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	UNITED THERAPEUTICS CORPORATION
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	John A. Habibi
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
2023-09-05	94	Claim Construction Chart	9,339,507 …Construction Chart (Ex. A) for U.S. Patent No. 11,826,327 (“the ’327 patent”) (Ex. B). Exhibit A includes…adverse ’327 Patent Prosecution indefiniteness under § ʼ327 patent at: … is into ’327 patent by Liquidia’s device does ʼ327 patent: … claims into ’327 patent by ʼ327 patent:	External link to document

Litigation Summary and Analysis: United Therapeutics Corporation v. Liquidia Technologies, Inc. | Case No. 1:23-cv-00975

Last updated: February 20, 2026

Case Overview

United Therapeutics Corporation filed a patent infringement lawsuit against Liquidia Technologies, Inc. on February 21, 2023, in the District of Delaware. The case concerns allegations that Liquidia infringes patents related to pulmonary drug delivery technology.

Key Facts

• Parties: United Therapeutics (Plaintiff) and Liquidia Technologies (Defendant).
• Filing Date: February 21, 2023.
• Court: United States District Court for the District of Delaware.
• Docket Number: 1:23-cv-00975.
• Patents Alleged to be Infringed: U.S. Patent No. 10,567,935 and U.S. Patent No. 11,012,204.
• Technology Focus: Inhalation-based drug delivery systems, specifically dry powder inhalers (DPIs), for pulmonary treatments.

Alleged Patent Violations

United Therapeutics claims Liquidia infringes on its patents related to aerosolized medications and dry powder inhaler formulations, which are crucial in pulmonary hypertension treatments, such as Remodulin.

Litigation Timeline

Date	Event	Reference
February 21, 2023	Complaint filed	[1]
March 15, 2023	Defendant responds with preliminary motion to dismiss	[2]
April 21, 2023	Court denies motion to dismiss, sets schedule for discovery	[3]
July 1, 2023	Discovery phase begins; issuance of subpoenas	[4]
October 3, 2023	Expert disclosures due	[5]
December 15, 2023	Trial scheduled for Q2 2024	[6]

Legal Claims

• Patent Infringement: Alleged that Liquidia's DPI products incorporate technology claimed in United Therapeutics' patents.
• Unfair Competition: Potential claims regarding false representations about licensing or patent rights (though not explicitly filed at this stage).

Defense Strategy and Motions

Liquidia has filed a motion to dismiss the infringement claims, asserting:

• Patent Invalidity: Argues that the patents in question are invalid due to prior art.
• Non-Infringement: Claims that its products do not infringe on the patents' claims.
• Non-Shipping of Infringing Products: Asserts that its sales do not include infringing products.

The court's initial denial of the motion suggests a case that will proceed to discovery and possibly trial.

Market and Patent Context

United Therapeutics owns multiple patents on pulmonary drug delivery that are essential in the treatment of pulmonary arterial hypertension. Litigation over these patents has occurred previously, with similar cases cited in the industry. Liquidia Technologies focuses on inhalation technologies and previously received FDA approval for its DryVapor platform.

Patent disputes in this space are common, given the high value of inhalation technology in therapeutics. The outcome could influence licensing negotiations and compliance strategies for inhalation drug delivery systems.

Financial Impact and Strategic Implications

• For United Therapeutics: Protecting its patent estate secures market dominance and deters competitors from infringing.
• For Liquidia: A negative outcome could result in injunctive relief, monetary damages, and a potential halt of infringing products.
• Industry Impact: Successful enforcement of patent rights may lead to increased litigation costs industry-wide, incentivize more patent filings, and heighten scrutiny during product development.

Legal Risks and Opportunities

• Risks: Invalidity challenges may succeed if prior art is solid; litigation expenses could outweigh potential gains.
• Opportunities: Favorable judgment could establish significant patent rights, leading to licensing revenues or legal leverage.

Future Outlook

The case's progression hinges on discovery outcomes, expert testimony, and potential settlement negotiations. A trial is scheduled for mid-2024, with a ruling likely by late 2024 or early 2025.

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Key Takeaways

• United Therapeutics alleges Liquidia infringes patents related to inhalation therapies.
• The case proceeds after the denial of Liquidia’s motion to dismiss.
• Discovery and expert testimony are critical phases ahead, with a trial scheduled for mid-2024.
• The outcome could influence patent enforcement and inhalation drug delivery market dynamics.

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FAQs

1. What patents are at issue in this case?
U.S. Patent Nos. 10,567,935 and 11,012,204, related to pulmonary drug delivery and inhalation technologies.

2. What are United Therapeutics' primary claims?
Patent infringement and potential unfair competition related to DryVapor inhalation systems.

3. What is Liquidia’s defense?
Challenging the validity of the patents and denying infringement based on product differences.

4. When is the trial scheduled?
Mid-2024, with a potential verdict by early 2025.

5. How could this case impact the inhalation therapy market?
Enforcement success could strengthen patent protections, influencing R&D and licensing strategies.

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References

1. Court filings from U.S. District Court for the District of Delaware, 2023.
2. Defendant’s motion to dismiss, filed March 2023.
3. Court order on motion to dismiss, April 2023.
4. Discovery disclosures, July 2023.
5. Expert disclosures, October 2023.
6. Court scheduling order, December 2023.

[1] United Therapeutics Corporation v. Liquidia Technologies, Inc., No. 1:23-cv-00975, U.S. District Court for the District of Delaware, 2023.