Momenta Pharma., Inc. v. Amphastar Pharma, Inc., No. 12-1062 (Fed. Cir. 2012)Annotate this Case
Lovenox (enoxaparin) prevents blood clots. Enoxaparin is a version of heparin. Heparin molecules have considerable diversity in characteristics. Additional diversity is introduced when heparin is broken down, raising a problem with the FDA abbreviated new drug application (ANDA) process. ANDAs are used to obtain approval for a generic version of an existing drug and do not require extensive studies needed to initially prove the drug’s safety and efficacy. Aventis, which marketed Lovenox, asked the FDA to deny ANDA approval for a generic enoxaparin unless the applicant took certain steps. The FDA rejected Aventis’s arguments, stating that ANDA does not describe the information necessary to demonstrate that the active ingredient in the generic product is the same as the active ingredient in the reference drug. The FDA identified its own criteria for determining that generic enoxaparin has the same active ingredient as Lovenox. Amphastar was first to file an ANDA for generic enoxaparin and received FDA approval in2011. Momenta was first to bring generic enoxaparin to market, obtaining FDA approval more than a year earlier. Momenta alleged that Amphastar infringed its patent for analyzing heparin and obtained an injunction. The district court found that Amphastar’s quality control batch testing infringed the patent. The Federal Circuit vacated. The court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. 271(e)(1).