United Therapeutics wins Yutrepia patent ruling

• United Therapeutics (NASDAQ:UTHR) said a Delaware federal court found Liquidia’s Yutrepia infringes two claims of a United Therapeutics patent.
• The ruling could lead to a court order requiring FDA action on Yutrepia’s approval for PH-ILD, subject to further proceedings.
• United Therapeutics stated it plans to seek damages related to past infringement and support patient access to Tyvaso therapies.

United Therapeutics (NASDAQ:UTHR) announced that a Delaware federal court found Liquidia’s Yutrepia infringes two claims of a patent covering inhaled treprostinil treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The court determined that Liquidia induced infringement of claims 1 and 14 of United Therapeutics’ U.S. Patent No. 11,826,327 by marketing Yutrepia for PH-ILD and concluded that Liquidia did not prove the claims were invalid.

"We are pleased with the Court’s decision, which reinforces our significant research and commitment to bring innovative therapies to the patients we serve," said United Therapeutics President and Chief Operating Officer Michael Benkowitz.

The patent relates to using inhaled treprostinil at specific dosages to improve exercise capacity in patients with PH-ILD, and United Therapeutics stated it may seek an order requiring the FDA to withdraw approval of Liquidia’s new drug application for Yutrepia.

United Therapeutics stated that if an FDA withdrawal order is granted, Yutrepia could be removed from the U.S. market until the FDA approves labeling that excludes the PH-ILD indication, while the court has given the parties one week to submit an agreed final judgment.

United Therapeutics markets Tyvaso DPI and nebulized Tyvaso, both containing treprostinil and approved for PH-ILD, and stated it has programs available to assist eligible patients with access to these therapies.