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Limitation on Future Patent Protection for Biosimilars?

August 06, 2012

By MELANIE R. RUPERT AND EVAN D. DIAMOND

On August 3, 2012, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating a preliminary injunction that had been granted by the U.S. District Court for the District of Massachusetts to Momenta Pharmaceuticals, Inc. and Sandoz, Inc. (collectively, "Momenta"). Momenta until recently the sole marketer in the United States of a generic version of sanofi-aventis's branded drug Lovenox® (enoxaparin) had previously brought suit against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively, "Amphastar") for infringement of Momenta's patents claiming quality control methods for generic versions of Lovenox®. At Momenta's request, the district court issued a preliminary injunction precluding Amphastar from selling its own generic version of Lovenox®, rejecting Amphastar's argument that its use of Momenta's patented methods after FDA approval of Amphastar's generic product could fall within the safe harbor of 35 U.S.C. § 271(e)(1). On appeal, the Federal Circuit vacated the preliminary injunction (over Chief Judge Rader's dissent), holding that in some circumstances, even post-approval manufacturing activities may fall within the § 271(e)(1) safe harbor and be immune from infringement liability.