Liquidia’s stock $LQDA rose about 10% on Monday following a win in the US Supreme Court for its treprostinil inhalation powder Yutrepia.
Liquidia has been fighting United Therapeutics over competing drugs in various court battles over the last several years. The FDA handed down a tentative approval for Yutrepia in August, but also said that Yutrepia won’t receive final approval until Tyvaso’s regulatory exclusivity is over in May 2025. Liquidia’s drug is approved to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Roger Jeffs“United Therapeutics has pulled out all the stops to prevent our product from coming to market at all. And I think with this decision, this product is now going to come to market,” Liquidia’s chief business officer Jason Adair told Endpoints News. “I think that’s a big milestone for us as a company, is that this product is going to come to market when the regulatory exclusivity expires, if not earlier.”
In an announcement, Liquidia said the court rejected United Therapeutics’ petition which requested permission to appeal prior decisions in Liquidia’s favor that found that all claims of one of United’s patents are unpatentable. The company added in its announcement that there are currently no patents preventing final FDA approval of Yutrepia, although a trial over another patent is scheduled for June 2025.
Thanks to the Supreme Court, the 2022 decision by the Patent Trial and Appeal Board, which invalidated United’s claims of patent infringement — and a decision by the US Court of Appeals for the Federal Circuit in 2023 that upheld the board’s decision — are now final and can’t be appealed.
Jeffs wrote in a statement that that patent is now unenforceable and Liquidia will “fight for the earliest possible launch” of Yutrepia.
Also on Monday, SCOTUS declined to hear a case involving former pharma executive Martin Shkreli, as he sought to reverse a $65 million payment he owes following allegations around his raising the price of the HIV drug Daraprim.
Editor’s note: This story has been updated to correctly identify Jason Adair’s quote.