In a 2-1 decision,the Federal Circuit held that a product is not "made by" a patented process for the purposes of infringement under 35 USC 271(g) if it is merely used to determine whether the intended product of a separately-patented process has been manufactured. Momenta Pharm. Inc. v. Teva Pharm. USA, Inc., No. 2014-1274 (Fed. Cir. Nov. 10, 2015). The court held that the routine use of a patented testing process in the commercial manufacture of a drug is not covered by 35 USC 271(e) safe harbor provision. In this case, Momenta, assignee of asserted patent, markets generic version of an anticoagulant Enoxaparin. Teva sources the generic version from Italian company Chemi S.p.A. that manufactures, analyzes, tests, packages and labels Teva's generic version which Teva imports into the U.S. Momenta sued Teva for infringement of its patented process. The court concluded that Teva's products were not "made by" Momenta's patented process for purposes of 271(g). Full text of the opinion is available here.
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