Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.

 
APPEAL NO.
21-1070
OP. BELOW
DCT
SUBJECT
Patent
AUTHOR
O'Malley

Question(s) Presented

  1. “The ‘405 patent claims 0.5 mg of fingolimod administered daily ‘absent an immediately preceding loading dose,’ yet the concept of loading dose is nowhere in the specification or the priority filing and the claim language was added years after the earliest claimed priority date. Does silence in the specification satisfy the written description requirement under 35 U.S.C. §112 for a negative claim limitation?”
  2. “Is this Court bound to findings of fact concerning what a patent specification discloses or fails to disclose where those district court findings are based solely on expert testimony that are contradicted by the intrinsic evidence and plain language of the specification?”