Federal Circuit Addresses Quality Control Testing in Infringement and Safe Harbor Determination | Practical Law
In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., the US Court of Appeals for the Federal Circuit held that two generic drug manufacturers' use of a patented process to determine whether generic drug compound batches meet certain quality standards do not infringe under 35 U.S.C. Section 271(g). The court also held that the district court erred in concluding that one of the generic manufacturer's activities fell within the 35 U.S.C. Section 271(e)(1) infringement safe harbor.