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SCOTUS to decide whether to hear generic enoxaparin case

June 7, 2013 12:57 AM UTC

The U.S. Supreme Court will discuss on June 20 whether it will hear an appeal from generic enoxaparin maker Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) of an August decision from the U.S. Court of Appeals for the Federal Circuit (CAFC). That 2-1 decision vacated a preliminary injunction granted by a district court that would have prevented Amphastar Pharmaceuticals Inc. (Rancho Cucamonga, Calif.) from selling its own generic version of the anticoagulant. Momenta is alleging that Amphastar infringed two of Momenta's patents by using Momenta's method of showing bioequivalence to Lovenox enoxaparin from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Aug. 3, 2012).

If SCOTUS decides not to hear the case, the appeals court's interpretation of the safe harbor provision of the Hatch-Waxman Act will stand. The provision exempts from infringement "the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." The CAFC said the provision is not specific to the ANDA approval process and also applies to any commercial manufacturing activity of an approved drug where FDA requires sponsors maintain records. Since FDA requires generic manufacturers to keep records detailing each step of an approved manufacturing process to maintain approval of an ANDA, the appeals court thus held that Amphastar is not liable for infringement for using Momenta's method to show bioequivalence. The dissenting judge argued that interpretation "would essentially render manufacturing method patents worthless." ...