Valeant Pharma North America LLC v. Solaris Pharma Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Valeant Pharmaceuticals North America LLC (Delaware); Valeant Pharmaceuticals Ireland Ltd. (Ireland); Dow Pharmaceutical Sciences, Inc. (Delaware); and Kaken Pharmaceutical Co., Ltd. (Japan)
  • Defendant: Solaris Pharma Corp. (New Jersey)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 3:18-cv-13695, D.N.J., 09/07/2018
• Venue Allegations: Venue is alleged to be proper as Defendant Solaris is incorporated in New Jersey and operates a principal place of business within the district.
• Core Dispute: Plaintiffs allege that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of JUBLIA® (efinaconazole) constitutes an act of infringement of eight U.S. patents covering the drug's active ingredient, formulations, and methods of use.
• Technical Context: The technology relates to pharmaceutical compositions for the topical treatment of onychomycosis (nail fungus), a condition notoriously difficult to treat due to the challenge of delivering an active drug through the dense keratin of the nail plate.
• Key Procedural History: The patents-in-suit are listed in the U.S. Food and Drug Administration's "Orange Book" in connection with New Drug Application (NDA) No. 203567 for Jublia®. This litigation was triggered by a notice letter from Solaris informing Plaintiffs of its ANDA filing (No. 212159) with a Paragraph IV certification, asserting that its generic product would not infringe the listed patents or that the patents are invalid.

Case Timeline

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

U.S. Patent No. 7,214,506 - “Method for Treating Onychomycosis”

• Issued: May 8, 2007
• The Invention Explained:
  • Problem Addressed: The patent’s background section describes the clinical challenge of treating tinea unguium (nail fungus), noting that topical agents often fail because the drug cannot sufficiently permeate the thick keratin nail plate to reach the site of infection ('506 Patent, col. 2:41-46). It also highlights the difficulty in accurately evaluating the true efficacy of antifungal drugs, as residual drug in skin samples can in-hibit fungal growth in culture studies, giving a false impression of eradication ('506 Patent, col. 1:49-col. 2:18).
  • The Patented Solution: While much of the specification details a novel method for evaluating drug efficacy, the asserted claims cover a method of treatment. The invention provides a method for treating onychomycosis by topically administering a therapeutically effective amount of a specific class of antifungal compounds, including the compound that would later be known as efinaconazole ('506 Patent, col. 18:1-32, Claim 1). This method aims to deliver the active agent directly to the nail to combat the infection.
  • Technical Importance: The invention provided a patented method of use for a new chemical entity for topical onychomycosis treatment, creating an alternative to oral medications which, while effective, were associated with potential systemic side effects ('506 Patent, col. 2:26-39).
• Key Claims at a Glance:
  The complaint asserts infringement of at least one claim (Compl. ¶29). Independent claim 1 is a representative method of treatment claim.
  • A method for treating a subject having onychomycosis
  • wherein the method comprises topically administering to a nail of said subject having onychomycosis
  • a therapeutically effective amount of an antifungal compound represented by a specific chemical structure (Formula II)

U.S. Patent No. 8,039,494 - “Compositions and Methods for Treating Diseases of the Nail”

• Issued: October 18, 2011
• The Invention Explained:
  • Problem Addressed: The patent identifies the nail plate as a "formidable barrier to drug penetration," approximately 100-fold thicker than the stratum corneum of the skin ('494 Patent, col. 1:31-40). Existing topical therapies, such as nail lacquers that form a solid film, were noted to have consistently low efficacy in treating nail disorders ('494 Patent, col. 1:41-col. 2:12).
  • The Patented Solution: The invention is a pharmaceutical composition specifically engineered for nail penetration. The key features are a low surface tension (40 dynes/cm or less) and the property of not forming a solid film upon application ('494 Patent, Abstract). This formulation, containing a volatile vehicle, a non-volatile solvent, a wetting agent, and the active ingredient, is designed to spread into nail folds and be "wicked by capillary action into the gap between the nail and nail bed," thereby delivering the drug to the site of infection more effectively ('494 Patent, col. 4:63-67).
  • Technical Importance: The technology represents a formulation-based approach to solving the drug delivery problem in onychomycosis, aiming to improve clinical outcomes for topical treatments and avoid the risks associated with systemic oral antifungals ('494 Patent, col. 3:9-24).
• Key Claims at a Glance:
  The complaint asserts infringement of at least one claim (Compl. ¶40). Independent claim 1 is a representative method claim.
  • A method for the treatment of a disorder of the nail or nail bed
  • comprising topically applying to the surface of the nail a pharmaceutical composition consisting essentially of a vehicle that is volatile and/or rapidly penetrates a nail
  • a triazole antifungal active pharmaceutical ingredient (API), and a wetting agent
  • and optionally a non-volatile solvent
  • wherein the surface tension of the composition is 40 dynes/cm or less
  • and wherein the composition, when applied to the surface of a nail, does not form a solid film

Multi-Patent Capsule: U.S. Patent No. 8,486,978

• Patent Identification: U.S. Patent No. 8,486,978, “Compositions and Methods for Treating Diseases of the Nail,” issued July 16, 2013.
• Technology Synopsis: This patent is related to the ’494 patent and claims pharmaceutical compositions with low surface tension that do not form a solid film, designed for treating nail disorders. The claims are directed to the composition itself, "consisting essentially of" specific components including a volatile vehicle, a triazole antifungal active ingredient (efinaconazole), and a wetting agent (Compl. ¶15).
• Asserted Claims: At least one claim (Compl. ¶51).
• Accused Features: The formulation of Solaris’s generic efinaconazole topical solution (Compl. ¶52).

Multi-Patent Capsule: U.S. Patent No. 9,302,009

• Patent Identification: U.S. Patent No. 9,302,009, “Compositions and Methods for Treating Diseases of the Nail,” issued April 5, 2016.
• Technology Synopsis: This patent claims pharmaceutical compositions for topical treatment of nail disorders, specifically identifying efinaconazole, ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant as components (Compl. ¶16).
• Asserted Claims: At least one claim (Compl. ¶62).
• Accused Features: The formulation of Solaris’s generic efinaconazole topical solution (Compl. ¶63).

Multi-Patent Capsule: U.S. Patent No. 9,566,272

• Patent Identification: U.S. Patent No. 9,566,272, “Compositions and Methods for Treating Diseases of the Nail,” issued February 14, 2017.
• Technology Synopsis: This patent claims methods for treating onychomycosis by topically applying pharmaceutical compositions that specifically include efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶17).
• Asserted Claims: At least one claim (Compl. ¶73).
• Accused Features: The intended use and formulation of Solaris’s generic efinaconazole topical solution (Compl. ¶74).

Multi-Patent Capsule: U.S. Patent No. 9,662,394

• Patent Identification: U.S. Patent No. 9,662,394, “Stabilized Efinaconazole Compositions,” issued May 30, 2017.
• Technology Synopsis: This patent is directed to stabilizing efinaconazole formulations to prevent discoloration during storage. It claims compositions containing efinaconazole along with specific stabilizers: butylated hydroxytoluene (BHT), a salt of EDTA, and citric acid. It also claims methods of treating fungal infections with these compositions (Compl. ¶18).
• Asserted Claims: At least one claim (Compl. ¶84).
• Accused Features: The formulation and intended use of Solaris’s generic efinaconazole topical solution (Compl. ¶85).

Multi-Patent Capsule: U.S. Patent No. 9,861,698

• Patent Identification: U.S. Patent No. 9,861,698, “Compositions and Methods for Treating Diseases of the Nail,” issued January 9, 2018.
• Technology Synopsis: This patent claims pharmaceutical formulations comprising specific components: ethanol, cyclomethicone, diisopropyl adipate, and mixed C12-15 alkyl lactates. It also covers methods of treating nail disorders by applying these compositions (Compl. ¶19).
• Asserted Claims: At least one claim (Compl. ¶95).
• Accused Features: The formulation and intended use of Solaris’s generic efinaconazole topical solution (Compl. ¶96).

Multi-Patent Capsule: U.S. Patent No. 9,877,955

• Patent Identification: U.S. Patent No. 9,877,955, “Compositions and Methods for Treating Diseases of the Nail,” issued January 30, 2018.
• Technology Synopsis: This patent claims methods for the treatment of onychomycosis by applying a pharmaceutical composition that includes efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶20).
• Asserted Claims: At least one claim (Compl. ¶106).
• Accused Features: The intended use and formulation of Solaris’s generic efinaconazole topical solution (Compl. ¶107).

III. The Accused Instrumentality

• Product Identification: Solaris Pharma Corp.’s generic efinaconazole topical solution, 10% (Compl. ¶6).
• Functionality and Market Context: The accused product is a generic drug for which Solaris is seeking FDA approval via ANDA No. 212159 (Compl. ¶23). It is intended to be a generic version of Plaintiffs’ commercial product, Jublia®, which is used for the topical treatment of onychomycosis (Compl. ¶¶22, 24). The act of infringement alleged in the complaint is the statutory act of filing the ANDA under 35 U.S.C. § 271(e)(2), which allows for infringement litigation prior to the commercial launch of the generic product (Compl. ¶6). The complaint alleges that Solaris’s generic solution is "the same, or substantially the same, as Jublia®" (Compl. ¶27).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a full claim chart analysis. The infringement allegations are based on the statutory act of filing an ANDA under 35 U.S.C. § 271(e)(2), which contemplates that the generic product, if approved and marketed, will infringe the asserted patents. The complaint alleges that Solaris’s generic product will meet the limitations of the asserted claims either literally or under the doctrine of equivalents (Compl. ¶¶30, 41).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

(from the '494 and '978 patents)

• Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." It limits the scope of a claim to the specified ingredients and those that do not materially affect the "basic and novel properties" of the invention. Practitioners may focus on this term because Solaris could argue that its generic formulation contains additional, unlisted excipients that materially alter the formulation's properties, thereby avoiding literal infringement. The central dispute will be defining the invention's "basic and novel properties" and determining the effect of any extra ingredients in the accused product.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The '494 Patent specification repeatedly emphasizes the functional outcomes of low surface tension, non-film formation, and enhanced nail penetration as the key inventive concepts ('494 Patent, col. 4:41-67). Plaintiffs may argue that any unlisted excipient that does not interfere with these specific functions does not "materially affect" the invention.
  • Evidence for a Narrower Interpretation: The '494 Patent provides specific examples of formulations ('494 Patent, col. 10:5-col. 16:65). Solaris may argue that these embodiments define the core of the invention and that the "basic and novel properties" should be narrowly tied to the performance of these specific recipes, suggesting that any additional functional excipient would be a material alteration.

The Term: "does not form a solid film"

(from the '494 and '978 patents)

• Context and Importance: This limitation is critical for distinguishing the claimed invention from prior art nail lacquers that were known to have poor efficacy. The definition of a "solid film" will be central to determining infringement. The parties will likely dispute the degree of residue, tackiness, or hardness required to meet the definition of a "solid film."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent contrasts the invention with a "hard lacquer, shell, or film" and compositions that remain in a "liquid or semi-solid state" after application ('494 Patent, col. 9:30-35). This language suggests that a "solid film" should be construed as something hard, lasting, and adherent, allowing for some amount of non-adherent or soft residue to fall outside the definition.
  • Evidence for a Narrower Interpretation: The patent does not provide an explicit test or quantitative metric for what constitutes a "solid film." A defendant could argue that any formulation that leaves behind a non-liquid residue after the volatile components evaporate meets the definition, thereby narrowing the claim scope.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Solaris will contributorily infringe and/or induce infringement (Compl. ¶¶31, 42). The basis for induced infringement in an ANDA case rests on the proposed product labeling. Plaintiffs allege that Solaris's product, if marketed, will come with instructions that will inevitably lead medical professionals and patients to use it in a manner that directly infringes the asserted method claims.
• Willful Infringement: The complaint does not use the word "willful," but it requests that the court declare this an "exceptional case" under 35 U.S.C. § 285 and award attorney's fees (Prayer for Relief, ¶12). This allegation is predicated on Solaris's filing of an ANDA with knowledge of the Orange Book-listed patents, which Plaintiffs will argue constitutes a deliberate act of infringement.

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

• A primary issue will be one of claim construction and scope: How will the court construe the term "consisting essentially of" in the composition patents? The case may turn on whether unlisted excipients in Solaris’s generic formulation are deemed to materially alter the "basic and novel properties"—namely, low surface tension and non-film formation—required by the claims.
• A second core issue will be validity: Given the crowded field of topical formulations, Solaris will likely challenge the validity of the patents as obvious over prior art combinations of known antifungal agents and penetration-enhancing excipients. The patentability of these specific formulations over what was previously known will be a central battleground.
• A key evidentiary question will be one of technical fact: Does Solaris's proposed generic product, which must be bioequivalent to Jublia®, actually possess the physical properties (e.g., a surface tension below 40 dynes/cm; the absence of a "solid film") recited in the asserted claims? This will likely involve significant expert testimony and testing of the accused formulation.