DCT

3:24-cv-04603

AbbVie Inc v. Zydus Pharma USA Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-04603, D.N.J., 11/26/2025
  • Venue Allegations: Venue is alleged as proper in the District of New Jersey because Defendant Zydus Pharmaceuticals is incorporated in and has its principal place of business in New Jersey, and Defendant Zydus Lifesciences is incorporated in India and may be sued in any U.S. judicial district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiffs' UBRELVY® (ubrogepant) tablets constitutes infringement of twelve patents related to pharmaceutical formulations and methods of treating migraine.
  • Technical Context: The technology concerns ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine, a debilitating neurological condition impacting over 37 million people in the United States.
  • Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiffs received a series of notice letters from Zydus regarding its ANDA No. 218662. These letters included Paragraph IV certifications alleging that claims of the asserted patents are invalid, unenforceable, and/or will not be infringed by Zydus's proposed generic products.

Case Timeline

Date Event
2014-02-05 Priority Date for '836, '709, '004, '408, '953, '632, and '633 Patents
2018-11-06 U.S. Patent No. 10,117,836 Issued
2019-12-23 FDA Approval of UBRELVY® NDA No. 211765
2020-12-22 Priority Date for '515, '542, '450, '030, and '750 Patents
2023-08-08 U.S. Patent No. 11,717,515 Issued
2024-01-02 U.S. Patent No. 11,857,542 Issued
2024-02-20 Zydus's Notice Letter I received by AbbVie
2024-03-12 U.S. Patent No. 11,925,709 Issued
2024-05-23 Zydus's Notice Letter II received by AbbVie
2024-08-27 U.S. Patent No. 12,070,450 Issued
2024-12-10 Zydus's Notice Letter III received by AbbVie
2024-12-17 U.S. Patent No. 12,168,004 Issued
2025-01-14 U.S. Patent No. 12,194,030 Issued
2025-02-11 U.S. Patent No. 12,220,408 Issued
2025-05-27 U.S. Patent No. 12,310,953 Issued
2025-06-17 U.S. Patent No. 12,329,750 Issued
2025-06-18 Zydus's Notice Letter IV received by AbbVie
2025-10-27 Zydus's Notice Letter V received by AbbVie
2025-11-04 U.S. Patent Nos. 12,458,632 and 12,458,633 Issued
2025-11-26 Complaint Filing Date

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

U.S. Patent No. 10,117,836 - "Tablet Formulation for CGRP Active Compounds"

  • Issued: November 6, 2018 (Compl. ¶44)

The Invention Explained

  • Problem Addressed: The patent describes the difficulty in creating a commercially viable solid oral dosage form (e.g., a tablet) for certain CGRP antagonist compounds due to their poor aqueous solubility, which hinders oral absorption ('836 Patent, col. 1:62-col. 2:14).
  • The Patented Solution: The invention is a specific tablet formulation designed for immediate release. It uses a hot-melt extrusion process to create an "extrudate" where the poorly soluble CGRP compound is dispersed in a water-soluble polymer matrix with a dispersing agent ('836 Patent, col. 3:40-47). This extrudate is then combined with a specialized "disintegration system" containing components like powdered sodium chloride, which allows the final tablet to disintegrate rapidly (in less than 5 minutes) upon ingestion, thereby making the drug immediately available for absorption ('836 Patent, col. 4:5-14; Fig. 3).
  • Technical Importance: This approach provides a method to formulate a stable, solid, immediate-release oral tablet for a class of potent but poorly soluble drugs, overcoming critical bioavailability challenges that could otherwise prevent their effective use as a commercial treatment ('836 Patent, col. 5:29-41).

Key Claims at a Glance

  • The complaint does not specify which claims are asserted, but Claim 1 is the broadest independent claim.
  • Key elements of independent claim 1 include:
    • A tablet comprising (a) an extrudate and (b) a disintegration system.
    • The extrudate comprises a water-soluble polymer matrix, a dispersing agent, and a CGRP compound of Formula I.
    • The tablet has a specified hardness (from about 12 kP to about 18 kP).
    • The tablet achieves complete disintegration in less than about 5 minutes in a standard test.
  • The complaint does not explicitly reserve the right to assert dependent claims, but infringement is alleged as to "one or more claims" of the patent (Compl. ¶120).

U.S. Patent No. 11,717,515 - "Treatment of Migraine"

  • Issued: August 8, 2023 (Compl. ¶49)

The Invention Explained

  • Problem Addressed: The patent addresses the need for safe and effective dosing regimens of ubrogepant for specific patient populations whose conditions can alter the drug's metabolism. This includes patients with severe hepatic (liver) impairment or patients concurrently taking drugs that are modulators of the CYP3A4 enzyme, which is primarily responsible for metabolizing ubrogepant ('515 Patent, col. 1:19-26, col. 3:30-43).
  • The Patented Solution: The invention claims specific methods for treating migraine in these patient subpopulations by administering tailored doses of ubrogepant. For instance, the patent claims a method of administering a 50 mg dose to a patient with severe hepatic impairment (Child-Pugh Class C), with the option for a second 50 mg dose, to ensure the treatment is both safe and effective despite the patient's compromised drug metabolism ('515 Patent, col. 1:51-col. 2:4; Abstract). Figures 1 and 2 of the patent illustrate the different pharmacokinetic profiles of ubrogepant in patients with varying degrees of hepatic impairment ('515 Patent, Figs. 1-2).
  • Technical Importance: By providing clinically validated, adjusted dosing regimens, the invention allows a therapeutic agent to be used safely and effectively in specific, potentially vulnerable patient populations, thereby expanding access to the treatment while managing risks.

Key Claims at a Glance

  • The complaint does not specify which claims are asserted, but Claim 1 is an independent claim.
  • Key elements of independent claim 1 include:
    • A method for the acute treatment of migraine with or without aura in a patient with severe hepatic impairment.
    • The method comprises orally administering 50 mg of ubrogepant to the patient.
    • The patient is defined as having a Child-Pugh score of Child-Pugh Class C.
    • The method results in the patient's migraine being "safely and effectively treated."
  • The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶153).

U.S. Patent No. 11,857,542 - "Treatment of Migraine"

  • Issued: January 2, 2024 (Compl. ¶53)
  • Technology Synopsis: This patent claims methods for the acute treatment of migraine with ubrogepant. It is directed to specific dosing regimens for patients with severe renal (kidney) impairment, ensuring safety and efficacy in a subpopulation with altered drug clearance capabilities ('542 Patent, Abstract; col. 1:12-18).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: Zydus's proposed generic ubrogepant tablets and their associated labeling, which is expected to instruct for uses that infringe the claimed methods (Compl. ¶¶ 182-185).

U.S. Patent No. 11,925,709 - "Tablet Formulation for CGRP Active Compounds"

  • Issued: March 12, 2024 (Compl. ¶57)
  • Technology Synopsis: Similar to the ’836 Patent, this patent is directed to a specific tablet formulation for poorly soluble CGRP compounds like ubrogepant. The formulation comprises an extrudate of the drug in a polymer matrix and a disintegration system, designed to achieve rapid tablet disintegration and immediate drug release ('709 Patent, Abstract; col. 16:42-col. 17:1).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: The formulation of Zydus's proposed generic ubrogepant tablets, which is alleged to meet the claimed elements to achieve bioequivalence with UBRELVY® (Compl. ¶¶ 209-211).

U.S. Patent No. 12,070,450 - "Treatment of Migraine"

  • Issued: August 27, 2024 (Compl. ¶62)
  • Technology Synopsis: This patent covers methods for treating migraine by administering ubrogepant to patients who are also taking drugs that are weak or moderate CYP3A4 inducers. The claimed dosing regimens are adjusted to account for the increased metabolism of ubrogepant caused by the co-administered drugs ('450 Patent, Abstract; col. 2:29-41).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: Zydus's proposed generic ubrogepant tablets and their associated labeling, which is expected to instruct for uses that infringe the claimed methods (Compl. ¶¶ 245-248).

U.S. Patent No. 12,168,004 - "Treatment of Migraine"

  • Issued: December 17, 2024 (Compl. ¶66)
  • Technology Synopsis: This patent claims specific tablet formulations of ubrogepant designed for rapid disintegration. The claims recite a tablet comprising an amorphous form of the compound within an extrudate, combined with a particular disintegration system to ensure fast release ('004 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: The formulation of Zydus's proposed generic ubrogepant tablets, which is alleged to be covered by the claims (Compl. ¶¶ 272-274).

U.S. Patent No. 12,194,030 - "Treatment of Migraine"

  • Issued: January 14, 2025 (Compl. ¶71)
  • Technology Synopsis: This patent claims methods of treating migraine with ubrogepant in patients who are concurrently taking moderate CYP3A4 inhibitors. The claims specify a reduced dose of ubrogepant to compensate for the decreased metabolism and avoid potential toxicity ('030 Patent, Abstract; col. 2:6-14).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: Zydus's proposed generic ubrogepant tablets and their associated labeling, which is expected to instruct for uses that infringe the claimed methods (Compl. ¶¶ 308-311).

U.S. Patent No. 12,220,408 - "Treatment of Migraine"

  • Issued: February 11, 2025 (Compl. ¶75)
  • Technology Synopsis: This patent claims specific tablet formulations of ubrogepant comprising an extrudate with a defined polymer matrix and a disintegration system. The claims are directed to achieving rapid tablet disintegration and drug release ('408 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: The formulation of Zydus's proposed generic ubrogepant tablets, which is alleged to be covered by the claims (Compl. ¶¶ 336-338).

U.S. Patent No. 12,310,953 - "Pharmaceutical Formulations for the Treatment of Migraine"

  • Issued: May 27, 2025 (Compl. ¶79)
  • Technology Synopsis: This patent relates to pharmaceutical tablet formulations of ubrogepant designed for rapid disintegration. The claims specify a tablet containing an amorphous form of the compound and a disintegration system, characterized by its rapid dissolution profile ('953 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: The formulation of Zydus's proposed generic ubrogepant tablets, which is alleged to be covered by the claims (Compl. ¶¶ 370-372).

U.S. Patent No. 12,329,750 - "Treatment of Migraine"

  • Issued: June 17, 2025 (Compl. ¶83)
  • Technology Synopsis: This patent covers methods of treating migraine by administering ubrogepant to patients who are also taking drugs that are weak CYP3A4 inhibitors. The claims specify a reduced dose of ubrogepant to ensure safety by compensating for the inhibitor's effect on drug metabolism ('750 Patent, Abstract; col. 2:15-24).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: Zydus's proposed generic ubrogepant tablets and their associated labeling, which is expected to instruct for uses that infringe the claimed methods (Compl. ¶¶ 406-409).

U.S. Patent No. 12,458,632 - "Treatment of Migraine"

  • Issued: November 4, 2025 (Compl. ¶87)
  • Technology Synopsis: This patent is directed to a specific tablet formulation for ubrogepant. It claims a rapid-release tablet comprising an amorphous form of the compound within an extrudate, combined with a particular disintegration system to achieve fast dissolution ('632 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: The formulation of Zydus's proposed generic ubrogepant tablets, which is alleged to be covered by the claims (Compl. ¶¶ 434-436).

U.S. Patent No. 12,458,633 - "Treatment of Migraine"

  • Issued: November 4, 2025 (Compl. ¶91)
  • Technology Synopsis: This patent is directed to a specific tablet formulation for ubrogepant. It claims a rapid-release tablet comprising an amorphous form of the compound within an extrudate, combined with a particular disintegration system to achieve fast dissolution ('633 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint does not specify, but independent claims include Claim 1.
  • Accused Features: The formulation of Zydus's proposed generic ubrogepant tablets, which is alleged to be covered by the claims (Compl. ¶¶ 468-470).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Zydus's proposed generic ubrogepant oral tablets in 50 mg and 100 mg dosage forms, for which Zydus is seeking FDA approval via ANDA No. 218662 (Compl. ¶¶ 1, 95).

Functionality and Market Context

The complaint alleges that Zydus's generic products are intended to be pharmaceutically and therapeutically equivalent to AbbVie's UBRELVY® tablets, an approved drug for the acute treatment of migraine (Compl. ¶¶ 38, 118). To gain FDA approval, Zydus's products must be bioequivalent to UBRELVY® and must have proposed labeling with the same conditions of use (Compl. ¶¶ 110-111). UBRELVY® was the first orally available CGRP receptor antagonist approved by the FDA for the acute treatment of migraine and is indicated for unique patient populations, such as those with severe hepatic impairment (Compl. ¶42).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint. The complaint does not provide a claim chart exhibit. The infringement allegations are summarized below based on the complaint's narrative theory.

U.S. Patent No. 10,117,836 - Infringement Allegations

The complaint alleges that Zydus's filing of ANDA No. 218662 for a generic ubrogepant tablet constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶119). The theory suggests that to be "pharmaceutically and therapeutically equivalent" to UBRELVY® tablets, Zydus's product must necessarily be formulated in a way that meets the limitations of the '836 Patent's claims, which cover a specific tablet formulation comprising an extrudate and a rapid disintegration system (Compl. ¶118; '836 Patent, Claim 1). Upon FDA approval, the commercial manufacture, use, or sale of Zydus's generic products is alleged to constitute direct infringement (Compl. ¶120).

U.S. Patent No. 11,717,515 - Infringement Allegations

Infringement of the '515 Patent is alleged on the basis of induced infringement under 35 U.S.C. § 271(b) (Compl. ¶153, 155). The complaint alleges that Zydus's proposed product label, which must contain the same safety and efficacy information as the UBRELVY® label, will instruct healthcare providers and patients to administer the generic product according to the patented method (Compl. ¶¶ 111, 156). Specifically, the UBRELVY® label and the '515 Patent claims both describe a method of administering a 50 mg dose of ubrogepant to patients with severe hepatic impairment (Compl. ¶40; '515 Patent, Claim 1). Therefore, Zydus's label will allegedly induce direct infringement of the '515 Patent by end-users (Compl. ¶155).

Identified Points of Contention

  • Scope Questions: A central question for the formulation patents (e.g., the '836 Patent) may be whether Zydus's formulation, while bioequivalent, was designed to avoid the literal scope of terms like "extrudate" or "disintegration system" as defined in the claims. For the method-of-use patents (e.g., the '515 Patent), a question may arise as to whether the language in Zydus's proposed label constitutes sufficient instruction or encouragement to meet the legal standard for inducement of infringement.
  • Technical Questions: A key technical question will be whether Zydus's generic product is manufactured using a hot-melt extrusion process and contains the claimed combination of a polymer matrix, dispersing agent, and disintegration system as required by the '836 Patent. Analysis of Zydus's ANDA filing will be central to determining whether the physical and performance characteristics of its tablet (e.g., hardness, disintegration time) fall within the claimed ranges.

V. Key Claim Terms for Construction

"disintegration system" ('836 Patent, Claim 1)

  • Context and Importance: This term is a core component of the claimed formulation, and its definition is critical to determining infringement. Practitioners may focus on this term because the patent requires a specific combination of components and a functional result (disintegration in <5 minutes), making it a potential area for a non-infringement argument if Zydus's formulation achieves rapid disintegration through a different mechanism or composition.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language recites the term functionally ("a disintegration system") before depending claims add specific components, which may support an argument that any combination of excipients achieving the claimed function falls within the scope of claim 1.
    • Evidence for a Narrower Interpretation: The specification explicitly defines the system as comprising "a conventional disintegrant in conjunction with Powdered Sodium Chloride, and more preferably in a weight ratio of 1:1" ('836 Patent, col. 11:36-39). This language may be used to argue that the term is limited to combinations including both a salt and a conventional disintegrant.

"safely and effectively treated" ('515 Patent, Claim 1)

  • Context and Importance: This term recites the outcome of the claimed method. Its construction will be critical because defendants in pharmaceutical cases often challenge such terms as being indefinite under 35 U.S.C. § 112 or attempt to import limitations from the specification to argue non-infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Plaintiffs may argue the term should be given its plain and ordinary meaning as understood by a person of ordinary skill in the art—that the claimed dosage reduces migraine symptoms without unacceptable side effects in the specified patient population.
    • Evidence for a Narrower Interpretation: Defendants may point to the detailed clinical trial data and endpoints discussed in the patent's specification (e.g., pain freedom at 2 hours, specific adverse event profiles) to argue that "safely and effectively treated" requires meeting specific, quantitative clinical benchmarks that may not be fully reflected in all real-world uses ('515 Patent, col. 24:3-48).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all patents-in-suit. The inducement allegations are based on the assertion that Zydus's proposed product labeling will instruct healthcare professionals and patients to use the generic product in an infringing manner (e.g., by administering it according to the patented methods) (Compl. ¶¶ 122-123, 155-156). Contributory infringement is alleged on the basis that Zydus's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶¶ 126-127).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement or a request for enhanced damages.

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

  • A core issue will be one of technical design and equivalence: For the formulation patents, can Plaintiffs demonstrate that Zydus's generic product, designed to be bioequivalent to UBRELVY®, necessarily falls within the scope of the claims reciting a specific "extrudate" and "disintegration system," or has Zydus successfully designed a different, non-infringing formulation that achieves the same clinical result?
  • A second key issue will be one of inducement via labeling: For the method-of-use patents, does the language in Zydus’s proposed product label, which is required by FDA regulation to mirror the branded drug's label, rise to the level of actively encouraging or instructing physicians to prescribe ubrogepant in a manner that directly infringes the patented dosing methods for specific patient subpopulations?
  • A central validity question, foreshadowed by Zydus's Paragraph IV certifications, will be obviousness: Can Zydus prove by clear and convincing evidence that the claimed formulations and specific dosing regimens would have been obvious to a person of ordinary skill in the art at the time of the invention, given the known properties of ubrogepant and standard pharmaceutical formulation techniques or clinical practices?