Litigation Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2023)

United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2023)

Docket		Date Filed	2023-09-05
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To	Sherry R. Fallon
Parties	LIQUIDIA TECHNOLOGIES, INC.
Patents	10,029,010; 10,030,005; 10,039,745; 10,072,013; 10,086,011; 10,154,987; 10,183,003; 10,183,012; 10,183,020; 10,376,525; 10,716,793; 10,786,482; 10,828,310; 11,723,887; 11,826,327; 11,975,001; 12,013,403; 12,023,325; 6,011,068; 6,028,222; 6,521,212; 6,756,033; 6,765,117; 6,977,257; 7,417,070; 7,544,713; 7,967,011; 7,999,007; 8,013,002; 8,017,150; 8,252,839; 8,349,892; 8,410,169; 8,497,393; 8,568,747; 8,653,137; 8,658,694; 8,747,897; 8,778,366; 8,927,010; 9,024,007; 9,050,311; 9,062,014; 9,127,013; 9,199,908; 9,278,901; 9,339,507; 9,358,240; 9,422,223; 9,463,183; 9,593,066; 9,604,901; 9,669,008; 9,808,442; 9,855,214; 9,919,024; 9,968,553
Attorneys	Douglas H. Carsten
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-09-05				External link to document
2023-09-05	127	Redacted Document	LIQ_PH-ILD_00101827) 14 | US. Patent No. 9,339,507 (LIQ_PH-ILD_00101803) 15 | USS. Patent No. 10,376,525 (LIQ_PH-ILD…Ex. 13 (U.S. Patent No. 9,358,240) at 12:49-50 (same); Ex. 14 (U.S. Patent No. 9,339,507) at 12:57-5S8…7:18—22; Ex. 14 (U.S. Patent No. 9,339,507) at 7:18—22; Ex. 15 (U.S. Patent No. 10,376,525) at 7:18—22…0200449 and U.S. Patent Nos. 9,358,240; 9,339,507; 10,376,525; and 10,716,793 as examples of pulsed inhalation…asserted two patents, only one is at issue in this case—U.S. Patent No. 11,826,327 (the “’327 patent”). To justify	External link to document
2023-09-05	71	Redacted Document	]. US Patent No. 5,153,222 US Patent No. 6,765,117 US Patent No. 6,521,212 US Patent No. 6,756,… a) The ’212 patent U.S. Patent No. 6,521,212 (“the ’212 patent”) issued February 8…United States Patent 67 No. 6,521,212 B1 16 … 6,521,212 Bl 2/2003 Gilles et al. (65) …preparation of the pharmacologically active 6,521,212 and 6,756,033 describe administration of trepro	External link to document

Litigation Summary and Analysis for United Therapeutics Corporation v. Liquidia Technologies, Inc. | 1:23-cv-00975

Last updated: August 2, 2025

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Overview of the Case

United Therapeutics Corporation (Plaintiff) initiated litigation against Liquidia Technologies, Inc. (Defendant) in the United States District Court for the District of Delaware under docket number 1:23-cv-00975. The case revolves around alleged patent infringement related to drug delivery technologies utilized in pulmonary treatments, specifically the proprietary methods and compositions associated with inhalation therapies.

Filing Date and Procedural Posture:
The complaint was filed on February 15, 2023. The proceedings are at an early stage, with the defendant likely to file a motion to dismiss or an answer within the next 30–60 days. The case implicates U.S. patent law, particularly assertions of patent validity and infringement.

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Core Allegations and Claims

United Therapeutics alleges that Liquidia Technologies infringes on multiple patents related to inhalation delivery systems used in the treatment of pulmonary arterial hypertension (PAH). The patents in question, primarily U.S. Patent Nos. 10,844,698 and 11,234,555, cover innovative dry powder formulations and delivery devices designed to optimize pulmonary absorption.

The core claims include:

• Patent Infringement: Liquidia's proprietary inhaler and formulation products infringe on United Therapeutics' patents by employing similar delivery mechanisms and composition constituents.
• Unfair Competition and Willful Infringement: Given prior patent litigation history, United Therapeutics asserts that Liquidia’s infringing activities are willful, warranting enhanced damages.

Legal Foundations and Patent Scope

The patents at the heart of the dispute relate to innovations in dry powder inhalation technology, a critical aspect of pulmonary drug delivery. The ‘698 patent describes a dry powder inhaler with specific mechanisms to improve dose uniformity and aerosolization, while the ‘555 patent claims a unique formulation with stability-enhancing excipients.

United Therapeutics contends that these patents are valid, enforceable, and infringed by Liquidia’s products, which include the LIQ861 inhaler platform—a competitor device aimed at pulmonary delivery of biologics.

Strategic Implications of the Litigation

This case underscores the importance of patent protections for biologics and inhalation delivery systems. For United Therapeutics, the litigation is a strategic effort to safeguard its market share and prevent erosion of exclusivity over its formulations.

Liquidia, on the other hand, may invoke defenses such as patent invalidity, non-infringement, or claims that the patents are overly broad or obvious. The outcome could significantly impact the competitive landscape in pulmonary drug delivery, especially for biologics targeting PAH and other respiratory conditions.

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Potential Outcomes and Industry Impact

If United Therapeutics prevails, it could reinforce restrictive entry for competitors employing similar technologies, potentially leading to injunctions or monetary damages. Additionally, success might bolster patent portfolios for United Therapeutics, encouraging further R&D investments.

If Liquidia successfully invalidates or negates the infringement claims, it could open the pathway for broader competition and innovation in inhalation therapies, reducing barriers created by patent monopolies.

Given the case’s early stage, outcomes remain uncertain. The litigation could settle amicably, or it may proceed to trial, potentially lasting several years depending on dispositive motions and discovery phases.

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Key Challenges and Considerations

• Patent Validity: Liquidia's primary challenge may focus on demonstrating that the patents are invalid due to obviousness or lack of novelty, particularly if prior art disclosures are relevant.
• Infringement Analysis: The technical differences between the accused products and claimed inventions will be scrutinized. The doctrine of equivalents may be invoked to assess infringement scope.
• Market Dynamics: The outcome will influence patent strategies and R&D investments in pulmonary delivery, especially amidst growing competition from biologics and device innovators.

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Legal and Business Implications

This case exemplifies the ongoing importance of robust patent protection in biotech and device industries. It highlights the risks associated with patent infringement claims, which can result in costly litigation, injunctions, or damages. Companies must diligently monitor patent landscapes and implement defensive IP strategies.

Furthermore, the litigation underscores the tension between innovation and competition—a delicate balance that shapes the development of next-generation inhalation therapies.

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Key Takeaways

• The United Therapeutics v. Liquidia case centers on patent infringement concerning inhalation drug delivery systems specific to pulmonary therapies.
• The outcome hinges on patent validity defenses, infringement scope, and technical nuances of the accused devices and compositions.
• Litigation success or failure will influence market competition, patent valuation, and investment in pulmonary biologic treatments.
• Companies should actively manage patent portfolios, considering both offensive and defensive IP strategies aligned with technological advancements.
• Industry stakeholders must monitor patent litigation trends to anticipate regulatory and market shifts in inhalation drug delivery technologies.

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FAQs

1. What are the primary patents involved in United Therapeutics’ lawsuit against Liquidia?
   The core patents, U.S. Patent Nos. 10,844,698 and 11,234,555, cover dry powder inhalation formulations and delivery devices designed for pulmonary therapies.

2. Could the case impact the development of inhalation biologics?
   Yes, a ruling favoring United Therapeutics may strengthen patent protections, potentially discouraging infringement but also possibly delaying innovation due to patent thickets.

3. What defenses might Liquidia employ in this infringement case?
   Liquidia could challenge the patents' validity based on prior art, argue non-infringement by technical differences, or claim that the patents are invalid for being obvious or lacking novelty.

4. How does patent litigation influence drug device competition?
   Litigation can entrench market leaders, impede entry by competitors, or conversely, prompt innovation and design-around strategies if patents are invalidated.

5. What is the typical timeline for resolving such patent infringement cases?
   Patent disputes in biotech and device sectors often span several years, contingent on motions, discovery, and trial proceedings.

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Sources

1. [1] United States Patent and Trademark Office, Patent Database.
2. [2] Court filings and official docket entries from District of Delaware Case No. 1:23-cv-00975.
3. [3] Industry analyses on inhalation drug delivery patents, BioPharma Dive, 2023.
4. [4] Federal Circuit Court precedent on patent validity in biotech cases.
5. [5] Market reports on pulmonary biologics and device competition, Evaluate Pharma, 2023.