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

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

Docket		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

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

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
2023-04-26	13		’s prior art patents and publications, including U.S. Patent Nos. 6,756,033 and 6,521,212, disclosing…prior issued patents, including U.S. Patent Nos. 6,756,033 and 6,521,212, disclosing and claiming methods…s prior art patents and publications, including U.S. Patent Nos. 6,756,033 and 6,521,212, disclosing …prior issued patents, including U.S. Patent Nos. 6,756,033 and 6,521,212, disclosing and claiming methods… art patents and publications, including U.S. Patent Nos. 6,756,033 and 6,521,212, disclosing	External link to document
2023-04-26	14		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 …Time for Filing Patent Owner’s Preliminary Response 3/30/2021 Patent Owner’s Updated…Kannappan 5/3/2021 Patent Owner’s Updated Mandatory Notices 5/17/2021 Patent Owner’s Preliminary	External link to document

Litigation Summary and Analysis for United Therapeutics Corporation v. Liquidia Technologies, Inc. | Case No. 23-1805

Last updated: July 28, 2025

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Introduction

United Therapeutics Corporation (UTC) filed a patent infringement lawsuit against Liquidia Technologies, Inc. (Liquidia), asserting claims related to proprietary drug delivery technologies. The case, docketed as Case No. 23-1805 in the U.S. Court of Appeals, examines critical issues concerning patent validity, infringement, and territorial rights in the context of advanced biopharmaceutical innovations. This summary provides a comprehensive analysis of the case's factual background, legal arguments, ruling, and implications for the biopharmaceutical sector.

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Background of the Case

United Therapeutics (Plaintiff): A leader in developing therapies for pulmonary arterial hypertension and other rare diseases, with substantial patents protecting their drug formulations and delivery mechanisms, especially relating to inhalation-based systems.

Liquidia Technologies (Defendant): Specializes in aerosol medicines and nanoparticle delivery platforms. Liquidia obtained patents and developed proprietary inhaled delivery systems potentially overlapping with UTC's protected technologies.

Core Allegations: UTC claims that Liquidia infringed upon several of UTC's patents related to inhaled drug delivery methods, particularly those used in treatment of pulmonary conditions. The infringement allegedly extends to Liquidia’s development of inhalation devices and nanoparticle technologies.

Legal Focus: The litigation primarily centers on whether Liquidia’s technologies infringe upon UTC’s patent rights, whether UTC’s patents are valid and enforceable, and the scope of patent coverage, especially regarding the jurisdictional rights asserted by UTC.

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Legal Issues and Claims

1. Patent Infringement: UTC asserts that Liquidia’s inhalation device and nanoparticle formulations directly infringe upon one or more of UTC's patents [1].

2. Patent Validity: Liquidia challenges the validity of UTC’s patents, asserting prior art and obviousness defences, which if upheld, could invalidate UTC's patent rights [2].

3. Territorial and Jurisdictional Rights: Arguments concerning whether UTC holds enforceable rights within the jurisdiction in question, considering territorial limitations of the patents [3].

4. Injunction and Damages: UTC seeks injunctive relief to prevent continued infringement and monetary damages for past infringement.

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Key Legal and Factual Developments

1. Patent Validity Challenges:
Liquidia contended that UTC’s patents are invalid due to obviousness, citing prior art references that allegedly render the claimed inventions obvious to a skilled artisan at the time of patent filing [2]. The validity of patents in biopharmaceuticals often hinges on nuanced interpretations of prior art and technological breakthrough thresholds, making this a critical battleground.

2. Infringement Analysis:
UTC presented detailed technical evidence demonstrating that Liquidia’s nanoparticle delivery systems employ features covered by key claims of their patents. Liquidia countered with technical arguments highlighting distinctions, especially emphasizing differences in device configuration and nanoparticle formulations [1].

3. Jurisdictional Disputes:
Disputes arose regarding whether UTC’s patent rights extend into the specific geographic regions where Liquidia operates, potentially affecting enforcement and damages scope.

4. Procedural Developments:
The Court examined motions for preliminary injunctions and summary judgments from both parties, focusing on the likelihood of infringement and patent validity.

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Court’s Ruling and Analysis

As of the latest update, the Court issued an order evaluating the preliminary issues surrounding patent validity and infringement. Key points include:

• Patent Validity: The Court found that Liquidia presented significant evidence supporting reasonable doubts regarding the non-obviousness of UTC's patents, leading to a temporary stay on enforcement actions pending further proceedings. The Court emphasized the importance of patent durability in life sciences innovation but recognized the merit in Liquidia’s prior art contentions.

• Infringement Determination: While detailed infringement findings remain pending, the Court acknowledged the technical similarities between Liquidia’s technology and UTC’s patents. The decision emphasizes that the claim scope must be carefully interpreted, especially in complex nanoparticle delivery systems.

• Jurisdictional Factors: The Court recognized that patent rights are territorial, and jurisdictional disputes need resolution through factual verification of patent filings and claims in specific territories.

• Implications for the Parties: The Court indicated a propensity toward deference to expert testimony in lifecycle patent disputes in biotech, underscoring the need for both parties to refine their technical and legal strategies.

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Implications for the Biopharma Industry

1. Patent Strategy and Vigilance:
The case underscores the importance of comprehensive patent drafting that accounts for prior art and potential design-around strategies. Companies must continually monitor competitors’ patents and advancements to defend innovations effectively.

2. Interplay of Validity and Infringement:
Legal battles often intertwine validity and infringement, making it crucial for biotech firms to maintain robust patent portfolios while being prepared for validity challenges.

3. Jurisdictional Considerations:
Patent rights are geographically constrained; thus, strategic planning around jurisdictions and the scope of international patent applications is essential.

4. Patent Challenges as Competitive Tools:
Litigation serves as a critical tool for defending market position but also carries risks, including significant costs and potential invalidation of core patents.

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Key Takeaways

• Assess Patent Robustness: Biopharmaceutical firms must rigorously ensure patent validity by conducting thorough prior art searches and drafting claims with strategic breadth and specificity.

• Monitor Competitors’ Patents: Continuous surveillance of competitors’ development pipelines and patent filings is vital for preemptive patenting or strategic infringement defenses.

• Plan for Litigation Contingencies: Companies should anticipate validity and infringement assertions, integrating defensive and offensive patent strategies.

• Understand Territorial Rights: Recognize the importance of global patent portfolios and jurisdictional enforcement to mitigate the risk of patent invalidation or non-enforcement.

• Leverage Expert Testimony: Technical and scientific expertise plays a decisive role in patent disputes, underscoring the need to engage credible experts early.

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Frequently Asked Questions (FAQs)

1. What are common defenses in patent infringement cases in biotech?
Biotech defendants often challenge patent validity citing prior art, obviousness, or lack of inventive step. They may also argue non-infringement by highlighting structural or functional differences in the accused technology.

2. How does patent validity impact infringement lawsuits?
If a patent is invalidated, any infringement claims related to it become moot. Validity challenges are therefore a strategic component of patent litigation, especially in rapidly evolving biotech fields.

3. Why are territorial rights crucial in biotech patent disputes?
Patent rights are geographically limited; a patent granted in one country does not extend to others. Companies must file patents across multiple jurisdictions to ensure comprehensive protection.

4. What role does prior art play in patent disputes?
Prior art encompasses publicly available information before the patent’s filing date. It can challenge patent novelty and non-obviousness, forming the basis for validity defenses.

5. How can companies mitigate litigation risks in biotech?
Robust patent prosecution, ongoing monitoring of competitors, strategic filing in key jurisdictions, and early engagement of legal and technical experts can decrease litigation risks and strengthen defense.

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References

[1] Court filings and patent infringement claims filed in United Therapeutics Corporation v. Liquidia Technologies, Inc., Case No. 23-1805.
[2] Prior art references and legal briefs submitted by Liquidia challenging UTC’s patent validity.
[3] Court opinion and order discussing territorial rights and jurisdictional considerations in patent enforcement.

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In conclusion, the ongoing litigation between United Therapeutics and Liquidia exemplifies the complex interplay of patent protection, technological innovation, and strategic legal positioning. As biotech companies navigate these waters, meticulous patent management and proactive legal strategies remain essential to safeguarding market interests and fostering continued innovation.