DCT

1:25-cv-01859

Incyte Corp v. Hikma Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01859, D.N.J., 03/13/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant maintaining a regular and established physical place of business in the district and having purposefully conducted business there, including activities related to its Abbreviated New Drug Application (ANDA).
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA seeking to market generic versions of Plaintiff's Jakafi® (ruxolitinib) drug product constitutes an act of infringement of five U.S. patents relating to the ruxolitinib compound and specific salt forms thereof.
  • Technical Context: The patents relate to chemical compounds that function as Janus kinase (JAK) inhibitors, a class of drugs used to treat myeloproliferative neoplasms and other immune-related disorders.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 219768 to the FDA. The suit was triggered by Defendant’s Paragraph IV Certification, which alleges that the patents-in-suit are invalid and/or will not be infringed by the proposed generic products. The complaint notes a related case against Apotex Inc. involving the same patents and pharmaceutical product.

Case Timeline

Date Event
2005-12-13 Priority Date for ’257 and ’362 Patents
2007-06-13 Priority Date for ’693, ’481, and ’013 Patents
2009-10-06 Issue Date for U.S. Patent No. 7,598,257
2013-04-09 Issue Date for U.S. Patent No. 8,415,362
2014-05-13 Issue Date for U.S. Patent No. 8,722,693
2014-09-02 Issue Date for U.S. Patent No. 8,822,481
2014-09-09 Issue Date for U.S. Patent No. 8,829,013
2025-01-28 Earliest Date of Hikma’s Paragraph IV Notice Letter
2025-03-13 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.

The Invention Explained

  • Problem Addressed: The patent describes that dysregulated activity of protein kinases, specifically the Janus kinase (JAK) family, is implicated in numerous diseases, including cancer and immune-related disorders (e.g., rheumatoid arthritis, asthma, and inflammatory bowel disease) ('257 Patent, col. 1:12-29; col. 3:1-40). This background establishes a need for therapeutic agents that can modulate JAK activity.
  • The Patented Solution: The invention provides a class of chemical compounds, based on a heteroaryl substituted pyrrolo[2,3-b]pyridine or pyrrolo[2,3-b]pyrimidine core structure, that are designed to modulate the activity of one or more JAKs ('257 Patent, col. 6:54-61; Abstract). These compounds are presented as useful for treating diseases associated with JAK activity.
  • Technical Importance: The development of small molecule kinase inhibitors represented a significant therapeutic strategy, offering the potential for orally available drugs that could target specific signaling pathways involved in cell proliferation and immune response ('257 Patent, col. 2:27-col. 3:1).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of "one or more" claims (Compl. ¶27). Independent Claim 1 is a composition of matter claim defining a broad chemical genus.
  • Claim 1 recites a compound of Formula I, which includes:
    • A core pyrrolo[2,3-b]pyrimidine or pyrrolo[2,3-b]pyridine ring system.
    • A substituted 5-membered heteroaryl ring attached to the 4-position of the core.
    • A variable substituent "-(Y)n-Z" attached to the heteroaryl ring.
    • Numerous variable substituents ("R¹", "R²", "R³", "R⁴") on the core ring system.
  • The complaint does not explicitly reserve the right to assert dependent claims.

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.

The Invention Explained

  • Problem Addressed: Similar to the ’257 Patent, this patent addresses the need for compounds that modulate JAK activity to treat a range of diseases, including immune-related disorders and cancers ('362 Patent, col. 1:18-25).
  • The Patented Solution: The ’362 Patent claims a more specific genus of compounds than the ’257 Patent, focusing on a pyrazolyl group as the heteroaryl substituent attached to a pyrrolo[2,3-b]pyrimidine core ('362 Patent, Abstract; col. 28:5-22). This structure corresponds to the active pharmaceutical ingredient ruxolitinib.
  • Technical Importance: This patent narrows the chemical space from the broader genus of the ’257 Patent to a class of compounds including a specific clinical candidate, reflecting a key step in the drug development process.

Key Claims at a Glance

  • The complaint alleges infringement of "one or more" claims (Compl. ¶36). Independent Claim 1 defines a class of pyrazolyl-substituted compounds.
  • Claim 1 recites a compound of Formula I, which includes:
    • A core pyrrolo[2,3-b]pyrimidine ring system.
    • A substituted pyrazolyl ring attached to the 4-position of the core.
    • A variable substituent "-(Y)n-Z" attached to the pyrazolyl ring.
    • Variable substituents on the core ring system.
  • The complaint does not explicitly reserve the right to assert dependent claims.

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"

  • Multi-Patent Capsule: 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. (Compl. ¶7).
    • Technology Synopsis: This patent claims specific salt forms of the (R)-enantiomer of the compound known as ruxolitinib. The selection of a specific salt form is a critical aspect of pharmaceutical development, affecting properties such as stability, solubility, and bioavailability.
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶45).
    • Accused Features: The accused features are Hikma’s proposed generic ruxolitinib drug products, which are alleged to infringe the claims covering specific salt forms of the active ingredient (Compl. ¶1).

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"

  • Multi-Patent Capsule: 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. ¶8).
    • Technology Synopsis: Like the ’693 Patent, this patent is directed to specific salt forms of the (R)-enantiomer of ruxolitinib. The claims cover different pharmaceutically acceptable salts of the same active pharmaceutical ingredient.
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶54).
    • Accused Features: The accused features are Hikma’s proposed generic ruxolitinib drug products, which are alleged to infringe the claims covering specific salt forms of the active ingredient (Compl. ¶1).

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"

  • Multi-Patent Capsule: 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. ¶9).
    • Technology Synopsis: This patent also claims specific salt forms of the (R)-enantiomer of ruxolitinib. Asserting multiple patents on different salt forms is a strategy to build comprehensive protection around a final drug product formulation.
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶63).
    • Accused Features: The accused features are Hikma’s proposed generic ruxolitinib drug products, which are alleged to infringe the claims covering specific salt forms of the active ingredient (Compl. ¶1).

III. The Accused Instrumentality

  • Product Identification: The accused products are the generic versions of Incyte’s Jakafi® (ruxolitinib) drug product in 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg tablet formulations, as described in Hikma’s ANDA No. 219768 (“Hikma’s Proposed Products”) (Compl. ¶1).
  • Functionality and Market Context:
    • The proposed products contain ruxolitinib as the active pharmaceutical ingredient, which functions as a Janus kinase (JAK) inhibitor (Compl. ¶1).
    • The complaint alleges that Hikma is seeking FDA approval to manufacture, use, import, distribute, and sell these generic products in the United States prior to the expiration of the patents-in-suit (Compl. ¶1, ¶16). This action is a direct challenge to Incyte's market exclusivity for Jakafi®, which is listed in the FDA's "Orange Book" as being covered by the patents-in-suit (Compl. ¶11).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not provide a claim chart or a detailed narrative mapping claim elements to the accused product. The infringement allegation is based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA for a drug claimed in a patent as a statutory act of infringement. The core theory is that Hikma's ANDA specifies a drug product whose active ingredient, ruxolitinib, is a chemical compound that falls within the scope of the claims of the '257 and '362 patents, and whose final formulation uses a salt form claimed by the '693, '481, and '013 patents. Because the complaint does not contain specific infringement contentions, a claim chart cannot be constructed.

  • Identified Points of Contention:
    • Scope Questions: A central question for the '693, '481, and '013 patents will be factual: does the specific salt form of ruxolitinib formulated in Hikma’s Proposed Products fall within the scope of the salt claims of these patents? The complaint does not provide details from Hikma's ANDA to resolve this.
    • Technical Questions: For the '257 and '362 compound patents, infringement is often straightforward if the generic product uses the same active ingredient. Therefore, the primary dispute will likely center on the validity of the patents, which Hikma has challenged in its Paragraph IV certification (Compl. ¶24). The litigation will likely focus on whether the claimed inventions were obvious or anticipated by the prior art at the time of the invention.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of potential claim construction disputes. However, in litigation involving broad Markush claims, as seen in the lead patents, the definitions of the variable substituent groups are often central to arguments about both infringement and validity.

  • The Term: "cycloalkyl" (appearing in Claim 1 of the ’362 Patent)
  • Context and Importance: The active ingredient, ruxolitinib, contains a cyclopentyl group. The precise definition of "cycloalkyl" is therefore critical to determining whether ruxolitinib is covered by the claims. Practitioners may focus on this term because its scope could be disputed in determining whether the claims were enabled or obvious over prior art that may have disclosed related, but not identical, cyclic structures.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a broad definition: "cycloalkyl refers to non-aromatic cyclic hydrocarbons including cyclized alkyl, alkenyl, and alkynyl groups" and notes they can be "monocyclic or polycyclic" ('362 Patent, col. 33:65-col. 34:1). This language may support an expansive construction.
    • Evidence for a Narrower Interpretation: The specification also provides a list of "Example cycloalkyl groups," which includes cyclopropyl, cyclobutyl, cyclopentyl, and cyclohexyl, among others ('362 Patent, col. 34:4-7). Parties arguing for a narrower scope may contend that the invention is limited to such conventional saturated carbocycles, particularly if the examples in the patent primarily feature these specific groups.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Hikma will induce infringement by encouraging acts of direct infringement and contribute to infringement because its products are especially adapted for an infringing use with no substantial non-infringing use (Compl. ¶¶30-31, 39-40, 48-49, 57-58, 66-67). These allegations are based on the future, intended use of the generic product according to its FDA-approved labeling.
  • Willful Infringement: The complaint does not explicitly allege "willful" infringement but asserts that each count presents an "exceptional case" entitling Incyte to attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶34, 43, 52, 61, 70). The basis for this allegation appears to be Hikma's alleged knowledge of the patents, evidenced by its submission of the Paragraph IV certification and Notice Letter prior to filing suit (Compl. ¶¶24-25).

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

  • A core issue will be one of validity: Given that Hikma's product contains the same active ingredient as Jakafi®, infringement of the compound claims appears likely. The central dispute will therefore be Hikma’s asserted defense that the claims of the '257 and '362 patents are invalid as being anticipated or rendered obvious by prior art.
  • A key evidentiary question will be one of compositional identity: For the '693, '481, and '013 patents, which claim specific salt forms of ruxolitinib, the case may turn on a factual determination of whether the salt form used in Hikma's proposed generic product is one of the claimed phosphate, sulfate, maleate, or other specified salt forms.
  • A final question will be one of claim scope: Should validity challenges arise, the litigation will likely involve disputes over the proper construction of key terms within the broad Markush claims, such as "cycloalkyl" and the definitions of various substituent groups, to determine the full breadth of the claimed invention and its patentability over the prior art.