MBHB Partner Kevin Noonan Authors DDNEWS Article Entitled, “Scope of safe harbor provisions of Hatch-Waxman Act still unclear”

McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “Scope of safe harbor provisions of Hatch-Waxman Act still unclear” that appears in the February 2016 online edition of DDNEWS. He question of the extent to which the “safe harbor” against infringement that is part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by the different conclusions arrived at by the Court of Appeals for the Federal Circuit in Classen Immunotherapies, Inc. v. Biogen IDEC and Momenta Pharmaceuticals, Inc. v. Amphastar Inc. The issue once again came before the court in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., in a decision handed down last month. The decision provides another example of the court setting forth the contours of the scope of the safe harbor, particularly with regard to activities performed by a generic drug maker to ensure quality control and other aspects of drug making post approval. view the article