ANDA litigation : CAFC Alert

CAFC redefines the singular phrase “a patient” as a plural patient population

| November 18, 2014

Braintree Laboratories, Inc. v. Novel Laboratories, Inc.

April 22, 2014

Panel: Dyk, Prost Moore. Majority opinion by Prost. Concurrence by Dyk. Dissent by Moore.


In this ANDA litigation, the claims recited a composition for purgation of the colon of “a patient”. The majority imported the preamble phrase of “a patient” into the claim, and also interpreted this as not a single patient, but rather a “patient population”. Judge Moore dissented on this point. Additionally, Judge Dyk dissented on the grounds that the majority based its analysis on an accused infringing product different from the subject of the ANDA application, contrary to Hatch-Waxman rules.

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