DCT

1:26-cv-00680

AbbVie Inc v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00680, D. Del., 06/10/2026
  • Venue Allegations: Venue is alleged to be proper for MSN Pharmaceuticals Inc. as a Delaware corporation. For MSN Laboratories Pvt. Ltd., an Indian corporation, venue is alleged to be proper as it may be sued in any judicial district. The complaint also notes that Defendants have previously litigated in the District of Delaware without contesting venue.
  • Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's RINVOQ® LQ oral solution constitutes an act of infringement of two patents covering processes for preparing upadacitinib and its formulations.
  • Technical Context: The technology relates to Janus kinase (JAK) inhibitors, specifically upadacitinib, used in oral formulations for treating pediatric immune-mediated diseases such as psoriatic arthritis and juvenile idiopathic arthritis.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendants' submission of ANDA No. 221518 and a subsequent Paragraph IV certification notice letter to Plaintiff. Plaintiff alleges the action was brought within the 45-day statutory window, triggering a 30-month stay of FDA approval. The complaint also notes a dispute over the terms of confidential access to the ANDA, which Plaintiff alleges were unreasonable.

Case Timeline

Date Event
2015-10-16 Earliest Priority Date for '584 and '689 Patents
2021-11-30 U.S. Patent No. 11,186,584 Issues
2025-07-22 U.S. Patent No. 12,365,689 Issues
2026-04-27 MSN sends Notice Letter to AbbVie
2026-06-10 Complaint Filed

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

U.S. Patent No. 11,186,584 - "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"

  • Patent Identification: U.S. Patent No. 11186584 ("the '584 Patent"), titled "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 November 30, 2021. Compl. ¶32 '584 Patent, cover

The Invention Explained

  • Problem Addressed: The patent's background section describes the challenges associated with the commercial-scale preparation of the active pharmaceutical ingredient upadacitinib ("Compound 1"). These include finding a solid-state form with acceptable properties (e.g., chemical stability, solubility, manufacturability) and developing a synthesis process that avoids the use of hazardous reagents found in earlier methods '584 Patent, col. 2:6-30
  • The Patented Solution: The patent discloses processes for preparing upadacitinib and various solid-state forms of the compound, such as crystalline hydrates, anhydrates, and salts '584 Patent, abstract These processes and forms are intended to provide an acceptable balance of properties for large-scale manufacturing and pharmaceutical formulation '584 Patent, col. 2:18-23 The manufacturing processes are detailed in process flow diagrams, such as the one for producing amorphous freebase shown in Figure 1A '584 Patent, FIG. 1A
  • Technical Importance: Developing a safe, scalable, and reproducible manufacturing process for a drug substance that yields a stable solid form is a critical step in bringing a pharmaceutical product to market. '584 Patent, col. 2:6-23

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not specify which claims will be asserted Compl. ¶46 Independent claim 1 (a process claim) and independent claim 21 (a composition claim) are representative of the patent's scope.
  • Independent Claim 1 (Process Claim): A process for preparing Compound 1, comprising the steps of:
    • (a) reacting a protected carboxylic acid of formula (I) with trimethylsulfoxonium chloride to form a sulfur ylide of formula (II);
    • (b) contacting the compound of formula (II) with LiX and a sulfonic acid to form a halomethyl ketone of formula (III);
    • (c) reacting the compound of formula (III) with a pyrazine compound of formula (IV) to produce a compound of formula (V);
    • (d) contacting the compound of formula (V) with a perfluoro acid anhydride and an organic base to form a compound of formula (VI);
    • (e) deprotecting the compound of formula (VI) to form a salt of the compound of formula (VII); and
    • (f) reacting the salt of formula (VII) with 2,2,2-trifluoroethylamine to produce Compound 1.
  • Independent Claim 21 (Composition Claim): An extended release pharmaceutical composition comprising:
    • a solid state form of Compound 1; and
    • from about 10 w/w % to about 35 w/w % of an organic acid selected from tartaric acid, fumaric acid, citric acid, succinic acid, malic acid, and combinations thereof.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the allegation against "one or more claims" is broad enough to include them.

U.S. Patent No. 12,365,689 - "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"

  • Patent Identification: U.S. Patent No. 12365689 ("the '689 Patent"), titled "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 July 22, 2025. Compl. ¶33 '689 Patent, cover

The Invention Explained

  • Problem Addressed: The patent background describes the need for safe and efficacious doses of upadacitinib for pediatric patients, who may have difficulty swallowing solid dosage forms like tablets. This creates a need for a stable, palatable liquid formulation that provides comparable plasma exposure to the doses found to be effective in adults '689 Patent, col. 2:11-34
  • The Patented Solution: The patent discloses stable liquid oral pharmaceutical compositions of upadacitinib. The invention combines the active ingredient with specific excipients, including solubilizers, buffers, preservatives, and sweeteners, to create a solution with a pH that ensures stability and palatability for pediatric administration '689 Patent, abstract '689 Patent, col. 77:43-65
  • Technical Importance: The development of a stable, taste-masked liquid oral formulation is critical for enabling the treatment of pediatric patients with chronic diseases, ensuring accurate dosing and improving patient compliance. '689 Patent, col. 2:28-34

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not specify which claims will be asserted Compl. ¶68 Independent claim 1 is representative of the patent's scope and directly relevant to the accused product.
  • Independent Claim 1 (Composition Claim): A liquid pharmaceutical composition comprising:
    • upadacitinib or a pharmaceutically acceptable salt thereof;
    • a solubilizer; and
    • water;
    • wherein the pH of the composition is in a range from about 2 to about 5.
  • The complaint's general allegation encompasses the right to assert dependent claims.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendants' ANDA Product, identified as ANDA No. 221518, which seeks approval to market a generic version of AbbVie's RINVOQ® LQ 1 mg/mL oral solution Compl. ¶1 Compl. ¶15
  • Functionality and Market Context: The accused product is a 1 mg/mL oral solution of upadacitinib, a Janus kinase (JAK) inhibitor with selectivity for JAK1 Compl. ¶1 Compl. ¶3 It is intended for treating pediatric patients with active psoriatic arthritis or polyarticular juvenile idiopathic arthritis Compl. ¶2 The complaint alleges that Defendants intend to commercially manufacture, market, and sell the ANDA Product throughout the United States upon receiving FDA approval Compl. ¶17

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed infringement allegations. The infringement theory is statutory under 35 U.S.C. § 271(e)(2)(A), based on the submission of an ANDA for a product that, if approved and marketed, would allegedly infringe. The analysis below is based on the description of the accused product as a generic version of RINVOQ® LQ. No probative visual evidence provided in complaint.

'584 Patent Infringement Allegations

The complaint provides insufficient detail to construct a meaningful claim chart for the process claims of the '584 Patent. An infringement analysis would require access to Defendants' confidential ANDA to compare their manufacturing process to the claimed steps.

  • Identified Points of Contention:
    • Factual Question: The central dispute would be evidentiary: does the process used by MSN to manufacture the upadacitinib active pharmaceutical ingredient for its ANDA product practice every limitation of an asserted process claim in the '584 Patent? This question can only be resolved through discovery of MSN's confidential manufacturing information.

'689 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A liquid pharmaceutical composition comprising upadacitinib or a pharmaceutically acceptable salt thereof MSN's ANDA product is a 1 mg/mL oral solution containing upadacitinib as the active ingredient. ¶1; ¶3 col. 2:1-5
a solubilizer The complaint does not specify the excipients in MSN's ANDA product, but as a generic equivalent, it is alleged to contain the necessary components, including a solubilizer, to achieve a stable solution. ¶1 col. 10:4-11
and water As an aqueous oral solution, MSN's ANDA product is alleged to contain water as a vehicle. ¶1 col. 9:55-61
wherein the pH of the composition is in a range from about 2 to about 5 The complaint does not specify the pH of MSN's ANDA product, but alleges it is a generic equivalent that infringes the patent. ¶1; ¶68 col. 9:55-61
  • Identified Points of Contention:
    • Scope Questions: The infringement analysis will likely focus on claim construction. A primary question for the court may be the proper scope of the term "a solubilizer". The dispute will depend on the specific excipients used in MSN's formulation and whether they fall within the definition of "solubilizer" as construed from the patent's specification.
    • Technical Questions: A key factual question will be whether the pH of MSN's ANDA product, as disclosed in its confidential application, falls within the claimed range of "about 2 to about 5."

V. Key Claim Terms for Construction

For the '584 Patent

The complaint does not provide sufficient detail for an analysis of key claim terms for the '584 Patent, as infringement of its process claims would turn on a factual comparison of MSN's manufacturing process with the claim language, rather than on the construction of specific terms.

For the '689 Patent

  • The Term: "a solubilizer" (from Claim 1)
  • Context and Importance: The identity and function of the excipients in MSN's ANDA product will be central to the infringement analysis. If MSN's formulation uses an excipient that is not explicitly listed as a "solubilizer" in the patent, its classification under this claim term will be a critical point of dispute. Practitioners may focus on this term because it is a functional limitation that is broadly recited in the claim but may be narrowed by the specification.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent states that the composition "may comprise one or more solubilizers" and provides a non-exhaustive list of examples, including "a pharmaceutically acceptable acid," "a nonionic surfactant," and others, suggesting the term is intended to be interpreted broadly to cover various agents that increase the solubility of upadacitinib. '689 Patent, col. 10:4-11
    • Evidence for a Narrower Interpretation: The patent's examples consistently use citric acid as the solubilizer to achieve the desired pH and stability '689 Patent, col. 78:1-12, Table 1 A defendant might argue that the term "solubilizer" should be limited to the types of pharmaceutically acceptable acids disclosed and exemplified, rather than encompassing any substance that might increase solubility.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, MSN will actively induce and contribute to infringement by marketing and selling the ANDA product with a label that will instruct physicians and patients on its use Compl. ¶71 Compl. ¶82 This is a standard allegation in ANDA litigation, premised on the idea that the approved use of the generic drug will directly infringe method-of-use claims, or that the product itself infringes composition claims.
  • Willful Infringement: The complaint does not use the word "willful" but alleges that MSN has "actual and constructive notice" of the patents-in-suit and is aware that submitting its ANDA constitutes an act of infringement Compl. ¶50 Compl. ¶72 These allegations of pre-suit knowledge via the Orange Book listing and the Paragraph IV notice could be used to support a later claim for enhanced damages under 35 U.S.C. § 284.

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

  1. Evidentiary Process Question: A primary issue for the '584 Patent will be a factual one, answerable only through discovery: does the confidential manufacturing process for upadacitinib detailed in MSN's ANDA No. 221518 practice all steps of an asserted process claim?
  2. Claim Construction and Scope: For the '689 Patent, the case will likely turn on a question of definitional scope: how will the court construe the term "a solubilizer", and do the specific excipients used in MSN's oral solution fall within that construed scope? The outcome will depend on the details of MSN's formulation, which are not yet public.
  3. Procedural and Access Issues: An immediate question for the case, as highlighted in the complaint, is procedural: will the court find that AbbVie's allegations regarding MSN's "unreasonable" offer of confidential access to its ANDA have merit, and how will that impact the early discovery schedule and subsequent litigation conduct?
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