DCT
2:24-cv-00197
Galderma Laboratories LP v. Teva Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Galderma Laboratories L.P. (Texas); Galderma S.A. (Switzerland); Galderma Research & Development, S.N.C. (France); and Galderma Holding, S.A. (Switzerland)
- Defendant: Teva Pharmaceuticals, Inc. (Delaware); Teva Pharmaceuticals USA, Inc. (Delaware); Teva Pharmaceuticals International GMBH (Switzerland); and Teva Pharmaceutical Industries Ltd. (Israel)
- Plaintiff’s Counsel: Haug Partners LLP
- Case Identification: 2:24-cv-00197, D.N.J., 01/11/2024
- Venue Allegations: Venue is alleged in the District of New Jersey based on Defendant Teva Pharmaceuticals USA, Inc. having its principal place of business in Parsippany, New Jersey, and other defendants allegedly conducting substantial business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA to market a generic version of Plaintiff's AKLIEF® (trifarotene cream) constitutes an act of infringement of two patents covering the drug's formulation.
- Technical Context: The technology concerns pharmaceutical formulations for topical retinoids, a class of compounds used in dermatology, primarily for the treatment of acne, that are known to be prone to instability and skin irritation.
- Key Procedural History: The lawsuit was triggered by Defendant Teva's filing of ANDA No. 218739 with a "Paragraph IV certification," a formal notice to the patent holder that the generic applicant believes the relevant patents are invalid, unenforceable, or will not be infringed by the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2012-06-01 | Earliest Priority Date for ’778 and ’465 Patents |
| 2015-07-21 | U.S. Patent No. 9,084,778 Issued |
| 2016-11-22 | U.S. Patent No. 9,498,465 Issued |
| 2019-10-04 | FDA Approval of AKLIEF® (NDA No. 211527) |
| 2021-04-21 | Teva listed as applicant for PCT/US2021/028279 |
| 2024-01-11 | 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," Issued Jul. 21, 2015
The Invention Explained
- Problem Addressed: The patent describes that topical application of retinoids can cause skin irritation, and the active compounds themselves are often chemically unstable in many pharmaceutical solvents and in the presence of emulsifiers, which are typically used to create creams and lotions (’778 Patent, col. 2:16-27, 42-44).
- The Patented Solution: The invention is a pharmaceutical composition formulated as an oil-in-water (O/W) emulsion that contains the retinoid compound. A key feature is that the formulation is preferably "without emulsifier," which is intended to reduce skin irritation and improve the chemical stability of the retinoid (’778 Patent, Abstract; col. 2:31-34). The stability is achieved by solubilizing the active ingredient in a specific combination of a principal solvent and a co-solvent oil within the fat phase of the emulsion (’778 Patent, col. 6:52-59).
- Technical Importance: This approach seeks to provide a way to deliver a potent but sensitive retinoid active ingredient in a stable, effective, and well-tolerated cream formulation, addressing a persistent challenge in topical drug development (’778 Patent, col. 2:45-46).
Key Claims at a Glance
- The complaint does not identify specific asserted claims. Independent claim 1 is representative.
- Essential Elements of Claim 1:
- A pharmaceutical composition comprising:
- An oily phase comprising at least one specific retinoid compound of formula (I).
- At least a principal solvent of the retinoid compound.
- At least a co-solvent oil of the retinoid compound.
- An aqueous phase comprising at least a gelifying agent.
- The complaint reserves the right to assert additional claims.
U.S. Patent No. 9,498,465 - "Topical Compositions In the Form of a Gel Containing a Particular Solubilized Retinoid," Issued Nov. 22, 2016
The Invention Explained
- Problem Addressed: The patent addresses the same core problem as the ’778 Patent: the need for a stable and well-tolerated topical formulation for a specific retinoid compound (trifarotene) that is insoluble in water and chemically unstable in many common pharmaceutical components (’465 Patent, col. 6:5-13).
- The Patented Solution: This invention provides an "aqueous-glycolic gel" formulation, as distinct from the emulsion of the ’778 patent. The solution involves solubilizing the retinoid using a specific "hydrophilic solvent" (e.g., phenoxyethanol) in combination with a "hydrophilic cosolvent" (e.g., propylene glycol) and a gelling agent, which creates a stable, semi-solid gel suitable for topical application (’465 Patent, Abstract; col. 5:61-65).
- Technical Importance: The gel formulation provides an alternative delivery vehicle to an emulsion, which may offer different therapeutic or cosmetic characteristics while still solving the critical technical hurdles of retinoid stability and skin tolerability (’465 Patent, col.4:55-59).
Key Claims at a Glance
- The complaint does not identify specific asserted claims. Independent claim 1 is representative.
- Essential Elements of Claim 1:
- A pharmaceutical composition comprising at least one specific retinoid compound of formula (I).
- Water.
- At least one gelling agent.
- At least one hydrophilic solvent.
- At least one hydrophilic cosolvent.
- Wherein the retinoid is soluble in the hydrophilic solvent and cosolvent.
- The complaint reserves the right to assert additional claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is "Teva's ANDA Product," a generic trifarotene cream (0.005%) for which Teva seeks FDA approval via ANDA No. 218739 (Compl. ¶1).
Functionality and Market Context
- The product is a generic version of Galderma's commercial product AKLIEF®, a topical cream approved for the treatment of acne vulgaris in patients nine years of age and older (Compl. ¶¶1, 41). As a generic, it is intended to be a bioequivalent substitute for the branded drug.
- The complaint alleges that Teva is one of the "leading generic pharmaceutical companies in the United States" and that, upon approval, it will manufacture, market, and sell the accused product in the U.S. before the expiration of the patents-in-suit (Compl. ¶¶27, 48).
IV. Analysis of Infringement Allegations
The complaint makes general allegations that the submission of Teva's ANDA and the future commercialization of the product described therein will infringe the patents-in-suit (Compl. ¶¶59, 68). It does not contain a detailed claim chart or specify how each claim element is met. The infringement theory is predicated on the fact that Teva's ANDA Product is a "generic version" of AKLIEF® and therefore must practice the patented formulations that cover AKLIEF®.
No probative visual evidence provided in complaint.
'778 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising: an oily phase comprising at least one compound of formula (I) | The complaint alleges Teva's ANDA Product is a generic version of AKLIEF® (trifarotene cream), which contains the claimed retinoid. | ¶1, ¶45 | col. 5:1-50 |
| at least a principal solvent of compound of formula(I) | The ANDA product, as a formulation of the claimed retinoid, necessarily includes a solvent system for the active ingredient. | ¶1, ¶59 | col. 6:52-59 |
| and at least a co-solvent oil of compound of formula(I); | The ANDA product, as a formulation of the claimed retinoid, necessarily includes a solvent system for the active ingredient. | ¶1, ¶59 | col. 6:52-59 |
| and an aqueous phase comprising at least a gelifying agent. | The ANDA product is a cream, a type of emulsion which contains an aqueous phase and typically requires a gelling/thickening agent. | ¶1, ¶41 | col. 6:56-60 |
'465 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising at least one active agent represented by a compound of general formula (I) | The complaint alleges Teva's ANDA Product is a generic version of AKLIEF® (trifarotene cream), which contains the claimed retinoid. | ¶1, ¶46 | col. 3:5-40 |
| water, | As an "aqueous-glycolic gel," the ANDA product necessarily contains water. | ¶1, ¶68 | col. 5:64 |
| at least one gelling agent, | The ANDA product, being a cream/gel, necessarily contains a gelling agent to achieve its semi-solid consistency. | ¶1, ¶68 | col. 5:64 |
| 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 | As a formulation of the claimed water-insoluble retinoid, the ANDA product must contain a solvent system that solubilizes the active ingredient. | ¶1, ¶68 | col. 5:61-65 |
- Identified Points of Contention:
- Scope Questions: A primary question for the ’778 Patent will be the scope of formulations "without emulsifier" or, as recited in dependent claim 4, "devoid of a seperate emulsifying agent." The specification suggests this may not require the absolute absence of any compound with emulsifying properties, but rather an amount below a functional threshold (’778 Patent, col. 8:3-9). The precise composition of Teva's product in relation to this limitation will be a central issue.
- Technical Questions: A key factual dispute will be whether the specific excipients (solvents, gelling agents, etc.) and their concentrations in Teva's confidential ANDA formulation fall within the scope of the claims of both the ’778 and ’465 patents.
V. Key Claim Terms for Construction
For the ’778 Patent
- The Term: "devoid of a seperate emulsifying agent" (Claim 4)
- Context and Importance: This term is critical because the patent positions the absence of a functional emulsifier as a key innovation for reducing irritation and improving stability. Infringement will depend on whether any component in Teva's formulation can be characterized as a "seperate emulsifying agent."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., allowing for non-functional presence): Plaintiff may argue that the specification sets a functional, not absolute, standard. It states that certain ingredients may contain low percentages of emulsifiers, but "they cannot be used as an emulsifier (lower than 0.6%)" in the final composition (’778 Patent, col. 8:6-9). This suggests the term means lacking an agent added for the purpose of emulsification or present in a functionally effective amount.
- Evidence for a Narrower Interpretation (i.e., requiring absolute absence): Defendant may argue for the plain meaning of "devoid," asserting it means completely free of any substance that is known to be an emulsifier, regardless of its intended purpose or concentration in the final product.
For the ’465 Patent
- The Term: "hydrophilic solvent" (Claim 1)
- Context and Importance: The invention's ability to solubilize the water-insoluble retinoid in an aqueous gel depends on this specific component. Whether Teva's product infringes may turn on whether its primary solvent for trifarotene meets the definition of a "hydrophilic solvent" as contemplated by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent defines "hydrophilic solvent" functionally as a liquid in which the retinoid has a solubility of at least 0.1% by weight, and it provides a list of examples (’465 Patent, col. 7:22-28, col. 10:1-15). Plaintiff could argue the term covers any solvent meeting this functional solubility requirement, not just the listed examples.
- Evidence for a Narrower Interpretation: The patent identifies a specific list of six "principal solvents" and notes that stability studies showed the active ingredient was only stable in two of them: phenoxyethanol and ethanol (’465 Patent, col. 10:35-42). Defendant may argue that a person of ordinary skill would understand the term to be limited to these proven stable solvents, or at least those with a very similar chemical nature.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Teva's filing of the ANDA, with the intent to market the product upon approval, constitutes inducement of infringement. The basis is that Teva's product label will inevitably instruct physicians and patients to use the product in a manner that directly infringes the patent claims (Compl. ¶¶59, 68).
- Willful Infringement: Willfulness is alleged based on Teva's knowledge of the patents-in-suit, which are listed in the FDA's Orange Book for AKLIEF®. The complaint alleges Teva received notice via a Paragraph IV letter and "acted without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶¶61, 70).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to be a classic Hatch-Waxman dispute over pharmaceutical formulation patents. The outcome will likely depend on the answers to two central questions for the court:
A core issue will be one of definitional scope: How should the court construe the term "devoid of a seperate emulsifying agent" in the ’778 patent? Does it mean the complete absence of any substance with emulsifying properties, or does it permit the presence of such substances below a functional concentration threshold?
A key evidentiary question will be one of technical overlap: Does the specific combination and concentration of solvents, co-solvents, and gelling agents in Teva's confidential ANDA formulation fall within the scope of the properly construed claims of the ’778 and ’465 patents? The answer will hinge on expert testimony and the comparison of Teva's undisclosed formula to the patent claims.