Litigation Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2020)

United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2020)

Docket		Date Filed	2020-06-04
Court	District Court, D. Delaware	Date Terminated	2022-09-09
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To	Jennifer L. Hall
Parties	LIQUIDIA TECHNOLOGIES, INC.
Patents	10,376,525; 10,716,793; 10,898,494; 11,826,327; 6,521,212; 6,756,033; 6,765,117; 7,417,070; 7,544,713; 7,999,007; 8,114,021; 8,497,393; 9,108,015; 9,339,507; 9,358,240; 9,593,066; 9,604,901
Attorneys	William C. Jackson
Firms	Shaw Keller LLP, DE
Link to Docket	External link to docket

Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-06-04				External link to document
2020-06-04	108	Redacted Document	the validity of patents related to the Patents-in-Suit, such as U.S. Patent Nos. 8,497,393 (“the ’393…concerning [U.S. Patent No. 8,497,393] in association with the ’901 and ’066 patents,” asserting that…concerning the Related Patents and Applications, including U.S. Patent Nos. 8,497,393; 9,339,507; 9,358,…PTAB's 4 The '393 patent is U.S. Patent No. 8,497,393. Case 1:20-cv-00755-RGA-JLH Document…Hatch‐Waxman litigation involving the Patents‐in‐Suit and U.S. Patent Nos. 8,497,393; 9,339,507; and 9,358,240,	External link to document
2020-06-04	109	Ex. 1 - Second Amended Complaint	seq., involving United States Patent Nos. 9,593,066 (“the ’066 patent”) (attached as Exhibit A hereto…the expiration of the ’066 patent, the ’901 patent, and the ’793 patent, to manufacture, market, and… more claims of the ’066 patent, the ’901 patent, and the ’793 patent, which have been listed in …Liquidia has infringed the ’066 patent, the ’901 patent, and the ’793 patent; and …or more of the ’066 patent, the ’901 patent, and the ’793 patent, prior to the expiration	External link to document
2020-06-04	11	Answer to Complaint AND Counterclaim	UTC’s U.S. Patent No. 8,497,393, finding that the product claimed in the ʼ393 patent was not novel … UTC’s U.S. Patent No. 8,497,393, finding that the product claimed in the ʼ393 patent was not novel …assert a patent infringement action. Liquidia admits that U.S. Patent No. 9,593,066 (the “’066 patent”) and… and U.S. Patent No. 9,604,901 (the “’901 patent”) (collectively the “patents-in-suit”) each bear the…the ’066 patent is a product-by-process patent, and that the product claimed in the ’066 patent is novel	External link to document
2020-06-04	117	Proposed Order	claims of U.S. Patent Nos. 8,593,066 (the “’066 patent”) and 9,604,901 (the “’901 patent”), the terms…range of 15°C to 30°C) ’066 patent, claims 6 and 8; ’901 patent, claim 6 “stored” / “storing…and ordinary meaning ’066 patent, claims 6 and 8; ’901 patent, claim 6 1 The Court… plain and ordinary meaning ’066 patent, claims 1 and 8 “ambient temperature” …treprostinil,” appearing in claims 1 and 8 of the ʼ901 patent, but will issue its order regarding these terms	External link to document
2020-06-04	125	Joint Claim Construction Brief	in IPR2020-00770 regarding U.S. Patent No. 9,604,901 (“the ’901 patent”) (Paper 29, Joint Paper Concerning…statements made in the [Patent Owner’s Response] suggesting that the ’901 patent requires that treprostinil…expressly rejected by the Patent Office,” making the record clear to POSAs “that Patent Owner’s arguments …withdrawal of certain statements made before the Patent Trial and Appeal Board (“PTAB” or “Board”) in…Concerning Petitioner’s Request to Strike Portions of Patent Owner’s Paper Nos. 12 and 25 and Exhibits 2002	External link to document
2020-06-04	16	Complaint - Amended	seq., involving United States Patent Nos. 9,593,066 (“the ’066 patent”) (attached as Exhibit A hereto…to the expiration of the ’066 patent, the ’901 patent, and the ’793 patent, to manufacture, market, and… or more claims of the ’066 patent, the ’901 patent, and the ’793 patent, which have been listed in …Liquidia has infringed the ’066 patent, the ’901 patent, and the ’793 patent; and…more of the ’066 patent, the ’901 patent, and the ’793 patent, prior to the expiration	External link to document

Litigation Summary and Analysis for United Therapeutics Corporation v. Liquidia Technologies, Inc. | 1:20-cv-00755

Last updated: August 3, 2025

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Introduction

The case of United Therapeutics Corporation v. Liquidia Technologies, Inc., designated as case number 1:20-cv-00755, represents a significant patent dispute within the biotechnology sector. This litigation revolves around allegations of patent infringement involving innovative drug delivery technologies and the potential impact on market competition. This analysis provides a comprehensive overview of the case's factual background, legal issues, procedural developments, and strategic implications, equipping stakeholders and industry professionals with critical insights.

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Factual Background

Parties Involved

• United Therapeutics Corporation (Plaintiff): A biopharmaceutical company specializing in products for pulmonary arterial hypertension and other indications, with a focus on complex drug delivery systems.

• Liquidia Technologies, Inc. (Defendant): An innovative biotech firm developing inhalation-based therapies, notably utilizing dry powder and microparticle technologies.

Core Technologies and Patent Claims

United Therapeutics accused Liquidia of infringing upon its patents related to controlled pulmonary drug delivery systems. Specifically, the patent portfolio encompasses innovations in microparticle formulations designed to improve bioavailability and reduce systemic side effects.

Liquidia’s primary technology, Touchless Dry Powder Inhaler (DPI) and microfabricated particle systems, allegedly infringe upon United Therapeutics’ patents concerning controlled-release pulmonary delivery mechanisms. The dispute hinges on whether Liquidia’s manufacturing processes and inhalation devices violate specific patent claims granted to United Therapeutics.

Allegations and Industry Context

United Therapeutics contends that Liquidia’s technology infringes upon patents that cover proprietary processes and apparatuses for inhalation drug delivery, giving United Therapeutics a competitive edge in the pulmonary hypertension market. The case reflects broader industry concerns about patent protection for complex biologics and drug device combinations.

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Legal Issues

Patent Infringement and Validity

Central to this litigation are two pivotal questions:

• Infringement: Does Liquidia’s development and commercialization of dry powder inhalers infringe United Therapeutics’ patents?

• Validity: Are the patents owned by United Therapeutics valid, sufficiently novel, and non-obvious under U.S. patent law?

Standard of Proof and Litigation Strategy

United Therapeutics bears the burden of proving infringement by a preponderance of the evidence, while Liquidia challenges the validity of the patents, asserting prior art and obviousness defenses. The case involves expert testimonies, technical comparisons, and prior art analyses.

Potential Remedies

If infringement is established, remedies sought include:

• Injunctive Relief: To cease infringement activities.
• Damages: Compensation for patent infringement, including reasonable royalties and lost profits.

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Procedural Developments

Jurisdiction and Initial Motions

The case was initiated in the United States District Court for the District of Delaware. Early motions included:

• Claim Construction: The court’s Markman hearing clarified the interpretation of key patent claim terms.
• Summary Judgment Motions: Both parties filed motions to resolve issues pre-trial regarding infringement validity.

Discovery and Evidence Gatherings

The discovery phase revealed extensive technical documents, internal research, and expert reports. Battery of depositions addressed claim scope, prior art references, and technical details of inhalation devices.

Trial Schedule and Notable Events

As of the latest filings, the case remains in the pre-trial phase, with trial dates potentially set for 2024. The parties continue to dispute claim scope and patent validity through motions and expert testimony.

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Strategic and Industry Implications

Patent Litigation in Biotech Innovation

This case underscores the importance of robust patent strategies where complex drug delivery systems intersect with biotech innovation. The outcome may influence how companies protect manufacturing processes and device patents.

Market Dynamics and Competitive Positioning

A favorable ruling for United Therapeutics could strengthen its patent portfolio, deterring competitors and enabling licensing revenues. Conversely, a ruling invalidating key patents might open the market to competitive replication.

Technology Development Risks

Liquidia’s defenses highlight the risks of patent infringement claims in high-innovation sectors, particularly where overlapping technologies and prior art are prevalent. Strategic patent drafting and thorough novelty assessments are critical.

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Legal and Commercial Outlook

Given the technical complexity and high stakes, the case could set legal precedents for patent scope and enforceability in pulmonary drug delivery technology. Additionally, it might influence licensing strategies and R&D investments across the biotech sector.

If the courts uphold United Therapeutics’ patents, expect increased patent enforcement efforts and potential licensing negotiations. Alternatively, if key patents are invalidated, Liquidia could accelerate commercialization efforts, intensifying market competition.

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Key Takeaways

• Robust Patent Portfolio is Critical: Protecting high-value biotech innovations requires precise patent drafting and proactive enforcement strategies.
• Technical Expertise is Essential: Litigation involves complex technical disputes necessitating specialized expert testimony.
• Patent Validity Challenges Remain Common: Prior art and obviousness defenses are frequently utilized to contest patent scope.
• Legal Outcomes Impact Industry Dynamics: Court rulings influence patent strategies, competitive positioning, and market access.
• Ongoing Litigation Means Future Uncertainty: The case remains in early stages, with potential rulings to significantly shape biotech patent law.

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FAQs

1. What are the main patents at stake in United Therapeutics v. Liquidia?
The case involves patents related to pulmonary drug delivery systems, specifically microparticle formulations and inhalation device technologies designed to improve drug bioavailability and reduce side effects.

2. How does patent infringement litigation impact biotech companies?
Such litigation can affect market exclusivity, licensing opportunities, R&D investments, and overall competitive positioning. It may also influence innovation strategies and patent portfolio management.

3. What are typical defenses in biotech patent infringement cases?
Common defenses include arguing patent invalidity due to prior art, obviousness, or insufficient patent scope. Challengers also contest infringement by emphasizing differences in technology or device design.

4. Why is claim construction critical in patent cases?
The court’s interpretation of patent claims defines the scope of patent protection and is pivotal in establishing infringement or validity. The Markman hearing is a key procedural step for clarifying legal and technical terms.

5. What precedents could this case establish for future biotech litigation?
The outcome may influence the scope of patent claims related to complex drug-device combinations, setting standards for claim drafting, validity assessments, and enforcement strategies in biotech patent law.

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Sources

[1] Court docket and filings from United States District Court, District of Delaware.
[2] Patent filings and claims related to United Therapeutics and Liquidia Technologies.
[3] Industry analysis reports on biotech patent litigation trends.