After the Federal Circuit vacated and remanded the district court's non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen's patent relating to dosing regimens of long-acting injectable antipsychotic medications were obvious.
The Federal Circuit affirmed the district court's finding of non-obviousness, holding that Teva was not entitled to a presumption of obviousness, and had otherwise failed to meet its burden of proof. While the Court found that the district court erred in reading past Federal Circuit cases to create strict rules on the applicability of the presumption of obviousness, the Court held that the facts-at-issue involved complex combinations of multi-step dosing sequences that supported the district court's conclusion that the presumption of obviousness did not apply. Moreover, the Court highlighted that Janssen's choices regarding loading doses did not cleanly fit within the presumption's focus of merely selecting and optimizing a dosage within a prior art's range. Since a presumption of obviousness did not apply, the Court found that a full obviousness analysis was required.
Turning to obviousness generally, the Court affirmed the district court's determination that Teva had not managed to meet its evidentiary burden, highlighting that: (1) the prior art differed from the invention because it taught maintenance doses, not loading doses, (2) skilled artisans would not reasonably infer from reduction of maintenance doses a motivation to reduce a second loading dose, (3) Haloperidol decanoate (Haldol) behaved differently from the invention and was properly not included within the relevant prior art, and (4) the prior art showed no expectation that multi-dose regimens would be safe or effective. In upholding the district court's finding of nonobviousness, the Federal Circuit confirmed that Teva had not established a sufficient reason for a skilled artisan to adopt the unequal, decreasing loading doses required by the patent and that there was no reasonable expectation of success.
Janssen Pharms. Inc., v. Teva Pharms. USA, Inc., No. 2025-1228 (Fed. Cir. Jul. 8, 2025)
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