Federal Circuit Affirms in Part Teva & Mylan’s Challenge to Janssen’s Invega Sustenna Patent
What would you like to do next?
Choose your path based on your current needs:
📋 Case Summary
| Case Name | Teva Pharmaceutical Industries, Ltd. and Mylan Laboratories, Ltd. v. Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica, N.V. |
| Case Number | 2017-2587 (Fed. Cir.) |
| Court | Federal Circuit, Appeal from District of Columbia Circuit |
| Duration | Dec 2021 – Apr 2024 2 years 4 months |
| Outcome | Split Disposition: Affirmed in Part, Vacated in Part, Remanded |
| Patents at Issue | |
| Accused Products | Proposed generic version of Invega Sustenna (paliperidone palmitate) |
Case Overview
The Parties
⚖️ Plaintiff
World’s largest generic drug manufacturer (Teva) and a major global generics player (Mylan/Viatris), seeking to market a generic version of Invega Sustenna.
🛡️ Defendant
Subsidiaries of Johnson & Johnson, holding a broad patent portfolio protecting the blockbuster antipsychotic Invega Sustenna (paliperidone palmitate).
The Patent at Issue
This landmark case involved **U.S. Patent No. 9,439,906 B2** (Application No. 12/337,144), which covers formulation and dosing regimen innovations for paliperidone palmitate long-acting injectable products. The patent’s claims relate to the therapeutic window, dosage strengths, and administration schedules that allow Invega Sustenna to deliver stable plasma concentrations without daily oral dosing — a clinically significant advance in schizophrenia treatment.
- • US 9,439,906 B2 — Formulation & Dosing for Paliperidone Palmitate
Developing a similar pharmaceutical product?
Check if your drug formulation or dosing regimen might infringe this or related patents before launch.
The Verdict & Legal Analysis
Outcome
The Federal Circuit issued a split disposition: affirming the lower court ruling in part, vacating it in part, and remanding specific issues for further proceedings. The appeal was also dismissed in part. No specific damages award was publicly disclosed, consistent with Hatch-Waxman litigation where the primary relief sought is typically a declaratory judgment or injunctive relief preventing FDA approval rather than monetary damages.
Key Legal Issues
The Federal Circuit’s analysis likely focused on claim construction, infringement analysis of Teva and Mylan’s proposed ANDA products, and validity challenges to the ‘906 patent. The affirmed-in-part component indicates the Federal Circuit found the lower court’s analysis legally sound on at least one material issue—potentially upholding a finding of validity, infringement, or both on certain claims. The vacated-and-remanded component signals reversible error on discrete questions, requiring the district court to revisit its analysis. This could reflect an incorrect claim construction standard applied below, insufficient findings on a validity defense, or an improperly resolved infringement question.
This mixed affirmance-and-remand outcome reinforces the importance of claim construction in pharmaceutical patent cases and that validity is not monolithic, with courts affirming some claims while vacating others. The partial dismissal suggests certain issues were resolved procedurally.
Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in long-acting injectable pharmaceutical formulation and dosing. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications from this pharmaceutical litigation.
- View all related patents in this therapeutic area
- See which companies are most active in long-acting injectable patents
- Understand claim construction patterns for dosing regimens
🔍 Check My Product’s Risk
Run a comprehensive FTO analysis for your own pharmaceutical formulation or dosing regimen.
- Input your product description or technical features
- AI identifies potentially blocking patents
- Get actionable risk assessment report
High Risk Area
Long-acting injectable dosing regimens
Many Related Patents
In long-acting injectable pharma
Design-Around Options
Often complex, but possible for some claims
✅ Key Takeaways
A split Federal Circuit decision affirming in part and remanding in part is a tactically significant outcome — neither side achieves a clean victory, and remand proceedings become the new battleground.
Search related case law →Claim construction errors remain the most common basis for Federal Circuit vacatur in pharmaceutical patent appeals.
Explore precedents →The partial dismissal of the appeal suggests procedural issues (standing, mootness, or jurisdictional questions) were resolved alongside the merits.
Analyze court records →Frequently Asked Questions
U.S. Patent No. 9,439,906 B2 (Application No. 12/337,144), covering formulation and dosing innovations for Invega Sustenna (paliperidone palmitate long-acting injectable).
The court affirmed in part, vacated in part, and remanded specific issues to the district court, while also partially dismissing the appeal — a mixed outcome preserving Janssen’s protections on some issues while requiring further lower court analysis on others.
The partial vacatur and remand leave the generic approval pathway uncertain pending district court resolution, likely extending Janssen’s period of market exclusivity on at least some patent claims.
Ready to Strengthen Your Patent Strategy?
Join 18,000+ IP professionals using PatSnap Eureka to conduct prior art searches, draft patents, and analyse competitive landscapes with AI-powered precision.
References
- United States Court of Appeals for the Federal Circuit – Case 22-1258
- USPTO Patent Center – US 9,439,906 B2
- FDA ANDA Information
- Cornell Legal Information Institute — Hatch-Waxman Act
- PatSnap — IP Intelligence Solutions for Law Firms
This article is for informational purposes only and does not constitute legal advice. All case information is drawn from publicly available court records. For platform capabilities, visit PatSnap.