DCT

3:24-cv-04403

AbbVie Inc v. Aurobindo Pharma USA Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-04403, D.N.J., 11/26/2025
  • Venue Allegations: Venue is alleged as proper in the District of New Jersey based on Defendant Aurobindo USA's principal place of business being located there. The other defendant entities are incorporated in India and may be sued in any U.S. judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for generic ubrogepant tablets constitutes an act of infringement against twelve patents covering pharmaceutical formulations and methods of use for Plaintiffs’ migraine treatment drug, UBRELVY®.
  • Technical Context: The technology relates to pharmaceutical formulations and methods for treating migraine using ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist that addresses a debilitating neurological disease affecting millions of people.
  • Key Procedural History: This is a Hatch-Waxman action initiated under 35 U.S.C. § 271(e)(2) following Defendants’ submission of ANDA No. 219088 to the U.S. Food and Drug Administration. The ANDA included a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the proposed generic products. Plaintiffs allege this suit was commenced within 45 days of receiving Defendants’ notice letters.

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 Approval of UBRELVY® New Drug Application (NDA)
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
2024-02-13 Aurobindo sends Notice Letter I regarding ’836 Patent
2024-03-12 U.S. Patent No. 11,925,709 Issued
2024-04-30 Aurobindo sends Notice Letter II regarding ’709 Patent
2024-08-22 Aurobindo sends Notice Letter III regarding ’515 and ’542 Patents
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
2025-04-25 Aurobindo sends Notice Letter IV regarding ’450, ’004, ’030, ’408 Patents
2025-05-27 U.S. Patent No. 12,310,953 Issued
2025-06-17 U.S. Patent No. 12,329,750 Issued
2025-10-10 Aurobindo sends Notice Letter V regarding ’953 and ’750 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 Filed

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

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

The Invention Explained

  • Problem Addressed: The patent’s background describes that certain CGRP antagonist compounds, including ubrogepant, have low aqueous solubility and do not form stable salts, making them difficult to formulate into a solid oral dosage form like a tablet ('836 Patent, col. 1:58–2:15). It further notes that these compounds are susceptible to thermal degradation when processed with common cellulosic polymers using techniques such as Hot Melt Extrusion (HME) ('836 Patent, col. 7:31-43).
  • The Patented Solution: The invention is a specific tablet formulation that enhances the oral delivery of these poorly soluble compounds. It involves creating a solid dispersion by dispersing the active pharmaceutical ingredient (API) into a water-soluble polyvinylpyrrolidone/vinyl acetate (PVP-VA) copolymer matrix, which surprisingly avoids the thermal degradation seen with other polymers ('836 Patent, Abstract; col. 8:20-34). This dispersion, or "extrudate," is combined with a "disintegration system" comprising powdered sodium chloride and croscarmellose sodium, which allows the final tablet to disintegrate rapidly and release the API quickly in the gastrointestinal tract ('836 Patent, col. 3:40–4:13; col. 6:13-20; Fig. 1).
  • Technical Importance: This formulation technology provided a stable and effective solid oral dosage form for a potent class of migraine drugs that were otherwise challenging to deliver commercially due to poor solubility and thermal sensitivity ('836 Patent, col. 2:5-15).

Key Claims at a Glance

The complaint does not specify which claims of the ’836 Patent are asserted. Independent claim 1 is representative of the formulation technology.

  • Independent Claim 1:
    • An extrudate comprising a water-soluble polymer matrix, a dispersing agent, and a compound of Formula I (e.g., ubrogepant), where the compound and agent are dispersed in the matrix.
    • A disintegration system.
    • A final tablet with a hardness of about 12-18 kP.
    • The tablet achieves complete disintegration in less than about 5 minutes in a specified test.

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

The Invention Explained

  • Problem Addressed: The patent background identifies a need for "optimized and targeted methodologies and dosing regimens to treat migraines" ('515 Patent, col. 1:24-26). It specifically addresses the clinical challenge of safely treating patients with severe hepatic impairment, because ubrogepant is primarily metabolized by liver enzymes (CYP isoenzymes), which can lead to higher systemic drug concentrations in these patients ('515 Patent, col. 3:30-35).
  • The Patented Solution: The invention claims a specific method of treating migraine in patients with severe hepatic impairment (defined as Child-Pugh Class C). The claimed method is the oral administration of a 50 mg dose of ubrogepant, with an option for a second 50 mg dose at least two hours later ('515 Patent, col. 2:50-59; Abstract). Clinical data presented in the patent, such as in Figure 1, shows that a standard dose would lead to significantly higher plasma concentrations in this patient group, thereby justifying the dose reduction ('515 Patent, Fig. 1).
  • Technical Importance: This patented method provides a specific, evidence-based dosing regimen that allows for the safe and effective use of ubrogepant in a vulnerable patient population that might otherwise be at risk of adverse events due to elevated drug exposure (Compl. ¶ 42; ’515 Patent, col. 4:50-56).

Key Claims at a Glance

The complaint does not specify which claims of the ’515 Patent are asserted. Independent claim 1 is representative of the method of use.

  • Independent Claim 1:
    • 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 characterized as having a Child-Pugh score of Child-Pugh Class C.
    • The patient’s migraine is "safely and effectively treated."

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

  • Technology Synopsis: This patent addresses the need for optimized dosing regimens for ubrogepant in specific patient populations ('542 Patent, col. 1:24-26). The claimed invention is a method of treating migraine in patients who are also taking a moderate CYP3A4 inhibitor, by administering a 50 mg dose of ubrogepant ('542 Patent, col. 2:5-15).
  • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
  • Accused Features: The complaint alleges that Defendants will induce infringement because their product’s proposed label will instruct healthcare providers and patients to use the patented dosing regimen (Compl. ¶¶ 183-185).

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

  • Technology Synopsis: This patent, related to the '836 Patent, covers a specific pharmaceutical tablet formulation for poorly soluble CGRP antagonists like ubrogepant ('709 Patent, col. 1:58–2:15). The invention comprises a hot-melt extrudate of the drug in a PVP-VA polymer matrix with a dispersing agent, combined with a specific disintegration system to ensure rapid drug release ('709 Patent, Abstract).
  • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
  • Accused Features: The complaint alleges that the composition of Defendants' proposed generic tablet will infringe the patent’s formulation claims (Compl. ¶¶ 212-214).

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

  • Technology Synopsis: This patent, related to the '515 Patent, claims methods for treating migraine in patients concurrently taking a weak or moderate CYP3A4 inducer ('450 Patent, col. 2:30-40). The claimed solution is to administer a 100 mg dose of ubrogepant to counteract the increased drug metabolism caused by the inducer ('450 Patent, Abstract).
  • Asserted Claims: The complaint does not specify claims; independent claims 1 and 11 are representative.
  • Accused Features: Infringement allegations are based on inducement, alleging that the proposed product label for the generic tablets will instruct the infringing use (Compl. ¶¶ 246-248).

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

  • Technology Synopsis: This patent claims a method of treating migraine by administering a tablet that is a product of the formulation technology described in the related '836 patent ('004 Patent, Abstract; col. 4:47-53). It focuses on the administration of a tablet that achieves rapid disintegration and drug release due to its specific composition ('004 Patent, col. 15:58-16:9).
  • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
  • Accused Features: Infringement is alleged based on inducement, where the Defendants' product label will instruct patients to take a tablet that allegedly meets the claim limitations, thereby infringing the method (Compl. ¶¶ 276-278).

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

  • Technology Synopsis: This patent, related to the '515 Patent, claims methods of treating migraine in patients with severe renal impairment ('030 Patent, col. 2:59-65). The claimed method involves administering a 50 mg dose of ubrogepant to this specific patient population to ensure safety and efficacy ('030 Patent, Abstract).
  • Asserted Claims: The complaint does not specify claims; independent claims 1 and 7 are representative.
  • Accused Features: The complaint alleges inducement, based on the assertion that Defendants’ proposed product label will instruct the use of the patented dosing method (Compl. ¶¶ 310-312).

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

  • Technology Synopsis: This patent, related to the '004 Patent, claims a method of treating migraine by administering a specific tablet formulation. The claims focus on the method of use of a tablet containing an amorphous dispersion of ubrogepant that achieves rapid disintegration ('408 Patent, claim 1).
  • Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
  • Accused Features: The complaint alleges that Defendants will induce infringement by instructing patients, via the product label, to administer a tablet that allegedly meets the properties of the claimed method (Compl. ¶¶ 340-342).

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

  • Technology Synopsis: This patent, related to the '836 Patent, claims a rapid-release pharmaceutical tablet comprising an amorphous compound of ubrogepant and a disintegration system ('953 Patent, Abstract). The claims focus on the amorphous nature of the drug and the rapid disintegration properties of the tablet as a whole ('953 Patent, claim 1).
  • Asserted Claims: The complaint does not specify claims; independent claims 1 and 19 are representative.
  • Accused Features: The complaint alleges direct infringement based on the composition of Defendants' proposed generic tablet (Compl. ¶¶ 374-376).

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

  • Technology Synopsis: This patent, related to the '515 Patent, claims methods of treating migraine in patients undergoing concurrent treatment with a BCRP and/or P-gp only inhibitor ('750 Patent, col. 2:41-51). The claimed method is to administer a 50 mg dose of ubrogepant to this patient population ('750 Patent, Abstract).
  • Asserted Claims: The complaint does not specify claims; independent claims 1 and 28 are representative.
  • Accused Features: The complaint alleges inducement, asserting that the product label for Defendants’ generic will instruct the infringing method of use (Compl. ¶¶ 408-410).

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

  • Technology Synopsis: This patent, related to the '836 family, claims a method of administering a tablet containing amorphous ubrogepant that disintegrates rapidly ('632 Patent, claims 1, 15). The claims are directed to the method of use of a specific formulation type to achieve a therapeutic effect.
  • Asserted Claims: The complaint does not specify claims; independent claims 1 and 15 are representative.
  • Accused Features: The complaint alleges inducement of infringement, based on the theory that Defendants' product label will instruct users to perform the patented method (Compl. ¶¶ 438-440).

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

  • Technology Synopsis: This patent is a counterpart to the '632 Patent, also claiming a method of administering a tablet with amorphous ubrogepant that has rapid disintegration properties ('633 Patent, claims 1, 15).
  • Asserted Claims: The complaint does not specify claims; independent claims 1 and 15 are representative.
  • Accused Features: The complaint alleges Defendants will induce infringement via the instructions on their proposed product label (Compl. ¶¶ 472-474).

III. The Accused Instrumentality

  • Product Identification: The accused products are Defendants' generic ubrogepant oral tablets in 50 mg and 100 mg dosage forms, for which Defendants filed Abbreviated New Drug Application (ANDA) No. 219088 with the FDA (Compl. ¶¶ 1, 97).
  • Functionality and Market Context: The complaint alleges that to gain FDA approval, Defendants’ generic products must be bioequivalent to Plaintiffs’ commercial product, UBRELVY® Tablets (Compl. ¶ 112). As such, the accused products are alleged to contain the same active ingredient, ubrogepant, and will have the same indication for the acute treatment of migraine with or without aura in adults (Compl. ¶¶ 40, 113). The complaint asserts that Defendants' purpose in filing the ANDA is to market and sell these generic products in the United States prior to the expiration of the patents-in-suit (Compl. ¶ 111).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide claim charts. The infringement allegations are based on the legal framework of ANDA litigation, where the filing of an ANDA for a drug claimed in a patent is a statutory act of infringement, and the product that will be marketed upon approval is presumed to meet the limitations of asserted claims.

10,117,836 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) an extrudate comprising: (i) a water-soluble polymer matrix; (ii) a dispersing agent; and (iii) a compound of Formula I... wherein the dispersing agent and compound of Formula I is dispersed within said polymer matrix The complaint alleges on information and belief that to be bioequivalent to UBRELVY® tablets, the accused product must contain a similar hot-melt extrudate of ubrogepant dispersed in a polymer matrix with a dispersing agent. ¶¶ 97, 112, 120 col. 3:41-47
(b) a disintegration system The accused product is alleged to contain a disintegration system that results in performance characteristics equivalent to the UBRELVY® product. ¶¶ 112, 120 col. 4:1-2
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... The accused product will allegedly be formulated to have physical characteristics, including hardness and disintegration time, that fall within the claimed ranges to achieve bioequivalence. ¶¶ 112, 120, 121 col. 4:3-10

11,717,515 Patent 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... wherein the patient has a Child-Pugh score of Child-Pugh Class C The complaint alleges that Defendants' proposed product label will instruct healthcare professionals to prescribe and patients to use the generic product for the acute treatment of migraine. ¶¶ 113, 155, 157 col. 2:50-54
the method comprising orally administering 50 mg of ubrogepant to the patient The proposed product label for the accused 50 mg tablet will allegedly instruct its administration to patients with severe hepatic impairment, thereby inducing performance of the claimed method. ¶¶ 42, 113, 157 col. 2:52-54
wherein the patient’s migraine is safely and effectively treated The instructions in the proposed label allegedly guide physicians to administer the drug in a manner that is considered safe and effective by regulatory standards, thus meeting this limitation. ¶¶ 113, 157 col. 1:24-26
  • Identified Points of Contention:
    • Scope Questions: For the formulation patents (e.g., the '836 Patent), a central question may be whether Defendants' formulation falls within the scope of terms like "extrudate," "water-soluble polymer matrix," and "disintegration system." For the method of use patents (e.g., the '515 Patent), a key question may be whether the instructions in Defendants' proposed label meet the legal standard for inducing infringement of the claimed methods.
    • Technical Questions: A primary technical question will be whether the accused generic product is actually formulated using the specific HME process and excipients (e.g., PVP-VA, TPGS, powdered sodium chloride) required by the '836 Patent claims, or if it achieves bioequivalence through a different, non-infringing formulation. The analysis will depend on discovery into the composition and manufacturing process detailed in the confidential ANDA filing.

V. Key Claim Terms for Construction

  • The Term: "disintegration system" ('836 Patent, Claim 1)

  • Context and Importance: This term is critical because the patent distinguishes its invention based on achieving rapid disintegration (<5 minutes), a functional property. The specification discloses a specific two-part system of powdered sodium chloride and croscarmellose sodium that achieves this result, while noting other salts failed ('836 Patent, Table II). Whether this term is construed broadly to cover any set of excipients achieving the function, or narrowly to the specific combination disclosed, will be central to the infringement analysis of the formulation patents.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language itself does not recite specific chemical components for the "disintegration system," defining it by its functional outcome, which may support a broader construction covering any system that achieves the claimed disintegration time ('836 Patent, col. 16:7-13).
    • Evidence for a Narrower Interpretation: The specification repeatedly highlights the combination of "Powdered Sodium Chloride" and croscarmellose sodium as a key feature that solves the disintegration problem ('836 Patent, col. 11:25-34). Experimental data in Table II showing the failure of other salts could be used to argue that the invention is limited to the specific embodiment that was shown to work.

  • The Term: "safely and effectively treated" ('515 Patent, Claim 1)

  • Context and Importance: This limitation appears in a method claim and relates to the outcome of the treatment. Defendants may argue the term is indefinite because what constitutes "safe and effective" is subjective. Plaintiffs will likely contend the term has a well-understood meaning in the art, tied to regulatory approval standards and clinical endpoints. Its construction will determine whether this element is easily met or is a potential point of non-infringement or invalidity.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification links the claimed dosing regimens to FDA-approved labeling and information from clinical trials, which provide objective metrics for safety (e.g., adverse event profiles) and efficacy (e.g., pain freedom at 2 hours) ('515 Patent, col. 29:1-15; Compl. ¶¶ 42-43). A POSA would understand the term in this regulatory and clinical context.
    • Evidence for a Narrower Interpretation: The claim itself does not define objective parameters for "safely" or "effectively." This could support an argument that the claim boundary is ambiguous, as outcomes can vary by patient, raising the question of whether the term provides clear notice of the scope of the invention.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all asserted method-of-use patents. The basis is the allegation that Defendants know and intend that healthcare providers will prescribe, and patients will use, the accused generic products according to the instructions in the proposed package insert, which will be the same as or similar to the UBRELVY® label and will instruct the performance of the patented methods (e.g., Compl. ¶¶ 155-158, 183-186).
  • Willful Infringement: The complaint does not explicitly plead willful infringement. However, it requests a finding that this is an "exceptional case" and an award of attorney fees, which is often predicated on a finding of willfulness or other litigation misconduct (Compl. p. 74, ¶ G). The factual basis for pre-suit knowledge of the patents is Defendants' submission of Paragraph IV notice letters for each patent family (Compl. ¶¶ 98-107).

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

  • A core issue will be one of technical identity: For the formulation patents, will discovery reveal that Defendants' ANDA product, designed for bioequivalence, literally replicates the claimed hot-melt extrudate composition and rapid-disintegration system of Plaintiffs' patents, or has it achieved bioequivalence via a non-infringing formulation "design around"?
  • A key legal question will be one of induced infringement: For the method-of-use patents, can Plaintiffs demonstrate that the language in Defendants' proposed product label not only describes but actively encourages or instructs medical professionals to perform the patented dosing regimens for specific patient subpopulations (e.g., those with hepatic impairment), thereby meeting the specific intent requirement for inducement?
  • A central question of claim construction will be whether functional language in the claims, such as "disintegration system" and "safely and effectively treated," will be interpreted broadly based on their stated function or narrowly based on the specific embodiments disclosed in the patent specifications.