Forest Laboratories, LLC v. Sigmapharm Laboratories, LLC, No. 17-2369 (Fed. Cir. 2019)Annotate this Case
Drug manufacturers filed Abbreviated New Drug Applications with the Food and Drug Administration seeking to market generic versions of Saphris, a drug product sold by Forest Laboratories. Saphris is a sublingually administered, atypical antipsychotic containing asenapine maleate. Forest sued for patent infringement, asserting that the proposed generic products would infringe claims of its patents. The district court held the generic manufacturers had not established certain claims to be invalid and held Forest had not established infringement of certain claims as to two manufacturers. The Federal Circuit vacated and remanded the validity determination, and for reconsideration infringement under a corrected claim construction. The district court erred in treating “excitation” as being limited to “excitation disorders.” The court rejected claims concerning sufficient written description, obviousness, and the construction of other claims.