DCT
3:25-cv-18972
AbbVie Inc v. Apotex Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: AbbVie Inc. (Delaware) and Allergan Pharmaceuticals International Limited (Ireland)
- Defendant: Apotex Inc. (Canada)
- Plaintiff’s Counsel: McCARTER & ENGLISH, LLP
- Case Identification: 3:25-cv-18972, D.N.J., 12/23/2025
- Venue Allegations: Plaintiffs allege venue is proper because Defendant is a Canadian corporation that may be sued in any U.S. judicial district and because Defendant has previously availed itself of the District of New Jersey for patent litigation and intends to market and sell its accused generic products in the district.
- Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval to market generic versions of Plaintiffs' QULIPTA® (atogepant) tablets constitutes an act of patent infringement under the Hatch-Waxman Act.
- Technical Context: The technology concerns oral methods for the preventive treatment of migraine using atogepant, a calcitonin gene-related (CGRP) receptor antagonist, which represents a significant therapeutic option in a large market.
- Key Procedural History: The lawsuit was triggered by a notice letter from Apotex dated November 12, 2025, which included a Paragraph IV certification alleging that claims of three of the four patents-in-suit are invalid, unenforceable, and/or will not be infringed by its proposed generic product. The complaint was filed within the 45-day window provided by the Hatch-Waxman Act, which triggers an automatic 30-month stay of FDA approval for Apotex's ANDA.
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 |
| 2021-09-27 | U.S. Patent No. 12,465,598 Priority Date |
| 2021-09-28 | FDA Approval for QULIPTA® (NDA No. 215206) |
| 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 |
| 2025-11-12 | Plaintiffs Receive Apotex's Notice Letter |
| 2025-12-23 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,090,148 - "Treatment of Migraine"
- Issued: September 17, 2024
The Invention Explained
- Problem Addressed: The patent background describes a "treatment gap" and an unmet need for optimized and targeted oral CGRP treatments to prophylactically treat migraines, as existing CGRP-targeted therapies were limited to injectables. (ʼ148 Patent, col. 1:41-48).
- The Patented Solution: The invention provides methods for the preventive treatment of migraine by orally administering a specific daily dose of atogepant (10 mg, 30 mg, or 60 mg), which is claimed to result in specific, measurable clinical benefits, such as a reduction in the number of monthly migraine days and, in some claims, an associated reduction in patient body weight. (ʼ148 Patent, Abstract; col. 2:1-17).
- Technical Importance: The invention provided an oral dosing regimen for a CGRP antagonist for the preventive treatment of migraine, distinguishing it from prior oral CGRP treatments approved only for acute treatment. (ʼ148 Patent, col. 1:41-44).
Key Claims at a Glance
- The complaint does not identify specific asserted claims, but Claim 1 is the first independent claim.
- Key elements of independent Claim 1 include:
- A method for the preventive treatment of migraine in a patient having migraine headaches.
- The method comprises administering to the patient 60 mg atogepant, or a pharmaceutically acceptable salt thereof, once daily for more than 12 weeks.
- Wherein administration is associated with a reduction in mean monthly migraine days.
- Wherein administration is associated with a reduction from baseline in body weight.
- The complaint does not explicitly reserve the right to assert dependent claims but makes general allegations against the patent as a whole (Compl. ¶¶ 68, 81).
U.S. Patent No. 12,350,259 - "Methods of Treating Migraine"
- Issued: July 8, 2025
The Invention Explained
- Problem Addressed: The patent addresses the need for safe and effective migraine treatment regimens for patients who are concurrently taking other medications that may interact with the migraine treatment, specifically strong inhibitors of the CYP3A4 enzyme, which is a primary metabolic pathway for atogepant. (ʼ259 Patent, col. 3:15-29).
- The Patented Solution: The invention provides a method for preventively treating migraine in patients who are also undergoing treatment with a strong CYP3A4 inhibitor. The solution is to administer a reduced dose of 10 mg of atogepant once daily, which the patent teaches is a safe and effective dose for this specific patient population. (ʼ259 Patent, Abstract; col. 4:35-42).
- Technical Importance: This invention provides a specific dosing instruction to manage a significant drug-drug interaction, allowing a vulnerable patient population to use atogepant safely and effectively for migraine prevention. (ʼ259 Patent, col. 4:30-42).
Key Claims at a Glance
- The complaint does not identify specific asserted claims, but Claim 1 is the first independent claim.
- Key elements of independent Claim 1 include:
- A method for the preventive treatment of migraine in a patient undergoing concurrent treatment with a strong CYP3A4 inhibitor.
- The method comprises orally administering 10 mg atogepant, or a pharmaceutically acceptable salt thereof, 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 general allegations against the patent as a whole (Compl. ¶¶ 96, 109).
U.S. Patent No. 12,383,545 - "Treatment of Migraine"
- Issued: August 12, 2025
- Technology Synopsis: The patent claims methods for prophylactically treating migraine by administering specific once-daily doses of atogepant (10 mg, 30 mg, or 60 mg) for a period of time, where the treatment results in a high degree of efficacy, specifically achieving at least a 75% or 100% reduction in monthly migraine days. (’545 Patent, Abstract; Claims 1, 10).
- Asserted Claims: The complaint does not specify asserted claims. Independent claims include 1 and 10.
- Accused Features: The accused features are Apotex's proposed instructions for use on its generic label, which will allegedly direct healthcare providers and patients to use the generic product in a way that meets the claimed dosage and efficacy limitations. (Compl. ¶¶ 125-127).
U.S. Patent No. 12,465,598 - "Methods of Treating Migraine"
- Issued: November 11, 2025
- Technology Synopsis: This patent addresses another drug-drug interaction scenario. It claims methods for preventively treating migraine in patients who are concurrently taking a moderate or strong inducer of the CYP3A4 enzyme, teaching the administration of an increased dose of atogepant (30 mg or 60 mg once daily) to maintain efficacy. (’598 Patent, Abstract; Claims 1, 3).
- Asserted Claims: The complaint does not specify asserted claims. Independent claims include 1 and 3.
- Accused Features: The accused features are the proposed label instructions for Apotex's generic product, which will allegedly describe the drug-drug interaction with CYP3A4 inducers and instruct for the claimed increased dosage, thereby inducing infringement. (Compl. ¶¶ 154-156).
III. The Accused Instrumentality
Product Identification
Apotex's generic atogepant oral tablets in 10 mg, 30 mg, and 60 mg dosage forms, for which Apotex submitted ANDA No. 220979 to the FDA for marketing approval. (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that Apotex's generic products are pharmaceutically and therapeutically equivalent to AbbVie's QULIPTA® Tablets. (Compl. ¶66). As such, they contain the same active ingredient, atogepant, and are intended for the same use: the preventive treatment of migraine in adults. (Compl. ¶¶ 27, 49).
- To gain FDA approval, Apotex's proposed product label must prescribe, recommend, or suggest the same conditions of use as the approved label for QULIPTA®. (Compl. ¶58). This includes instructions regarding dosing for specific patient populations, such as those taking interacting drugs, which are central to the patents-in-suit. The product is positioned to be a lower-cost generic alternative to QULIPTA®. (Compl. ¶9).
IV. Analysis of Infringement Allegations
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... | Apotex's proposed label will instruct use for the preventive treatment of migraine. | ¶¶ 58, 69 | col. 1:41-44 |
| ...comprising administering to the patient 60 mg atogepant... once daily for more than 12 weeks... | Apotex's proposed label will instruct patients and physicians to administer a 60 mg once-daily dose of atogepant. | ¶¶ 29, 58 | col. 5:54-56 |
| ...wherein administration...is associated with a reduction in mean monthly migraine days... | Apotex's proposed label will state that administration of the product leads to a reduction in mean monthly migraine days, mirroring the approved label for QULIPTA®. | ¶¶ 58, 66 | col. 2:1-4 |
| ...and wherein administration...is associated with a reduction from baseline in body weight. | Apotex's proposed label, to be identical to the QULIPTA® label, will include information regarding decreases in body weight observed in clinical trials. | ¶¶ 30, 58 | col. 3:15-19 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the phrase "associated with a reduction from baseline in body weight" requires that every patient experience weight loss, or if it is satisfied by the product label merely noting that weight loss was an observed outcome in a clinical trial population.
- Technical Questions: Does the scope of "preventive treatment of migraine" as defined in the patent's specification impose limitations beyond what is described on the FDA-approved label for QULIPTA®?
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... | Apotex's proposed label will instruct use for the preventive treatment of migraine. | ¶¶ 58, 97 | col. 1:21-23 |
| ...in a patient undergoing concurrent treatment with a strong CYP3A4 inhibitor... | Apotex's proposed label will include instructions for dosing patients who are concomitantly using strong CYP3A4 inhibitors. | ¶¶ 29, 99 | col. 3:15-20 |
| ...the method comprising orally administering 10 mg atogepant... once daily to the patient... | Apotex's proposed label will specifically instruct a 10 mg once-daily dose for this patient sub-population. | ¶¶ 29, 99 | col. 4:35-42 |
| ...wherein the patient's migraines are safely and effectively treated. | Apotex has represented to the FDA that its product is therapeutically equivalent to QULIPTA®, and its label will reflect the FDA's finding that this dosing regimen is safe and effective. | ¶¶ 66, 94 | col. 2:50-57 |
- Identified Points of Contention:
- Scope Questions: The case may turn on the construction of "safely and effectively treated." Does this term import a specific quantitative efficacy threshold from the patent's clinical trial data, or is it met by the FDA's general approval of the dosing regimen as safe and effective?
- Technical Questions: What evidence will be required to establish that the instructions on Apotex's proposed label will inevitably lead physicians to prescribe, and patients to take, the drug in a manner that constitutes "concurrent treatment" as required by the claim?
V. Key Claim Terms for Construction
Term: "associated with a reduction from baseline in body weight" (’148 Patent, Claim 1)
- Context and Importance: This limitation distinguishes Claim 1 from other claims directed purely to migraine reduction. Its construction is critical because it adds a required clinical outcome beyond the primary indication. Practitioners may focus on this term because Apotex could argue that this is a therapeutic outcome that is not guaranteed for every patient, and thus a physician following the label does not necessarily perform the claimed method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses clinical trial results where atogepant treatment was "associated with weight loss" in the trial population as a whole, which may support an interpretation that the claim is satisfied if the drug is merely known to have this association, as would be stated on the product label. (ʼ148 Patent, col. 3:15-19).
- Evidence for a Narrower Interpretation: The detailed description links specific dosages to specific percentages of patients experiencing weight decrease (e.g., "5.3% for QULIPTA 60 mg"). (ʼ148 Patent, col. 57:31-35, referencing Compl. ¶30). This could support an argument that the term requires a specific, statistically significant level of weight loss association, not just any incidental reduction.
Term: "safely and effectively treated" (’259 Patent, Claim 1)
- Context and Importance: This term defines the required outcome of the claimed method. Its construction is central to determining the standard of efficacy required for infringement. Practitioners may focus on this term because its potential ambiguity allows for arguments about whether the standard is met simply by FDA approval or if it requires a higher, patent-defined threshold of effectiveness that may not be met in all patients.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract states the disclosure "provides methods for the treatment of migraine," which could support a broad interpretation that any FDA-approved safe and effective treatment regimen meets the claim limitation. (ʼ259 Patent, Abstract). The term itself is general and does not contain a quantitative metric.
- Evidence for a Narrower Interpretation: The detailed description of the invention and the associated clinical trial data provide specific quantitative results for efficacy, such as the reduction in mean monthly migraine days. (ʼ259 Patent, col. 29:1-62). A party could argue that "effectively treated" must be interpreted in light of these specific results, imposing a higher standard than mere FDA approval.
VI. Other Allegations
Indirect Infringement
The complaint alleges that Apotex will induce infringement by others under 35 U.S.C. § 271(b). (Compl. ¶¶ 68, 96, 124, 153). The basis for this allegation is that Apotex's proposed product label and promotional activities will instruct and encourage healthcare professionals and patients to administer the generic atogepant tablets in accordance with the patented methods. (Compl. ¶¶ 71, 99, 127, 156). The complaint alleges Apotex has knowledge of the patents, as evidenced by its notice letter. (Compl. ¶70).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of definitional scope: How will the court construe outcome-based limitations such as "associated with a reduction from baseline in body weight" and "safely and effectively treated"? The degree to which these terms are limited to the specific quantitative results disclosed in the patents' clinical trial data, versus being satisfied by the general findings of safety and efficacy in the FDA-approved label, will be critical.
- A key legal and factual question will be one of infringement via labeling: Assuming the patents are valid, do the instructions and clinical information on the FDA-approved QULIPTA® label—which Apotex's generic label must mirror—directly map onto all limitations of the asserted claims as construed by the court? The dispute will likely focus on whether the label necessarily directs users to perform the patented methods.
- An underlying issue, though not directly addressed in the infringement analysis, will be one of patentability: In response to the complaint, Defendant is expected to challenge the validity of the method-of-use claims, potentially arguing they are invalid as obvious based on prior knowledge of atogepant's primary effects or as lacking written description for the specific patient populations and outcomes claimed.