CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

In  a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court's grant of summary judgment of noninfringement in favor of Breckenridge, and remanded for entry of judgment in favor of Braintree. In reaching its decision, the court held Breckenridge to its previous stipulations, and found that proposed ANDA labeling for "colon cleansing" induced infringement of claims directed to "inducing purgation."

The Patent At Issue

The patent at issue was Braintree's U.S. Patent 6,946,149, which is listed in the Orange Book for its SUPREP® Bowel Prep Kit for preparing patients for colonoscopies. Reexamined claim 15 was treated as representative (emphasis added to terms at issue):