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Federal Circuit confines the infringement analysis in generic drug cases to the product as described in the defendant’s FDA application

November 4, 2013

Federal Circuit confines the infringement analysis in generic drug cases to the product as described in the defendant’s FDA application

November 4, 2013

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The criteria for determining Hatch-Waxman infringement may now have something new to consider at a federal circuit’s recent decision in Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc. Sunovion held that if the ANDA describes an aspect of the defendant’s product that is determinative of infringement, then the ANDA’s description of the product controls, and the defendant may not use extrinsic evidence to argue non-infringement.

Fish’s Craig Countryman, Associate in our Southern California office, wrote this blog post and answer’s a question unique to Hatch-Waxman cases in light of this federal circuit decision: what sources of information can a court consider to determine what the defendant would sell if it obtained FDA approval?

Fish’s Litigation Blog is a community site where our intellectual property, commercial, and white collar litigators share information on nationwide litigation developments and trends. Stay current with Fish – read this blog post about determining infringement in Hatch-Waxman cases and join the conversation.

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