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.).

(Petition for writ of certiorari available. Document #78-160620-009B.)

The Federal Circuit U.S. Court of Appeals ruled Nov. 10 that although a Massachusetts federal judge properly...
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