Janssen v. EVER Valinject: Trabectedin Patent Settled with Full Injunction
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📋 Case Summary
| Case Name | Janssen Products, L.P. v. EVER Valinject GmbH |
| Case Number | 1:24-cv-07319 (N.D. Ill.) |
| Court | Northern District of Illinois, Chief Judge Sunil R. Harjani |
| Duration | Aug 2024 – Feb 2026 1 year 6 months |
| Outcome | Plaintiff Win — Permanent Injunction |
| Patents at Issue | |
| Accused Products | EVER Product (Trabectedin IV Formulation under NDA No. 219617) |
Case Overview
The Parties
⚖️ Plaintiff
Janssen Products, L.P., a Johnson & Johnson affiliate, markets YONDELIS® (trabectedin) 1 mg/vial for intravenous infusion in the United States under NDA No. 207953. Co-plaintiff Pharma Mar, S.A., the Spanish biotechnology company that originally developed trabectedin, holds underlying IP rights in the compound.
🛡️ Defendant
EVER Valinject GmbH, an Austrian pharmaceutical company, filed NDA No. 219617 under §505(b)(2) referencing Janssen’s NDA. Nexus Pharmaceuticals, LLC, a U.S.-based co-defendant, was named as a commercialization partner for the proposed EVER Product.
The Patent at Issue
The primary patent at issue is **U.S. Patent No. 8,895,557**, covering formulation and/or method claims related to trabectedin pharmaceutical products. Application No. 11/249,172 forms the prosecution history basis. The patent protects the active pharmaceutical ingredient trabectedin as commercialized under the Janssen NDA, with patent term extensions and potential pediatric exclusivity extending protection beyond the base patent term. This patent is listed in the FDA Orange Book.
- • US 8,895,557 — Formulation and/or method claims for trabectedin products
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The Verdict & Legal Analysis
Outcome
The litigation resolved through a consent judgment and order entered by the Northern District of Illinois, incorporating the following critical provisions: Validity Admission: The EVER Defendants expressly admitted that the claims of U.S. Patent No. 8,895,557 are valid and enforceable with respect to products sold, offered for sale, or distributed under NDA No. 219617 referencing NDA No. 207953 as the RLD. Permanent Injunction: EVER Valinject, Nexus Pharmaceuticals, and their affiliates are permanently enjoined from manufacturing, using, offering for sale, selling in, or importing into the United States the EVER Product until patent expiration—including any patent term extensions, patent term adjustments, and associated pediatric exclusivity—unless authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims were dismissed with prejudice, and each party bears its own attorneys’ fees and costs. No monetary damages were publicly disclosed as part of the settlement, consistent with most negotiated Hatch-Waxman resolutions where injunctive relief is the primary commercial objective.
Key Legal Issues
The infringement claim arose under the Hatch-Waxman Act’s artificial infringement framework (35 U.S.C. § 271(e)(2)), which treats the filing of a 505(b)(2) NDA referencing an RLD as an act of patent infringement when an Orange Book-listed patent covers the reference product. EVER’s NDA filing triggered mandatory notice requirements and the automatic 30-month stay mechanism, after which Janssen timely filed suit to maintain its statutory market exclusivity. The validity admission embedded in the consent judgment is strategically significant: rather than simply agreeing not to launch, EVER Defendants affirmatively conceded patent validity—a stronger concession that eliminates any post-settlement invalidity challenge against this patent as it applies to their product and NDA.
Freedom to Operate (FTO) Analysis for Pharmaceutical Products
This case highlights critical IP risks in 505(b)(2) pharmaceutical development. Choose your next step:
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High Risk Area
Trabectedin formulation/method patents
45 Related Orange Book Patents
In oncology drug space
Design-Around Options
Potential for new excipients or delivery methods
✅ Key Takeaways
Consent judgments incorporating express validity admissions provide stronger downstream protection than stipulated dismissals—pursue this formulation in Hatch-Waxman settlements.
Search related case law →The 14-attorney plaintiff team signals Janssen’s commitment to full enforcement leverage, which likely influenced EVER’s decision to concede validity rather than challenge claims.
Explore litigation strategy →Orange Book patent mapping must be a mandatory gate in any 505(b)(2) NDA development program.
Automate Orange Book analysis →Validity admissions in consent judgments may impact related Orange Book listings and future licensing negotiations involving the same patent family.
Assess patent family strength →Frequently Asked Questions
U.S. Patent No. 8,895,557, covering trabectedin pharmaceutical formulations, was the patent-in-suit. It protects the active ingredient in YONDELIS® (trabectedin 1 mg/vial), Janssen’s FDA-approved intravenous oncology product.
The case closed February 19, 2026, via consent judgment. EVER Defendants admitted patent validity and were permanently enjoined from commercializing their trabectedin NDA product (NDA No. 219617) in the United States until patent expiry, including extensions.
It reinforces that 505(b)(2) NDA applicants referencing branded oncology drugs face full Hatch-Waxman patent infringement exposure and that branded manufacturers are willing to litigate to extract validity concessions—not just market exclusivity—in negotiated resolutions.
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References
- PACER – Case No. 1:24-cv-07319 (Northern District of Illinois)
- USPTO Patent Center – U.S. Patent No. 8,895,557
- FDA Orange Book
- Cornell Legal Information Institute — 35 U.S.C. § 271(e)(2)
- 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.