DCT

3:24-cv-04852

AbbVie Inc v. Hetero USA Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-04852, D.N.J., 11/26/2025
  • Venue Allegations: Venue is asserted based on Defendant Hetero USA Inc.’s principal place of business in New Jersey. The other Defendant entities are 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 the migraine drug UBRELVY® (ubrogepant) infringes twelve U.S. patents covering tablet formulations and specific methods of use.
  • Technical Context: The technology relates to pharmaceutical compositions and dosing regimens for ubrogepant, an orally administered small molecule antagonist of the calcitonin gene-related peptide (CGRP) receptor for the acute treatment of migraine.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants’ submission of ANDA No. 219113 to the FDA. Plaintiffs received two separate Paragraph IV notice letters from Hetero: one in February 2024 concerning the ’836 and ’515 patents, and a second in August 2025 concerning eight other patents. The complaint alleges that notice has not yet been received for the ’632 and ’633 patents but that infringement is demonstrated by the ANDA filing itself.

Case Timeline

Date Event
2014-02-05 Priority Date for ’836, ’709, ’004, ’408, ’953, ’632, ’633 Patents
2018-11-06 U.S. Patent No. 10,117,836 Issued
2019-12-23 FDA approved New Drug Application for UBRELVY® Tablets
2020-12-22 Priority Date for ’515, ’542, ’450, ’030, ’750 Patents
2023-08-08 U.S. Patent No. 11,717,515 Issued
2024-01-02 U.S. Patent No. 11,857,542 Issued
2024-02-26 Plaintiffs received Hetero's Notice Letter I (’836, ’515 patents)
2024-03-12 U.S. Patent No. 11,925,709 Issued
2024-08-27 U.S. Patent No. 12,070,450 Issued
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
2025-08-01 Plaintiffs received Hetero's Notice Letter II (multiple patents)
2025-11-04 U.S. Patent No. 12,458,632 Issued
2025-11-04 U.S. Patent No. 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

The Invention Explained

  • Problem Addressed: The patent describes that certain CGRP antagonist compounds, including the active pharmaceutical ingredient (API) ubrogepant, have low aqueous solubility and do not readily form salts, which makes creating a stable, effective solid oral dosage form like a tablet challenging (’836 Patent, col. 5:2-14, 61-65).
  • The Patented Solution: The invention uses a hot-melt extrusion (HME) process to create a solid solution where the API is dispersed in a water-soluble polymer matrix with a dispersing agent. This resulting "extrudate" is then formulated into a tablet with a specific "disintegration system," which allows the tablet to break apart rapidly (in less than five minutes) upon ingestion, thereby enabling immediate release of the API for absorption (’836 Patent, Abstract; col. 6:1-21; Fig. 1).
  • Technical Importance: This formulation technology provides a method to create a commercially viable, immediate-release oral tablet for a class of potent but poorly soluble drugs, overcoming significant bioavailability challenges (’836 Patent, col. 5:35-46).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims but makes general allegations against the patent (Compl. ¶¶ 109-124). Independent claim 1 is representative of the formulation technology.
  • The essential elements of independent claim 1 include:
    • A tablet comprising:
    • (a) an extrudate, which itself comprises a water-soluble polymer matrix, a dispersing agent, and a compound of Formula I (ubrogepant);
    • (b) a disintegration system;
    • wherein the tablet has a specified hardness (12 kP to 18 kP);
    • and wherein the tablet achieves complete disintegration in less than about 5 minutes in a standard test.
  • The complaint reserves the right to assert additional claims.

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

  • Issued: August 8, 2023

The Invention Explained

  • Problem Addressed: The patent background notes the significant burden of migraine and the need for optimized and targeted dosing regimens for CGRP antagonists like ubrogepant (’515 Patent, col. 1:19-26).
  • The Patented Solution: The invention claims specific methods of administering a 50 mg dose of ubrogepant for the acute treatment of migraine in a defined patient subpopulation: those with severe hepatic impairment (Child-Pugh Class C). The claimed method also contemplates the option of administering a second 50 mg dose after at least two hours (’515 Patent, Abstract; col. 2:51-60). A chart in the patent illustrates the pharmacokinetic profile of ubrogepant in patients with normal and impaired hepatic function (’515 Patent, Fig. 1).
  • Technical Importance: This method provides a clinically evaluated, safe, and effective dosing regimen for a specific, vulnerable patient population that may experience altered drug metabolism, thereby tailoring the therapy to their physiological needs (’515 Patent, col. 4:55-63).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims but makes general allegations against the patent (Compl. ¶¶ 142-155). Independent claim 1 is representative of the method of use.
  • The essential 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;
    • wherein the patient has a Child-Pugh score of Child-Pugh Class C;
    • and wherein the patient's migraine is safely and effectively treated.
  • The complaint reserves the right to assert additional claims.

Multi-Patent Capsules

  • Patent Identification: U.S. Patent No. 11,857,542, "Treatment of Migraine," issued January 2, 2024.

    • Technology Synopsis: This patent is directed to methods of treating migraine by administering specific doses of ubrogepant to patients with renal impairment. The invention provides a specific dosing regimen for patients with severe renal impairment, which differs from the standard dose (’542 Patent, Abstract; claim 1).
    • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
    • Accused Features: The proposed label for Hetero's generic product is alleged to instruct physicians and patients to use the claimed dosing regimen for patients with severe renal impairment (Compl. ¶¶ 105, 178).

  • Patent Identification: U.S. Patent No. 11,925,709, "Tablet Formulation for CGRP Active Compounds," issued March 12, 2024.

    • Technology Synopsis: This patent relates to the same formulation technology as the ’836 Patent, describing a tablet made from an extrudate of ubrogepant in a polymer matrix with a dispersing agent. The claims focus on the tablet's properties, including the specific composition of the disintegration system (powdered sodium chloride and croscarmellose sodium) (’709 Patent, Abstract; claim 1).
    • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
    • Accused Features: Hetero's generic ubrogepant tablets are alleged to be pharmaceutically equivalent to UBRELVY® and are therefore alleged to possess the claimed formulation and properties (Compl. ¶¶ 202, 207).

  • Patent Identification: U.S. Patent No. 12,070,450, "Treatment of Migraine," issued August 27, 2024.

    • Technology Synopsis: This patent is directed to methods of treating migraine by administering ubrogepant to patients who are concurrently taking a weak or moderate CYP3A4 inducer. The invention claims a specific dosage (100 mg) for this patient population to ensure efficacy (’450 Patent, Abstract; claim 1).
    • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
    • Accused Features: The proposed label for Hetero's generic product is alleged to instruct for the claimed co-administration regimen, mirroring the label for UBRELVY® (Compl. ¶¶ 105, 241).

  • Patent Identification: U.S. Patent No. 12,168,004, "Treatment of Migraine," issued December 17, 2024.

    • Technology Synopsis: This patent is part of the formulation patent family and claims a rapidly disintegrating tablet comprising an extrudate of the active compound. The claims specify tablet properties such as hardness and disintegration time, ensuring rapid release of the drug (’004 Patent, Abstract; claim 1).
    • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
    • Accused Features: Hetero's generic tablets are alleged to be therapeutically equivalent to UBRELVY® and thus to contain the claimed formulation and exhibit the claimed rapid-disintegration properties (Compl. ¶¶ 266, 271).

  • Patent Identification: U.S. Patent No. 12,194,030, "Treatment of Migraine," issued January 14, 2025.

    • Technology Synopsis: This method-of-use patent claims a method of treating migraine by administering ubrogepant to patients concurrently taking a weak CYP3A4 inhibitor. The invention specifies a 50 mg dose of ubrogepant for this patient group (’030 Patent, Abstract; claim 18).
    • Asserted Claims: The complaint does not specify claims; independent claim 18 is representative.
    • Accused Features: The proposed label for Hetero's generic product is alleged to contain instructions for the specified dosing when co-administered with weak CYP3A4 inhibitors (Compl. ¶¶ 105, 305).

  • Patent Identification: U.S. Patent No. 12,220,408, "Treatment of Migraine," issued February 11, 2025.

    • Technology Synopsis: This patent claims a method of treating migraine by administering ubrogepant to patients concurrently taking a moderate CYP3A4 inhibitor. The claimed method requires a dose adjustment to 50 mg of ubrogepant (’408 Patent, Abstract; claim 12).
    • Asserted Claims: The complaint does not specify claims; independent claim 12 is representative.
    • Accused Features: Hetero's generic product label is alleged to instruct physicians to use the claimed dose-adjusted regimen when co-administered with moderate CYP3A4 inhibitors (Compl. ¶¶ 105, 335).

  • Patent Identification: U.S. Patent No. 12,310,953, "Pharmaceutical Formulations for the Treatment of Migraine," issued May 27, 2025.

    • Technology Synopsis: This patent is part of the formulation family and claims a rapid-release tablet comprising an amorphous compound of ubrogepant. The claims are directed to the final pharmaceutical composition and its dissolution properties, ensuring the drug is released quickly when ingested (’953 Patent, Abstract; claim 1).
    • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
    • Accused Features: Hetero's generic tablets are alleged to be bioequivalent and therefore contain the claimed amorphous formulation and exhibit the claimed dissolution profile (Compl. ¶¶ 364, 369).

  • Patent Identification: U.S. Patent No. 12,329,750, "Treatment of Migraine," issued June 17, 2025.

    • Technology Synopsis: This patent claims a method of treating migraine in patients concurrently taking a BCRP and/or P-gp only inhibitor. The invention specifies a 50 mg dose of ubrogepant for this patient population to manage potential drug-drug interactions (’750 Patent, Abstract; claim 1).
    • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
    • Accused Features: The proposed label for Hetero's generic product is alleged to include instructions for the claimed dosing regimen for patients taking BCRP and/or P-gp only inhibitors (Compl. ¶¶ 105, 403).

  • Patent Identification: U.S. Patent No. 12,458,632, "Treatment of Migraine," issued November 4, 2025.

    • Technology Synopsis: The complaint does not provide sufficient detail for analysis of this specific patent's contribution beyond the general allegations.
    • Asserted Claims: The complaint does not specify claims.
    • Accused Features: Hetero's ANDA filing for a generic version of UBRELVY® is alleged to infringe (Compl. ¶¶ 427-429).

  • Patent Identification: U.S. Patent No. 12,458,633, "Treatment of Migraine," issued November 4, 2025.

    • Technology Synopsis: The complaint does not provide sufficient detail for analysis of this specific patent's contribution beyond the general allegations.
    • Asserted Claims: The complaint does not specify claims.
    • Accused Features: Hetero's ANDA filing for a generic version of UBRELVY® is alleged to infringe (Compl. ¶¶ 461-463).

III. The Accused Instrumentality

  • Product Identification: The accused products are Hetero’s proposed generic ubrogepant oral tablets in 50 mg and 100 mg dosage forms, as described in ANDA No. 219113 submitted to the U.S. Food and Drug Administration (FDA) (Compl. ¶¶ 1, 95).
  • Functionality and Market Context: The complaint alleges that Hetero's generic products are intended to be generic versions of Plaintiffs’ commercial pharmaceutical product, UBRELVY® Tablets (Compl. ¶95). As such, they are designed for the acute treatment of migraine attacks in adults (Compl. ¶¶ 38, 105). The complaint asserts that Hetero's products are represented to the FDA as "pharmaceutically and therapeutically equivalent" to UBRELVY® (Compl. ¶112). Plaintiffs allege that Hetero’s purpose in filing the ANDA is to market its generic products in the United States before the expiration of the Patents-in-Suit (Compl. ¶103).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain claim charts or detailed infringement contentions. The infringement theory is predicated on the allegation that Hetero’s ANDA product is a generic version of UBRELVY® that is pharmaceutically and therapeutically equivalent and will be sold with a label instructing for the same uses (Compl. ¶¶ 105, 112).

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

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A tablet comprising: (a) an extrudate comprising: (i) a water-soluble polymer matrix; (ii) a dispersing agent; and (iii) a compound of Formula I... Hetero's generic product is a tablet alleged to be therapeutically equivalent to UBRELVY®, which contains ubrogepant formulated as the claimed extrudate. ¶¶ 95, 112 col. 6:1-5
...and (b) a disintegration system, Hetero's generic tablet is alleged to contain the claimed disintegration system necessary to achieve therapeutic equivalence with UBRELVY®. ¶¶ 95, 112 col. 6:9-10
wherein said tablet has a hardness of from about 12 kP to about 18 kP, and wherein said tablet achieves complete disintegration in less than about 5 minutes... As a purported therapeutic equivalent, Hetero's generic tablet is alleged to have the physical properties, including hardness and rapid disintegration time, required by the claim. ¶¶ 95, 112 col. 6:16-21

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

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the acute treatment of migraine...in a patient with severe hepatic impairment, the method comprising orally administering 50 mg of ubrogepant to the patient... Hetero's proposed product label will allegedly instruct healthcare providers and patients to administer the 50 mg tablet for the acute treatment of migraine in patients with severe hepatic impairment. ¶¶ 105, 148, 150 col. 2:51-56
...wherein the patient has a Child-Pugh score of Child-Pugh Class C, The proposed label will allegedly contain the same information and instructions as the UBRELVY® label regarding use in patients with this specific classification of hepatic impairment. ¶¶ 42, 105 col. 2:56-57
...and wherein the patient's migraine is safely and effectively treated. The proposed label will allegedly contain the same FDA-approved safety and efficacy information as the UBRELVY® label, meeting this claim limitation. ¶105 col. 2:59-60
  • Identified Points of Contention:
    • Scope Questions: For the formulation patents (e.g., ’836 Patent), a primary question may be whether the term "extrudate," in the context of the specification, is limited to a product made by the described hot-melt extrusion process. For the method-of-use patents (e.g., ’515 Patent), a question may arise as to whether Hetero’s proposed label actively encourages the specific, claimed method of administration, or merely provides information that a physician might use.
    • Technical Questions: The infringement case for the formulation patents depends on whether Hetero’s generic product is a technical copy or uses a different, non-infringing formulation to achieve bioequivalence. The complaint's allegations of equivalence are made on "information and belief," raising the question of what evidence Plaintiffs will present to show that Hetero's tablets actually contain the claimed "extrudate" and "disintegration system."

V. Key Claim Terms for Construction

  • The Term: "extrudate" (’836 Patent, claim 1)

    • Context and Importance: This term defines the core component of the claimed tablet formulation. The scope of "extrudate" will be critical, as it determines whether Hetero's formulation technology falls within the claim. Practitioners may focus on this term because its construction could decide the infringement analysis for the entire family of formulation patents.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language defines "extrudate" structurally as a composition "comprising: (i) a water-soluble polymer matrix; (ii) a dispersing agent; and (iii) a compound of Formula I." This suggests a structural, rather than process-based, definition (’836 Patent, col. 16:36-41).
      • Evidence for a Narrower Interpretation: The specification repeatedly and extensively describes the preparation of the "extrudate" using a hot-melt extrusion (HME) process (’836 Patent, col. 9:28-35). Defendants may argue that a person of ordinary skill in the art would understand the term, in the context of this patent, to be limited to a product made by HME.

  • The Term: "safely and effectively treated" (’515 Patent, claim 1)

    • Context and Importance: This phrase sets the standard of care required by the claimed method. Its definition is crucial for both infringement and validity. Practitioners may focus on this term because such functional language is often a target for indefiniteness challenges under 35 U.S.C. § 112.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification includes clinical trial data showing efficacy (e.g., pain freedom) and safety outcomes, which formed the basis for FDA approval (’515 Patent, Figs. 6-7; col. 23:4-25:47). This may suggest the term refers to meeting the standard for FDA approval for the indicated use.
      • Evidence for a Narrower Interpretation: The patent does not provide a precise quantitative definition for "safely and effectively treated" in the claims themselves. A defendant may argue that the term is subjective and fails to inform those skilled in the art about the scope of the invention with reasonable certainty.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement across all asserted patents, based on the allegation that Hetero’s proposed product labeling will instruct and encourage physicians and patients to use the generic tablets in an infringing manner (e.g., by administering the claimed formulation or by following the claimed method of use) (Compl. ¶¶ 116, 149). The complaint also alleges contributory infringement, stating that Hetero's products are especially adapted for infringing uses and have no substantial non-infringing use (Compl. ¶¶ 120-121).
  • Willful Infringement: The complaint does not explicitly plead willful infringement. However, it establishes a basis for pre-suit knowledge of at least ten of the twelve patents-in-suit by citing Hetero’s Paragraph IV notice letters dated February 26, 2024, and August 1, 2025 (Compl. ¶¶ 96, 98, 116, 149). For the remaining patents, the complaint itself serves as notice.

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

  • A central issue will be one of technical implementation: for the formulation patents, does Hetero's generic product achieve bioequivalence using the specific hot-melt extrudate and rapid-disintegration system claimed by Plaintiffs, or does it employ a different, non-infringing formulation design? The case may turn on evidence uncovered during discovery regarding the actual composition and manufacturing process of Hetero's product.
  • A second core issue will be the scope and evidence of induced infringement for the method-of-use patents: will the language in Hetero's proposed label, by virtue of mirroring the innovator's FDA-approved label, be sufficient to prove that Hetero actively encouraged physicians to prescribe its product for the specific, patented patient subpopulations (e.g., those with severe hepatic impairment)?
  • Given the assertion of twelve patents from two distinct technological families (formulation and method-of-use), a key strategic question is one of litigation focus: will the dispute concentrate on claim construction and infringement of a few lead patents, or will it involve a broader validity challenge across the portfolio, potentially raising issues such as obviousness-type double patenting between related claims?