DCT

1:25-cv-00420

Urovant Sciences GmbH v. MSN Laboratories Pvt Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00420, D. Del., 04/03/2025
  • Venue Allegations: Venue is asserted based on Defendant MSN Pharmaceuticals Inc. being a Delaware corporation and Defendants MSN Laboratories Private Limited and MSN Organics Private Limited being foreign corporations that may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' overactive bladder drug, GEMTESA® (vibegron), constitutes an act of infringement of a patent covering a specific dosage regimen for the drug.
  • Technical Context: The technology involves a method-of-use patent for vibegron, a beta-3 adrenergic receptor agonist, for treating overactive bladder (OAB) at a specific daily dosage.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendants’ filing of ANDA No. 220285 with a Paragraph IV certification, asserting that U.S. Patent No. 12,102,638 is invalid, unenforceable, or will not be infringed by their proposed generic product. The patent-in-suit is listed in the FDA's Orange Book for GEMTESA®, and the complaint was filed within the 45-day statutory window following receipt of Defendants' notice letter, triggering a potential 30-month stay of FDA approval for the ANDA. The patent 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® (vibegron) NDA
2024-10-01 ’638 Patent Issue Date
2025-02-19 Plaintiffs' Receipt of MSN's Paragraph IV Notice Letter
2025-04-03 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.

The Invention Explained

  • Problem Addressed: The patent's background section notes that the predominant drugs for treating overactive bladder (OAB), antimuscarinics, are limited by "modest efficacy and poor tolerability" due to side effects like dry mouth and constipation, which leads to "high discontinuation rates" among patients (’638 Patent, col. 1:35-44).
  • The Patented Solution: The invention is a method of treating OAB by administering a specific daily dose of vibegron, a potent and selective beta-3 adrenergic receptor (B3-AR) agonist (’638 Patent, Abstract). As described in the detailed description, activating the B3-AR in the bladder's detrusor muscle leads to muscle relaxation and an increase in bladder capacity, thereby alleviating OAB symptoms (’638 Patent, col. 1:53-58). The patent claims a method centered on a daily dose of "about 75 mg" of vibegron (’638 Patent, col. 2:50-53).
  • Technical Importance: This therapeutic approach provided a different mechanism of action for OAB treatment, aiming to offer improved efficacy and/or a better side-effect profile compared to the established class of antimuscarinic drugs (’638 Patent, col. 1:35-53).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶59).
  • 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 alleges infringement of "one or more claims" and does not foreclose the assertion of other claims (Compl. ¶59).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "MSN's Generic Product," a 75 mg vibegron tablet for which Defendants filed Abbreviated New Drug Application (ANDA) No. 220285 with the FDA (Compl. ¶¶1, 44).

Functionality and Market Context

  • The complaint alleges that MSN's product is a generic version of Plaintiffs' GEMTESA® and is "pharmaceutically and therapeutically equivalent" (Compl. ¶55). The product is intended for oral administration for the treatment of OAB, the same indication as GEMTESA® (Compl. ¶¶39, 44). The filing of the ANDA represents a commercial effort by MSN to market a lower-cost generic equivalent to the branded drug upon receiving FDA approval (Compl. ¶¶1, 10-11).

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, and the proposed product label will instruct this use. ¶¶39, 62 col. 2:29-32
the method comprising administering to the subject The proposed product is an oral tablet, and the product labeling will instruct patients and healthcare providers to administer it. ¶¶61-62 col. 2:29-32
about 75 mg per day of vibegron or a pharmaceutically acceptable salt thereof. Defendants' ANDA is for a vibegron tablet with a strength of 75 mg, to be administered for the treatment of OAB. ¶¶1, 44 col. 4:51-53
  • Identified Points of Contention:
    • Scope Questions: The infringement allegation appears facially direct, as the ANDA specifies the exact 75 mg dosage recited in the claim. The primary dispute will therefore likely center on the patent's validity. A secondary question for the court may involve construing the term "about 75 mg", as this definition establishes the precise boundary of the claimed dosage range.
    • Technical Questions: The complaint alleges that MSN's product is therapeutically equivalent to GEMTESA® (Compl. ¶55). Based on the pleadings, there are no apparent technical disputes regarding the operation or composition of the accused product itself; the central conflict is the legal right to market it for the claimed method.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "about 75 mg per day"
  • Context and Importance: This term is the central limitation of the independent claim, defining the specific dosage that forms the basis of the patented method. Its construction is critical to defining the scope of Plaintiffs' right to exclude, as the case hinges on whether Defendants' 75 mg product falls within this claimed range.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides an explicit definition, stating that "The term 'about' as used in connection with a numerical value... denotes an interval of accuracy... of ±10%" (’638 Patent, col. 3:1-4). 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: A party seeking a narrower scope might point to the patent’s repeated and specific focus on "75 mg" in the abstract, examples, and dosage compositions as the optimal embodiment, potentially arguing that the term "about" should be construed narrowly in light of the specific clinical results and pharmacokinetic profiles associated with the exact 75 mg dose (’638 Patent, Abstract; col. 12:45-56).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendants know of the ’638 patent and that the proposed package insert for their generic product will instruct healthcare professionals and patients to administer the 75 mg tablet for OAB, thereby directly infringing the method claim (Compl. ¶¶61-62). The complaint also pleads contributory infringement, alleging the product is a material part of the invention and lacks substantial non-infringing uses (Compl. ¶¶63-64).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the ’638 patent, evidenced at least by the date of their Paragraph IV notice letter (Compl. ¶56). The complaint further asserts that Defendants acted "without a reasonable basis for believing that it would not be liable" (Compl. ¶68).

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

As is typical in ANDA litigation where infringement is premised on a generic product mirroring the branded drug's dosage and indication, the central questions for the court will likely be:

  • A question of patent validity: Can Defendants demonstrate by clear and convincing evidence that the asserted claims—which cover the method of treating OAB with approximately 75 mg of vibegron per day—are invalid, likely on grounds of obviousness or anticipation over prior art related to vibegron or other OAB treatments?
  • A question of statutory infringement: Does the act of filing an ANDA for a 75 mg vibegron product for the treatment of OAB legally constitute infringement under 35 U.S.C. § 271(e)(2), assuming the patent is found valid and enforceable?