United Therapeutics Faces Patent Decision, Impacting Treprostinil Inhalation Solution

United Therapeutics Corporation, the manufacturer of Tyvaso and Tyvaso DPI, received a significant blow from the U.S. Court of Appeals for the Federal Circuit on December 20, 2023. The court's decision regards United Therapeutics' U.S. Patent No. 10,716,793, which was challenged by Liquidia Technologies, Inc. in an inter partes review. The patent, which covers treprostinil inhalation solution and powder, has been affirmed as invalid by the Federal Circuit, potentially clearing the way for Liquidia's proposed Yutrepia product to enter the market.

Key Takeaways:

• The U.S. Court of Appeals for the Federal Circuit upheld an inter partes review decision, canceling the claims of United Therapeutics' U.S. Patent No. 10,716,793.
• The patent, which covers Tyvaso and Tyvaso DPI, is listed in the FDA's Orange Book for the treatment of pulmonary arterial hypertension.
• The court's decision could allow Liquidia's Yutrepia product to launch prior to the patent's expiration unless United Therapeutics seeks and obtains a rehearing or Supreme Court review.
• United Therapeutics has the right to appeal the decision and is evaluating its options.
• The FDA has tentatively approved Liquidia's new drug application (NDA) for Yutrepia, and a subsequent lawsuit by United Therapeutics alleges that the proposed NDA infringes the '793 patent.
• The litigation between United Therapeutics and Liquidia includes a newly-issued patent, U.S. Patent No. 11,826,327, which covers the use of inhaled treprostinil at specific dosages to improve exercise capacity in PH-ILD patients.
• Forward-looking statements in the Current Report on Form 8-K, filed by UT on December 20, 2023, were made under the guidance of the Private Securities Litigation Reform Act of 1995 and may contain risks and uncertainties.
• UT has provided a cautionary statement for potential differences between actual results and expected outcomes based on such forward-looking statements.

Statistics:

• The patented treprostinil inhalation solution has been listed in the FDA's Orange Book since filing date.
• The patent (U.S. Patent No. 10,716,793) was successfully challenged in an inter partes review by Liquidia Technologies, Inc.
• The '793 patent's expiration date remains unchanged after the Federal Circuit's decision.
• The forward-looking statements included in the Current Report on Form 8-K show a potential risk that actual results may differ from the presented projections.

Sources:

• UNITED THERAPEUTICS Corp, FORM 8-K (Current Report) with the U.S. Securities and Exchange Commission on Dec 20, 2023.
• UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT.
• Federal Circuit's decision on December 20, 2023, regarding U.S. Patent No. 10,716,793.