DCT

2:26-cv-00539

Incyte Corp v. Encube Ethicals Pvt Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-00539, D.N.J., 01/16/2026
  • Venue Allegations: Plaintiff alleges venue is proper in any judicial district because Defendant is a foreign corporation organized under the laws of India.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff’s Opzelura® (ruxolitinib) cream constitutes an act of infringement of eight U.S. patents directed to topical pharmaceutical formulations and their methods of use.
  • Technical Context: The technology concerns oil-in-water topical cream formulations for ruxolitinib, a Janus kinase (JAK) inhibitor used to treat inflammatory skin disorders such as atopic dermatitis and vitiligo.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 218765 and a Paragraph IV Certification alleging that the patents-in-suit are invalid and/or will not be infringed. The complaint also certifies that this matter is related to other pending litigation filed by Incyte against different generic drug manufacturers (Padagis Israel Pharmaceuticals Ltd. and Taro Pharmaceuticals Inc.) concerning generic versions of the same brand-name drug product.

Case Timeline

Date Event
2010-05-21 Earliest Priority Date ('543, '870, '624, '425, '136, '419 Patents)
2019-09-05 Earliest Priority Date ('923, '137 Patents)
2020-09-01 U.S. Patent No. 10,758,543 Issues
2020-12-22 U.S. Patent No. 10,869,870 Issues
2022-01-11 U.S. Patent No. 11,219,624 Issues
2022-11-29 U.S. Patent No. 11,510,923 Issues
2023-02-07 U.S. Patent No. 11,571,425 Issues
2023-02-28 U.S. Patent No. 11,590,136 Issues
2023-02-28 U.S. Patent No. 11,590,137 Issues
2025-02-18 U.S. Patent No. 12,226,419 Issues
2025-12-01 Earliest date Defendant sent Paragraph IV Notice Letter to Plaintiff
2026-01-16 Complaint Filed

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

U.S. Patent No. 10,758,543 - *“Topical Formulation for a JAK Inhibitor”*

Issued September 1, 2020

The Invention Explained

  • Problem Addressed: The patent addresses the need for improved topical formulations of Janus kinase (JAK) inhibitors for treating skin disorders, noting a specific need for stable, easily applied formulations that exhibit good skin permeation characteristics (Compl., Ex. A, ’543 Patent, col. 2:30-35).
  • The Patented Solution: The invention is an oil-in-water emulsion formulated as a "solubilized cream" containing the JAK inhibitor ruxolitinib. This formulation is described as having superior appearance, spreadability, stability, and skin permeation compared to other formulations like anhydrous ointments or water-in-oil emulsions (’543 Patent, col. 4:29-54; Abstract). The manufacturing process for this specific type of formulation is depicted in a flowchart (’543 Patent, Fig. 1).
  • Technical Importance: The development of a stable and effective topical delivery system for JAK inhibitors was important for treating skin immune disorders such as psoriasis locally, potentially avoiding systemic side effects associated with oral administration (’543 Patent, col. 2:13-15, 2:36-39).

Key Claims at a Glance

The complaint does not specify which claims it asserts, alleging infringement of "one or more of the claims" (Compl. ¶ 31). As a representative independent claim, Claim 1 requires:

  • A pharmaceutical composition for topical skin application comprising:
  • An oil-in-water emulsion, which itself comprises water, an oil component, an emulsifier component, and a solvent component;
  • From about 0.5% to about 1.5% by weight of the emulsion (on a free base basis) of a 1:1 phosphoric acid salt of (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl-]propanenitrile;
  • Wherein the emulsion is a "solubilized cream" for topical application; and
  • Wherein the emulsion has a pH of "not greater than 3.6."
    The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,869,870 - *“Topical Formulation for a JAK Inhibitor”*

Issued December 22, 2020

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’543 Patent: the need for an improved topical formulation of a JAK inhibitor with good stability and skin permeation properties (Compl., Ex. B, ’870 Patent, col. 2:30-35).
  • The Patented Solution: The invention described is an oil-in-water emulsion containing the JAK inhibitor ruxolitinib. The patent highlights that this specific formulation type demonstrates superior stability and skin transport characteristics compared to alternatives like water-in-oil formulations, which exhibited syneresis (separation of liquid) when stored at 40° C (’870 Patent, col. 4:51-57).
  • Technical Importance: As with the ’543 Patent, this invention provided a vehicle for effective topical delivery of a JAK inhibitor to treat skin immune disorders (’870 Patent, col. 2:13-15).

Key Claims at a Glance

The complaint alleges infringement of "one or more of the claims" without specification (Compl. ¶ 40). Independent claim 1 is nearly identical to Claim 1 of the ’543 Patent, but recites a more specific pH range. It requires:

  • A pharmaceutical composition for topical skin application comprising:
  • An oil-in-water emulsion, which itself comprises water, an oil component, an emulsifier component, and a solvent component;
  • From about 0.5% to about 1.5% by weight of the emulsion (on a free base basis) of a 1:1 phosphoric acid salt of (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl-]propanenitrile;
  • Wherein the emulsion is a "solubilized cream" for topical application; and
  • Wherein the emulsion has a pH of "2.9 to 3.6."
    The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 11,219,624 - *“Topical Formulation for a JAK Inhibitor”*

Issued January 11, 2022

  • Technology Synopsis: This patent covers a topical oil-in-water emulsion formulation containing ruxolitinib. The invention addresses the need for a stable, effective topical delivery system for JAK inhibitors to treat skin disorders like psoriasis (Compl., Ex. C, ’624 Patent, col. 2:30-39; Abstract).
  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims (Compl. ¶ 49). Independent claims include 1, 8, 14, and 19.
  • Accused Features: The complaint alleges that Encube's proposed generic product, which is intended to be a copy of Opzelura®, will contain the claimed pharmaceutical composition (Compl. ¶ 49).

U.S. Patent No. 11,510,923 - *“Ruxolitinib Formulation for Reduction of Itch in Atopic Dermatitis”*

Issued November 29, 2022

  • Technology Synopsis: This patent is directed to methods of reducing itch and treating atopic dermatitis by administering a topical ruxolitinib cream two times per day. The invention is based on the discovery that this treatment regimen leads to significant improvements in patient outcomes (Compl., Ex. D, ’923 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims (Compl. ¶ 58). Independent claims include 1, 38, and 84.
  • Accused Features: The complaint alleges that the use of Encube's proposed generic product according to its FDA-approved labeling will infringe the claimed methods of use (Compl. ¶ 18, 58).

U.S. Patent No. 11,571,425 - *“Topical Formulation for a JAK Inhibitor”*

Issued February 7, 2023

  • Technology Synopsis: This patent covers a topical oil-in-water emulsion formulation containing ruxolitinib. The claims are directed to specific compositions for treating skin disorders, addressing the need for a stable and effective delivery vehicle (Compl., Ex. E, ’425 Patent, Abstract; col. 2:30-39).
  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims (Compl. ¶ 67). Independent claims include 1, 8, 15, and 22.
  • Accused Features: The complaint alleges that Encube's proposed generic product will have the claimed pharmaceutical composition (Compl. ¶ 67).

U.S. Patent No. 11,590,136 - *“Topical Formulation for a JAK Inhibitor”*

Issued February 28, 2023

  • Technology Synopsis: This patent, like others in the family, claims a topical oil-in-water emulsion containing the JAK inhibitor ruxolitinib. The invention is presented as a solution for providing a stable and effective topical formulation for treating skin disorders (Compl., Ex. F, ’136 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims (Compl. ¶ 76). The sole independent claim is Claim 1.
  • Accused Features: The complaint alleges that Encube's proposed generic product will embody the claimed pharmaceutical composition (Compl. ¶ 76).

U.S. Patent No. 11,590,137 - *“Ruxolitinib Formulation for Reduction of Itch in Atopic Dermatitis”*

Issued February 28, 2023

  • Technology Synopsis: This patent covers methods for treating moderate to severe atopic dermatitis by administering a topical ruxolitinib cream two times per day. The patent focuses on achieving specific clinical outcomes, such as IGA treatment success and a reduction in the itch Numerical Rating Scale score (Compl., Ex. G, ’137 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims (Compl. ¶ 85). Independent claims include 1, 7, 16, and 38.
  • Accused Features: The complaint alleges that the use of Encube's proposed generic product as instructed by its labeling will constitute infringement of the claimed methods (Compl. ¶ 18, 85).

U.S. Patent No. 12,226,419 - *“Topical Formulation for a JAK Inhibitor”*

Issued February 18, 2025

  • Technology Synopsis: This patent claims a topical oil-in-water emulsion containing ruxolitinib, intended for the treatment of skin disorders. The patent is part of a family focused on solving the technical challenges of creating a stable and effective topical formulation for JAK inhibitors (Compl., Ex. H, ’419 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of one or more unspecified claims (Compl. ¶ 94). The sole independent claim is Claim 1.
  • Accused Features: The complaint alleges that Encube's proposed generic product will infringe by containing the claimed composition (Compl. ¶ 94).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Encube’s Proposed Generic Product," which is the subject of Abbreviated New Drug Application (“ANDA”) No. 218765 submitted to the FDA (Compl. ¶¶ 1, 22).

Functionality and Market Context

  • The complaint alleges that this product is a generic version of Incyte’s Opzelura® (ruxolitinib) cream (Compl. ¶ 1). As such, it is intended for topical application for the treatment of mild to moderate atopic dermatitis and nonsegmental vitiligo (Compl. ¶¶ 16-17). In the context of this Hatch-Waxman litigation, the statutory act of infringement is the submission of the ANDA itself, which seeks FDA approval to market the generic product before the expiration of the patents-in-suit (Compl. ¶ 31).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of specific infringement allegations on a claim-by-claim basis. It is a notice-pleading complaint filed under the Hatch-Waxman Act, which makes the conclusory allegation that Encube’s submission of ANDA No. 218765 constitutes infringement of one or more claims of each of the patents-in-suit (e.g., Compl. ¶ 31). The complaint does not include or reference a claim chart. The narrative theory of infringement is that, by seeking approval for a generic version of Opzelura®, Encube’s proposed product will necessarily have the composition claimed in the formulation patents and will be administered according to the methods claimed in the method-of-use patents.

  • Identified Points of Contention:
    • Scope Questions: For the formulation patents (e.g., ’543 and ’870 Patents), a central issue may be whether the specific excipients and their concentrations in Encube's proposed product fall within the scope of the functionally and quantitatively defined claim elements. This raises the question of how broadly terms like "solubilized cream" or "stiffening agent component" will be construed.
    • Technical Questions: A key technical question will be one of direct comparison. The complaint provides no evidence regarding the specific composition of the accused product. Therefore, discovery will be required to determine if Encube’s formulation, as described in its confidential ANDA, contains every component in the amounts required by the asserted claims. For the method-of-use patents (e.g., '923 and '137 Patents), the analysis will turn on whether Encube's proposed product label instructs or encourages physicians and patients to administer the drug in a manner that performs all steps of the claimed methods.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific terms that will be at issue. However, based on the representative independent claims of the lead formulation patents, the following terms may be central to the dispute.

  • The Term: "solubilized cream" (’543 Patent, cl. 1; ’870 Patent, cl. 1)

    • Context and Importance: This term appears to define the physical state of the final formulation. Its construction is critical because it may distinguish the claimed invention from other formulation types, such as dispersions or suspensions where the active ingredient is not fully dissolved. Practitioners may focus on this term because the patents' own examples explicitly contrast "solubilized cream" with "dispersed cream" and note issues with crystallization, suggesting a specific technical meaning is intended (’543 Patent, Example 5, Table 22).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue that the term does not require perfect molecular dissolution but rather refers to a macroscopically uniform and stable cream where the active ingredient is effectively incorporated and deliverable.
      • Evidence for a Narrower Interpretation: The specification’s discussion of preventing the active ingredient from crystallizing out of solution could support a narrower definition requiring the active ingredient to be fully dissolved in the formulation under specified conditions (’543 Patent, col. 36:23-28).

  • The Term: "stiffening agent component" (’543 Patent, cl. 9)

    • Context and Importance: This is a functional claim term that describes one of the excipient categories in the oil-in-water emulsion. The definition of this term will determine whether certain ingredients in Encube’s formulation meet this limitation, making it a likely point of contention in claim construction.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a broad functional definition: "a substance or mixture of substances that increases the viscosity and/or consistency of the formulation or improves the rheology of the formulation" (’543 Patent, col. 5:62-67). This language may support an interpretation covering a wide range of viscosity-modifying agents.
      • Evidence for a Narrower Interpretation: A party might argue that the term should be limited by the specific examples provided in the specification, such as "cetyl alcohol and stearyl alcohol" (’543 Patent, col. 6:15-18).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for each asserted patent. The inducement allegations are based on the assertion that Defendant, with knowledge of the patents, will encourage infringement by physicians and patients through its product and labeling (e.g., Compl. ¶ 34). The contributory infringement allegations are based on the assertion that the proposed generic product is especially adapted for an infringing use and has no substantial non-infringing uses (e.g., Compl. ¶ 35).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, for each patent, it alleges that the case is "exceptional" and requests an award of reasonable attorneys' fees under 35 U.S.C. § 285 (e.g., Compl. ¶ 38). The factual basis for this allegation appears to be Defendant's knowledge of the patents, as evidenced by its Paragraph IV Certification letter sent to Incyte (Compl. ¶¶ 28-29).

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

  • A core issue will be one of claim construction and scope: Can the functional and descriptive terms used in the formulation claims, such as "solubilized cream" and "stiffening agent component," be construed broadly enough to read on the specific excipients and physical characteristics of Encube's proposed generic product?
  • A central evidentiary question will be one of factual identity: Does the precise chemical composition of Encube's proposed product, as detailed in its confidential ANDA submission, meet every quantitative and qualitative limitation of at least one asserted patent claim?
  • For the method-of-use patents, the case will likely turn on an infringement analysis of the proposed label: Does the label for Encube’s proposed generic product instruct or encourage physicians and patients to administer the drug in a manner that directly infringes the claimed methods for treating atopic dermatitis and reducing itch?