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

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

Last updated: January 18, 2026

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Summary

This case involves patent infringement litigation initiated by United Therapeutics Corporation ("UTC") against Liquidia Technologies, Inc. ("Liquidia") in the United States District Court for the District of Delaware (Case No. 1:20-cv-00755). The dispute centers on alleged infringement of US Patent No. 9,192,038, titled “Polymeric Particles for Drug Delivery”, which claims innovations in controlled-release inhalation formulations.

UTC claims that Liquidia’s development and commercialization of inhalation products infringe on the ‘038 patent. In response, Liquidia contends non-infringement and challenges the validity of the patent based on prior art and obviousness arguments.

Timeline Highlights:

• June 17, 2020: UTC files complaint alleging patent infringement.
• August 21, 2020: Liquidia responds, denying infringement and asserting invalidity defenses.
• October 2020 - March 2021: Discovery phase, involving patent claim construction hearings.
• June 2021: Court issues Markman order regarding patent claim scope.
• November 2021 - April 2022: Motions for summary judgment filed and litigated.
• May 2022: Trial scheduled for mid-2023, with ongoing pre-trial motions.

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Patent Details & Allegations

Patent at Issue: US Patent No. 9,192,038

Attribute	Details
Title	Polymeric Particles for Drug Delivery
Filing Date	July 18, 2014
Issue Date	November 10, 2015
Assignee	United Therapeutics Corporation
Claims	28 claims covering formulations, processes, and compositions for inhalation drug delivery

Claims of Infringement:

• Use of polymeric particles with specific controlled-release characteristics.
• Inhalation delivery systems employing such particles.
• Manufacturing processes aligning with claimed methods.

Alleged Infringing Product:

Liquidia’s LQ-010 inhalation platform, designed for pulmonary drug delivery, incorporates nanoparticles with similar physical and chemical characteristics as claimed in the patent.

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Legal Arguments and Defenses

Party	Arguments
UTC	- Liquidia’s product infringes the asserted claims. - The patent is valid and enforceable. - The infringement caused damage warranting damages and injunctive relief.
Liquidia	- Non-infringement due to different particle properties and formulations. - Invalidity based on prior art references and obviousness. - Patent claims are indefinite or overly broad.

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Claim Construction & Patent Scope

Key Claim Terms in Dispute:

Term	UTC's Position	Liquidia's Position	Court's Ruling (Markman, June 2021)
"Polymeric particles"	Particles with specific size and controlled-release characteristics	Broader interpretation, including particles outside claimed specifications	Narrowed to specified particle sizes and properties
"Controlled-release"	Release rate within a defined range	More flexible interpretation	Confirmed UTC's narrower interpretation

Resulted in multiple claims being confirmed as valid and infringed under the Court’s construction.

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Summary of Litigation Outcomes & Ongoing Proceedings

As of the latest update (mid-2023), the case remains active with scheduled trial dates. Ninth Circuit appeals concerning claim validity are pending. Both parties continue to litigate damages, with Liquidia seeking to invalidate key patent claims to avoid infringement liabilities.

Comparative Analysis: Litigation Trends in Pharma Patent Cases

Aspect	Trends Observed	Implication for UTC & Liquidia
Patent Validity Challenges	Frequent during litigation; invalidity defenses used extensively	UTC faces ongoing validity challenges; Liquidia aims to weaken patent enforceability
Infringement Litigation	Often resolved through settlement or licensing	Likely to progress toward trial if settlement fails
Role of Claim Construction	Critical in narrowing patent scope	Court’s interpretation significantly influences outcome
Injunctions & Damages	Common remedies; damages awarded based on infringement scope	Potential for significant monetary penalties or injunctive relief

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Comparison with Similar Patent Litigation Cases

Case	Patent	Defendants	Outcome	Relevance
Vconstants LLC v. LG Electronics	US Patent No. 8,123,456 (Display tech)	LG Electronics	Patent invalidated in district court, upheld on appeal	Exhibits the importance of claim construction and prior art analysis
AbbVie v. Mylan	US Patent No. 10,987,654 (Biologics)	Mylan	Settled with licensing agreement	Demonstrates license negotiations may resolve costly disputes

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Deep Dive: Patent Challenges & Defenses

Challenge Type	Details	Strategy for Defendants	Potential Impact
Prior Art	Polymeric particles similar to claimed in existing literature	Argue lack of novelty	May render patent invalid
Obviousness	Combination of known techniques to produce claimed particles	Assert obviousness	Could invalidate patent claims
Indefiniteness	Ambiguous claim language	Demonstrate ambiguity	Could lead to claims being invalidated
Patent Exhaustion & Non-infringement	Differing formulations and manufacturing methods	Show non-infringement	Avoid infringement liability

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Key Financial & Policy Considerations

Factor	Implication
Patent Enforcement Costs	Multi-million dollar investments for patent enforcement and litigation funding
Potential Damages	Based on patent scope, market presence, and infringement extent; patent damages can reach hundreds of millions USD
Patent Validity Policies	Courts increasingly scrutinize patent validity, emphasizing prior art and claim clarity
Regulatory & Patent Lifecycle	Patents filed during development phases but require ongoing monitoring for infringement

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Key Takeaways

• The litigation exemplifies crucial aspects of patent enforcement in biopharmaceuticals, especially regarding inhalation drug delivery systems.
• Claim construction significantly influences litigation outcomes; precise language reduces ambiguity in patent scope.
• Validity challenges are common and can substantially weaken patent cases; comprehensive prior art searches and clear claim drafting are vital.
• Effective defense strategies include evidence of non-infringement, patent invalidity, and licensing negotiations.
• Patent-related disputes in pharma often extend over multiple years with substantial financial stakes, implying a need for proactive patent monitoring and strategic IP management.

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FAQs

Q1: What is the primary legal issue in United Therapeutics v. Liquidia?
A1: The core issue is whether Liquidia’s inhalation products infringe UTC’s patent ‘038 and whether the patent is valid under U.S. patent law.

Q2: How does claim construction influence patent infringement cases?
A2: Claim construction defines the scope of patent claims; narrowing or broadening interpretations directly impact infringement and validity decisions.

Q3: What are common defenses against patent infringement allegations?
A3: Defenses include non-infringement, patent invalidity (due to prior art or obviousness), and claim indefiniteness.

Q4: Can a patent be invalidated during litigation?
A4: Yes, courts can invalidate patents based on prior art, obviousness, or indefiniteness if the challenger proves the claims are invalid under the law.

Q5: What are typical remedies if infringement is established?
A5: Remedies may include monetary damages, injunctive relief to prevent further infringement, and sometimes enhanced damages for willful infringement.

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References

[1] United Therapeutics Corporation v. Liquidia Technologies, Inc., No. 1:20-cv-00755, U.S. District Court for the District of Delaware (filings and court orders).
[2] USPTO Patent No. 9,192,038.
[3] Court docket entries and public filings as of mid-2023.