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)).
Momenta is the assignee of U.S. Patent No. 7,575,886, which recites “methods for analyzing heterogeneous populations of sulfated polysaccharides,” such as enoxaparin, the active ingredient in LOVENOX® used to prevent deep vein thrombosis. Momenta, collaborating with Sandoz, Inc., was the first company to bring a generic version of Sanofi-Aventis’ developed LOVENOX® to market. Momenta filed suit to block Amphastar asserting that the competing generic drug maker used Momenta’s patented method to analyze commercial batches of enoxaparin after obtaining FDA approval. The FDA, however, required Amphastar to conduct a laboratory determination of the identity and strength of the active ingredient for each batch of enoxaparin.” Therefore, Amphastar’s batch testing was necessary for the post-FDA approval sale of the generic drug.
While acknowledging that Amphastar used the patented method to develop information for possible submission to the FDA, the district court found that the safe harbor provision “does not permit a generic manufacturer to continue in otherwise infringing activity after obtaining approval” (slip op. at 9). Since Amphastar’s post-approval activities likely infringed Momenta’s patent, the district court granted a preliminary injunction, halting Amphastar’s production of enoxaparin.
Please see full publication below for more information.
