Location of Accused Activity Informs Post-Approval Enforceability of
Location of Accused Activity Informs Post-Approval Enforceability of "Quality-Control" Process Patents

Location of Accused Activity Informs Post-Approval Enforceability of "Quality-Control" Process Patents

On November 10, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in two companion cases: Momenta Pharms. Inc. v. Teva Pharms. USA Inc. (14-CV-1274, 14-CV-1277) and Momenta Pharms. Inc. v. Amphastar Pharms., Inc. (14-CV-1276, 14-CV-1278). In these cases, the court considered Teva's and Amphastar's manufacture of generic enoxaparin. Both companies' manufacturing processes include a quality-control (or "QC") step which is allegedly covered by a patent assigned to Momenta. Notably, the patented QC step is not directly involved in the making of the finished enoxaparin product, but rather is used to separate "conforming" and "non-conforming" batches of enoxaparin during the manufacturing process. Teva manufactures its generic enoxaparin product in Italy. In contrast, Amphastar manufactures its generic enoxaparin in the United States.

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