DCT

1:25-cv-13227

Incyte Corp v. Granules India Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-13227, D.N.J., 07/11/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant maintains a regular and established physical place of business through its wholly-owned New Jersey subsidiary, Granules USA, Inc., and conducts business in the district through this entity.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of Plaintiff's Jakafi® (ruxolitinib) tablets constitutes an act of infringement of five U.S. patents covering the ruxolitinib compound and its salts.
  • Technical Context: The technology involves small molecule inhibitors of Janus kinases (JAKs), a class of enzymes crucial for signaling pathways involved in immunity and cell growth, which are therapeutic targets for myeloproliferative disorders, inflammatory conditions, and cancers.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 220521 and its corresponding Paragraph IV Certifications, in which Defendant asserted that the patents-in-suit are invalid and/or will not be infringed by its proposed generic product. The complaint also identifies related litigation brought by Incyte against other ANDA filers (Apotex Inc. and Hikma Pharms. USA Inc.) over the same patents and drug product, indicating an ongoing, multi-front defense of the Jakafi® patent estate.

Case Timeline

Date Event
2005-12-13 ’257 Patent Priority Date
2006-11-16 ’362 Patent Priority Date
2007-06-13 ’693, ’481, & ’013 Patents Priority Date
2009-10-06 ’257 Patent Issued
2013-04-09 ’362 Patent Issued
2014-05-13 ’693 Patent Issued
2014-09-02 ’481 Patent Issued
2014-09-09 ’013 Patent Issued
2025-07-11 Complaint Filing Date

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. (Compl. ¶6).

The Invention Explained

  • Problem Addressed: The patent describes that protein kinases, and specifically the Janus Kinase (JAK) family, play a critical role in cytokine-dependent signaling pathways that regulate cell growth, survival, and immune function. The dysregulation of these kinase pathways is implicated in a host of human diseases, including cancer and immune disorders, creating a need for therapeutic agents that can modulate their activity. (’257 Patent, col. 1:18-30; col. 4:26-38).
  • The Patented Solution: The invention provides a class of chemical compounds, defined by a core structure of heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrimidines, that are designed to inhibit the activity of one or more JAK family members. By inhibiting these enzymes, the compounds are intended to treat diseases associated with JAK activity. (’257 Patent, Abstract; col. 6:54-61).
  • Technical Importance: The development of specific JAK inhibitors offered a targeted therapeutic approach for certain cancers and autoimmune diseases by directly interfering with the signaling pathways believed to drive the pathology. (’257 Patent, col. 5:32-40; col. 6:1-9).

Key Claims at a Glance

The complaint does not identify specific asserted claims, alleging infringement of "one or more claims." (Compl. ¶35). The following analysis is based on a representative independent claim covering the ruxolitinib compound.

  • Independent Claim 2:
    • A compound which is 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof. (’257 Patent, col. 374:10-14).

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. (Compl. ¶7).

The Invention Explained

  • Problem Addressed: Similar to the ’257 Patent, this patent addresses the need for therapeutic compounds that can modulate the activity of the JAK family of protein kinases to treat diseases where these signaling pathways are dysregulated, such as cancer and immune-related disorders. (’362 Patent, col. 1:21-41).
  • The Patented Solution: The patent discloses a genus of pyrazolyl-substituted compounds that inhibit JAKs. The claimed invention is directed to a sub-group of specific compounds from this genus, including ruxolitinib, which are useful for treating diseases associated with JAK activity. (’362 Patent, Abstract; col. 6:55-62).
  • Technical Importance: This patent, a continuation of the family that includes the ’257 Patent, provides further patent protection over specific chemical entities within the broader class of invented JAK inhibitors, securing rights to individual compounds with demonstrated therapeutic potential.

Key Claims at a Glance

The complaint does not identify specific asserted claims. (Compl. ¶44). The following analysis is based on a representative independent claim covering the ruxolitinib compound.

  • Independent Claim 17:
    • The compound of claim 1, selected from a list of specifically enumerated chemical compounds, wherein one of the enumerated compounds is 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile.
    • or a pharmaceutically acceptable salt of any of the afore-mentioned.
      (’362 Patent, col. 386:35-41, col. 387:9-11).

U.S. Patents No. 8,722,693; 8,822,481; and 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"

  • Patent Identification: U.S. Patent No. 8,722,693; U.S. Patent No. 8,822,481; and U.S. Patent No. 8,829,013, all titled "Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile." (Compl. ¶¶8-10).
  • Technology Synopsis: These patents are directed not to the ruxolitinib compound itself, but to specific, pharmaceutically acceptable salt forms of the compound. The patents describe these salt forms as having advantageous properties such as high crystallinity, aqueous solubility, and chemical stability, which can facilitate the preparation of pharmaceutical formulations and improve handling and storage. (e.g., ’693 Patent, col. 3:1-9).
  • Asserted Claims: The complaint does not specify which claims are asserted from these patents. (Compl. ¶¶53, 62, 71).
  • Accused Features: The complaint alleges that Granules' proposed generic ruxolitinib tablets, which will contain a salt form of the active ingredient, will infringe one or more claims of these patents. (Compl. ¶¶53, 62, 71).

III. The Accused Instrumentality

Product Identification

  • Defendant Granules India Ltd.’s proposed generic version of Jakafi® (ruxolitinib) tablets, in 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg dosage strengths, for which Defendant submitted ANDA No. 220521 to the FDA. (Compl. ¶¶1, 19).

Functionality and Market Context

  • The accused products are alleged to be generic versions of Incyte's Jakafi®, a Janus kinase inhibitor. (Compl. ¶1). As a generic, the product is intended to contain the same active pharmaceutical ingredient, ruxolitinib, and be bioequivalent to the branded drug. (Compl. ¶29). The complaint alleges that upon approval, the accused products will be sold with prescribing information similar to that of Jakafi®, instructing their use for FDA-approved indications, thereby encouraging administration according to methods claimed in the patents-in-suit. (Compl. ¶¶13, 31).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide specific, element-by-element infringement allegations. The infringement theory is based on the statutory act of filing an ANDA seeking approval to market a generic drug prior to the expiration of patents listed in the FDA's Orange Book. (Compl. ¶¶12, 35). The core of the allegation is that the active ingredient in the Defendant's proposed product is the same as the compound claimed in the patents-in-suit.

No probative visual evidence provided in complaint.

'257 Patent Infringement Allegations

Claim Element (from Independent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound which is 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof. Defendant’s ANDA No. 220521 seeks approval to manufacture and sell generic tablets containing ruxolitinib, which is the compound recited in the claim. ¶¶1, 29 col. 113:29-33

'362 Patent Infringement Allegations

Claim Element (from Independent Claim 17) Alleged Infringing Functionality Complaint Citation Patent Citation
The compound... selected from... 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt... Defendant’s ANDA No. 220521 seeks approval to manufacture and sell generic tablets containing ruxolitinib, which is the compound recited in the claim. ¶¶1, 29 col. 118:3-7
  • Identified Points of Contention:
    • Scope Questions: A central question for the '693, '481, and '013 patents will be whether the specific salt form used in Granules' proposed product falls within the scope of the asserted claims of those patents. The complaint does not specify the salt form contained in the ANDA product, making this a likely area of dispute.
    • Technical Questions: For the '257 and '362 patents, the infringement analysis will depend on whether the active pharmaceutical ingredient in the Defendant's product is chemically identical to the claimed compound. While typically straightforward in ANDA cases, disputes could arise concerning stereoisomerism (e.g., racemic mixtures vs. a specific enantiomer) or polymorphism, should the claims be construed to cover only a specific form.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a deep analysis of claim construction. However, based on the nature of the patents, certain terms may become focal points.

  • The Term: "(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile" (from the title of the '693, '481, and '013 salt patents)
  • Context and Importance: The titles of the later three patents explicitly recite the "(R)" stereoisomer of ruxolitinib. The '257 and '362 patents claim the compound without specifying its stereochemistry. Practitioners may focus on whether the claims of the earlier patents are limited to a specific stereoisomer or cover racemic mixtures, and whether Granules' product contains the specific (R)-enantiomer, which could be critical for determining infringement of the salt patents.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims of the '257 and '362 patents recite the compound name without stereochemical identifiers, which may support a construction that covers both individual enantiomers and racemic mixtures. The specification of the '257 patent states that compounds can be asymmetric and that the invention includes "such enantiomers and diastereomers, are intended unless otherwise indicated." ('257 Patent, col. 31:27-30).
    • Evidence for a Narrower Interpretation: The titles of the later patents, which are part of the same family, explicitly identify the "(R)" enantiomer. A defendant may argue this suggests the specific stereoisomer is a distinct invention. Furthermore, specific examples in the '257 patent detail the separation and characterization of enantiomers, which could be used to argue that the inventors viewed them as distinct chemical entities. (e.g., ’257 Patent, col. 107:1-108:21).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all five patents. The inducement allegation is based on the claim that Defendant's proposed product labeling will instruct and encourage medical professionals and patients to administer the drug for its approved indications, which allegedly infringes one or more claims. (Compl. ¶¶31, 38, 47, 56, 65, 74). The contributory infringement allegation is based on the claim that the proposed generic products are especially adapted for an infringing use and have no substantial non-infringing use. (Compl. ¶¶39, 48, 57, 66, 75).
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, for each patent, it alleges that Defendant acted with knowledge of the patent and with knowledge that its acts were encouraging infringement. (e.g., Compl. ¶38). It also requests an award of attorneys' fees under 35 U.S.C. § 285, asserting that the case is "exceptional." (Compl. ¶¶42, 51, 60, 69, 78). These allegations may form the basis for a future willfulness claim or a motion for enhanced damages.

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

The resolution of this case will likely depend on the court's findings on three central questions:

  • A primary issue will be one of chemical identity and scope: For the later salt patents ('693, '481, '013), does the specific salt form utilized in Defendant’s ANDA product fall within the literal scope of the asserted claims? The complaint provides no detail on the defendant's salt form, making this a critical factual question for discovery.
  • A second issue will be one of validity: Can the patents-in-suit, particularly the later-issued patents covering specific salt forms of a known compound, withstand Defendant's inevitable challenges of obviousness based on the prior disclosure of the ruxolitinib free base and general knowledge in the art regarding salt formation?
  • An evidentiary question will be one of inducement: Assuming the asserted claims are valid and directly infringed, what evidence does the proposed product label provide to establish that Defendant possessed the specific intent to encourage infringement of the claimed subject matter?