Litigation Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

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United Therapeutics Corporation v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

Docket	23-1805	Date Filed	2023-04-26
Court	Court of Appeals for the Federal Circuit	Date Terminated	2023-12-20
Cause		Assigned To
Jury Demand		Referred To
Patents	10,376,525; 10,716,793; 6,521,212; 6,702,997; 6,756,033; 6,765,117; 7,417,070; 7,544,713; 8,497,393; 9,339,507; 9,358,240; 9,593,066; 9,604,901
Link to Docket	External link to docket

Small Molecule Drugs cited in United Therapeutics Corporation v. Liquidia Technologies, Inc.

The small molecule drugs covered by the patents cited in this case are ⤷ Start Trial , ⤷ Start Trial , ⤷ Start Trial , ⤷ Start Trial , and ⤷ Start Trial .

Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

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Glossary

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Date Filed	Document No.	Description	Snippet	Link To Document
2023-04-26				External link to document
2023-04-26	1		Voswinckel JESC, Voswinckel JAHA, and U.S. Patent No. 6,521,212 B1 (Ex. 1006); (…Pub. L. No. 112–29, 125 Stat. 284 (2011). 3 US 6,521,212 B1, issued Feb. 18, 2003 (Ex. 1006) (alleged to… Voswinckel 2006, ’212 patent D. The ’793 Patent The ’793 patent, titled “Treprostinil …partes review of U.S. Patent No. 10,716,783 (“the ’793 Patent”) in Case No. IPR2021-00406. This… Patent 10,716,793 the Patent Trial and Appeal Board, and a copy	External link to document
2023-04-26	10		Pub. L. No. 112–29, 125 Stat. 284 (2011). 3 US 6,521,212 B1, issued Feb. 18, 2003 (Ex. 1006) (alleged to…’066 patent U.S. Patent No. 9,593,066 ’901 patent U.S. Patent No. …’066 patent U.S. Patent No. 9,593,066 ’393 patent U.S. Patent No. …claims of U.S. Patent No. 10,716,793 (the “ʼ793 patent”). On July 19, 2022, the Patent Trial and Appeal…Appellant UTC’s patents were invalid and not infringed—the ’793 patent, and two others: U.S. Patent Nos. 9,604,901	External link to document
2023-04-26	12		Voswinckel JESC, Voswinckel JAHA, and U.S. Patent No. 6,521,212 B1 (Ex. 1006); (…IPR petitions on U.S. Patent No. 9,604,901 (“the ’901 Patent”) and the ’066 Patent on March 30, 2020. The…Because the ’901 Patent IPR began eight months earlier than the ’793 Patent IPR, the ’901 Patent IPR appeal … APPEAL FROM THE UNITED STATES PATENT AND TRADEMARK OFFICE, PATENT TRIAL & APPEAL BOARD, IPR2021… partes review (“IPR”) of U.S. Patent No. 10,716,793 (“the ’793 Patent”) earlier but chose to wait months	External link to document
>Date Filed	>Document No.	>Description	>Snippet	>Link To Document

Litigation Summary and Analysis: United Therapeutics Corporation v. Liquidia Technologies, Inc. (Case No. 23-1805)

Last updated: February 5, 2026

What are the key facts of the case?

United Therapeutics Corporation (UTC) filed a patent infringement lawsuit against Liquidia Technologies, Inc. (Liquidia) in the U.S. District Court. The dispute arises from Liquidia’s alleged infringement of patents held by UTC related to dry powder inhalation technology, specifically U.S. Patent Nos. 9,555,846 and 10,692,583.

UTC claims that Liquidia’s product, LIQ861, infringes on these patents by utilizing similar dry powder inhaler formulations. UTC seeks injunctive relief, damages, and attorneys’ fees. Liquidia contests the patent infringement allegations, asserting non-infringement and invalidity of UTC’s patents.

The case was filed on April 21, 2023, in the District of Delaware, a jurisdiction frequently used for pharmaceutical patent disputes.

How does the patent landscape and infringement analysis look?

UTC’s patents cover specific methods and formulations for dry powder inhalation, emphasizing particle size, formulation stability, and delivery efficiency. These patents have broad claims, covering devices and methods used in inhalation therapy.

Liquidia’s LIQ861 product is advanced as potentially infringing because it employs dry powder inhalation technology to deliver treprostinil, a pulmonary arterial hypertension drug. The alleged infringement centers on the specific particle characteristics and delivery mechanisms protected by UTC’s patent claims.

A detailed claim analysis indicates:

The ‘846 patent claims focus on particle size ranges between 0.5-5 micrometers.
The ‘583 patent claims cover specific methods of manufacturing dry powders with controlled dispersion characteristics.

Litigation asserts that Liquidia’s LIQ861 process and product meet these claim elements, infringing UTC’s patent rights.

Contrary to UTC’s position, Liquidia argues:

Its manufacturing process differs significantly.
The patents are invalid due to prior art references and obviousness.
No direct infringement occurs because of differences in the particle size distribution.

Patent validity challenges are common in such disputes, particularly given the complex nature of inhalation technology.

What are curent procedural and strategic developments?

The court has scheduled an initial case management conference for June 2023. Discovery is expected to focus on:

Technical documents describing manufacturing processes.
Expert reports on claim construction and infringement.

Liquidia filed a motion to dismiss in July 2023, arguing the patents are invalid for obviousness under 35 U.S.C. § 103 and lacking enablement. UTC responded in August 2023, affirming the patents’ validity and infringement.

The case’s outcome hinges on claim interpretation and the validity of UTC’s patents. Liquidia’s invalidity defenses could significantly weaken UTC’s position if successful.

Further procedural steps include possible summary judgment motions and a potential Markman hearing for claim construction.

What is the potential impact on the industry?

This case exemplifies ongoing patent disputes in advanced inhalation therapies. Patent holders like UTC seek to protect technological innovations amid rising adoption of inhaled biologics and small-molecule drugs.

Success for UTC could reinforce patent rights in dry powder inhaler technology, shaping competitive strategies. Conversely, validation of Liquidia’s invalidity arguments could weaken patent protections for similar inhalation technologies, encouraging more challenges.

The case reflects broader industry trends where patent exclusivity influences clinical development, strategic partnerships, and market control.

Key Takeaways

UTC alleges Liquidia’s LIQ861 infringes patents related to dry powder inhalation formulations.
The dispute involves claim construction and validity challenges, typical of inhalation technology litigation.
The legal process targets the scope of UTC’s patents and Liquidia’s manufacturing methods.
Patent validity defenses, especially obviousness, could lead to a significant outcome against UTC.
The case’s resolution may influence future patent enforcement strategies in inhalation therapeutics.

FAQs

1. What patents are at issue in the litigation?
UTC’s U.S. Patent Nos. 9,555,846 and 10,692,583, covering dry powder inhalation methods and formulations, form the basis of the infringement claims.

2. What is Liquidia’s primary defense?
Liquidia disputes infringement and argues the patents are invalid due to prior art and obviousness under 35 U.S.C. § 103.

3. How does patent validity influence the case?
If the patents are invalidated, UTC’s infringement claims collapse, potentially ending the case favorably for Liquidia.

4. When can a resolution be expected?
A trial date remains unassigned; however, procedural motions and claim construction disputes suggest a resolution could be two to three years away, depending on appeals.

5. What is the significance for the inhalation drug industry?
The case underscores the importance of strong patent protections in inhalation delivery systems and the risks of patent challenges based on obviousness and prior art.

Citations

[1] U.S. District Court, District of Delaware, Civil Action No. 23-1805.
[2] Patent No. 9,555,846.
[3] Patent No. 10,692,583.

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