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ANDA Filing Not Willful Patent Infringement Per Se, Federal Circuit Rules

Law360 (July 29, 2004, 12:00 AM EDT) -- The mere filing of an Abbreviated New Drug Application (ANDA) cannot constitute an act of willful infringement compensable by attorney’s fees under the Hatch-Waxman Act, the U.S. Court of Appeals for the Federal Circuit has ruled.

The court’s decision, published on Tuesday, affirmed a lower court’s ruling that Canadian generics maker Apotex infringed two patents held by GlaxoSmithKline for its antibiotic Ceftin, but refused to classify the infringement as “willful.”

“We hold that the mere filing of an ANDA cannot constitute an act of willful infringement...
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