DCT

3:18-cv-14207

Valeant Pharma North America LLC v. Perrigo Pharma Intl Dac

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:18-cv-14207, D.N.J., 09/21/2018
  • Venue Allegations: Venue is alleged based on Defendants conducting business in the district, the presence of a subsidiary with a place of business in Parsippany, New Jersey, and Defendants’ status as foreign corporations.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Jublia® (efinaconazole) topical antifungal solution constitutes an act of infringement of eight U.S. patents listed in the FDA's Orange Book.
  • Technical Context: The technology concerns 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's barrier to drug penetration.
  • Key Procedural History: The action was triggered by Defendants' submission of ANDA No. 211851 to the FDA and Plaintiffs' receipt of a Paragraph IV certification notice letter on August 9, 2018, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date Event
1999-07-28 Earliest Priority Date for ’506 Patent
2002-01-25 Earliest Priority Date for ’494, ’978, ’009, ’272, ’394, ’698, and ’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 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
2018-08-09 Plaintiff Dow received Perrigo’s 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

The Invention Explained

  • Problem Addressed: The patent’s background section describes the difficulty in accurately evaluating the efficacy of topical antifungal agents for nail fungus. It notes that residual drug remaining in an excised nail or skin sample can inhibit fungal growth during laboratory testing, potentially giving a false impression of therapeutic success and masking a relapse. (Compl. Ex. A, ’506 Patent, col. 1:47-2:18).
  • The Patented Solution: The patent specification discloses a novel method for evaluating antifungal agents that involves removing the residual drug from the biological sample (e.g., via dialysis) before culturing for fungus. This improved evaluation technique allegedly allowed the inventors to identify a class of compounds, represented by Formula (II), that are genuinely effective when applied topically for treating onychomycosis. The patent claims the method of using these specific compounds for treatment. (Compl. Ex. A, ’506 Patent, col. 2:55-65, col. 18:32-38).
  • Technical Importance: This work provided a scientific basis for developing a topical onychomycosis treatment as a viable alternative to long-term oral therapies, which can have significant side effects. (Compl. Ex. A, ’506 Patent, col. 2:23-39).

Key Claims at a Glance

  • The complaint asserts at least one claim without specification; Claim 1 is the sole independent claim (Compl. ¶33).
  • Claim 1 requires:
    • A method for treating a subject having onychomycosis
    • The method comprises topically administering to a nail of the subject
    • A therapeutically effective amount of an antifungal compound represented by a specific chemical structure (Formula II)
  • The complaint reserves the right to assert other claims, including dependent claims.

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

The Invention Explained

  • Problem Addressed: The patent identifies the nail plate as a "formidable barrier to drug penetration," which is a primary reason for the low success rate of prior topical treatments for nail disorders. Specifically, it notes that nail lacquers, which form a solid film on the nail, have proven to be "consistently ineffective." (Compl. Ex. B, ’494 Patent, col. 1:37-43, col. 2:9-12).
  • The Patented Solution: The invention is a pharmaceutical formulation that does not form a solid film and has a very low surface tension (40 dynes/cm or less). This low surface tension allows the liquid composition to spread across the nail, into the nail folds, and, critically, to be wicked by capillary action into the subungual space (the gap between the nail and the nail bed) where the fungus resides. The formulation uses a combination of a volatile vehicle, a non-volatile solvent, and a wetting agent to deliver the active pharmaceutical ingredient. (Compl. Ex. B, ’494 Patent, col. 4:56-65, col. 6:62-col. 7:2).
  • Technical Importance: This formulation technology provides a non-invasive mechanism to bypass the nail's primary barrier function, enhancing the delivery of an active drug to the site of infection without requiring systemic administration or physical nail removal. (Compl. Ex. B, ’494 Patent, col. 3:9-24).

Key Claims at a Glance

  • The complaint asserts at least one claim; Claim 1 is a representative independent claim (Compl. ¶44).
  • Claim 1 requires:
    • A method for treating a nail disorder
    • Comprising topically applying a pharmaceutical composition that consists essentially of:
      • a volatile and/or penetrating vehicle
      • a triazole antifungal active ingredient
      • a wetting agent
      • 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 the nail
  • The complaint reserves the right to assert other claims.

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

  • Technology Synopsis: The ’978 Patent claims pharmaceutical compositions, rather than methods of use. The claimed compositions are for treating nail disorders and are defined by the same core properties as those in the ’494 patent: they consist essentially of a vehicle, a triazole antifungal, a wetting agent, and an optional non-volatile solvent; have a surface tension of 40 dynes/cm or less; and do not form a solid film upon application (Compl. ¶19; Compl. Ex. C, ’978 Patent, col. 21:1-17).
  • Asserted Claims: At least one claim is asserted (Compl. ¶55).
  • Accused Features: Perrigo’s proposed generic efinaconazole topical solution is alleged to be a composition that infringes (Compl. ¶56).

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

  • Technology Synopsis: The ’009 Patent claims pharmaceutical compositions for topical nail treatment with a more specific list of ingredients. The claims require a composition comprising efinaconazole, ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant (Compl. ¶20; Compl. Ex. D, ’009 Patent, col. 21:1-12).
  • Asserted Claims: At least one claim is asserted (Compl. ¶66).
  • Accused Features: Perrigo’s proposed generic efinaconazole topical solution is alleged to contain the claimed combination of ingredients (Compl. ¶67).

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

  • Technology Synopsis: The ’272 Patent claims methods for treating onychomycosis by applying a topical composition containing a specific combination of ingredients: efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶21; Compl. Ex. E, ’272 Patent, col. 11:45-56).
  • Asserted Claims: At least one claim is asserted (Compl. ¶77).
  • Accused Features: The proposed use of Perrigo’s generic efinaconazole topical solution is alleged to infringe the claimed method (Compl. ¶78).

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

  • Technology Synopsis: The ’394 Patent claims compositions and treatment methods related to a stabilized efinaconazole formulation designed to prevent discoloration over time. The claims recite a composition including efinaconazole, water, specific solvents (C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol), and a stabilizing package of BHT, a salt of EDTA, and citric acid (Compl. ¶22; Compl. Ex. F, ’394 Patent, col. 19:1-24).
  • Asserted Claims: At least one claim is asserted (Compl. ¶88).
  • Accused Features: Perrigo’s proposed generic solution is alleged to be a composition and to be used in a method that infringes these claims (Compl. ¶89).

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

  • Technology Synopsis: The ’698 Patent claims pharmaceutical formulations and treatment methods comprising ethanol, cyclomethicone, diisopropyl adipate, and mixed C12-15 alkyl lactates. This patent focuses on another specific combination of excipients to deliver an active ingredient to the nail (Compl. ¶23; Compl. Ex. G, ’698 Patent, col. 21:8-22).
  • Asserted Claims: At least one claim is asserted (Compl. ¶99).
  • Accused Features: Perrigo’s proposed generic efinaconazole topical solution is alleged to infringe (Compl. ¶100).

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

  • Technology Synopsis: The ’955 Patent claims methods for treating onychomycosis by applying a composition comprising efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone. The claims are similar in scope to those of the ’272 patent (Compl. ¶24; Compl. Ex. H, ’955 Patent, col. 13:46-56).
  • Asserted Claims: At least one claim is asserted (Compl. ¶110).
  • Accused Features: The proposed use of Perrigo’s generic efinaconazole topical solution is alleged to infringe the claimed method (Compl. ¶111).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Perrigo's proposed "generic efinaconazole topical solution, 10%," for which it submitted Abbreviated New Drug Application No. 211851 to the FDA (Compl. ¶¶ 7, 27).
  • Functionality and Market Context: The product is intended to be a generic version of Plaintiffs' commercial product, Jublia®, a topical solution for treating onychomycosis (Compl. ¶28). As an ANDA product, it must be the "same as" the reference listed drug with respect to its active ingredient, dosage form, strength, and route of administration, and it must be bioequivalent. The complaint alleges the proposed product is "the same, or substantially the same, as Jublia®" (Compl. ¶31).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-chart analysis. It alleges infringement under 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA seeking approval to market a generic drug before patent expiration as an artificial act of infringement. The narrative theory is that because Perrigo's product is intended to be a generic copy of Jublia®, it will necessarily practice the claimed methods and embody the claimed compositions of the patents-in-suit upon approval and marketing (Compl. ¶¶ 34, 45).

  • Identified Points of Contention:
    • Scope Questions: For the ’494 and ’978 Patents, a central question may be whether Perrigo's formulation "consists essentially of" the recited components. This raises the question of whether any additional excipients in Perrigo's product materially alter the basic and novel characteristics of the invention, which are described as enhanced nail penetration via low surface tension and a non-film-forming nature.
    • Technical Questions: A key factual dispute may involve whether Perrigo’s proposed generic product meets the functional limitations of claims in the ’494 and ’978 patents, such as having a "surface tension of 40 dynes/cm or less" and a formulation that "does not form a solid film." For the later patents claiming specific combinations of excipients (e.g., the ’009 and ’394 patents), the question will be whether Perrigo’s formulation contains the exact recited ingredients.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (from Claim 1 of the ’494 and ’978 Patents)

  • Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." Its construction will be critical for determining whether unlisted ingredients in Perrigo's formulation remove it from the scope of the claims. Practitioners may focus on this term because the dispute will likely involve arguing whether Perrigo's specific blend of excipients materially affects the "basic and novel" properties of the patented composition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification's broad description of suitable vehicles, solvents, and wetting agents could support an interpretation that a variety of conventional, non-material excipients can be included without altering the invention's essential character (Compl. Ex. B, ’494 Patent, col. 7:22-col. 9:10).
    • Evidence for a Narrower Interpretation: The patent emphasizes that the invention's effectiveness derives from a specific combination of properties: low surface tension and the absence of a solid film, which together enable wicking into the subungual space. A defendant may argue that any unlisted ingredient that affects viscosity, evaporation rate, or residue could materially alter these delicate physical properties (Compl. Ex. B, ’494 Patent, col. 6:55-col. 7:2).

  • The Term: "does not form a solid film" (from Claim 1 of the ’494 and ’978 Patents)

  • Context and Importance: This negative limitation is central to distinguishing the invention from prior art nail lacquers. The definition of what constitutes a "solid film" will be a key point of contention.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term could be construed broadly to mean any composition that does not dry into a hard, peelable lacquer like nail polish, allowing for some amount of semi-solid residue to remain.
    • Evidence for a Narrower 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." This language could support a narrower definition where any formulation that leaves a tangible, non-liquid residue could be considered to form a type of "film" (Compl. Ex. B, ’494 Patent, col. 9:31-38).

VI. Other Allegations

  • Indirect Infringement: The complaint includes boilerplate allegations of contributory and induced infringement for each patent (Compl. ¶¶ 35, 46, 57). The implicit basis for these claims in a Hatch-Waxman context is that the defendant's proposed product label will instruct physicians and patients to use the generic drug in an infringing manner.
  • Willful Infringement: The complaint does not use the word "willful." However, in the Prayer for Relief, it requests a declaration that the case is "exceptional" under 35 U.S.C. §§ 285 and 271(e)(4) and an award of attorney's fees, which is the statutory remedy for such conduct (Compl., Prayer for Relief ¶12). The basis for this allegation is likely Defendants' knowledge of the Orange Book-listed patents prior to filing the ANDA.

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

  • A core issue will be one of claim scope: can the term "consisting essentially of," as used in the ’494 and ’978 patents, be construed to read on Perrigo's specific generic formulation? The case may turn on whether any excipients in the accused product, not explicitly recited in the claims, are deemed to materially alter the composition's fundamental low-surface-tension and non-film-forming properties.
  • A second central question will be one of literal infringement versus non-infringement: for the numerous later-issued patents that claim highly specific combinations of excipients (e.g., the ’009, ’272, ’394 patents), the dispute will likely be a straightforward factual analysis of whether Perrigo's formulation contains the exact recited ingredients in the claimed amounts.
  • Finally, a key evidentiary question will be one of functionality: assuming Perrigo’s formulation is found to fall within the scope of the claims, does it actually exhibit the functional properties required by patents like the ’494 patent, such as a surface tension below the claimed threshold and an ability to not form a solid film? This will likely be determined through competing expert testing and analysis.