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Federal court upholds judgment preventing a generic version of ketorolac

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IRVINE, Calif. — The U.S. Court of Appeals for the Federal Circuit has affirmed a favorable ruling for Allergan and Roche Palo Alto, formerly known as Syntex, in a patent infringement lawsuit against three companies seeking to market a generic version of ketorolac, Allergan announced in a press release.

The decision upholds a 2006 ruling by the U.S. District Court for the Northern District of California against Apotex Inc., Apotex Corp. and Novex Pharma. In that ruling, the court decided that a proposed generic version of Acular (ketorolac tromethamine ophthalmic solution 0.5%, Allergan) infringed a valid and enforceable patent owned by Roche Palo Alto and licensed to Allergan, according to the release.

The new ruling prevents the defendants from obtaining U.S. Food and Drug Administration approval to market a generic version of the drug until the patent expires in 2009. It also prevents them from preparing to manufacture or sell the drug in the United States.

Acular is indicated for temporarily relieving symptoms of seasonal allergic conjunctivitis and for treating post-cataract surgery inflammation, according to the release.