DCT

1:18-cv-01699

Anacor Pharma Inc v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01699, D. Del., 10/29/2018
  • Venue Allegations: Plaintiff alleges jurisdiction is proper in Delaware because Defendants transact business in the state, have engaged in systematic and continuous business contacts, and should have anticipated being sued there as Plaintiff is a Delaware corporation that was the target of Defendants' Abbreviated New Drug Application (ANDA) filing.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an ANDA to market a generic version of Kerydin® (tavaborole) Topical Solution, 5% constitutes an act of infringement of four patents related to the drug's formulation and methods of use for treating toenail fungus.
  • Technical Context: The technology concerns a topical antifungal pharmaceutical composition containing the active ingredient tavaborole, formulated for effective penetration of the human nail to treat onychomycosis.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiff on September 17, 2018, that it had filed an ANDA with the U.S. Food and Drug Administration (FDA), including a "Paragraph IV certification" asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed.

Case Timeline

Date Event
2005-02-16 Earliest Priority Date for ’289, ’290, and ’823 Patents
2010-12-09 Priority Date for ’938 Patent
2016-10-04 ’938 Patent Issued
2017-02-14 ’289 Patent Issued
2017-02-14 ’290 Patent Issued
2017-02-21 ’823 Patent Issued
2018-09-17 Mylan sends Notice Letter to Anacor regarding ANDA filing
2018-10-29 Complaint Filed

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

U.S. Patent No. 9,459,938 - "Personal Trend Management"

The Invention Explained

  • Problem Addressed: The patent's background section describes the problem that consumers using various data collection devices (e.g., fitness trackers, mobile phones) are limited by the manufacturer's proprietary software for data analysis, which often lacks customization and cannot integrate data from different devices (’938 Patent, col. 2:4-19).
  • The Patented Solution: The invention proposes a centralized trend management system that receives data from multiple, distinct user devices. The system applies user-selected "templates," which contain predefined data analysis strategies, to process the collected data and generate reports on personal trends (’938 Patent, Abstract). The system architecture, illustrated in Figure 2, comprises logic modules for data collection, template application programming interface (API), analysis, and presentation (’938 Patent, Fig. 2; col. 6:3-12).
  • Technical Importance: The described technology aims to decouple data collection hardware from analysis software, creating a platform where third parties can develop analysis strategies and users can gain insights from combined data streams that would otherwise be siloed (’938 Patent, col. 3:5-18).

Key Claims at a Glance

  • The complaint asserts infringement of claims 3, 5, and 6 (Compl. ¶44). However, the issued ’938 Patent contains only four claims, with claim 1 as the sole independent claim.
  • Independent Claim 1 requires, in part:
    • Receiving a request to associate a "template" with a user, where the template defines a "data analysis strategy."
    • Receiving "first data" from a "first data collection device," including "events" and "time stamps."
    • Generating a result based on the template's strategy and the first data.
    • Receiving "second data" of a "different type of event."
    • Receiving user input defining a "composite reporting strategy."
    • Generating a "composite report" with a "trend category metric."

U.S. Patent No. 9,566,289 - "Boron-Containing Small Molecules"

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of treating onychomycosis (fungal infections of the nail), as the dense keratin structure of the nail plate is a significant barrier to the penetration of topical antifungal agents, while systemic oral drugs can have adverse side effects (’289 Patent, col. 2:39-43; col. 1:63-col. 2:1).
  • The Patented Solution: The invention is a specific pharmaceutical formulation that enables the boron-containing compound tavaborole (1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole) to effectively penetrate the nail and treat the infection. The formulation includes the active ingredient at a specific concentration along with a solvent system and other excipients, such as a chelating agent, to achieve the desired therapeutic effect (’289 Patent, Abstract; col. 133:14-30).
  • Technical Importance: The formulation provides a topical treatment for onychomycosis that is capable of delivering a therapeutically effective amount of an active agent through the nail, offering an alternative to less effective topical treatments or systemic treatments with greater potential for side effects (’289 Patent, col. 2:1-12).

Key Claims at a Glance

  • The complaint asserts claims 10 and 12-15 (Compl. ¶44). These include independent claim 12 and claims dependent from independent claim 4.
  • Independent Claim 4 includes the following essential elements:
    • A pharmaceutical formulation, comprising: about 5% w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof;
    • a solvent system;
    • and a chelating agent.
  • Independent Claim 12 includes the following essential elements:
    • A pharmaceutical formulation, comprising: about 5% w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof;
    • propylene glycol;
    • ethanol;
    • and ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof.

U.S. Patent No. 9,566,290 - "Boron-Containing Small Molecules"

  • Patent Identification: U.S. Patent No. 9,566,290, "Boron-Containing Small Molecules," issued February 14, 2017 (Compl. ¶29).
  • Technology Synopsis: This patent claims a method of treating onychomycosis in a human caused by specific fungi (Trichophyton rubrum or Trichophyton mentagrophytes). The method comprises the topical administration of a tavaborole solution that is effective to inhibit a specific fungal enzyme, aminoacyl tRNA synthetase (specifically, leucyl tRNA synthetase), thereby treating the infection (’290 Patent, Abstract).
  • Asserted Claims: Claims 2, 5-6, 8, and 11-12 are asserted (Compl. ¶44). Independent claims are 1 and 6.
  • Accused Features: The use of Mylan's generic tavaborole product as directed by its proposed labeling is alleged to constitute performance of the claimed treatment method (Compl. ¶¶30-35, 50).

U.S. Patent No. 9,572,823 - "Boron-Containing Small Molecules"

  • Patent Identification: U.S. Patent No. 9,572,823, "Boron-Containing Small Molecules," issued February 21, 2017 (Compl. ¶36, ’823 Patent, front page).
  • Technology Synopsis: This patent claims a method for delivering a compound to the nail bed to treat onychomycosis. The method requires contacting the dorsal (top) layer of the nail plate with a pharmaceutical composition containing tavaborole, where the compound penetrates the nail plate to treat the infection below (’823 Patent, Abstract).
  • Asserted Claims: Claim 2 is asserted (Compl. ¶44). The independent claim is 1.
  • Accused Features: The use of Mylan's generic tavaborole product is alleged to practice this method of delivering the active compound through the nail (Compl. ¶¶37, 50).

III. The Accused Instrumentality

Product Identification

  • "Mylan's ANDA Product," identified as a generic version of Kerydin® (Tavaborole) Topical Solution, 5%, for which Mylan seeks FDA approval under ANDA No. 212065 (Compl. ¶¶1-2).

Functionality and Market Context

  • The accused instrumentality is a proposed generic drug product, with the act of infringement being the submission of the ANDA to the FDA for approval to market the product before the expiration of the patents-in-suit (Compl. ¶¶1, 47).
  • The product is alleged to be a generic version of Kerydin®, containing the same active pharmaceutical ingredient (tavaborole) in the same concentration (5%) (Compl. ¶¶1, 3).
  • Upon approval, the product would be manufactured and sold in the United States for the topical treatment of onychomycosis, directly competing with Plaintiff's branded product (Compl. ¶15).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Mylan’s ANDA Product, and its use, are covered by claims of the patents-in-suit (Compl. ¶44). The complaint does not provide a claim chart or detailed element-by-element infringement analysis.

’938 Patent Infringement Allegations

The complaint alleges infringement of claims 3, 5, and 6 of the ’938 Patent (Compl. ¶44). The provided ’938 Patent, however, is directed to "Personal Trend Management" and contains only four claims. The patent's subject matter concerns a system for analyzing data from electronic devices, not pharmaceutical compositions. The complaint provides no factual allegations that map any feature of Mylan’s topical antifungal solution to the claim elements of the ’938 Patent, which relate to data, templates, and reporting strategies.

  • Identified Points of Contention:
    • Scope Questions: A foundational question is whether the ’938 Patent, as identified by its number in the complaint, has any relevance to the accused product. The patent's subject matter (personal data trend management) and the accused product (a topical antifungal solution) appear entirely unrelated.
    • Technical Questions: The complaint does not present a technical basis for its infringement allegation against the ’938 Patent. It also asserts claims (5 and 6) that do not exist in the issued patent.

’289 Patent Infringement Allegations

The infringement theory for the ’289 Patent is based on the allegation that Mylan's ANDA Product is a generic equivalent of Kerydin® and therefore contains the same composition claimed in the patent (Compl. ¶¶3, 24-28, 39).

Claim Element (from Independent Claim 12) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical formulation, comprising: about 5% w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof... Mylan's ANDA product is a topical solution containing 5% tavaborole. ¶1, ¶3 col. 323:3-6, 12-15
...propylene glycol... The complaint alleges Mylan's product contains the same or equivalent ingredients as Kerydin®, which is covered by the claims. ¶3, ¶39 col. 323:16
...ethanol... The complaint alleges Mylan's product contains the same or equivalent ingredients as Kerydin®, which is covered by the claims. ¶3, ¶39 col. 323:17
...and ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof. The complaint alleges Mylan's product contains the same or equivalent ingredients as Kerydin®, which is covered by the claims. ¶3, ¶39 col. 323:18-19
  • Identified Points of Contention:
    • Technical Questions: While the complaint alleges the generic product contains the "same or equivalent ingredients," a potential question is whether Mylan's ANDA specification discloses a formulation that meets every recited compositional element and concentration, particularly the non-active excipients such as propylene glycol, ethanol, and EDTA.

V. Key Claim Terms for Construction

  • The Term: "about 5% w/w" (from ’289 Patent, Claim 12)

    • Context and Importance: This term defines the concentration of the active ingredient, tavaborole. The scope of "about" will be critical if Mylan's ANDA specifies a formulation with a concentration that deviates, even slightly, from exactly 5.0% by weight. Practitioners may focus on this term to determine if any such deviation falls within the claim's scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification uses "about" consistently when referring to concentrations, including for other ingredients, suggesting the patentee intended the term to connote a degree of numerical approximation rather than a precise value (’289 Patent, col. 170:5-6).
      • Evidence for a Narrower Interpretation: The patent repeatedly highlights "about 5%" as the concentration in exemplary embodiments, and this is the concentration of the commercial product. A party could argue that in this context, "about" should be construed narrowly to encompass only minor variations consistent with standard pharmaceutical manufacturing tolerances.

  • The Term: "chelating agent" (from ’289 Patent, Claim 4)

    • Context and Importance: Claim 4 recites the general category "chelating agent," while dependent claims and claim 12 specify EDTA. The construction of this general term is important for the scope of claim 4 and could capture formulations that use chelators other than EDTA.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of suitable chelating agents, stating they "include, but are not limited to," EDTA and several others, which supports a broad interpretation consistent with the term's ordinary meaning in chemistry (’289 Patent, col. 170:9-15).
      • Evidence for a Narrower Interpretation: A party might argue that the function of the chelating agent is specific to stabilizing tavaborole in this particular solvent system, potentially limiting the scope of the term to agents demonstrated to be effective in the patent, such as EDTA.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both active inducement and contributory infringement. The inducement allegation is based on the assertion that Mylan's proposed product labeling will instruct physicians and patients to use the generic product in a manner that directly infringes the asserted method claims (Compl. ¶¶50-51). The contributory infringement allegation is based on the assertion that Mylan's product is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶52).
  • Willful Infringement: The complaint alleges Mylan acted with full knowledge of the patents-in-suit, pointing to the September 17, 2018 notice letter as evidence of pre-suit knowledge (Compl. ¶¶2, 55). It is alleged that Mylan's continued intent to manufacture and sell its product despite this knowledge constitutes willful infringement (Compl. ¶53).

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

  • A threshold issue appears to be one of patent identification and relevance: What is the basis for the allegation that a topical antifungal solution infringes U.S. Patent No. 9,459,938, which is directed to a system for managing personal data trends, and for asserting claims that do not exist in the issued patent? This discrepancy on the face of the complaint raises a fundamental question about the scope and basis of the lawsuit as pleaded.
  • A central question in this Hatch-Waxman litigation will likely be one of patent validity. As the complaint alleges that Mylan’s proposed product is a generic equivalent, the dispute may focus less on infringement and more on Defendants' defenses, referenced in their Paragraph IV certification, that the asserted claims of the ’289, ’290, and ’823 patents are invalid as obvious or anticipated by the prior art (Compl. ¶43).
  • For the formulation claims, a key evidentiary question will be one of compositional identity. Does the chemical specification detailed in Mylan’s confidential ANDA filing meet every limitation of the asserted composition claims of the ’289 Patent, including the concentration of tavaborole and the presence and concentration of all specified excipients?