DCT

1:25-cv-00373

Urovant Sciences GmbH v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00373, D. Del., 03/26/2025
  • Venue Allegations: Venue is asserted in Delaware primarily because Defendant Intas is a foreign corporation incorporated in India and may be sued in any judicial district in the United States.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' GEMTESA® (vibegron) tablets constitutes an act of infringement of a patent covering a method of using the drug.
  • Technical Context: The technology at issue is a pharmaceutical method for treating overactive bladder (OAB), a common urological condition, by administering a specific daily dosage of the compound vibegron.
  • Key Procedural History: This litigation was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 220254 and a Paragraph IV certification, which asserted that the patent-in-suit is invalid, unenforceable, or will not be infringed. Plaintiffs state they commenced this action within the 45-day statutory window after receiving Defendants' notice letter, triggering a potential 30-month stay of FDA approval for the generic product. The complaint also notes the patent-in-suit was granted a 655-day patent term adjustment.

Case Timeline

Date Event
2017-06-06 '638 Patent Priority Date
2020-12-23 FDA Approval of GEMTESA® (NDA No. 213006)
2024-10-01 '638 Patent Issue Date
2025-02-10 Defendants Send Paragraph IV 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, titled “Use of Vibegron to Treat Overactive Bladder,” issued on October 1, 2024. (Compl. ¶31).

The Invention Explained

  • Problem Addressed: The patent describes overactive bladder (OAB) as a chronic and debilitating condition. It notes that the predominant class of drugs used to treat OAB, antimuscarinics, suffers from modest efficacy and poor tolerability due to side effects such as dry mouth and constipation, leading to high rates of patients discontinuing treatment. (’638 Patent, col. 1:7-44).
  • The Patented Solution: The invention is a method of treating OAB by orally administering a specific daily dosage of vibegron—about 75 mg. (’638 Patent, Abstract). Vibegron is a beta-3 adrenergic receptor (β3-AR) agonist. Activating this receptor in the bladder's detrusor muscle leads to muscle relaxation and an increased bladder capacity, thereby alleviating OAB symptoms. (’638 Patent, col. 1:45-60). The patent suggests that this specific dosage range provides the desired therapeutic efficacy while minimizing undesirable side effects. (’638 Patent, col. 3:11-17).
  • Technical Importance: This therapeutic approach provides a targeted mechanism of action that differs from traditional antimuscarinics, offering a potential alternative for OAB patients with a different efficacy and side-effect profile. (’638 Patent, col. 1:45-60).

Key Claims at a Glance

  • The complaint asserts infringement of at least claim 1. (Compl. ¶49).
  • Independent Claim 1 requires:
    • 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’s reference to "one or more claims" suggests the right to assert additional claims, including dependent claims, is reserved. (Compl. ¶49).

III. The Accused Instrumentality

Product Identification

  • Defendants’ proposed generic product is identified as “Vibegron Tablets (75 mg),” which is the subject of ANDA No. 220254. (Compl. ¶1).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs’ GEMTESA® (vibegron) tablets and is alleged to be “pharmaceutically and therapeutically equivalent” to the branded drug. (Compl. ¶¶ 1, 45). The ANDA seeks FDA approval to manufacture and sell these 75 mg tablets for the treatment of OAB, directly competing with Plaintiffs’ product. (Compl. ¶¶ 1, 35). The complaint alleges that the proposed package insert for the generic product will instruct for its use in treating OAB. (Compl. ¶52).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'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... Defendants’ ANDA seeks approval to market their Generic Product for the treatment of OAB, the same indication as Plaintiffs' GEMTESA®. The proposed label will instruct this use. ¶¶1, 30, 52 col. 2:29-33
...the method comprising administering to the subject about 75 mg per day of vibegron... Defendants’ ANDA is for a 75 mg tablet of vibegron, and the proposed labeling will instruct for daily administration to treat OAB. ¶¶1, 35, 52 col. 2:29-33
...or a pharmaceutically acceptable salt thereof. Defendants’ Generic Product is described as containing vibegron as its active ingredient. ¶¶1, 30 col. 4:41-49
  • Identified Points of Contention:
    • Scope Questions: The complaint makes a notable allegation that the Defendants’ Paragraph IV notice letter "did not provide non-infringement allegations." (Compl. ¶44). This raises the question of whether Defendants will contest infringement at all, or instead focus their defense entirely on the patent's validity. If infringement is not contested, claim construction may be of secondary importance to that issue.
    • Technical Questions: Given that the accused product is a 75 mg tablet of vibegron intended for the same use as the branded drug, there appears to be a direct correspondence with the elements of claim 1. The central dispute is therefore unlikely to be a technical mismatch between the claim language and the accused product. Instead, the case will likely turn on whether the claimed method is valid over the prior art.

V. Key Claim Terms for Construction

  • The Term: "about 75 mg"
  • Context and Importance: While Defendants’ product has a strength of exactly 75 mg, the construction of "about" is critical for assessing patent validity. The breadth of this term will determine what prior art disclosures might be considered anticipatory or render the claim obvious. Practitioners may focus on this term because its scope could be determinative in an obviousness analysis if prior art teaches dosages close to, but not exactly, 75 mg.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification explicitly defines "about" as denoting an "interval of accuracy" of "±10%," which would construe the claimed dosage as encompassing 67.5 mg to 82.5 mg. (’638 Patent, col. 3:1-4). The patent also discloses wider ranges, such as "from about 60 mg to about 90 mg," which could be used to argue for a flexible interpretation. (’638 Patent, col. 4:41-42).
    • Evidence for a Narrower Interpretation: A party challenging the patent might argue that in the context of pharmaceutical dosing and the patent's own clinical data, "about 75 mg" should be construed more narrowly to reflect the specific dosage form. The specification's extensive discussion of the pharmacokinetic properties and clinical effects related to specific dosages could be cited to argue that the 75 mg amount is not arbitrary but a precise, critical selection. (’638 Patent, col. 27, Table 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, with knowledge of the ’638 patent, will market their generic product with a package insert that instructs and encourages medical professionals and patients to perform the patented method—namely, administering the 75 mg tablet daily to treat OAB. (Compl. ¶¶ 46, 51-52).
  • Willful Infringement: The complaint does not use the term "willful," but it requests a declaration that this is an "exceptional case" and alleges Defendants acted "without a reasonable basis for believing that they would not be liable for... infringing." (Compl. ¶¶ 58, Prayer for Relief ¶G). This lays the groundwork for seeking enhanced damages and attorneys' fees. The alleged basis for this claim is Defendants' knowledge of the patent, established at least as of the date of their notice letter. (Compl. ¶46).

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

  • A core issue will be one of patent validity: The complaint indicates Defendants' primary challenge to the patent is based on invalidity and/or unenforceability, rather than non-infringement. (Compl. ¶¶ 39, 44). The central question for the court will therefore be whether the claimed method of administering "about 75 mg" of vibegron for OAB was anticipated or rendered obvious by prior art publications or other public disclosures existing before the patent's priority date.
  • The dispositive legal question is one of statutory infringement: This case is an archetypal Hatch-Waxman dispute where the act of infringement is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2). The ultimate outcome will determine whether Defendants can receive FDA approval and launch their generic product before the ’638 patent, including its term adjustment, expires in 2040.
  • A key procedural question will be whether this is an exceptional case: The court will have to evaluate the objective and subjective strength of Defendants' invalidity positions. A finding that the challenge was brought without a reasonable basis could lead to an award of attorneys' fees, influencing the economic calculus of the litigation for both sides.