DCT

1:24-cv-00151

AbbVie Inc v. Hetero Labs Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Name: AbbVie Inc. v. Hetero Labs Limited
  • Case Identification: 1:24-cv-00151, D. Del., 02/05/2024
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendant Hetero USA Inc. is a Delaware corporation, and the other foreign-based Hetero defendants may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's ORILISSA® product constitutes an act of infringement of two patents related to methods of administering elagolix.
  • Technical Context: The technology concerns elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist used for managing pain associated with endometriosis and treating heavy menstrual bleeding.
  • Key Procedural History: This lawsuit follows two prior suits filed by AbbVie against Hetero concerning the same ANDA but asserting different patents. The patents-in-suit in this action, U.S. Patent Nos. 11,690,845 and 11,690,854, issued on July 4, 2023, after the initiation of the prior litigations.

Case Timeline

Date Event
2018-04-19 Priority Date for ’854 Patent
2018-07-23 FDA approves AbbVie's ORILISSA® (elagolix)
2020-03-05 Priority Date for ’845 Patent
2022-09-12 Hetero sends First Notice Letter for ANDA No. 217690
2022-10-27 AbbVie files "First Suit" against Hetero
2023-03-10 Hetero sends Second Notice Letter for ANDA No. 217690
2023-04-24 AbbVie files "Second Suit" against Hetero
2023-07-04 U.S. Patent No. 11,690,845 Issues
2023-07-04 U.S. Patent No. 11,690,854 Issues
2024-02-05 Complaint Filed in Present Action

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

U.S. Patent No. 11,690,845 - Methods of Administering Elagolix (Issued Jul. 4, 2023)

The Invention Explained

  • Problem Addressed: The patent addresses the potential for drug-drug interactions when elagolix is administered with other drugs that are metabolized by specific liver enzymes, such as CYP2B6 (which metabolizes the antidepressant bupropion) or CYP2C19 (which metabolizes the proton pump inhibitor omeprazole) (’845 Patent, col. 1:21-46). The background notes a relationship between peak plasma concentrations of bupropion and certain adverse events, highlighting the need to understand and manage such interactions (’845 Patent, col. 1:33-37).
  • The Patented Solution: The patent discloses methods of co-administering elagolix with a CYP2B6 or CYP2C19 substrate. The invention is based on the discovery that, contrary to what in vitro studies suggested, co-administration of elagolix with bupropion resulted in an increased peak concentration (Cmax) of bupropion and its metabolite, but not a clinically significant change in total drug exposure (AUC) (’845 Patent, col. 8:50-67). The patent claims specific methods of administration that result in defined pharmacokinetic outcomes. A chart in the patent visually summarizes the ratios of key pharmacokinetic parameters for bupropion when administered with and without elagolix (’845 Patent, FIG. 3).
  • Technical Importance: Characterizing specific drug-drug interaction profiles is critical for ensuring patient safety and providing physicians with guidance for safely co-prescribing medications for patients with comorbid conditions (’845 Patent, col. 1:21-37).

Key Claims at a Glance

  • The complaint asserts at least one claim without specifying which one (Compl. ¶65). Independent claim 1 is representative of the invention related to bupropion.
  • Independent Claim 1 requires:
    • A method for treating a gynecological disorder.
    • Orally administering elagolix sodium in an amount equivalent to 300 mg of elagolix free acid twice daily.
    • The patient receiving a once daily dose of 150 mg of bupropion.
    • Wherein the co-administration results in specific, defined ratios for the peak concentration (Cmax) and total exposure (AUCinf) of both bupropion and its metabolite (hydroxybupropion) compared to when bupropion is administered alone.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 11,690,854 - Methods of Treating Heavy Menstrual Bleeding (Issued Jul. 4, 2023)

The Invention Explained

  • Problem Addressed: The patent’s background section identifies heavy menstrual bleeding (HMB), particularly when associated with uterine fibroids, as a highly prevalent condition that is inconvenient, may lead to iron-deficiency anemia, and is a leading cause of surgical interventions such as hysterectomy (’854 Patent, col. 1:31-44).
  • The Patented Solution: The invention provides a method for treating HMB by administering elagolix, a GnRH receptor antagonist that blocks the release of certain pituitary hormones, thereby reducing estrogen levels (’854 Patent, col. 2:5-10). The method can also include co-administering estrogens and progestogens ("add-back" therapy) to mitigate potential side effects of low estrogen, such as bone mineral density loss (’854 Patent, col. 2:42-47). A figure in the patent shows the high percentage of subjects who achieved the clinically significant endpoint of reducing menstrual blood loss to less than 80 mL and by at least 50% from baseline (’854 Patent, FIG. 1).
  • Technical Importance: The invention provides an oral, non-surgical treatment option that can effectively manage HMB, potentially allowing patients to avoid major surgery like hysterectomy (’854 Patent, col. 1:42-44).

Key Claims at a Glance

  • The complaint asserts at least one claim without specifying which one (Compl. ¶89). Independent claim 1 is representative.
  • Independent Claim 1 requires:
    • A method of treating heavy menstrual bleeding in a subject with uterine fibroids.
    • Administering an effective amount of elagolix (or a pharmaceutically acceptable salt thereof).
    • In combination with an estrogen and a progestogen.
    • Wherein the subject experiences a reduction of menstrual blood loss to less than 80 mL per cycle and at least a 50% reduction from a baseline volume.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Hetero's Generic Product," identified as a generic version of ORILISSA® (elagolix sodium oral tablets) for which Hetero has filed ANDA No. 217690 (Compl. ¶¶1-2, 59). The ANDA seeks approval for dosage forms equivalent to 150 mg and 200 mg of elagolix base (Compl. ¶59).
  • Functionality and Market Context: The complaint alleges that Hetero’s product is a GnRH receptor antagonist indicated for managing moderate to severe pain associated with endometriosis (Compl. ¶6). Plaintiff alleges that Hetero has represented to the FDA that its product is "pharmaceutically and therapeutically equivalent" to AbbVie's branded ORILISSA® tablets (Compl. ¶¶66, 90). The product is intended for commercial manufacture and sale in the United States upon FDA approval (Compl. ¶¶2, 22).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a full claim-chart analysis. It pleads infringement in a conclusory manner, stating that the product described in Hetero's ANDA will infringe "at least one claim" of each patent-in-suit (Compl. ¶¶65, 89). The infringement theory is based on 35 U.S.C. § 271(e)(2)(A), where the filing of the ANDA is the statutory act of infringement. For these method-of-use patents, the allegation is that the proposed label for Hetero's Generic Product will induce infringement by instructing or encouraging physicians and patients to use the drug in a manner that falls within the scope of the patent claims (Compl. ¶¶72, 96).

  • Identified Points of Contention:
    • Scope Questions: A primary question arises from a mismatch between the dosages accused in the complaint and those recited in the representative independent claims. The complaint accuses generic versions of the 150 mg and 200 mg ORILISSA® products (Compl. ¶59), while the independent claims of the ’845 and ’854 patents recite specific methods involving a 300 mg twice-daily dose of elagolix (’845 Patent, cl. 1; ’854 Patent, Abstract). This raises the question of which specific claims AbbVie intends to assert and whether its infringement theory will rely on different independent claims, dependent claims, or the doctrine of equivalents.
    • Technical Questions: For the ’845 Patent, a factual question will be whether the administration of Hetero’s product, as described in its ANDA, in combination with drugs like bupropion, would actually result in the specific pharmacokinetic ratios required by the claims. For the ’854 Patent, a key question is whether the proposed label for Hetero's product will contain an indication for treating heavy menstrual bleeding associated with uterine fibroids, which would support a claim of induced infringement.

V. Key Claim Terms for Construction

  • ’845 Patent:

    • The Term: "co-administration"
    • Context and Importance: This term is central to the method claimed. The infringement allegation is one of inducement, which requires showing that the defendant took active steps to encourage the infringing method. Practitioners may focus on this term because its construction will determine what level of instruction or foreseeability is required in the accused product's label to establish infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification uses the term "concomitant administration" synonymously, which could be interpreted broadly to mean any contemporaneous use of the two drugs, whether explicitly instructed or not (’845 Patent, col. 2:7).
      • Evidence for a Narrower Interpretation: The claim recites a multi-step "method for treating," which could suggest that the co-administration must be an intentional part of a prescribed therapeutic regimen, potentially requiring a more direct instruction on the product label.

  • ’854 Patent:

    • The Term: "heavy menstrual bleeding"
    • Context and Importance: This term defines the medical condition being treated and is thus critical to the scope of infringement. Whether a patient's condition meets this definition determines if the method is practiced.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim itself uses the general clinical term "heavy menstrual bleeding," which a party could argue should be given its plain and ordinary meaning as understood by a clinician, which may be subjective.
      • Evidence for a Narrower Interpretation: The background section provides a specific, quantitative definition: "menorrhagia, defined as greater than 80 mL per menstrual cycle" (’854 Patent, col. 1:40-42). A party could argue this specific definition, provided by the patentee, should be used to construe the claim term.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for both patents. The basis is the allegation that Hetero's promotional activities and proposed package insert will instruct healthcare providers and patients to use the generic product in a manner that directly infringes the claimed methods (Compl. ¶¶71-72, 95-96). For the ’854 Patent, the complaint also alleges contributory infringement, asserting that Hetero’s product is especially adapted for an infringing use and that there is no substantial non-infringing use for it (Compl. ¶¶93, 98-99).
  • Willful Infringement: While the complaint does not use the word "willful," it alleges that Hetero has knowledge of the patents-in-suit and that its continued pursuit of FDA approval in the face of this knowledge constitutes a refusal to change course, which could form the basis for a future claim of willful infringement (Compl. ¶¶62, 80, 95, 106).

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

  • A core issue will be one of infringement scope: Given that the complaint accuses 150 mg and 200 mg dosage forms, while the representative independent claims of the asserted patents recite methods using a 300 mg twice-daily dose, a central question will be how AbbVie intends to prove infringement. The court will need to determine if the infringement theory relies on other asserted claims not analyzed here, or on a doctrine of equivalents argument to bridge the dosage gap.
  • A key evidentiary question will be one of inducement: As this case concerns method-of-use patents, the outcome will depend on whether the evidence, particularly the proposed label for Hetero's generic product, is found to contain sufficient instruction or encouragement to persuade physicians and patients to perform the specific steps of the claimed methods, thereby inducing infringement.