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Motivation, expectation of success negate obviousness presumption in overlapping range case

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.

Injunctive Relief Available Even Where Laches Bars Trademark Infringement, Unfair Competition Damage Claims

The US Court of Appeals for the 11th Circuit affirmed a district court’s conclusion that laches barred an advertising and marketing company’s claims for monetary damages for trademark infringement and unfair competition, but remanded the case for assessment of injunctive relief to protect the public’s interest in avoiding confusion between two similarly named companies operating in the advertising sector. Pinnacle Advertising and Marketing Group, Inc. v. Pinnacle Advertising and Marketing Group, LLC, Case No. 19-15167 (11th Cir. Aug. 2, 2021) (Branch, J.)

Pinnacle Advertising and Marketing Group (Pinnacle Illinois) is an Illinois-based company and owner of two registered trademarks including the name “Pinnacle.” Pinnacle Illinois learned of a Florida-based company operating under almost the same name that was also in the advertising and marketing space—Pinnacle Advertising and Marketing Group (Pinnacle Florida) —through potential clients and a magazine’s accidental conflation of the two unrelated companies. Several years later, Pinnacle Illinois sued Pinnacle Florida for trademark infringement, unfair competition and cybersquatting. Pinnacle Florida filed a counterclaim seeking to cancel Pinnacle Illinois’s trademark registrations and also alleged that Pinnacle Illinois’s claims were barred by the doctrine of laches.

Following a jury trial, the district court granted Pinnacle Florida’s motion for judgment as a matter of law on Pinnacle Illinois’s cybersquatting claim. The jury returned a verdict in favor of Pinnacle Illinois on its claims for trademark infringement and unfair competition, awarding Pinnacle Illinois $550,000 in damages. The district court then granted Pinnacle Florida’s motion for judgment as a matter of law on its laches defense, concluding that Pinnacle Illinois’s trademark infringement and unfair competition claims were barred by laches because it waited more than four years to bring suit after it should have known that it had a potential infringement claim against Pinnacle Florida. The district court also cancelled Pinnacle Illinois’s registrations because it concluded that Pinnacle Illinois’s marks were merely descriptive and lacked secondary meaning. Pinnacle Illinois appealed.

Pinnacle Illinois argued that the district court abused its discretion in finding that Pinnacle Illinois’s claims were barred by laches, and that even if laches did bar Pinnacle Illinois’s claims for money damages, the district court should have considered whether injunctive relief was proper to protect the public’s interest in avoiding confusion between the two companies. Pinnacle Illinois also argued that the district court erred when it cancelled its registrations without regard to the jury’s findings of distinctiveness and protectability or the presumption of distinctiveness afforded to its registered marks.

The 11th Circuit found that the district court did not abuse its discretion in determining that laches barred Pinnacle Illinois from bringing its trademark infringement and unfair competition claims for monetary damages. Pinnacle Illinois sued after the Florida four-year statute of limitations had passed, and the Court found that the company was not excused for its delay because it did not communicate with Pinnacle Florida about the infringement until it filed suit. Pinnacle Florida also suffered economic prejudice because it invested significant time and money, including around $2 million, in developing its business under [...]

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