United Therapeutics Corporation Prevails in Patent Litigation Against Liquidia

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the United States District Court for the District of Delaware issued an opinion that finds Liquidia Technologies, Inc. (Liquidia) infringes two claims of United Therapeutics’ patent covering the use of inhaled treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).

“We are pleased with the Court’s decision, which reinforces our significant research and commitment to bring innovative therapies to the patients we serve. Our immediate priority is ensuring that no patient goes without the therapy they need, and we are ready to support a seamless transition to Tyvaso or Tyvaso DPI should PH-ILD be removed from the Yutrepia label. We look forward to working closely with patients, prescribers, and all other stakeholders throughout this process,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics.

The opinion was rendered in litigation concerning United Therapeutics’ U.S. Patent No. 11,826,327 (the ’327 patent), which relates to a method of improving exercise capacity in patients with PH-ILD by inhaling treprostinil at specific dosages. Specifically, the Court determined that Liquidia induces infringement of claims 1 and 14 of the ’327 patent by marketing Yutrepia for PH-ILD. The Court also concluded that Liquidia failed to prove that those claims are invalid.

As a result of the Court’s decision, United Therapeutics believes that it is entitled to an order instructing the U.S. Food and Drug Administration (FDA) to withdraw approval of Liquidia’s new drug application (NDA) for Yutrepia as required by 35 U.S.C. § 271(e)(4)(A). If such an order is granted, it may result in Yutrepia being removed from the U.S. market until such time as FDA can approve labeling omitting the PH-ILD indication. United Therapeutics also intends to seek monetary damages for past infringement, which could include a royalty on past sales of Yutrepia. The Court set a deadline of one week for the parties to submit “an agreed upon form of final judgment” including any such order. If the parties cannot agree on the scope of the final judgment, the Court will need to rule on the issue.

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