DCT

1:25-cv-00190

AbbVie Inc v. Hetero USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00190, D. Del., 04/22/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Hetero USA, Inc. is a Delaware corporation, and the foreign-domiciled Hetero entities 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 RINVOQ® product constitutes infringement of four U.S. patents covering methods of treating inflammatory bowel diseases and processes for preparing the active pharmaceutical ingredient.
  • Technical Context: The technology concerns upadacitinib, an oral Janus kinase (JAK) inhibitor used to treat various immune-mediated diseases by modulating intracellular signaling pathways.
  • Key Procedural History: This action is related to prior, consolidated patent infringement lawsuits filed by AbbVie Inc against Hetero and other generic manufacturers concerning their respective ANDA submissions for generic RINVOQ®. The current complaint was filed in response to a new Notice Letter from Hetero, dated February 5, 2025, which included Paragraph IV certifications for two of the patents-in-suit.

Case Timeline

Date Event
2015-10-16 Earliest Priority Date for ’393 and ’621 Patents
2017-03-09 Earliest Priority Date for ’411 and ’922 Patents
2019-02-12 ’393 Patent Issue Date
2019-08-16 RINVOQ® First FDA Approval
2021-02-16 ’393 Patent Certificate of Correction Issue Date
2023-01-31 ’922 Patent Issue Date
2023-03-21 ’411 Patent Issue Date
2023-10-16 Hetero's Original Notice Letter Sent to AbbVie
2024-11-05 ’621 Patent Issue Date
2024-12-03 ’621 Patent Certificate of Correction Issue Date
2025-02-05 Hetero's New Notice Letter Sent to AbbVie
2025-04-22 Complaint Filing Date

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

U.S. Patent No. 11,607,411 - Methods of treating Crohn’s disease and ulcerative colitis (Issued: 03/21/2023)

The Invention Explained

  • Problem Addressed: The patent's background describes inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis, as chronic and debilitating conditions for which existing therapeutic options are limited and may have significant adverse effects or lose efficacy over time (U.S. Patent No. 11607411, col. 2:38-4:66).
  • The Patented Solution: The patent discloses specific methods for treating ulcerative colitis by administering the JAK1 inhibitor upadacitinib. The core of the invention is a two-phase treatment regimen: an initial, higher "induction dose" to achieve clinical remission, followed by a lower "maintenance dose" to sustain that remission over time ('411 Patent, Abstract; col. 5:29-6:66).
  • Technical Importance: The invention provides a specific, clinically evaluated dosing schedule intended to improve outcomes for patients with ulcerative colitis, particularly those who have not responded adequately to other treatments like anti-TNF therapies ('411 Patent, col. 3:55-4:15).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims and specifically notes that Hetero did not contest infringement of claims 1-4 in its Paragraph IV notice letter (Compl. ¶¶54, 55). Independent claim 1 is representative.
  • Claim 1 Elements:
    • A method of inducing and maintaining clinical remission of ulcerative colitis in an adult patient.
    • The method comprises:
      • (a) administering to the patient an induction dose of 45 mg of upadacitinib once daily for 8 weeks.
      • (b) after the last induction dose, administering a maintenance dose of 15 mg of upadacitinib once daily.
    • Wherein the method achieves clinical remission of the ulcerative colitis in the patient.
    • Wherein the adult patient had an inadequate response or intolerance to a previous treatment with an anti-TNF agent.

U.S. Patent No. 11,564,922 - Methods of treating Crohn’s disease and ulcerative colitis (Issued: 01/31/2023)

The Invention Explained

  • Problem Addressed: The patent addresses the significant medical challenge of treating moderately to severely active Crohn's disease, particularly in patients for whom other therapies, such as corticosteroids, immunosuppressants, or biologic agents, have failed (U.S. Patent No. 11564922, col. 3:1-5:26).
  • The Patented Solution: The invention describes methods for achieving clinical remission in Crohn's disease patients using specific dosing regimens of upadacitinib. The claimed method involves an induction phase with a 45 mg daily dose, followed by a maintenance phase with a 15 mg daily dose, with remission being achieved at specific time points ('922 Patent, Abstract; col. 5:27-6:26).
  • Technical Importance: The claimed dosing method offers a therapeutic option for a difficult-to-treat patient population suffering from refractory Crohn's disease, providing specific, clinically tested induction and maintenance schedules ('922 Patent, col. 33:24-33).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims and notes that Hetero did not contest infringement of claims 1-4 (Compl. ¶¶64, 65). Independent claim 1 is representative.
  • Claim 1 Elements:
    • A method of treating Crohn's disease in an adult patient having moderately to severely active Crohn's disease.
    • The method comprising:
      • (a) administering to the patient an induction dose of 45 mg of upadacitinib once daily for 12 weeks.
      • (b) orally administering to the patient a first maintenance dose of 15 mg of upadacitinib once daily, after the last induction dose.
    • Wherein the method achieves clinical remission of the Crohn's disease in the patient.
    • Wherein the adult patient had an inadequate response or intolerance to a previous treatment with an anti-TNF agent.

U.S. Patent No. 10,202,393 - Processes for the Preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof (Issued: 02/12/2019)

  • Patent Identification: U.S. Patent No. 10202393, "Processes for the Preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof" (Compl. ¶42).
  • Technology Synopsis: The patent addresses technical challenges in the commercial-scale manufacturing of upadacitinib (referred to as "Compound 1"), including the use of hazardous reagents in prior processes and difficulties in obtaining stable, crystalline forms suitable for pharmaceutical formulations (U.S. Patent No. 10,202,393, col. 1:47-2:31). It discloses specific chemical synthesis processes and various solid-state forms (e.g., hydrates, anhydrates) of the compound with improved physical and chemical properties ('393 Patent, col. 2:32-45).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" of the ’393 Patent (Compl. ¶74).
  • Accused Features: The complaint alleges that "Hetero's 45 mg ANDA Product infringes" the patent, suggesting the product is either made by a claimed process or contains a claimed solid-state form of upadacitinib (Compl. ¶74).

U.S. Patent No. 12,134,621 - Processes for the Preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof (Issued: 11/05/2024)

  • Patent Identification: U.S. Patent No. 12134621, "Processes for the Preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof" (Compl. ¶43).
  • Technology Synopsis: Belonging to the same family as the ’393 Patent, this patent also discloses processes for preparing upadacitinib and its intermediates, as well as various solid-state forms of the compound (U.S. Patent No. 12,134,621, col. 1:43-2:48). The invention aims to provide manufacturing methods that avoid hazardous reagents and yield crystalline products with properties amenable to large-scale pharmaceutical production ('621 Patent, col. 2:9-24).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" of the ’621 Patent (Compl. ¶83).
  • Accused Features: The complaint alleges that "Hetero's 45 mg ANDA Product infringes," which implies the product is accused of being made by a claimed process or containing a claimed solid-state form (Compl. ¶83).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "Hetero's ANDA Products," which are purported generic versions of RINVOQ® extended-release tablets in 15 mg, 30 mg, and 45 mg dosages (Compl. ¶¶1, 9, 44). The act of infringement is the submission of Abbreviated New Drug Application No. 218859 to the U.S. Food and Drug Administration (FDA) (Compl. ¶44).

Functionality and Market Context

  • The accused products contain upadacitinib, a Janus kinase (JAK) inhibitor that modulates cellular signaling pathways to treat immune-mediated diseases (Compl. ¶4). Hetero's ANDA seeks FDA approval to market these products as generic equivalents to AbbVie's "highly successful" and "ground-breaking" RINVOQ® drug, which has been used to treat over 160,000 patients in the United States for conditions including rheumatoid arthritis and ulcerative colitis (Compl. ¶¶1, 3). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail to construct a claim chart. The infringement theory is based on Hetero's submission of ANDA No. 218859 under 35 U.S.C. § 271(e)(2)(A), which seeks approval to market generic versions of RINVOQ® for indications and at dosages that are allegedly covered by the patents-in-suit (Compl. ¶¶56, 66). The complaint alleges that Hetero's Paragraph IV notice letters failed to provide a factual or legal basis for non-infringement and did not contest infringement of claims 1-4 of the '411 and '922 patents (Compl. ¶¶49, 55, 65). Infringement of the method-of-use claims ('411 and '922 patents) will depend on whether Hetero's proposed product labeling instructs or encourages use in a manner that meets all claim limitations. Infringement of the process and composition claims ('393 and '621 patents) will depend on the specific processes used to manufacture, and the specific solid-state forms contained within, Hetero's ANDA products (Compl. ¶¶74, 83).

  • Identified Points of Contention:
    • Scope Questions: A central issue for the '411 and '922 patents will be whether Hetero's proposed label for its generic product instructs administration in a manner that falls within the specific dosing regimens of the asserted claims. This raises questions about the construction of terms defining the patient population (e.g., "inadequate response... to an anti-TNF agent") and the precise steps of the dosing schedule (e.g., the duration of the "induction dose"). For the '393 and '621 patents, a key question will be whether Hetero’s product contains one of the specifically claimed solid-state forms of upadacitinib.
    • Technical Questions: A key evidentiary question for the method-of-use patents will be how the language of Hetero’s proposed label will be interpreted by physicians and what clinical outcomes (e.g., "achieves clinical remission") can be expected from following those instructions. For the process patents, the central technical question will be what evidence exists within Hetero's confidential ANDA filing to demonstrate that its manufacturing process or final product composition meets the claim limitations.

V. Key Claim Terms for Construction

  • The Term: "achieves clinical remission" (from Claim 1 of the '411 and '922 Patents)

    • Context and Importance: This term defines a required clinical outcome of the patented method. Its construction is critical because infringement will depend on whether the use directed by Hetero's proposed label would be expected to "achieve" this result. Practitioners may focus on whether this term requires a specific, quantifiable level of efficacy as demonstrated in the patent's own clinical trials.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides general definitions, such as "a state of controlling a disease or disorder" or "regression or cessation of a symptom" ('411 Patent, col. 42:1-5). This language may support a construction based on general clinical understanding.
      • Evidence for a Narrower Interpretation: The specification also defines "clinical remission" with high specificity by reference to clinical scoring systems, such as an "Adapted Mayo score... of ≤1 and not greater than baseline, an RBS of 0, and an endoscopic subscore ≤1" ('411 Patent, col. 37:25-30). This suggests the possibility of a narrower construction tied to objective metrics.

  • The Term: "an adult patient had an inadequate response or intolerance to a previous treatment with an anti-TNF agent" (from Claim 1 of the '411 and '922 Patents)

    • Context and Importance: This limitation defines the specific patient population to whom the patented method applies. The scope of the claim hinges on how "inadequate response or intolerance" is defined. The dispute may turn on whether this requires failure on a specific type or number of prior treatments, or if it has a more general clinical meaning.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term is used throughout the specification in a general clinical context, which could support an interpretation based on its plain and ordinary meaning to a person of skill in the art ('411 Patent, col. 4:10-15).
      • Evidence for a Narrower Interpretation: The detailed description of the clinical studies on which the patent is based specifies the exact criteria used to enroll patients who had an "inadequate response" to prior anti-TNF agents ('411 Patent, col. 187:51-188:22). This detailed criteria could be cited to support a narrower construction limited to the types of treatment failures observed in the patent's examples.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if its ANDA is approved, Hetero will actively induce and contribute to infringement by physicians and patients who prescribe and use the generic products according to their labels (Compl. ¶¶50, 57, 67).
  • Willful Infringement: The complaint alleges that Hetero had actual and constructive notice of the patents prior to submitting its ANDA and filed its application "without adequate justification" for its Paragraph IV certifications (Compl. ¶¶58-59, 68-69). This conduct is alleged to make the case "exceptional" under 35 U.S.C. § 285, entitling AbbVie to attorneys' fees (Compl. ¶¶59, 69, 78, 87).

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

  • A core issue will be one of label interpretation: Will the instructions for use in Hetero's proposed product label be found to direct or encourage physicians and patients to perform the specific, multi-step dosing regimens required by the asserted method-of-use claims, particularly for the specified patient population?
  • A second key question will be one of claim construction: How will the court define clinical outcome terms like "achieves clinical remission" and patient population terms like "inadequate response"? The case may turn on whether these terms are given a broad clinical meaning or are limited to the specific, quantifiable metrics detailed in the patents' clinical trial examples.
  • Finally, for the '393 and '621 patents, a central evidentiary question will be whether AbbVie can demonstrate, likely through discovery of Hetero's confidential ANDA, that the accused generic product contains a specific, patented crystalline form of upadacitinib or was manufactured using a patented process.