Janssen v. MedChemExpress: Trabectedin Patent Injunction Secured

Introduction

In a decisive resolution for pharmaceutical patent holders, Janssen Products, LP secured a consent judgment and permanent injunction against MedChemExpress LLC (MCE) in the U.S. District Court for the District of New Jersey on February 20, 2026. The case, docketed as 2:25-cv-01867, centered on alleged infringement of two patents protecting Yondelis® (trabectedin) 1 mg/vial, a marine-derived oncology compound used to treat soft tissue sarcoma and relapsed ovarian cancer.

The outcome—achieved in under 12 months—underscores a growing pattern in pharmaceutical patent infringement litigation: strategic early resolution through consent decrees that preserve market exclusivity without protracted trial proceedings. For patent attorneys, in-house IP counsel, and R&D teams operating in the oncology and small-molecule drug space, this case offers critical insights into ANDA/NDA-related litigation tactics, patent term protection mechanisms, and the enforcement leverage available to innovator pharmaceutical companies under U.S. patent law.

Case Overview

The Parties

The Patents at Issue

This litigation involved two U.S. patents providing robust protection for trabectedin’s chemical composition and formulation, characteristic of a well-constructed pharmaceutical patent portfolio:

• • US8895557B2 — The “557 Patent,” defining market exclusivity restriction. (Application No. 11/261,876)
• • US7420051B2 — The “051 Patent,” covering foundational trabectedin compound chemistry. (Application No. 11/249,172)

Litigation Timeline & Procedural History

The 343-day resolution timeline is notably efficient for pharmaceutical patent infringement litigation, where cases routinely extend two to four years through claim construction, summary judgment, and trial. The absence of prolonged motion practice suggests that negotiations toward a consent decree began relatively early, potentially concurrent with or shortly after the initial pleadings phase.

Legal Representation:

• • Plaintiff (Janssen): Charles Michael Lizza, Daniel D. Williams, Irena Royzman, and William C. Baton from Orrick, Herrington & Sutcliffe LLP and Saul Ewing, LLP
• • Defendant (MCE): Jennifer Mara of Baldassare & Mara LLC

The Verdict & Legal Analysis

Outcome

The District Court entered a Consent Judgment and Permanent Injunction on February 20, 2026. The operative relief includes:

• • Patent Validity Admission: MedChemExpress expressly admitted that the claims of both the 557 Patent and the 051 Patent are valid and enforceable with respect to products sold or distributed under NDA No. 219617.
• • Permanent Injunction: MCE and all affiliates are permanently enjoined from manufacturing, using, offering for sale, selling in the United States, or importing the EVER Product until expiration of the 557 Patent, inclusive of any patent term extensions (PTEs), patent term adjustments (PTAs), and any associated pediatric exclusivity periods.
• • No Monetary Damages Disclosed: The parties agreed to bear their own attorneys’ fees and costs. No damages award is reflected in the available case record.
• • Dismissal with Prejudice: All claims, counterclaims, and affirmative defenses were dismissed with prejudice, providing Janssen with finality on all asserted theories.

Legal Significance

The case was resolved as an Infringement Action under the Hatch-Waxman Act framework, where MCE’s NDA filing referencing Janssen’s approved drug constituted a technical act of infringement under 35 U.S.C. § 271(e)(2). This statutory mechanism—designed to resolve patent disputes before a competing product reaches the market—allowed Janssen to act preemptively, securing injunctive relief before any commercial harm materialized.

MCE’s admission of patent validity is legally significant. Rather than pursuing Inter Partes Review (IPR) at the USPTO or mounting invalidity defenses, MCE conceded enforceability. This admission forecloses future validity challenges tied to the specific NDA pathway—a powerful precedent-shaping concession.

The pediatric exclusivity protection referenced in the injunction warrants attention. Under the Best Pharmaceuticals for Children Act (BPCA), FDA may grant six months of additional market exclusivity to NDA holders who conduct qualifying pediatric studies. The court’s injunction explicitly preserves this exclusivity period, signaling judicial recognition of all statutory exclusivity layers—not merely patent term—as enforceable boundaries.