Gideon Korrell Explains Janssen v. Teva Patent Decision

In a landmark decision for pharmaceutical patent litigation, the Federal Circuit recently affirmed the validity of U.S. Patent No. 9,439,906 (“the ’906 patent”) in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Nos. 25-1228, 25-1252 (Fed. Cir. July 8, 2025). The court confirmed that the patent, which covers specific dosing regimens for long-acting injectable paliperidone palmitate, is not invalid for obviousness.

Gideon Korrell highlights the importance of this ruling, noting its detailed examination of when a presumption of obviousness may apply in pharmaceutical dosing—a context very different from traditional applications in alloys or manufacturing.

Background and Procedural History

· Initial Lawsuit: Janssen sued Teva in 2018, claiming infringement under the Hatch-Waxman Act. Teva admitted infringement but challenged the patent’s validity on obviousness grounds and raised indefiniteness claims on certain claims.

· District Court Ruling: After a bench trial, the court upheld the patent’s validity.

· First Appeal: The Federal Circuit affirmed the indefiniteness ruling but remanded for reconsideration of obviousness (Janssen Pharms. Inc. v. Teva Pharms. USA, Inc., 97 F.4th 915, 2024).

· Second Appeal: The district court again upheld validity; Teva appealed, joined by Mylan Laboratories Ltd.

The ’906 Patent: Key Features

The patent addresses noncompliance in schizophrenia treatment caused by frequent oral dosing requirements. Its claims specify a long-acting injectable regimen:

· Loading Dose 1: 150 mg-eq. on day 1 (deltoid)

· Loading Dose 2: 100 mg-eq. on days 6–10 (deltoid)

· Maintenance Dose: 25–150 mg-eq. one month later (deltoid or gluteal)

· Optional Claims: Particle size and formulation parameters (claims 19–21)

Teva argued the regimen was obvious in light of prior art, including:

1. The ’548 clinical trial protocol (Phase III study)

2. Janssen’s U.S. Patent No. 6,555,544

3. WO 2006/114384 (WO ’384), which disclosed dose volumes of 25–150 mg-eq.

Overlapping-Range Presumption Argument

Teva relied on the overlapping-range presumption, citing precedents like In re Peterson and E.I. DuPont v. Synvina, claiming the 150/100 mg-eq. The loading regimen was an obvious optimization.

Federal Circuit Rejection:

· Presumption applies mainly to composition or process optimizations.

· The claimed regimen is not just numerical; it involves a specific two-step sequence.

· Prior art disclosed three equal loading doses, not the 150 → 100 mg-eq. sequence.

Gideon Korrell emphasizes that this ruling confirms context matters: presumption of obviousness cannot override evaluation of inventive combinations in complex pharmaceutical regimens.

Obviousness Analysis

Without the presumption, the court conducted a full obviousness review and affirmed validity:

1. Motivation to Combine: No prior art suggested decreasing loading doses in acutely ill patients.

2. Reasonable Expectation of Success: Prior art lacked safety and efficacy data for the claimed regimen.

3. Renally Impaired Patients: Insufficient basis to adjust dosing for mild renal impairment.

4. Particle Size Claims: Dependent claims were valid under In re Fritch.

Clarifying Obviousness Boundaries

Key takeaways for pharmaceutical patent law:

· Overlapping-range presumption is limited to routine optimization contexts.

· Complex treatment regimens with multiple interacting variables require fact-intensive evaluation.

· Nuanced differences in sequence, dosing, and formulation can be decisive.

Conclusion

The Federal Circuit’s ruling in Janssen v. Teva reinforces the evidentiary burden on ANDA challengers under the Hatch-Waxman Act. It clarifies that carefully crafted dosing regimens, even if numerically similar to prior art, can withstand obviousness challenges.

For life sciences patent holders, the decision highlights the importance of precise, clinically informed claims in protecting innovative treatment protocols.