Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

By Kevin E. Noonan — When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim? This is a question that comes readily to mind when reading the Federal Circuit’s opinion (and Chief Judge Moore’s dissent) in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022). The case arose in ANDA litigation over U.S. Patent No. 9,187,405, which recites methods for treating recurring remitting multiple sclerosis (RRMS), a degenerative disorder of the myelin surrounding nervous tissue, with fingolimod…