DCT

3:26-cv-00114

AbbVie Inc v. Hetero USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:26-cv-00114, D.N.J., 01/07/2026
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Hetero USA Inc.'s principal place of business in Piscataway, New Jersey. For the foreign-domiciled Defendant entities, venue is alleged to be proper in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market generic versions of Plaintiffs' QULIPTA® (atogepant) migraine treatment, constitutes an act of patent infringement.
  • Technical Context: The technology relates to methods of using atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of migraine.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 220986 and a Paragraph IV certification, which asserts that the asserted patents are invalid, unenforceable, or will not be infringed. The complaint also notes that the patents-in-suit are the subject of other pending infringement proceedings against different generic manufacturers, suggesting a broader enforcement strategy by the Plaintiffs.

Case Timeline

Date Event
2018-06-08 Earliest Priority Date ('545 Patent)
2020-07-29 Earliest Priority Date ('148 Patent)
2021-09-27 Earliest Priority Date ('259 & '598 Patents)
2021-09-28 FDA Approval of QULIPTA® New Drug Application
2024-09-17 Issue Date (U.S. Patent No. 12,090,148)
2025-07-08 Issue Date (U.S. Patent No. 12,350,259)
2025-08-12 Issue Date (U.S. Patent No. 12,383,545)
2025-11-11 Issue Date (U.S. Patent No. 12,465,598)
2025-11-24 Date of Hetero's Notice Letter to AbbVie
2026-01-07 Complaint Filing Date

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 a need for optimized and targeted oral treatments for the prophylactic (preventive) treatment of migraines, noting that existing CGRP-targeted treatments were limited to injectable monoclonal antibodies (U.S. Patent No. 12090148, col. 1:35-47).
  • The Patented Solution: The invention provides methods for the preventive treatment of migraine by administering a specific once-daily 60 mg dose of the oral CGRP antagonist atogepant. The specification discloses that this specific dosing regimen, administered for more than 12 weeks, is associated not only with a reduction in mean monthly migraine days but also with a reduction in patient body weight ('148 Patent, col. 1:48-2:17, col. 63:49-60). The patent presents clinical trial data, such as that shown in Figure 19, to demonstrate these effects ('148 Patent, col. 4:5-17).
  • Technical Importance: The invention provides a clinically validated oral dosing regimen that offers a more convenient alternative to injectable therapies for the prevention of migraine, a highly prevalent and disabling condition ('148 Patent, col. 1:22-34).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims ('148 Patent, Compl. ¶82). Independent claim 1 is representative of the patent's core method.
  • The essential elements of independent claim 1 are:
    • A method for the preventive treatment of migraine in a patient having migraine headaches;
    • comprising administering to the patient 60 mg atogepant, or a pharmaceutically acceptable salt thereof, 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"*

The Invention Explained

  • Problem Addressed: The patent background acknowledges the need for targeted dosing regimens for oral CGRP treatments, particularly to account for potential drug-drug interactions (DDIs) with other medications a patient may be taking, such as strong inhibitors of the cytochrome P450 3A4 (CYP3A4) enzyme ('259 Patent, col. 1:41-47, col. 4:15-29).
  • The Patented Solution: The invention provides a method for safely and effectively treating migraine in patients who are concurrently taking a strong CYP3A4 inhibitor. The patented solution is a specific dose reduction: administering 10 mg of atogepant once daily to counteract the increased drug exposure caused by the inhibitor, thereby avoiding potential toxicity while maintaining therapeutic effect ('259 Patent, col. 4:34-42).
  • Technical Importance: The invention provides a clinically necessary dosing adjustment for a specific patient sub-population, ensuring the safe use of atogepant in a common scenario of polypharmacy and mitigating the risk of adverse events from DDIs ('259 Patent, col. 4:15-29).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims ('259 Patent, Compl. ¶110). Independent claim 1 is representative.
  • The essential elements of independent claim 1 are:
    • A method for the preventive treatment of migraine in a patient undergoing concurrent treatment with a strong CYP3A4 inhibitor;
    • the method comprising orally administering 10 mg atogepant once daily to the patient;
    • wherein the patient's migraines are safely and effectively treated.

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

  • Technology Synopsis: The patent addresses the need for migraine treatments that are both effective and have a favorable safety profile. The invention covers methods of prophylactically treating migraine by administering specific once-daily doses of atogepant (10 mg, 30 mg, or 60 mg), with the asserted claims noting that the treatment does not significantly affect the patient's liver enzyme levels (U.S. Patent No. 12383545, Abstract; col. 6:40-48).
  • Asserted Claims: The complaint asserts one or more unspecified claims; independent claim 1 is representative.
  • Accused Features: The complaint alleges that Defendants' filing of an ANDA for 10 mg, 30 mg, and 60 mg generic atogepant tablets, which will be administered according to the same label as QULIPTA®, constitutes infringement (Compl. ¶135, 137).

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

  • Technology Synopsis: The patent addresses the need for safe and effective migraine treatments in specific, vulnerable patient populations. The invention provides a method for treating migraine in patients with severe renal impairment or end-stage renal disease, which involves administering a reduced dose of 10 mg of atogepant once daily (U.S. Patent No. 12465598, Abstract; col. 25:62-67).
  • Asserted Claims: The complaint asserts one or more unspecified claims; independent claim 1 is representative.
  • Accused Features: The complaint alleges infringement based on Defendants' ANDA seeking approval for a 10 mg atogepant tablet. The infringement theory relies on the fact that the generic product's label will include instructions for use in this specific patient population, mirroring the approved label for QULIPTA® (Compl. ¶72, 164, 166).

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendants' "atogepant oral tablets, 10 mg, 30 mg, and 60 mg," for which they seek FDA approval under ANDA No. 220986 (Compl. ¶1, 63).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs' QULIPTA® tablets (Compl. ¶1). As part of the ANDA process, Defendants have represented to the FDA that their generic products are "pharmaceutically and therapeutically equivalent" to QULIPTA® (Compl. ¶80). FDA regulations require that the proposed labeling for a generic drug generally mirrors that of the reference listed drug, including indications, dosing, and administration instructions (Compl. ¶72). The complaint alleges that Defendants intend to commercially manufacture and sell these generic products in the United States prior to the expiration of the patents-in-suit (Compl. ¶70).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide claim charts or detailed element-by-element infringement allegations. The infringement theory is predicated on the act of filing the ANDA under 35 U.S.C. § 271(e)(2)(A) and the future, post-approval infringement that will occur when the generic product is marketed with a label instructing infringing uses. The following charts summarize this theory.

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 Defendants' proposed product label will instruct its use for the preventive treatment of migraine, consistent with the QULIPTA® label. ¶72 col. 5:1-17
comprising administering to the patient 60 mg atogepant...once daily for more than 12 weeks Defendants seek approval for a 60 mg atogepant tablet, and the proposed label will instruct once-daily dosing for a prophylactic purpose, which implies long-term use. ¶1, 72 col. 5:47-54
wherein administration...is associated with a reduction in mean monthly migraine days As a therapeutically equivalent product, administration of Defendants' 60 mg tablet is alleged to produce the same clinical efficacy as QULIPTA®, including a reduction in migraine days. ¶80, 108 col. 2:59-62
and wherein administration...is associated with a reduction from baseline in body weight As a bioequivalent product, administration of Defendants' 60 mg tablet is alleged to produce the same clinical outcomes and side effect profile as QULIPTA®, including the patented association with weight reduction. ¶80, 108 col. 63:58-60
  • Identified Points of Contention:
    • Scope Questions: A potential issue may arise from the functional limitation "associated with a reduction from baseline in body weight." The question for the court may be whether this requires proof of weight reduction in an individual patient for direct infringement, or if a statistical association demonstrated in a population (as disclosed in the patent) is sufficient.
    • Technical Questions: The complaint's allegations are based on the legal fiction of infringement under the Hatch-Waxman Act. An evidentiary question for trial would be whether Plaintiffs can demonstrate that administration of Defendants' specific formulation will, in fact, result in the claimed outcomes, particularly the reduction in body weight.

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 undergoing concurrent treatment with a strong CYP3A4 inhibitor Defendants' proposed product label is expected to contain the same instructions as the QULIPTA® label regarding dose adjustments for patients also taking strong CYP3A4 inhibitors. ¶43, 72 col. 4:34-42
the method comprising orally administering 10 mg atogepant once daily to the patient Defendants are seeking approval to market a 10 mg atogepant tablet, and the product label will instruct this specific dosing regimen for the specified patient population. ¶1, 72 col. 4:34-42
wherein the patient's migraines are safely and effectively treated Following the FDA-approved labeling for the bioequivalent product is alleged to result in the claimed safe and effective treatment. ¶72, 80 col. 38:34-35
  • Identified Points of Contention:
    • Scope Questions: The construction of "safely and effectively treated" may be a central dispute. This result-oriented language could be challenged as indefinite, or the parties may dispute the specific clinical metrics required to satisfy the limitation.
    • Technical Questions: Infringement of this claim will likely be asserted under a theory of inducement. A key question will be whether the language in Defendants' proposed label constitutes active encouragement or instruction to doctors and patients to perform the claimed method, thereby meeting the legal standard for inducing infringement.

V. Key Claim Terms for Construction

  • The Term: "associated with a reduction from baseline in body weight" ('148 Patent, Claim 1)

  • Context and Importance: This functional limitation requires a specific clinical outcome. The definition is critical because if it requires a guaranteed result in every patient, it may be difficult to prove infringement. If it only requires a statistical probability based on population data, infringement may be easier to establish.

    • Intrinsic Evidence for a Broader Interpretation: The patent specification repeatedly frames the relationship as a statistical finding from clinical trials, stating, "treatment with atogepant over the 52-week treatment period was associated with weight loss" ('148 Patent, col. 4:15-17). This language may support an interpretation where the association observed in a population is sufficient.
    • Intrinsic Evidence for a Narrower Interpretation: The patent also discloses specific data showing that only a subset of patients experienced weight loss (e.g., Table 38 noting that 4.9% of patients on 60 mg atogepant achieved ≥7% weight loss) ('148 Patent, col. 58:1-25). This could support an argument that the "association" must be proven for the specific act of infringement, not just inferred from population data.

  • The Term: "strong CYP3A4 inhibitor" ('259 Patent, Claim 1)

  • Context and Importance: The scope of this term defines the universe of co-administered drugs that could lead to an act of infringement. A narrow construction would limit the patent's reach, while a broad one would expand it.

    • Intrinsic Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of examples: "a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin)" ('259 Patent, col. 4:39-40). The use of "e.g." suggests the list is illustrative, not limiting, allowing the term to cover any drug understood by a person skilled in the art to be a strong CYP3A4 inhibitor.
    • Intrinsic Evidence for a Narrower Interpretation: A defendant could argue that the term's meaning should be confined to the specific examples disclosed, particularly if the prosecution history contains any statements distinguishing the invention from prior art based on these specific compounds. The claims themselves do not provide a definition.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all patents-in-suit. The basis for inducement is that Defendants' proposed product labeling will instruct and encourage healthcare professionals and patients to administer the generic atogepant tablets in a manner that directly practices the methods claimed in the patents (Compl. ¶84-85, 112-113, 140-141, 169-170).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it establishes a basis for potential enhancement of damages by alleging that Defendants had knowledge of the patents-in-suit, at the latest, upon receipt of the "Hetero's Notice Letter" dated November 24, 2025 (Compl. ¶64, 84).

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

  • A core issue will be one of induced infringement based on labeling: Will the instructions and clinical information in Defendants' proposed product label, which must largely mirror the QULIPTA® label, be found to specifically encourage or direct medical professionals to prescribe the generic product in a way that practices the patented methods for specific patient populations (e.g., those on CYP3A4 inhibitors or with renal impairment)?
  • A key question will be the enforceability of functional claim language: Can Plaintiffs prove that the claimed clinical outcomes, such as being "associated with a reduction from baseline in body weight" ('148 patent) or resulting in migraines being "safely and effectively treated" ('259 patent), are necessary and inevitable results of using Defendants' product, or will these outcome-based limitations be deemed too variable or indefinite to support a finding of infringement?
  • The case may also turn on claim construction: How the court defines key terms such as "strong CYP3A4 inhibitor" and the scope of the various functional limitations will be critical in determining the breadth of the patent claims and whether the use of Defendants' generic product falls within them.