DCT

3:24-cv-04403

AbbVie Inc v. Aurobindo Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-04403, D.N.J., 03/29/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Aurobindo USA has its principal place of business there. The other two defendants are incorporated in India and may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' Abbreviated New Drug Application (ANDA) to market generic versions of the migraine drug UBRELVY® constitutes an act of infringement of four patents covering tablet formulations and specific methods of treatment.
  • Technical Context: The technology relates to pharmaceutical compositions and methods for treating migraine, a widespread neurological condition, by antagonizing the calcitonin gene-related peptide (CGRP) receptor.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 219088 to the FDA. Plaintiffs received a Paragraph IV certification notice letter regarding the ’836 patent on February 13, 2024, which asserted that the patent is invalid, unenforceable, or will not be infringed by the proposed generic products.

Case Timeline

Date Event
2014-02-05 Earliest Priority Date ('836 and '709 Patents)
2018-11-06 Issue Date (U.S. Patent No. 10,117,836)
2019-12-23 FDA Approval of NDA No. 211765 for UBRELVY®
2020-12-22 Earliest Priority Date ('515 and '542 Patents)
2023-08-08 Issue Date (U.S. Patent No. 11,717,515)
2024-01-02 Issue Date (U.S. Patent No. 11,857,542)
2024-02-13 Aurobindo's Paragraph IV Notice Letter Received
2024-03-12 Issue Date (U.S. Patent No. 11,925,709)
2024-03-29 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 the technical challenge of formulating certain CGRP antagonist compounds, which are promising for migraine treatment, into a solid oral dosage form. These compounds have low aqueous solubility, making them difficult to deliver effectively in a tablet, while liquid formulations are considered commercially undesirable for this type of therapy (’836 Patent, col. 2:1-14).
  • The Patented Solution: The invention is a tablet composition that enhances the delivery of the poorly soluble CGRP compound. The solution involves creating an "extrudate" by dispersing the active compound and a dispersing agent (e.g., vitamin E TPGS) within a specific water-soluble polymer matrix (polyvinylpyrrolidone/vinyl acetate copolymer). This extrudate is then combined with a specialized "disintegration system" containing powdered sodium chloride, which allows the tablet to break apart rapidly when administered ('836 Patent, Abstract; col. 3:40-4:34).
  • Technical Importance: This formulation technology provides a method to create a stable, immediate-release oral tablet that can improve the absorption and bioavailability of a class of drugs otherwise difficult to deliver effectively. (’836 Patent, col. 2:15-33).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specifying them (Compl. ¶81). Independent claim 1 is representative.
  • Essential elements of independent claim 1 include:
    • A tablet comprising:
    • (a) an extrudate, which itself comprises: (i) a water-soluble polymer matrix, (ii) a dispersing agent, and (iii) a CGRP compound of Formula I, where the agent and compound are dispersed in the matrix; and
    • (b) a disintegration system.
    • The tablet must have a hardness of from about 12 kP to 18 kP.
    • The tablet must achieve complete disintegration in less than 5 minutes in a specified test. (’836 Patent, col. 16:35-50).
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 11,717,515 - "Treatment of Migraine," issued August 8, 2023

The Invention Explained

  • Problem Addressed: The patent addresses the need for safe and effective migraine treatments for specific patient populations. It notes that prior CGRP antagonists were discontinued due to observations of elevated liver enzymes, highlighting the importance of establishing safe dosing regimens, particularly for patients with pre-existing liver conditions (’515 Patent, col. 1:40-51).
  • The Patented Solution: The invention is a method for the acute treatment of migraine in patients with severe hepatic impairment. The claimed solution is a specific dosing regimen: administering a first 50 mg dose of ubrogepant to a patient identified as having a Child-Pugh Class C score, with the option of administering a second 50 mg dose at least two hours after the first (’515 Patent, Abstract; col. 2:52-64).
  • Technical Importance: The claimed method provides a clinically evaluated, safe, and effective treatment protocol for a vulnerable patient population (those with severe liver impairment) who may be at higher risk for adverse drug effects. (’515 Patent, col. 3:35-49).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specification (Compl. ¶113). Independent claim 1 is representative.
  • 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 administering a first dose of 50 mg of ubrogepant.
    • The patient is one who has a Child-Pugh score of Child-Pugh Class C. (’515 Patent, col. 30:40-45).
  • The complaint does not explicitly reserve the right to assert dependent claims.

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 in patients with severe renal impairment. The invention claims a method comprising administering a first 50 mg dose of ubrogepant to a patient whose estimated creatinine clearance is between 15-29 mL/min, with an option for a second 50 mg dose. (’542 Patent, Abstract; col. 2:47-56).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶141).
  • Accused Features: The accused features relate to the anticipated use of Aurobindo's generic product. The complaint alleges that the product's label will instruct or encourage physicians to prescribe the drug to patients with severe renal impairment according to the claimed method, thereby inducing infringement (Compl. ¶¶142-143).

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

  • Technology Synopsis: This patent, like the ’836 patent, is directed to a tablet formulation for CGRP compounds. The invention claims a tablet made of an extrudate (comprising the active compound, a water-soluble polymer matrix, and a dispersing agent) and a disintegration system, characterized by specific physical properties of hardness and rapid disintegration. (’709 Patent, Abstract; col. 4:1-18).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶170).
  • Accused Features: The accused features are the physical and chemical composition of Aurobindo's proposed generic ubrogepant tablets. The complaint alleges these tablets will be bioequivalent to UBRELVY® and will therefore possess the claimed formulation characteristics (Compl. ¶¶168-169).

III. The Accused Instrumentality

Product Identification

  • The accused products are Aurobindo’s ubrogepant oral tablets in 50 mg and 100 mg dosage forms, for which Aurobindo filed Abbreviated New Drug Application (ANDA) No. 219088 with the FDA (Compl. ¶¶1, 63).

Functionality and Market Context

  • The products are proposed generic versions of Plaintiffs' commercial product, UBRELVY® Tablets (Compl. ¶1). Ubrogepant is a calcitonin gene-related (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults (Compl. ¶40). The complaint alleges that to secure FDA approval, Aurobindo's generic products must be shown to be "bioequivalent" to UBRELVY® and that their proposed labeling will contain the same indications and safety information as the approved UBRELVY® label (Compl. ¶¶70-71).

IV. Analysis of Infringement Allegations

The complaint does not provide specific technical details about the accused generic product's formulation or proposed final label, as Plaintiffs state they have not yet received access to Aurobindo's ANDA (Compl. ¶72). The infringement allegations are therefore based on the regulatory framework requiring a generic drug to be the same as its reference listed drug.

The infringement theory for the product claims (’836 and ’709 patents) is that for Aurobindo's product to be "pharmaceutically and therapeutically equivalent" to UBRELVY®, it must necessarily contain the same active ingredient and possess a formulation with the same characteristics, thereby meeting the limitations of the asserted product claims (Compl. ¶¶79, 168).

The infringement theory for the method of use claims (’515 and ’542 patents) is that Aurobindo’s proposed label will necessarily mirror the approved UBRELVY® label, which includes instructions for use in specific patient populations (e.g., those with severe hepatic or renal impairment). The complaint alleges that by providing these instructions, Aurobindo will actively induce healthcare providers to prescribe and patients to use the generic product in a manner that directly infringes the claimed methods (Compl. ¶¶115, 143).

The complaint does not provide sufficient detail for a claim chart analysis. No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

For the ’836 Patent (Formulation)

  • The Term: "disintegration system" (Claim 1)
  • Context and Importance: The invention's asserted novelty includes its ability to disintegrate rapidly (in less than 5 minutes). The composition of the "disintegration system" is critical to this function. The construction of this term will be central to determining infringement, particularly if Aurobindo's formulation uses different excipients to achieve rapid disintegration.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 recites the term without listing specific required components, suggesting it could cover any combination of excipients that performs the function of disintegration (’836 Patent, col. 16:47). The specification provides examples such as "croscarmellose sodium or crospovidone, and Powdered Sodium Chloride," but does not explicitly state these are the only possibilities (’836 Patent, col. 10:48-51).
    • Evidence for a Narrower Interpretation: The patent's detailed description strongly emphasizes the combination of a conventional disintegrant and "Powdered Sodium Chloride" as a key inventive feature, noting that tablets with other salts failed to meet the 5-minute disintegration target (’836 Patent, col. 11:1-13, Table II). A party might argue that the term should be construed to require this specific combination, which the patent presents as essential to solving the technical problem.

For the ’515 Patent (Method of Use)

  • The Term: "severe hepatic impairment" (Claim 1)
  • Context and Importance: This term defines the specific patient population for which the claimed method is intended. A finding of infringement requires that the accused conduct involves treating patients who fall within this definition.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term itself is a recognized clinical classification. A party could argue it should be given its plain and ordinary meaning as understood by a person of ordinary skill in the medical arts.
    • Evidence for a Narrower Interpretation: Claim 1 explicitly defines the term by reference to a specific clinical standard: "wherein the patient has a Child-Pugh score of Child-Pugh Class C" (’515 Patent, col. 30:43-45). This language provides a precise, objective, and narrow definition that is integral to the claim's scope, suggesting little room for a broader interpretation beyond this clinical classification.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents-in-suit. The inducement allegations are based on the contention that Aurobindo's proposed package insert and promotional activities will instruct and encourage healthcare professionals and patients to use the generic ubrogepant tablets in an infringing manner, particularly for the methods of use claimed in the ’515 and ’542 patents (Compl. ¶¶83, 115, 143). The contributory infringement allegations assert that Aurobindo’s products are especially adapted for infringing uses and have no substantial non-infringing uses (Compl. ¶¶87-88).

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

  • A central issue will be one of factual identity: For the formulation patents (’836 and ’709), the case will depend on whether Aurobindo's generic product, once its composition is revealed, contains the exact "water-soluble polymer matrix," "dispersing agent," and "disintegration system" required by the claims, or if Aurobindo has developed a formulation that is technically different but still bioequivalent.
  • A key evidentiary question will be one of induced infringement: For the method patents (’515 and ’542), the dispute will focus on whether the language of Aurobindo’s final, FDA-approved label actively encourages or instructs physicians to prescribe the specific 50 mg dose to patients specifically identified as having "severe hepatic impairment (Child-Pugh Class C)" or "severe renal impairment," thereby meeting the legal standard for inducement.