DCT
2:25-cv-05380
Incyte Corp v. Padagis Israel Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Incyte Corp. and Incyte Holdings Corporation (Delaware)
- Defendant: Padagis Israel Pharmaceuticals Ltd. (Israel)
- Plaintiff’s Counsel: Saul Ewing LLP
- Case Identification: 2:25-cv-05380, D.N.J., 05/23/2025
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation that may be sued in any judicial district and has purposefully availed itself of the rights of the District of New Jersey.
- Core Dispute: This is a Hatch-Waxman action in which Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Opzelura® (ruxolitinib) cream constitutes an act of infringement of a patent covering the drug's formulation.
- Technical Context: The technology involves a specific oil-in-water topical cream formulation for ruxolitinib, a Janus kinase (JAK) inhibitor used to treat autoimmune and inflammatory skin disorders.
- Key Procedural History: The suit was triggered by Defendant’s submission of ANDA No. 218657 with a Paragraph IV Certification, asserting that the patent-in-suit is invalid and/or will not be infringed by its proposed generic product. The complaint notes a related case between the same parties involving the same drug product.
Case Timeline
| Date | Event |
|---|---|
| 2010-05-21 | ’419 Patent Priority Date |
| 2025-02-18 | ’419 Patent Issue Date |
| 2025-04-22 | Earliest Date Defendant Sent Paragraph IV Notice Letter |
| 2025-05-23 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,226,419 - "Topical Formulation for a JAK Inhibitor"
- Patent Identification: U.S. Patent No. 12,226,419, "Topical Formulation for a JAK Inhibitor," issued February 18, 2025.
The Invention Explained
- Problem Addressed: The patent addresses the need for improved topical formulations of JAK inhibitors for treating skin disorders. The stated goal is to create formulations that are stable, easily applied, and have good skin permeation characteristics, which can be a challenge for active pharmaceutical ingredients (’419 Patent, col. 2:49-55).
- The Patented Solution: The invention is a specific oil-in-water cream formulation designed to effectively deliver the JAK inhibitor ruxolitinib through the skin. The patent describes a multi-phase manufacturing process, depicted in a flowchart in Figure 1, to create a stable emulsion with specific percentages of an oil component, an emulsifier, a stabilizer, and a solvent to carry the active ingredient (’419 Patent, Fig. 1; col. 4:20-24). The patent asserts that this oil-in-water approach provides better spreadability and skin permeation compared to other formulation types like anhydrous ointments (’419 Patent, col. 4:41-52).
- Technical Importance: Developing a stable and effective topical cream allows for localized delivery of a potent JAK inhibitor, which may treat inflammatory skin conditions with a lower risk of systemic side effects compared to oral administration of the same drug.
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the patent-in-suit (Compl. ¶24). Independent claim 1 is representative of the core invention.
- Independent Claim 1: A pharmaceutical formulation for topical skin application, which is an oil-in-water emulsion comprising:
- from 35% to 65% by weight of water;
- from 10% to 40% by weight of a mixture of petrolatum, C16-18 fatty alcohols, mineral oil, a triglyceride, and a silicone oil;
- from 2% to 6% by weight of a mixture of a glyceryl fatty ester and a sorbitan fatty ester;
- from 0.05% to 5% by weight of a polysaccharide;
- from 10% to 35% by weight of a mixture of an alkylene glycol and a polyalkylene glycol; and
- 1.5% of (R)-3-cyclopentyl-3-[4-(7H-pyrrolo [2,3-d] pyrimidin-4-yl)-1H- pyrazol-1-yl]propanenitrile phosphoric acid salt by weight of the formulation on a free base basis.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation of infringement of "one or more claims" (Compl. ¶24).
III. The Accused Instrumentality
Product Identification
- Defendant’s proposed generic version of Opzelura® (ruxolitinib) cream, which is the subject of ANDA No. 218657 ("Padagis's Proposed Product") (Compl. ¶1, ¶12).
Functionality and Market Context
- The complaint identifies the accused product as a generic equivalent to Incyte's approved Opzelura® cream, which is used for the topical treatment of skin disorders (Compl. ¶1, ¶6).
- The complaint does not provide specific details regarding the formulation or technical characteristics of Padagis's Proposed Product, other than to allege that it is a generic drug product that will infringe the ’419 patent (Compl. ¶12, ¶24). Its commercial importance stems from being a lower-cost generic alternative to a branded pharmaceutical product.
Visual Evidence
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint provides a generalized allegation of infringement without a detailed claim chart. The following table summarizes the infringement theory for a representative independent claim, which posits that the defendant's ANDA product meets the specific formulation requirements of the patent.
’419 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation for topical skin application, wherein the formulation is an oil-in-water emulsion | Padagis’s Proposed Product is alleged to be an oil-in-water cream formulation. | ¶1, ¶22 | col. 4:22-24 |
| from 35% to 65% by weight of the formulation of water | The complaint alleges that the Proposed Product will infringe, which implies its formulation contains water within the claimed weight percentage range. | ¶24 | col. 5:48-54 |
| from 10% to 40% by weight of the formulation of a mixture of petrolatum, C16-18 fatty alcohols, mineral oil, a triglyceride, and a silicone oil | The complaint alleges the Proposed Product will infringe, which implies its formulation contains an oil component mixture with the recited ingredients within the claimed weight percentage range. | ¶24 | col. 5:29-32 |
| from 2% to 6% by weight of the formulation of a mixture of a glyceryl fatty ester and a sorbitan fatty ester | The complaint alleges the Proposed Product will infringe, which implies its formulation contains an emulsifier mixture with the recited ingredients within the claimed weight percentage range. | ¶24 | col. 7:4-6 |
| from 0.05% to 5% by weight of the formulation of a polysaccharide | The complaint alleges the Proposed Product will infringe, which implies its formulation contains a polysaccharide stabilizer within the claimed weight percentage range. | ¶24 | col. 7:26-29 |
| from 10% to 35% by weight of the formulation of a mixture of an alkylene glycol and a polyalkylene glycol | The complaint alleges the Proposed Product will infringe, which implies its formulation contains a solvent mixture with the recited ingredients within the claimed weight percentage range. | ¶24 | col. 7:62-65 |
| 1.5% of (R)-3-cyclopentyl-3-[4-(7H-pyrrolo [2,3-d] pyrimidin-4-yl)-1H- pyrazol-1-yl]propanenitrile phosphoric acid salt by weight ... on a free base basis. | The complaint alleges the Proposed Product contains ruxolitinib as its active ingredient and will infringe, implying it contains the active ingredient at the claimed concentration. | ¶1, ¶7, ¶24 | col. 8:1-15 |
Identified Points of Contention
- Factual Question: The central dispute will be factual: does the precise formulation of Padagis's Proposed Product, as detailed in its confidential ANDA submission, literally meet every compositional and quantitative limitation of the asserted claims? Discovery into the ANDA's contents will be necessary to resolve this.
- Scope Question: A potential dispute may arise over the proper interpretation of claim limitations reciting "a mixture of" several ingredients connected by "and" (e.g., "a mixture of petrolatum, C16-18 fatty alcohols, mineral oil, a triglyceride, and a silicone oil"). The parties may contest whether this requires the presence of all listed ingredients or only a subset of them.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for analysis of specific claim terms. However, based on the language of representative claim 1, the following term may be a focus of claim construction.
- The Term: "a mixture of petrolatum, C16-18 fatty alcohols, mineral oil, a triglyceride, and a silicone oil"
- Context and Importance: This term defines the multi-ingredient "oil component" of the formulation. The construction of this phrase is critical because it will determine whether an accused product must contain all five specified ingredient types to literally infringe, or if a product containing only a subset could still infringe. Practitioners may focus on this term because its conjunctive ("and") phrasing differs from a typical disjunctive Markush group ("selected from the group consisting of").
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (requiring a subset): The specification describes the "oil component" as comprising "one or more substances independently selected from petrolatums, fatty alcohols, mineral oils, triglycerides, and silicone oils" (’419 Patent, col. 5:29-32). A party might argue this broader disclosure informs the meaning of the claim and suggests the listed ingredients are exemplary members of the required mixture.
- Evidence for a Narrower Interpretation (requiring all five): The plain language of the claim connects the five ingredient types with the word "and," which typically functions as a conjunction requiring all listed elements to be present. A party could argue that if the patentee intended to claim a subset, it would have used "or" or drafted a formal Markush group.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. It alleges inducement will occur upon FDA approval when Padagis "intentionally encourage[s] acts of direct infringement with knowledge of the '419 patent" (Compl. ¶25). It alleges contributory infringement on the basis that Padagis's product is "especially adapted for a use that infringes" and has "no substantial non-infringing use" (Compl. ¶26).
- Willful Infringement: The complaint does not explicitly allege willfulness, but it requests a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶29, Prayer ¶J). The factual basis for this appears to be Defendant's knowledge of the patent, evidenced by its Paragraph IV certification and notice letter sent to Incyte (Compl. ¶19-20).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be a factual determination of infringement: Does the specific formulation of Padagis's Proposed Product, as disclosed in its ANDA, contain each of the components recited in the asserted patent claims within the specified weight-percentage ranges?
- A dispositive legal issue will be one of claim scope: How should the court construe the phrase "a mixture of [A, B, C, D, and E]"? The determination of whether this limitation requires the presence of all five listed ingredient types, or merely a subset, will be central to the infringement analysis.