DCT

3:24-cv-04662

AbbVie Inc v. MSN Pharma Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-04662, D.N.J., 11/26/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant MSN Pharmaceuticals has its principal place of business in New Jersey, and 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 patents covering tablet formulations and methods of use.
  • Technical Context: The patents relate to formulations and specific dosing regimens for ubrogepant, an orally available calcitonin gene-related peptide (CGRP) receptor antagonist used for the acute treatment of migraine attacks.
  • Key Procedural History: The litigation was triggered by Defendants’ submission of ANDA No. 219218 to the U.S. Food and Drug Administration, which included Paragraph IV certifications alleging that claims of the '836, '515, '542, and '709 patents are invalid, unenforceable, or will not be infringed by the proposed generic products.

Case Timeline

Date Event
2014-02-05 Earliest Priority Date for '836, '709, '004, '408, '953, '632, '633 Patents
2018-11-06 U.S. Patent 10,117,836 Issues
2019-12-23 FDA approves NDA for UBRELVY® Tablets
2020-12-22 Earliest Priority Date for '515, '542, '450, '030, '750 Patents
2023-08-08 U.S. Patent 11,717,515 Issues
2024-01-02 U.S. Patent 11,857,542 Issues
2024-02-23 MSN sends Notice Letter I regarding '836 and '515 patents
2024-03-12 U.S. Patent 11,925,709 Issues
2024-06-21 MSN sends Notice Letter II regarding '542 and '709 patents
2024-08-27 U.S. Patent 12,070,450 Issues
2024-12-17 U.S. Patent 12,168,004 Issues
2025-01-14 U.S. Patent 12,194,030 Issues
2025-02-11 U.S. Patent 12,220,408 Issues
2025-05-27 U.S. Patent 12,310,953 Issues
2025-06-17 U.S. Patent 12,329,750 Issues
2025-11-04 U.S. Patents 12,458,632 and 12,458,633 Issue
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

The Invention Explained

  • Problem Addressed: The patent describes that certain CGRP antagonist compounds have low aqueous solubility and do not form salts suitable for creating a stable pharmaceutical formulation, making oral delivery in a solid form like a tablet difficult (Compl. ¶ 1; ’836 Patent, col. 1:59-2:13).
  • The Patented Solution: The invention uses a process called hot melt extrusion (HME) to create a "solid solution" where the active pharmaceutical ingredient (API) is dispersed within a water-soluble polymer matrix. This composition, which also includes a dispersing agent and a "disintegration system," is designed to allow a tablet to rapidly disintegrate and release the API for absorption ('836 Patent, Abstract; col. 2:47-53). A flowchart in the patent illustrates the multi-step process of blending, melting, extrusion, and milling to create the formulation ('836 Patent, Fig. 1).
  • Technical Importance: This formulation approach provides a method to deliver poorly-soluble "class II" compounds as immediate-release oral tablets, overcoming bioavailability challenges that might otherwise require less commercially attractive liquid formulations ('836 Patent, col. 2:1-13).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specifying which ones (Compl. ¶ 115). Independent claim 1 is representative of the formulation technology.
  • The essential elements of independent claim 1 are:
    • A tablet comprising:
    • (a) an extrudate comprising (i) a water-soluble polymer matrix, (ii) a dispersing agent, and (iii) a compound of Formula I (the CGRP antagonist);
    • (b) a disintegration system;
    • Wherein the tablet has a hardness of from about 12 kP to about 18 kP; and
    • Wherein the tablet achieves complete disintegration in less than about 5 minutes in a standard test.

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

The Invention Explained

  • Problem Addressed: The patent addresses the need for optimized and targeted dosing regimens for treating migraine, particularly for specific patient populations who may be vulnerable to altered drug metabolism or exposure ('515 Patent, col. 1:20-26). These populations include patients with hepatic (liver) impairment, renal (kidney) impairment, or those concurrently taking other medications that modulate certain drug-metabolizing enzymes (CYP3A4) or transporters (BCRP/P-gp) ('515 Patent, col. 1:44-2:49).
  • The Patented Solution: The patent claims methods for the acute treatment of migraine by administering specific, adjusted doses of ubrogepant to these special patient populations. For example, the patent describes administering a 50 mg dose to a patient with severe hepatic impairment, in contrast to the standard 50 mg or 100 mg dose, to ensure the treatment is both safe and effective ('515 Patent, Abstract; col. 2:50-55). Figures in the patent present clinical data showing how plasma concentrations of ubrogepant differ in patients with varying degrees of hepatic impairment compared to normal function ('515 Patent, Fig. 1).
  • Technical Importance: This invention provides a clinically validated, tailored dosing strategy that allows a CGRP antagonist to be used safely and effectively in patients who might otherwise be at risk of adverse effects from overexposure or lack of efficacy from underexposure ('515 Patent, col. 1:44-48).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specifying which ones (Compl. ¶ 148). Independent claim 1 is representative of the method of use technology.
  • The essential elements of independent claim 1 are:
    • 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.

Multi-Patent Capsule: U.S. Patent No. 11,857,542

  • Patent Identification: U.S. Patent No. 11,857,542 (“the '542 patent”), Treatment of Migraine, issued January 2, 2024 (Compl. ¶ 54).
  • Technology Synopsis: This patent, similar to the '515 patent, claims methods for the acute treatment of migraine. It focuses on specific dosing regimens for ubrogepant in patients with renal impairment or those taking certain other drugs that affect ubrogepant metabolism, ensuring safe and effective treatment in these populations ('542 Patent, Abstract).
  • Asserted Claims: One or more claims are asserted (Compl. ¶ 176).
  • Accused Features: The complaint alleges that MSN's proposed product label will instruct healthcare providers and patients to administer the generic drug according to the patented dosing regimens, thereby inducing infringement (Compl. ¶¶ 177-179).

Multi-Patent Capsule: U.S. Patent No. 11,925,709

  • Patent Identification: U.S. Patent No. 11,925,709 (“the '709 patent”), Tablet Formulation for CGRP Active Compounds, issued March 12, 2024 (Compl. ¶ 58).
  • Technology Synopsis: This patent, similar to the '836 patent, is directed to tablet formulations comprising an extrudate of a CGRP active compound (like ubrogepant) in a water-soluble polymer matrix. The formulation is designed to create a rapidly disintegrating tablet to facilitate the release and absorption of the poorly water-soluble drug ('709 Patent, Abstract).
  • Asserted Claims: One or more claims are asserted (Compl. ¶ 205).
  • Accused Features: The complaint alleges that MSN’s ANDA product is a tablet formulation that infringes the claims of the patent (Compl. ¶¶ 202-204).

Note: Ten patents-in-suit are asserted in total. The remaining eight patents ('450, '004, '030, '408, '953, '750, '632, and '633) are also directed to either tablet formulations or methods of treating migraine with specific dosing regimens for ubrogepant, following the patterns of the '836 and '515 patents, respectively (Compl. ¶¶ 63, 67, 72, 76, 80, 84, 88, 92).

III. The Accused Instrumentality

Product Identification

  • The accused products are MSN’s ubrogepant oral tablets in 50 mg and 100 mg dosage forms, for which MSN seeks FDA approval via ANDA No. 219218 (Compl. ¶¶ 1, 96).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs' UBRELVY® Tablets and are intended for the acute treatment of migraine attacks in adults (Compl. ¶¶ 39, 96).
  • As a requirement for FDA approval, the generic products must be bioequivalent to UBRELVY® and are alleged to have the same indications and safety information on their proposed product labeling as the branded product (Compl. ¶¶ 105, 106).
  • The complaint alleges that MSN intends to market and sell its generic products in the United States prior to the expiration of the patents-in-suit, following FDA approval (Compl. ¶ 104). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide specific technical details about the accused generic product's formulation beyond the assertion that it is a bioequivalent version of UBRELVY® tablets submitted for approval under an ANDA. The infringement allegations are based on the act of filing the ANDA under 35 U.S.C. § 271(e)(2)(A) and the future infringement that would occur upon commercialization (Compl. ¶¶ 114, 147).

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... The complaint alleges MSN's ANDA product is a tablet that is pharmaceutically and therapeutically equivalent to UBRELVY® and necessarily contains the claimed extrudate with a polymer matrix, dispersing agent, and ubrogepant. ¶¶ 96, 113 col. 6:49-55
(b) a disintegration system... The complaint alleges MSN's product contains the claimed elements, including a disintegration system, by virtue of its required bioequivalence to UBRELVY®. ¶¶ 105, 113 col. 4:4-11
wherein said tablet has a hardness of from about 12 kP to about 18 kP... The complaint does not provide specific details on the hardness of MSN's tablet but alleges it will infringe one or more claims of the '836 patent. ¶ 114 col. 4:6-11
and wherein said tablet achieves complete disintegration in less than about 5 minutes... The complaint does not provide specific data on disintegration time but alleges the ANDA filing itself constitutes infringement of the patent claims. ¶ 114 col. 4:6-11

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... The complaint alleges that MSN's proposed product labeling will instruct healthcare providers and patients to administer the 50 mg generic tablet for the acute treatment of migraine in patients with severe hepatic impairment. ¶¶ 106, 149-151 col. 2:50-55
wherein the patient has a Child-Pugh score of Child-Pugh Class C... The complaint alleges MSN's proposed label will contain the same safety and efficacy information as UBRELVY®, which includes dosing instructions for this specific patient population. ¶¶ 41, 106, 151 col. 4:45-51
and wherein the patient’s migraine is safely and effectively treated. The complaint alleges that MSN's product, being bioequivalent, will be used to safely and effectively treat migraine as instructed by its label, thereby inducing infringement of this claim element. ¶¶ 105, 151 col. 2:50-55

Identified Points of Contention

  • Scope Questions: A central question for the formulation patents (e.g., '836 Patent) will be whether MSN's generic product, despite being bioequivalent, is actually formulated using the claimed "extrudate" comprising a specific "polymer matrix" and "dispersing agent." For the method patents (e.g., '515 Patent), a question may arise as to whether the term "safely and effectively treated" requires a specific clinical outcome or is met simply by administering the drug as indicated.
  • Technical Questions: A key factual dispute for the '836 Patent will be whether MSN’s ANDA product meets the specific physical parameters of the claims, such as hardness and disintegration time. The complaint does not provide sufficient detail for analysis of these parameters. For the '515 Patent, the dispute will likely focus on evidence of intent, raising the question of whether MSN's proposed label is sufficient to establish that MSN will induce medical professionals to perform the patented method.

V. Key Claim Terms for Construction

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

  • Context and Importance: This term is central to the '836 Patent's formulation claims. The patent claims a specific functional result: rapid disintegration. The construction of this term will be critical to determining whether the excipients used in MSN's product perform the function of the claimed "disintegration system."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Claim 3 suggests the system "comprises powdered sodium chloride and croscarmellose sodium," which may imply that other components or combinations could also serve as a disintegration system ('836 Patent, col. 17:3-5). The specification describes the system as comprising a "conventional disintegrant" and a "rapidly dissolving salt," which could be read to cover a variety of components ('836 Patent, col. 13:35-41).
    • Evidence for a Narrower Interpretation: The specification heavily emphasizes the combination of powdered sodium chloride and croscarmellose sodium as being particularly effective and surprising compared to other salts or disintegrants alone ('836 Patent, col. 11:1-14; Table II). A defendant may argue that the invention is narrowly focused on this specific combination to achieve the claimed rapid disintegration.

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

  • Context and Importance: This limitation appears in the method of use claims and is a common point of contention. Its definition determines the standard of proof for infringement. Practitioners may focus on this term because its interpretation could require Plaintiffs to show not just that the drug is administered, but that it achieves a particular clinical outcome.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue this term simply means the drug provides a therapeutic benefit for migraine as indicated on its FDA-approved label, without being tied to a specific statistical threshold of efficacy. The patent's abstract describes the method as being for the "acute treatment of migraine" ('515 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The patent specification provides detailed clinical trial data, including endpoints like "pain freedom at 2 hours" and "most bothersome symptom (MBS) freedom" ('515 Patent, col. 23:24-24:45; Table 14). A party may argue that "effectively treated" should be construed to require meeting the specific efficacy endpoints disclosed and claimed as the invention's contribution.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for the method-of-use patents (e.g., '515, '542). The basis for inducement is the allegation that MSN knows of the patents and, through its proposed product labeling, will knowingly and intentionally encourage and instruct healthcare professionals and patients to use the generic product in an infringing manner (Compl. ¶¶ 150-152).
  • Willful Infringement: The complaint does not explicitly use the term "willful infringement." However, it establishes a basis for such a claim by alleging that MSN had pre-suit knowledge of at least the '836, '515, '542, and '709 patents via the Notice Letters it sent as part of its ANDA filing (Compl. ¶¶ 97-100). The complaint requests a declaration that this is an "exceptional case" and an award of attorney fees, which is relief often associated with findings of willfulness or litigation misconduct (Compl. p. 71, ¶ G).

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

  • A core issue for the formulation patents will be one of technical identity: does MSN's proposed generic product, which is required by the FDA to be bioequivalent to UBRELVY®, necessarily embody the specific "extrudate" structure and "disintegration system" recited in claims of patents like the '836 Patent, or can bioequivalence be achieved through a non-infringing formulation?
  • A central question for the method-of-use patents will be one of induced infringement: will MSN's act of providing a product label that mirrors the FDA-approved label for UBRELVY®—including specific dosing instructions for patient subpopulations—constitute sufficient evidence that MSN possessed the specific intent to encourage direct infringement of the patented methods by doctors and patients?
  • A key legal question will be one of claim scope: can the functional language in the method claims, such as "safely and effectively treated," be construed to require a specific level of clinical efficacy detailed in the patent specification, and if so, what level of proof will be required to show that the use of the accused generic product meets that standard?