Liquidia Corporation Provides Update on Litigation Filed by United Therapeutics

Rhea-AI Summary

Liquidia Corporation (NASDAQ: LQDA) faces new litigation from United Therapeutics (UTHR) over alleged patent infringement. The lawsuit, filed on May 9, 2025, in North Carolina's U.S. District Court, concerns UTHR's '782 patent and seeks to prevent Liquidia from commercializing YUTREPIA™, their inhaled treprostinil treatment for PAH and PH-ILD.

The disputed '782 patent is from the same family as UTHR's previously invalidated '793 patent. Notably, the '793 patent was declared invalid by the Patent Trial and Appeal Board (PTAB), a decision upheld through multiple appeals including the Supreme Court. The litigation does not affect FDA's ability to approve YUTREPIA, which has a PDUFA date of May 24, 2025.

Positive

• Previous similar patent ('793) from same family was successfully invalidated through multiple court levels
• Litigation does not prevent FDA from approving YUTREPIA on scheduled PDUFA date
• Company leadership shows confidence in defending against the patent challenge

Negative

• New patent infringement lawsuit could potentially block YUTREPIA commercialization
• Legal battle with larger competitor (UTHR) continues, potentially increasing legal costs
• Uncertainty around product launch timing due to litigation

Insights

Patent Litigation Expert

UTHR's new patent lawsuit against Liquidia appears weak given previous invalidation of similar claims, unlikely to block YUTREPIA's May 24 approval.

This new litigation represents another chapter in the ongoing patent battle between United Therapeutics (UTHR) and Liquidia over inhaled treprostinil treatments. UTHR has filed a complaint alleging Liquidia's YUTREPIA infringes their '782 patent, seeking to block its commercialization for PAH and PH-ILD indications.

The key legal weakness in UTHR's case is that the '782 patent claims essentially the same method of administering inhaled treprostinil as their '793 patent, which was previously invalidated by the Patent Trial and Appeal Board. This invalidation was subsequently affirmed by the Federal Circuit Court and the Supreme Court rejected UTHR's appeal, making the invalidation final.

Critically, UTHR is not seeking an FDA injunction to prevent approval, meaning the FDA can still approve YUTREPIA on the May 24, 2025 PDUFA date. This strategic omission suggests UTHR recognizes the weakness of their position following the definitive invalidation of the related '793 patent.

The timing is particularly noteworthy - filing just two weeks before YUTREPIA's PDUFA date appears to be a desperate tactical maneuver rather than a substantive legal challenge. Given the judicial history invalidating similar claims and the CEO's confident response about defending against "repeated, last-minute attempts," this litigation appears unlikely to prevent YUTREPIA's market entry, though it may create some short-term market uncertainty for Liquidia.

• New litigation filed against Liquidia in U.S. District Court for the Middle District of North Carolina alleges infringement of UTHR’s ‘782 patent and seeks to enjoin Liquidia from commercializing YUTREPIA
• ‘782 patent claims same general subject matter as UTHR’s invalidated ‘793 patent
• Does not impact FDA’s ability to take final action on NDA for YUTREPIA on PDUFA goal date of May 24, 2025
  

MORRISVILLE, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that United Therapeutics Corporation (UTHR) filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00368) against Liquidia alleging infringement of U.S. Patent No. 11,357,782 (the ‘782 patent). Additionally, the complaint seeks to enjoin Liquidia from commercializing YUTREPIA™ (treprostinil) inhalation powder if approved by the U.S. Food and Drug Administration (FDA) to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Dr. Roger Jeffs, CEO, Liquidia said: “We are not surprised by UTHR’s repeated, last-minute attempts to deny PAH and PH-ILD patients access to an alternative therapy. We have invalidated similar claims covering the treatment of pulmonary hypertension patients with inhaled treprostinil in the past and will continue to defend the rights of patients suffering with these critical illnesses to choose the therapy that works best for them.”

The ‘782 patent, which issued on June 14, 2022, arises out of the same patent family as U.S. Patent No. 10,716,793 (the ‘793 patent) and claims the same general method of administering inhaled treprostinil to pulmonary hypertension patients. As disclosed in July 2022, the ‘793 patent was held to be invalid in a proceeding before the Patent Trial and Appeal Board (PTAB). The PTAB’s decision was affirmed by the U.S. Court of Appeals for the Federal Circuit in December 2023. The United States Supreme Court rejected UTHR’s petition for a writ of certiorari, thereby upholding PTAB’s decision which found that all claims of the ‘793 patent are unpatentable due to prior art as final and not subject to further appeal.

UTHR is currently not seeking any injunction against the FDA to prevent final approval of the New Drug Application (NDA) for YUTREPIA. As previously announced, the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025.

About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT^® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.

Cautionary Statements Regarding Forward-Looking Statements 
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related submission contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, the timeline or outcome related to patent litigation in the U.S. District Court for the District of Delaware or the U.S. District Court for the Middle District of North Carolina, including rehearings or appeals of decisions in any such proceedings, the issuance of patents by the USPTO and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein.   The invalidity of one patent is not necessarily determinative as to the validity of a second patent, even if the patents arise out of the same patent family or claim similar subject matter. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information

Investors:
Jason Adair
Chief Business Officer
919.328.4350
jason.adair@liquidia.com

Media:
Patrick Wallace
Director, Corporate Communications
919.328.4383
patrick.wallace@liquidia.com

FAQ

What is the new lawsuit filed against Liquidia (LQDA) about?

United Therapeutics filed a lawsuit on May 9, 2025, alleging Liquidia's infringement of the '782 patent and seeking to prevent commercialization of YUTREPIA, their inhaled treprostinil treatment for PAH and PH-ILD.

When is the PDUFA date for Liquidia's YUTREPIA?

The FDA has set a PDUFA goal date of May 24, 2025, for YUTREPIA's New Drug Application.

How does the new patent lawsuit affect FDA approval of YUTREPIA?

The lawsuit does not impact FDA's ability to take final action on YUTREPIA's NDA by the PDUFA date, as UTHR is not seeking any injunction against the FDA.

What happened to the previous patent ('793) in United Therapeutics' lawsuit against Liquidia?

The '793 patent was invalidated by the Patent Trial and Appeal Board, a decision that was upheld by the Federal Circuit Court and Supreme Court, making it final and not subject to further appeal.

What conditions will Liquidia's YUTREPIA treat if approved?

YUTREPIA is being developed to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).