DCT

1:19-cv-00053

Arbor Pharma LLC v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00053, D. Del., 01/09/2019
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Teva USA is a Delaware corporation and has committed the alleged acts of infringement in the district, has systematic and continuous contacts with the state, and has previously submitted to the court's jurisdiction in other matters.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic ivermectin lotion infringes patents covering Plaintiff's branded product, SKLICE®.
  • Technical Context: The technology relates to topical pharmaceutical formulations for the treatment of head lice, a common parasitic infestation affecting millions annually.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a Paragraph IV Notification letter from Defendants, dated November 28, 2018. The letter stated Defendants' intent to market a generic version of Plaintiff's drug SKLICE® prior to the expiration of the patents-in-suit, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). The complaint was filed within the 45-day statutory window, triggering a potential 30-month stay on the FDA’s approval of the generic product.

Case Timeline

Date Event
2006-10-12 '153 and '595 Patents Priority Date
2014-07-29 U.S. Patent No. 8,791,153 Issues
2015-01-06 U.S. Patent No. 8,927,595 Issues
2018-11-28 Date of Teva's Paragraph IV Notification Letter
2019-01-09 Complaint Filing Date

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

U.S. Patent No. 8,791,153

  • Patent Identification: U.S. Patent No. 8791153, "Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment-resistant strains of head lice," issued July 29, 2014.
  • The Invention Explained:
    • Problem Addressed: The patent's background describes an increase in strains of head lice that are resistant to common over-the-counter and prescription insecticides like pyrethrins and permethrin, rendering existing treatments less effective. Furthermore, some older treatments like lindane pose toxicity risks to the human host (’153 Patent, col. 2:20-44).
    • The Patented Solution: The invention is a topical formulation, such as a shampoo-conditioner, that uses ivermectin, a compound that kills lice via a different biological mechanism than older insecticides. Ivermectin blocks glutamate-gated chloride channels in the parasite's nerve cells, leading to paralysis and death (’153 Patent, col. 3:13-25). Because ivermectin is hydrophobic, the invention discloses a specific emulsion-based carrier system—comprising particular solubilizers, suspending agents, surfactants, and other excipients—to effectively deliver the active ingredient to the scalp and hair (’153 Patent, Abstract; col. 9:1-12).
    • Technical Importance: This approach provided a new therapeutic option with a different mechanism of action designed to be effective against lice strains that had developed resistance to traditional pediculicides (’153 Patent, col. 2:65 - col. 3:4).
  • Key Claims at a Glance:
    • The complaint does not identify specific asserted claims, but independent claim 1 is a representative composition claim.
    • Independent Claim 1 recites a topical formulation comprising:
      • an effective amount of dissolved ivermectin;
      • about 20% to about 35% by weight olive oil;
      • about 1% to about 5% by weight shea butter;
      • nonionic surfactants comprising oleyl alcohol, sorbitan tristearate, and lanolin alcohol;
      • a solubilizing agent comprising cetyl acetate, polysorbate 80, and acetylated lanolin alcohol;
      • about 0.01% to about 2% by weight methylparaben and about 0.01% to about 0.5% by weight propylparaben;
      • about 1% to about 5% by weight of a conditioner comprising cyclomethicone; and
      • about 30% to about 40% by weight water.
    • The complaint reserves the right to assert additional claims (Compl. ¶33).

U.S. Patent No. 8,927,595

  • Patent Identification: U.S. Patent No. 8927595, "Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment-resistant strains of head lice," issued January 6, 2015.
  • The Invention Explained:
    • Problem Addressed: As a divisional of the '153 Patent, the '595 Patent addresses the same problem of emerging lice resistance to conventional treatments and the need for a safe and effective alternative (’595 Patent, col. 2:36-58).
    • The Patented Solution: The patent claims a method of treating or preventing a lice infestation by applying the specific topical ivermectin formulation described in the '153 Patent. The claimed method requires maintaining the formulation in contact with the affected area for a specified duration, from about one minute to sixty minutes, to ensure sufficient exposure to kill the lice (’595 Patent, col. 7:5-18).
    • Technical Importance: The patent defines a specific treatment protocol for using the novel formulation, providing a complete therapeutic regimen intended to be effective against both susceptible and resistant lice strains (’595 Patent, col. 1:21-29).
  • Key Claims at a Glance:
    • The complaint does not identify specific asserted claims, but independent claim 1 is a representative method claim.
    • Independent Claim 1 recites a method for treating or preventing lice infestation, comprising the steps of:
      • Applying topically to a host a formulation comprising the same list of ingredients and weight percentages as in claim 1 of the '153 Patent.
      • Maintaining the composition in contact with the surface area for a period of time from about 1 to about 60 minutes in length.
    • The complaint reserves the right to assert additional claims (Compl. ¶33).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendants' "Ivermectin Lotion, 0.5%," which is the subject of Abbreviated New Drug Application (ANDA) No. 212485 submitted to the FDA (Compl. ¶7).
  • Functionality and Market Context: The complaint alleges that the ANDA Product is a generic version of Plaintiff's SKLICE® (ivermectin lotion) and is intended for the commercial manufacture, use, and sale in the United States for the treatment of head lice (Compl. ¶¶7, 17, 23). The complaint states that, at the time of filing, Defendants had not provided Plaintiff with a copy of the ANDA or detailed information about the product's formulation beyond what was in the Paragraph IV Notification (Compl. ¶27).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed, element-by-element analysis of infringement. The core allegation is that the submission of the '485 ANDA for a product that, if approved, would be sold for the treatment of head lice constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶30). The implicit theory is that the product described in the ANDA will meet all the limitations of the asserted claims of the patents-in-suit, and that the product's proposed label will instruct for an infringing use.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Technical Questions: A central factual dispute will likely be whether Defendants' ANDA Product, as described in the confidential ANDA filing, contains every ingredient recited in claim 1 of the '153 Patent within the specified percentage ranges. Given the specificity of the claimed formulation, any deviation in composition could support a non-infringement argument.
    • Scope Questions: For the '595 Patent, a key question will be whether the proposed label for the ANDA product instructs users to apply the lotion for a duration that falls within the claimed range of "about 1 to about 60 minutes." The interpretation of "about" may be a point of contention affecting both patents.

V. Key Claim Terms for Construction

  • The Term: "about"

  • Context and Importance: This term modifies every numerical percentage range in the asserted independent claims of both the '153 and '595 patents. The scope of "about" will be critical to determining infringement, as it controls how much deviation from the recited percentages is permissible. Practitioners may focus on this term because the infringement analysis will likely involve a direct comparison of the accused product's quantitative formula with the claim limitations.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent uses the term generally throughout the specification, which may suggest that the inventors did not intend for the numerical ranges to be strict and exact, but rather to allow for normal manufacturing and measurement tolerances (’153 Patent, col. 10:39-54).
    • Evidence for a Narrower Interpretation: The patent provides a detailed example formulation in Table 1 with highly precise weight percentages (e.g., "27.75" for Olive Oil, "0.25" for Acetylated Lanolin Alcohol). A party could argue this specific embodiment informs the meaning of "about," suggesting it does not grant a wide degree of variance from the recited figures (’153 Patent, col. 12, Table 1).

  • The Term: "an effective amount" (of dissolved ivermectin)

  • Context and Importance: This term appears in the preamble of the composition claim and as part of the formulation in the method claim. The parties may dispute what concentration of ivermectin is "effective" in the context of the patented formulation, especially in relation to the 0.5% concentration of the accused product.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discloses that an effective concentration of ivermectin could be in a broad range "from about 0.005% to 5.0% (w/v)," which could support an argument that the term is not limited to a single value (’153 Patent, col. 8:30-34).
    • Evidence for a Narrower Interpretation: The patent's examples focus on testing 1%, 0.5%, and 0.25% formulations, with the primary exemplified formulation being 0.5% ivermectin. A party could argue that "effective amount" should be construed in light of these examples, which demonstrate efficacy against resistant lice at these specific concentrations (’153 Patent, col. 12:21-24, Table 1).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Defendants' ANDA Product is marketed, they will induce infringement under 35 U.S.C. § 271(b) (Compl. ¶33). The factual basis for this allegation is the presumed instructions on the product's label, which would direct end-users to apply the lotion in a manner that infringes the method claims of the '595 Patent.
  • Willful Infringement: The complaint does not use the term "willful" but does request that the case be declared "exceptional" and seeks an award of attorneys' fees (Compl. p. 8, Prayer for Relief E). The basis for alleging knowledge of the patents is Defendants' Paragraph IV certification, in which they necessarily had to address the patents-in-suit, demonstrating pre-suit knowledge (Compl. ¶31).

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

The resolution of this case will likely depend on the answers to two central questions that require access to Defendants' confidential ANDA:

  • A core issue will be one of compositional identity: Does the formulation detailed in Teva's ANDA contain every excipient within the precise numerical ranges specified in the asserted composition claims? The case may turn on a fact-intensive comparison of the two formulations and the legal construction of the term "about."
  • A key evidentiary question will be one of induced infringement: Will the "Instructions for Use" section of Teva's proposed product label direct medical professionals and patients to apply the lotion for a duration that falls within the "about 1 to about 60 minutes" required by the asserted method claims?