With a yearslong patent dispute between the two drugmakers finally put to bed—complete with a hefty settlement payout—United Therapeutics has clinched what one analyst calls a “clearcut win” over lung disease rival Liquidia Technologies.
As first communicated in late September, the U.S. District Court for the District of Delaware has found that Liquidia infringed two claims of a United Therapeutics patent related to its inhaled treprostinil drug Tyvaso. The decision specifically concerns Tyvaso in pulmonary hypertension associated with interstitial lung disease (PH-ILD), with the alleged patent violations on Liquidia’s part revolving around its rival treprostinil medicine Yutrepia.
Despite United Therapeutics bringing its latest lawsuit to bear against Liquidia in February 2024, Yutrepia ultimately won formal FDA sign-off in PH-ILD, as well as pulmonary arterial hypertension (PAH), last May.
Under the terms of the settlement unveiled this week, Liquidia will pay out a little over $380 million to United Therapeutics in installments through 2026 and 2027, which it said Wednesday will be “inclusive of payments to resolve antitrust litigation against United Therapeutics.”
Crucially, Liquidia has also agreed to “immediately” work with the FDA to remove the PH-ILD indication from Yutrepia’s label, according to a United Therapeutics securities filing.
“Going forward, Liquidia agrees that it will only market, detail, and promote Yutrepia to health care practitioners who, to Liquidia’s knowledge, treat patients with pulmonary arterial hypertension,” United Therapeutics said.
Liquidia, for its part, said in an Oct. 14 release that it won’t appeal the court’s ruling and framed the resolution as a positive overall, given that it ensures Yutrepia will remain on tap for patients with PAH.
According to Liquidia’s communique, Yutrepia generated $222.7 million in preliminary third-quarter sales, which had helped build out some $396 million in cash reserves at the company as of Sept. 30.
Liquidia clarified that it will continue to advance its Yutrepia postmarketing studies, as well as those for L606, a next-generation sustained-released liposomal formulation of treprostinil being aimed at both PAH and PH-ILD. The settlement “resolves all pending litigation between the companies,” Liquidia added in its release.
The company will look to the settlement as something of a clean slate, with CEO Roger Jeffs noting in a statement Wednesday that the company can focus its “full attention and resources on further growing the Yutrepia brand, with the goal of making it the prostacyclin therapy of choice in PAH.”
United Therapeutics launched its latest legal challenge against Liquidia in early 2024 after facing a setback at federal appeals court, where it had at the time failed to resurrect an invalidated patent on Tyvaso.
The company’s lawsuit took aim at the FDA as well as Liquidia, asserting that the U.S. regulator had let Liquidia to sidestep “rules, precedents and procedures” when amending its pending new drug application for a potential PH-ILD indication. United Therapeutics had argued this additional niche should have been pursued in a separate Yutrepia application.
In a release late last month, United Therapeutics noted that the court’s decision ultimately came down to Liquidia’s violations of two claims related to its so-called ‘327 patent, which covers a method of “improving exercise capacity in patients with PH-ILD by inhaling treprostinil at specific dosages.” The court further determined that Liquidia had failed to prove those intellectual property claims were invalid.
“We view the outcome as a clear win” for United Therapeutics, analysts at Jefferies remarked on the settlement in a Wednesday note to clients. The resolution clears up line-of-sight for Tyvaso growth in PH-ILD and also lets investors refocus on other emerging opportunities in United Therapeutics’ pipeline, they said.
With two phase 3 wins under its belt, United Therapeutics is eyeing Tyvaso's next opportunity in idiopathic pulmonary fibrosis, where Jefferies previously flagged a whopping $5 billion to $10 billion opportunity for Tyvaso as a potential new standard of care in the lung scarring disease, estimated to affect more than 100,000 people in the U.S.
Meanwhile, the settlement also serves to remove a “major overhang that has weighed on both stocks,” the Jefferies team said.
The broader litigation saga originally dates back to the summer of 2020, several months after Liquidia initially filed its Yutrepia application with the FDA.
United Therapeutics’ share price was trading down near 0.6% heading into mid-morning Wednesday, while Liquidia enjoyed a major 37.6% bump to its stock.