Amphastar Tells U.S. High Court Hatch-Waxman Patent Safe Harbor Is Too Narrow

(June 17, 2016, 7:43 AM EDT) -- WASHINGTON, D.C. — The U.S. Supreme Court should rule that an appellate court’s interpretation of the Hatch-Waxman safe harbor, 35 U.S. Code Section 271(e)(1), is “overly narrow” and puts generic manufacturers at risk of patent suits, Amphastar Pharmaceuticals Inc. argues in a May 17 petition (Amphastar Pharmaceuticals, Inc., et al. v. Momenta Pharmaceuticals, Inc. and Sandoz, Inc., No. 15-1402, U.S. Sup.)....