DCT

3:26-cv-00518

AbbVie Inc v. Micro Labs Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:26-cv-00518, D.N.J., 01/15/2026
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Micro Labs USA has its principal place of business in the district, and Defendant Micro Labs Limited, an Indian corporation, may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's QULIPTA® (atogepant) tablets constitutes an act of infringement of four U.S. patents related to methods of treating migraine.
  • Technical Context: The technology involves oral pharmaceuticals for the preventive treatment of migraine, a prevalent and debilitating neurological condition, using atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 220772 with a Paragraph IV certification, alleging the patents-in-suit are invalid, unenforceable, or will not be infringed. The complaint notes that the patents-in-suit are also the subject of other pending infringement actions against different generic pharmaceutical manufacturers in the same district.

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® New Drug Application
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
2025-12-04 Defendant sends first Paragraph IV Notice Letter
2026-01-05 Defendant sends second Paragraph IV Notice Letter
2026-01-15 Complaint Filed

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

U.S. Patent No. 12,090,148 - *“Treatment of Migraine”*

The Invention Explained

  • Problem Addressed: The patent’s background section describes migraine as a highly prevalent and disabling neurological condition for which a need remains for optimized and targeted oral treatments for prophylactic (preventive) use, particularly treatments targeting the calcitonin gene-related peptide (CGRP) pathway. (’148 Patent, col. 1:22-49).
  • The Patented Solution: The invention provides a method for the preventive treatment of migraine through the daily oral administration of atogepant, a small molecule CGRP receptor antagonist. The specification describes clinical trial results demonstrating that specific daily doses (e.g., 60 mg) lead to a statistically significant reduction in mean monthly migraine days compared to placebo, and also notes an associated reduction in body weight. (’148 Patent, Abstract; col. 2:20-27; FIG. 19).
  • Technical Importance: The invention provides an oral CGRP-targeted therapy for migraine prevention, addressing a treatment gap where such targeted therapies were primarily injectable monoclonal antibodies. (’148 Patent, col. 1:40-45).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims without specifying them; Claim 1 is the first independent claim. (Compl. ¶76).
  • Claim 1 of the ’148 Patent includes the following essential elements:
    • A method for the preventive treatment of migraine in a patient.
    • Administering 60 mg of atogepant (or a salt thereof) once daily for more than 12 weeks.
    • The administration is associated with a reduction in mean monthly migraine days.
    • The administration is associated with a reduction from baseline in body weight.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,350,259 - *“Methods of Treating Migraine”*

The Invention Explained

  • Problem Addressed: The patent addresses the need for safe and effective migraine treatment regimens for patients who are also taking other medications. Specifically, it recognizes that co-administration with strong inhibitors of the CYP3A4 enzyme can significantly increase a patient's exposure to atogepant, creating potential safety concerns. (’259 Patent, col. 3:45-56).
  • The Patented Solution: The invention provides a method for preventively treating migraine in patients who are concurrently taking a strong CYP3A4 inhibitor. The patented solution is to administer a reduced dose of 10 mg of atogepant once daily, which allows the patient's migraines to be "safely and effectively treated" despite the drug-drug interaction. (’259 Patent, Abstract; col. 4:8-17).
  • Technical Importance: This dosing method enables the safe use of atogepant in a specific patient subpopulation who might otherwise have to avoid the treatment due to drug-drug interaction risks. (’259 Patent, col. 4:8-17).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims without specifying them; Claim 1 is the first independent claim. (Compl. ¶104).
  • Claim 1 of the ’259 Patent includes the following essential elements:
    • A method for the preventive treatment of migraine.
    • The patient is undergoing concurrent treatment with a strong CYP3A4 inhibitor.
    • Orally administering 10 mg of atogepant once daily to the patient.
    • Wherein the patient’s migraines are safely and effectively treated.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,383,545 - *“Treatment of Migraine”*

  • Technology Synopsis: The patent addresses the treatment of migraine in patients who have elevated liver enzymes. The invention is a method of administering atogepant at specified doses (10, 30, or 60 mg once daily) while not significantly affecting the patient’s level of liver enzymes like alanine aminotransferase (ALT) or aspartate aminotransferase (AST). (’545 Patent, Abstract; col. 6:10-23).
  • Asserted Claims: The patent contains independent claims 1, 7, and 13; the complaint does not specify which are asserted.
  • Accused Features: The accused instrumentality is Defendant's ANDA filing for generic atogepant. Infringement is alleged based on the fact that the proposed product label will instruct uses that are covered by the patent's claims. (Compl. ¶¶ 133-136).

U.S. Patent No. 12,465,598 - *“Methods of Treating Migraine”*

  • Technology Synopsis: The patent document was not provided with the complaint. The complaint alleges the patent is listed in the FDA’s Orange Book for the 10 mg dosage form of QULIPTA®. (Compl. ¶55). Based on this listing and the subject matter of the other patents-in-suit, the patent likely claims a specific method of using the 10 mg dosage of atogepant for the preventive treatment of migraine in a particular patient population or according to a specific regimen.
  • Asserted Claims: The complaint does not specify which claims are asserted.
  • Accused Features: The accused instrumentality is Defendant's ANDA filing for generic atogepant. The complaint alleges that Defendant’s proposed product labeling will induce infringement of the patent by instructing physicians and patients to use the 10 mg product in a manner that falls within the scope of the patent's claims. (Compl. ¶¶ 162-165).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant Micro Labs’ proposed generic atogepant oral tablets in 10 mg, 30 mg, and 60 mg dosage forms, for which Micro Labs filed Abbreviated New Drug Application (ANDA) No. 220772 with the FDA. (Compl. ¶¶ 1, 56).

Functionality and Market Context

  • The proposed generic products are intended to be pharmaceutically and therapeutically equivalent to Plaintiffs’ commercial product, QULIPTA® Tablets. (Compl. ¶74). QULIPTA® is an oral calcitonin gene-related (CGRP) receptor antagonist approved for the preventive treatment of migraine in adults. (Compl. ¶34). The complaint alleges that upon approval, the labeling for Micro Labs’ generic products will have the same indication and safety information as QULIPTA® and will be prescribed for the same conditions of use. (Compl. ¶66). The complaint notes that QULIPTA® is one of only two orally available CGRP receptor antagonists approved for this indication. (Compl. ¶38).

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 drug claimed in a patent as an act of infringement. The substantive infringement theory is one of induced infringement, alleging the proposed product label will instruct users to perform the patented methods. No probative visual evidence provided in complaint.

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... Defendant’s ANDA seeks approval for atogepant, a drug indicated for the preventive treatment of migraine. ¶¶34, 56 col. 2:3-5
comprising administering to the patient 60 mg atogepant... once daily for more than 12 weeks; Defendant's ANDA seeks approval for a 60 mg dosage form, and the proposed label will allegedly instruct once-daily administration for an ongoing preventive therapy. ¶¶36, 56, 79 col. 5:48-54
wherein administration of atogepant is associated with a reduction in mean monthly migraine days, The purpose of the approved drug is to reduce migraine days, and the proposed product labeling will allegedly describe this clinical outcome. ¶¶34, 66 col. 2:59-62
and wherein administration of atogepant is associated with a reduction from baseline in body weight. The approved QULIPTA® label, which the generic label will allegedly mirror, reports decreases in body weight associated with treatment. ¶37 col. 23:3-10

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... Defendant’s ANDA seeks approval for atogepant, a drug indicated for the preventive treatment of migraine. ¶¶34, 56 col. 3:30-34
undergoing concurrent treatment with a strong CYP3A4 inhibitor, The QULIPTA® label, which the generic label will allegedly mirror, provides specific instructions for this patient sub-population. ¶36 col. 4:8-11
the method comprising orally administering 10 mg atogepant once daily to the patient, The proposed label will allegedly instruct a 10 mg once-daily dose for these patients, and Defendant seeks approval for a 10 mg dosage form. ¶¶36, 56 col. 4:11-14
wherein the patient’s migraines are safely and effectively treated. This is the intended and FDA-approved outcome of following the specific dosing instructions on the allegedly mirrored product label for this patient group. ¶36 col. 4:14-17

Identified Points of Contention

  • Scope Questions: For the ’148 Patent, a central question may be whether the claim limitation "associated with a reduction from baseline in body weight" requires that weight loss be an intended therapeutic purpose of the method. A defendant may argue it only induces the treatment of migraine, and that an observed side effect mentioned on a label does not satisfy this element for inducement.
  • Technical Questions: For the ’259 Patent, infringement is predicated on inducement. A question will be whether the language on the defendant's proposed label rises to the level of actively encouraging or instructing physicians to prescribe the 10 mg dose specifically for patients on strong CYP3A4 inhibitors, as required to prove inducement of the claimed method. The interpretation of the functional outcome "safely and effectively treated" may also become a point of contention.

V. Key Claim Terms for Construction

  • Term from the ’148 Patent: "is associated with a reduction from baseline in body weight"

  • Context and Importance: The construction of this phrase is critical for infringement of the ’148 Patent. If the court construes "is associated with" to require that weight loss is an intended therapeutic outcome of the method, the defendant may have a strong non-infringement argument. If it is construed more broadly to describe a known, inevitable result or characteristic of the administration, Plaintiff's infringement case may be stronger.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim uses the broad phrase "is associated with," which does not explicitly require intent or purpose. The detailed description presents clinical data on weight loss alongside efficacy data, suggesting it is a known characteristic of the method. (’148 Patent, FIG. 19; col. 23:3-10).
    • Evidence for a Narrower Interpretation: The patent’s title, background, and summary sections focus exclusively on the "Treatment of Migraine," suggesting the core invention does not concern weight management. A defendant could argue this context limits the claim scope to methods where migraine is the sole intended target. (’148 Patent, Title; col. 1:22-49).

  • Term from the ’259 Patent: "safely and effectively treated"

  • Context and Importance: This term is a functional limitation defining the required outcome of the method. Its construction will determine the evidentiary burden for proving infringement. Practitioners may focus on this term because its potential ambiguity could be a basis for either non-infringement or invalidity (indefiniteness) arguments.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The complaint links this standard to the FDA's approval of the dosing regimen for this patient subgroup. (Compl. ¶¶36, 38). A party may argue that if a generic product is approved as bioequivalent and its label recommends this use, it is presumed to be safe and effective for that use, thereby meeting the limitation.
    • Evidence for a Narrower Interpretation: The patent itself does not provide a quantitative definition for what constitutes "safely and effectively treated," which could support an argument that the term is indefinite. A party may argue that this limitation requires proof of a specific clinical outcome beyond what can be inferred from a product label alone. (’259 Patent, claim 1).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all patents-in-suit. The basis for inducement is that Defendant, with knowledge of the patents, will sell its generic products with a package insert that instructs and encourages healthcare providers and patients to use the product in accordance with the patented methods. (Compl. ¶¶ 77-80, 105-108, 134-136, 163-165).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it establishes a basis for pre-suit knowledge by citing the Paragraph IV notice letters sent by Defendant to Plaintiff on December 4, 2025, and January 5, 2026, which demonstrate Defendant's awareness of the patents prior to the lawsuit's filing. (Compl. ¶¶ 57, 60, 78). The complaint also requests an award of attorneys' fees for an "exceptional case," a remedy often associated with findings of willfulness or other litigation misconduct. (Request for Relief G).

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

  • A core issue will be one of definitional scope: can the limitation "associated with a reduction from baseline in body weight" in the ’148 Patent be met by a product label that merely notes weight loss as an observed side effect, or must the defendant be shown to induce a method where weight loss is a therapeutic goal?
  • A key evidentiary question will be one of inducement via labeling: assuming the defendant's proposed label mirrors the innovator's label, does the language regarding specific patient populations (e.g., those on CYP3A4 inhibitors) constitute active encouragement sufficient to prove inducement, or is it merely informational?
  • A central legal question will be the construction of functional language: how will the court define the requirement that migraines be "safely and effectively treated" in the context of the ’259 Patent, and what level of proof will be required to demonstrate that the proposed generic product meets this standard when used as instructed?