DCT

3:18-cv-13701

Valeant Pharma North America LLC v. Par Pharmaceutical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:18-cv-13701, D.N.J., 09/09/2018
  • Venue Allegations: Plaintiffs allege venue is proper because Defendant Par markets and sells generic drug products in the District of New Jersey, has purposefully conducted business in the district, and maintains a regular and established place of business in the district through a wholly-owned subsidiary.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ Jublia® (efinaconazole topical solution, 10%) constitutes an act of infringement of eight U.S. patents related to the drug's active ingredient, formulation, and methods of use.
  • Technical Context: The technology relates to pharmaceutical compositions and methods for the topical treatment of onychomycosis (fungal infection of the nail), a condition notoriously difficult to treat due to the nail plate acting as a significant barrier to drug penetration.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act, triggered by Defendant Par’s submission of ANDA No. 211742 to the FDA. Plaintiffs received a notice letter from Par on July 27, 2018, which included a Paragraph IV certification alleging that the patents-in-suit are invalid, unenforceable, or will not be infringed by Par's proposed generic product.

Case Timeline

Date Event
1999-07-28 Earliest Priority Date for ’506 Patent
2007-05-08 ’506 Patent Issued
2008-01-09 Earliest Priority Date for ’494, ’978, ’009, ’272, ’698, ’955 Patents
2011-10-18 ’494 Patent Issued
2013-07-16 ’978 Patent Issued
2013-10-03 Earliest Priority Date for ’394 Patent
2014-06-06 FDA Approved NDA No. 203567 for Jublia®
2016-04-05 ’009 Patent Issued
2017-02-14 ’272 Patent Issued
2017-05-30 ’394 Patent Issued
2018-01-09 ’698 Patent Issued
2018-01-30 ’955 Patent Issued
2018-07-27 Plaintiffs received Par’s Notice of Certification for ANDA No. 211742
2018-09-09 Complaint Filed

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 describes the difficulty in treating tinea unguium (onychomycosis) and notes that while oral preparations exist, they require long-term use and can have systemic side effects, creating a desire for an effective topical treatment (’506 Patent, col. 2:21-39). It also discusses challenges in accurately evaluating the efficacy of antifungal drugs, as residual drug in skin samples can inhibit fungal growth in culture, masking a potential relapse (’506 Patent, col. 1:47-61).
  • The Patented Solution: The patent claims a method of treating onychomycosis by topically administering a specific triazole antifungal compound, efinaconazole, to the nail of a subject (’506 Patent, Claim 1). While much of the specification describes a novel method for evaluating drug efficacy by removing residual drug from samples before culturing, the issued claims are directed to a method of treatment using the specific compound (’506 Patent, col. 17:34 - col. 18:32).
  • Technical Importance: The invention provided a specific chemical compound for topical application, aiming to improve patient compliance and reduce the systemic side effects associated with long-term oral antifungal therapies (’506 Patent, col. 2:35-39).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶ 32). Independent claim 1 is representative:
  • A method for treating a subject having onychomycosis, comprising:
    • topically administering to a nail of the subject
    • a therapeutically effective amount of an antifungal compound represented by a specific chemical formula (efinaconazole) or a salt thereof.

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," noting that its thickness and composition of hard keratin make topical treatment of nail disorders like onychomycosis difficult and largely ineffective with existing technologies, such as nail lacquers (’494 Patent, col. 1:36-40).
  • The Patented Solution: The invention is a pharmaceutical composition designed for enhanced nail penetration. The solution has a low surface tension (40 dynes/cm or less) and, crucially, "does not form a solid film when applied to the surface of a nail" (’494 Patent, col. 4:48-50). This combination of properties is described as allowing the active ingredient to penetrate the nail itself and also to be wicked by capillary action into the subungual space between the nail and the nail bed, delivering the drug to the site of infection (’494 Patent, col. 4:56-67).
  • Technical Importance: This formulation technology seeks to overcome the physical barrier of the nail plate, a primary reason for the low efficacy of previous topical antifungal treatments, thereby offering a potentially more effective non-systemic treatment option (’494 Patent, col. 3:8-24).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶ 43). Independent claim 1 is representative:
  • A method for treating a nail disorder, comprising topically applying to the nail a pharmaceutical composition that includes:
    • a vehicle that is volatile and/or rapidly penetrates a nail;
    • a triazole antifungal active pharmaceutical ingredient (API);
    • a wetting agent;
    • optionally, a non-volatile solvent;
    • wherein the composition has a surface tension of 40 dynes/cm or less;
    • and wherein the composition, when applied to a nail, does not form a solid film.

U.S. Patent No. 8,486,978 - "Compositions and Methods for Treating Diseases of the Nail"

  • Issued: July 16, 2013
  • Technology Synopsis: A continuation of the ’494 Patent, this patent claims pharmaceutical compositions (rather than methods) for treating nail disorders. The technology is based on a formulation "consisting essentially of" a vehicle that is volatile and/or rapidly penetrates the nail, a triazole antifungal, and a wetting agent, possessing low surface tension and non-film-forming properties to enhance drug delivery (’978 Patent, Abstract; col. 24:14-25).
  • Asserted Claims: At least one claim, including independent claims 1 and 41 (Compl. ¶ 54).
  • Accused Features: Par’s generic efinaconazole topical solution, which is alleged to be the same or substantially the same as the formulation covered by the patent (Compl. ¶¶ 30, 55).

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 specific pharmaceutical compositions for topical treatment of nail disorders. The claimed composition includes particular ingredients: efinaconazole, ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant (’009 Patent, Abstract; Claim 1).
  • Asserted Claims: At least one claim, including independent claim 1 (Compl. ¶ 65).
  • Accused Features: Par’s generic efinaconazole topical solution, which is alleged to embody the specific combination of ingredients claimed (Compl. ¶¶ 30, 66).

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 a pharmaceutical composition with a specific combination of ingredients. The recited ingredients are efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (’272 Patent, Abstract; Claim 1).
  • Asserted Claims: At least one claim, including independent claim 1 (Compl. ¶ 76).
  • Accused Features: The intended use of Par’s generic efinaconazole topical solution for treating onychomycosis, where the solution is alleged to contain the claimed ingredients (Compl. ¶¶ 30, 77).

U.S. Patent No. 9,662,394 - "Stabilized Efinaconazole Compositions"

  • Issued: May 30, 2017
  • Technology Synopsis: This patent addresses the problem of discoloration and instability in triazole formulations. It claims compositions of efinaconazole that are stabilized by the inclusion of butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and optionally citric acid, to ensure the product remains colorless or pale yellow during storage (’394 Patent, Abstract).
  • Asserted Claims: At least one claim, including independent claims 1 and 16 (Compl. ¶ 87).
  • Accused Features: Par’s generic efinaconazole topical solution, which is alleged to contain the claimed stabilizing agents in addition to the active ingredient (Compl. ¶¶ 30, 88).

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 specific pharmaceutical formulations comprising ethanol, cyclomethicone, diisopropyl adipate, and mixed C12-15 alkyl lactates. It also covers methods of treating nail disorders by applying these compositions. The invention focuses on a particular combination of solvents and wetting agents to achieve its therapeutic effect (’698 Patent, Abstract).
  • Asserted Claims: At least one claim, including independent claims 1 and 11 (Compl. ¶ 98).
  • Accused Features: Par’s generic efinaconazole topical solution and its intended method of use, which are alleged to align with the claimed formulation and method (Compl. ¶¶ 30, 99).

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 treating onychomycosis by applying a pharmaceutical composition with a specific list of ingredients. The claimed method requires applying a solution comprising efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (’955 Patent, Abstract; Claim 1).
  • Asserted Claims: At least one claim, including independent claims 1 and 14 (Compl. ¶ 109).
  • Accused Features: The intended use of Par’s generic efinaconazole topical solution for the treatment of onychomycosis, which Plaintiffs allege will constitute practice of the claimed method (Compl. ¶¶ 30, 110).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Par's generic efinaconazole topical solution, 10%," for which Defendant Par seeks FDA approval via ANDA No. 211742 (Compl. ¶¶ 6, 26).
  • Functionality and Market Context:
    • The accused product is a pharmaceutical formulation intended for the topical treatment of onychomycosis (Compl. ¶ 16). As a generic drug, it is designed to be a therapeutic equivalent to the plaintiffs' branded product, Jublia® (Compl. ¶ 27). The complaint alleges that the accused product is "the same, or substantially the same, as Jublia®" (Compl. ¶ 30). The act of infringement alleged in the complaint is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2), which constitutes a formal step toward marketing a product that, if approved, would allegedly infringe the patents-in-suit upon commercialization (Compl. ¶ 32). The complaint does not provide specific details regarding the formulation of the accused generic product beyond its active ingredient and strength.

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’506 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating a subject having onychomycosis wherein the method comprises topically administering to a nail of said subject... Defendant's ANDA seeks approval to market a product for topical administration to treat onychomycosis, and its proposed label will instruct users to perform this step. ¶¶ 16, 27, 34 col. 17:34-37
...a therapeutically effective amount of an antifungal compound represented by the following formula... [efinaconazole] The accused product is a topical solution containing 10% efinaconazole as its active pharmaceutical ingredient. ¶¶ 6, 27, 30 col. 17:40-64

’494 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
...topically applying... a pharmaceutical composition comprising... a vehicle that is volatile and/or that rapidly penetrates a nail... The complaint alleges Par's generic solution is the same or substantially the same as Jublia®, which is based on the patented formulation technology. ¶¶ 30, 44 col. 7:51-54
...a triazole antifungal active pharmaceutical ingredient (API)... The accused product contains the triazole antifungal efinaconazole. ¶¶ 6, 30 col. 7:35-45
...and a wetting agent... Par's generic solution is alleged to contain the same or substantially the same components as Jublia®, including a wetting agent. ¶¶ 30, 44 col. 8:1-3
...wherein the surface tension of the composition is 40 dynes/cm or less... The complaint alleges Par's product will infringe, implying it possesses the claimed low surface tension property. ¶¶ 30, 44 col. 4:45-48
...and wherein the composition, when applied to the surface of a nail, does not form a solid film. The complaint alleges Par's product will infringe, implying it possesses the claimed non-film-forming property. ¶¶ 30, 44 col. 4:48-50

Identified Points of Contention

  • Evidentiary Questions: The complaint's infringement allegations for the formulation patents (e.g., the ’494 Patent) are based on the premise that the accused generic product is "the same, or substantially the same, as Jublia®" (Compl. ¶ 30). A central point of contention will be whether discovery reveals that Par's specific formulation in its ANDA actually meets the quantitative and qualitative limitations of the asserted claims, such as having a surface tension below 40 dynes/cm and being non-film-forming.
  • Scope Questions: For the ’506 Patent method claim, the dispute may focus on validity rather than direct infringement, as the administration of a topical efinaconazole solution for onychomycosis appears to read directly on the claim language. For the family of formulation patents, disputes may arise over the meaning and scope of terms like "rapidly penetrates a nail" and "does not form a solid film."

V. Key Claim Terms for Construction

  • The Term: "does not form a solid film" (’494 Patent, Claim 1)

  • Context and Importance: This limitation is critical for distinguishing the claimed invention from prior art nail lacquers that form hard, polymeric films on the nail surface. The definition will determine whether the accused product, which may leave some form of residue after the volatile vehicle evaporates, falls within the claim scope. Practitioners may focus on this term because the physical nature of the post-application residue will be a key factual question.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification contrasts the invention with lacquers that leave behind a "solid residue that forms the lacquer, shell or film which is lasting, hard, and/or adherent" (’494 Patent, col. 9:35-39). A plaintiff may argue this language implies that only a hard, adherent, lacquer-like residue constitutes a "solid film," allowing for other types of non-solid residues to be non-infringing.
    • Evidence for a Narrower Interpretation: The specification also states the composition is "intended to remain in a liquid or semi-solid state after application to the nail" (’494 Patent, col. 9:30-32). A defendant may cite this to argue that any state other than liquid or semi-solid, including a waxy or greasy residue, could be construed as a "solid film."

  • The Term: "consisting essentially of" (’978 Patent, Claim 1)

  • Context and Importance: This transitional phrase limits the claimed composition to the specified ingredients and any others that do not "materially affect the basic and novel characteristics" of the invention. Its construction is central because Par's generic formulation may contain different or additional inactive ingredients (excipients) compared to the branded product or the patent's examples. The case may turn on whether these additional excipients materially alter the claimed invention's properties.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Plaintiffs may argue that the "basic and novel characteristics" are limited to the core functional properties, such as antifungal activity and enhanced nail penetration, and that minor variations in excipients that do not affect these core functions fall within the scope of the claim.
    • Evidence for a Narrower Interpretation: The "basic and novel characteristics" are described as enhanced penetration of the API through the nail, which is achieved by a composition with low surface tension that does not form a solid film (’494 Patent, col. 4:41-54, parent to ’978 Patent). A defendant may argue that any additional excipient that alters properties like viscosity, evaporation rate, or surface tension, even slightly, would "materially affect" these characteristics, thereby placing the accused product outside the claim scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement for all asserted patents (e.g., Compl. ¶¶ 34, 45). The factual basis for this, typical in an ANDA case, is that Defendant’s submission of its ANDA seeks approval to market the generic drug with a proposed label that will instruct physicians and patients to use the product in a manner that directly infringes the asserted method claims.
  • Willful Infringement: The complaint does not use the word "willful" but requests that the court declare the case "exceptional" under 35 U.S.C. § 285, which allows for the award of attorney's fees (Compl. Prayer for Relief ¶ 12). The basis for this allegation is Defendant's knowledge of the asserted patents, as evidenced by its filing of a Paragraph IV certification and its service of a notice letter upon the Plaintiffs, which occurred prior to the filing of the complaint (Compl. ¶ 28).

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

  • A central issue will be one of claim scope and construction: How will the court define key limitations in the formulation patents, such as "does not form a solid film" and "consisting essentially of"? The outcome of infringement will depend heavily on whether the specific formulation disclosed in Par's ANDA, once revealed in discovery, falls within the boundaries of these construed terms.
  • A key evidentiary question will be one of factual correspondence: Does the accused generic product, as formulated in its ANDA, actually possess the physical properties required by the claims, such as a surface tension below 40 dynes/cm? The complaint relies on the assertion that the generic is a copy of Jublia®, but the ultimate infringement analysis will require a direct comparison of the generic product's measured properties against the claim limitations.
  • A third major question will concern validity: Will the asserted patents, particularly the later-issued formulation patents that claim specific combinations of known pharmaceutical excipients, withstand challenges of obviousness? The defense will likely argue that formulating efinaconazole in a low-surface-tension, non-film-forming vehicle was an obvious design choice for a skilled formulator seeking to improve topical nail delivery.