DCT
3:26-cv-11156
AbbVie Inc v. Macleods Pharma Ltd
Key Events
Complaint
Table of Contents
complaint Intelligence
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: 3:26-cv-11156, D.N.J., 08/28/2026
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Macleods USA has a principal place of business in the district, and Defendant Macleods Ltd. is an alien corporation that may be sued 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 infringement of two patents covering specific methods of treating migraine.
- Technical Context: The technology relates to dosing regimens for atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist used for the preventive treatment of migraine, a common and debilitating neurological condition.
- Key Procedural History: This action is filed under the Hatch-Waxman Act following Defendants' submission of ANDA No. 220982 and notice letters asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed. The complaint notes that a prior lawsuit ("First Suit") was filed between the same parties concerning other patents listed in the FDA's Orange Book for QULIPTA®.
Case Timeline
| Date | Event |
|---|---|
| 2021-09-27 | Priority Date for '897 and '341 Patents |
| 2021-09-28 | FDA approves AbbVie's New Drug Application for QULIPTA® |
| 2025-11-15 | Macleods sends First Notice Letter regarding other patents |
| 2025-12-29 | Plaintiffs file "First Suit" against Macleods |
| 2026-02-27 | Macleods sends Second Notice Letter regarding another patent |
| 2026-05-12 | U.S. Patent No. 12,622,897 issues |
| 2026-06-23 | U.S. Patent No. 12,661,341 issues |
| 2026-07-15 | Macleods sends Third Notice Letter regarding the '897 patent |
| 2026-08-28 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,622,897 - "Methods of Treating Migraine"
- Patent Identification: U.S. Patent No. 12,622,897, titled "Methods of Treating Migraine," issued May 12, 2026 Compl. ¶43
The Invention Explained
- Problem Addressed: The patent addresses the need for effective preventive treatments for migraine, a highly prevalent and disabling neurological condition for which existing therapies have limitations '897 Patent, col. 1:25-45
- The Patented Solution: The invention provides specific methods for the preventive treatment of migraine using atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The patent specifically claims dosing regimens for patients who are concurrently taking other drugs known as OATP inhibitors, which can alter the body's processing of atogepant and lead to potentially significant drug-drug interactions '897 Patent, col. 2:57-62 '897 Patent, col. 4:11-17 The claimed methods aim to ensure atogepant remains safe and effective in this specific patient subpopulation.
- Technical Importance: By defining specific dosage adjustments for patients on interacting medications, the invention enables the safe and effective prophylactic use of atogepant in a broader patient population that might otherwise be at risk for adverse effects from drug-drug interactions.
Key Claims at a Glance
- The complaint alleges infringement of one or more unspecified claims of the '897 patent Compl. ¶71 The patent contains one independent claim.
- Independent Claim 1 recites:
- A method for the preventive treatment of migraine in a patient;
- wherein the patient is undergoing concurrent treatment with an OATP inhibitor;
- the method comprising orally administering a therapeutically effective dose of 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 this is standard practice.
U.S. Patent No. 12,661,341 - "Methods of Treating Migraine"
- Patent Identification: U.S. Patent No. 12,661,341, titled "Methods of Treating Migraine," issued June 23, 2026 Compl. ¶47
The Invention Explained
- Problem Addressed: Similar to the '897 patent, the invention addresses the need for safe and effective migraine prophylaxis, but focuses on the specific patient population of individuals with liver disease '341 Patent, col. 1:30-40
- The Patented Solution: The patent claims methods for preventively treating migraine in patients who have mild or moderate hepatic impairment. It specifies administering a once-daily oral dose of atogepant selected from 10 mg, 30 mg, or 60 mg, based on pharmacokinetic data for this vulnerable population '341 Patent, abstract '341 Patent, col. 1:62-65
- Technical Importance: The invention provides a defined, evidence-based dosing strategy that allows atogepant to be used for migraine prevention in patients with compromised liver function, a group for whom drug safety and metabolism are significant concerns.
Key Claims at a Glance
- The complaint alleges infringement of one or more unspecified claims of the '341 patent Compl. ¶100 The patent contains one independent claim.
- Independent Claim 1 recites:
- A method for the preventive treatment of migraine in a patient having mild or moderate hepatic impairment;
- the method comprising orally administering a dose selected from the group consisting of 10 mg, 30 mg, and 60 mg atogepant once daily to the patient.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The accused products are Defendants' proposed generic versions of QULIPTA® (atogepant) oral tablets, in 10 mg, 30 mg, and 60 mg dosage forms, for which Defendants filed ANDA No. 220982 with the FDA Compl. ¶2 Compl. ¶51
Functionality and Market Context
The complaint alleges that the accused generic products are intended for the preventive treatment of migraine in adults Compl. ¶38 As a generic, the product is alleged to be pharmaceutically and therapeutically equivalent to the brand-name drug QULIPTA® Compl. ¶69 Compl. ¶98 The complaint further alleges that Defendants' purpose in filing the ANDA is to market these generic products in the United States before the expiration of the patents-in-suit Compl. ¶60
IV. Analysis of Infringement Allegations
The complaint alleges that the act of filing the ANDA is an act of infringement under 35 U.S.C. § 271(e)(2)(A), and that future commercialization will induce infringement of the patented methods. The core theory is that the label for the accused generic products will instruct or encourage medical professionals and patients to use the drug in a manner that infringes the asserted method claims. Figure 5A of the '897 patent, attached to the complaint as Exhibit A, graphically depicts pharmacokinetic data comparing atogepant plasma concentrations over time in patients with varying degrees of hepatic impairment versus those with normal hepatic function '897 Patent, Fig. 5A This data provides a scientific basis for the specific dosing regimens claimed in the '341 Patent.
12,622,897 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 | Macleods' proposed generic product is for the preventive treatment of migraine, and its proposed labeling will allegedly state this indication. | ¶38; ¶62 | col. 2:62-65 |
| wherein the patient is undergoing concurrent treatment with an OATP inhibitor | The proposed generic product's label is expected to mirror the QULIPTA® label, which allegedly provides a recommended dosage for patients concomitantly using OATP inhibitors. | ¶40; ¶41 | col. 2:57-62 |
| the method comprising orally administering a therapeutically effective dose of 10 mg atogepant once daily to the patient | Macleods' ANDA seeks approval for a 10 mg dosage form, and the proposed label will allegedly instruct its once-daily administration for the patient population specified in the claim. | ¶40; ¶51 | col. 2:50-52 |
| wherein the patient's migraines are safely and effectively treated. | This element describes the result of practicing the method. The complaint alleges the proposed label will represent the product as safe and effective for its indicated use. | ¶62 | col. 43:66-67 |
12,661,341 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for the preventive treatment of migraine | Macleods' proposed generic product is for the preventive treatment of migraine, and its proposed labeling will allegedly state this indication. | ¶38; ¶62 | col. 1:30-31 |
| in a patient having mild or moderate hepatic impairment | The proposed generic product's label is expected to mirror the QULIPTA® label, which allegedly provides a specific dosing regimen for patients with mild or moderate hepatic impairment. | ¶40 | col. 1:62-65 |
| the method comprising orally administering a dose selected from the group consisting of 10 mg, 30 mg, and 60 mg atogepant once daily to the patient. | Macleods' ANDA seeks approval for 10 mg, 30 mg, and 60 mg dosage forms, and its proposed label will allegedly instruct their once-daily use in the specified patient population. | ¶40; ¶51 | col. 1:62-65 |
Identified Points of Contention
- Scope Questions: A primary issue will be whether the final, FDA-approved labeling for Macleods' generic products will contain instructions or recommendations that actively encourage or instruct physicians to prescribe the drug in the specific manner claimed by the patents-namely, for patients on concurrent OATP inhibitors ('897 patent) or for patients with mild to moderate hepatic impairment ('341 patent). The infringement analysis will turn on the precise language of the generic drug's label.
- Technical Questions: The patents claim methods of use based on pharmacokinetic data in specific populations. A potential defense could challenge the validity of these claims, for instance by arguing that such dosage adjustments would have been obvious to a person of ordinary skill in the art through routine clinical study, raising the question of the inventive step embodied in the claimed methods.
V. Key Claim Terms for Construction
Term: "concurrent treatment with an OATP inhibitor" ('897 Patent, Claim 1)
- Context and Importance: This term defines the specific circumstance under which the claimed 10 mg dosing method is performed. The scope of what constitutes "concurrent treatment" (e.g., timing) and which substances qualify as an "OATP inhibitor" will be central to determining infringement. Practitioners may focus on this term because the infringement case depends on Macleods' label inducing this specific concomitant use.
- Intrinsic Evidence for a Broader Interpretation: The specification uses the term "concomitantly" and provides examples of OATP inhibitors, but does not appear to limit the term to only those examples, suggesting a potentially broad scope covering the general class of such drugs '897 Patent, col. 4:11-12 '897 Patent, col. 6:45-50
- Intrinsic Evidence for a Narrower Interpretation: A party might argue that the term should be limited by the specific examples disclosed or by the understanding of what constituted a clinically significant OATP inhibitor at the time of the invention. However, the specification lacks explicit language that would mandate such a narrow construction.
Term: "mild or moderate hepatic impairment" ('341 Patent, Claim 1)
- Context and Importance: This term defines the patient population for the entire method claimed in the '341 patent. Its definition is therefore critical to both infringement and validity analyses.
- Intrinsic Evidence for Interpretation: The shared specification of the patents-in-suit provides a clear and specific definition by referencing an established clinical standard: "In embodiments, mild hepatic impairment refers to Child-Pugh Class A; moderate hepatic impairment refers to Child-Pugh Class B" '897 Patent, col. 9:5-9 This reference to the Child-Pugh score may substantially limit the scope of potential claim construction disputes, grounding the term in an objective, external standard well-known in the relevant medical field.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis for this allegation is that Defendants' proposed product labeling will instruct and encourage healthcare professionals to prescribe, and patients to use, the generic atogepant products in a manner that directly infringes the patented methods Compl. ¶74 Compl. ¶103
- Willful Infringement: The complaint does not include a formal count for willful infringement. However, it alleges Defendants had knowledge of the '897 patent via a notice letter and knowledge of the '341 patent via the filing of the complaint itself Compl. ¶73 Compl. ¶96 Plaintiffs request a finding that the case is "exceptional" and an award of attorney fees under 35 U.S.C. § 285, which is often associated with allegations of willful infringement or other litigation misconduct Compl., Request for Relief G
VII. Analyst's Conclusion: Key Questions for the Case
- A central question of induced infringement: Will the final, FDA-approved label for Macleods' generic atogepant include specific instructions or dosage recommendations for patients with hepatic impairment or for those concurrently taking OATP inhibitors? The case for induced infringement will likely depend on whether this label language actively encourages or is "substantially for no other purpose" than the infringing uses claimed in the '897 and '341 patents.
- A fundamental question of patent validity: Can AbbVie and Allergan defend the non-obviousness of the claimed methods? A key issue for the court will be to determine whether establishing specific dosing regimens for known patient subpopulations (those with hepatic impairment or those taking interacting drugs) through standard pharmacokinetic studies constitutes an inventive step, or if it represents a routine and therefore obvious optimization to a person of ordinary skill in the art at the time of the invention.
Analysis metadata