DCT

1:20-cv-00046

Bausch Health US LLC v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00046, N.D. W. Va., 03/13/2020
  • Venue Allegations: Venue is alleged to be proper as Defendant is organized under the laws of West Virginia, maintains a place of business within the district, and has previously submitted to the court's jurisdiction in related matters. The complaint also asserts the district is a likely destination for the accused generic drug.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the branded drug Jublia® constitutes an act of infringement of three U.S. patents covering the drug's formulation, method of use, and applicator.
  • Technical Context: The technology at issue relates to topical pharmaceutical formulations and delivery systems for treating onychomycosis (fungal nail infection), a prevalent and difficult-to-treat condition due to the challenge of penetrating the nail plate.
  • Key Procedural History: The complaint notes that this action follows prior patent infringement lawsuits between the parties concerning the same Mylan ANDA (No. 212064), indicating an ongoing, multi-patent dispute over the same proposed generic product. This lawsuit was initiated after Plaintiffs received a notice letter from Mylan dated January 28, 2020, regarding the patents-in-suit.

Case Timeline

Date Event
2008-01-03 '640 Patent Earliest Priority Date
2011-07-05 '601 Patent Earliest Priority Date
2013-10-03 '875 Patent Earliest Priority Date
2014-06-06 FDA Approval of New Drug Application for Jublia®
2019-07-09 '875 Patent Issue Date
2019-11-19 '601 Patent Issue Date
2019-12-24 '640 Patent Issue Date
2020-01-28 Date of Mylan's Notice Letter to Plaintiffs
2020-03-13 Complaint Filing Date

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

U.S. Patent No. 10,512,640 - "Compositions and methods for treating diseases of the nail," issued December 24, 2019

The Invention Explained

  • Problem Addressed: The patent's background describes the significant challenge of treating nail disorders like onychomycosis, as the nail plate is a "formidable barrier to drug penetration" that is approximately 100-fold thicker than the skin's stratum corneum ('640 Patent, col. 1:41-49). Previous topical treatments, such as lacquers, have had limited success ('640 Patent, col. 1:50-55).
  • The Patented Solution: The invention is a pharmaceutical composition that enhances the penetration of an antifungal agent through the nail without forming a hard film or lacquer. It achieves this through a specific combination of a vehicle (e.g., alcohol), a non-volatile solvent (e.g., diisopropyl adipate, C12-15 alkyl lactate), and a wetting agent (e.g., cyclomethicone) ('640 Patent, col. 7:1-6; col. 3:41-52). This formulation is designed to remain in a liquid or semi-solid state after application, distinguishing it from prior art that relies on solvent evaporation to leave a solid film ('640 Patent, col. 7:1-11).
  • Technical Importance: The claimed formulation provides a non-invasive topical treatment method that may improve drug delivery to the nail bed, offering a potential alternative to systemic medications with associated side effects or the physical removal of the nail ('640 Patent, col. 2:40-54).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim, and a representative independent claim is Claim 1 ('640 Patent, col. 11:42-12:15).
  • The essential elements of independent Claim 1, a method claim, include:
    • Topically applying to the surface of a nail a pharmaceutical composition comprising ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent.
    • The composition is formulated as a solution.
    • The components are present within specific weight-per-weight percentage ranges.
    • The composition "does not comprise a polymeric film forming compound."
    • The application is sufficient to "ameliorate the symptoms of the onychomycosis."
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,342,875 - "Stabilized Efinaconazole Compositions," issued July 9, 2019

The Invention Explained

  • Problem Addressed: The patent identifies an instability problem where certain formulations containing triazole active ingredients, such as efinaconazole, can "discolor within storage periods as short as one or two days," resulting in colors from yellow to red or brown ('875 Patent, col. 1:29-34). This discoloration can discourage patients from using the medication ('875 Patent, col. 1:35-37).
  • The Patented Solution: The invention is a liquid or semi-solid composition stabilized against discoloration by including butylated hydroxytoluene (BHT) and a salt of ethylenediaminetetraacetic acid (EDTA). This combination is described as sufficient to ensure the composition remains "colorless or pale yellow" even after storage for extended periods at elevated temperatures ('875 Patent, Abstract; col. 2:42-52). The patent describes using UV-vis absorbance values as a quantitative method for assessing color stability ('875 Patent, col. 8:38-44).
  • Technical Importance: By preventing the aesthetic degradation of the drug product, the invention aims to improve shelf-life and maintain patient compliance, which is critical for the effective treatment of chronic conditions like onychomycosis.

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim, and a representative independent claim is Claim 1 ('875 Patent, col. 19:46-59).
  • The essential elements of independent Claim 1, a composition claim, include:
    • A composition comprising about 10% efinaconazole by weight.
    • The composition further comprises water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, and ethanol.
    • The composition includes the stabilizers butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid.
    • The amounts of BHT, EDTA salt, and citric acid fall within specified ranges.
    • The composition is formulated as a solution.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,478,601 - "Applicator," issued November 19, 2019

  • Technology Synopsis: The patent addresses the difficulty and potential irritation associated with applying liquid medicine to affected nails, particularly between the nail and skin ('601 Patent, col. 1:21-30). The invention is an applicator featuring a "columnar brush member" made of bundled synthetic fibers, where the tip is formed into a soft, fan-like shape with a decreasing thickness, designed to reduce irritation and allow for precise application ('601 Patent, Abstract).
  • Asserted Claims: The complaint alleges infringement of at least one claim of the patent (Compl. ¶ 45); independent claims 1 and 8 are representative.
  • Accused Features: The complaint alleges that Mylan's generic product infringes, which suggests Mylan will market its solution with an applicator that Plaintiffs believe has the claimed physical characteristics (Compl. ¶¶ 14, 46).

III. The Accused Instrumentality

  • Product Identification: Mylan's generic efinaconazole topical solution, 10%, which is the subject of ANDA No. 212064 (Compl. ¶¶ 17-18).
  • Functionality and Market Context: The product is a topical pharmaceutical solution intended for the treatment of onychomycosis (Compl. ¶ 12). As the subject of an ANDA, it is intended to be a generic version of the branded drug Jublia® (Compl. ¶ 18). The complaint alleges that Mylan's product is "the same, or substantially the same, as Jublia®," which forms the basis for the infringement allegations regarding the product's formulation, method of use, and associated applicator (Compl. ¶ 21).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'640 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the treatment of onychomycosis comprising topically applying to the surface of the nail of an individual suffering from onychomycosis a pharmaceutical composition... The labeling for Mylan's generic product will instruct users to topically apply the solution to the nail for the treatment of onychomycosis, the approved indication for Jublia®. ¶24 col. 11:42-46
...comprising ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent... On information and belief, Mylan's ANDA specifies a formulation that contains these exact excipients, with efinaconazole as the triazole antifungal agent, to establish bioequivalence with Jublia®. ¶¶12, 24 col. 11:47-49
...wherein the composition is formulated as a solution... Mylan's ANDA submission is for an "efinaconazole topical solution." ¶18 col. 11:50-51
...wherein the composition does not comprise a polymeric film forming compound... Mylan's generic solution, to be equivalent to Jublia®, will be a non-film-forming solution rather than a lacquer. ¶24 col. 12:8-10
  • Identified Points of Contention:
    • Technical Questions: A primary factual question is whether Mylan's ANDA formulation contains every recited ingredient within the claimed concentration ranges. The infringement case rests on the assumption that Mylan's product will be identical to the formulation described in the patent, which will be a key area for discovery. Mylan may have attempted to design around the patent by omitting or substituting an excipient.
    • Scope Questions: The negative limitation "does not comprise a polymeric film forming compound" raises a question of scope. The parties may dispute what constitutes a "polymeric film forming compound," especially if Mylan's formulation includes any polymers that do not form a hard, lacquer-like film.

'875 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising about 10% efinaconazole by weight... Mylan's product is identified as "efinaconazole topical solution, 10%." ¶18 col. 19:46-47
...water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol... On information and belief, Mylan's formulation will contain these excipients to be equivalent to the branded Jublia® product. ¶¶13, 35 col. 19:47-49
...butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid... On information and belief, Mylan's product will include this specific combination of stabilizers to ensure its color stability matches that of Jublia®. ¶¶13, 35 col. 19:49-51
...the composition is formulated as a solution. Mylan's ANDA is for a "topical solution." ¶18 col. 19:58-59
  • Identified Points of Contention:
    • Technical Questions: The central issue will be whether Mylan’s formulation includes the specific stabilizing combination of BHT, an EDTA salt, and citric acid. Mylan could argue non-infringement if it uses a different stabilizer system or omits one of the claimed components.
    • Scope Questions: The patent links color stability to specific UV-vis absorbance values ('875 Patent, col. 2:20-45). A dispute could arise if Mylan's product achieves a "pale yellow" appearance but its formulation does not meet the precise quantitative metrics for stability described in the specification, raising questions about the scope of the claimed functional outcome.

V. Key Claim Terms for Construction

For the '640 Patent

  • The Term: "polymeric film forming compound"
  • Context and Importance: This is a negative limitation in Claim 1 of the ’640 Patent. The infringement analysis depends on whether Mylan's product contains a substance meeting this definition. The patent distinguishes its invention from prior art nail lacquers, making the scope of this term critical.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide an explicit definition, which may support an argument for applying the term's plain and ordinary meaning to cover a wide range of polymers capable of forming any type of film.
    • Evidence for a Narrower Interpretation: The specification contrasts the invention with lacquers that form a "hard lacquer, shell, or film" upon evaporation of a solvent ('640 Patent, col. 7:1-6). This context may support a narrower construction limited to compounds that form a hard, solid, non-pliable residue, potentially excluding excipients that might be polymeric but do not form such a structure.

For the '875 Patent

  • The Term: "colorless or pale yellow"
  • Context and Importance: This term defines the desired outcome of the stabilization technology in the ’875 Patent. Its definition is central to determining whether a composition that includes the claimed stabilizers achieves the claimed result and thus infringes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term could be construed according to its plain meaning, as assessed by visual inspection by a person of ordinary skill.
    • Evidence for a Narrower Interpretation: The specification provides a specific, quantitative definition, stating that "pale yellow compositions have UV-vis absorbance values below 0.2 AU at 400 nm, below 0.1 AU at 500 nm, and below 0.1 AU at 600 nm" ('875 Patent, col. 8:60-64). A party could argue this language serves as a lexicographical definition, limiting the claim scope to compositions meeting these precise instrumental measurements.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Mylan will induce and contribute to infringement of the asserted patents (Compl. ¶¶ 25, 36, 47). The basis for an inducement claim is the allegation that Mylan's product labeling will necessarily instruct medical professionals and patients to apply the generic solution in a manner that directly infringes the asserted method claims.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it requests that the court declare the case "exceptional" under 35 U.S.C. § 285, which allows for an award of attorney's fees (Compl., Prayer for Relief ¶ 7). The basis for this request may stem from allegations that Mylan had knowledge of the patents, at least as of its receipt of the notice letter dated January 28, 2020 (Compl. ¶ 19).

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

  • A central factual question will be one of compositional identity: does Mylan’s proposed generic formulation, as specified in its ANDA, contain the exact combination of excipients and stabilizers (e.g., BHT, EDTA, citric acid, and specific non-volatile solvents) required by the asserted claims of the '640 and '875 patents, or has Mylan successfully designed a non-infringing formulation?
  • A key infringement question for the '601 patent will be one of structural equivalence: does the applicator Mylan intends to market possess the specific "fan shape" with a decreasing thickness toward the tip, as described and claimed in the patent, or does it utilize a structurally distinct, non-infringing design?
  • The outcome of the dispute may turn on claim construction, particularly how the court defines the scope of the negative limitation "polymeric film forming compound" in the '640 patent and whether the quantitative UV-vis absorbance values in the '875 patent's specification are read into the claims as a binding definition of "colorless or pale yellow."