DCT
3:24-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: Gibbons P.C.; Haug Partners LLP
- Case Identification: 3:24-cv-00197, D.N.J., 01/11/2024
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendants' maintenance of a regular and established place of business in Parsippany, New Jersey, and systematic and continuous business contacts with the state, including the preparation and submission of the at-issue Abbreviated New Drug Application (ANDA).
- Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff's AKLIEF® (trifarotene) cream constitutes an act of infringement of two patents covering topical formulations of the drug.
- Technical Context: The technology relates to pharmaceutical formulations, specifically emulsions and gels, designed to improve the stability and skin tolerability of trifarotene, a potent retinoid used for the topical treatment of acne vulgaris.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Teva's submission of ANDA No. 218739 and its notification to Galderma via a Paragraph IV certification letter, asserting that its proposed generic product would not infringe, or that the patents-in-suit are invalid or unenforceable.
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 Plaintiff's AKLIEF® (NDA No. 211527) |
| 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 July 21, 2015
The Invention Explained
- Problem Addressed: The patent addresses the dual challenges of formulating a specific class of retinoid compounds (trifarotene). These compounds are prone to chemical degradation in many common pharmaceutical solvents and in the presence of emulsifiers, and their topical application can cause significant skin irritation, such as dryness and erythema (’778 Patent, col. 2:16-20, col. 6:49-52).
- The Patented Solution: The invention is an oil-in-water (O/W) emulsion composition where the retinoid is solubilized in the fat (oily) phase (’778 Patent, col. 6:53-57). Crucially, the formulation is preferably made without a separate emulsifying agent, which the patent suggests reduces the potential for skin irritation (’778 Patent, col. 2:27-33, Abstract). This specific formulation vehicle is designed to provide good physical and chemical stability while being well-tolerated by the skin (’778 Patent, col. 6:58-59).
- Technical Importance: The invention provides a method for delivering a potent but unstable and irritating active pharmaceutical ingredient in a stable and less-irritating final product, a significant objective in topical dermatological drug development (’778 Patent, col. 2:42-46).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims of the ’778 patent (Compl. ¶60). Independent claim 1 is representative.
- Independent Claim 1 Elements:
- 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 does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,498,465 - "Topical Compositions In the Form of a Gel Containing a Particular Solubilized Retinoid," issued November 22, 2016
The Invention Explained
- Problem Addressed: Like the ’778 patent, this patent addresses the need for stable and well-tolerated pharmaceutical compositions for the retinoid of formula (I), which is noted to be insoluble in water and stable in only a very limited number of solvents (’465 Patent, col. 4:54-56, col. 6:49-55).
- The Patented Solution: The invention is an "aqueous-glycolic gel" in which the retinoid is solubilized (’465 Patent, Abstract). The composition requires water, a gelling agent, a "hydrophilic solvent" for the retinoid, and a "hydrophilic cosolvent" (’465 Patent, col. 5:65-col. 6:1). This formulation is presented as an alternative approach to delivering the active ingredient with good skin tolerance (’465 Patent, col. 4:57-61).
- Technical Importance: This patent describes a different type of formulation vehicle—a gel rather than an emulsion—for the same challenging active ingredient, offering a potentially distinct set of physical and therapeutic characteristics.
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims of the ’465 patent (Compl. ¶69). Independent claim 1 is representative.
- Independent Claim 1 Elements:
- 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.
- The complaint does not explicitly reserve the right to assert dependent 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 under ANDA No. 218739 (Compl. ¶1).
Functionality and Market Context
- The product is a topical cream intended for the treatment of acne vulgaris in patients nine years of age and older (Compl. ¶41). As an ANDA product, it is intended to be a generic equivalent to Galderma’s commercial product, AKLIEF® (Compl. ¶1). The complaint alleges that upon approval, Teva will manufacture, market, and sell this product in the United States, competing directly with AKLIEF® (Compl. ¶48).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed, element-by-element infringement analysis. The infringement theory is predicated on the allegation that Teva’s ANDA Product is a generic version of Plaintiffs’ AKLIEF® product, which is alleged to be covered by the patents-in-suit (Compl. ¶1, ¶42).
9,084,778 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising: an oily phase... and an aqueous phase | The complaint alleges Teva’s ANDA Product is a cream formulation that will infringe the patent, which implies the presence of both oily and aqueous components consistent with an oil-in-water emulsion. | ¶¶1, 59, 60 | col. 6:53-57 |
| comprising at least one compound of formula (I) | Teva’s ANDA Product contains trifarotene (0.005%) as its active ingredient, which is a compound of formula (I). | ¶1 | col. 1:15-col. 2:49 |
| at least a principal solvent... and at least a co-solvent oil | It is alleged that the excipients in Teva’s ANDA Product will include components that function as a principal solvent and a co-solvent oil for trifarotene as required by the claim. | ¶¶59, 60 | col. 40:60-col. 41:4 |
| an aqueous phase comprising at least a gelifying agent | It is alleged that Teva’s ANDA Product contains a gelling agent in its aqueous phase to achieve the required cream consistency. | ¶¶59, 60 | col. 40:5-9 |
- Identified Points of Contention:
- Scope Questions: A central dispute may concern the negative limitation in dependent claim 4, which requires the composition to be "devoid of a separate emulsifying agent." The question will be whether any excipient in Teva's formulation, even if present for other reasons, has an emulsifying effect that takes the product outside the scope of this claim. The patent's own tolerance for low levels of emulsifiers (less than 0.6%) could become a key point of interpretation (’778 Patent, col. 8:1-9).
- Technical Questions: Evidentiary questions will focus on whether the specific excipients in Teva's ANDA product can be properly characterized as a "principal solvent" and a "co-solvent oil" as those terms are used in the patent, or if they function in a technically distinct manner.
9,498,465 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising at least one active agent...of formula (I) | Teva’s ANDA Product contains the active ingredient trifarotene (0.005%), which is a compound of formula (I). | ¶1 | col. 3:9-col. 4:14 |
| water, at least one gelling agent, at least one hydrophilic solvent, and at least one hydrophilic cosolvent | The complaint alleges Teva's ANDA Product is an infringing formulation, which implies it contains water, a gelling agent, and excipients that function as the claimed hydrophilic solvent and cosolvent for solubilizing the trifarotene. | ¶¶68, 69 | col. 5:65-col. 6:1 |
| wherein the compound of formula (I) is soluble in the hydrophilic solvent and the hydrophilic cosolvent | The infringement allegation implies that the excipients chosen in Teva's ANDA product are ones in which trifarotene is soluble, as required by the claim. | ¶¶68, 69 | col. 5:25-30 |
- Identified Points of Contention:
- Scope Questions: The primary point of contention will likely be whether Teva's product, described as a "cream," falls within the scope of the term "aqueous-glycolic gel" as claimed in the ’465 patent. Teva may argue its product is an emulsion, as covered by the ’778 patent, and not a gel, creating a potential distinction between the two patents' scopes.
- Technical Questions: Does Teva's formulation contain distinct components that function as both a "hydrophilic solvent" and a "hydrophilic cosolvent," or does it achieve solubilization through a different mechanism not contemplated by the claim?
V. Key Claim Terms for Construction
Term from the ’778 Patent: "devoid of a separate emulsifying agent" (Claim 4)
- Context and Importance: This negative limitation is central to distinguishing the invention from prior art that required emulsifiers. Its construction will determine whether Teva's product infringes this set of claims, as many pharmaceutical excipients can have secondary emulsifying properties.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (favoring non-infringement): A party could argue that the presence of any compound known to be an emulsifier, regardless of its concentration or primary purpose, would satisfy this limitation.
- Evidence for a Narrower Interpretation (favoring infringement): The specification states that while no emulsifier is used "as an ingredient," some components might contain "low percentages of emulsifier" and that because of this low percentage, they "cannot be used as an emulsifier (lower than 0.6%)" (’778 Patent, col. 8:1-9). A party could argue the term only excludes ingredients added for the express purpose of emulsification or present above a functional concentration.
Term from the ’465 Patent: "aqueous-glycolic gel" (Claim 4)
- Context and Importance: This term defines the fundamental nature of the claimed formulation. Whether Teva's cream product meets this definition will be a dispositive issue for infringement of the ’465 patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (favoring infringement): The specification provides an FDA-based definition of a "gel" as a "semi-solid pharmaceutical form which contains a gelling agent conferring consistency" and an "aqueous-glycolic gel" as one whose "gelled phase...contains water and one or more glycols" (’465 Patent, col. 4:62-67). Plaintiff may argue that Teva's cream meets this functional definition.
- Evidence for a Narrower Interpretation (favoring non-infringement): The patent repeatedly distinguishes its "gel" from "emulsions" discussed in the prior art (’465 Patent, col. 4:34-40). Defendant may argue that a cream, which is fundamentally an emulsion, is therefore distinct from and outside the scope of the claimed "gel."
VI. Other Allegations
- Indirect Infringement: The complaint alleges that by filing an ANDA, Defendants have engaged in acts of induced and contributory infringement (Compl. ¶¶59, 68). The basis is the allegation that Defendants intend for the ANDA product to be used by physicians and patients in a manner that directly infringes the patents upon FDA approval.
- Willful Infringement: The complaint alleges that Defendants' infringement is willful (Compl. ¶¶61, 70). This allegation is based on Defendants' knowledge of the patents-in-suit via their listing in the FDA's Orange Book and the receipt of the Paragraph IV notice letter, and the assertion that Defendants acted "without a reasonable basis for believing that it would not be liable for infringement."
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: Can Teva’s product, a topical cream, be simultaneously characterized as both the "oil-in-water emulsion" claimed in the ’778 patent and the "aqueous-glycolic gel" claimed in the ’465 patent, or are the claim scopes mutually exclusive? The resolution will determine whether one or both patents could be found infringed.
- A second key question will be one of compositional mapping: Does the specific combination of excipients in Teva's ANDA product contain components that function as the distinct "principal solvent" and "co-solvent oil" required by the ’778 patent, or the "hydrophilic solvent" and "hydrophilic cosolvent" of the ’465 patent? This will be an evidentiary battle dependent on the details of Teva's undisclosed formulation.
- A dispositive legal question for a subset of claims will turn on the construction of the negative limitation "devoid of a separate emulsifying agent" (’778 patent). The case may hinge on whether an excipient's mere identity as a potential emulsifier, versus its concentration and function in the final product, controls the infringement analysis.