DCT

3:20-cv-02737

Bausch Health US LLC v. Alkem Laboratories Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:20-cv-02737, D.N.J., 03/12/2020
  • Venue Allegations: Plaintiffs allege venue is proper because Defendant Alkem is a foreign corporation subject to personal jurisdiction in the district. Allegations supporting personal jurisdiction include that Alkem conducts business in the U.S. and New Jersey, has a wholly-owned subsidiary in New Jersey, and has previously submitted to the court's jurisdiction in related litigation.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Jublia® product constitutes an act of infringement of three U.S. patents covering the drug's formulation, stabilization, and method of use.
  • Technical Context: The technology concerns topical pharmaceutical formulations for treating onychomycosis (nail fungus), a condition where delivering an effective dose of medication through the dense nail plate is a significant challenge.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant's ANDA filing. The complaint notes that a related action involving the same parties and the same ANDA, but concerning a different set of patents, is already pending in the district.

Case Timeline

Date Event
2008-01-03 Earliest Priority Date for ’640 Patent
2011-07-05 Earliest Priority Date for ’601 Patent
2013-10-03 Earliest Priority Date for ’875 Patent
2014-06-06 FDA approves New Drug Application for Jublia®
2019-07-09 U.S. Patent No. 10,342,875 issues
2019-11-19 U.S. Patent No. 10,478,601 issues
2019-12-24 U.S. Patent No. 10,512,640 issues
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 addresses the difficulty of delivering therapeutic agents through the nail plate to treat fungal infections like onychomycosis. It notes that the nail is a "formidable barrier to drug penetration" and that prior art solutions, particularly those forming a hard lacquer or film, have not been consistently effective (US 10,512,640, col. 2:41-54).
  • The Patented Solution: The patent discloses a non-film-forming liquid composition designed for enhanced nail penetration. The invention combines a volatile vehicle (like ethanol), a non-volatile solvent, and a volatile silicone wetting agent. This specific combination is designed to remain liquid on the nail and deliver an active ingredient (like the antifungal efinaconazole) into and through the nail without forming a hard, polymeric film (US 10,512,640, col. 3:10-21; col. 7:1-9).
  • Technical Importance: The technology provides an alternative to systemic medications or nail-removal procedures by creating a topical formulation with purportedly superior nail penetration compared to standard lacquers (US 10,512,640, col. 2:41-54).

Key Claims at a Glance

  • The complaint asserts at least one claim (Compl. ¶22). Independent claim 1 is representative:
  • A method for treating onychomycosis by topically applying a pharmaceutical composition comprising:
    • ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent;
    • where the composition is formulated as a solution;
    • where ethanol is at a concentration of at least 50% w/w; and
    • where the composition does not comprise a polymeric film forming compound.

U.S. Patent No. 10,342,875 - "Stabilized Efinaconazole Compositions"

  • Issued: July 9, 2019

The Invention Explained

  • Problem Addressed: The patent's background section states that some pharmaceutical formulations containing triazole antifungal agents are known to "discolor within storage periods as short as one or two days," resulting in colors from yellow to deep red or brown that can discourage patient use (US 10,342,875, col. 1:30-38).
  • The Patented Solution: The invention is a specific liquid or semisolid composition that solves the discoloration problem by including two key stabilizers: butylated hydroxytoluene (BHT) and a salt of ethylenediaminetetraacetic acid (EDTA). The patent asserts that the specified amounts of BHT and EDTA are sufficient to ensure the composition remains colorless or pale yellow, even after storage at elevated temperatures (US 10,342,875, Abstract; col. 2:42-53). The specification provides data showing this combination is superior to other antioxidants like BHA or propyl gallate (US 10,342,875, col. 15:5-16:8).
  • Technical Importance: This invention provides a commercially viable formulation for efinaconazole that maintains its aesthetic properties over its shelf life, which is critical for patient compliance with a long-term treatment regimen (US 10,342,875, col. 1:35-38).

Key Claims at a Glance

  • The complaint asserts at least one claim (Compl. ¶33). Independent claim 1 is representative:
  • A composition comprising:
    • about 10% efinaconazole by weight;
    • water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol;
    • butylated hydroxytoluene (BHT);
    • a salt of ethylenediaminetetraacetic acid (EDTA); and
    • citric acid;
    • wherein the composition is formulated as a solution.

U.S. Patent No. 10,478,601 - "Applicator"

  • Issued: November 19, 2019

Technology Synopsis

  • The patent addresses problems with prior art applicators for nail medicines, which can cause irritation, be impractical, or lead to dripping (US 10,478,601, col. 1:11-66). The invention is a solution applicator featuring a soft, fan-shaped brush tip made of bundled synthetic fibers, which allows for gentle, precise application of a liquid medicine to the affected nail area with reduced irritation and leakage (US 10,478,601, Abstract).

Asserted Claims

  • The complaint asserts at least one claim (Compl. ¶44). The patent includes independent claims 1, 8, and 10.

Accused Features

  • The complaint alleges infringement based on the future commercial manufacture, use, or sale of Alkem's generic efinaconazole topical solution, which is presumed to be supplied with an infringing applicator (Compl. ¶¶ 45-46).

III. The Accused Instrumentality

Product Identification

  • "Alkem's generic efinaconazole topical solution, 10%," for which Alkem has filed ANDA No. 212195 with the FDA (Compl. ¶¶ 6, 18).

Functionality and Market Context

  • The product is a generic version of Jublia®, a topical solution for the treatment of onychomycosis (Compl. ¶¶ 17, 19). The complaint alleges that the proposed generic product is "the same, or substantially the same, as Jublia®" (Compl. ¶20). The patents-in-suit are listed in the FDA's Orange Book in connection with Jublia®, signifying that they cover the approved drug product or its method of use (Compl. ¶16). The act of filing the ANDA to obtain approval for this generic product before patent expiration is the basis of the infringement action (Compl. ¶22).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’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... Alkem's ANDA seeks approval for a generic efinaconazole topical solution, and its proposed labeling will instruct for the topical application to nails for treating onychomycosis. ¶¶ 19, 23 col. 11:38-42
...comprising ethanol, diisopropyl adipate, C12-15 alkyl lactate, cyclomethicone, and a triazole antifungal agent... The complaint alleges Alkem's product is the same or substantially the same as Jublia®, which contains these components, with efinaconazole being the triazole antifungal agent. ¶¶ 20, 23 col. 5:39-64; col. 6:45-53
...wherein the composition is formulated as a solution... Alkem's product is identified as a "topical solution." ¶6 col. 8:1-2
...wherein the ethanol is present in the composition at a concentration of at least 50% w/w... Alkem's ANDA product formulation, to be bioequivalent to Jublia®, is alleged to contain ethanol at the claimed concentration. ¶¶ 20, 23 col. 8:6-9
...wherein the composition does not comprise a polymeric film forming compound... The complaint's allegation that Alkem's product is the same as Jublia® implies that it is a non-film-forming solution as claimed. ¶¶ 20, 23 col. 7:6-9
  • Identified Points of Contention:
    • Factual Question: A central question will be whether the specific formulation detailed in Alkem's confidential ANDA filing meets every concentration and component limitation of the asserted claims. While the complaint alleges the products are the same, this will be a matter for discovery.
    • Scope Question: The negative limitation "does not comprise a polymeric film forming compound" may become a point of contention. The parties could dispute whether any excipients in Alkem's product, even if not primarily film-formers, meet the definition of a "polymeric film forming compound" as understood in the art and defined by the patent.

’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... Alkem's product is identified as "efinaconazole topical solution, 10%." ¶6 col. 2:56
...water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol... The complaint alleges Alkem's product is substantially the same as Jublia® and will therefore contain the same base excipients. ¶¶ 20, 34 col. 11:46-52
...butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid... To be bioequivalent to Jublia®, which is covered by the ’875 patent, Alkem's product is alleged to contain the same stabilization package of BHT, EDTA, and citric acid. ¶¶ 14, 20, 34 col. 5:36-col. 7:49
...wherein the composition is formulated as a solution. Alkem's product is identified as a "topical solution." ¶6 col. 2:1-3
  • Identified Points of Contention:
    • Technical Question: Infringement will depend on whether Alkem's formulation contains the precise combination of stabilizers (BHT, EDTA salt, and citric acid) in amounts that fall within the scope of the claims. Any deviation in Alkem's ANDA could be a basis for a non-infringement argument.
    • Scope Question: The term "about 10% efinaconazole" introduces a degree of flexibility. The court may need to determine the acceptable range covered by "about," which could be critical if Alkem's formulation deviates slightly from 10.0%.

V. Key Claim Terms for Construction

  • The Term: "composition does not comprise a polymeric film forming compound" (’640 Patent, Claim 1)

  • Context and Importance: This negative limitation is central to distinguishing the invention from prior art nail lacquers. The patent's theory of enhanced penetration relies on the composition not forming a film. Practitioners may focus on this term because if Alkem's formulation contains any excipient that could be characterized as a film-former, even for a secondary purpose, it could potentially escape infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation (i.e., excluding more compositions): The specification repeatedly contrasts the invention with prior art that forms a "substantive nail coating or film" (US 10,512,640, col. 2:17-18) or a "hard lacquer, shell, or film" (US 10,512,640, col. 7:2-4), suggesting the exclusion applies to any compound that creates such a substantive, hard layer.
    • Evidence for a Narrower Interpretation (i.e., excluding fewer compositions): The patent explicitly mentions "cellulose derivatives" as examples of film formers (US 10,512,640, col. 2:1-2). A party could argue the term should be limited to conventional, dedicated film-forming agents like those listed, and not multi-function excipients that might have minor film-forming properties.

  • The Term: "colorless or pale yellow after storage" (’875 Patent, Summary of the Invention)

  • Context and Importance: This term defines the successful outcome of the stabilization technology. Practitioners may focus on this term because it is not merely subjective; the patent provides objective, quantitative metrics for it. Infringement could turn on whether Alkem's product meets these specific performance criteria after stability testing.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Narrower (more specific) Interpretation: The specification provides explicit UV-vis absorbance values to define acceptable color. For example, "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" (US 10,342,875, col. 8:60-63). This language provides a clear, numerical boundary for the claim term.
    • Evidence for a Broader Interpretation: The patent also allows for color determination by "visual inspection" (US 10,342,875, col. 4:34-35). A party might argue that if a composition appears "pale yellow" to a human observer, it meets the limitation, even if it slightly exceeds the numerical UV-vis thresholds, raising a potential conflict between the subjective and objective definitions.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Alkem will indirectly infringe by inducing and contributing to infringement by others (e.g., patients and doctors) (Compl. ¶¶ 24, 35, 46). The basis for inducement is the allegation that Alkem's product labeling and marketing materials will instruct users to apply the generic product in a manner that directly infringes the asserted method claims.
  • Willful Infringement: The complaint does not contain a specific count for willful infringement. However, the prayer for relief requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which would entitle Plaintiffs to an award of attorney's fees (Compl. p. 11, ¶7). The basis for this request is not detailed in the pleadings.

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

  • A core issue will be one of compositional identity: does the precise formulation disclosed in Alkem's confidential ANDA—including the identity and concentration of the API, solvents, and particularly the stabilization agents (BHT and EDTA)—fall within the literal scope of the asserted composition claims, or are there legally significant differences?
  • A key evidentiary question will be one of functional performance: will Alkem's proposed generic product, if manufactured, exhibit the specific functional properties required by the patents? This includes both the negative limitation of not forming a polymeric film (for the '640 patent) and the affirmative requirement of maintaining color stability as defined by the objective UV-vis absorbance metrics (for the '875 patent).
  • A third central question will concern the applicator: does the physical applicator that Alkem intends to market with its generic solution infringe the structural and functional claims of the '601 patent, particularly with respect to the fan-shaped, soft-fiber brush tip design?