November 18, 2015
Authored and Edited by Paula E. Miller; Justin J. Hasford
In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., 809 F.3d 610 (Fed. Cir. 2015), the CAFC affirmed a summary judgment determination by the district court that Teva’s particular importation and Amphastar’s particular domestic manufacture of generic versions of enoxaparin did not infringe Momenta’s method patent claims under 35 USC 271(g). The CAFC also vacated and remanded a summary judgment determination by the district court that Amphastar’s particular domestic manufacture of generic versions of enoxaparin fell within the 35 USC 271(e)(2) safe harbor and therefore did not infringe under 35 USC 271(a). The patent in both cases was related to a process of quality control release testing, not a method of making the pharmaceutical product. Further discussion of the decision can be found on Finnegan’s Federal Circuit IP Blog.
United States Court of Appeals for the Federal Circuit (CAFC), Food and Drug Administration (FDA), drugs, generic drug, infringement
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