The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the presumption of obviousness does not apply automatically and must be grounded in specific factual findings, particularly regarding a skilled artisan’s motivation and expectations. Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 25-1228 (Fed. Cir. July 8, 2025) (Prost, Reyna, Taranto, JJ.)

Janssen sued Teva under the Hatch-Waxman Act in 2018 after Teva filed an abbreviated new drug application (ANDA) seeking approval for a generic version of Janssen’s drug. Teva stipulated infringement but challenged the patent’s validity, arguing that all claims were obvious in light of prior art. The patent at issue covered a dosing regimen involving two “loading doses” spaced about a week apart, followed by monthly maintenance injections, designed to improve patient compliance compared to traditional oral dosing.

In 2021, the district court rejected Teva’s obviousness arguments, citing key differences between the claims and prior art, including the specific dosage amounts, the sequence of administration, and the requirement for deltoid injections. In 2024, the Federal Circuit initially vacated that decision and remanded for further analysis. On remand, the district court again found the claims nonobvious, and Teva appealed again.

A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. Teva argued that a presumption of obviousness should apply because the prior art disclosed equal loading doses (150 or 100 mg-eq) within the claimed range. The Federal Circuit disagreed, emphasizing that the presumption depends on factual premises (such as a skilled artisan’s motivation to optimize and expectations from routine experimentation), which were not met here. The Court noted that Janssen’s specific choice of a higher first dose followed by a lower second dose did not clearly fall within the presumption’s scope.

Turning to the obviousness analysis, the Federal Circuit found that the three primary prior art references did not disclose a loading-dose regimen. Teva’s additional references, which it claimed taught dose reduction strategies, were also deemed insufficient. The Court found that one expert cited a reference recommending a high first dose for acutely ill patients while another noted that long-acting injectables were not typically used for such patients. The Court found that the prior art taken as a whole undermined Teva’s position.

Teva further contended that the district court improperly considered safety and efficacy (factors not recited in the claims) and erred in finding that the multidose regimen added complexity that would discourage a skilled artisan. The Federal Circuit rejected these arguments, affirming that the district court appropriately considered the motivation to develop a safe and effective regimen and correctly found that the prior art lacked relevant safety or efficacy data for multidose approaches.