Liquidia, a biopharmaceutical company, has suffered a setback in its patent dispute with United Therapeutics, which could potentially delay the U.S. launch of Liquidia’s Yutrepia treatment for pulmonary arterial hypertension. On Monday, the appellate court for the Federal Circuit affirmed a lower court’s ruling that Yutrepia, a generic formulation of treprostinil inhalation powder, would infringe upon United Therapeutics’ 793 patent, which is set to expire in May 2027. This ruling has caused concern for Wall Street analysts covering Liquidia, resulting in a 14% drop in the company’s shares, which now stand at $7.02.
It is important to note that this recent decision does not impact the Patent Trial and Appeal Board’s previous ruling that the claims under the 793 patent are unpatentable. United Therapeutics has appealed this decision to the Federal Circuit, and a briefing is scheduled for the fourth quarter. Oral arguments will be heard after the briefing concludes, likely in late 2023 or early 2024. Following this, the court will issue a ruling, which could take anywhere from a few days to a few months, according to Liquidia.
In the event that the Federal Circuit upholds the Patent Trial and Appeal Board’s ruling, Liquidia intends to pursue final regulatory approval for Yutrepia.