Court rules for Teva and Apotex in Vanda's HETLIOZ patent suits

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) said in its 10-Q filed October 29, 2026 that the U.S. District Court for the District of Delaware granted summary judgment of non-infringement in September 2026 in its patent suits over generic HETLIOZ. The defendants are Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp. Vanda is the plaintiff, so the ruling went against the company. The 10-Q gives no case number.

The ruling covers U.S. Patent No. 11,285,129 and U.S. Patent No. 11,918,556. Vanda says it is evaluating its options. The 10-Q does not say whether it will appeal.

The case

Vanda sued Teva and Apotex in December 2022 in the District of New Jersey, with Hatch-Waxman Act claims. It asserted that the '129 patent will be infringed by their generic versions of HETLIOZ, each approved by the FDA. It asked the court to set the effective date of those approvals no earlier than the patent's expiration and to bar manufacture and sale until then. The case moved to Delaware in February 2023.

Teva and Apotex moved for judgment on the pleadings in April 2023, and the court denied the motions in June 2024. After a claim construction hearing in March 2025, two disputed claim terms were resolved in Vanda's favor and a third was left open.

In December 2024 Vanda filed a second suit against the same two companies on the '556 patent, which the 10-Q describes as a method of administration patent. Teva answered in March 2025 with counterclaims that include an alleged violation of the antitrust laws and inequitable conduct. The court consolidated the two actions in May 2025.

Defendants

The 10-Q names three defendants: Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp. It names no individuals. The Teva counterclaims also sit in this case, which makes Vanda the counterclaim defendant on those claims. The 10-Q does not say how the counterclaims were handled in the September ruling.

Where it stands

The court heard summary judgment and Daubert motions in March 2026. In September 2026 it granted summary judgment of non-infringement for Teva and Apotex on both patents. It relied in part on the U.S. Supreme Court's June 2026 decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. in analyzing Vanda's induced infringement claims. The 10-Q states: "The Company is currently evaluating future options with respect to this litigation."

Related matters

The same note describes several other proceedings:

• Aurobindo Pharma Limited sent a Paragraph IV notice in April 2026 over a generic HETLIOZ. Vanda sued Aurobindo and affiliates in May 2026, and the suit is pending.
• Alembic Pharmaceuticals Limited sent a Paragraph IV notice in June 2026 over a generic Fanapt. Vanda sued Alembic in Delaware in July 2026 and settled in October 2026. Vanda agreed to a non-exclusive license beginning November 2, 2027, and the court entered a consent judgment and permanent injunction.
• In the HETLIOZ LQ suit against MSN, a trial is scheduled to begin on June 1, 2027.
• On September 8, 2026, the Third Circuit ordered Vanda's Lanham Act appeal against MSN, Amneal and Impax decided on the briefs.

Why it matters to shareholders

The 10-Q also reports a Department of Justice matter. Vanda received a Civil Investigative Demand in October 2024 in a False Claims Act investigation concerning historical HETLIOZ practices. In October 2026 the DOJ told the company it is considering filing a civil complaint. The 10-Q says no complaint has been filed and that Vanda would contest any allegation. It adds that the company cannot predict the timing of any proceeding.

Vanda also lists the status of litigation over its products and intellectual property among the factors that could make its results fluctuate. The 10-Q gives no loss estimate for the Teva and Apotex case, where Vanda is the plaintiff.

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