DCT

1:23-cv-02843

Theravance Biopharma R&D IP LLC v. Orbicular Pharmaceutical Tech Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-02843, D.N.J., 05/24/2023
  • Venue Allegations: Venue is asserted on the basis that the defendant, Orbicular, is a foreign corporation that may be sued in any judicial district. The complaint further notes that Orbicular has previously litigated in the District of New Jersey without contesting venue.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs’ YUPELRI® (revefenacin) product constitutes an act of infringement of a patent covering a method for treating Chronic Obstructive Pulmonary Disease (COPD).
  • Technical Context: The dispute is in the field of respiratory medicine, specifically concerning methods for selecting and treating a sub-population of COPD patients who may benefit more from a nebulized bronchodilator than from a dry powder inhaler.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act following Defendant's April 12, 2023 notice letter, which included a Paragraph IV certification against the patent-in-suit. This certification asserts that the patent is invalid, unenforceable, or will not be infringed by the Defendant's proposed generic product. The complaint also notes a related, earlier-filed lawsuit between the parties concerning other patents covering YUPELRI®.

Case Timeline

Date Event
2018-08-30 '531 Patent Priority Date
2022-11-01 '531 Patent Issue Date
2023-01-13 Defendant's first notice letter to Plaintiffs regarding ANDA No. 217868
2023-04-12 Defendant's second notice letter, including Paragraph IV certification for the '531 Patent
2023-05-24 Complaint Filing Date

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

U.S. Patent No. 11,484,531 - "Methods for Treating Chronic Obstructive Pulmonary Disease" (issued Nov. 1, 2022)

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of identifying which specific COPD patients will derive greater benefit from treatment with a nebulizer compared to a dry powder inhaler (DPI) ('531 Patent, col. 2:36-49). The background section notes that while nebulizers are sometimes recommended for patients with a low peak inspiratory flow rate (PIFR), this single factor "low PIFR alone" is not sufficient to predict which patients will see a marked improvement with a nebulizer over a DPI ('531 Patent, col. 2:56-59).
  • The Patented Solution: The invention is a method of treatment that involves first selecting a specific subgroup of COPD patients and then administering a nebulized bronchodilator. The key inventive step is the selection criteria: identifying patients who have 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 about 50 percent ('531 Patent, col. 2:60-col. 3:4). The patent asserts the unexpected discovery that this particular patient cohort achieves "significantly greater improvements" in lung function when a bronchodilator is administered via a nebulizer as opposed to a DPI ('531 Patent, col. 2:60-65).
  • Technical Importance: This method provides a more precise, two-factor diagnostic approach for personalizing COPD therapy, aiming to improve clinical outcomes for a specific patient population that may not respond optimally to more common DPI-based treatments ('531 Patent, Abstract).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('Compl. ¶61).
  • The essential elements of independent claim 1 are:
    • A method for treating chronic obstructive pulmonary disease in a patient, the method comprising:
    • (a) selecting a patient having chronic obstructive pulmonary disease for treatment based on the patient having a peak inspiratory flow rate less than about 60 L/min and a percent predicted force expiratory volume in one second less than about 50 percent; and
    • (b) administering a pharmaceutical composition comprising about 175 µg of revefenacin, or a pharmaceutically acceptable salt thereof, in 3 mL of an aqueous solution to the selected patient once daily using a nebulizer.
  • The complaint does not explicitly reserve the right to assert dependent claims, but infringement is alleged for "one or more claims" ('Compl. ¶57).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Orbicular's Abbreviated New Drug Application (ANDA) No. 217868, which seeks FDA approval to market a generic version of YUPELRI® (revefenacin) inhalation solution ("Orbicular ANDA Product") (Compl. ¶1, ¶12). Under 35 U.S.C. § 271(e)(2), the filing of such an ANDA is a technical act of infringement.
  • Functionality and Market Context: The Orbicular ANDA Product contains revefenacin, the same active ingredient as YUPELRI®, and is intended for the same indication: the maintenance treatment of patients with COPD (Compl. ¶46, ¶49). The complaint alleges that Orbicular's product, upon approval, will be administered once daily via a nebulizer according to an FDA-approved package insert (Compl. ¶59, ¶75). The plaintiffs allege that this package insert will be "substantially similar" to the YUPELRI® insert and will cause healthcare providers to use the generic product in a manner that infringes the '531 patent (Compl. ¶65).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'531 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) selecting a patient having chronic obstructive pulmonary disease for treatment based on the patient having a peak inspiratory flow rate less than about 60 L/min and a percent predicted force expiratory volume in one second less than about 50 percent The complaint alleges that upon approval, healthcare providers will be induced to select patients for treatment with Orbicular's product who have a PIFR of less than about 60 L/min and a percent predicted FEV1 of less than 50%. This allegation is supported by references to the YUPELRI® package insert and general medical guidelines (GOLD guidelines). ¶71, ¶80-82 col. 9:1-5
(b) administering a pharmaceutical composition comprising about 175 µg of revefenacin... in 3 mL of an aqueous solution to the selected patient once daily using a nebulizer. Orbicular's ANDA product is alleged to be a revefenacin inhalation solution containing 175 mcg of revefenacin in 3 mL of aqueous solution, which will be administered once daily by a nebulizer as instructed by its package insert. ¶46, ¶69, ¶70, ¶75 col. 12:30-34
  • Identified Points of Contention:
    • Scope Questions: A central issue will be whether Orbicular’s proposed product label will actively induce infringement. The question is not just whether a doctor could use the product in an infringing way, but whether Orbicular’s label instructs or encourages a physician to perform the specific two-part selection step of claim 1(a). The complaint’s reliance on the existing YUPELRI® label and general GOLD guidelines (Compl. ¶74, ¶77) suggests that the language of Orbicular's own proposed label will be a critical and potentially dispositive piece of evidence.
    • Technical Questions: What evidence will support the allegation that Orbicular "specifically intends" for healthcare providers to select patients based on the combination of PIFR and FEV1 criteria as required by the claim? (Compl. ¶82). The defense may argue that its label will, at most, describe the characteristics of the patient population in clinical trials without affirmatively instructing or recommending the patented selection method. The dispute will likely focus on the precise language of the proposed label and marketing materials.

V. Key Claim Terms for Construction

  • The Term: "selecting a patient... based on"

  • Context and Importance: This phrase is the active step in the method claim and is central to the infringement analysis, particularly for inducement. The definition will determine what action by a healthcare provider constitutes infringement. Practitioners may focus on this term because the infringement case hinges on whether Orbicular’s drug label will cause physicians to perform this specific selection act.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent’s "Summary of the Invention" frames the discovery as identifying a patient group that achieves "significantly greater improvements," which could support an argument that a physician who treats a patient meeting the criteria is inherently "selecting based on" those criteria to achieve a better outcome, even without a formal, documented checklist ('531 Patent, col. 2:60-65).
    • Evidence for a Narrower Interpretation: The claim language recites an affirmative step of "selecting... based on" two distinct criteria. The patent's clinical trial example describes a process where subjects were explicitly chosen according to inclusion criteria, which could support a narrower reading that requires a conscious and direct application of both the PIFR and FEV1 thresholds by the physician ('531 Patent, col. 9:9-17).

  • The Term: "about" (e.g., "about 60 L/min," "about 50 percent")

  • Context and Importance: This term of degree affects the literal scope of the patient population defined by the claim. Its interpretation will determine how much deviation from the stated numerical values is permissible while still falling within the claim. Practitioners may focus on this term because clinical measurements often have inherent variability, and the breadth of "about" could expand or contract the pool of potentially infringing acts.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent uses the term "about" consistently with numerical values, suggesting an intent to avoid a strict, literal interpretation and to encompass minor variations expected in a clinical setting. The term "Definitions" section provides a general definition of "about" as "±10 percent of the specified value," which would give the term a clear and relatively broad scope ('531 Patent, col. 4:19-20).
    • Evidence for a Narrower Interpretation: A defendant might argue that the context of the clinical data presented in the patent's examples should guide the interpretation of "about." Further, the specification provides distinct embodiments with different numerical limits (e.g., "less than about 50 L/min," "less than 40 percent"), implying that the numbers are not arbitrary and the scope of "about" should not be so broad as to render these distinctions meaningless ('531 Patent, col. 3:29-32).

VI. Other Allegations

  • Indirect Infringement: The complaint's primary infringement theory is active inducement under 35 U.S.C. § 271(b) (Compl. ¶58). It alleges that Orbicular, with knowledge of the '531 Patent, will sell its generic product with a package insert that will instruct and encourage healthcare providers to perform all steps of the claimed method, thereby inducing infringement (Compl. ¶59-60). The basis for intent is the allegation that Orbicular knows and "specifically intends" that its product will be prescribed to patients meeting the claimed criteria (Compl. ¶82).
  • Willful Infringement: Willfulness is implicitly alleged. The complaint states that Orbicular had knowledge of the '531 patent at the time it amended its ANDA to include a Paragraph IV certification (Compl. ¶50). It further alleges Orbicular "knowingly has taken and intends to take active steps to, and will, induce infringement" (Compl. ¶53).

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

  • A core issue will be one of inducement and evidence: Will the final, FDA-approved label for Orbicular’s generic product contain language that actively instructs or encourages physicians to select patients using the specific two-factor criteria of PIFR and FEV1, or will it merely describe a patient population in a way that falls short of the legal standard for inducement?
  • A second critical question will be one of claim construction: Can the method step "selecting a patient... based on" be satisfied if a physician prescribes the drug to a patient who happens to meet the claim's PIFR and FEV1 criteria, or does it require proof of a specific, affirmative decision by the physician that was consciously based on both parameters simultaneously?