Written by Michael Garcia and Andrea Cheek

The Federal Circuit affirmed the PTAB’s final written decisions holding that claims directed to Novartis’s dementia drug compositions containing Exelon were obvious in Novartis AG v. Noven Pharm. Inc., No. 2016-1679 (Fed. Cir. Apr. 4, 2017).

Novartis sought review of the PTAB’s decisions in two IPR proceedings that found Novartis’s claims obvious over the prior art. Novartis contended that the PTAB’s findings improperly reached different conclusions than prior district court litigation, which, Novartis argued, addressed the same arguments and the same evidence, and yet ultimately found the same claims to be nonobvious.

The Federal Circuit rejected Novartis’s arguments on factual and legal grounds. Factually, the Federal Circuit found that the district court proceeding did not share the same record as the PTAB, noting that the PTAB considered evidence not of record in the prior litigation. Legally, the Federal Circuit noted that a petitioner in an IPR must prove unpatentability by a preponderance of the evidence, whereas in district court, the burden of proof is clear and convincing evidence. Due to the different burdens of proof, the Federal Circuit reasoned that “the PTAB properly may reach a different conclusion based on the same evidence.”

The Federal Circuit reviewed the PTAB’s factual findings for substantial evidence. The patents disclosed a pharmaceutical compound useful for the treatment of Alzheimer’s disease. Novartis argued that substantial evidence did not support the PTAB’s factual findings regarding obviousness. The Federal Circuit disagreed, finding that Novartis’s arguments ignored the knowledge of organic chemistry possessed by one of ordinary skill in the art. Accordingly, the Federal Circuit affirmed the PTAB’s conclusions of obviousness.