Teva v. Almaject: Bendeka® Patent Suit Voluntarily Dismissed

Case Overview

In a case that underscores the fluid and strategically complex nature of pharmaceutical patent litigation, Teva Pharmaceutical Industries, Ltd. and affiliated plaintiffs voluntarily dismissed their patent infringement action against Almaject, Inc. and Alvogen, Inc. before Delaware District Court. Filed on September 18, 2025, and closed just 166 days later on March 3, 2026, the case centered on Bendeka® (bendamustine hydrochloride) Injection—a critical oncology product—and a sweeping portfolio of 19 U.S. patents.

The voluntary dismissal, entered pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i), signals that the underlying commercial or legal calculus shifted significantly between filing and resolution. For patent attorneys, in-house IP counsel, and R&D professionals navigating pharmaceutical patent infringement risk, the case offers instructive lessons about assertion strategy, portfolio management, and the tactical use of voluntary dismissal in ANDA-related litigation. This analysis unpacks the procedural record, the patent portfolio at stake, and what the outcome means for bendamustine patent litigation and specialty pharmaceutical IP strategy broadly.

The Parties

The Patents at Issue

The plaintiffs asserted a remarkably broad portfolio of 19 U.S. patents, spanning formulation chemistry, methods of treatment, and manufacturing processes related to bendamustine hydrochloride. Key patent numbers include:

• • US8609707B2 – An early foundational patent (App. No. 13/016473)
• • US9034908B2, US9000021B2, US9265831B2 – Covering formulation and composition claims
• • US9579384B2, US9597397B2, US9597398B2, US9597399B2 – A cluster of patents filed around App. Nos. 14/820291–15/008827, likely covering refined formulation parameters
• • US12138248B2, US12350257B2, US12343333B2 – Among the most recently issued, suggesting ongoing patent prosecution through continuation filings
• • US11844783B2, US11872214B2 – Intermediate-generation patents covering potentially updated methods or delivery systems

This layered portfolio reflects a classic evergreening strategy—the systematic filing of continuation, divisional, and improvement patents to extend market exclusivity around a commercially significant branded drug.

The Verdict & Legal Analysis

Outcome

The case was resolved by voluntary dismissal with prejudice to all claims. The formal dismissal notice, entered pursuant to Rule 41(a)(1)(A)(i), dismissed all claims and defenses asserted by plaintiffs against both Almaject, Inc. and Alvogen, Inc. No damages were awarded, no injunctive relief was granted, and no court ruling on the merits was issued. The specific terms of any settlement or licensing arrangement, if one exists, were not disclosed in the public record.

Key Legal Issues

The initiating cause of action was patent infringement—consistent with Hatch-Waxman paragraph IV certification litigation, where a branded pharmaceutical patent holder sues a generic applicant upon receiving notice that the ANDA applicant has certified that the listed patents are invalid, unenforceable, or will not be infringed by the generic product.

Because the case resolved before any substantive court rulings, there is no judicial claim construction, no invalidity determination, and no infringement finding on the record. The legal significance lies not in what the court decided, but in what the parties decided before the court could.