DCT

1:25-cv-00299

Liquidia Tech Inc v. United Therap Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00299, M.D.N.C., 04/21/2025
  • Venue Allegations: Venue is alleged to be proper in the Middle District of North Carolina because Defendant United Therapeutics Corporation resides in the district, maintaining its corporate headquarters there, and because a substantial part of the events giving rise to the claim allegedly occurred there.
  • Core Dispute: Plaintiff alleges that Defendant’s marketing and instructions for its TYVASO DPI® product induce infringement of a patent claiming a method for treating pulmonary hypertension with a specific dosage of dry powder treprostinil administered over a limited number of breaths.
  • Technical Context: The technology concerns dry powder inhalation formulations for delivering treprostinil, a drug used to treat pulmonary hypertension, offering a potentially more convenient alternative to traditional nebulizer devices.
  • Key Procedural History: The complaint notes that the parties are adversaries in other litigation in the same district, indicating a history of legal disputes between them.

Case Timeline

Date Event
2016-05-05 '494' Patent - Earliest Priority Date
2021-01-26 '494 Patent - Issue Date
2022-05-23 TYVASO DPI® - FDA Approval Date
2025-03-29 American College of Cardiology conference begins
2025-04-21 Complaint Filing Date

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

U.S. Patent No. 10,898,494 - Dry powder treprostinil for the treatment of pulmonary hypertension

Issued January 26, 2021

The Invention Explained

  • Problem Addressed: The patent identifies drawbacks with the then-current inhaled treatment for pulmonary arterial hypertension (PAH), which required a "large, cumbersome nebulization device that requires power, water and user manipulation for cleaning and operating" ('494 Patent, col. 2:5-9).
  • The Patented Solution: The invention provides a more convenient treatment method using a dry powder inhaler ('494 Patent, col. 4:1-9). The method involves administering a specific dose of treprostinil, delivered as a dry powder, to a patient over a specified number of breaths to treat pulmonary hypertension ('494 Patent, Abstract; col. 13:4-11).
  • Technical Importance: This approach provided a stable, user-friendly, and portable alternative to nebulized treprostinil, potentially improving patient convenience and adherence to therapy ('494 Patent, col. 2:13-16).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶¶ 44, 48).
  • The essential elements of Claim 1 are:
    • [a] method for treating a patient,
    • comprising administration of a dry powder composition comprising from about 100 micrograms to about 300 micrograms treprostinil or a pharmaceutically acceptable salt thereof
    • to a patient by inhalation using a dry powder inhaler
    • over one to four breaths
    • to treat pulmonary hypertension.
  • The complaint’s prayer for relief seeks judgment on "at least one claim of the '494 patent" (Compl. p. 17, ¶A).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the TYVASO DPI® (treprostinil) inhalation powder, its associated kits, and the method of its use as instructed by Defendant United Therapeutics Corporation ("UTC") (Compl. ¶1).

Functionality and Market Context

  • TYVASO DPI® is a dry powder formulation of treprostinil indicated for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) (Compl. ¶23).
  • The product is supplied in single-dose plastic cartridges containing 16, 32, 48, 64, or 80 mcg of treprostinil, which are administered using the TYVASO DPI® Inhaler (Compl. ¶27). The complaint includes a visual from the "Instructions for Use" showing these different color-coded cartridge strengths (Compl. p. 8, Figure D).
  • The complaint alleges that UTC’s instructions and marketing materials direct patients and prescribers to combine multiple cartridges to achieve a single prescribed dose higher than 80 mcg (Compl. ¶¶ 27, 34). A visual from the instructions demonstrates combining a 32 mcg and a 64 mcg cartridge for a 96 mcg dose (Compl. p. 8, Figure I).

IV. Analysis of Infringement Allegations

The complaint alleges that UTC indirectly infringes, through active inducement and contributory infringement, by instructing and encouraging physicians and patients to use TYVASO DPI® in a manner that meets all limitations of claim 1 of the '494 patent (Compl. ¶¶ 47-52).

10,898,494 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
administration of a dry powder composition comprising from about 100 micrograms to about 300 micrograms treprostinil... UTC allegedly instructs users to achieve single-session dosages within this range by combining multiple lower-dose cartridges. Examples cited include a 112 mcg dose (48+64 mcg) and a 128 mcg dose (16+48+64 mcg). A marketing brochure allegedly shows these combinations. ¶¶ 30-31, 39, 47 col. 13:5-8
...to a patient by inhalation using a dry powder inhaler... The TYVASO DPI® product is administered using the TYVASO DPI® Inhaler. ¶26 col. 13:8-9
...over one to four breaths... Each cartridge is allegedly administered in a single breath. Therefore, a 112 mcg dose (two cartridges) is administered in two breaths, and a 128 mcg dose (three cartridges) in three breaths, both falling within the claimed range. ¶¶ 35, 38, 48 col. 13:9-10
...to treat pulmonary hypertension. TYVASO DPI® is indicated for the treatment of pulmonary arterial hypertension. ¶23 col. 13:10-11

Identified Points of Contention

  • Scope Questions: The case centers on indirect infringement, as the direct infringer would be the patient or healthcare provider following UTC's instructions. A primary legal question is whether UTC's marketing materials and instructions demonstrate the specific intent required to induce infringement of the claimed method (Compl. ¶49).
  • Technical Questions: A key dispute may arise over whether the administration of multiple, discrete cartridges in succession constitutes a single "administration... over one to four breaths" as claimed. The complaint alleges this is the case for a single "treatment session" (Compl. ¶48), but a defendant could argue these are separate administrations, each comprising a single breath, that do not meet the claim limitations.

V. Key Claim Terms for Construction

  • The Term: "administration... over one to four breaths"
  • Context and Importance: The construction of this entire phrase is critical. Plaintiff's infringement theory depends on construing a "treatment session"—which involves inhaling from multiple separate cartridges, one after the other—as a single "administration" that occurs "over" the total number of breaths taken. Practitioners may focus on this term because if "administration" is construed to mean a single, uninterrupted act of inhaling from one powder source, the infringement case may be weakened.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent repeatedly discusses dose levels (e.g., 100, 150, 200 mcg) that, in some embodiments, could be achieved by combining lower-dose capsules, and it is plausible that this would require multiple breaths ('494 Patent, col. 13:58-62, col. 14:55-62). The patent also broadly claims a method of treating a patient, which could encompass a full prescribed dosing session.
    • Evidence for a Narrower Interpretation: The patent discusses providing a patient with "at least one capsule" and instructing the patient to inhale from "each capsule in one to two breaths" ('494 Patent, col. 10:4-11). This language could support an argument that the "administration" unit is tied to a single capsule, not a multi-capsule "session."

VI. Other Allegations

Indirect Infringement

The complaint alleges active inducement under 35 U.S.C. § 271(b), asserting UTC has knowledge of the '494 patent and, with specific intent, instructs users to infringe via its Prescribing Information, Instructions for Use, and marketing materials like the "TYVASO Brochure" (Compl. ¶¶ 49, 51). The complaint also alleges contributory infringement under § 271(c), stating that the accused product kits (e.g., for 112 mcg and 128 mcg doses) are not suitable for substantial non-infringing use (Compl. ¶50).

Willful Infringement

The complaint alleges that UTC's infringement is willful, asserting that UTC acted "without a reasonable basis for believing that it would not be liable for infringement," rendering the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶54). The allegations appear based on post-suit knowledge, as no pre-suit notice is mentioned.

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

  • A core issue will be one of claim scope and construction: can the phrase "administration... over one to four breaths," as used in the patent, be construed to cover a "treatment session" that involves the sequential inhalation from multiple, distinct, single-use cartridges?
  • A key evidentiary question will be one of intent for indirect infringement: does the evidence from UTC's product labeling, user instructions, and marketing materials suffice to prove that UTC specifically intended for patients and physicians to perform the exact steps of the patented method, thereby inducing infringement?