZOLT(TM).

SOURCE Labopharm Inc.