DCT

3:18-cv-14194

Valeant Pharma North America LLC v. Acrux DDS Pty Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:18-cv-14194, D.N.J., 09/21/2018
  • Venue Allegations: Venue is alleged to be proper as Defendant Acrux is a foreign corporation, has purposefully conducted business in the district, and the district is a likely destination for the accused generic product. Plaintiffs also note that the branded product, Jublia®, is manufactured for a Valeant entity in Bridgewater, New Jersey.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ Jublia® (efinaconazole) topical solution constitutes an act of infringement of eight U.S. patents covering the drug’s formulation and methods of use.
  • Technical Context: The technology relates to pharmaceutical compositions and methods for the topical treatment of onychomycosis, a fungal infection of the nail that is difficult to treat due to the challenge of delivering an active drug through the dense keratin of the nail plate.
  • Key Procedural History: The litigation was triggered by Defendant Acrux filing ANDA No. 211969 with the U.S. Food and Drug Administration (FDA) seeking approval to market its generic efinaconazole product. Pursuant to the Hatch-Waxman Act, this filing is considered a technical act of infringement, allowing Plaintiffs to sue before the generic product enters the market. Plaintiffs received a notice letter from Acrux regarding the ANDA filing on August 9, 2018.

Case Timeline

Date Event
1999-07-28 Earliest Priority Date for ’506 Patent
2007-05-08 U.S. Patent No. 7,214,506 Issued
2010-07-08 Earliest Priority Date for ’494, ’978, ’009, ’272, ’698, ’955 Patents
2011-10-18 U.S. Patent No. 8,039,494 Issued
2013-07-16 U.S. Patent No. 8,486,978 Issued
2013-10-03 Earliest Priority Date for ’394 Patent
2014-06-06 FDA Approves New Drug Application for Jublia®
2016-04-05 U.S. Patent No. 9,302,009 Issued
2017-02-14 U.S. Patent No. 9,566,272 Issued
2017-05-30 U.S. Patent No. 9,662,394 Issued
2018-01-09 U.S. Patent No. 9,861,698 Issued
2018-01-30 U.S. Patent No. 9,877,955 Issued
2018-08-09 Plaintiffs Receive Acrux's ANDA Notice Letter
2018-09-21 Complaint Filed

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

U.S. Patent No. 7,214,506 - "Method for Treating Onychomycosis"

Issued May 8, 2007

The Invention Explained

  • Problem Addressed: The patent's background section describes the difficulty in accurately evaluating the efficacy of antifungal agents for skin and nail infections. Conventional testing methods, which involve culturing excised tissue, can be misleading because residual drug in the tissue sample may inhibit fungal growth in the culture, giving a false impression that the fungus has been eradicated when viable fungus remains (a "relapse") (’506 Patent, col. 1:52-col. 2:18).
  • The Patented Solution: The specification proposes a novel method for evaluating drug effect by first removing the residual drug from the tissue sample (e.g., through dialysis) before attempting to culture any remaining fungus (’506 Patent, col. 2:55-65). While the specification focuses on this evaluation method, the patent's claims are directed to a method of treating onychomycosis by topically administering a specific class of antifungal compounds (which includes efinaconazole) to the nail of a subject (’506 Patent, Claim 1).
  • Technical Importance: The claimed method provides a direct approach for treating nail fungus topically, aiming to circumvent the systemic side effects associated with oral antifungal medications (’506 Patent, col. 2:25-39).

Key Claims at a Glance

  • The complaint asserts infringement of at least one unspecified claim (Compl. ¶29). Independent claim 1 is a representative method claim.
  • Claim 1 Elements:
    • A method for treating a subject having onychomycosis.
    • The method comprises topically administering to a nail of said subject a therapeutically effective amount of an antifungal compound represented by a specific chemical formula (Formula II).
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

Issued October 18, 2011

The Invention Explained

  • Problem Addressed: The patent identifies the nail plate as a "formidable barrier to drug penetration," making topical treatment of nail disorders like onychomycosis difficult (’494 Patent, col. 1:36-41). Prior art solutions, such as nail lacquers that form a film, have demonstrated low clinical effectiveness (’494 Patent, col. 2:42-col. 3:4).
  • The Patented Solution: The invention is a pharmaceutical composition designed for enhanced nail penetration that does not form a solid film. The solution combines a volatile and/or penetrating vehicle with a non-volatile solvent and a wetting agent (’494 Patent, col. 4:40-54). A key characteristic is the low surface tension (40 dynes/cm or less), which allows the liquid to spread across the nail, into the nail folds, and be wicked by capillary action into any gap between the nail and the nail bed, thereby delivering the active ingredient to the site of infection (’494 Patent, col. 4:56-col. 5:2).
  • Technical Importance: This approach seeks to improve drug delivery to the nail bed—the primary site of onychomycosis infection—without requiring nail removal or relying on film-forming lacquers that may hinder continuous drug release.

Key Claims at a Glance

  • The complaint asserts infringement of at least one unspecified claim (Compl. ¶40). Independent claim 1 is a representative method claim.
  • Claim 1 Elements:
    • A method for the treatment of a disorder of the nail or nail bed.
    • Comprising topically applying to the surface of the nail a pharmaceutical composition "consisting essentially of":
      • a vehicle that is volatile and/or that rapidly penetrates a nail.
      • a triazole antifungal active pharmaceutical ingredient (API).
      • a wetting agent.
      • and optionally a non-volatile solvent.
    • Wherein the surface tension is 40 dynes/cm or less.
    • Wherein the composition does not form a solid film when applied.
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

Issued July 16, 2013

  • Technology Synopsis: This patent, related to the ’494 patent, claims pharmaceutical compositions for treating nail disorders. The invention focuses on a low-surface-tension formulation "consisting essentially of" a volatile vehicle, a triazole antifungal, a wetting agent, and optionally a non-volatile solvent, designed to penetrate the nail without forming a solid film (Compl. ¶15; ’978 Patent, Abstract).
  • Asserted Claims: At least one unspecified claim is asserted (Compl. ¶51).
  • Accused Features: The accused features are the components and properties of Acrux's generic efinaconazole topical solution (Compl. ¶¶51-52).

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

Issued April 5, 2016

  • Technology Synopsis: This patent claims pharmaceutical compositions for topical nail treatment that include specific ingredients: efinaconazole, ethanol, cyclomethicone, diisopropyl adipate, C12-15 alkyl lactate, and an antioxidant (Compl. ¶16; ’009 Patent, Abstract). This patent narrows the broader formulation concepts of the parent patents to a more defined set of excipients.
  • Asserted Claims: At least one unspecified claim is asserted (Compl. ¶62).
  • Accused Features: The accused features are the specific chemical components of Acrux's generic efinaconazole topical solution (Compl. ¶¶62-63).

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

Issued February 14, 2017

  • Technology Synopsis: This patent claims methods for treating onychomycosis by topically applying a pharmaceutical composition containing efinaconazole, ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶17; ’272 Patent, Abstract). It claims a method of using a composition similar to that claimed in the ’009 patent.
  • Asserted Claims: At least one unspecified claim is asserted (Compl. ¶73).
  • Accused Features: The infringement allegation is based on the future, intended use of Acrux's generic solution according to its FDA-approved labeling (Compl. ¶¶73-74).

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

Issued May 30, 2017

  • Technology Synopsis: This patent addresses the problem of discoloration and instability in efinaconazole solutions during storage. The invention is a stabilized composition that includes efinaconazole along with specific stabilizers: butylated hydroxytoluene (BHT), a salt of EDTA, and citric acid, which together ensure the solution remains colorless or pale yellow over time (Compl. ¶18; ’394 Patent, Abstract).
  • Asserted Claims: At least one unspecified claim is asserted (Compl. ¶84).
  • Accused Features: The accused features are the active ingredient and stabilizing agents within Acrux's generic formulation (Compl. ¶¶84-85).

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

Issued January 9, 2018

  • Technology Synopsis: This patent claims pharmaceutical formulations comprising specific excipients (ethanol, cyclomethicone, diisopropyl adipate, and mixed C12-15 alkyl lactates) and methods of using them to treat nail disorders (Compl. ¶19; ’698 Patent, Abstract). The claims are directed to both the composition itself and its method of use.
  • Asserted Claims: At least one unspecified claim is asserted (Compl. ¶95).
  • Accused Features: The accused features are the chemical components and intended use of Acrux's generic solution (Compl. ¶¶95-96).

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

Issued January 30, 2018

  • Technology Synopsis: This patent claims methods for treating onychomycosis by applying a pharmaceutical composition that includes efinaconazole and a specific combination of excipients: ethanol, diisopropyl adipate, C12-15 alkyl lactate, and cyclomethicone (Compl. ¶20; ’955 Patent, Abstract).
  • Asserted Claims: At least one unspecified claim is asserted (Compl. ¶106).
  • Accused Features: The infringement allegation is based on the future, intended use of Acrux's generic solution according to its FDA-approved labeling (Compl. ¶¶106-107).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Acrux's generic efinaconazole topical solution, 10%," for which Acrux filed Abbreviated New Drug Application (ANDA) No. 211969 with the FDA (Compl. ¶¶6, 23).

Functionality and Market Context

  • The complaint alleges that Acrux's product is intended to be a generic version of Plaintiffs’ commercially successful product, Jublia® (Compl. ¶24). The product is a topical solution for treating onychomycosis (Compl. ¶6). The complaint alleges that the formulation of Acrux's ANDA product "is the same, or substantially the same, as Jublia®" (Compl. ¶27). The filing of the ANDA itself, seeking approval before the expiration of the patents-in-suit, is the statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶29).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or specific mapping of the accused product’s features to the elements of the asserted claims. Instead, it alleges infringement based on the assertion that Acrux's generic efinaconazole topical solution is the same or substantially the same as the commercial product Jublia®, which is listed in the FDA's Orange Book as being covered by the patents-in-suit (Compl. ¶¶21, 27). The infringement counts for each patent are pleaded generally, stating that the ANDA filing infringes "at least one claim" of the respective patent (e.g., Compl. ¶¶29, 40, 51).

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions (Composition Patents): For composition claims, such as those in the ’494 and ’978 patents, that use the transitional phrase "consisting essentially of," a central question will be whether any unrecited excipients in Acrux's formulation materially alter the basic and novel properties of the claimed invention (e.g., nail penetration, low surface tension, non-film-forming).
  • Technical Questions (Composition Patents): For composition claims in the later patents (e.g., ’009, ’394, ’698), which recite more specific ingredients, the dispute will turn on factual questions of chemical equivalence. Does Acrux’s formulation contain the exact recited ingredients (e.g., ethanol, cyclomethicone, specific stabilizers), or does it use substitutes that raise questions of literal infringement or infringement under the doctrine of equivalents?
  • Induced Infringement Questions (Method Patents): For method of treatment claims (e.g., ’506, ’272, ’955), the analysis will focus on induced infringement. A key question for the court will be whether the proposed product label for Acrux’s generic solution will instruct or encourage medical professionals and patients to administer the product in a manner that performs all steps of the claimed methods.

V. Key Claim Terms for Construction

"consisting essentially of"

(from claim 1 of the ’494 and ’978 Patents)

Context and Importance: This term is a legal term of art that is narrower than "comprising" but broader than "consisting of." It permits the presence of unlisted ingredients so long as they do not "materially affect the basic and novel characteristics of the claimed invention." The infringement analysis for Acrux's product, which is alleged to be "the same, or substantially the same" as Jublia®, will depend heavily on what the court defines as the "basic and novel characteristics" and whether any differences in Acrux's formulation are deemed "material."

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party arguing for a broader scope (allowing more unlisted ingredients) may point to specification language describing the invention in general terms, focusing on the functional results like low surface tension and wickability, suggesting that any unlisted ingredient not affecting these functions is permissible (’494 Patent, col. 4:56-col. 5:2).
  • Evidence for a Narrower Interpretation: A party arguing for a narrower scope may cite the specification's emphasis on avoiding "film forming polymeric compounds" and the specific benefits of the recited components (’494 Patent, col. 4:50-51). They may argue the "basic and novel" properties include not just penetration but also the specific chemical interactions of the recited vehicle, solvent, and wetting agent.

"topically administering"

(from claim 1 of the ’506 Patent)

Context and Importance: In the context of a method of treatment claim for onychomycosis, the definition of this term is critical. Practitioners may focus on whether this term simply means applying the composition to the external surface of the nail or if it implies a specific technique or outcome that must be encouraged by the generic drug's label to support a finding of induced infringement.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The plain and ordinary meaning of "topically administering" suggests application to a surface of the body. A party may argue that any instruction to apply the solution to the nail meets this limitation.
  • Evidence for a Narrower Interpretation: A party could argue that, in the context of the patent, "administering" implies more than simple application and must be effective administration. They may point to specification language discussing the challenges of nail penetration and the goal of curing the underlying infection, suggesting the term requires a method of application sufficient to achieve a therapeutic effect (’506 Patent, col. 2:29-39).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges contributory and induced infringement for all asserted patents (e.g., Compl. ¶¶31, 42). The factual basis is not detailed but is premised on the future marketing of Acrux's product with a label that will allegedly instruct users to perform the infringing methods of use and apply the infringing compositions.
  • Willful Infringement: The complaint does not contain a specific count for willful infringement or allege pre-suit knowledge beyond what is required for an ANDA case. However, the prayer for relief requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney's fees, often in cases of litigation misconduct or willful infringement (Prayer for Relief ¶12).

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

This case appears to be a standard Hatch-Waxman litigation involving a large patent portfolio covering a single drug product. The resolution will likely center on the following key questions:

  • A primary issue will be one of formulation identity and scope: Does Acrux’s generic formulation fall within the literal scope of the asserted composition claims, particularly those with the limiting phrase “consisting essentially of”? The case may turn on whether any differences between the generic and branded formulations are sufficient to avoid infringement, either literally or under the doctrine of equivalents.
  • A second core question will be one of induced infringement: Will the instructions for use on Acrux’s proposed product label lead users to perform every step of the patented methods of treatment? The outcome will depend on the court's interpretation of the claim language and its comparison with the specific language of the proposed label.
  • A broader strategic question involves the portfolio effect: With eight patents covering various aspects from broad formulation concepts to specific stabilizing ingredients, how will Plaintiffs leverage the portfolio to create multiple, independent infringement arguments? Conversely, how might the Defendant use the prosecution histories of this extensive patent family to argue for narrow claim constructions or raise validity challenges based on, for example, obviousness-type double patenting?