Galderma vs. Teva: Permanent Injunction Secured in AKLIEF® Retinoid Patent Case
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📋 Case Summary
| Case Name | Galderma Laboratories, L.P., et al. v. Teva Pharmaceuticals USA, Inc., et al. |
| Case Number | 3:24-cv-00197 (D.N.J.) |
| Court | U.S. District Court for the District of New Jersey |
| Duration | Jan 11, 2024 – Mar 27, 2024 76 days |
| Outcome | Plaintiff Win — Permanent Injunction |
| Patents at Issue | |
| Accused Products | Teva’s ANDA No. 218739 (Generic AKLIEF®) |
Case Overview
The Parties
⚖️ Plaintiff
A global dermatology company holding the IP portfolio for AKLIEF® (trifarotene), a leading topical retinoid treatment.
🛡️ Defendant
One of the world’s largest generic drug manufacturers, routinely challenging branded pharmaceutical patents via the ANDA pathway.
Patents at Issue
This case involved two U.S. patents protecting distinct topical retinoid formulation technologies critical to AKLIEF®’s pharmaceutical profile, including skin penetration, stability, and tolerability characteristics.
- • US9,084,778B2 — Covers topical compositions in the form of a gel containing a particular solubilized retinoid.
- • US9,498,465B2 — Covers topical compositions containing a retinoid of the oil-in-water emulsion type.
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The Verdict & Legal Analysis
Outcome
The parties entered a consent judgment that delivered virtually every remedy Galderma sought. Teva admitted infringement, abandoned all validity challenges, and accepted a permanent injunction blocking commercialization of its generic product for the remaining patent terms. Each party bore its own costs, typical in consent judgment resolutions.
Key Legal Issues
The rapid 76-day resolution suggests Teva’s internal patent validity and infringement assessment reached an unfavorable conclusion early. Rather than investing resources in prolonged litigation, Teva consented to judgment. The consent order contains an estoppel provision, permanently barring Teva from challenging the validity or enforceability of the litigated patents, significantly strengthening Galderma’s position. This case reinforces that formulation patents remain potent barriers to generic entry when drafted to cover multiple composition variations.
Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in pharmaceutical formulation development. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications from this litigation.
- View all related patents in the retinoid formulation space
- See which companies are most active in dermatology IP
- Understand formulation claim construction patterns
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High Risk Area
Topical retinoid gel and emulsion formulations
2 Patents Litigated
In retinoid formulation space
Design-Around Options
Available for some claims
✅ Key Takeaways
Consent judgments with permanent injunctions and estoppel provisions offer durable, cost-efficient resolutions for patent holders with strong formulation portfolios.
Search related case law →Dual-patent assertions across multiple formulation types increase litigation leverage in ANDA disputes.
Explore precedents →Frequently Asked Questions
The case involved U.S. Patent Nos. 9,084,778 and 9,498,465, covering topical retinoid gel and oil-in-water emulsion formulations underlying Galderma’s AKLIEF® product.
Teva stipulated via consent judgment that it would infringe both asserted patents absent a license. The court entered the permanent injunction by agreement of the parties, prohibiting Teva from commercializing its ANDA product for the remaining patent terms.
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References
- PACER — Case No. 3:24-cv-00197, D.N.J.
- USPTO Patent Center — US9084778 and US9498465
- FDA Orange Book — ANDA Litigation Trends
- 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.