DCT

1:25-cv-00422

AbbVie Inc v. Aurobindo Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00422, D. Del., 04/04/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation and Defendant Aurobindo Pharma Ltd. allegedly has continuous and systematic contacts with the state and intends to sell its products there.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug RINVOQ® constitutes an act of infringement of a patent covering the drug's active ingredient.
  • Technical Context: The technology is in the field of medicinal chemistry, specifically concerning tricyclic compounds that function as Janus kinase (JAK) inhibitors for the treatment of immune-mediated diseases.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendants' ANDA submission and a Paragraph IV certification sent to Plaintiff. The complaint notes that this suit follows a new Notice Letter dated February 19, 2025, and that related, consolidated litigation against Defendants and other generic manufacturers is already pending in the same district. The asserted patent, RE47,221, is a reissue of U.S. Patent No. 8,426,411.

Case Timeline

Date Event
2009-12-01 RE’221 Patent Priority Date
2013-04-23 Original Patent (8,426,411) Issue Date
2019-02-05 RE’221 Patent Issue Date
2019-08-16 RINVOQ® First FDA Approval
2025-01-03 FDA Tentative Approval of Aurobindo's ANDA
2025-02-19 Aurobindo's Notice Letter to AbbVie
2025-04-04 Complaint Filing Date

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

U.S. Patent No. RE47,221 - "Tricyclic compounds"

The Invention Explained

  • Problem Addressed: The patent addresses diseases associated with abnormal activity of protein kinases, a large family of enzymes that regulate cellular processes (RE’221 Patent, col. 1:43-46). Specifically, it targets Janus kinases (JAKs), which are involved in signaling pathways that can lead to immunological disorders, such as autoimmune diseases, when dysregulated (RE’221 Patent, col. 39:1-12; Compl. ¶4).
  • The Patented Solution: The invention provides a new class of tricyclic compounds designed to inhibit the activity of protein kinases, particularly JAKs (RE’221 Patent, Abstract; col. 1:61-64). By inhibiting these enzymes, the compounds can modulate the immune response and are therefore proposed as treatments for a variety of immune-mediated conditions and other diseases (RE’221 Patent, col. 39:21-26). The specification provides numerous examples of such compounds and methods for their synthesis (RE’221 Patent, col. 7:6-34:64).
  • Technical Importance: The development of selective JAK inhibitors represented a shift toward targeted oral therapies for autoimmune diseases previously treated primarily with injectable biologics (Compl. ¶¶3, 8).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" and specifically notes that Defendants did not contest infringement of claims 13 and 14 in their notice letter (Compl. ¶¶44, 45).
  • Independent Claim 13: This is a compound claim directed to a specific chemical structure, which corresponds to the active ingredient upadacitinib. The essential elements are the specific arrangement of atoms and bonds forming the molecule:
    • A compound represented by the chemical structure for (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.
    • Or a pharmaceutically acceptable salt thereof.

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendants' generic versions of RINVOQ® 15 mg and 30 mg tablets, for which Defendants seek FDA approval via ANDA No. 218866 (the "Aurobindo ANDA Products") (Compl. ¶35).

Functionality and Market Context

  • The Aurobindo ANDA Products contain upadacitinib, the same active pharmaceutical ingredient as AbbVie's RINVOQ® (Compl. ¶¶1, 3). As a JAK inhibitor, the product functions by modulating cellular signaling pathways to treat various immune-mediated diseases, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis (Compl. ¶¶3, 4, 7).
  • The complaint alleges that RINVOQ® is a "highly successful" and "ground-breaking" drug, and that Defendants intend to commercially manufacture and sell their generic versions in the United States upon receiving final FDA approval, thereby competing directly with RINVOQ® (Compl. ¶¶1, 3, 18).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement theory is based on the allegation that Defendants' ANDA filing for a generic version of RINVOQ® is a technical act of infringement under 35 U.S.C. § 271(e)(2). The core of the allegation is that the Aurobindo ANDA Products contain the specific chemical compound claimed in the RE’221 Patent.

  • RE’221 Patent Infringement Allegations
Claim Element (from Independent Claim 13) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound represented by the following structure: [structure for upadacitinib] The Aurobindo ANDA Products are alleged to be generic versions of RINVOQ® and to contain the active ingredient upadacitinib, which is the compound represented by the claimed structure. ¶¶35, 44 col. 953:1-15
or a pharmaceutically acceptable salt thereof. Defendants' ANDA filing seeks approval for a drug product that necessarily contains the claimed compound, either in its base form or as a pharmaceutically acceptable salt, for administration to patients. ¶¶35, 44 col. 50:47-68
  • Identified Points of Contention:
    • Legal Questions: The complaint's primary assertion regarding infringement is that "Aurobindo did not contest infringement of claims 13–14 of the RE’221 Patent in Aurobindo's February 19, 2025 Notice Letter" (Compl. ¶45). This raises the legal question of what preclusive or evidentiary effect, if any, this alleged omission has on Defendants' ability to contest infringement in litigation.
    • Technical Questions: In a Hatch-Waxman case involving a compound claim, the central technical question is whether the active ingredient in the proposed generic product is the same as the claimed compound. Given the nature of the ANDA process, which requires the generic to have the same active ingredient as the reference listed drug, a significant dispute on this point is not suggested by the complaint. The primary dispute will likely concern the patent's validity.

V. Key Claim Terms for Construction

  • The Term: "pharmaceutically acceptable salt thereof"
  • Context and Importance: This term defines a portion of the claim's scope beyond the specific base compound structure. If Defendants' product were to use a different salt form of upadacitinib, the precise boundaries of what constitutes a "pharmaceutically acceptable salt" could become a focus of the dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a conventional and broad definition, stating that the term refers to salts that are "within the scope of sound medical judgment, suitable for use in contact with the tissues of humans and lower animals without undue toxicity, irritation, allergic response and the like" (RE’221 Patent, col. 50:48-53). It further provides an extensive, non-limiting list of acid addition and base addition salts that would be included (RE’221 Patent, col. 50:56-col. 51:4).
    • Evidence for a Narrower Interpretation: The specification does not appear to contain language that would support a narrower interpretation of this standard pharmaceutical term. A party seeking a narrower construction would likely need to rely on arguments from the prosecution history or expert testimony, neither of which is detailed in the complaint.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Defendants will actively induce infringement by marketing the Aurobindo ANDA Products for the same indications as RINVOQ® (Compl. ¶47). The product's label and instructions would allegedly encourage and instruct physicians and patients to administer the claimed compound, thereby inducing infringement (Compl. ¶47).
  • Willful Infringement: Willfulness is alleged based on Defendants having "actual and constructive notice" of the RE’221 Patent prior to submitting their ANDA (Compl. ¶48). The complaint further contends that filing the ANDA "without adequate justification" renders the case "exceptional" under 35 U.S.C. § 285, which may entitle Plaintiff to attorneys' fees (Compl. ¶49).

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

Based on the complaint, the litigation appears poised to center on the following questions:

  • A central issue will be one of patent validity: As the complaint asserts that infringement of the key compound claims is not contested, the case will almost certainly pivot to Defendants' affirmative defenses that the RE’221 Patent is invalid for reasons such as anticipation, obviousness, or lack of written description.
  • A key procedural question will be the legal effect of the notice letter: What is the legal significance of Defendants' alleged failure to provide "a full and detailed explanation of why the claim is not infringed," as required by FDA regulations, for claims 13 and 14? The court may need to decide if this constitutes a waiver or admission of infringement for the purposes of this litigation.