DCT

1:25-cv-17832

Incyte Corp v. DR Reddy's Laboratories Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-17832, D.N.J., 11/21/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Dr. Reddy's Laboratories, Inc. maintains a regular and established physical place of business in Princeton, New Jersey, is registered to do business in the state, and has purposefully availed itself of the rights and benefits of the jurisdiction, including by not contesting jurisdiction in prior litigation it initiated in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval to market a generic version of Plaintiff’s Jakafi® (ruxolitinib) drug products constitutes an act of infringement of five patents related to Janus kinase (JAK) inhibitors.
  • Technical Context: The technology concerns small molecule compounds that inhibit the activity of Janus kinases (JAKs), a family of enzymes involved in cell signaling pathways that are crucial to the immune response and cell growth.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 220797 with a Paragraph IV certification, alleging that the patents-in-suit are invalid and/or will not be infringed. The complaint notes that the matter is related to other pending consolidated cases filed by Incyte against different generic drug manufacturers (Apotex Inc., Sun Pharmaceutical Industries, Inc., and Granules India Ltd.), indicating a broad enforcement strategy for the Jakafi® patent portfolio.

Case Timeline

Date Event
2005-12-13 '257 & '362 Patents - Earliest Priority Date
2007-06-13 '693, '481 & '013 Patents - Earliest Priority Date
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
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"

The Invention Explained

  • Problem Addressed: The patent background describes that protein kinases (PKs) regulate numerous critical biological processes, and their dysregulation can lead to diseases such as cancer. The Janus Kinase (JAK) family is identified as a subset of PKs whose role in cytokine-dependent immune cell regulation makes them a promising therapeutic target for immune disorders and cancers ('257 Patent, col. 2:25-30, col. 3:1-19).
  • The Patented Solution: The invention provides a class of novel chemical compounds, defined by Formula I, which are heteroaryl-substituted pyrrolo-pyrimidines and pyridines designed to modulate the activity of one or more JAKs. By inhibiting JAK activity, these compounds are intended to treat diseases associated with JAK signaling pathways ('257 Patent, Abstract; col. 6:50-54).
  • Technical Importance: The technology provided a new class of chemical entities for targeting the JAK signaling pathway, which was recognized as an important mechanism for therapeutic intervention in various inflammatory diseases and cancers ('257 Patent, col. 2:1-10).

Key Claims at a Glance

The complaint alleges infringement of "one or more claims" of the '257 Patent without further specification (Compl. ¶32). Independent Claim 1 defines a large genus of chemical compounds.

  • Independent Claim 1: A compound of Formula II, which includes:
    • A core pyrrolo[2,3-b]pyridine moiety.
    • Substituted with a five-membered heteroaryl ring (defined by variables A¹, A², U, T, and V).
    • Further defined by a large number of possible substituent groups represented by variables including Z, R¹, and R².
      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"

The Invention Explained

  • Problem Addressed: Like its parent, the ’362 Patent is directed to the problem of treating diseases associated with the activity of Janus kinases, including immune-related disorders and cancers, by developing compounds that can modulate the JAK signaling pathway ('362 Patent, col. 2:15-23).
  • The Patented Solution: The patent claims a specific chemical compound, 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile (ruxolitinib), and its pharmaceutically acceptable salts. This compound is a specific embodiment of the broader chemical genus described in the '257 patent family and is identified as a JAK inhibitor ('362 Patent, Abstract; Claim 1).
  • Technical Importance: This patent claims the specific active pharmaceutical ingredient in the commercial drug Jakafi®, representing a successful clinical candidate from the broader class of JAK inhibitors developed by the patentee ('362 Patent, Claim 1).

Key Claims at a Glance

The complaint alleges infringement of "one or more claims" of the '362 Patent (Compl. ¶41).

  • Independent Claim 1: 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.
  • Independent Claim 14: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
    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"

  • Technology Synopsis: This patent claims specific salt forms of the (R)-enantiomer of ruxolitinib. The invention is based on the discovery that certain salt forms, particularly the phosphate salt, can exist in a highly crystalline state, which provides advantages for pharmaceutical manufacturing, stability, and formulation ('693 Patent, Abstract; col. 2:9-27).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶50). Independent claims include Claim 1 (the phosphate salt) and Claim 5 (a crystalline form of the phosphate salt).
  • Accused Features: The infringement allegation is based on DRL's submission of ANDA No. 220797 for a generic version of Jakafi® (ruxolitinib) (Compl. ¶50).

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"

  • Technology Synopsis: This patent is also directed to specific salt forms of the (R)-enantiomer of ruxolitinib. It claims the maleic acid salt and the sulfuric acid salt, which are described as providing new, improved, and more effective pharmaceutical formulations of the active ingredient ('481 Patent, Abstract; col. 2:19-27).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶59). Independent claims include Claim 1 (the maleic acid salt), Claim 2 (the sulfuric acid salt), and various method of treatment claims (e.g., Claim 15).
  • Accused Features: The allegation arises from DRL's ANDA filing to market a generic version of Jakafi® (ruxolitinib) (Compl. ¶59).

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"

  • Technology Synopsis: This patent claims a specific crystalline form of the phosphate salt of the (R)-enantiomer of ruxolitinib. The invention asserts that this crystalline form is highly stable and facilitates the preparation of pharmaceutical formulations ('013 Patent, Abstract; col. 2:20-29).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶68). Independent claims include Claim 1 (the crystalline phosphate salt) and Claim 8 (a drug product comprising the crystalline salt).
  • Accused Features: The allegation is based on DRL's ANDA filing to market a generic equivalent of Jakafi® (ruxolitinib) (Compl. ¶68).

III. The Accused Instrumentality

Product Identification

The accused products are Defendant DRL’s proposed generic versions of Incyte's Jakafi® (ruxolitinib) drug products, in 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg tablet formulations, which are the subject of ANDA No. 220797 submitted to the FDA (Compl. ¶¶ 1, 18, 26).

Functionality and Market Context

As proposed generic versions of Jakafi®, DRL's products are intended to contain the same active ingredient, ruxolitinib, and be therapeutically equivalent for the same approved indications (Compl. ¶26). The complaint alleges that DRL's proposed products will include prescribing information similar to that for Jakafi®, which instructs administration for methods claimed in the patents-in-suit (Compl. ¶28). The filing of the ANDA with a Paragraph IV certification signals DRL's intent to market these generic products in the United States prior to the expiration of the patents-in-suit (Compl. ¶¶ 29-30).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim chart analysis. The infringement counts are pleaded generally, based on the statutory act of infringement under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent as an act of infringement (Compl. ¶¶ 32, 41, 50, 59, 68). The complaint alleges that this act, and the subsequent commercial manufacture, use, or sale of the proposed products, will infringe one or more claims of each of the five patents-in-suit (Compl. ¶¶ 34, 43, 52, 61, 70).

Identified Points of Contention

  • Scope Questions: For the '257 Patent, a potential issue may be whether the specific ruxolitinib compound falls within the scope of the broad genus claimed in Claim 1. For the '362 Patent, which claims the specific ruxolitinib compound, infringement is likely to be straightforward if the claim is valid and DRL's product contains that compound.
  • Technical Questions: A central technical question for the '693, '481, and '013 Patents will be whether DRL's proposed generic product utilizes the exact salt forms (phosphate, maleate, sulfate) and/or crystalline structures claimed in those patents. Generic manufacturers frequently attempt to design around such formulation patents by using an alternative salt or an amorphous form of the active ingredient. The details of DRL's formulation in its ANDA will be a key point of discovery.

V. Key Claim Terms for Construction

The complaint does not identify any specific claim terms as a basis for the dispute. However, based on the nature of the patents, practitioners may focus on the following terms during litigation.

The Term: "pharmaceutically acceptable salt"

(from Claim 1 of the '362 Patent)

  • Context and Importance: This term is critical because the '362 patent claims the base ruxolitinib molecule or a "pharmaceutically acceptable salt thereof." If DRL's product uses a salt form different from the specific phosphate, maleate, or sulfate salts claimed in the later patents, the scope of this term in the '362 patent will determine whether DRL's product still literally infringes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the related '257 Patent provides a broad, conventional definition, stating the term refers to salts prepared from a wide variety of "pharmaceutically acceptable non-toxic bases or acids" and provides extensive exemplary lists ('257 Patent, col. 32:36-53).
    • Evidence for a Narrower Interpretation: A defendant might argue that the term should be limited to the common salt forms known at the time of filing and should not extend to a novel salt form with unexpected properties that required inventive effort to discover.

The Term: "crystalline"

(from Claim 5 of the '693 Patent and Claim 1 of the '013 Patent)

  • Context and Importance: These claims are directed specifically to crystalline forms of the phosphate salt. Infringement will depend on whether DRL's product contains a form that meets the definition of "crystalline" and potentially whether it is the same crystalline polymorph. A dispute could arise over the degree of crystallinity required to meet the claim limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent may not define the term, leaving it to its plain and ordinary meaning in chemistry, which could encompass any material with a long-range ordered atomic structure, regardless of the specific crystal lattice.
    • Evidence for a Narrower Interpretation: The specification provides data for specific crystalline forms, such as X-ray powder diffraction (XRPD) patterns and differential scanning calorimetry (DSC) results ('693 Patent, Examples 2-3). A defendant could argue the term "crystalline" should be construed as limited to the specific polymorphs disclosed and characterized in the patent.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for all five patents-in-suit. The basis for inducement is the allegation that DRL's product labeling will instruct healthcare providers and patients to administer the drug for indications covered by method-of-use claims (Compl. ¶¶ 35, 44, 53, 62, 71). The basis for contributory infringement is the allegation that DRL's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶¶ 36, 45, 54, 63, 72).

Willful Infringement

The complaint does not explicitly allege "willful infringement," but for each count, it asserts that the case is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶ 39, 48, 57, 66, 75). The allegation that DRL provided written notice of its Paragraph IV certifications serves to establish DRL's pre-suit knowledge of the patents-in-suit (Compl. ¶30).

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

  • A core issue will be one of validity: Given that the active ingredient in DRL's product is likely the compound claimed in the '362 Patent, the central defense will probably be an invalidity challenge, questioning whether the claims to the ruxolitinib compound and its methods of use were non-obvious and enabled at the time of filing.
  • A key factual question will be one of form selection: Does the specific formulation detailed in DRL's confidential ANDA filing utilize the phosphate, maleate, or sulfate salt forms, or the specific crystalline structures, claimed in Incyte’s later-issued patents ('693, '481, '013)? Resolution of this question will determine the relevance of these patents and may turn the case into a classic design-around dispute.
  • The case may raise a question of claim scope: If DRL uses a novel or different salt form not explicitly claimed in the formulation patents, a central legal issue will be whether the phrase "pharmaceutically acceptable salt" in the '362 patent is broad enough to cover DRL's chosen form, or whether Incyte must rely on the doctrine of equivalents to prove infringement.