DCT

2:25-cv-01858

Incyte Corp v. Taro Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-01858, D.N.J., 03/13/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants are foreign corporations that may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' proposed generic versions of the Opzelura® (ruxolitinib) cream, for which they have filed Abbreviated New Drug Applications (ANDAs), infringe seven patents related to topical pharmaceutical formulations of a Janus kinase (JAK) inhibitor.
  • Technical Context: The technology concerns oil-in-water topical cream formulations for the JAK inhibitor ruxolitinib, used in treating skin disorders such as atopic dermatitis and psoriasis by modulating immune responses.
  • Key Procedural History: The action arises from Defendants' submission of ANDAs to the U.S. Food and Drug Administration (FDA). As part of this process, Defendants provided Paragraph IV certifications, asserting that the patents-in-suit are invalid and/or will not be infringed by their proposed generic products. This act of filing an ANDA with a Paragraph IV certification constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2), creating the basis for this lawsuit.

Case Timeline

Date Event
2010-05-21 Earliest Priority Date ('543, '870, '624, '425, '136, '137, '923 Patents)
2020-09-01 Issue Date: U.S. Patent No. 10,758,543
2020-12-22 Issue Date: U.S. Patent No. 10,869,870
2022-01-11 Issue Date: U.S. Patent No. 11,219,624
2022-11-29 Issue Date: U.S. Patent No. 11,510,923
2023-02-07 Issue Date: U.S. Patent No. 11,571,425
2023-02-28 Issue Date: U.S. Patent No. 11,590,136
2023-02-28 Issue Date: U.S. Patent No. 11,590,137
2025-01-27 Earliest Date Defendants Sent Paragraph IV Notice Letters
2025-03-13 Complaint Filing Date

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

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

  • Patent Identification: U.S. Patent No. 10,758,543, titled “Topical Formulation for a JAK Inhibitor,” issued September 1, 2020.

The Invention Explained

  • Problem Addressed: The patent background describes a need for improved topical formulations of JAK inhibitors for treating skin disorders. Specifically, it notes the need for stable, easily applied formulations that exhibit good skin permeation characteristics (’543 Patent, col. 2:31-36).
  • 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 better appearance, spreadability, stability, and skin permeation compared to other types of formulations, such as anhydrous ointments (’543 Patent, Abstract; col. 4:29-47). The manufacturing process is illustrated in a flowchart (ʼ543 Patent, Fig. 1).
  • Technical Importance: The use of JAK inhibitors for skin immune disorders like psoriasis is considered therapeutically beneficial, as many inflammatory cytokines that maintain the disease signal through the JAK kinases (’543 Patent, col. 2:10-30).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’543 patent without specifying particular claims (Compl. ¶42). Independent claim 1 is representative of the core invention.
  • Independent Claim 1 of the '543 patent includes these essential elements:
    • 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.
    • Comprising from about 0.5% to about 1.5% by weight of the emulsion (on a free base basis) of a specific 1:1 phosphoric acid salt of (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl-]propanenitrile (ruxolitinib).
    • Wherein the oil-in-water emulsion is a "solubilized cream".
    • Wherein the oil-in-water emulsion has a pH of not greater than 3.6.

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

  • Patent Identification: U.S. Patent No. 10,869,870, titled “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 effective and stable topical formulations of JAK inhibitors for treating skin disorders (’870 Patent, col. 2:31-36).
  • The Patented Solution: The ’870 Patent describes a similar oil-in-water emulsion of ruxolitinib phosphate. The specification emphasizes that this formulation provides good spreadability, which leads to better skin permeation compared to anhydrous alternatives (’870 Patent, col. 4:29-47). The manufacturing process is again depicted in a flowchart (ʼ870 Patent, Fig. 1).
  • Technical Importance: The patent notes that blocking signal transduction at the level of JAK kinases may result in therapeutic benefits for patients suffering from psoriasis or other immune disorders of the skin (’870 Patent, col. 2:10-30).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’870 patent (Compl. ¶51). Independent claim 1 is representative.
  • Independent Claim 1 of the '870 patent includes these essential elements:
    • A pharmaceutical composition for topical skin application.
    • Comprising an oil-in-water emulsion which includes water, an oil component, an emulsifier component, and a solvent component.
    • Comprising about 1.5% by weight of the emulsion (on a free base basis) of a 1:1 ruxolitinib phosphoric acid salt.
    • Wherein the emulsion is a "solubilized cream".
    • Wherein the emulsion has a pH of 2.9 to 3.6.

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

  • Patent Identification: U.S. Patent No. 11,219,624, “Topical Formulation for a JAK Inhibitor,” issued January 11, 2022.
  • Technology Synopsis: This patent covers a similar oil-in-water emulsion formulation containing ruxolitinib phosphate, designed to provide a stable and effective topical treatment for skin disorders like psoriasis by inhibiting JAK kinases (’624 Patent, col. 2:10-36).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" (Compl. ¶60). Independent claim 1 is representative.
  • Accused Features: Taro's Proposed Product (ANDA No. 219040) is accused of infringement (Compl. ¶60).

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

  • Patent Identification: 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 in patients with atopic dermatitis by administering a topical ruxolitinib cream. The invention claims a method of treatment that achieves a reduction in the patient's self-reported itch score (’923 Patent, col. 1:12-21; Abstract).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" against Taro and Zydus (Compl. ¶¶87, 105). Independent claim 1 is representative.
  • Accused Features: Taro's Proposed Product and Zydus's Proposed Product are accused of infringement (Compl. ¶¶87, 105).

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

  • Patent Identification: U.S. Patent No. 11,571,425, “Topical Formulation for a JAK Inhibitor,” issued February 7, 2023.
  • Technology Synopsis: The patent covers an oil-in-water emulsion for topical application containing ruxolitinib phosphate. The formulation is designed for stability and effective skin permeation to treat skin disorders by inhibiting JAK kinases (’425 Patent, col. 2:31-36).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" (Compl. ¶69). Independent claim 1 is representative.
  • Accused Features: Taro's Proposed Product is accused of infringement (Compl. ¶69).

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

  • Patent Identification: U.S. Patent No. 11,590,136, “Topical Formulation for a JAK Inhibitor,” issued February 28, 2023.
  • Technology Synopsis: This patent claims an oil-in-water emulsion formulation containing ruxolitinib phosphate. The formulation is intended to provide a stable and effective vehicle for delivering the JAK inhibitor topically to treat skin disorders such as psoriasis (’136 Patent, col. 2:10-36).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" (Compl. ¶78). Independent claim 1 is representative.
  • Accused Features: Taro's Proposed Product is accused of infringement (Compl. ¶78).

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

  • Patent Identification: U.S. Patent No. 11,590,137, “Ruxolitinib Formulation for Reduction of Itch in Atopic Dermatitis,” issued February 28, 2023.
  • Technology Synopsis: This patent claims methods for reducing itch in atopic dermatitis patients by administering a topical ruxolitinib cream. The invention is based on achieving a clinically meaningful reduction in the patient's itch score (’137 Patent, col. 1:12-21; Abstract).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" against Taro and Zydus (Compl. ¶¶96, 114). Independent claim 1 is representative.
  • Accused Features: Taro's Proposed Product and Zydus's Proposed Product are accused of infringement (Compl. ¶¶96, 114).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "Taro’s Proposed Product," the subject of ANDA No. 219040, and "Zydus’s Proposed Product," the subject of ANDA No. 218568 (Compl. ¶¶ 1, 20, 28).

Functionality and Market Context

  • The complaint alleges that these products are generic versions of Incyte’s Opzelura® (ruxolitinib) cream (Compl. ¶1). Opzelura® is an FDA-approved drug for the "topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis" (Compl. ¶15). The Defendants' ANDA submissions seek FDA approval to manufacture, use, and sell these generic versions in the United States prior to the expiration of the patents-in-suit (Compl. ¶¶ 1, 36, 40). The act of filing the ANDAs is the statutory basis for the infringement claims under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶ 42, 51).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement on an element-by-element basis. The infringement counts are pleaded generally, stating that the submission of the ANDAs for the proposed generic products constitutes infringement of "one or more of the claims" of each asserted patent (Compl. ¶¶ 42, 51, 60, 69, 78, 87, 96, 105, 114). The underlying theory in such ANDA litigation is that a generic product, which must be the same as the branded reference drug to secure FDA approval, will necessarily meet the limitations of the patents covering the branded drug's formulation and/or method of use.

  • Identified Points of Contention:
    • Scope Questions: A central question for the composition-of-matter claims (e.g., in the ’543 and ’870 Patents) will be whether the specific excipients, their concentrations, and the resulting formulation properties (such as pH) of the Defendants' proposed products fall within the literal scope of the asserted claims. For the method-of-use claims (e.g., in the ’923 and ’137 Patents), a key question may be whether the label for the proposed generic products will instruct or encourage physicians and patients to use the product in a manner that performs the claimed steps for reducing itch.
    • Technical Questions: A primary technical question is whether the Defendants' products are in fact "solubilized creams" as required by claims in patents like the ’543 Patent, or if they can be characterized as a different type of formulation, such as a dispersion, that might fall outside the claim scope. The precise physical and chemical properties of the final generic formulations, which are confidential within the ANDAs, will be central to resolving these infringement questions.

V. Key Claim Terms for Construction

The Term: "solubilized cream" (’543 Patent, Claim 1)

  • Context and Importance: This term appears in the independent claims of patents covering the formulation itself. Its construction will be critical because infringement may turn on whether the active pharmaceutical ingredient (API) in the Defendants' generic products exists in a "solubilized" state within the cream base, as opposed to being merely dispersed or suspended. Practitioners may focus on this term because Defendants could argue their formulation achieves bioequivalence without creating what the patent defines as a "solubilized cream."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification does not appear to provide an explicit definition of "solubilized cream." A party might argue that any formulation where the API is sufficiently dissolved to be effective meets the term's plain and ordinary meaning.
    • Evidence for a Narrower Interpretation: The patent contrasts its oil-in-water formulations with anhydrous ointments and describes a general trend of increased permeability when the "solubilized cream" strength was increased, a trend not seen with water-in-oil formulations (’543 Patent, col. 4:56-62). A party could argue these functional characteristics are required for a formulation to be considered a "solubilized cream."

The Term: "pH of not greater than 3.6" (’543 Patent, Claim 1)

  • Context and Importance: This is a precise numerical limitation defining a property of the final composition. Infringement will require the Defendants' products to have a pH that meets this upper bound. Because numerical ranges are often strictly construed, this term will be a straightforward but critical point of factual dispute once the composition of the generic products is known.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue for some level of measurement tolerance, although this is generally disfavored for claim construction.
    • Evidence for a Narrower Interpretation: The patent presents stability and viscosity data for formulations with pH values of 3.1, 3.3, and 3.6, suggesting the inventors considered this specific range to be important for the invention's properties (’543 Patent, Table 6). This may support a strict interpretation of the "not greater than 3.6" limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will induce infringement by "intentionally encourag[ing] acts of direct infringement" and contribute to infringement because their products are "especially adapted for a use that infringes" and have "no substantial non-infringing use" (Compl. ¶¶ 45-46, 54-55). These allegations are based on the premise that Defendants' product labels will instruct users to apply the cream in an infringing manner.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, for each count, it alleges the case is "an exceptional one" and requests an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶ 49, 58). This suggests Plaintiff believes Defendants' conduct in challenging the patents is baseless or otherwise justifies enhanced remedies.

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

  • A core issue will be one of factual correspondence: once discovery reveals the exact composition of the Defendants' ANDA products, will their formulations—including the specific excipients, API concentration, and resulting pH—fall within the literal scope of the asserted composition claims? The case for these patents will likely turn on a comparison of the Defendants' confidential formulation data against the claim limitations.
  • A key question will be one of claim construction and scope: can the term “solubilized cream,” which is not explicitly defined in the patents, be construed narrowly enough to exclude the Defendants' formulations? The outcome of this definitional dispute could be dispositive for the patents claiming the formulation itself.
  • A central challenge for the Defendants, implied by their Paragraph IV letters, will be one of validity: can the Defendants prove by clear and convincing evidence that the asserted patent claims are invalid, for instance, by arguing that the claimed formulations would have been obvious to a person of ordinary skill in the art in light of prior art pharmaceutical compositions?