DCT

3:26-cv-00115

AbbVie Inc v. MSN Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:26-cv-00115, D.N.J., 01/07/2026
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant MSN Pharmaceuticals Inc. has its principal place of business in the district, and the other defendant entities are incorporated in India and may be sued in any U.S. judicial district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiffs’ QULIPTA® (atogepant) tablets constitutes an act of infringement of four U.S. patents directed to methods of treating migraine.
  • Technical Context: The technology relates to pharmaceutical methods for the preventive treatment of migraine using atogepant, an orally available calcitonin gene-related peptide (CGRP) receptor antagonist.
  • Key Procedural History: The complaint notes that the patents-in-suit are concurrently the subject of separate infringement proceedings in the same court against other generic drug manufacturers, including Apotex Inc., Macleods Pharmaceuticals Ltd., Dr. Reddy's Laboratories, Ltd., and Hetero USA Inc.

Case Timeline

Date Event
2018-06-08 U.S. Patent No. 12,383,545 Priority Date
2020-07-29 U.S. Patent No. 12,090,148 Priority Date
2021-09-27 U.S. Patent No. 12,350,259 Priority Date
2021-09-28 FDA Approval of QULIPTA® (NDA No. 215206)
2022-09-27 U.S. Patent No. 12,465,598 Priority Date
2024-09-17 U.S. Patent No. 12,090,148 Issues
2025-07-08 U.S. Patent No. 12,350,259 Issues
2025-08-12 U.S. Patent No. 12,383,545 Issues
2025-11-11 U.S. Patent No. 12,465,598 Issues
2025-11-24 Plaintiffs Receive Notice Letter Regarding MSN's ANDA Filing
2026-01-07 Complaint Filed

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

U.S. Patent No. 12,090,148 - *Treatment of Migraine* (issued Sep. 17, 2024)

The Invention Explained

  • Problem Addressed: Migraine is described as a highly prevalent and disabling neurological condition for which available CGRP-targeted preventive treatments were limited to injectables, creating a treatment gap for patients and physicians who overwhelmingly prescribe oral preventives (ʼ148 Patent, col. 1:23-48).
  • The Patented Solution: The invention provides a method for the prophylactic (preventive) treatment of migraine by orally administering atogepant, a small molecule CGRP receptor antagonist, at specific once-daily dosages (10 mg, 30 mg, or 60 mg). This administration is disclosed to result in clinically significant outcomes, including a reduction in the mean number of monthly migraine days and an associated reduction in body weight (ʼ148 Patent, col. 2:1-16; Abstract).
  • Technical Importance: The invention provides an oral, targeted CGRP therapy for migraine prevention, addressing a significant need for non-injectable treatment options in this therapeutic area (ʼ148 Patent, col. 1:40-48).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, alleging infringement of "one or more claims" (Compl. ¶2). Independent claim 1 is representative.
  • Claim 1 requires:
    • A method for the preventive treatment of migraine in a patient with migraine headaches.
    • Administering 60 mg of atogepant once daily for more than 12 weeks.
    • Wherein the administration is "associated with a reduction in mean monthly migraine days."
    • And wherein the administration is "associated with a reduction from baseline in body weight."

U.S. Patent No. 12,350,259 - *Methods of Treating Migraine* (issued Jul. 8, 2025)

The Invention Explained

  • Problem Addressed: The patent addresses the need for targeted and optimized dosing regimens for oral CGRP treatments for migraine prophylaxis, particularly for patient populations taking other medications that may cause drug-drug interactions (ʼ259 Patent, col. 1:22-45).
  • The Patented Solution: The invention provides a method for safely and effectively treating migraine in patients who are also taking a strong CYP3A4 inhibitor, a class of drugs that can significantly increase exposure to atogepant. The patented solution is to administer a reduced dose of 10 mg of atogepant once daily to this specific patient population (ʼ259 Patent, col. 3:34-43; Abstract).
  • Technical Importance: This method provides a specific dosing instruction that manages a significant drug-drug interaction risk, thereby allowing a broader population of migraine patients to be treated safely with atogepant (ʼ259 Patent, col. 3:16-29).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Independent claim 1 is representative.
  • Claim 1 requires:
    • A method for the preventive treatment of migraine.
    • In a patient undergoing concurrent treatment with a "strong CYP3A4 inhibitor."
    • Orally administering 10 mg of atogepant once daily.
    • Wherein the patient's migraines are "safely and effectively treated."

U.S. Patent No. 12,383,545 - *Treatment of Migraine* (issued Aug. 12, 2025)

  • Technology Synopsis: The patent is directed to a method for the preventive treatment of migraine by administering atogepant (10, 30, or 60 mg once daily) wherein the treatment does not significantly affect the level of liver enzymes, such as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (ʼ545 Patent, col. 5:9-14; Abstract). This claims a method of treatment with a specific favorable safety profile.
  • Asserted Claims: The complaint is silent; independent claims 1, 7, and 13 are included in the patent.
  • Accused Features: MSN's filing of an ANDA for 10, 30, and 60 mg generic atogepant tablets. To gain FDA approval, the proposed generic product must demonstrate bioequivalence and adopt a label with the same indications and safety information as QULIPTA®, which includes data on liver enzyme levels (Compl. ¶¶ 59, 67-68).

U.S. Patent No. 12,465,598 - *Methods of Treating Migraine* (issued Nov. 11, 2025)

  • Technology Synopsis: The patent claims a method for the preventive treatment of migraine specifically in patients with severe renal impairment or end-stage renal disease. The method comprises administering a 10 mg once-daily dose of atogepant to this patient sub-population (ʼ598 Patent, col. 2:58-65; Abstract).
  • Asserted Claims: The complaint is silent; independent claim 1 is included in the patent.
  • Accused Features: MSN's filing of an ANDA for a 10 mg generic atogepant tablet. The branded QULIPTA® label, which the generic label must mirror, includes specific dosing instructions for patients with severe renal impairment (Compl. ¶¶ 39, 41, 68).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the proposed generic versions of QULIPTA® (atogepant) oral tablets in 10 mg, 30 mg, and 60 mg dosage forms, for which Defendants (collectively "MSN") filed Abbreviated New Drug Application No. 221083 with the U.S. Food and Drug Administration (FDA) (Compl. ¶¶ 1, 59).

Functionality and Market Context

MSN's generic products are intended to be pharmaceutically and therapeutically equivalent to AbbVie's branded QULIPTA® tablets (Compl. ¶76). QULIPTA® is an oral CGRP receptor antagonist approved for the preventive treatment of migraine in adults (Compl. ¶37). The complaint alleges that upon approval, MSN's generic products will have the same indications, safety, and efficacy information as QULIPTA® (Compl. ¶68). The complaint highlights that QULIPTA® is the only orally available CGRP receptor antagonist indicated for preventive migraine treatment in patients concomitantly using strong CYP3A inhibitors or those with end-stage renal disease, suggesting a distinct market position for these uses (Compl. ¶41).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a generic drug before patent expiration as a technical act of infringement. The infringement theory is that MSN's proposed generic products, if approved, will have labeling that instructs physicians and patients to use the drug in a manner that directly infringes the asserted patents.

U.S. Patent No. 12,090,148 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the preventive treatment of migraine in a patient having migraine headaches... MSN's ANDA seeks approval for its product for the preventive treatment of migraine, and its proposed label will instruct this use. ¶¶ 1, 37, 68 col. 2:50-52
...the method comprising administering to the patient 60 mg atogepant... once daily for more than 12 weeks... MSN's ANDA seeks approval to market a 60 mg dosage form of atogepant intended for once-daily administration. ¶¶ 39, 59, 68 col. 2:52-54
...wherein administration of atogepant is associated with a reduction in mean monthly migraine days... The proposed generic label, to mirror the branded drug's label, will include efficacy data demonstrating this reduction. ¶¶ 68, 76 col. 2:55-57
...and wherein administration of atogepant is associated with a reduction from baseline in body weight. The proposed generic label will also include data demonstrating an association with body weight reduction. ¶¶ 40, 68 col. 2:57-59

U.S. Patent No. 12,350,259 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the preventive treatment of migraine in a patient... MSN's ANDA seeks approval for its product for the preventive treatment of migraine, and its proposed label will instruct this use. ¶¶ 1, 37, 68 col. 3:34-36
...undergoing concurrent treatment with a strong CYP3A4 inhibitor... The proposed generic label will contain specific dosing instructions for this patient sub-population, as the branded label does. ¶¶ 39, 41, 68 col. 3:37-39
...the method comprising orally administering 10 mg atogepant once daily to the patient... MSN seeks approval to market a 10 mg dosage form, and its proposed label will instruct this specific dosing for this patient group. ¶¶ 39, 59, 68 col. 3:39-41
...wherein the patient's migraines are safely and effectively treated. The proposed generic label will contain the FDA-approved safety and efficacy data demonstrating this outcome. ¶¶ 68, 76 col. 3:42-43

Identified Points of Contention

  • Scope Questions: A potential dispute may arise over the construction of "associated with" in Claim 1 of the ’148 Patent. MSN may argue this requires a specific causal link or statistical threshold not met by the data on the proposed label, while Plaintiffs may argue it only requires that the effect is observed in patients taking the drug, as the label will report.
  • Technical Questions: A central question in ANDA litigation is whether the proposed generic label will induce infringement. This raises the question of whether MSN might attempt to "carve out" patented methods of use from its label to avoid infringement, although the complaint alleges the labels will be the same (Compl. ¶68). For the ’259, ’545, and ’598 patents, which cover specific patient populations or safety profiles, the analysis will focus on whether MSN’s proposed labeling includes instructions for these specific uses and communicates these specific benefits or safety profiles.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of claim construction disputes. However, based on the patent language, the following terms may become central to the case.

Term: "associated with" (’148 Patent, Claim 1)

  • Context and Importance: This term links the administration of atogepant to the claimed outcomes of reduced migraine days and reduced body weight. Its construction is critical because it defines the required relationship between the drug and its effects for infringement to occur.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification extensively references clinical trial data where these outcomes were observed in the treatment group, suggesting an observational or correlational link is sufficient (ʼ148 Patent, col. 2:20-30). The phrase "statistically significant weight loss was observed" supports an interpretation based on clinical study results (ʼ148 Patent, col. 4:5-8).
    • Evidence for a Narrower Interpretation: The patent does not appear to explicitly define the term. A party arguing for a narrower construction might contend that "associated with" implies a direct causative link that goes beyond mere statistical observation reported on a product label.

Term: "strong CYP3A4 inhibitor" (’259 Patent, Claim 1)

  • Context and Importance: This term defines the specific patient sub-population to which this method of treatment applies. The scope of infringement for the ’259 patent depends entirely on what drugs fall within this category.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification introduces the term in a general sense, stating that co-administration with such inhibitors resulted in a "significant increase in exposure of atogepant" (ʼ259 Patent, col. 3:19-22). This could support a functional definition covering any drug known to have this effect.
    • Evidence for a Narrower Interpretation: The specification provides specific examples, stating "In embodiments, the CYP3A4 inhibitor is ketoconazole, itraconazole, or clarithromycin" (ʼ259 Patent, col. 4:39-40). A party could argue that the claim term should be limited to these examples or compounds with a similar mechanism and magnitude of inhibition.

VI. Other Allegations

Indirect Infringement

The complaint alleges that MSN knows of the patents-in-suit, as evidenced by its Paragraph IV certification letter (Compl. ¶¶ 61, 80). It further alleges that MSN will induce infringement by "its promotional activities and proposed package insert for MSN's generic products," which will instruct healthcare professionals and patients to prescribe and use the products in a manner that directly infringes the patents (Compl. ¶¶ 80-81, 108-109).

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

As this case is in the earliest procedural stage, the core questions remain open for the court's determination. The dispute will likely center on the following issues:

  • Invalidity vs. Infringement: While the complaint focuses on infringement, the central battleground in ANDA litigation is often the defendant's counterclaim for patent invalidity (anticipated by MSN's Paragraph IV certification, Compl. ¶61). The resolution of the case will depend on whether the patents-in-suit withstand challenges to their validity based on prior art or other legal requirements.
  • Label-Based Infringement: A key infringement question will be one of induced infringement via labeling: will MSN's final, FDA-approved label for its generic atogepant tablets contain instructions and efficacy/safety data that directly encourage physicians to prescribe the drug for the specific preventive methods and patient subpopulations (e.g., those on CYP3A4 inhibitors, those with renal impairment) claimed in the patents-in-suit?
  • Claim Scope: A core legal issue will be one of definitional scope: how will the court construe key terms like "associated with" ('148 Patent) and "strong CYP3A4 inhibitor" ('259 Patent)? The breadth of these definitions will determine whether the expected content of MSN's generic label falls within the scope of the patent claims.