In a significant ruling for pharmaceutical patent litigation, the Federal Circuit in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Nos. 25-1228, 25-1252 (Fed. Cir. July 8, 2025), affirmed the district court’s determination that U.S. Patent No. 9,439,906 (“the ’906 patent”)—which claims specific dosing regimens for long-acting injectable formulations of the antipsychotic paliperidone palmitate—is not invalid for obviousness. This opinion resolves Teva’s second appeal in a protracted Hatch-Waxman dispute and clarifies the limited applicability of the presumption of obviousness based on overlapping numerical ranges.
Charles Gideon Korrell observes that the Federal Circuit’s ruling is particularly notable for its detailed discussion of when, and under what conditions, a presumption of obviousness may apply in the pharmaceutical dosing context—a context far removed from the traditional realm of alloy compositions and manufacturing parameters where such presumptions originated.
Background and Procedural History
Janssen Pharmaceuticals sued Teva in 2018, asserting that Teva’s Abbreviated New Drug Application (ANDA) infringed the ’906 patent under the Hatch-Waxman Act. Teva stipulated to infringement but challenged the validity of all 21 claims on obviousness grounds, and additionally challenged claims 19–21 for indefiniteness.
After a bench trial, the district court upheld the patent’s validity. On initial appeal, the Federal Circuit affirmed the indefiniteness ruling but remanded for reconsideration of obviousness. See Janssen Pharms. Inc. v. Teva Pharms. USA, Inc., 97 F.4th 915 (Fed. Cir. 2024). On remand, the district court again upheld the patent’s validity, and Teva appealed a second time—joined by Mylan Laboratories Ltd., which had agreed to be bound by the outcome of the Teva case.
The ’906 Patent and the Claimed Invention
The ’906 patent addresses the challenge of noncompliance in schizophrenia treatment due to the frequent dosing requirements of oral medications. It claims a specific regimen using long-acting injectable formulations of paliperidone palmitate, administered via intramuscular injection.
The representative claims require:
- A first loading dose of 150 mg-eq. on day 1 (deltoid),
- A second loading dose of 100 mg-eq. on days 6–10 (deltoid),
- A first maintenance dose of 25–150 mg-eq. one month later (deltoid or gluteal), and
- Optional particle size and formulation parameters (claims 19–21).
Teva argued these regimens were obvious in light of prior art including:
- The ’548 clinical trial protocol (Phase III study),
- Janssen’s own prior U.S. Patent No. 6,555,544,
- WO 2006/114384 (WO ’384), which disclosed dose volumes of 25–150 mg-eq.
Teva’s Primary Argument: Overlapping-Range Presumption
Teva’s central contention was that the district court erred by not applying a presumption of obviousness based on overlapping numerical ranges. Teva pointed to precedents like In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996 (Fed. Cir. 2018), to argue that the claimed 150/100 mg-eq. loading regimen was merely an optimization within known ranges.
The Federal Circuit rejected this argument, explaining that:
- The overlapping-range presumption applies typically in composition or process optimization scenarios.
- The claimed regimen involved not just a range of numbers but a specific sequence of two unequal, decreasing loading doses.
- Prior art, including the ’548 protocol, disclosed three equal loading doses—not the claimed 150 followed by 100 mg-eq.
Because the combination of specific dosing amounts, sequence, and injection sites formed an integrated, multi-step treatment strategy, the court found the presumption inapplicable.
As Charles Gideon Korrell explains, the court’s decision underscores that context matters: a presumption rooted in numerical overlap does not override the requirement to evaluate inventive combinations within dosing regimens, especially in the unpredictable arts of pharmacology.
Substantive Obviousness Analysis
Having refused to apply the presumption, the Federal Circuit reviewed the full obviousness analysis. It affirmed the district court’s findings that Teva failed to prove:
- Motivation to Combine: No prior art taught or suggested the use of decreasing loading doses for long-acting injectables, particularly in acutely ill patients. While Teva cited articles on haloperidol decanoate and olanzapine, those involved stabilized patients or immediate-release medications.
- Reasonable Expectation of Success: The prior art lacked safety or efficacy data for the claimed regimen. Testimony supported the view that dosing with two injections (150 mg-eq. followed by 100 mg-eq.) would raise concerns about accumulation and side effects.
- Application to Renally Impaired Patients (Claims 10 & 13): The court found insufficient motivation to adjust the prior art’s dosing for patients with mild renal impairment. Teva’s expert conceded that moderate to severe renal impairment would contraindicate use of the product entirely.
- Particle Size Claims (20 & 21): Because these depended on the previously upheld claims, the court summarily affirmed their validity under In re Fritch, 972 F.2d 1260 (Fed. Cir. 1992).
Clarifying the Boundaries of Obviousness Doctrines
This case contributes to the ongoing dialogue on the boundaries of the overlapping-range presumption. The Federal Circuit emphasized that:
- The presumption is rooted in expectations of routine optimization, which must be supported by the record.
- Application is limited in contexts involving complex treatment regimens, particularly where multiple variables interact in non-linear ways.
- Courts must still apply the traditional Graham factors and cannot bypass fact-intensive analysis.
As Charles Gideon Korrell notes, the ruling affirms that even where prior art discloses elements within claimed ranges, nuanced differences in sequence and formulation matter—especially in unpredictable arts like pharmaceuticals.
Conclusion
The Federal Circuit’s opinion in Janssen v. Teva provides a thoughtful reaffirmation of the evidentiary burdens facing ANDA challengers in Hatch-Waxman litigation. It clarifies the scope of the overlapping-range presumption, distinguishing optimization within compositions from integrated pharmaceutical regimens. For patent holders in the life sciences sector, the decision provides some assurance that precise treatment protocols—backed by clinical insight and carefully drafted claims—can withstand obviousness challenges even in the face of seemingly similar prior art.









