In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit ('Federal Circuit') held patent claims invalid for lack of written description where a negative limitation was not 'necessarily excluded' by the specification, reversing the district court's judgment finding adequate written description. See Case No. 2021-1070 (June 21, 2022). The Federal Circuit found that the claim limitation 'absent an immediately preceding loading dose' lacked written description because the patent 'fail[ed] to disclose the absence of a loading dose' and the specification's silence on the loading dosage did not satisfy written description. Id. at 2. Although the written description requirement does not require a negative limitation to be recited verbatim in the specification, the language of the specification must indicate that the inventor intended exclusion. A person of ordinary skill in the art, reading the specification, must 'understand [the] negative limitation to necessarily be present in the disclosure.' Id. at 12.
This decision underscores the need to describe all possible permutations of the claims in the patent specification, including...
