DCT

3:18-cv-14204

Valeant Pharma North America LLC v. Macleods Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:18-cv-14204, D.N.J., 09/21/2018
  • Venue Allegations: Plaintiffs allege venue is proper because Defendant Macleods Pharma USA, Inc. has a regular and established place of business in the District of New Jersey, and Defendant Macleods Pharmaceuticals Ltd. is a foreign corporation subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Jublia® (efinaconazole) topical solution constitutes an act of infringement of eight U.S. patents related to antifungal compositions and methods of treating onychomycosis.
  • Technical Context: Onychomycosis, a fungal infection of the nail, is a prevalent and difficult-to-treat condition, and effective topical therapies are commercially significant as they can avoid the systemic side effects associated with oral antifungal medications.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 212147 to the U.S. Food and Drug Administration (FDA), which sought approval to market a generic efinaconazole product. This submission included a certification that the patents-in-suit are invalid or will not be infringed. Plaintiffs received notice of this certification on or about August 9, 2018. All eight patents-in-suit are listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") for Jublia®.

Case Timeline

Date Event
1999-07-28 Earliest Priority Date ('506' Patent)
2007-01-29 Earliest Priority Date ('494', '978', '009', '272', '394', '698', '955' Patents)
2007-05-08 '506 Patent Issued
2011-10-18 '494 Patent Issued
2013-07-16 '978 Patent Issued
2014-06-06 FDA Approved New Drug Application 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
2018-08-09 Plaintiff Dow received Defendants' ANDA notice letter
2018-09-21 Complaint Filed

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

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

  • Patent Identification: U.S. Patent No. 7,214,506, "Method for Treating Onychomycosis," issued May 8, 2007.

The Invention Explained

  • Problem Addressed: The patent describes the clinical challenge of treating onychomycosis (tinea unguium), noting that long-term oral therapies carry risks of systemic side effects like hepatotoxicity, while existing topical agents are generally ineffective because they cannot sufficiently permeate the dense keratin of the nail plate to reach the fungal infection ('506 Patent, col. 2:21-44).
  • The Patented Solution: The invention claims a method of treating onychomycosis by topically administering a specific triazole antifungal compound, identified in the patent as KP-103 and known commercially as efinaconazole ('506 Patent, col. 10:14-20). The specification presents data from animal models suggesting this compound has superior nail permeability and fungicidal activity compared to existing oral and topical treatments, allowing it to cure the infection in a shorter period ('506 Patent, col. 4:40-48, FIG. 3).
  • Technical Importance: This patent established a specific, novel antifungal agent as a potentially viable topical treatment for onychomycosis, a condition for which effective and safe therapies were lacking.

Key Claims at a Glance

  • The complaint asserts at least one claim of the patent (Compl. ¶32). Independent claim 1 is representative.
  • The essential elements of independent claim 1 are:
    • A method for treating a subject having onychomycosis.
    • The method comprises topically administering to a nail of the subject a therapeutically effective amount of a specific antifungal compound (efinaconazole, as defined by formula II).
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

  • Patent Identification: 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, which renders most topical therapies ineffective ('494 Patent, col. 1:31-40). Existing topical treatments, such as film-forming lacquers, had demonstrated low clinical efficacy ('494 Patent, col. 2:46-65).
  • The Patented Solution: The invention is a pharmaceutical composition designed to enhance nail penetration by focusing on the physical properties of the delivery vehicle itself. The claimed solution has a low surface tension (40 dynes/cm or less) and, critically, does not form a solid film or lacquer upon application. This combination of properties allows the liquid formulation to spread into the nail folds and be drawn by capillary action into the subungual space between the nail plate and nail bed, delivering the active drug directly to the site of infection ('494 Patent, Abstract; col. 4:55-6:2).
  • Technical Importance: The patented solution represented a shift in formulation strategy, moving away from drug-releasing films toward a low-viscosity, low-surface-tension liquid designed to physically circumvent the nail plate barrier.

Key Claims at a Glance

  • The complaint asserts at least one claim of the patent (Compl. ¶43). Independent claim 1 is representative.
  • The essential elements of independent claim 1 are:
    • A method for treating a nail disorder by topically applying a pharmaceutical composition.
    • The composition consists essentially of a volatile and/or penetrating vehicle, a triazole antifungal active ingredient, a wetting agent, and optionally a non-volatile solvent.
    • The composition has a surface tension of 40 dynes/cm or less.
    • The composition does not form a solid film when applied to a nail.
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

  • 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, a continuation from the '494 Patent family, claims pharmaceutical compositions for treating nail disorders. The invention focuses on a non-film-forming formulation with low surface tension containing a volatile vehicle, a triazole antifungal, and a wetting agent, designed to enhance penetration into the nail and nail bed (Compl. ¶18).

Asserted Claims

The complaint asserts infringement of at least one unspecified claim ('978 Patent, Compl. ¶54).

Accused Features

The accused instrumentality is Macleods's generic efinaconazole topical solution (Compl. ¶55).

U.S. Patent No. 9,302,009 - "Compositions and Methods for Treating Diseases of the Nail"

  • 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 specific pharmaceutical compositions for topical nail treatment. The claims recite a formulation comprising efinaconazole, ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant (Compl. ¶19).

Asserted Claims

The complaint asserts infringement of at least one unspecified claim ('009 Patent, Compl. ¶65).

Accused Features

The accused instrumentality is Macleods's generic efinaconazole topical solution (Compl. ¶66).

U.S. Patent No. 9,566,272 - "Compositions and Methods for Treating Diseases of the Nail"

  • 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. The claimed methods involve topically applying a pharmaceutical composition comprising a specific combination of ingredients: efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶20).

Asserted Claims

The complaint asserts infringement of at least one unspecified claim ('272 Patent, Compl. ¶76).

Accused Features

The accused instrumentality is Macleods's generic efinaconazole topical solution, the use of which allegedly infringes the claimed methods (Compl. ¶77).

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

  • Patent Identification: U.S. Patent No. 9,662,394, "Stabilized Efinaconazole Compositions," issued May 30, 2017.

Technology Synopsis

This patent claims compositions and treatment methods using formulations designed to be chemically stable. The invention addresses the problem of discoloration in efinaconazole solutions over time by including specific stabilizers: butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid, in addition to the active ingredient and other vehicle components (Compl. ¶21).

Asserted Claims

The complaint asserts infringement of at least one unspecified claim ('394 Patent, Compl. ¶87).

Accused Features

The accused instrumentality is Macleods's generic efinaconazole topical solution (Compl. ¶88).

U.S. Patent No. 9,861,698 - "Compositions and Methods for Treating Diseases of the Nail"

  • 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 and associated treatment methods. The claims specify a composition comprising ethanol, cyclomethicone, diisopropyl adipate, and mixed C12-15 alkyl lactates, distinguishing it from related patents that may claim a single lactate species (Compl. ¶22).

Asserted Claims

The complaint asserts infringement of at least one unspecified claim ('698 Patent, Compl. ¶98).

Accused Features

The accused instrumentality is Macleods's generic efinaconazole topical solution (Compl. ¶99).

U.S. Patent No. 9,877,955 - "Compositions and Methods for Treating Diseases of the Nail"

  • 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. The invention involves applying a pharmaceutical composition that includes efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶23).

Asserted Claims

The complaint asserts infringement of at least one unspecified claim ('955 Patent, Compl. ¶109).

Accused Features

The accused instrumentality is Macleods's generic efinaconazole topical solution, the use of which is alleged to infringe the claimed methods (Compl. ¶110).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Macleods's generic efinaconazole topical solution, 10%," for which Macleods filed ANDA No. 212147 with the FDA (Compl. ¶¶ 7, 26).

Functionality and Market Context

  • The product is a topical pharmaceutical solution intended for the treatment of onychomycosis (Compl. ¶16). As an ANDA product, it is intended to be a generic version of the plaintiffs' commercially successful branded drug, Jublia® (Compl. ¶27). The complaint alleges that the accused product is "the same, or substantially the same, as Jublia®," which in the context of an ANDA filing implies it contains the same active ingredient, has the same dosage form and strength, and is administered by the same route (Compl. ¶30).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed narrative theory of infringement for any of the asserted patents. The allegations are general, stating that the marketing of Macleods's ANDA product will infringe at least one claim of each patent-in-suit (e.g., Compl. ¶¶ 33, 44). This level of detail is common in initial complaints filed to meet the 45-day statutory deadline in Hatch-Waxman litigation.

  • Identified Points of Contention ('506 Patent): Since the '506 Patent claims a method of treatment, the infringement analysis will likely focus on induced infringement. A key question will be whether the proposed label for Macleods's generic product instructs or encourages physicians and patients to perform the claimed method—specifically, to topically apply the efinaconazole solution to a nail for the purpose of treating onychomycosis ('506 Patent, col. 18:1-12).
  • Identified Points of Contention ('494 Patent): The infringement analysis for the '494 Patent will likely concentrate on the specific physical and chemical properties of Macleods's formulation. Central technical questions will be:
    • Scope Questions: Does the term "consisting essentially of," as used in the claims, permit the inclusion of any unlisted excipients present in Macleods's formulation? This raises the question of whether any such additional ingredients materially affect the "basic and novel properties" of the invention, such as its low surface tension and non-film-forming character ('494 Patent, Abstract).
    • Technical Questions: Does Macleods's product in fact have a "surface tension of 40 dynes/cm or less" and does it refrain from forming a "solid film" upon application, as required by the claims ('494 Patent, col. 21:1-8)? The definitions of these terms and the experimental methods used to measure them will be critical points of dispute.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (from independent claim 1 of the '494 Patent)

  • Context and Importance: This transitional phrase is critical for defining the scope of the claimed composition. Its construction will determine whether any additional, unlisted ingredients in Macleods's generic formulation take the product outside the scope of the claims. Practitioners may focus on this term because the dispute will center on what constitutes the "basic and novel properties" of the invention and whether any excipients in the generic product materially affect those properties.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the core inventive concept as providing "enhanced penetration of the API through an intact nail and into the nailbed" by virtue of having a low surface tension and not forming a solid film ('494 Patent, col. 4:41-54). A party may argue that this functional outcome is the sole "basic and novel property," allowing for the presence of any unlisted excipient that does not interfere with it.
    • Evidence for a Narrower Interpretation: The patent repeatedly distinguishes the invention from prior art "nail lacquers, coating, polishes, enamels, and varnishes" ('494 Patent, col. 1:41-44). A party may argue that the "basic and novel property" is the specific physical state of the liquid—one that remains a non-film-forming liquid capable of wicking—and that any unlisted ingredient altering viscosity, drying characteristics, or residue could be considered a material alteration.

  • The Term: "does not form a solid film" (from independent claim 1 of the '494 Patent)

  • Context and Importance: This negative limitation is a primary point of distinction over prior art lacquer-based treatments. The definition of what constitutes a "solid film" will be central to the infringement analysis, particularly if the accused product leaves any residue after its volatile components evaporate.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent’s background section discusses prior art in terms of "nail lacquers, coating, polishes, enamels, and varnishes" containing "water-insoluble film-forming substance[s]" like polymeric compounds ('494 Patent, col. 1:41-55). A party may argue that "solid film" should be construed narrowly to mean only a hard, polymeric, adherent layer characteristic of a lacquer, and that any non-polymeric, oily, or easily removed residue would not meet this definition.
    • Evidence for a Narrower Interpretation: The abstract and detailed description emphasize that the composition "remains in a liquid or semi-solid state after application" ('494 Patent, col. 9:30-32). A party may argue this implies that any continuous, solid-state residue, regardless of hardness or composition, would constitute a "solid film" within the meaning of the claim, as it would no longer be in a liquid or semi-solid state.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Macleods will contributorily infringe and/or induce infringement of the patents-in-suit (e.g., Compl. ¶¶ 34, 45). For method claims (e.g., in the '506 and '272 Patents), the allegation of inducement is likely based on the proposed product labeling, which would instruct medical professionals and patients to use the generic product in an infringing manner.
  • Willful Infringement: The complaint does not include an explicit allegation of willful infringement. It does, however, request a declaration that the case is "exceptional" under 35 U.S.C. § 285, which could entitle Plaintiffs to an award of attorney's fees (Compl., p. 23, ¶ 12).

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

  • A core issue will be one of formulation equivalence: will discovery show that the specific combination of active ingredient and excipients in Macleods's proposed generic product meets all the limitations of the asserted composition claims, particularly the negative limitation of "not form[ing] a solid film" and the transitional phrase "consisting essentially of"?
  • A second key question will be one of patentability over the family: given the assertion of eight patents stemming from two priority applications, the litigation will likely involve significant validity challenges based on obviousness-type double patenting and the extent to which later-issued claims are patentably distinct from the disclosures and claims of earlier family members.
  • A final evidentiary question will be one of induced infringement: for the asserted method-of-use patents, will the language in Macleods's proposed product labeling be sufficient to establish the specific intent required to prove that Macleods would induce physicians and patients to infringe the patented methods of treatment?