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Explore the latest in patent, trademark, and copyright cases on the Merchant & Gould LLP blog. Stay informed with expert insights on intellectual property law updates.

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Last week, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in <a href="https://www.cafc.uscourts.gov/opinions-orders/25-1228.OPINION.7-8-2025_2541042.pdf"><em>Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.</em>, No. 25-1228 (July 8, 2025)</a>, affirming the district court’s holding that Teva had failed to prove invalidity based on obviousness because the presumption of obviousness for overlapping ranges did not apply in this case.

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In 2018, Janssen sued Teva, alleging Teva infringed Janssen’s U.S. Patent No. 9,439,906, which claims dosing regimens for long-acting, injectable antipsychotic medications. Teva challenged the validity of Janssen’s patent on both obviousness and indefiniteness grounds. After a bench trial, district court held Teva failed to meet its burden to prove that the asserted claims were invalid. In a first appeal, the Federal Circuit affirmed the district court’s rejection of Teva’s indefiniteness challenge but vacated its rejection of Teva’s obviousness challenge due to analytical errors and remanded for further proceedings. On remand, the district court reconsidered Teva’s obviousness challenge and once again held that Teva had not proven any of the asserted claims invalid. Teva again appealed.

The Federal Circuit affirmed. Regarding claim 2 of the patent, Teva argued that the district court erred in failing to apply a presumption of obviousness and that, even absent a presumption, the court still erred in finding obviousness had not been proven. The Federal Circuit rejected both arguments. The Court declined to apply a presumption of obviousness based on overlapping ranges because, as the district court found, the claimed dosing regimen involved a unique combination of dosing amounts and administration timing not directly taught or suggested by the prior art. Those findings distinguished this case from typical overlapping-range scenarios. Conducting a fulsome obviousness analysis, the Court determined that the district court reasonably relied on the evidentiary record, including testimony from Teva’s own experts, to conclude that Teva’s theories on motivation to combine references and reasonable expectation of success were not persuasive. Further, the Court explained, it was not clear error for the district court to consider unclaimed factors, such as safety and efficacy, because those are factors that a skilled artisan would have reasonably considered in the process of creating a useful invention.

The Court also rejected as unpersuasive Teva’s assertions of error in the district court’s nonobviousness findings on the other asserted claims.

This blog post was co-authored by Tom Leach &amp; Isabel Carlisano.

CAFC Clarifies Standard for Presumption of Obviousness

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