DCT
3:25-cv-19038
AbbVie Inc v. Macleods Pharmaceutical Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: AbbVie Inc. (Delaware) and Allergan Pharmaceuticals International Limited (Ireland)
- Defendant: Macleods Pharmaceuticals Ltd. (India) and Macleods Pharma USA, Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 3:25-cv-19038, D.N.J., 12/29/2025
- Venue Allegations: Venue is based on Defendant Macleods Pharma USA, Inc. having its principal place of business in New Jersey, and Defendant Macleods Pharmaceuticals Ltd. being a foreign corporation subject to suit in any 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 patent infringement.
- Technical Context: The technology relates to methods for the preventive treatment of migraine using atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist.
- Key Procedural History: The complaint notes that the patents-in-suit are also the subject of a separate proceeding before the same court in AbbVie Inc v. Apotex Inc, Civil Action No.: 25-18972, though the defendants in this matter are not involved in that case.
Case Timeline
| Date | Event |
|---|---|
| 2018-06-08 | Earliest Priority Date for ’545 Patent |
| 2020-07-29 | Earliest Priority Date for ’148 Patent |
| 2021-09-27 | Earliest Priority Date for ’259 and ’598 Patents |
| 2021-09-28 | FDA approves NDA for QULIPTA® (atogepant) tablets |
| 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 |
| 2025-11-15 | Date of Macleods' Notice Letter received by AbbVie |
| 2025-12-29 | 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: The patent background identifies a need for optimized and targeted oral treatments to prophylactically treat migraines, noting that currently available CGRP-targeted preventive treatments are limited to injectable monoclonal antibodies (’148 Patent, col. 1:40-48).
- The Patented Solution: The invention provides a method for the preventive treatment of migraine by orally administering a specific daily dose (e.g., 60 mg) of atogepant. The patent claims that this treatment regimen results in specific clinical outcomes, including not only a reduction in mean monthly migraine days but also an associated reduction from baseline in body weight (’148 Patent, col. 2:5-16, claim 1). Figures 19-24 graphically depict clinical trial data related to changes in body weight over time for patients treated with atogepant (’148 Patent, col. 2:5-16).
- Technical Importance: The invention provides an oral, small-molecule CGRP-targeted therapy for migraine prevention, offering a different mode of administration from existing injectable antibody treatments and claiming a specific secondary clinical outcome related to body weight (’148 Patent, col. 1:40-48).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims; Claim 1 is the sole independent claim.
- Claim 1 requires:
- A method for the preventive treatment of migraine in a patient having migraine headaches.
- Administering to the patient 60 mg atogepant, or a pharmaceutically acceptable salt thereof, once daily for more than 12 weeks.
- Wherein administration of atogepant is associated with a reduction in mean monthly migraine days.
- And wherein administration of atogepant is associated with a reduction from baseline in body weight.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against the patent.
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 specific dosing regimens for atogepant when used concurrently with other drugs that may affect its metabolism, specifically strong inhibitors of the enzyme CYP3A4 (’259 Patent, col. 3:15-29). Co-administration can significantly increase exposure to atogepant, raising potential safety or tolerability issues.
- The Patented Solution: The invention provides a method for preventively treating migraine in patients who are also undergoing concurrent treatment with a strong CYP3A4 inhibitor. The patented solution is to administer a reduced dose of 10 mg of atogepant once daily, ensuring the patient's migraines are treated safely and effectively despite the drug interaction (’259 Patent, col. 4:35-42, claim 1).
- Technical Importance: This method provides a specific, clinically tested dosing instruction that allows patients to continue using atogepant for migraine prevention even while taking other necessary medications known to be strong CYP3A4 inhibitors, thereby managing a significant drug-drug interaction risk (’259 Patent, col. 3:15-29).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims; Claim 1 is an independent claim.
- Claim 1 requires:
- 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.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against the patent.
Multi-Patent Capsule: U.S. Patent No. 12,383,545
- Patent Identification: U.S. Patent No. 12,383,545, "Treatment of Migraine," issued Aug. 12, 2025.
- Technology Synopsis: The patent describes methods for the prophylactic treatment of migraine by administering atogepant once daily in specific doses (10 mg, 30 mg, or 60 mg). The claims cover the administration of these doses to achieve specific clinical outcomes, such as a reduction in mean monthly migraine days or headache days (’545 Patent, Abstract; claim 1).
- Asserted Claims: The complaint asserts one or more claims; Claim 1 is an independent claim.
- Accused Features: The complaint alleges that Defendants' proposed generic atogepant product, intended to be administered for migraine prevention, will infringe the claimed methods (Compl. ¶¶ 129, 131).
Multi-Patent Capsule: U.S. Patent No. 12,465,598
- Patent Identification: U.S. Patent No. 12,465,598, "Methods of Treating Migraine," issued Nov. 11, 2025.
- Technology Synopsis: The patent addresses the need for specific dosing regimens for atogepant when used concurrently with drugs that are moderate or strong inducers of the CYP3A4 enzyme. The invention claims a method of administering a 30 mg or 60 mg once-daily dose of atogepant to patients undergoing such concurrent treatment (’598 Patent, Abstract; claim 1).
- Asserted Claims: The complaint asserts one or more claims; Claim 1 is an independent claim.
- Accused Features: The complaint alleges that Defendants' proposed generic atogepant product, whose label will presumably contain instructions for this patient sub-population, will infringe the claimed methods (Compl. ¶¶ 158, 160).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants' proposed generic atogepant oral tablets in 10 mg, 30 mg, and 60 mg dosage forms, for which Defendants filed ANDA No. 220982 with the FDA (Compl. ¶¶ 1-2, 57).
Functionality and Market Context
The complaint alleges that Defendants' generic products contain atogepant as the active ingredient and are designed to be pharmaceutically and therapeutically equivalent to Plaintiffs' branded QULIPTA® tablets (Compl. ¶¶ 57, 74). As this is an ANDA case, the infringement allegation is predicated on the act of filing the ANDA to seek approval for a generic drug that, if commercially launched, would be used in a manner that infringes the patents-in-suit (Compl. ¶ 75). The proposed labeling for the generic products is alleged to prescribe, recommend, or suggest conditions of use that fall within the scope of the patents-in-suit (Compl. ¶¶ 66, 79). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’148 Patent 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, the method comprising administering to the patient 60 mg atogepant... once daily for more than 12 weeks; | Defendants' ANDA seeks approval to market a 60 mg atogepant tablet that is bioequivalent to QULIPTA®, which is approved for the preventive treatment of migraine. The proposed label will allegedly instruct once-daily administration. | ¶¶ 57, 66, 74 | col. 6:49-54 |
| wherein administration of atogepant is associated with a reduction in mean monthly migraine days, | The proposed generic product is therapeutically equivalent to QULIPTA®, for which this clinical outcome is an established basis for its FDA approval and is described on its label. | ¶¶ 65, 66, 74 | col. 64:12-16 |
| and wherein administration of atogepant is associated with a reduction from baseline in body weight. | The proposed generic label will allegedly contain the same safety and efficacy information as the QULIPTA® label, which includes data showing this clinical outcome. | ¶¶ 38, 66 | col. 64:17-19 |
- Identified Points of Contention:
- Scope Questions: A central question may be the interpretation of the limitation "associated with a reduction from baseline in body weight." The parties may dispute whether this functional language requires a guaranteed outcome for every patient or merely describes a statistically significant outcome observed in a patient population, and what evidence is required from an ANDA filer to meet or avoid this limitation.
- Technical Questions: An evidentiary question may arise as to what the final approved label for Defendants' generic product will state regarding clinical outcomes, including body weight reduction. Infringement will depend on whether the label instructs, encourages, or describes a use that meets all limitations of the asserted claim.
’259 Patent 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, | The proposed generic product is allegedly therapeutically equivalent to QULIPTA®, whose FDA-approved label includes instructions for this specific patient sub-population. | ¶¶ 37, 39, 66 | col. 4:35-42 |
| the method comprising orally administering 10 mg atogepant once daily to the patient, | Defendants' ANDA seeks approval for a 10 mg atogepant tablet. The proposed label will allegedly instruct or recommend this specific dosage for patients concurrently taking strong CYP3A4 inhibitors. | ¶¶ 57, 66, 79 | col. 4:38-40 |
| wherein the patient's migraines are safely and effectively treated. | As the proposed generic product must be bioequivalent to the reference listed drug to gain approval, it is presumed to be safe and effective when used according to the approved labeling. | ¶¶ 65, 66, 74 | col. 4:41-42 |
- Identified Points of Contention:
- Scope Questions: The definition of "strong CYP3A4 inhibitor" may be a point of construction. While the QULIPTA® label provides examples, the parties could dispute whether the term is limited to those examples or has a broader, functional definition based on pharmacological properties.
- Technical Questions: The primary question will be whether the language in Defendants' proposed label for its 10 mg product actively induces infringement. The analysis will focus on whether the label instructs, encourages, or merely informs physicians that this dosage should be used in patients taking strong CYP3A4 inhibitors.
V. Key Claim Terms for Construction
For the ’148 Patent
- The Term: "associated with a reduction from baseline in body weight"
- Context and Importance: This functional limitation is a key element distinguishing the claimed method. Its construction will determine whether infringement requires proof that the generic product will cause weight loss in any particular patient, or if it is sufficient that the product's approved use is for a therapy that has this characteristic in a patient population.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of "associated with" suggests a correlational link rather than a guaranteed outcome in every individual. The specification's reliance on clinical trial population data to describe this effect may support an interpretation where the association is established on a population level (’148 Patent, col. 47:5-15; FIG. 19).
- Evidence for a Narrower Interpretation: Defendants may argue this language requires the "reduction from baseline in body weight" to be a direct and intended therapeutic outcome of the administration step for the method to be practiced, potentially requiring a higher standard of proof.
For the ’259 Patent
- The Term: "concurrent treatment"
- Context and Importance: The definition of this term is critical for determining when the claimed method is practiced. It dictates the timing and relationship between the administration of atogepant and the strong CYP3A4 inhibitor.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification uses the term "concomitantly," which it defines broadly to include administration "at the same time" or "at different times but within the course of a common treatment schedule," supporting a flexible interpretation that does not require simultaneous administration (’259 Patent, col. 4:10-15).
- Evidence for a Narrower Interpretation: A defendant could argue that "concurrent" implies a more immediate temporal relationship, potentially limiting the claim's scope to situations where the two drugs are taken within a narrower time window, though the specification's express definition may make this a difficult position to sustain.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b) for all patents-in-suit. The allegations are based on the assertion that Defendants' promotional activities and proposed package inserts will instruct and encourage healthcare providers and patients to use the generic products in a manner that directly infringes the claimed methods (Compl. ¶¶ 77-79, 105-107, 133-135, 162-164).
- Willful Infringement: The complaint does not contain a separate count for willful infringement. However, it alleges that Defendants had knowledge of the patents-in-suit, at a minimum, as a result of sending the Paragraph IV Notice Letter to Plaintiffs, which forms a basis for a potential willfulness claim based on post-notice conduct (Compl. ¶¶ 58, 78, 106, 134, 163).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of inducement and labeling: Will the language in Macleods' final, FDA-approved label be found to actively encourage or instruct physicians and patients to perform the patented methods, particularly for the specific patient sub-populations claimed in the ’259 and ’598 Patents (those on CYP3A4 inhibitors or inducers), or will it merely provide information without rising to the level of inducement?
- A key question of claim scope will concern the functional limitations in the ’148 Patent. Can infringement be established based on the reference drug's known clinical profile (including body weight reduction), which the generic must match for bioequivalence, or will a more direct evidentiary showing related to the generic product itself be required to prove the claimed "association"?
- An underlying validity challenge is noted, as Macleods' Notice Letter alleges the patents are "invalid, unenforceable, and/or will not be infringed" (Compl. ¶ 59). While not detailed in the complaint, the litigation will almost certainly involve Defendants asserting invalidity defenses based on prior art or other statutory requirements, turning the focus to the novelty and non-obviousness of the claimed methods of treatment.