Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. (Fed. Cir. 2024)

By Kevin E. Noonan — The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after Defendant Norwich submitted a revised ANDA containing a Section viii “carveout” in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. The majority opinion raises issues in its invalidity analysis regarding the extent to which the prior art should be required to disclose the recited administered dose to satisfy the “reasonable expectation of success” prong for obviousness for pharmaceutical claims (wherein the standard…