Published on August 17, 2009 at 7:45 PM
Labopharm Inc. today commented on the outcome of patent-infringement litigation initiated by Purdue Pharma Products L.P. against Par Pharmaceutical Companies, Inc. relating to Ultram(R) ER (tramadol hydrochloride extended-release tablets).
The patents-in-suit are owned by Purdue and are licensed to Ortho-McNeil, Inc., the marketer of Ultram(R) ER. In his decision, Circuit Judge Kent Jordan 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. Judge Jordan, however, entered judgment in favor of Par and against Purdue on the issue of validity, citing obviousness.
This judgment could permit Par to market its generic formulation of Ultram ER in the U.S., should it receive final regulatory approval from the U.S. Food and Drug Administration. Although Labopharm is not a party to this action, if Par was to launch its generic formulation of Ultram ER, it could impact U.S. sales of Labopharm's own once-daily tramadol product, Ryzolt(TM), which is marketed in the U.S. by Purdue. Ultram ER, and therefore any generic version of it, is not A/B rated to Ryzolt, meaning it cannot be substituted for Ryzolt at the pharmacy.
Labopharm is currently in discussions with Purdue to evaluate next steps in this matter, including a potential appeal of the decision.
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