Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Novartis Pharmaceuticals v. Accord Healthcare Inc. et al., No. 2021-1070 (Jan. 3, 2022), affirming the district court’s decision that the asserted patent was not invalid for insufficient written description.
HEC filed an ANDA (Abbreviated New Drug Application) with the FDA seeking approval to market a generic version of a drug to treat relapsing remitting multiple sclerosis. Novartis sued for infringement of U.S. Patent No. 9,187,405. HEC alleged the claims of the ‘405 patent were invalid for insufficient written description of (1) the 0.5 mg/day dosage limitation and (2) a negative claim limitation, namely the “absent an immediately preceding loading dose” limitation. A loading dose is a higher than daily dose usually given as the first dose. After a bench trial, the district court ruled in favor of Novartis. HEC appealed.
The Federal Circuit affirmed. Regarding the 0.5 mg/day dosage limitation, the Court held that the district court did not commit clear error in finding that the claims were not invalid for lack of written description in view of the discussion of that dosage in the specification and expert testimony concerning the same. Regarding the negative claim limitation, the Court rejected HEC’s argument that the district court’s written description finding—that silence on loading doses in the ’405 patent’s specification supported the negative limitation in the claims—contradicted its other finding that the prior art Kappos abstract, which was similarly silent on loading doses, does not anticipate claims of the ’405 patent. The Court reasoned that the ’405 patent is presumed valid and, thus, it is also presumed to have a complete written description. No such presumption, however, applies to disclosures in a prior art reference that is not itself a granted patent, such as the Kappos abstract. Because the understanding of one of the skill in the art is important in both the written description and the anticipation inquiries, the Court looked to expert testimony on whether the Kappos abstract would have been understood to be complete. The Court held it was not clear error for the district court to find that one of skill in the art would read the ‘405 patent’s specification to disclose no loading dose and would read the Kappos abstract as silent on the presence or absence of a loading dose such that it does not anticipate the claims.