Federal Circuit Denies Presumption of Obviousness in Affirming Validity of Loading Dose Regimen Patent

In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Nos. 2025-1228, 2025-1252 (Fed. Cir. July 8, 2025), the Federal Circuit affirmed a district court’s decision that found Janssen’s U.S. Patent No. 9,439,906 (the ’906 patent) had not been proven invalid.

The ’906 patent claims a schizophrenia treatment regimen that uses decreasing dosages to increase medication compliance. Janssen sued Teva under the Hatch-Waxman Act asserting that Teva’s proposed generic infringed the ’906 patent. Teva stipulated to infringement but countered that the ’906 patent was invalid as obvious in view of the prior art. The district court disagreed, finding a lack of motivation to combine asserted prior art references and rejecting Teva’s argument that claim 2 was entitled to a presumption of obviousness.

On appeal, the Federal Circuit held that the district court did not commit clear error in its factual findings. The Court found that Janssen’s choice to start with a particularly high first dose followed by a lower loading dose is more than merely selecting a number within a range disclosed in the prior art and thus did not support a presumption of obviousness. Further, the Court found that the record supported the district court’s finding that a skilled artisan would not have been motivated to modify the prior art to create the claimed invention. The Court affirmed.