DCT

3:20-cv-02746

Bausch Health US LLC v. Strides Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:20-cv-02746, D.N.J., 03/12/2020
  • Venue Allegations: Venue is based on Defendant Strides USA being a New Jersey corporation with a principal place of business in the district, and on Strides Global being a foreign corporation subject to suit in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' JUBLIA® (efinaconazole) topical solution constitutes an act of patent infringement.
  • Technical Context: The technology at issue involves pharmaceutical compositions for the topical treatment of onychomycosis (nail fungus) and the specific applicators used for their delivery.
  • Key Procedural History: The complaint notes that a related action against Strides is pending in the same district, concerning the same ANDA but asserting infringement of a different set of patents, indicating a broader, ongoing dispute between the parties over this generic product.

Case Timeline

Date Event
2007-01-05 U.S. Patent No. 10,512,640 Priority Date
2011-07-05 U.S. Patent No. 10,478,601 Priority Date
2013-10-03 U.S. Patent No. 10,342,875 Priority Date
2014-06-06 FDA approves NDA No. 203567 for JUBLIA®
2019-07-09 U.S. Patent No. 10,342,875 Issued
2019-11-19 U.S. Patent No. 10,478,601 Issued
2019-12-24 U.S. Patent No. 10,512,640 Issued
2020-03-12 Complaint Filed

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 describes the nail plate as a "formidable barrier to drug penetration," making topical treatment of nail disorders like onychomycosis difficult and often ineffective with existing therapies, particularly those that form a hard film or lacquer on the nail surface (Compl. ¶17; ’640 Patent, col. 1:41-43, col. 2:19-21).
  • The Patented Solution: The invention is a non-film-forming pharmaceutical composition designed to enhance drug delivery into the nail. It employs a specific combination of a vehicle (e.g., alcohol), a non-volatile solvent, and a wetting agent (e.g., volatile silicone) that remains in a liquid or semi-solid state after application, which is intended to facilitate superior penetration of the active ingredient through the nail plate (’640 Patent, Abstract; col. 7:1-14).
  • Technical Importance: This formulation technology seeks to improve the clinical efficacy of topical antifungal treatments, offering a potential alternative to systemic medications or nail removal, which can have significant drawbacks (’640 Patent, col. 2:37-54).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim of the '640 patent (Compl. ¶26).
  • Independent claim 1 is a method claim with the following essential elements:
    • A method for the treatment of onychomycosis.
    • Topically applying to the surface of the nail a pharmaceutical composition.
    • The composition comprises ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent.
    • The composition is formulated as a solution.
    • The composition contains specific weight-per-weight percentage ranges for ethanol, cyclomethicone, diisopropyl adipate, and C12-15 alkyl lactate.

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

The Invention Explained

  • Problem Addressed: The patent identifies an instability issue where pharmaceutical formulations containing triazole antifungal compounds, such as efinaconazole, can "discolor within storage periods as short as one or two days," which may discourage patient compliance (’875 Patent, col. 1:28-37).
  • The Patented Solution: The invention claims to solve this problem by adding specific stabilizers to the efinaconazole formulation. The patented solution is a liquid or semisolid composition containing efinaconazole, butylated hydroxytoluene (BHT), and a salt of ethylenediaminetetraacetic acid (EDTA), optionally with citric acid, which together prevent discoloration and maintain a colorless or pale yellow appearance during storage (’875 Patent, Abstract; col. 2:42-53).
  • Technical Importance: By preventing discoloration, the invention improves the chemical stability and commercial viability of the topical drug product, enhancing its shelf-life and patient acceptability (’875 Patent, col. 1:35-39).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim of the ’875 patent (Compl. ¶37).
  • Independent claim 1 is a composition claim with the following essential elements:
    • A composition comprising about 10% efinaconazole by weight.
    • The composition further comprises water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol, butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid.
    • The amounts of BHT, the EDTA salt, and citric acid fall within specified ranges.
    • The composition is formulated as a solution.

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

Technology Synopsis

The patent addresses the challenge of applying liquid medicine to sensitive or hard-to-reach areas, such as an infected nail bed, without causing irritation or dripping (’601 Patent, col. 1:11-49). The invention is an applicator featuring a columnar brush member made of bundled synthetic fibers, with a unique "fan-shaped" tip that is soft and allows for precise application of a solution to the affected area (’601 Patent, Abstract).

Asserted Claims

The complaint asserts infringement of at least one claim of the '601 patent (Compl. ¶48). Independent claim 1 is representative.

Accused Features

The complaint alleges that the applicator to be marketed with Strides's generic drug product infringes by possessing the specific physical characteristics and enabling the method of use claimed in the patent (Compl. ¶¶19, 49).

III. The Accused Instrumentality

Product Identification

  • "Strides's generic efinaconazole topical solution, 10%," for which Strides filed Abbreviated New Drug Application (ANDA) No. 211985 with the U.S. Food and Drug Administration (FDA) (Compl. ¶¶8, 22).

Functionality and Market Context

  • The accused instrumentality is the subject of an ANDA filing under the Hatch-Waxman Act, which itself is the statutorily defined act of infringement (Compl. ¶¶8, 26).
  • The product is a topical solution intended to be a generic version of JUBLIA®, a commercially successful treatment for onychomycosis (Compl. ¶¶21, 23).
  • The complaint alleges that the proposed generic product is "the same, or substantially the same, as Jublia®" and that it will be marketed with an applicator (Compl. ¶¶19, 24). The infringement allegations are premised on the ANDA product's formulation and its intended method of use, as would be detailed in its FDA-approved labeling, necessarily mirroring that of JUBLIA®.

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

10,512,640 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the treatment of onychomycosis... Strides seeks approval to market its generic product for the treatment of onychomycosis. ¶17 col. 11:38-39
comprising topically applying to the surface of the nail of an individual suffering from onychomycosis a pharmaceutical composition... Strides's product is a "topical solution" intended for application to the nail. ¶8 col. 11:39-41
comprising ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent... The ANDA product is alleged to be a 10% efinaconazole (a triazole antifungal) solution with a formulation that is the same or substantially the same as JUBLIA®, which is covered by the patent. ¶¶8, 17, 24 col. 11:41-44
wherein the composition is formulated as a solution... The accused product is identified as a "topical solution." ¶8 col. 11:44-45

10,342,875 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising about 10% efinaconazole by weight... The accused product is identified as "efinaconazole topical solution, 10%." ¶8 col. 15:47
...water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol... The generic formulation is alleged to be bioequivalent to JUBLIA® and therefore contains the same core excipients claimed in the patent. ¶¶18, 24 col. 15:47-49
...butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid... The generic formulation is alleged to contain the claimed combination of stabilizers, as it is intended to be a substitute for JUBLIA®, which is protected by this stabilization patent. ¶¶18, 24 col. 15:49-51
...wherein the composition is formulated as a solution. The accused product is identified as a "topical solution." ¶8 col. 15:56-57

Identified Points of Contention

  • Factual Mismatch: The primary point of contention will be factual: does the precise formulation detailed in Strides's confidential ANDA filing contain every ingredient in the concentrations required by the asserted claims of the '640 and '875 patents? A common defense strategy is to argue that the generic formulation was designed to avoid one or more claimed elements, for instance, by using a different stabilizer or solvent.
  • Scope Questions: For the '601 patent, the dispute will center on whether the physical device supplied with Strides's product meets the specific structural and dimensional limitations of the applicator claims (e.g., the "fan shape" of the brush tip). This raises the question of whether Strides's applicator is structurally identical or merely functionally similar to the patented design.

V. Key Claim Terms for Construction

  • The Term: "a salt of ethylenediaminetetraacetic acid (EDTA)" (’875 Patent, Claim 1)
  • Context and Importance: The definition of this term is critical for the '875 patent. Infringement requires the presence of this specific component. Practitioners may focus on this term because Strides could argue its formulation uses a different, non-infringing chelating agent, EDTA in a non-salt form, or a salt that falls outside a properly construed scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that the salt "can be any suitable salt" and that it "will be one that is acceptable for pharmaceutical formulations" (’875 Patent, col. 6:61-64). This language suggests the inventors did not intend to limit the claim to only the specific examples provided.
    • Evidence for a Narrower Interpretation: The specification notes that "Frequently used salts are the disodium and tetrasodium salts" (’875 Patent, col. 6:64-66), and the working examples exclusively use "EDTA disodium" (e.g., '875 Patent, Table 3). A defendant may argue that the invention is limited to these specifically disclosed and exemplified salts.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement for all three patents (Compl. ¶¶28, 39, 50). The factual basis is that Strides's proposed product label will allegedly instruct physicians and patients to use the generic product in a manner that directly infringes the method claims (e.g., by topically applying the claimed formulation to treat onychomycosis).
  • Willful Infringement: The complaint does not explicitly allege "willful infringement." However, it requests that the court "declare this to be an exceptional case" under 35 U.S.C. § 285, which allows for the award of attorney's fees (Compl., Prayer for Relief ¶7). Such a request is typically predicated on allegations of egregious infringement or litigation misconduct. The complaint does not allege pre-suit knowledge, but the filing of the complaint establishes knowledge for the purpose of any potential future infringement.

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

  • An Evidentiary Question of Composition: The central issue for the '640 and '875 patents is one of fact: does the confidential formulation in Strides’s ANDA No. 211985 contain every element, in the claimed concentrations, of at least one asserted claim? The outcome will depend on a direct comparison of the ANDA filing with the patent claims.
  • A Structural Question of Equivalence: For the '601 patent, a key question will be whether the physical applicator that Strides intends to market with its generic product meets the precise structural and dimensional limitations of the patent’s claims, or if it was designed to be structurally different while achieving a similar functional result.
  • A Legal Question of Claim Scope: The case may turn on claim construction, particularly for the '875 patent. A core legal issue will be whether the term "a salt of ethylenediaminetetraacetic acid (EDTA)" is construed broadly to encompass any pharmaceutically acceptable EDTA salt, or is limited to the specific disodium and tetrasodium salts disclosed in the patent’s specification.