Addressing the scope of the Hatch-Waxman safe harbor provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit found that practicing a patented method in the commercial manufacture of a drug was not an act of infringement.  Momenta Pharm., Inc. v. Amphastar Pharm., Inc.., Case Nos. 12-1062, -1103, -1104 (Fed. Cir., Aug. 3, 2012) (Moore, J.) (Rader, C.J., dissenting).

The Momenta patents at-issue contained claims directed to manufacturing methods for analyzing the anticoagulant drug enoxaparin.  Amphastar received approval by the U.S. Food and Drug Administration (FDA) to market enoxaparin and subsequently began to manufacture and market the drug.  Momenta alleged that Amphastar, as part of its commercial manufacturing processes, practiced Momenta’s patented manufacturing methods.

The Federal Circuit found that Amphastar’s activity fell within the safe harbor provision of § 271(e)(1) and was, thus, not an act of infringement.  The Court explained that “post approval studies that are ‘reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs’ fall within the scope of the § 271(e)(1) safe harbor.”  The Court further explained that the FDA requirement that information from Amphastar’s testing be retained for FDA inspection “satisfies the requirement that the uses be reasonably related to the development and submission of information to the FDA.”  According to the majority, “we think that the requirement to maintain records for FDA inspection satisfies the requirement that the uses be reasonably related to the development and submission of information to the FDA.”

Chief Judge Rader dissented, arguing that the majority opinion conflicted with the Court’s prior decision in Classen Immunotherapies, Inc. v. Biogen IDEC.  Chief Judge Rader wrote “[t]his court’s interpretation of § 271(e)(1) would essentially render manufacturing method patents worthless.”  Momenta has filed a petition for rehearing en banc.