A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry.  In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.

As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886.  The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides.  Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale.  (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.)  The district court granted Momenta a preliminary injunction, concluding that Amphastar’s testing … Read More »