DCT

1:25-cv-13225

Incyte Corp v. Sun Pharmaceutical Industries Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-13225, D.N.J., 07/11/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Sun Pharmaceutical Industries, Inc. maintains a regular and established place of business in the district, conducts continuous business in the state, and has not contested personal jurisdiction in the district in prior Abbreviated New Drug Application (ANDA) litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA seeking approval to market a generic version of Plaintiff's Jakafi® (ruxolitinib) product constitutes an act of infringement of four patents related to specific salt forms and methods of use of the ruxolitinib compound.
  • Technical Context: The technology concerns specific pharmaceutical salt forms of a Janus kinase (JAK) inhibitor, which are designed to improve properties such as stability and solubility, making the active ingredient suitable for a commercial drug product.
  • Key Procedural History: The action arises under the Hatch-Waxman Act, triggered by Defendant’s submission of ANDA No. 219852 with a Paragraph IV certification, alleging that the patents-in-suit are invalid and/or will not be infringed by its proposed generic product. The complaint also notes related litigation against other generic manufacturers involving the same drug product and some of the same patents.

Case Timeline

Date Event
2007-06-13 Earliest Priority Date (’693, ’481, ’013, ’429 Patents)
2014-05-13 U.S. Patent No. 8,722,693 Issued
2014-09-02 U.S. Patent No. 8,822,481 Issued
2014-09-09 U.S. Patent No. 8,829,013 Issued
2018-07-10 U.S. Patent No. 10,016,429 Issued
2025-07-11 Complaint Filing Date

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

U.S. Patent No. 8,722,693 - "Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile," Issued May 13, 2014

The Invention Explained

  • Problem Addressed: The patent background describes the role of the Janus Kinase (JAK) family of enzymes in immune response and notes that inhibitors of these enzymes are widely sought for therapeutic purposes (e.g., for treating cancer and skin disorders) (’693 Patent, col. 1:46-62). The unstated technical problem is the need to convert a promising active pharmaceutical ingredient—a JAK inhibitor—into a form with suitable physical and chemical properties for development into a commercial drug product.
  • The Patented Solution: The invention provides specific salt forms of the ruxolitinib compound, which is a JAK inhibitor (’693 Patent, Abstract). These salt forms are described as having advantageous properties over the free base form, including high crystallinity, which can facilitate manufacturing, improve stability, and ensure reproducibility of the final drug product (’693 Patent, col. 2:66-3:8). The claims of the ’693 patent are directed specifically to the phosphoric acid salt of the compound.
  • Technical Importance: The creation of stable, crystalline salt forms is a critical step in pharmaceutical development that enables a potent molecule to be manufactured consistently and formulated into a safe and effective medicine with a viable shelf life.

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims of the patent but does not specify which claims are asserted (Compl. ¶36). The patent contains one independent claim.
  • Independent Claim 1:
    • A (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphoric acid salt.

U.S. Patent No. 10,016,429 - "Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile," Issued July 10, 2018

The Invention Explained

  • Problem Addressed: The patent addresses the same general problem as the ’693 Patent: the need for effective treatments for diseases related to JAK activity, such as immune-related disorders (’429 Patent, col. 1:30-58).
  • The Patented Solution: The patent claims methods of treating specific diseases by administering the phosphoric acid salt of ruxolitinib (’429 Patent, col. 4:3-13). Whereas the ’693 Patent claims the salt compound itself (a composition of matter), this patent claims a specific application of that compound (a method of use).
  • Technical Importance: This patent provides a layer of protection directed at the therapeutic application of the drug, a common strategy to protect a marketed drug product's approved uses from generic competition.

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims but does not specify which are asserted (Compl. ¶63). The patent contains two independent claims.
  • Independent Claim 1:
    • A method of treating a disease selected from allograft rejection and graft versus host disease
    • in a patient in need thereof,
    • comprising administering to said patient a therapeutically effective amount
    • of a compound that is (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphoric acid salt.

Multi-Patent Capsule: U.S. Patent No. 8,822,481

  • Patent Identification: U.S. Patent No. 8,822,481, "Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile," Issued September 2, 2014 (Compl. ¶7).
  • Technology Synopsis: The title is identical to the other patents-in-suit, suggesting the patent claims other specific salt forms, crystalline forms (polymorphs), or formulations of the ruxolitinib compound not covered by the other patents in the family.
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶45).
  • Accused Features: Infringement is based on Defendant's filing of ANDA No. 219852, which seeks FDA approval to market a generic version of Jakafi® (Compl. ¶45).

Multi-Patent Capsule: U.S. Patent No. 8,829,013

  • Patent Identification: U.S. Patent No. 8,829,013, "Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile," Issued September 9, 2014 (Compl. ¶8).
  • Technology Synopsis: The title suggests this patent also claims specific salt forms, polymorphs, or formulations of the ruxolitinib compound.
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶54).
  • Accused Features: Infringement is based on Defendant's filing of ANDA No. 219852 for a generic ruxolitinib product (Compl. ¶54).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are "Sun's Proposed Products," which are the subject of ANDA No. 219852 submitted to the FDA (Compl. ¶18, ¶30).
  • Functionality and Market Context: The proposed products are generic versions of Incyte’s Jakafi® (ruxolitinib) tablets in 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg dosages (Compl. ¶1). The complaint alleges that the submission of the ANDA itself, seeking approval to manufacture, use, and sell these products prior to the expiration of the patents-in-suit, constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶36, 45, 54, 63). The complaint further alleges that upon approval, Defendant’s products will include prescribing information that instructs and encourages administration according to methods claimed in the patents-in-suit (Compl. ¶32).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed infringement contentions. The infringement allegations are based on the statutory framework of the Hatch-Waxman Act, where the submission of an ANDA is an artificial act of infringement that creates a justiciable controversy.

  • Narrative Infringement Theory:

    • Direct Infringement (’693, ’481, ’013 Patents): The complaint alleges that Defendant’s submission of ANDA No. 219852 for a product that is or contains the claimed salt form of ruxolitinib is an act of direct infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶36, 45, 54). It further alleges that upon FDA approval, the actual manufacture, use, or sale of the generic product will constitute direct infringement under 35 U.S.C. § 271(a) (Compl. ¶¶38, 47, 56).
    • Induced Infringement (’429 Patent): The primary infringement theory for the method-of-use ’429 Patent is inducement. The complaint alleges that Defendant's proposed product will be accompanied by prescribing information and instructions that will encourage physicians, pharmacists, and patients to administer the drug in a manner that practices the steps of the claimed methods (Compl. ¶32, ¶66). The filing of an ANDA seeking approval for such a use is the predicate act of infringement.

  • Identified Points of Contention:

    • Scope Questions: A principal question for the composition-of-matter patents (e.g., the ’693 Patent) will be whether the specific salt form in Defendant's ANDA product is identical to the salt form claimed in the patent. For the method-of-use patent (the ’429 Patent), a key question is whether the indications for use sought in Defendant's ANDA and described in its proposed label fall within the scope of the claimed methods of "treating" specific diseases.
    • Technical Questions: The dispute will likely focus on chemical and crystalline characterization (e.g., using XRPD, DSC, NMR) of Defendant’s proposed product compared to the characterization data in the patents. For the method claims, the central question will be whether the language of Defendant's proposed label actively encourages, recommends, or promotes the infringing administration, as opposed to merely making it possible.

V. Key Claim Terms for Construction

The complaint does not identify any claim terms for construction. However, based on the asserted patents, certain terms may become central to the dispute.

  • The Term: "phosphoric acid salt" (from ’693 Patent, Claim 1)

    • Context and Importance: The definition of this term is fundamental, as it defines the composition of matter. Practitioners may focus on this term because any subtle differences in the chemical structure, stoichiometry, or crystalline form of Defendant’s proposed product could form the basis of a non-infringement argument.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discusses the preparation of salts generally, suggesting the term could encompass various forms unless explicitly limited (’693 Patent, col. 3:21-28).
      • Evidence for a Narrower Interpretation: The patent provides a specific example of preparing the phosphoric acid salt and includes detailed characterization data, such as a sharp melting peak from DSC analysis, which could be used to argue the term is limited to the specific crystalline form disclosed (’693 Patent, col. 11:13-33).

  • The Term: "treating" (from ’429 Patent, Claim 1)

    • Context and Importance: As this is a method-of-use claim, the scope of the word "treating" is critical. A defendant in an ANDA case may argue that its proposed product label, while overlapping with the patentee's, is for a different or narrower purpose (e.g., palliative care vs. curative treatment) that does not meet the definition of "treating" as used in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification provides an explicit, broad definition, stating that "treating" or "treatment" refers to preventing, inhibiting, or ameliorating a disease, including reversing its pathology or symptomatology (’429 Patent, col. 6:50-64).
      • Evidence for a Narrower Interpretation: A party could argue that, in the context of the specific diseases recited in the claims (e.g., allograft rejection), the term implies a specific clinical outcome or mechanism that must be encouraged by an accused label.

VI. Other Allegations

  • Indirect Infringement: The complaint explicitly alleges future induced infringement for all asserted patents. The basis for these allegations is that Defendant, upon approval of its ANDA, will "intentionally encourage acts of direct infringement" through its product's prescribing information, which will instruct users to administer the product in an infringing manner (Compl. ¶¶39, 48, 57, 66). This is particularly relevant for the method-of-use claims in the ’429 Patent.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, for each count, it alleges the case is "an exceptional one" and requests an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶¶43, 52, 61, 70). The factual basis for this allegation is not specified but is predicated on Defendant's alleged knowledge of the patents-in-suit.

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

  • A central issue will be one of chemical identity and scope: does the active ingredient in Sun’s proposed generic product meet every limitation of the asserted composition claims, including any specific crystalline form requirements? For the method claims, does the language of Sun’s proposed label instruct or encourage administration for the specific diseases claimed in the patent, thereby satisfying the requirements for induced infringement?
  • A core defense, foreshadowed by the Paragraph IV certification, will be an invalidity challenge. The case will likely turn on whether the claimed salt forms and methods of use were obvious to a person of ordinary skill in the art at the time of the invention, given the prior knowledge of the ruxolitinib free base and standard pharmaceutical salt selection practices.
  • A key evidentiary question for the method-of-use patent will be intent to induce infringement. The dispute will focus on whether the text of Sun’s proposed label, which is required to be substantially similar to the brand-name label, rises to the level of affirmative intent to encourage the specific infringing uses claimed in the patent.