DCT

5:25-cv-00163

Urovant Sciences GmbH v. Intas Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 5:25-cv-00163, E.D.N.C., 03/27/2025
  • Venue Allegations: Venue is asserted based on Defendant Accord Healthcare Inc.'s incorporation in North Carolina. Plaintiffs note they believe the case belongs in Delaware but filed in this district "out of an abundance of caution."
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of GEMTESA® (vibegron) tablets constitutes an act of infringement of a patent covering a method of using vibegron to treat overactive bladder.
  • Technical Context: The technology relates to a specific dosage regimen for vibegron, a beta-3 adrenergic receptor agonist used for the treatment of overactive bladder (OAB), a chronic condition affecting the lower urinary tract.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendants' submission of ANDA No. 220254 with a Paragraph IV certification, challenging U.S. Patent No. 12,102,638. The patent, which covers Plaintiffs' product GEMTESA®, is listed in the FDA's Orange Book and has a term adjustment of 655 days. The complaint alleges that Defendants' notice letter, dated February 10, 2025, did not provide any factual or legal basis for a non-infringement position, suggesting the primary dispute will center on patent validity.

Case Timeline

Date Event
2017-06-06 Earliest Priority Date for '638 Patent
2020-12-23 FDA Approval of NDA for GEMTESA®
2024-10-01 Issue Date of '638 Patent
2025-02-10 Defendants' ANDA Notice Letter Date
2025-03-27 Complaint Filing Date
2040-03-22 '638 Patent Expiration Date (with PTA)

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, issued October 1, 2024.

The Invention Explained

  • Problem Addressed: The patent's background section identifies the limitations of then-predominant drugs for overactive bladder (OAB), known as antimuscarinics. These drugs are described as having "modest efficacy and poor tolerability" due to side effects like dry mouth, constipation, and potential cognitive impairment, leading to high rates of patient discontinuation ('638 Patent, col. 1:35-42).
  • The Patented Solution: The invention is a method of treating OAB by orally administering a specific daily dosage of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist ('638 Patent, Abstract). By activating β3-ARs in the bladder's detrusor muscle, vibegron causes the muscle to relax, thereby increasing bladder capacity and alleviating OAB symptoms ('638 Patent, col. 1:55-60). The patent discloses that a daily dose of "about 75 mg" achieves the desired therapeutic effect while minimizing undesirable side effects, such as cardiovascular events, that can be associated with this class of drugs ('638 Patent, col. 4:11-17).
  • Technical Importance: The claimed invention provides a specific, effective, and well-tolerated dosage regimen for a β3-AR agonist, offering a new therapeutic option for OAB patients that may avoid the tolerability issues associated with older antimuscarinic treatments ('638 Patent, col. 1:44-52).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶43).
  • The essential elements of 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 states Plaintiffs may assert infringement of additional claims of the ’638 Patent (Compl. ¶43).

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed generic version of Vibegron Tablets, 75 mg, which is the subject of ANDA No. 220254 (Compl. ¶1, ¶29).

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" (Compl. ¶1, ¶39).
  • The ANDA was filed to obtain FDA approval to manufacture and sell this product for the treatment of OAB, the same indication for which GEMTESA® is approved (Compl. ¶1, ¶24, ¶29).
  • Plaintiffs allege that Defendants' proposed package insert for the generic product will recommend, suggest, and instruct healthcare providers and patients to use the 75 mg tablets in a manner that directly infringes the claimed method (Compl. ¶45, ¶46).
  • 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 as a treatment for overactive bladder, and the proposed labeling will allegedly instruct medical professionals and patients to use it for this purpose. ¶¶ 1, 29, 44-46 col. 4:9-12
the method comprising administering to the subject about 75 mg per day of vibegron or a pharmaceutically acceptable salt thereof. Defendants' ANDA product is a Vibegron Tablet with a proposed strength of 75 mg, and the proposed labeling will allegedly instruct for its administration. ¶¶ 29, 46 col. 4:50-51

Identified Points of Contention

  • Validity vs. Infringement: The complaint alleges that Defendants' notice letter "did not provide non-infringement allegations addressing infringement for any claims of the '638 patent" (Compl. ¶38). This suggests that the central dispute in the case may not be over whether the accused product meets the claim limitations, but rather whether the patent's claims are valid and enforceable.
  • Legal Question of Infringement: The act of infringement alleged is the submission of the ANDA under 35 U.S.C. § 271(e)(2)(A), which is a statutory act of infringement (Compl. ¶42). A key question for the court will be to assess the legal and factual basis for Defendants' Paragraph IV certification that the '638 Patent is "invalid, unenforceable and/or will not be infringed" (Compl. ¶33).

V. Key Claim Terms for Construction

  • The Term: "about 75 mg"
  • Context and Importance: This term is central to the claim as it defines the specific dosage that forms the basis of the patented method. The accused product is a 75 mg tablet, making the interpretation of "about" critical to defining the precise scope of infringement. Practitioners may focus on this term because while there appears to be a literal correspondence, any ambiguity in the scope of "about" could become a focal point, particularly in the context of validity arguments concerning prior art dosages.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification repeatedly frames the invention within a range. The Summary section provides for a method using "from 60 mg to 90 mg of vibegron per day" ('638 Patent, col. 2:31-32), and the Detailed Description discloses administration of "from about 60 mg to about 90 mg" ('638 Patent, col. 4:46-47). This language may support an interpretation that "about 75 mg" is an exemplary embodiment within a broader claimed range.
    • Evidence for a Narrower Interpretation: The patent's abstract specifically recites "about 75 mg," and the claims are directed to this specific amount rather than a range ('638 Patent, Abstract; col. 40:31). Furthermore, the patent presents data suggesting a 75 mg dose is an optimal balance of efficacy and safety compared to other doses, which could be used to argue that "about 75 mg" refers to a narrow range centered on the unique properties of that specific dosage ('638 Patent, col. 37:11-34, Fig. 1).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Defendants, through their proposed product labeling and package insert, will knowingly and intentionally encourage and instruct healthcare professionals and patients to administer the 75 mg generic vibegron tablet for the treatment of OAB, thereby infringing the '638 Patent (Compl. ¶¶ 44-46).
  • Willful Infringement: The complaint alleges Defendants have actual knowledge of the '638 patent and acted "without a reasonable basis for believing that they would not be liable" for infringement (Compl. ¶40, ¶52). While not using the term "willful," Plaintiffs seek a declaration that the case is "exceptional" and an award of attorney fees under 35 U.S.C. § 285, which is the standard procedural vehicle for such allegations (Compl., Request for Relief G).

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

  • A central issue will be one of patent validity: Given that the complaint alleges Defendants have not provided a basis for non-infringement, the case will likely turn on whether Defendants can prove by clear and convincing evidence that the claims of the '638 Patent, which are directed to a method of using "about 75 mg" of vibegron, are invalid as anticipated or obvious over the prior art.
  • A key legal and evidentiary question will be whether Defendants' conduct rises to the level of an exceptional case. The court will have to determine if Defendants' filing of a Paragraph IV certification, allegedly without a good-faith basis for non-infringement as asserted in the complaint, constitutes litigation misconduct or is otherwise so unreasonable as to warrant an award of attorney fees under 35 U.S.C. § 285.
  • A secondary issue may concern definitional scope: Should the validity of the patent be challenged, the construction of "about 75 mg" will be critical. The question will be whether the term is limited to the immediate proximity of 75 mg, as suggested by the specific claim language, or encompasses the broader 60-90 mg range disclosed in the specification, a determination that could significantly affect the patent's vulnerability to prior art.