DCT

1:24-cv-08558

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

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-08558, D.N.J., 08/19/2024
  • Venue Allegations: Venue is alleged based on Defendants having principal places of business, regular and established places of business, and committing acts of infringement in the District of New Jersey. For foreign defendants, venue is alleged to be proper in any district where personal jurisdiction exists.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of Abbreviated New Drug Applications (ANDAs) to market generic versions of the COPD drug YUPELRI® constitutes an act of infringement of a patent claiming a specific method of treating a sub-population of COPD patients.
  • Technical Context: The dispute is in the field of pharmaceutical treatments for Chronic Obstructive Pulmonary Disease (COPD), focusing on patient stratification based on specific physiological metrics to optimize therapeutic outcomes with an inhaled bronchodilator.
  • Key Procedural History: This lawsuit follows extensive, ongoing litigation between the same parties concerning other patents covering YUPELRI® and the same ANDAs. The current action was triggered by the recent issuance of the patent-in-suit and, for Defendant Mankind, a subsequent notice letter. The complaint also notes that Defendants have previously litigated Hatch-Waxman cases in the District of New Jersey without contesting jurisdiction or venue.

Case Timeline

Date Event
2018-08-30 U.S. Patent No. 12,048,692 Priority Date
2023-01-05 Mankind provides notice letter for other patents
2023-01-09 Eugia provides notice letter for other patents
2023-01-17 Cipla provides notice letter for other patents
2024-07-30 U.S. Patent No. 12,048,692 Issues
2024-08-08 Mankind provides notice letter concerning the '692 patent
2024-08-19 Complaint Filed

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

U.S. Patent No. 12,048,692 - "Methods for Treating Chronic Obstructive Pulmonary Disease"

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of optimizing bronchodilator therapy for patients with Chronic Obstructive Pulmonary Disease (COPD). While it was known that patients with a low peak inspiratory flow rate (PIFR) may be unable to use dry powder inhalers effectively, the patent asserts that PIFR alone is not sufficient to predict which patients will benefit from switching to a nebulizer for drug delivery (’692 Patent, col. 6:39-50).
  • The Patented Solution: The patent describes the discovery that a specific subgroup of COPD patients—those who have both a low PIFR and a low percent predicted forced expiratory volume in one second (FEV₁ <50%)—achieve "significantly greater improvements" in lung function when a bronchodilator is administered via a nebulizer compared to a dry powder inhaler (’692 Patent, col. 6:1-11, Abstract). The invention is thus a method of treating this specific patient population with the drug revefenacin using a nebulizer.
  • Technical Importance: This method provides a more precise patient stratification tool, enabling clinicians to identify a specific subset of severe COPD patients who are likely to receive a superior clinical benefit from a particular drug-device combination (nebulized revefenacin) (’692 Patent, col. 6:1-11).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" and specifically recites independent claim 1 (Compl. ¶¶ 151, 181, 211).
  • Essential elements of Independent Claim 1:
    • A method for treating COPD in a patient with severe to very severe COPD.
    • Selecting a patient having a percent predicted forced expiratory volume in one second (FEV₁) less than 50 percent.
    • Administering a pharmaceutical composition comprising an aqueous solution of revefenacin or a pharmaceutically acceptable salt thereof to the selected patient using a nebulizer.
    • Wherein the patient has a low peak inspiratory flow rate.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic revefenacin inhalation solutions described in ANDA No. 218128 (Eugia), ANDA No. 218089 (Mankind), and ANDA No. 217958 (Cipla) (Compl. ¶1). The act of infringement alleged is the submission of these ANDAs to the FDA seeking approval to market a generic version of Plaintiffs' YUPELRI® product (Compl. ¶¶ 98, 119, 136).

Functionality and Market Context

The defendants' products are alleged to be aqueous solutions containing revefenacin, the same active ingredient as YUPELRI®, intended for administration by a nebulizer for the maintenance treatment of patients with COPD (Compl. ¶¶ 99, 102, 120, 123, 137, 140). The complaint alleges that the defendants' proposed package inserts will be substantially similar to the YUPELRI® label and will instruct healthcare providers to administer the drug, thereby inducing infringement of the patented method (Compl. ¶¶ 149-150, 155).

IV. Analysis of Infringement Allegations

’692 Patent 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 with severe to very severe COPD... Defendants seek approval to market their products for the maintenance treatment of patients with COPD, which includes patients with severe to very severe COPD. ¶¶102, 123, 140 col. 13:1-4
(a) selecting a patient having a percent predicted forced expiratory volume in one second less than 50 percent; The complaint alleges a healthcare provider will select such patients for treatment, pointing to GOLD guidelines that categorize severe COPD as having an FEV₁ of less than 50% and noting that the YUPELRI® label discusses trials in severe patients. ¶¶161, 165, 170 col. 13:5-7
(b) administering a pharmaceutical composition comprising an aqueous solution of revefenacin... to the selected patient using a nebulizer; The defendants' ANDA products are aqueous solutions of revefenacin. It is alleged their proposed labels will instruct administration once daily using a nebulizer, consistent with the YUPELRI® label. ¶¶99, 159, 166 col. 13:8-12
wherein the patient has a low peak inspiratory flow rate. The complaint alleges that many patients selected for having a low FEV₁ will also have a low PIFR, and that healthcare providers will use a nebulizer for such patients, citing clinical literature and awareness of issues with dry powder inhalers. ¶¶162, 170-171 col. 13:13-14

Identified Points of Contention

  • Scope Questions: The infringement theory relies on induced infringement by the product label. A primary question will be whether the defendants' proposed labels will actively encourage or instruct physicians to perform the specific two-part selection process required by claim 1 (selecting for FEV₁ < 50% and the patient having a low PIFR), or if the labels will only contain a general indication for COPD treatment. The complaint uses Figure 3.10 of the GOLD guidelines to show that proper inhaler technique is a key consideration for healthcare providers (Compl. ¶88, p. 20). This may support the argument that providers are attuned to factors like PIFR when choosing a delivery device.
  • Technical Questions: A key evidentiary question will be what facts establish that Defendants "specifically intend" for their products to be used in the infringing method. The complaint alleges that Defendants know some providers will select patients based on low FEV₁, and many of those patients will also have a low PIFR (Compl. ¶¶ 172-173, 202-203, 232-233). The dispute may focus on whether this constitutes inducement or is merely the foreseeable result of placing a drug on the market for a broad indication.

V. Key Claim Terms for Construction

The Term: "selecting a patient"

  • Context and Importance: This active step is central to the method claim. Its construction will determine what level of deliberate action by a healthcare provider is required. The dispute will likely focus on whether simply prescribing the accused product to a patient who happens to meet the claim's criteria is sufficient, or if the claim requires a conscious, diagnostic decision based on both the FEV₁ and PIFR criteria.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's title and summary describe "methods for treating" COPD, and the claim language itself does not specify the state of mind of the person performing the selection (’692 Patent, Title; col. 6:1-11). This may support an argument that the act of choosing the therapy for a patient with the defined characteristics constitutes "selecting."
    • Evidence for a Narrower Interpretation: The patent repeatedly emphasizes the "unexpected discovery" that patients with both low PIFR and low FEV₁ gain additional benefit (’692 Patent, col. 6:1-11). This may suggest that "selecting" requires a deliberate identification of a patient as belonging to this specific dual-criteria group to leverage that discovered benefit, rather than an incidental prescription.

The Term: "low peak inspiratory flow rate"

  • Context and Importance: This is a critical patient characteristic required by the claim. While the specification provides a definition, the key issue in an inducement context will be how this characteristic is identified and acted upon based on the defendants' proposed product labeling.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification defines the term as "less than about 60 L/min" and notes that nebulizers are sometimes recommended for patients with lower than normal inspiratory flow rates (’692 Patent, col. 7:26-28, col. 6:42-45). This could support an argument that any instruction to use a nebulizer inherently targets patients for whom low PIFR is a concern.
    • Evidence for a Narrower Interpretation: The claim requires the patient to have this property; it does not explicitly require the physician to measure it. However, the context of the "selection" step suggests a diagnostic element. A defendant may argue that unless its label instructs a physician to measure or consider PIFR, it cannot be inducing infringement of a method that depends on this specific patient trait.

VI. Other Allegations

Indirect Infringement

The complaint is premised entirely on induced infringement under 35 U.S.C. § 271(b). It alleges that upon FDA approval, Defendants intend to market and sell their ANDA products with package inserts that will direct and encourage healthcare providers to perform the patented method, and that Defendants know their products are especially adapted for this infringing use (Compl. ¶¶ 104-106, 148-150, 178-180, 208-210).

Willful Infringement

The complaint does not explicitly plead willfulness. However, it alleges that Defendants have "actual knowledge" of the ’692 patent as of the filing of the complaint (Compl. ¶¶ 103, 141) and, in Mankind's case, had knowledge when it filed its Paragraph IV certification and sent its notice letter (Compl. ¶¶ 114, 124). These allegations may form the basis for a later claim of post-suit willful infringement.

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

  • A core issue will be one of inducement: will the evidence, particularly the defendants' proposed product labels, demonstrate a specific intent to encourage healthcare providers to perform the complete, multi-step method of claim 1? The case will likely turn on whether the label merely describes a product for general COPD maintenance or actively instructs the specific patient selection process that defines the invention.
  • A related central question will be one of claim scope and action: does the claim term "selecting a patient" require a conscious, diagnostic identification of the dual criteria (low FEV₁ and low PIFR), or can it be satisfied by a physician prescribing a nebulizer-based therapy to a patient who, as a matter of clinical reality, happens to fit that profile? The answer will determine the evidentiary burden on the Plaintiffs to prove that the defendants' labels cause the complete infringing act.