DCT

1:25-cv-00372

Urovant Sciences GmbH v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00372, D. Del., 03/26/2025
  • Venue Allegations: Venue is alleged to be proper as to Apotex Corp. because it is incorporated in Delaware, and as to Apotex Inc. because it is a foreign corporation that may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic 75 mg vibegron tablet constitutes an act of infringement of a patent covering a method of using vibegron to treat overactive bladder.
  • Technical Context: The technology concerns a specific pharmaceutical dosage regimen for treating overactive bladder (OAB), a chronic urological condition affecting a significant portion of the adult population.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following a notice letter from Apotex, which included a Paragraph IV certification stating its belief that the asserted patent is invalid, unenforceable, and/or will not be infringed by its proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" for Plaintiffs' GEMTESA® product and was granted a 655-day patent term adjustment. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay on the FDA’s approval of Apotex's ANDA.

Case Timeline

Date Event
2017-06-06 Earliest Priority Date for '638 Patent
2020-12-23 FDA Approval of Plaintiffs' NDA for GEMTESA®
2024-10-01 Issue Date of U.S. Patent No. 12,102,638
2025-02-14 Date of Apotex's Notice Letter
2025-03-26 Complaint Filing Date

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 ('638 Patent, front page; Compl. ¶31).

The Invention Explained

  • Problem Addressed: The patent describes overactive bladder (OAB) as a chronic and debilitating condition characterized by urinary urgency and frequency ('638 Patent, col. 1:5-9). It notes that the predominant class of drugs used to treat OAB, antimuscarinics, are limited by "modest efficacy and poor tolerability" due to side effects such as dry mouth and cognitive impairment, which leads to high rates of patient discontinuation ('638 Patent, col. 1:35-43).
  • The Patented Solution: The invention is a method for treating OAB by orally administering a specific daily dosage of vibegron, namely "about 75 mg" ('638 Patent, Abstract). Vibegron is a potent and "highly selective" beta-3 adrenergic receptor (β3-AR) agonist that works by relaxing the detrusor muscle in the bladder, thereby increasing bladder capacity ('638 Patent, col. 2:58-65). The patent suggests this specific dosage regimen achieves the desired therapeutic efficacy while minimizing undesirable side effects ('638 Patent, col. 4:11-16).
  • Technical Importance: The invention's claimed contribution lies in identifying a specific, effective, and well-tolerated dosage for a highly selective β3-AR agonist, offering an alternative to older, less-tolerated treatments for OAB ('638 Patent, col. 1:35-43, col. 2:58-65).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶48).
  • Independent Claim 1 contains the following essential elements:
    • 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 reserves the right to assert infringement of other claims of the '638 patent (Compl. ¶48).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Apotex's proposed generic vibegron tablet (75 mg), for which it seeks FDA approval via ANDA No. 220169 (Compl. ¶¶1, 35).

Functionality and Market Context

  • The complaint alleges that Apotex's product is a generic version of Plaintiffs' branded drug, GEMTESA® (Compl. ¶1).
  • The product is a 75 mg vibegron tablet intended for oral administration to treat OAB, the same indication for which GEMTESA® is approved (Compl. ¶¶30, 35). Apotex has represented to the FDA that its product is "pharmaceutically and therapeutically equivalent" to GEMTESA® (Compl. ¶44). The commercialization of this product is contingent upon FDA approval of the ANDA (Compl. ¶9).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary: The complaint alleges infringement under 35 U.S.C. § 271(e)(2) based on the submission of the ANDA. The theory of infringement relies on the proposed use outlined in Apotex's ANDA filing, which will be reflected in the product's labeling.

'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, Apotex seeks FDA approval to market its generic product for the treatment of overactive bladder, which is the approved indication for the reference listed drug, GEMTESA®. ¶1, ¶30, ¶35 col. 2:31-34
the method comprising administering to the subject about 75 mg per day of vibegron or a pharmaceutically acceptable salt thereof. Apotex's ANDA describes a vibegron tablet with a strength of 75 mg, and its proposed label will instruct for administration of this dose for the treatment of OAB. ¶1, ¶35, ¶51 col. 4:51-54
  • Identified Points of Contention:
    • Validity Questions: The complaint notes that Apotex's notice letter asserts that the claims of the '638 patent are invalid (Compl. ¶38). In ANDA litigation involving dosage patents, a central dispute is often whether the claimed dosage regimen is obvious over the prior art. The key question for the court will likely be whether the selection of "about 75 mg per day" was a product of routine, predictable optimization or if it produced unexpected results (e.g., a superior efficacy and safety profile) not suggested by the art.
    • Infringement Questions: While the infringement allegation appears straightforward based on the ANDA's 75 mg dosage strength for the OAB indication, Apotex has also asserted non-infringement (Compl. ¶38). The complaint does not specify Apotex's non-infringement theory, which raises the question of what technical or legal distinction Apotex will argue separates its proposed product or its use from the scope of the asserted claims.

V. Key Claim Terms for Construction

  • The Term: "about 75 mg"
  • Context and Importance: This term is the central limitation defining the patented dosage. Its construction is critical because it delineates the scope of the invention. While the accused product has a strength of exactly 75 mg, the interpretation of "about" may be relevant for assessing the patent's validity in view of prior art disclosures that may teach dosages near, but not exactly, 75 mg. Practitioners may focus on this term to understand the patent's defensible scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses the invention as a method of administering "an amount of from 60 mg to 90 mg of vibegron per day," with "about 75 mg" presented as a preferred embodiment within that range ('638 Patent, col. 2:31-34). This could support an interpretation where "about 75 mg" encompasses a numerical range around 75 mg.
    • Evidence for a Narrower Interpretation: The patent presents specific clinical and pharmacokinetic data suggesting a 75 mg dose achieves a particular balance of efficacy and reduced side effects, stating that a 75 mg dose "captures a majority of the efficacy achieved with 100 mg" while avoiding the exposure levels of the higher dose ('638 Patent, col. 38:5-15). This could support an argument that "about 75 mg" should be narrowly construed to the dosage that achieves this specific, disclosed outcome.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Apotex will induce infringement by providing a product label that instructs healthcare professionals and patients to administer the 75 mg vibegron tablet for the treatment of OAB, which is the patented method (Compl. ¶¶50-51). It further alleges contributory infringement, stating that Apotex's product is especially adapted for this infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶52-53).
  • Willful Infringement: The complaint alleges that Apotex acted "without a reasonable basis for believing that it would not be liable for... infringing the '638 patent" and characterizes the case as "exceptional," which forms the basis for a claim of enhanced damages and attorneys' fees (Compl. ¶57). This claim is based on Apotex's alleged knowledge of the patent, at least as of the date of its notice letter (Compl. ¶45).

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

  • A central issue for the court will be one of validity: Is the claimed dosage regimen of "about 75 mg per day" of vibegron non-obvious? The case will likely turn on whether the evidence shows that selecting this specific dosage was a matter of routine clinical optimization or if it achieved an unexpected and superior safety and efficacy profile that would not have been predictable from the prior art.
  • A key secondary question will be one of statutory infringement: Given that Apotex's ANDA is for a 75 mg vibegron product for the same indication, what is the precise factual and legal basis for the non-infringement defense asserted in its Paragraph IV notice letter? The complaint does not detail this defense, making it a pivotal unknown that will likely define the contours of discovery and motion practice.