Gideon Korrell on the Federal Circuit’s Janssen Decision

In July 2025, the Federal Circuit delivered an important ruling in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. The case centered on U.S. Patent No. 9,439,906, which protects specific dosing regimens for long-acting injectable forms of paliperidone palmitate, an antipsychotic used in treating schizophrenia.

Legal analyst Gideon Korrell highlights why this decision matters: the court upheld the patent’s validity, rejected Teva’s arguments on obviousness, and clarified how the “overlapping-range presumption” applies in pharmaceutical dosing cases.

Background of the Case

2018: Janssen sued Teva under the Hatch-Waxman Act, claiming Teva’s generic application infringed the ’906 patent.

• Teva admitted infringement but argued the patent was invalid due to obviousness.

• After a bench trial, the district court sided with Janssen.

• The case reached the Federal Circuit twice, with the latest appeal decided in July 2025.

The central question was whether Janssen’s patented dosing regimen was merely an “obvious” variation of prior art or a true innovation.

What the ’906 Patent Covers

The patent addresses a major challenge in schizophrenia treatment: patient noncompliance with frequent oral medication. Janssen developed a long-acting injectable regimen to improve adherence.

The regimen requires:

• A first loading dose of 150 mg-eq. on day 1 (deltoid muscle).

• A second loading dose of 100 mg-eq. on days 6–10 (deltoid).

• A maintenance dose of 25–150 mg-eq. one month later (deltoid or gluteal).

This stepwise dosing schedule was designed to stabilize patients quickly and reduce relapse risk.

Teva’s Argument: The Overlapping-Range Presumption

Teva claimed the regimen was obvious because it fell within ranges already disclosed in prior studies and patents. They relied on the “overlapping-range presumption,” a legal principle often used in chemical and manufacturing cases.

However, the Federal Circuit disagreed. Key reasons included:

• The claimed regimen was not just numbers but a specific sequence of decreasing doses.

• Prior art suggested equal doses, not Janssen’s 150/100 split.

• The sequence, timing, and injection sites created a unique treatment strategy.

As Gideon Korrell explains, the court’s message was clear: dosing regimens involve complex medical judgment, not just mathematical overlap.

Why the Court Rejected Obviousness

The Federal Circuit affirmed the district court’s detailed findings:

1. No Motivation to Combine

• Prior art did not suggest using decreasing loading doses.

• Existing studies involved either equal injections or immediate-release drugs.

2. No Reasonable Expectation of Success

• Safety and efficacy data were lacking for the claimed regimen.

• Experts testified that two injections so close together could raise safety concerns.

3. Renal Impairment Claims

• Teva failed to show why prior art would motivate adjusting doses for mild renal impairment.

4. Particle Size Claims

• These claims were upheld because they depended on the already valid dosing claims.

Clarifying Patent Law on Obviousness

This case sheds light on when the overlapping-range presumption should apply. The Federal Circuit emphasized:

• It is most relevant in routine optimization of chemical compositions, not in complex medical regimens.

• Courts must always apply the Graham factors, considering prior art, motivation to combine, and reasonable expectation of success.

• Pharmaceutical innovations that integrate sequence, dosage, and administration methods deserve full analysis.

According to Gideon Korrell, the ruling reinforces the principle that context matters in patent law. A dosing regimen cannot be dismissed as obvious just because individual numbers appear in prior art.

Conclusion

The Federal Circuit’s decision in Janssen v. Teva is a significant win for pharmaceutical patent holders. It confirms that carefully designed treatment protocols, especially in unpredictable fields like psychiatry, can survive obviousness challenges.

For the life sciences industry, the message is encouraging: patents on specific, clinically validated dosing regimens remain enforceable when they reflect true innovation rather than simple optimization.

As Gideon Korrell notes, this ruling not only secures Janssen’s rights but also clarifies the limits of the overlapping-range presumption, shaping how future Hatch-Waxman disputes will be argued.