Federal Circuit, district court, and arbitration victories protect Cumberland Pharmaceuticals’ flagship product, Acetadote^®

In decisions from the U.S. Federal Circuit Court of Appeals, U.S. District Court for the Northern District of Illinois, and the American Arbitration Association (AAA), Finnegan successfully prevented a larger competitor from manufacturing or selling a generic version of Finnegan client Cumberland Pharmaceuticals’ flagship product, Acetadote^®, a life-saving intravenous formulation of acetylcysteine for the treatment of acetaminophen overdose. Cumberland’s current patent-protected formulation is free of the EDTA chelating agent, which is an improvement over earlier formulations sold by Cumberland and others. First, in the AAA decision, the arbitrator issued a final award in favor of Cumberland enjoining the competitor and further awarded attorney’s fees and costs to Cumberland. Second, in the Abbreviated New Drug Application (ANDA) district court case, following claim construction rulings favorable to Cumberland, the generic company conceded infringement. A trial proceeded on the generic’s three validity attacks—derivation, anticipation, and obviousness—which were all rejected by the presiding judge. Finally, in response to the generic’s appeal of the district court’s decision, the Federal Circuit further considered and expressly rejected the generic’s validity attacks. The Federal Circuit’s affirmance of the district court’s ruling thus confirms Cumberland’s patent protection for ten years.