Federal Circuit Summary

Before Prost, Dyk, and Moore. Appeal from District of Delaware.

Summary: A district court’s construction of a claim term that is contrary to the plain language of the claims and usage of the term in the specification was erroneous.

Sigmapharm, Hikma, Breckenridge, Alembic, and Amneal filed ANDAs with the FDA seeking to market generic versions of Saphris, a drug product sold by Forest. Saphris is an antipsychotic drug administered under the tongue. Forest sued for patent infringement. After a bench trial, the district court held, inter alia, that Forest had not established infringement of one of the asserted claims as to Alembic and Breckenridge because the claim at issue was directed to “a method for treating tension, excitation, anxiety, and psychotic and schizophrenic disorders” and Alembic’s and Breckenridge’s ANDA products were indicated for treatment of “manic episodes” associated with bipolar I disorder. Forest appealed the district court’s finding of non-infringement by Breckenridge and Alembic.

The Federal Circuit vacated and remanded for the district court to reconsider infringement of the relevant claim under a corrected claim construction for “excitation.” The Federal Circuit held that the district court erred in treating “excitation” as limited to “excitation disorders,” not to symptoms of such, because “[t]he use of the conjunction ‘and’ before ‘psychotic and schizophrenic disorders’ indicates that ‘psychotic and schizophrenic disorders’ is a distinct item on the list, and that unlike the terms ‘psychotic’ and ‘schizophrenic,’ the words ‘tension,’ ‘excitation,’ and ‘anxiety’ are not describing ‘disorders.’ This is consistent with how ‘excitation’ is used elsewhere in the specification.” The Federal Circuit construed “excitation” to refer to a symptom of a disease or disorder and remanded the case for the district court to consider infringement using the proper construction of “excitation.”

This case is: FOREST LABORATORIES, LLC v. SIGMAPHARM LABORATORIES

Editor: Paul Stewart

Written by: April K. White & Christie Matthaei