DCT

3:19-cv-07296

Valeant Pharma North America LLC v. Macleods Pharma Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:19-cv-07296, D.N.J., 02/28/2019
  • Venue Allegations: Venue is alleged to be proper based on Defendant Macleods Pharma USA, Inc.’s regular and established place of business in the district, and against foreign corporation Macleods Pharmaceuticals Ltd. based on personal jurisdiction. The complaint alleges both entities have purposefully conducted business in the district and have previously submitted to the court's jurisdiction in other actions.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ Jublia® product constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology concerns topical pharmaceutical formulations designed to treat nail diseases, such as onychomycosis (nail fungus), by enhancing drug delivery through the dense nail plate.
  • Key Procedural History: The complaint notes that the filing of the ANDA is a technical act of infringement under the Hatch-Waxman Act. It also incorporates by reference a prior, pending lawsuit between the parties in the same district (Case No. 3:18-cv-14204) concerning a family of related patents, suggesting an established litigation history between the parties over this product.

Case Timeline

Date Event
2010-07-08 '444 Patent Priority Date
2014-06-06 FDA approves New Drug Application for Jublia®
2018-10-23 '444 Patent Issue Date
2019-01-14 Plaintiffs receive Defendants' Notice of Certification for ANDA No. 212147
2019-02-28 Complaint Filing Date

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

U.S. Patent No. 10,105,444 - "Compositions and Methods for Treating Diseases of the Nail," issued October 23, 2018

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of topically treating nail disorders like onychomycosis, where the nail plate acts as a "formidable barrier to drug penetration" (’444 Patent, col. 1:45-47). Prior art solutions, such as medicated nail lacquers, form films on the nail surface and have demonstrated low clinical effectiveness (Compl. ¶16; ’444 Patent, col. 3:10-20).
  • The Patented Solution: The invention is a pharmaceutical composition with a low surface tension that does not form a hard, solid film or lacquer after application (’444 Patent, Abstract; col. 10:8-10). This low surface tension allows the liquid formulation to spread into nail folds and be "wicked by capillary action into the gap between the nail and nail bed," thereby improving drug delivery to the site of infection without requiring high pressure or nail removal (’444 Patent, col. 5:6-15).
  • Technical Importance: The technology provides a non-lacquer-based approach to enhance the permeation of an active pharmaceutical ingredient through an intact nail and into the nail bed, aiming to improve clinical outcomes for topical treatments (’444 Patent, col. 4:31-38).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" without specifying which ones (Compl. ¶25). Independent claim 1 is representative and includes the following essential elements:
    • A pharmaceutical formulation comprising:
      • a. ethanol, 50% to 70% (w/w),
      • b. cyclomethicone, 10% to 15% (w/w),
      • c. diisopropyl adipate, 8% to 15% (w/w),
      • d. C12-15 alkyl lactate, 8% to 15% (w/w), and
      • e. antioxidant, 0.001% to 0.50% (w/w)
    • wherein the surface tension of the composition is 40 dynes/cm or less; and
    • wherein the formulation is free of polymeric film forming compounds.
  • The complaint’s general allegation suggests a reservation of the right to assert other independent or dependent claims.

III. The Accused Instrumentality

Product Identification

  • Macleods's generic efinaconazole topical solution, 10%, which is the subject of ANDA No. 212147 filed with the FDA (Compl. ¶19).

Functionality and Market Context

  • The product is intended to be a generic version of Jublia®, a commercially available treatment for onychomycosis (Compl. ¶20). The complaint alleges that the generic product described in the ANDA is "the same, or substantially the same, as Jublia®" (Compl. ¶23). Under the Hatch-Waxman Act, the filing of an ANDA seeking approval to market a generic drug before the expiration of a patent listed in the FDA's Orange Book for the branded equivalent is considered a technical act of infringement, enabling the patent holder to sue before the generic product enters the market (Compl. ¶25).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement theory is that by filing an ANDA for a product that is bioequivalent to Jublia®, Macleods necessarily seeks to market a product whose formulation is covered by the asserted claims of the ’444 patent.

'444 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical formulation comprising a. ethanol, 50% to 70% (w/w), Macleods’s generic efinaconazole topical solution, as described in ANDA No. 212147, is alleged to be the same or substantially the same as Jublia® and to contain the claimed components, thereby infringing at least one claim of the '444 patent. ¶¶ 19, 23, 26 col. 17:7-8
b. cyclomethicone, 10% to 15% (w/w), Macleods’s generic efinaconazole topical solution, as described in ANDA No. 212147, is alleged to be the same or substantially the same as Jublia® and to contain the claimed components, thereby infringing at least one claim of the '444 patent. ¶¶ 19, 23, 26 col. 17:9-10
c. diisopropyl adipate, 8% to 15% (w/w), Macleods’s generic efinaconazole topical solution, as described in ANDA No. 212147, is alleged to be the same or substantially the same as Jublia® and to contain the claimed components, thereby infringing at least one claim of the '444 patent. ¶¶ 19, 23, 26 col. 17:11-12
d. C12-15 alkyl lactate, 8% to 15% (w/w), and Macleods’s generic efinaconazole topical solution, as described in ANDA No. 212147, is alleged to be the same or substantially the same as Jublia® and to contain the claimed components, thereby infringing at least one claim of the '444 patent. ¶¶ 19, 23, 26 col. 17:13-14
e. antioxidant, 0.001% to 0.50% (w/w), Macleods’s generic efinaconazole topical solution, as described in ANDA No. 212147, is alleged to be the same or substantially the same as Jublia® and to contain the claimed components, thereby infringing at least one claim of the '444 patent. ¶¶ 19, 23, 26 col. 17:15-16
wherein the surface tension of the composition is 40 dynes/cm or less The complaint alleges Macleods’s product will infringe, which implies it possesses the claimed properties, including the required low surface tension. ¶26 col. 17:17-19
and wherein the formulation is free of polymeric film forming compounds. The complaint alleges Macleods’s product will infringe, which implies it possesses the claimed properties, including the absence of polymeric film formers. ¶26 col. 17:20-22

Identified Points of Contention

  • Factual Question: The central dispute will be a factual comparison between the precise formulation detailed in Macleods's confidential ANDA and the limitations of the asserted claims. The case will depend on whether the concentrations of ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and any antioxidant in the generic product fall within the specific ranges recited in the claims.
  • Scope Question: A potential point of contention may arise over the negative limitation "free of polymeric film forming compounds." The parties may dispute whether any excipients present in the accused formulation, even if in small quantities or not primarily intended as such, qualify as "polymeric film forming compounds," which could be a basis for a non-infringement argument.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of most claim terms, as they are standard chemical names and concentration ranges. However, one term may be pivotal.

  • The Term: "free of polymeric film forming compounds"
  • Context and Importance: This negative limitation is critical for distinguishing the invention from prior art nail lacquers. Practitioners may focus on this term because the presence of any ingredient that could be characterized as a "polymeric film forming compound" in Macleods's formulation could be dispositive of non-infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's background consistently contrasts the invention with prior art that forms a "substantive nail coating or film" or a "hard lacquer, shell, or film" (’444 Patent, col. 2:22-24, col. 10:51-54). A party could argue this context implies the term means free of compounds included for the express purpose of creating a durable, substantive film, not necessarily precluding any substance that has incidental or minor film-forming properties.
    • Evidence for a Narrower Interpretation: The specification explicitly states, "it is most preferred that the composition is free of polymeric film forming compounds" and provides a non-exhaustive list of examples, including "cellulose derivatives" and "polymers and copolymers of polyvinyl acetate" (’444 Patent, col. 10:9-17). A party could use this language to argue for a strict interpretation where the presence of any compound from these classes, regardless of concentration or purpose, would place the formulation outside the claim scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Macleods will induce and contribute to infringement through the future "manufacture, use, import, offer for sale, and/or sale" of its generic product (Compl. ¶27). In the ANDA context, this is based on the allegation that Macleods is seeking FDA approval for a product with a label that will inevitably instruct physicians and patients to use it in an infringing manner.
  • Willful Infringement: The complaint does not contain a direct allegation of willful infringement. However, the prayer for relief requests a declaration that the case is "exceptional under 35 U.S.C. §§ 285 and 271(e)(4)," which, if granted, could entitle Plaintiffs to an award of attorney's fees (Compl. p.8, ¶5). This request is premised on the statutory framework for ANDA litigation.

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

  • A key evidentiary question will be one of compositional identity: Does the precise formulation disclosed in Macleods's confidential ANDA No. 212147 meet every quantitative and qualitative limitation of an asserted claim of the '444 patent? The outcome will likely depend on discovery into the ANDA's contents and expert analysis of its components and their concentrations.
  • A central issue may be one of definitional scope: How should the court construe the negative limitation "free of polymeric film forming compounds"? Whether this requires the absolute absence of such substances or merely the absence of a functionally effective amount to form a lacquer-like film will be critical to the infringement analysis, particularly if the accused generic formulation contains excipients with arguable film-forming properties.