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Overlapping Range Presumption Not Applied Given Specified Doses Administered At Specified Times
07/22/2025On July 8, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the validity of a Janssen patent, finding that Teva did not meet its burden to prove obviousness. In so doing, the Federal Circuit provided direction regarding how the overlapping range presumption should be applied and the need for a fact-specific analysis in obviousness challenges.
Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV (collectively, “Janssen”) own U.S. Patent No. 9,439,906 (“the ’906 patent”). The patent covers a specific dosing schedule for a long-lasting injectable form of paliperidone palmitate, a drug used to treat schizophrenia and similar conditions. The patent seeks to improve treatment adherence by offering an alternative to a daily oral pill.
In 2018, Teva filed an Abbreviated New Drug Application (ANDA) seeking to manufacture a generic version of Janssen’s paliperidone palmitate. Janssen sued Teva for patent infringement under the Hatch-Waxman Act. Teva stipulated to infringement but challenged the validity of the claims of the ’906 patent on grounds of obviousness over the prior art, lack of adequate written description, and indefiniteness. The district court held that Teva had not proven the patent claims to be invalid on any of these grounds. On appeal, the Federal Circuit affirmed the district court’s opinion on indefiniteness but vacated its opinion on obviousness. On remand, the district court again found that Teva had not proven the ’906 claims invalid for obviousness. Teva appealed the remanded decision to the Federal Circuit, which affirmed the district court’s judgment.
On appeal, Teva argued that the “overlapping range” presumption applied. Under this doctrine, a claimed range is presumed obvious where it overlaps or is close to a range disclosed in the prior art. If the presumption applies, the burden shifts to the patentee to prove that the claims are non-obvious. Here, the dosing regimen disclosed in the ’906 patent involved an initial loading dose of about 150 mg-eq. (milligram-equivalents), a second dose of about 100 mg-eq., and a monthly maintenance dose of 25-150 mg-eq. The Federal Circuit disagreed with Teva, explaining that Janssen’s dosing regimen—involving a higher first dose followed by a lower second dose administered at specified times—was based on the relationship between those doses, rather than on the selection of individual values from a known range. The court clarified that the “overlapping range” presumption does not automatically apply when the claimed invention involves a unique combination of elements or dosing regimens that are not directly disclosed in prior art.
Teva then contended that, even if the overlapping range presumption did not apply, a person of ordinary skill in the art (“POSA”) would have been motivated to combine the prior art references to make the claimed invention and would have had a reasonable expectation of success in doing so. The claimed treatment regimen combined, among other things, a larger first loading dose followed by a decreased second dose, coupled with a set injection schedule. The Federal Circuit affirmed the district court’s conclusion of non-obviousness, agreeing that a POSA would not have been motivated to combine the prior art references to arrive at the claimed treatment regimen and would not have had a reasonable expectation of success in doing so.
