Liquidia Patent Ruling Threatens YUTREPIA U.S. Sales
Liquidia patent ruling found YUTREPIA infringes UTHR's patent, raising the prospect of an FDA-directed withdrawal and prompting investor scrutiny.
KEY TAKEAWAYS
- A Delaware court found Liquidia infringes two claims of the '327 patent and held those claims valid.
- United Therapeutics says the ruling allows it to seek an FDA-directed withdrawal that could remove PH-ILD labeling.
- The court set a one-week deadline for proposed-judgment filings, focusing immediate attention on remedies.
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Liquidia (LQDA) said on Sept. 30, 2026, that a Delaware court found its inhaled treprostinil product YUTREPIA infringes two claims of United Therapeutics’ (UTHR) U.S. Patent No. 11,826,327. The ruling raises the prospect of an FDA-directed withdrawal of the pulmonary hypertension associated with interstitial lung disease (PH-ILD) indication, increasing the drug’s commercial risk in the U.S.
Court Ruling on ’327 Patent and Litigation Background
The U.S. District Court for the District of Delaware ruled that Liquidia induces infringement of claims 1 and 14 of the ’327 patent by marketing YUTREPIA for PH-ILD and held those claims valid. Liquidia said the other four asserted claims in the case were found invalid. YUTREPIA is Liquidia’s treprostinil inhalation powder, and the litigation proceeded under the Hatch-Waxman Act, which governs patent disputes related to drug approvals.
By the start of a June 2025 bench trial, Liquidia had conceded infringement of claims 1 and 14, leaving validity as the main contested issue for those claims. The ’327 patent covers methods of improving exercise capacity in PH-ILD patients by inhaling treprostinil at specified dosages.
In a related order, the court denied Liquidia’s motion to exclude evidence about United Therapeutics’ patent ownership, finding Liquidia had adequate notice and did not object in time.
Remedies and FDA-Directed Withdrawal Risk
The court directed the parties to submit a proposed final judgment and remedies within one week, with filings due around Oct. 7, 2026. If the parties cannot agree, the court will decide the scope of the final judgment.
United Therapeutics said it believes the ruling entitles it to seek an order directing the FDA to withdraw Liquidia’s YUTREPIA new-drug application approval under 35 U.S.C. §271(e)(4)(A). Such an order could remove YUTREPIA from the U.S. market until the FDA approves labeling that omits the PH-ILD indication.
Liquidia said it “respectfully disagree[s] with the Court’s decision regarding claims 1 and 14” and is “fully prepared to pursue all available appellate options.” The ruling increases legal and commercial risk to YUTREPIA’s U.S. outlook. The parties’ proposed-judgment submissions and any court order will determine whether the FDA is asked or directed to alter approval or labeling for the PH-ILD indication.
