DCT

1:25-cv-00368

United Therap Corp v. Liquidia Tech Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00368, M.D.N.C., 05/09/2025
  • Venue Allegations: Venue is alleged to be proper in the Middle District of North Carolina because Defendant Liquidia resides in the district, maintains its corporate headquarters there, and conducts business in the district, and because a substantial part of the events giving rise to the claims occurred there.
  • Core Dispute: Plaintiff alleges that Defendant’s development, manufacturing, and planned commercialization of its Yutrepia™ dry powder inhalation product for treating pulmonary hypertension will infringe a patent covering a specific method for administering the drug treprostinil by inhalation.
  • Technical Context: The technology relates to pharmaceutical treatments for pulmonary hypertension (PH), a serious condition of high blood pressure in the lungs, focusing on non-invasive delivery via a dry powder inhaler.
  • Key Procedural History: The complaint is filed in the context of the U.S. Food and Drug Administration (FDA) regulatory framework. Plaintiff UTC markets Tyvaso DPI®, an FDA-approved dry powder treprostinil product. Defendant Liquidia has received tentative FDA approval for its competing product, Yutrepia™, with final approval anticipated upon the expiration of UTC's regulatory exclusivity. The complaint also notes this case is related to prior litigation between the parties.

Case Timeline

Date Event
2006-05-15 '782 Patent Priority Date
2022-05-23 FDA approval of Plaintiff's Tyvaso DPI®
2022-06-14 '782 Patent Issue Date
2024-08-19 Tentative FDA approval for Defendant's Yutrepia™
2025-03-28 FDA acceptance of Defendant's Yutrepia™ resubmission
2025-05-09 Complaint Filing Date
2025-05-24 Anticipated date of final FDA approval for Yutrepia™

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,357,782 - "Treprostinil administration by inhalation," issued June 14, 2022

The Invention Explained

  • Problem Addressed: The patent addresses the need for an effective, non-invasive treatment for pulmonary hypertension that can be administered using a compact inhalation device, giving patients more autonomy than existing intravenous or subcutaneous methods ('782 Patent, col. 2:60-62, col. 3:19-22).
  • The Patented Solution: The invention is a specific method for administering the drug treprostinil using a dry powder inhaler. The method claims a precise dosing regimen: a "single event dose" of 15 to 90 micrograms is delivered in a small number of breaths (1 to 3) and within a short time frame (less than 5 minutes), with subsequent doses spaced at least 3 hours apart ('782 Patent, Claim 1, col. 18:21-48). This approach aims to provide a potent therapeutic effect with pulmonary selectivity, minimizing systemic side effects ('782 Patent, col. 9:56-62).
  • Technical Importance: This method provides a rapid, discrete, and non-invasive means of delivering a targeted dose of a prostacyclin analogue, which could improve patient compliance and quality of life compared to more burdensome administration routes ('782 Patent, col. 3:19-22).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('782 Patent, col. 18:21-48; Compl. ¶38).
  • The essential elements of independent claim 1 include:
    • A method of treating pulmonary hypertension.
    • Providing an inhalation device comprising a powder formulation of treprostinil and a dry powder inhaler.
    • The inhaler is configured to administer a "single event dose" of 15-90 micrograms in 1-3 breaths.
    • The inhaler is configured to administer the entire dose in less than 5 minutes.
    • At least 5 micrograms are inhaled per breath via "coordinated actuation of the dry powder inhaler with each breath."
    • Administering this dose to a human.
    • Subsequent administrations of a single event dose occur at least 3 hours later.
  • The complaint alleges infringement of "one or more claims" of the patent, which may implicitly reserve the right to assert other claims (Compl. ¶40).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Liquidia’s Yutrepia™ (treprostinil) inhalation powder and its accompanying inhalation device (Compl. ¶1).

Functionality and Market Context

  • Yutrepia™ is a dry powder formulation of treprostinil sodium contained in a capsule, intended for oral inhalation to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) (Compl. ¶21-22, ¶24).
  • The complaint, citing the product's Prescribing Information and Instructions for Use, alleges that Yutrepia™ is administered using a disposable plastic inhalation device (Compl. ¶24). The instructions allegedly direct patients to take a single dose, corresponding to one capsule, over two breaths (Compl. ¶25, ¶27).
  • The complaint alleges specific dosages ranging from 26.5 mcg to 106 mcg per capsule, which result in a delivered dose to the patient of 15.1 mcg to 75.7 mcg (Compl. ¶26, ¶43). It is positioned as a direct competitor to UTC's Tyvaso DPI® product (Compl. ¶2, ¶33).

IV. Analysis of Infringement Allegations

'782 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating pulmonary hypertension... Yutrepia™ is indicated for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. ¶21 col. 18:21-22
providing an inhalation device...comprising a powder formulation of treprostinil...and a dry powder inhaler configured to administer [the dose]... Liquidia provides Yutrepia™, a powder formulation of treprostinil, with an accompanying disposable plastic inhalation device for oral inhalation. ¶22, ¶24 col. 18:22-29
wherein the single event dose comprises at least 15 micrograms to 90 micrograms of treprostinil...delivered in 1 to 3 breaths... The Yutrepia™ Prescribing Information allegedly directs administration in "2 breaths," resulting in a delivered dose ranging from 15.1 mcg to 75.7 mcg. ¶27, ¶43 col. 18:29-33
wherein the dry powder inhaler is configured to administer the entire single event dose in less than 5 minutes... The Yutrepia™ Instructions for Use allegedly state that each capsule "must be inhaled within 5 minutes." This is supported by an image from the instructions. ¶28, ¶44 col. 18:33-36
with at least 5 micrograms of treprostinil...being inhaled per breath through coordinated actuation of the dry powder inhaler with each breath... The Instructions for Use allegedly direct patients to inhale twice to empty a single capsule. Figure Q from the instructions shows a "STEP 12. Inhale again" directive to ensure the full dose is received. ¶25 col. 18:36-40
and administering to a human suffering from pulmonary hypertension...the single event dose... Yutrepia™ is prescribed to and administered by human patients suffering from pulmonary hypertension according to the Prescribing Information. ¶21, ¶46 col. 18:40-42
and wherein administration of an additional single event dose in the same manner occurs at least 3 hours later. The Yutrepia™ Prescribing Information allegedly discloses a "minimum recommended dosing interval of four hours." ¶29, ¶45 col. 18:46-48
  • Identified Points of Contention:
    • Scope Questions: The case is founded on a theory of indirect infringement, where Liquidia is alleged to instruct patients and physicians to perform the patented method. A central question will be whether following the Yutrepia™ Instructions for Use necessarily results in direct infringement of every element of Claim 1 by the end-user.
    • Technical Questions: What evidence demonstrates that "at least 5 micrograms" of treprostinil is inhaled "per breath"? The complaint alleges a total delivered dose of 15.1 mcg over two breaths, which suggests the limitation is met (7.55 mcg/breath), but this may require factual proof of the per-breath delivery consistency (Compl. ¶43).

V. Key Claim Terms for Construction

  • The Term: "coordinated actuation"
  • Context and Importance: This term is critical because infringement requires that the dose be delivered via "coordinated actuation of the dry powder inhaler with each breath." Practitioners may focus on this term because the defendant could argue that simply inhaling twice from a passive device does not constitute "actuation" in a manner that is "coordinated" by the device itself, but rather is an uncoordinated series of user actions.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification discusses instructions that teach a user "how to coordinate patient's breathing, and actuation of the inhaler" ('782 Patent, col. 8:25-27), suggesting that user-involved coordination based on instructions falls within the claim's scope. Plaintiff may argue that the instruction to inhale twice from the same capsule (Compl. ¶25, Figure Q) is the claimed "coordination."
    • Evidence for a Narrower Interpretation: The term "actuation" often implies a mechanical action to trigger a device. A defendant could argue that in a breath-actuated dry powder inhaler, the "actuation" is the single act of piercing the capsule, and subsequent inhalations are not separate "actuations." The patent's discussion of a "Respimat® Inhaler" ('782 Patent, col. 9:8), a different type of device, may be used to argue for a specific meaning of actuation not met by the accused device.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Induction is based on allegations that Liquidia’s Prescribing Information and Instructions for Use will intentionally encourage and instruct physicians and patients to use Yutrepia™ in a manner that directly infringes Claim 1 (Compl. ¶47, ¶49). Contributory infringement is based on the allegation that Yutrepia™ has no substantial non-infringing use when administered in the claimed dosages for treating PH (Compl. ¶48).
  • Willful Infringement: Willfulness is alleged based on Liquidia’s purported knowledge of the ’782 patent since its issuance on June 14, 2022 (Compl. ¶17, ¶53). The complaint further alleges that one of the named inventors on the patent, Robert Roscigno, was an employee at Liquidia as late as June 2020, which may be used to support allegations of pre-suit knowledge and an objectively high likelihood of infringement (Compl. ¶18).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of indirect infringement: will the evidence show that the instructions and intended use of Yutrepia™ are so specific that they lead physicians and patients to perform every step of the method of Claim 1, establishing Liquidia's liability for inducing infringement?
  • The case may turn on a question of claim construction: does the user action of inhaling twice from a single pierced capsule, as directed by the Yutrepia™ instructions, meet the "coordinated actuation of the dry powder inhaler with each breath" limitation of Claim 1?
  • A key question for damages will be willfulness: can UTC prove that Liquidia knew of the patent and the high risk of infringement—potentially supported by the allegation that a named inventor was a former employee—and proceeded with its commercialization plans regardless?