DCT

3:24-cv-00333

Galderma Laboratories LP v. Taro Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-00333, D.N.J., 01/19/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendants maintaining a regular and established place of business in Cranbury, New Jersey, regularly transacting business in the state, and deriving substantial revenue from pharmaceutical sales within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's AKLIEF® cream infringes patents related to topical retinoid formulations.
  • Technical Context: The technology concerns pharmaceutical formulations designed to improve the stability and skin tolerability of topical retinoids, which are potent compounds used to treat dermatological conditions like acne.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant Taro's submission of ANDA No. 218978 to the FDA. The ANDA included a Paragraph IV certification, asserting that Plaintiff's patents covering the branded drug AKLIEF® are invalid or will not be infringed by Taro's proposed generic product.

Case Timeline

Date Event
2012-06-01 Priority Date for '778 Patent and '465 Patent
2015-07-21 Issue Date for U.S. Patent No. 9,084,778
2016-11-22 Issue Date for U.S. Patent No. 9,498,465
2019-10-04 FDA approval for Plaintiff's AKLIEF® (NDA No. 211527)
2023-03-31 Defendant Taro submits Drug Master File for trifarotene
2024-01-19 Complaint Filed

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

U.S. Patent No. 9,084,778 - "Topical Compositions Containing a Retinoid of the Oil-In-Water Emulsion Type"

  • Patent Identification: U.S. Patent No. 9,084,778, "Topical Compositions Containing a Retinoid of the Oil-In-Water Emulsion Type," issued July 21, 2015 (Compl. ¶39).

The Invention Explained

  • Problem Addressed: The patent's background describes that topical retinoid treatments can cause significant skin irritation, such as dryness and erythema. It also notes that many common excipients, particularly emulsifiers, can contribute to this irritation, and that the retinoid compounds themselves are often chemically unstable in many formulation solvents (’778 Patent, col. 2:16-45).
  • The Patented Solution: The invention is an oil-in-water (O/W) emulsion for delivering a retinoid active ingredient. The composition is specifically designed to be stable and effective without using a traditional emulsifier. It achieves this by combining the retinoid with a carefully selected principal solvent, a co-solvent oil, and an aqueous phase containing a gelling agent, which work together to stabilize the emulsion and deliver the drug (’778 Patent, Abstract; col. 3:38-41).
  • Technical Importance: This approach sought to create a topical retinoid product with improved patient tolerability and chemical stability, potentially increasing patient compliance for treating conditions like acne (’778 Patent, col. 2:42-45).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specifying them (Compl. ¶51). Independent claim 1 is the primary composition claim.
  • Independent Claim 1:
    • A pharmaceutical composition comprising:
    • an oily phase comprising at least one compound of formula (I);
    • at least a principal solvent of compound of formula(I) and at least a co-solvent oil of compound of formula(I);
    • and an aqueous phase comprising at least a gelifying agent.
  • The complaint may be interpreted as reserving the right to assert additional independent and dependent claims.

U.S. Patent No. 9,498,465 - "Topical Compositions In the Form of a Gel Containing a Particular Solubilized Retinoid"

  • Patent Identification: U.S. Patent No. 9,498,465, "Topical Compositions In the Form of a Gel Containing a Particular Solubilized Retinoid," issued November 22, 2016 (Compl. ¶40).

The Invention Explained

  • Problem Addressed: The patent identifies a need for stable and well-tolerated pharmaceutical compositions for retinoids, noting that conventional formulations often use irritating emulsifiers and that the active ingredients can be chemically unstable (’465 Patent, col. 4:28-56).
  • The Patented Solution: The invention is an "aqueous-glycolic gel" composition. Instead of an oil-based emulsion, this invention solubilizes the water-insoluble retinoid in a specific hydrophilic solvent system (containing a "hydrophilic solvent" and a "hydrophilic cosolvent"). This active phase is then combined with water and a gelling agent to form a stable gel, avoiding the need for emulsifiers (’465 Patent, Abstract; col. 6:61-65).
  • Technical Importance: This technology provides an alternative, non-emulsion delivery vehicle for retinoids, aiming to enhance stability and reduce skin irritation, thereby providing a therapeutic advantage (’465 Patent, col. 4:57-62).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specification (Compl. ¶60). Independent claim 1 is the primary composition claim.
  • Independent Claim 1:
    • A pharmaceutical composition comprising at least one active agent represented by a compound of general formula (I),
    • water,
    • at least one gelling agent,
    • at least one hydrophilic solvent and at least one hydrophilic cosolvent,
    • wherein the compound of formula (I) is soluble in the hydrophilic solvent and the hydrophilic cosolvent,
    • and wherein the hydrophilic solvent is selected from the group consisting of methylpyrrolidone, ethoxydiglycol, benzyl alcohol, polyethylene glycol, phenoxyethanol, ethanol, and mixtures thereof.
  • The complaint may be interpreted as reserving the right to assert additional independent and dependent claims.

III. The Accused Instrumentality

Product Identification

  • Defendant's proposed generic drug, identified as "Taro's ANDA Product," is a trifarotene cream (0.005%) for topical use, submitted for FDA approval under ANDA No. 218978 (Compl. ¶1).

Functionality and Market Context

  • The accused product is a generic version of Plaintiff's AKLIEF® cream and is intended for the topical treatment of acne vulgaris (Compl. ¶1, ¶35). As an ANDA product, it is designed to be a therapeutic equivalent to the branded drug. The complaint alleges that upon approval, Defendants will manufacture, market, and sell the product in the United States, in direct competition with Plaintiff's AKLIEF® (Compl. ¶42, ¶49).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or specific, element-by-element infringement allegations. The infringement counts are 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 generic version of a patented drug as an act of infringement (Compl. ¶51, ¶60). The implicit theory is that because Taro's ANDA Product is a generic copy intended to be equivalent to AKLIEF®, a product Plaintiff asserts is covered by the Patents-in-Suit, the ANDA product must necessarily contain all the elements of at least one asserted claim of each patent.

  • Identified Points of Contention:
    • Scope Questions: The dispute will likely center on whether the specific formulation of Taro's ANDA Product falls within the scope of the claims. For the '778 Patent, a potential issue is whether Taro's formulation meets the limitations of an emulsifier-free system, or if one of its excipients could be characterized as having an emulsifying function. For the '465 Patent, a question may arise as to whether Taro’s formulation is properly classified as an "aqueous-glycolic gel" as claimed.
    • Technical Questions: A key technical question for the '465 Patent will be whether the trifarotene in Taro's product is "solubilized" as required by the claim, or if it exists in another physical state (e.g., as a dispersion or suspension). The precise identity, concentration, and interaction of the excipients in Taro's formulation compared to the claim language will be a central focus.

V. Key Claim Terms for Construction

  • Term: "gelifying agent" ('778 Patent, Claim 1)

  • Context and Importance: The definition of this term is critical because the invention relies on the gelifier to help stabilize an emulsion in the absence of a dedicated emulsifier. Practitioners may focus on this term because a defendant could argue that its chosen thickening agent either falls outside the definition of a "gelifying agent" or, conversely, that it also functions as an emulsifier, thereby taking the formulation outside the scope of claims that require an emulsifier-free system (e.g., dependent claim 4).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a long, non-exhaustive list of potential "Gelling agents," including various polymer families like polyacrylamides, carbomers, polysaccharides, and silicates, suggesting the term is intended to be construed broadly (’778 Patent, col. 7:12-58).
    • Evidence for a Narrower Interpretation: The patent's explicit statement that "no emulsifier is used as an ingredient" and that any emulsifying properties of other ingredients are minimal and incidental could support an argument that a "gelifying agent" must be functionally distinct from an emulsifier (’778 Patent, col. 8:3-9).

  • Term: "solubilized" ('465 Patent, Claim 1)

  • Context and Importance: Infringement of claim 1 of the '465 Patent requires the active ingredient to be "solubilized" in the specified solvent system. This term is critical because a defendant could design a formulation where the active ingredient is merely dispersed or suspended, rather than fully dissolved, potentially avoiding infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent does not provide an explicit numerical or quantitative definition of "solubilized" in the claims, which may support a more general, qualitative interpretation.
    • Evidence for a Narrower Interpretation: The pre-formulation studies in the specification discuss achieving solubility greater than 0.1% as a threshold for consideration (’465 Patent, col. 9, tbl. 1). A party could argue that "solubilized" should be interpreted in light of these examples to mean fully dissolved at a concentration relevant to the final product's efficacy and stability.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that the submission of the ANDA itself constitutes induced and contributory infringement (Compl. ¶51, ¶60). It further alleges that upon commercial launch, Defendants will induce infringement by providing a product label that instructs medical professionals and patients to use the product in an infringing manner (Compl. ¶52, ¶61).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the Patents-in-Suit, as evidenced by the Paragraph IV certification letter sent to Plaintiff. The complaint alleges that Defendants acted without a reasonable basis for believing they would not be liable for infringement, rendering the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶53, ¶62).

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

  • A central issue will be one of formulation equivalence and claim scope: Does the specific combination of excipients in Taro's proposed generic cream meet the precise compositional and functional limitations of the asserted claims? For the '778 Patent, this may hinge on whether the formulation is truly "emulsifier-free," while for the '465 Patent, it may depend on whether the active ingredient is technically "solubilized" as required.
  • A second key question, prompted by Taro’s Paragraph IV certification, will concern patent validity: Given the state of the art in topical formulations, were the specific patented solutions—an emulsifier-free O/W emulsion (’778 Patent) and an aqueous-glycolic gel (’465 Patent) for delivering trifarotene—non-obvious advancements over what was previously known for addressing retinoid instability and irritation?