DCT

1:25-cv-17833

Incyte Corp v. Eugia Pharma Specialities Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-17833, D.N.J., 11/21/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant Eugia US has an established place of business in New Jersey, Defendant Eugia Pharma is a foreign entity that may be sued in any district, and Defendants have purposefully availed themselves of the district by previously litigating other pharmaceutical patent cases in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the drug Jakafi® (ruxolitinib) constitutes an act of infringement of six U.S. patents covering the compound, its salt forms, and methods of use.
  • Technical Context: The technology concerns small molecule compounds that function as Janus kinase (JAK) inhibitors, a class of drugs used to treat myeloproliferative neoplasms, autoimmune diseases, and other conditions by modulating key enzyme signaling pathways.
  • Key Procedural History: The action was triggered by Defendant’s submission of ANDA No. 220517 to the FDA, which included a "Paragraph IV Certification" alleging that Plaintiff's patents are invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint also notes related, consolidated litigation against other generic manufacturers involving some of the same patents and drug products.

Case Timeline

Date Event
2005-12-13 Earliest Priority Date Claimed (’257, ’362, ’912 Patents)
2007-06-13 Earliest Priority Date Claimed (’693, ’481, ’013 Patents)
2009-10-06 U.S. Patent No. 7,598,257 Issued
2013-04-09 U.S. Patent No. 8,415,362 Issued
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
2015-07-14 U.S. Patent No. 9,079,912 Issued
2025-11-21 Complaint Filed

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

U.S. Patent No. 7,598,257 - "Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors"

  • Patent Identification: U.S. Patent No. 7,598,257, "Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors," issued October 6, 2009 (’257 Patent). (Compl. ¶6).

The Invention Explained

  • Problem Addressed: The patent background describes that protein kinases (PKs) are enzymes that regulate critical biological processes. The dysregulation of certain PKs, particularly those in the Janus Kinase (JAK) family, is associated with diseases including cancer and immune-related disorders, creating a need for therapeutic inhibitors. (’257 Patent, col. 1:26-30; col. 2:66-3:4).
  • The Patented Solution: The invention provides a class of chemical compounds, generally described as heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines, designed to modulate the activity of one or more JAK enzymes. These compounds and pharmaceutical compositions containing them are disclosed for use in treating JAK-associated diseases. (’257 Patent, Abstract; col. 6:21-25).
  • Technical Importance: This technology provided specific molecular structures for targeting the JAK signaling pathway, which is implicated in a wide range of myeloproliferative disorders, cancers, and immune system diseases. (’257 Patent, col. 1:17-25).

Key Claims at a Glance

The complaint does not identify any specific asserted claims, alleging only infringement of "one or more claims" of the ’257 Patent (Compl. ¶38). Without identification of specific claims, a detailed breakdown of claim elements is not possible.

U.S. Patent No. 8,415,362 - "Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors"

  • Patent Identification: U.S. Patent No. 8,415,362, "Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors," issued April 9, 2013 (’362 Patent). (Compl. ¶7).

The Invention Explained

  • Problem Addressed: Similar to the ’257 Patent, the ’362 Patent addresses the role of the JAK family of protein kinases in cytokine-dependent regulation and immune response. It posits that inhibiting these enzymes can be a therapeutic approach for various human diseases. (’362 Patent, col. 3:3-7).
  • The Patented Solution: The patent discloses a genus of compounds, described as pyrazolyl substituted pyrrolo[2,3-b]pyrimidines, that are stated to be useful for modulating the activity of JAKs. The invention covers the compounds themselves, compositions containing them, and methods of their use. (’362 Patent, Abstract; col. 6:26-30).
  • Technical Importance: The invention provides a family of chemical compounds designed as JAK inhibitors, offering potential treatments for diseases driven by dysregulated JAK signaling, such as immune disorders and cancers. (’362 Patent, col. 1:15-22).

Key Claims at a Glance

The complaint does not identify any specific asserted claims, alleging only infringement of "one or more claims" of the ’362 Patent (Compl. ¶47).

Multi-Patent Capsules

  • U.S. Patent No. 8,722,693

    • Patent Identification: 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 (’693 Patent). (Compl. ¶8).
    • Technology Synopsis: The ’693 Patent is directed to specific salt forms of the ruxolitinib compound. It states that new or improved forms of JAK inhibitors are needed for developing better pharmaceutical formulations and discloses maleic, sulfuric, and phosphoric acid salts as solutions that may offer advantageous properties such as crystallinity. (’693 Patent, Abstract; col. 2:19-27).
    • Asserted Claims: The complaint does not identify specific asserted claims. (Compl. ¶56).
    • Accused Features: The infringement allegation is directed at Eugia's proposed generic ruxolitinib drug product. (Compl. ¶54).

  • 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 (’481 Patent). (Compl. ¶9).
    • Technology Synopsis: The ’481 Patent is also directed to salt forms of the ruxolitinib compound, with claims specifically covering the phosphate salt. The patent suggests such salt forms are useful for creating pharmaceutical formulations with improved properties for modulating JAK activity. (’481 Patent, Abstract; col. 2:50-57).
    • Asserted Claims: The complaint does not identify specific asserted claims. (Compl. ¶65).
    • Accused Features: The infringement allegation is directed at Eugia's proposed generic ruxolitinib drug product. (Compl. ¶63).

  • 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 (’013 Patent). (Compl. ¶10).
    • Technology Synopsis: The ’013 Patent is also directed to salt forms of the ruxolitinib compound, with claims specifically covering the maleate salt. The patent describes this salt form as a solution to the ongoing need for improved forms of JAK inhibitors for pharmaceutical development. (’013 Patent, Abstract; col. 2:50-57).
    • Asserted Claims: The complaint does not identify specific asserted claims. (Compl. ¶74).
    • Accused Features: The infringement allegation is directed at Eugia's proposed generic ruxolitinib drug product. (Compl. ¶72).

  • U.S. Patent No. 9,079,912

    • Patent Identification: U.S. Patent No. 9,079,912, "Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors," issued July 14, 2015 (’912 Patent). (Compl. ¶11).
    • Technology Synopsis: Similar to the ’257 Patent, the ’912 Patent covers a genus of chemical compounds described as heteroaryl substituted pyrrolo[2,3-b]pyridines and related structures. The invention is presented as a solution to the need for therapeutic agents capable of modulating JAK activity for the treatment of associated diseases. (’912 Patent, Abstract; col. 1:21-29).
    • Asserted Claims: The complaint does not identify specific asserted claims. (Compl. ¶83).
    • Accused Features: The infringement allegation is directed at Eugia's proposed generic ruxolitinib drug product. (Compl. ¶81).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are "Eugia's Proposed Products," which are generic versions of Incyte’s Jakafi® (ruxolitinib) drug products in 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg tablet formulations. (Compl. ¶1, ¶21).

Functionality and Market Context

The products contain ruxolitinib, an inhibitor of Janus kinases (JAKs), and are intended for the same therapeutic uses as the branded drug Jakafi®, which is approved to treat certain myeloproliferative neoplasms. (Compl. ¶1, ¶12). Defendant Eugia has filed ANDA No. 220517 with the U.S. FDA seeking approval to manufacture and sell these generic products in the United States prior to the expiration of the patents-in-suit. (Compl. ¶1, ¶30). The filing of this ANDA is the statutory act of infringement alleged in the complaint. (Compl. ¶36).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement on a claim-element-by-element basis. The pleading does not identify specific claims or include any allegations mapping features of the accused product to claim limitations.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint does not identify specific claims or infringement theories, providing no basis for an analysis of key claim terms for construction.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon receiving FDA approval, Eugia will induce infringement by distributing prescribing information that instructs and encourages physicians, pharmacists, and patients to administer the generic product in a manner that practices methods claimed in the patents-in-suit. (Compl. ¶32, ¶39, ¶48). It further alleges contributory infringement on the basis that Eugia’s products are especially adapted for an infringing use and have no substantial non-infringing use. (Compl. ¶40, ¶49).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Eugia had knowledge of the patents-in-suit, at the latest, as a result of the ANDA process and the required Paragraph IV certification sent to Incyte. (Compl. ¶33-34). The complaint characterizes the case as "exceptional" and requests attorneys' fees under 35 U.S.C. § 285, which suggests an intent to pursue a claim based on egregious conduct. (Compl. ¶43, ¶52, ¶61, ¶70, ¶79, ¶88).

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

  • A primary issue will be one of chemical identity and scope: For the compound patents (’257, ’362, ’912), the question will be whether ruxolitinib is covered by the scope of a valid and enforceable claim. For the salt-form patents (’693, ’481, ’013), the dispositive question will be whether the specific crystalline form of the active pharmaceutical ingredient in Eugia’s proposed product is identical to a claimed salt form, raising questions of both literal infringement and potential design-arounds.
  • A second core issue will concern patent validity: Eugia’s Paragraph IV certification signals its intent to challenge the validity of the asserted patents. The litigation will likely involve disputes over whether the claimed inventions were obvious over the prior art at the time of filing or whether the patent specifications provide adequate written description and enablement for the scope of the claims.
  • A third key question will be one of induced infringement: For any asserted method-of-use claims, the case will examine whether the language in Eugia's proposed product label would inevitably lead medical professionals to prescribe the drug for patented indications, thereby establishing the intent required for induced infringement.