DCT

1:25-cv-00419

Urovant Sciences GmbH v. Annora Pharma Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00419, D. Del., 04/03/2025
  • Venue Allegations: Venue is asserted in the District of Delaware based on the incorporation of defendants Hetero USA and Camber in Delaware, and on the status of the remaining foreign-domiciled defendants, who may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of the drug vibegron constitutes an act of infringement of a patent directed to a method of treating overactive bladder by administering approximately 75 mg of vibegron per day.
  • Technical Context: The technology concerns a specific pharmaceutical dosing regimen for vibegron (marketed as GEMTESA®), a treatment for overactive bladder, a prevalent urological condition.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of Defendants' Paragraph IV certification notice letters, which seek FDA approval to market a generic vibegron product prior to the expiration of the asserted patent. The patent-in-suit, which is listed in the FDA's Orange Book, was granted a 655-day patent term adjustment.

Case Timeline

Date Event
2017-06-06 Earliest Priority Date for U.S. Patent No. 12,102,638
2020-12-23 FDA approves Plaintiff's New Drug Application for GEMTESA®
2024-10-01 U.S. Patent No. 12,102,638 issues
2025-02-20 Defendants send First Notice Letter with Paragraph IV certification
2025-02-28 Defendants send Second Notice Letter
2025-04-03 Complaint for Patent Infringement filed

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

U.S. Patent No. 12,102,638 - "Use of Vibegron to Treat Overactive Bladder"

  • Patent Identification: U.S. Patent No. 12,102,638, "Use of Vibegron to Treat Overactive Bladder," issued October 1, 2024.

The Invention Explained

  • Problem Addressed: The patent's background section describes that the predominant class of drugs for treating overactive bladder (OAB), antimuscarinics, suffers from modest efficacy and poor tolerability due to side effects, leading to high rates of patient discontinuation (ʼ638 Patent, col. 1:36-43).
  • The Patented Solution: The invention is a method of treatment using a specific oral dosage of the known compound vibegron—from about 60 mg to 90 mg per day, and specifically about 75 mg per day—to treat OAB (ʼ638 Patent, Abstract). The detailed description suggests this dosage selection is intended to achieve desired efficacy while minimizing undesirable side effects that may be associated with elevated peak plasma concentrations (Cmax) of the drug (ʼ638 Patent, col. 4:11-18).
  • Technical Importance: The patented approach sought to define an optimized therapeutic window for a B3-AR agonist, a different class of drug than antimuscarinics, to provide an effective OAB therapy with a more favorable side-effect profile, potentially improving patient adherence (ʼ638 Patent, col. 1:39-43, col. 1:44-58).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶67).
  • The essential elements of independent claim 1 are:
    • A method of treating overactive bladder in a human subject in need thereof,
    • the method comprising administering to the subject about 75 mg per day of vibegron or a pharmaceutically acceptable salt thereof.
  • The complaint does not explicitly reserve the right to assert dependent claims, but alleges infringement of "one or more claims" (Compl. ¶67).

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed "Generic Product," identified as "Vibegron Tablets 75 mg; Oral," which is the subject of ANDA No. 220207 submitted to the FDA (Compl. ¶¶ 1, 52).

Functionality and Market Context

  • The accused product is a 75 mg oral tablet containing vibegron. The complaint alleges that in their ANDA, Defendants have represented to the FDA that this generic product is "pharmaceutically and therapeutically equivalent" to Plaintiffs' branded GEMTESA® product (Compl. ¶63). As a generic drug, its intended use, as specified in its proposed labeling, is for the treatment of OAB, mirroring the approved indications for GEMTESA® (Compl. ¶¶ 68, 70). The product is intended to be a lower-cost market competitor to GEMTESA® following FDA approval (Compl. ¶1).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The core of the infringement allegation under 35 U.S.C. § 271(e)(2)(A) is that the use for which Defendants seek FDA approval would infringe the ’638 patent.

’638 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating overactive bladder in a human subject in need thereof, The complaint alleges that Defendants are seeking FDA approval for their Generic Product for the treatment of OAB, and that the proposed package insert will instruct healthcare professionals and patients on this infringing use. ¶¶ 68, 70 col. 1:7-9
the method comprising administering to the subject about 75 mg per day of vibegron or a pharmaceutically acceptable salt thereof. Defendants' ANDA is for a product identified as "Vibegron Tablets 75 mg; Oral." The proposed use will therefore involve administering a 75 mg daily dose of vibegron. ¶¶ 1, 52 col. 4:51-54
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges that Defendants' Paragraph IV notice letter asserts non-infringement, though it does not detail the basis for this assertion (Compl. ¶54). A potential, though perhaps narrow, point of dispute could concern whether the proposed label instructs the specific "method of treating" as claimed, but given the nature of ANDA labeling, the primary dispute is more likely to be over the patent's validity.
    • Technical Questions: In an ANDA case, the infringement analysis focuses on the proposed product label. The central technical question is whether the administration of a 75 mg vibegron tablet, as instructed by the proposed label for the treatment of OAB, meets every limitation of the asserted claims. Based on the allegations, the dosage and indication appear to align directly with the claim language.

V. Key Claim Terms for Construction

  • The Term: "about 75 mg"
  • Context and Importance: This term is the central limitation of the independent claim, defining the specific dosage that constitutes the patented method. Its construction is critical for both infringement and validity analyses. While the accused product is exactly 75 mg, the scope of "about" could be relevant to distinguishing the claim from prior art that may have disclosed different dosages of vibegron.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides an explicit definition, stating: "The term 'about' as used in connection with a numerical value... denotes an interval of accuracy... Such interval of accuracy is ±10%" (ʼ638 Patent, col. 4:1-4). This language may support an interpretation that the claim covers a range from 67.5 mg to 82.5 mg.
    • Evidence for a Narrower Interpretation: The specification also discloses a broader range of "from about 60 mg to about 90 mg" (ʼ638 Patent, Abstract). Parties may argue that the choice to claim "about 75 mg" specifically, rather than the broader disclosed range, was a deliberate narrowing of the claim scope to the specific amount tested and proven to be optimally effective, as detailed in the patent's clinical data tables (ʼ638 Patent, Tables 13-14, 19).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Defendants know of the '638 patent and that their proposed package insert for the generic product will "recommend, suggest, encourage, and/or instruct" healthcare professionals and patients to take the 75 mg tablet for the treatment of OAB, thereby performing the patented method (Compl. ¶¶ 69-70).
  • Willful Infringement: The complaint alleges that Defendants have had "actual knowledge of the ’638 patent, at least as of the date of Defendants’ First Notice Letter" (Compl. ¶64). It further alleges that Defendants acted "without a reasonable basis for believing that they would not be liable" and that this is an "exceptional case," which provides the basis for a willfulness claim (Compl. ¶76).

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

As is common in ANDA litigation where the generic product's dosage and indication directly map onto the patent's claims, the central dispute will likely focus on the validity of the patent, rather than on non-infringement.

  • A core issue for the court will be one of obviousness: given that vibegron was a known compound for treating overactive bladder, was it obvious to a person of ordinary skill in the art to select a daily dose of "about 75 mg" to achieve an optimal balance of safety and efficacy? The case will likely turn on whether this specific dosage selection represents a patentable invention or was merely the product of routine, predictable optimization.
  • A key evidentiary question will be one of induced infringement: assuming the patent is valid, will the final, FDA-approved label for Defendants’ generic product provide sufficient evidence of their intent to "encourage, recommend, or promote" the patented method of treatment to satisfy the requirements for inducement under 35 U.S.C. § 271(b)?