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Published on 2/6/2006 in the Prospect News Biotech Daily.

Endo to continue to market its bioequivalent version of OxyContin

By Lisa Kerner

Erie, Pa., Feb. 6 - Endo Pharmaceuticals Holdings Inc. said its wholly owned subsidiary, Endo Pharmaceuticals Inc., will continue its commercial sales of its bioequivalent version of OxyContin.

The Federal Circuit Court of Appeals had vacated a previous unanimous affirmance of the opinion and order issued in Endo's favor by the U.S. District Court for the Southern District of New York. The order found Purdue Pharma had committed inequitable conduct in the U.S. Patent and Trademark Office, according to a company news release.

The Federal Circuit also affirmed the District Court's finding that, if Purdue's patents are enforceable, Endo's oxycodone extended-release tablets infringe these patents.

The Federal Circuit issued a new opinion on Feb. 1 remanding the case to the same district court for its further consideration.

Upon reviewing the Federal Circuit Court's opinion with counsel, Endo believes the District Court should again find that Purdue's patents are unenforceable, due to Purdue's conduct before the Patent and Trademark Office.

The company intends to pursue the remand proceedings in the District Court. In the event of a final, nonappealable adverse determination against it, the Endo would be required to terminate its sales of its bioequivalent version of OxyContin.

If Purdue's patents are found to be valid and enforceable, Endo could face liability for patent infringement and be obligated to pay Purdue damages.

Endo is a specialty pharmaceutical company based in Chadds Ford, Pa.


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