DCT

3:18-cv-17518

Valeant Pharma North America LLC v. Perrigo Pharma Intl Dac

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:18-cv-17518, D.N.J., 12/21/2018
  • Venue Allegations: Venue is alleged to be proper as Defendants are foreign corporations subject to personal jurisdiction in the district. The complaint further alleges that a subsidiary of Defendant Perrigo Pharma has a place of business in Parsippany, New Jersey, and that New Jersey is a likely destination for the accused generic product.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs’ Jublia® antifungal treatment constitutes an act of infringement of a patent covering the drug’s formulation.
  • Technical Context: The technology relates to topical pharmaceutical formulations for treating nail diseases, such as onychomycosis (nail fungus), which are designed to enhance drug penetration through the dense nail plate.
  • Key Procedural History: The complaint notes that the asserted patent is listed in the FDA's "Orange Book" for the drug Jublia®. It also incorporates by reference a separate, pending lawsuit between the parties involving eight other patents related to the same drug product (Case No. 3:18-cv-14207). This action was triggered by a notice letter from Perrigo, dated November 6, 2018, certifying that its generic product would not infringe or that the patent-in-suit is invalid.

Case Timeline

Date Event
2010-07-08 U.S. Patent No. 10,105,444 Priority Date
2014-06-06 FDA approves New Drug Application (NDA) for Jublia®
2018-10-23 U.S. Patent No. 10,105,444 Issues
2018-11-06 Plaintiff Dow receives Perrigo's notice letter regarding ANDA filing
2018-12-21 Complaint Filed

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

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

  • Patent Identification: U.S. Patent No. 10105444, "Compositions and Methods for Treating Diseases of the Nail", issued October 23, 2018.

The Invention Explained

  • Problem Addressed: The patent's background describes the significant challenge of treating nail diseases topically, noting that the nail plate is a "formidable barrier to drug penetration" and is approximately 100-fold thicker than the stratum corneum of the skin (’444 Patent, col. 1:43-50). Existing topical treatments, such as film-forming lacquers, are noted for having low clinical efficacy (’444 Patent, col. 3:5-18).
  • The Patented Solution: The invention is a pharmaceutical composition that enhances drug delivery without forming a solid film or lacquer. The formulation is characterized by a low surface tension (40 dynes/cm or less), which allows it to spread into nail folds and, critically, to be "wicked by capillary action into the gap between the nail and nail bed" where the infection often resides (’444 Patent, col. 5:6-14). It achieves this using a specific combination of a vehicle (e.g., ethanol), a wetting agent (e.g., cyclomethicone), and non-volatile solvents, while being "free of polymeric film forming compounds" (’444 Patent, Abstract; col. 10:10-11).
  • Technical Importance: This approach provides a non-invasive method to increase the concentration of an active pharmaceutical ingredient at the site of a nail bed infection, addressing the "unmet medical need for a safe treatment for onychomycosis" (’444 Patent, col. 3:14-16).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" of the ’444 Patent (Compl. ¶26). Independent claim 1 is a representative composition claim.
  • Independent Claim 1: A pharmaceutical formulation comprising:
    • ethanol, 50% to 70% (w/w)
    • cyclomethicone, 10% to 15% (w/w)
    • diisopropyl adipate, 8% to 15% (w/w)
    • C12-15 alkyl lactate, 8% to 15% (w/w)
    • 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 does not specify dependent claims but reserves the right to assert them.

III. The Accused Instrumentality

Product Identification

  • "Perrigo's generic efinaconazole topical solution, 10%," for which Perrigo has filed Abbreviated New Drug Application (ANDA) No. 211851 with the FDA (Compl. ¶7, ¶20).

Functionality and Market Context

  • The accused instrumentality is Perrigo's ANDA filing, which under 35 U.S.C. § 271(e)(2) is a technical act of infringement. The complaint alleges that Perrigo's product is "intended to be a generic version of Jublia®" and that the formulation described in the ANDA is "the same, or substantially the same, as Jublia®" (Compl. ¶21, ¶24). The lawsuit seeks to prevent the commercial manufacture and sale of this generic product upon potential FDA approval (Compl., Prayer for Relief ¶3). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement theory is based on the statutory framework for ANDA litigation: that in seeking approval for a generic version of Jublia®, Perrigo's product will necessarily practice the invention claimed in the ’444 Patent, which is listed in the FDA's Orange Book for Jublia®.

’444 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a. ethanol, 50% to 70% (w/w), The complaint alleges Perrigo's ANDA product is a generic version of Jublia® and will, if approved, contain the claimed components within the claimed ranges, either literally or under the doctrine of equivalents. ¶27 col. 17:5
b. cyclomethicone, 10% to 15% (w/w), The complaint alleges Perrigo's ANDA product is a generic version of Jublia® and will, if approved, contain the claimed components within the claimed ranges, either literally or under the doctrine of equivalents. ¶27 col. 17:6
c. diisopropyl adipate, 8% to 15% (w/w), The complaint alleges Perrigo's ANDA product is a generic version of Jublia® and will, if approved, contain the claimed components within the claimed ranges, either literally or under the doctrine of equivalents. ¶27 col. 17:7
d. C12-15 alkyl lactate, 8% to 15% (w/w), and The complaint alleges Perrigo's ANDA product is a generic version of Jublia® and will, if approved, contain the claimed components within the claimed ranges, either literally or under the doctrine of equivalents. ¶27 col. 17:8
e. antioxidant, 0.001% to 0.50% (w/w), The complaint alleges Perrigo's ANDA product is a generic version of Jublia® and will, if approved, contain the claimed components within the claimed ranges, either literally or under the doctrine of equivalents. ¶27 col. 17:9
wherein the surface tension of the composition is 40 dynes/cm or less; The complaint alleges the ANDA product is substantially the same as Jublia®, implying it will possess the claimed physical properties. ¶24, ¶27 col. 17:11-12
and wherein the formulation is free of polymeric film forming compounds. The complaint alleges the ANDA product is substantially the same as Jublia®, implying it will possess the claimed characteristics. ¶24, ¶27 col. 17:14-16
  • Identified Points of Contention:
    • Factual Questions: A central question will be whether Perrigo's ANDA formulation, once disclosed in discovery, in fact meets every quantitative and qualitative limitation of the asserted claims. This will involve analysis of the precise excipients used, their weight percentages, and the physical properties (e.g., surface tension) of the resulting mixture.
    • Scope Questions: The dispute may turn on whether any excipients in Perrigo's formulation, even if not explicitly listed as such in the patent, could be characterized as a "polymeric film forming compound," which would place the product outside the scope of the claims.

V. Key Claim Terms for Construction

  • The Term: "free of polymeric film forming compounds"

  • Context and Importance: This negative limitation is critical to defining the boundary of the invention. Whether Perrigo's formulation infringes will depend on whether any of its inactive ingredients fall within the definition of this term. Practitioners may focus on this term because its scope is not exhaustively defined, creating a potential avenue for a non-infringement defense.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party might argue that the term should be given its plain and ordinary meaning, covering any polymer that has the function of forming a film, regardless of whether it is explicitly listed in the patent.
    • Evidence for a Narrower Interpretation: The specification provides a list of examples of such compounds, including "polymers and copolymers of polyvinyl acetate, polyvinylpyrrolidone, methacrylic acid... and cellulose derivatives" (’444 Patent, col. 10:11-17). A party could argue this list implicitly limits the scope of the term to these specific classes of polymers or others with very similar chemical structures and properties.

  • The Term: "surface tension"

  • Context and Importance: This is a key functional property of the claimed invention. While the claim provides a quantitative upper limit ("40 dynes/cm or less"), disputes can arise over the methodology used to measure this property for the accused product.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of this element.
    • Evidence for a Narrower Interpretation: The patent specification provides a precise definition of how this property is to be measured: "by the Du Noüy ring method utilizing an EasyDyne tensiometer model K20" (’444 Patent, col. 6:24-27). This disclosure may significantly constrain the parties' arguments, focusing the dispute on the application of this specific test method to the accused product rather than on the meaning of the term itself.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement if their generic product is approved and marketed (Compl. ¶28, ¶34). The basis for this allegation is the future sale of the product, which would be accompanied by a label instructing its use for treating nail conditions, thereby allegedly inducing physicians and patients to perform infringing methods.
  • Willful Infringement: The complaint does not explicitly allege "willful infringement." However, it alleges that Defendants had knowledge of the ’444 Patent at least as of November 6, 2018, via a notice letter (Compl. ¶22). Furthermore, the prayer for relief requests the court to "declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4)," seeking an award of attorney's fees (Compl., Prayer for Relief ¶5).

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

As an ANDA case, the dispute will likely center on two primary axes: the interpretation of the patent's claims and the factual characteristics of the accused generic product.

  1. A core issue will be one of definitional scope: How broadly will the court construe the negative limitation "free of polymeric film forming compounds"? The resolution of this question could be dispositive if Perrigo’s formulation contains any excipients that are arguably, but not explicitly, film-forming polymers.

  2. A key evidentiary question will be one of factual compliance: Does Perrigo's specific formulation, as detailed in its confidential ANDA, meet every quantitative limitation of the asserted claims? This includes not only the specific weight-percent ranges for each ingredient but also the resulting physical property of having a surface tension of 40 dynes/cm or less, as measured by the method described in the patent.