DCT

2:18-cv-13635

Kaken Pharmaceutical Co Ltd v. Strides Pharma Global Pte Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-13635, D.N.J., 07/18/2019
  • Venue Allegations: Venue is alleged to be proper against Aleor, a foreign corporation, in any district with personal jurisdiction. The complaint asserts personal jurisdiction based on Aleor’s business activities directed at the United States and New Jersey, and notes that Aleor's pre-suit notice letters invoked the jurisdiction of the District of New Jersey.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Jublia® (efinaconazole topical solution, 10%) constitutes an act of infringement of eight U.S. patents under 35 U.S.C. § 271(e)(2).
  • Technical Context: The technology relates to topical pharmaceutical formulations for treating onychomycosis (nail fungus), designed to enhance drug penetration through the dense nail plate to the underlying nail bed.
  • Key Procedural History: This is a Hatch-Waxman patent infringement action triggered by Defendant’s filing of ANDA No. 212027 with the U.S. Food and Drug Administration (FDA). Plaintiffs’ patents are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) in connection with Jublia®, the reference listed drug. Defendant provided notice of its ANDA filing to Plaintiffs via letters dated August 3, 2018, and June 5, 2019.

Case Timeline

Date Event
2010-07-08 Earliest Patent Priority Date for all patents-in-suit
2011-10-18 U.S. Patent No. 8,039,494 Issues
2013-07-16 U.S. Patent No. 8,486,978 Issues
2014-06-06 FDA Approves New Drug Application for Jublia®
2016-04-05 U.S. Patent No. 9,302,009 Issues
2017-02-14 U.S. Patent No. 9,566,272 Issues
2017-05-30 U.S. Patent No. 9,662,394 Issues
2018-01-09 U.S. Patent No. 9,861,698 Issues
2018-01-30 U.S. Patent No. 9,877,955 Issues
2018-08-03 Plaintiff Dow receives first notice letter from Aleor
2018-10-23 U.S. Patent No. 10,105,444 Issues
2019-06-05 Plaintiff Dow receives second notice letter from Aleor
2019-07-18 Amended Complaint Filed

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

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

The Invention Explained

  • Problem Addressed: The patent’s background section describes the difficulty of treating nail disorders like onychomycosis with topical medications because the nail plate is a thick, dense barrier that hinders drug penetration to the underlying nail bed where the infection resides (Compl. ¶13; ’494 Patent, col. 1:45-54). Existing topical treatments, such as nail lacquers that form a solid film, were noted to have low efficacy, while systemic oral drugs carried risks of side effects (Compl. ¶13; ’494 Patent, col. 2:56-col. 3:9).
  • The Patented Solution: The invention is a liquid pharmaceutical formulation designed for high-penetrability without forming a solid film or lacquer. It achieves this through a low surface tension (40 dynes/cm or less), which allows the liquid to spread across the nail, into the surrounding nail folds, and, critically, to be wicked by capillary action into the subungual space (the gap between the nail plate and nail bed) to deliver the antifungal agent directly to the infection site (’494 Patent, Abstract; col. 4:52-65).
  • Technical Importance: This approach sought to create a more effective topical treatment for nail fungus by improving drug delivery to the site of infection, thereby offering a potentially safer alternative to systemic oral medications (’494 Patent, col. 3:10-23).

Key Claims at a Glance

  • The complaint asserts at least one claim without specifying which one (Compl. ¶29). Independent claim 1 is a method claim.
  • The essential elements of independent claim 1 are:
    • A method for treating a disorder of the nail or nail bed by topically applying a pharmaceutical composition.
    • The composition consists essentially of: a vehicle that is volatile and/or rapidly penetrates a nail, a triazole antifungal active pharmaceutical ingredient (API), and a wetting agent.
    • The composition optionally includes 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 surface of a nail.

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

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’494 patent, the ’978 patent addresses the same technical problem of delivering a topical drug through the nail plate to effectively treat onychomycosis (’978 Patent, col. 1:11-51).
  • The Patented Solution: The patent claims pharmaceutical compositions, rather than methods of use, that embody the same core technological concept as the ’494 patent: a low-surface-tension, non-film-forming liquid that enhances nail penetration. The patent more specifically claims compositions that use the particular antifungal agent efinaconazole (’978 Patent, col. 4:47-67).
  • Technical Importance: This patent protects the specific formulation itself, complementing the method-of-use claims in the parent ’494 patent and providing a different form of intellectual property protection for the Jublia® product.

Key Claims at a Glance

  • The complaint asserts at least one claim without specifying which one (Compl. ¶40). Independent claim 41 is a composition claim specifically naming the active ingredient in Jublia®.
  • The essential elements of independent claim 41 are:
    • A pharmaceutical composition.
    • Consisting essentially of: a vehicle that is volatile and/or rapidly penetrates a nail, the specific antifungal agent (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol (efinaconazole), and a wetting agent.
    • The composition optionally includes 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 surface of a nail.

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

  • Technology Synopsis: This patent claims pharmaceutical compositions for topical nail treatment containing a specific combination of ingredients: efinaconazole, ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant (Compl. ¶15). The formulation is designed to be a low-surface-tension, non-film-forming solution to enhance drug delivery.
  • Asserted Claims: At least one unspecified claim (Compl. ¶51).
  • Accused Features: The composition of Aleor's generic efinaconazole topical solution as described in its ANDA submission (Compl. ¶¶24, 27).

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

  • Technology Synopsis: This patent claims methods for treating onychomycosis by topically applying a pharmaceutical composition comprising a specific combination of ingredients, including efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶16).
  • Asserted Claims: At least one unspecified claim (Compl. ¶62).
  • Accused Features: The intended use and composition of Aleor's generic efinaconazole topical solution as described in its ANDA submission (Compl. ¶¶24, 27).

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

  • Technology Synopsis: This patent addresses the problem of discoloration and instability in efinaconazole formulations during storage. It claims compositions that include specific stabilizers—namely butylated hydroxytoluene (BHT), a salt of EDTA, and citric acid—to maintain a stable color profile (Compl. ¶17).
  • Asserted Claims: At least one unspecified claim (Compl. ¶73).
  • Accused Features: The stabilizing agents and overall composition of Aleor's generic efinaconazole topical solution (Compl. ¶¶24, 27).

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

  • Technology Synopsis: This patent claims pharmaceutical formulations comprising ethanol, cyclomethicone, diisopropyl adipate, and mixed C12-15 alkyl lactates, as well as methods for treating nail disorders by applying them (Compl. ¶18). This patent continues the focus on specific, low-viscosity formulations for enhanced nail penetration.
  • Asserted Claims: At least one unspecified claim (Compl. ¶84).
  • Accused Features: The composition and intended use of Aleor's generic efinaconazole topical solution (Compl. ¶¶24, 27).

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

  • Technology Synopsis: This patent claims methods for treating onychomycosis by applying a pharmaceutical composition that includes efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶19). It covers the application of the specific formulation for the indicated medical use.
  • Asserted Claims: At least one unspecified claim (Compl. ¶95).
  • Accused Features: The intended use and composition of Aleor's generic efinaconazole topical solution as described in its ANDA (Compl. ¶¶24, 27).

U.S. Patent No. 10,105,444 - "Compositions and Methods for Treating Diseases of the Nail"

  • Technology Synopsis: This patent claims pharmaceutical formulations containing ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant (Compl. ¶20). It protects specific compositions embodying the core inventive concept of a low-viscosity, penetrating nail solution.
  • Asserted Claims: At least one unspecified claim (Compl. ¶106).
  • Accused Features: The composition of Aleor's generic efinaconazole topical solution (Compl. ¶¶24, 27).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Aleor Dermaceuticals Ltd.’s generic efinaconazole topical solution, 10%, for which it seeks FDA approval under ANDA No. 212027 (Compl. ¶¶6, 23).

Functionality and Market Context

The product is a topical pharmaceutical solution intended for the treatment of onychomycosis (Compl. ¶6). As an ANDA product, it is intended to be a generic version of the plaintiffs' commercial product, Jublia®, and the complaint alleges it is "the same, or substantially the same, as Jublia®" (Compl. ¶¶24, 27). The filing of the ANDA itself is the statutorily defined act of infringement under 35 U.S.C. § 271(e)(2) that gives rise to this lawsuit (Compl. ¶29).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detail a specific infringement theory beyond alleging that the submission of ANDA No. 212027 is an act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶29, ¶40). The core of the infringement allegation is that Aleor's proposed generic product, as described in its confidential ANDA, will possess the formulation and properties required by at least one claim of each asserted patent if and when it is commercially manufactured and sold (Compl. ¶30, ¶41). Because the ANDA process requires a generic drug to have the same active ingredient, dosage form, and strength as the reference listed drug (Jublia®), the plaintiffs' theory is that Aleor's product will necessarily practice the patented inventions covering the Jublia® formulation and its method of use.

  • Identified Points of Contention:
    • Scope Questions: The term "consisting essentially of" in the independent claims of the ’494 and ’978 patents may be a central point of dispute. This raises the question of whether any differences in excipients between Aleor's proposed formulation and the claimed invention would "materially affect the basic and novel properties" of the composition—specifically, its low surface tension and non-film-forming characteristics.
    • Technical Questions: A primary factual dispute will concern whether Aleor’s proposed product, as defined in its ANDA, meets the quantitative and qualitative limitations of the claims. This includes whether the formulation has a "surface tension of 40 dynes/cm or less" and whether it satisfies the negative limitation that it "does not form a solid film" upon application. The precise definition and method of measurement for these properties may become contested technical issues.

V. Key Claim Terms for Construction

The Term: "consisting essentially of"

Context and Importance: This transitional phrase appears in the independent claims of the lead ’494 and ’978 patents. Its construction is critical because it determines whether Aleor's formulation can include unrecited ingredients (e.g., different stabilizers, pH adjusters, or manufacturing aids) without falling outside the scope of the claims. The dispute will center on what constitutes a "material" effect on the invention's "basic and novel properties."

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification discloses numerous "additional optional components" such as preservatives, stabilizers, humectants, and antioxidants that may be added to the formulation, suggesting that the presence of such components was contemplated by the inventors and may not materially alter the invention ('494 Patent, col. 10:41-51).
  • Evidence for a Narrower Interpretation: The patent defines the invention by its ability to provide enhanced penetration through low surface tension and a non-film-forming character ('494 Patent, col. 4:52-65). A defendant may argue that any unlisted ingredient that affects viscosity, surface tension, or evaporation rate would materially alter these core properties, thereby supporting a narrower construction of what is permitted.

The Term: "does not form a solid film"

Context and Importance: This negative limitation distinguishes the invention from prior art nail lacquers. The definition of "solid film" will be central to infringement. If the term is construed broadly to include any non-liquid residue, it may be easier for Aleor to argue non-infringement; if construed narrowly to mean only a hard, polymeric lacquer, it may favor the patentee.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation (favors non-infringement): The patents do not provide an explicit quantitative test for what constitutes a "solid film." A party could argue for a plain and ordinary meaning where any residue that is not in a liquid or semi-solid state after the volatile components evaporate would meet the definition of a "solid film."
  • Evidence for a Narrower Interpretation (favors infringement): The specification contrasts the invention with prior art nail treatments that form a "hard lacquer, shell, or film" using "polymeric film forming compounds" ('494 Patent, col. 10:10-18, 52-58). This context suggests that "solid film" should be construed to mean a durable, lasting, polymeric coating, not merely an oily or waxy residue left by the non-volatile solvents.

VI. Other Allegations

Indirect Infringement

The complaint includes boilerplate allegations of induced and contributory infringement for each asserted patent (e.g., Compl. ¶31, ¶42). In the context of an ANDA case, an inducement theory would typically be based on the defendant's proposed product label, which would instruct physicians and patients to use the generic drug in an infringing manner (i.e., by applying the claimed composition to treat onychomycosis).

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 and award attorney's fees (Compl., Prayer for Relief ¶12). The factual basis for this allegation is Defendant’s knowledge of the patents-in-suit, as evidenced by its ANDA certification and the notice letters sent to Plaintiffs (Compl. ¶25).

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

  • A core issue will be one of claim scope: can the phrase "consisting essentially of" be construed to permit the inclusion of excipients in Aleor's generic formulation that are not explicitly recited in the claims? The answer will depend on whether those excipients are found to materially alter the invention's fundamental properties of low surface tension and non-film-forming character.
  • A second central question will be one of factual infringement: does Aleor’s proposed generic product, as specified in its confidential ANDA, actually exhibit the properties required by the claims? This will involve discovery into the product's precise composition and empirical testing to determine if its surface tension is "40 dynes/cm or less" and if it "does not form a solid film" under an agreed-upon or court-ordered definition.