• “Safe Harbor” Provisions of Hatch-Waxman Offer Protection for Certain Post-Approval Activities
  • August 13, 2012 | Authors: Joshua B. Aronson; William L. Warren
  • Law Firm: Sutherland Asbill & Brennan LLP - Atlanta Office
  • After finding that the Hatch-Waxman Act’s “safe harbor” provision protects “post-approval studies that are ‘reasonably related to the development and submission of information under a Federal law,’” a split panel of the U.S. Court of Appeals for the Federal Circuit vacated a preliminary injunction blocking the sale of a generic version of LOVENOX® (enoxaparin injection) by Amphastar Pharmaceuticals, Inc. and Watson Pharmaceuticals, Inc., because the generic drug makers’ protected post-FDA approval activities did not infringe a Momenta Pharmaceuticals, Inc. patent (Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., No. 2012-1062 (Fed. Cir. Aug. 3, 2012)).