DCT

1:25-cv-03790

Theravance Biopharma R&D IP LLC v. Eugia Pharma Specialities Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-03790, D.N.J., 05/02/2025
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because defendant subsidiaries maintain regular and established places of business in the state, and because the defendants have committed acts of infringement related to their ANDA filings within or directed at the district. The complaint also notes the defendants have previously litigated related patent cases in this district without contesting venue.
  • Core Dispute: Plaintiffs allege that Defendants' Abbreviated New Drug Application (ANDA) filings to market generic versions of the COPD drug YUPELRI® constitute an act of infringement of a patent covering a method for treating specific subpopulations of COPD patients.
  • Technical Context: The technology concerns a personalized medicine approach for treating Chronic Obstructive Pulmonary Disease (COPD), a progressive lung disease, by identifying and treating a specific patient subset that receives enhanced benefits from a nebulized therapy.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' submission of ANDAs with Paragraph IV certifications. The complaint notes extensive prior litigation between the same parties involving the same ANDAs but concerning different patents in the YUPELRI® portfolio, which have been consolidated in the District of New Jersey. This suit focuses on a newly issued patent.

Case Timeline

Date Event
2018-08-30 '417 Patent Priority Date
2023-01-05 Mankind First Notice Letter re: ANDA 218089
2023-01-09 Eugia First Notice Letter re: ANDA 218128
2023-01-17 Cipla First Notice Letter re: ANDA 217958
2023-02-16 Plaintiffs file initial complaint against Defendants on other patents
2023-07-10 Mankind Second Notice Letter
2023-07-31 Eugia Second Notice Letter
2023-08-21 Plaintiffs file complaint on '948 patent
2023-08-24 Cipla Second Notice Letter
2023-12-04 Plaintiffs file First Amended Consolidated Complaint adding more patents
2024-01-09 Plaintiffs file complaint on '898 patent
2024-08-08 Mankind Third Notice Letter
2024-08-19 Plaintiffs file complaint on '692 patent
2024-08-22 Eugia Third Notice Letter
2024-11-07 Cipla Third Notice Letter
2025-04-29 U.S. Patent No. 12,285,417 Issues
2025-05-02 Complaint Filed

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

U.S. Patent No. 12,285,417 - "Methods for Treating Chronic Obstructive Pulmonary Disease"

  • Patent Identification: U.S. Patent No. 12,285,417, "Methods for Treating Chronic Obstructive Pulmonary Disease", issued April 29, 2025. (Compl. ¶74).

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of identifying which Chronic Obstructive Pulmonary Disease (COPD) patients will receive the most therapeutic benefit from a bronchodilator administered via a nebulizer versus a dry powder inhaler (DPI). (’417 Patent, col. 2:30-50). While it was known that patients with a low Peak Inspiratory Flow Rate (PIFR) might be better suited for nebulizers, the patent suggests this single criterion was insufficient to optimize treatment selection. (’417 Patent, col. 2:44-50).
  • The Patented Solution: The patent discloses a method of treatment based on an asserted discovery that patients with both a low PIFR (less than about 60 L/min) and a low percent predicted Forced Expiratory Volume in one second (FEV1 of less than 50%) gain "significantly greater improvements" when a bronchodilator is delivered via a nebulizer. (’417 Patent, col. 2:51-68). The method involves affirmatively selecting this specific patient subgroup for treatment with revefenacin administered by a nebulizer. (’417 Patent, Abstract; col. 2:10-18).
  • Technical Importance: The claimed method purports to provide a more precise, dual-criteria approach for personalizing COPD therapy, aiming to improve clinical outcomes by targeting a patient population that is uniquely responsive to nebulized drug delivery. (’417 Patent, col. 2:5-9).

Key Claims at a Glance

  • The complaint asserts independent claim 1 against all Defendants. (Compl. ¶¶ 151, 182, 213).
  • The essential elements of independent claim 1 are:
    • A method for treating chronic obstructive pulmonary disease (COPD) in a patient having severe to very severe COPD, the method comprising:
    • selecting a patient having a percent predicted force expiratory volume in one second of less than 50 percent; and
    • selecting a nebulizer as an inhalation delivery device to administer revefenacin, or a pharmaceutically acceptable salt thereof, to the patient,
    • wherein the patient has a peak inspiratory flow rate of less than about 60 L/min; and
    • wherein the method comprises administering a pharmaceutical composition comprising an aqueous solution of revefenacin, or a pharmaceutically acceptable salt thereof, to the patient using the nebulizer.
  • The complaint seeks a judgment that Defendants have infringed "one or more claims" of the ’417 Patent, which may suggest an intent to assert dependent claims later. (Compl. p. 42, ¶(a)).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants' submissions of Abbreviated New Drug Applications (ANDAs) to the FDA for approval to market generic versions of YUPELRI® (revefenacin) inhalation solution. The specific filings are Eugia ANDA No. 218128, Mankind ANDA No. 218089, and Cipla ANDA No. 217958. (Compl. ¶1).

Functionality and Market Context

  • The proposed products are aqueous solutions containing revefenacin, intended for administration via a nebulizer for the maintenance treatment of patients with COPD. (Compl. ¶¶ 101, 119, 137). As generic drugs, they are intended to be bioequivalent to and compete directly with Plaintiffs' branded product, YUPELRI®. (Compl. ¶¶ 102, 120, 138). The infringement allegation is not based on the composition itself, but on the grounds that the proposed product labeling for the generic drugs will induce healthcare providers to perform the patented method. (Compl. ¶¶ 149, 180, 211).

IV. Analysis of Infringement Allegations

The complaint alleges that each Defendant's ANDA filing constitutes infringement and that, upon approval, their marketing of the generic product with its proposed label will induce infringement by healthcare providers. The infringement theory is substantially identical for all three defendant groups.

Claim Chart Summary

U.S. Patent No. 12,285,417 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating chronic obstructive pulmonary disease (COPD) in a patient having severe to very severe COPD... The proposed product label is for the maintenance treatment of patients with COPD. The complaint alleges the label describes use in patients with severe and very severe COPD. ¶158, ¶164 col. 10:1-2
selecting a patient having a percent predicted force expiratory volume in one second of less than 50 percent; and The complaint alleges healthcare providers will be directed by the label and clinical guidelines to select patients with an FEV1 of less than 50% for treatment. ¶161, ¶166, ¶173 col. 2:11-14
selecting a nebulizer as an inhalation delivery device to administer revefenacin... The proposed product is an inhalation solution for use with a nebulizer, and the label allegedly instructs administration via nebulizer, directing physicians to select this delivery device. ¶162, ¶168 col. 2:5-8
wherein the patient has a peak inspiratory flow rate of less than about 60 L/min; and The complaint alleges that providers, guided by clinical standards and the product label, will identify and treat patients with low PIFR (<60 L/min) because such patients are known to be candidates for nebulizer therapy. ¶163, ¶171 col. 2:11-13
wherein the method comprises administering a pharmaceutical composition comprising an aqueous solution of revefenacin... using the nebulizer. The proposed product is an aqueous solution of revefenacin, and the label allegedly instructs once-daily administration by oral inhalation using a nebulizer. ¶159-160, ¶167 col. 4:24-28

Identified Points of Contention

  • Scope Questions: The case may turn on whether the Defendants' proposed product labels are found to actively induce the affirmative "selecting" steps of Claim 1. A question for the court will be whether describing the characteristics of patients in clinical trials on a product label is equivalent to instructing or encouraging physicians to use those specific characteristics (FEV1 < 50% and PIFR < 60 L/min) as a basis for patient selection.
  • Technical Questions: The complaint alleges infringement will occur but also states that the clinical trials described on the YUPELRI® label (which the generic labels are expected to mirror) enrolled patients with a mean percent predicted FEV1 of 55%. (Compl. ¶165). This raises the question of whether a label describing a patient population with a mean FEV1 above the claimed threshold can be found to induce the selection of patients below that threshold. To support its theory, the complaint references external clinical guidelines. (Compl. ¶¶ 87, 166). The complaint includes a visual aid from these guidelines. Figure 3.10 is a table from the GOLD guidelines, titled 'Key Points for Inhalation of Drugs,' which emphasizes the importance of proper inhaler technique and patient-specific device choice. (Compl. p. 20, Fig. 3.10).

V. Key Claim Terms for Construction

The Term: "selecting a patient"

  • Context and Importance: This term is critical because the infringement theory is based on inducing this affirmative act. The dispute will likely focus on what level of instruction from a product label is required to cause a physician to perform this claimed selection step. Practitioners may focus on this term because it is the active step that distinguishes the claimed method from merely treating a patient who happens to have certain characteristics.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes the invention as a method comprising "selecting a patient having a peak inspiratory flow rate (PIFR) less than about 60 L/min and a percent predicted force expiratory volume in one second (FEV₁) less than about 50 percent". (’417 Patent, col. 2:10-14). This could support an interpretation where "selecting" means simply identifying a patient who meets these criteria in the course of normal medical practice.
    • Evidence for a Narrower Interpretation: The patent frames the invention as an "unexpected discovery" that this specific patient group gains "additional benefit," which may support an argument that "selecting" implies a more deliberate act of targeting this specific, newly-identified subpopulation, a level of direction that a defendant might argue is absent from its product label. (’417 Patent, col. 2:5-9).

The Term: "severe to very severe COPD"

  • Context and Importance: The claim is explicitly limited to this patient population. The definition of this phrase will determine the scope of infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint relies on the external GOLD guidelines to define "severe" and "very severe" COPD based on specific FEV1 percentages. (Compl. ¶87). A party could argue this reflects the plain and ordinary meaning of the term to a person of ordinary skill in the art.
    • Evidence for a Narrower Interpretation: The patent specification does not provide an explicit definition for "severe to very severe COPD." It does, however, refer to clinical trial subjects as having "moderate to very severe COPD". (’417 Patent, col. 10:1-2). A party could argue that the claim term should be interpreted only through the lens of the intrinsic evidence, or that the lack of a precise definition renders the term indefinite.

VI. Other Allegations

Indirect Infringement

  • The complaint is premised entirely on a theory of induced infringement. It alleges that Defendants, by seeking approval for and intending to market their generic products with labels that are substantially similar to the YUPELRI® label, will actively and intentionally induce healthcare providers to perform the patented method. (Compl. ¶¶ 148-150, 179-181, 210-212). The basis for knowledge and intent is the alleged instruction provided in the FDA-approved package insert. (Compl. ¶150).

Willful Infringement

  • The complaint does not include a formal count for willful infringement. However, the prayer for relief requests an award of reasonable attorney fees for an "exceptional case" pursuant to 35 U.S.C. § 285, suggesting Plaintiffs may pursue such a finding. (Compl. p. 43, ¶(h)). The allegations of knowledge are tied to the notice letters and the filing of the lawsuit itself. (Compl. ¶¶ 105, 123, 141).

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

  • A core issue will be one of inducement: Does the proposed product label for the generic drugs—which is expected to mirror the brand-name YUPELRI® label—go beyond merely describing clinical trial data to actively instruct or encourage physicians to perform the specific, two-part patient selection method required by Claim 1?
  • A key evidentiary question will be one of technical alignment: Can Plaintiffs demonstrate that a product label describing clinical trials with a mean patient FEV1 of 55% provides sufficient basis to find inducement of a method that requires selecting patients with an FEV1 of less than 50%? The outcome may depend on how the court weighs the label's text against extrinsic evidence like clinical practice guidelines.