The § 271(e)(1) Safe Harbor Covers Generic Quality Control Batch Testing Even After FDA Approval

In Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., Nos. 12-1062, -1103, -1104 (Fed. Cir. Aug. 3, 2012), the Federal Circuit vacated the district court's grant of a preliminary injunction and remanded for further proceedings, holding that the district court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1).

Lovenox (enoxaparin), a drug that prevents blood clots, is marketed by Aventis Pharmaceuticals, Inc.  Enoxaparin is made up of a range of different molecules, because it is produced from heparin starting material that includes molecules that vary in the length of the component polysaccharide chains, and in the types and distribution of disaccharide units in the polysaccharide chains.  In light of this molecular diversity, the FDA, which has "broad discretion" regarding the information it considers for bioequivalence, "identified five . . . 'standards for identity,' that 'together provide sufficient