Liquidia’s Yutrepia Path Clear As UTC Loses Axed Patent Appeal

Liquidia Corp. moved closer to gaining final regulatory approval for its Yutrepia drug as a US appeals court rejected United Therapeutics Corp.'s attempt to revive a patent for Tyvaso that an administrative tribunal canceled.

“Substantial evidence” supported the Patent Trial and Appeal Board’s conclusion that abstracts of two scientific papers “were sufficiently disseminated such that each constituted a printed publication,” Circuit Judge Alan D. Lourie wrote in an opinion issued Wednesday for a three-judge panel of the US Court of Appeals for the Federal Circuit. The ruling affirmed the PTAB’s cancellation of the patent.

The decision, which followed oral arguments on Dec. 4, clears the path for the US Food and Drug Administration to approve Yutrepia about three and half years before US Patent No. 10,716,793 was set to expire, in May 2027. Yutrepia, like its more established rival Tyvaso, treats high blood pressure in the lungs.

Tyvaso had sales of $873 million in 2022, 45.1% of UTC’s revenue and up from $607.5 million in 2021, according to data compiled by Bloomberg LP.

Shares of Liquidia rose by as much as 44% on the news, touching their highest level in three years, Bloomberg News reported; UTC fell by as much as 5.9%. Shares of MannKind Corp, which provides the dry powder used in UTC’s Tyvaso, fell by as much as 16%.

Last week, Judge Richard G. Andrews denied Liquidia’s lingering request to partially stay enforcement of his August 2022 judgment, which found the patent valid and infringed, pending resolution of UTC’s appeal—a motion that, if granted, also would have allowed the FDA to approve Yutrepia ahead of the patent’s expiration.

Andrews also said in his Dec. 15 ruling that if the Federal Circuit upheld the PTAB’s invalidity findings, “it appears that Liquidia could launch its product.”

Andrews found the UTC patent infringed and valid at trial in the US District Court for the District of Delaware one month after the PTAB, an arm of the US Patent and Trademark Office, first canceled it. He rejected Liquidia’s argument that the PTAB’s ruling meant that Liquidia couldn’t be liable for induced infringement according to Supreme Court precedent.

But the patent tribunal again canceled the ‘793 patent in February after a rehearing, spurring UTC’s appeal that yielded Wednesday’s decision.

More than 20,000 people attended the two 2004 conferences at which the abstracts were presented, the PTAB determined. The Federal Circuit said “both Liquidia’s and UTC’s experts testified that every attendee of either conference would have received a copy of the abstract book in which each” appeared.

“Further still, the Board found that neither abstract book would have been disseminated with any expectation of privacy,” it said, “given that the conference attendees included scientists, physicians, and nurses, as well as journalists.”

Tyvaso is UTC’s inhaled-solution formulation of treprostinil that the FDA approved in 2009. The agency in 2022 approved Tyvaso DPI, the first dry-powder treprostinil formulation sold in the US. Liquidia’s proposed Yutrepia is also a dry-powder formulation.

The competitors have another lingering courtroom dispute.

UTC again sued Liquidia on Sept. 5, alleging its amended application for Yutrepia’s approval “provides the basis for a new infringement” case, whose filing UTC said triggered an automatic regulatory delay. The 30-month stay, UTC’s court filing said, blocks FDA approval of Yutrepia through Jan. 25, 2026.

On Nov. 30, UTC filed an amended complaint in the new case adding an allegation that Tyvaso also infringes US Patent No. 11,826,327, which covers methods of treating diseases that leave lung tissue scarred, making breathing difficult. It was issued two days earlier and expires in January 2042—the latest of all Orange Book-listed patents for Tyvaso’s powder- and solution-based formulations.

Liquidia’s response to the allegations in the lawsuit UTC filed in September is due Jan. 16. The case is pending in Delaware district court.

Goodwin Procter LLP and McDermott Will & Emery represent UTC. Cooley LLP represents Liquidia.

The case is United Therapeutics Corp. v. Liquidia Techs. Inc., Fed. Cir., No. 23-1805, opinion affirming PTAB decision issued 12/20/23.