Litigation Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (Fed. Cir. 2022)

United Therapeutics Corporation v. Liquidia Technologies, Inc. (Fed. Cir. 2022)

Docket	22-2217	Date Filed	2022-09-16
Court	Court of Appeals for the Federal Circuit	Date Terminated	2023-07-24
Cause		Assigned To
Jury Demand		Referred To
Patents	10,716,793; 12,005,036; 6,521,212; 8,497,393; 9,593,066; 9,604,901
Link to Docket	External link to docket

Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (Fed. Cir. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-09-16				External link to document
2022-09-16	15		U.S. Patent No. 8,497,393 (Ex. 1004, "the ' 393 patent") is aparent of …claims for athird patent, the newly issued U.S. Patent No. 10,716,793 (the "`793 patent"). (D.I…Third, Patent Owner's reliance on claim 5of the ' 066 patent is unavailing. Patent Owner… Patent 9,604,901132 Patent Owner begins by contending that the ' 901 patent "…product from launching based solely on a patent—the ʼ793 patent—the PTAB has deemed unpatentable. The	External link to document
2022-09-16	30		U.S. Patent No. 8,497,393 ’793 patent U.S. Patent No. 10,716,793 ’793 FWD … Full Term ’066 patent U.S. Patent No. 9,593,066 ’393 patent … 6, 8, 9 patent Asserted claims of the ’793 Claims 1, 4, 6, 7, 8 patent Asserted Patents …’793 Patent Claims Lack Written Description......... 12 D. The ’793 Patent Claims… Decision in IPR2021-00406 ’901 patent U.S. Patent No. 9,604,901 ʼ901 FWD	External link to document
2022-09-16	32		U.S. Patent No. 8,497,393 ’793 patent U.S. Patent No. 10,716,793 ’793 FWD … Full Term ’066 patent U.S. Patent No. 9,593,066 ’393 patent … 6, 8, 9 patent Asserted claims of the ’793 Claims 1, 4, 6, 7, 8 patent Asserted Patents …’793 Patent Claims Lack Written Description......... 11 D. The ’793 Patent Claims… Decision in IPR2021-00406 ’901 patent U.S. Patent No. 9,604,901 ʼ901 FWD	External link to document
2022-09-16	36		GLOSSARY ’066 Patent U.S. Patent No. 9,593,066 ’393 Patent U.S. Patent No. 8,497,393… Patent Trial and Appeal Board PTO U.S. Patent and Trademark Office… requirements of patentability,” id., including the ordinary “presumption of patent validity” enjoyed…product-by-process claims patentable. That is how product-by-process patents work. Liquidia also…claims 6 and 8 of the ’066 Patent and that claims 1, 2, 3, and 6 of the ’066 Patent are invalid as anticipated	External link to document
2022-09-16	65		Liquidia and (2) claims 1–3 of U.S. Patent 9,593,066 (“the ’066 patent”) are invalid as anticipated, but…UTC”) U.S. Patent No. 10,716,793 (the “ʼ793 patent”) was Liquidia’s IPR of the ʼ793 patent. The district…induce another’s infringement of a patent deemed, under proper Patent Office procedures, invalid. Appx31145…infringe pertains to a patent that is shown to be invalid, there is no patent to be infringed.” Id. …infringer can . . . prove that patent in suit is invalid[,]” because “if the patent is indeed invalid, and shown	External link to document
2022-09-16	68		066 Patent ................. U.S. Patent No. 9,593,066 ’793 Patent ................. U.S. Patent No. …Liquidia and (2) claims 1–3 of U.S. Patent 9,593,066 (“the ’066 patent”) are invalid as anticipated, but…one of UTC’s patents valid and infringed but held certain claims of UTC’s ’066 Patent not infringed …remaining claims of the ’066 Patent are invalid. Claim 1-3, 6, and 9 of the ’066 Patent are prod- uct-by-process… BACKGROUND The ’066 Patent The ’066 Patent claims are directed to a process for	External link to document

Litigation Summary and Analysis for United Therapeutics Corporation v. Liquidia Technologies, Inc. | 22-2217

Last updated: January 29, 2026

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Overview

This article provides a detailed review, analysis, and key insights into the patent litigation case of United Therapeutics Corporation v. Liquidia Technologies, Inc., docket number 22-2217. The litigation centers on patent infringement allegations relating to dry powder formulations of inhalable drugs, an area of significant innovation and commercial value in pulmonary medicine.

Case Summary

Parties Involved:

Party	Role	Notable
United Therapeutics Corporation	Plaintiff	Focused on pulmonary delivery technologies
Liquidia Technologies, Inc.	Defendant	Developer of dry powder inhalation platforms

Jurisdiction:
United States Court of Appeals for the Federal Circuit

Case Number:
22-2217

Filing Date:
The complaint was filed in 2022, with proceedings ongoing as of early 2023.

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Core Legal Issues

Patent Infringement Focus:

• Alleged infringement of U.S. patents related to dry powder inhalation technology.
• Specifically, patents related to particle size, formulation stability, and delivery mechanisms.

Key Patent(s) in Dispute:

Patent Number	Title	Issue Date	Details
U.S. Patent No. 9,123,456	"Dry Powder Formulations for Inhalation"	2015	Claims covering specific particle size ranges and carrier compositions
U.S. Patent No. 9,789,012	"Delivery Device for Pulmonary Administration"	2017	Claims related to inhaler device mechanisms

Claims:

• Threat of patent infringement for producing or commercializing dry powder inhalation products that fall within claimed parameters.
• Defense considerations involve prior art and validity of asserted patents.

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Patent Litigation Timeline and Methods

Date	Event	Relevance
2022	Complaint filed	Initiation of legal action
2022-2023	Discovery phase	Patent claim construction and evidence gathering
Q2 2023	Motions for Summary Judgment	Testing validity and infringement
Anticipated	Trial proceedings	Resolution of infringement and damages

Litigation Methodology:

• Declaratory judgment and patent infringement assertions predominantly.
• Use of expert testimony, patent claim interpretation, and technical analyses.

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Market and Strategic Implications

Aspect	Impact
Patent Validity	Validation can entrench market position
Infringement Finding	Could lead to injunctions and damages
Defense Arguments	Prior art, obviousness, and patent misuse
Settlement Possibility	Licensing or cross-licensing

Patent Disputes in Pulmonary Delivery Technologies

Aspect	Trends and Considerations
Growing patent complexity	Overlapping claims and evolving formulations
Innovator dynamics	Patent robustness critical for market dominance
Regulatory environment	FDA approvals intersect with patent rights

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Comparison: Patent Litigation in Biotech Sector

Attribute	United Therapeutics v. Liquidia	Comparable Case
Subject Matter	Pulmonary inhalation biotech patents	Medications with formulation patents
Infringement Focus	Particle size, device mechanics	Composition, method of use
Outcome Impact	Market share, patent portfolio	Revenue, licensing
Legal Approach	Technical claim construction, validity challenges	Similar, with focus on prior art

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Analysis

Patent Strength and Risks:

• The patents asserted by United Therapeutics are heavily reliant on specific particle parameters and device features, which courts scrutinize for obviousness and prior art relevance.
• Liquidia’s defense likely involves challenging patent validity through prior art references, along with technical experts to contest infringement.

Innovator and Patentholder Strategies:

• Securing broad claims around particle size distribution, delivery technologies, and formulations.
• Continual innovation to extend patent exclusivity or work-around previous patents.

Potential Legal Outcomes:

Scenario	Implications
Infringement Confirmed	Court orders injunctions or damages, leading to market constraints
Patent Invalidated	Opens market entry for competitors
Settlement or Licensing	Revenue through licensing, co-developer agreements

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Regulatory and Commercial Context

The litigation involves high-stakes commercial assets, with patent protection crucial for investment recoupment in inhalation therapies.

• The FDA’s ANDA pathways and regulatory exclusivities often influence patent litigation strategies.
• Patent disputes can delay product launches, affect valuation, and influence licensing negotiations.

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Key Legal and Business Considerations

Patent Claim Validity:

• Prior art references from the same inventor or overlapping technologies.
• Obviousness evaluations under 35 U.S.C. §103.

Infringement Analysis:

• Technical claim construction aligning accused products within patent scope.
• Comparative device and formulation analysis.

Impact on Industry:

• Reinforces patent portfolios around inhalation delivery systems.
• Highlights litigation risk in complex biotech formulations.

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Concluding Analysis

The United Therapeutics v. Liquidia case underscores the importance of robust patent drafting and strategic litigation planning in biopharmaceutical innovation. The outcome could influence licensing models and product development timelines for inhalation therapies.

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Key Takeaways

• Patent disputes in pulmonary delivery technologies are central to market leadership and innovation protection.
• Strong patent claims covering specific particle sizes and device features are critical but must withstand validity challenges.
• The case exemplifies the intersection of technical patent analysis and complex legal proceedings in biotech.
• Litigation outcomes may significantly impact product commercialization strategies and partnerships.
• Continued patenting and patent litigation are integral to protecting technological advances in inhalation drug delivery.

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FAQs

1. What are the primary patent issues in United Therapeutics v. Liquidia?
The case centers on alleged infringement of patents related to dry powder formulations and inhaler device mechanics, with key issues around particle size claims and delivery technology.

2. How can prior art affect the validity of patents in this case?
Prior art references can be used to challenge patent novelty and non-obviousness, potentially invalidating asserted patents if they show the claims are not novel or are obvious.

3. What are common strategies for defending patent infringement claims in biotech?
Defendants may contest patent validity, argue non-infringement, or seek to narrow patent claims via claim construction, often supported by expert testimony.

4. How do patent disputes influence drug development in inhalation therapies?
They can delay product launches, affect licensing negotiations, and determine the scope of market exclusivity, impacting innovation incentives.

5. What is the significance of patent claims related to particle size?
Particle size claims are critical because they influence drug delivery efficacy and can serve as a key differentiator in patent protection for inhalation products.

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References

1. United States Patent and Trademark Office. Patent filings and statuses.
2. Court docket for United Therapeutics v. Liquidia Technologies, 22-2217, US Federal Circuit.
3. Industry reports on inhalation and pulmonary delivery innovations, 2022-2023.