DCT

1:18-cv-01606

Anacor Pharma Inc v. Lupin Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01606, D. Del., 10/17/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because each defendant is subject to personal jurisdiction in the district, either by being incorporated in Delaware or through purposeful availment and systematic business contacts.
  • Core Dispute: Plaintiff alleges that Defendants' filing of Abbreviated New Drug Applications (ANDAs) to market a generic version of Kerydin® (tavaborole) topical solution constitutes an act of infringement of four patents related to the drug's formulation and methods of use for treating onychomycosis (toenail fungus).
  • Technical Context: The technology relates to pharmaceutical compositions and methods for the topical treatment of onychomycosis, a common fungal infection of the nail that is notoriously difficult to treat due to the challenge of delivering an active agent through the dense nail plate.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following receipt by Plaintiff of notice letters from each Defendant, informing Plaintiff of their respective ANDA filings with the FDA. The patents-in-suit are listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) in connection with Kerydin.

Case Timeline

Date Event
2005-02-16 Earliest Priority Date for ’289, ’290, and ’823 Patents
2010-12-09 Priority Date for ’938 Patent
2017-01-24 U.S. Patent No. 9,459,938 Issued
2017-02-14 U.S. Patent No. 9,566,289 Issued
2017-02-14 U.S. Patent No. 9,566,290 Issued
2017-02-14 U.S. Patent No. 9,572,823 Issued
2018-09-04 Lupin and Encube send notice letters to Anacor
2018-09-06 Glasshouse sends notice letter to Anacor
2018-09-07 FlatWing sends notice letter to Anacor
2018-09-11 Encube sends second notice letter to Anacor
2018-10-17 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 describes the problem of users being limited in their ability to analyze personal data collected by various devices (e.g., fitness trackers, mobile phones). The software provided by device manufacturers often lacks customization and cannot combine data from different devices for a more holistic analysis ('938 Patent, col. 1:50-2:19).
  • The Patented Solution: The invention is a computer-implemented system for personal trend management. The system receives data from a user's collection devices and applies "templates" selected by the user. These templates contain instructions that define specific data analysis strategies, allowing the system to generate customized reports and identify trends based on the user's data and analytical preferences ('938 Patent, Abstract; Fig. 2).
  • Technical Importance: This system architecture decouples the hardware for data collection from the software for data analysis, which could reduce costs for device manufacturers and empower third parties to develop novel analysis strategies for existing devices ('938 Patent, col. 3:5-18).

Key Claims at a Glance

  • The complaint asserts dependent claims 3, 5, and 6 against all defendants (Compl. ¶¶ 81, 100, 119, 138). These depend from independent claim 1.
  • Independent Claim 1: A method comprising the essential elements of:
    • Receiving a request to associate a first "template" with a user, where the template includes instructions defining a data analysis strategy.
    • Receiving "first data" associated with a "first data collection device," the data including events and time stamps.
    • Generating a "first result" by applying the template's strategy to the first data to convey information about trends.
    • Receiving a request for a second template and "second data" of a different event type.
    • Generating a "second result."
    • Receiving user input defining a "composite reporting strategy," including relationships between templates and weight metrics.
    • Generating a "composite report" that includes a "trend category metric" based on the strategy.

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

The Invention Explained

  • Problem Addressed: The patent addresses the clinical challenge of treating onychomycosis (fungal infections of the nail, particularly the toenail). It notes that topical therapies often fail because they cannot effectively penetrate the dense keratin of the nail plate to reach the underlying infection, while systemic oral therapies can cause undesirable side effects (’289 Patent, col. 1:45-2:15).
  • The Patented Solution: The invention provides specific pharmaceutical formulations containing the boron-based antifungal compound 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole (tavaborole). The formulations are designed with particular physicochemical properties, such as low molecular weight and a specific solubility profile, to enhance the compound's ability to penetrate the nail plate and treat the infection topically (’289 Patent, Abstract; col. 133:55-134:21).
  • Technical Importance: The invention provides a topical antifungal composition with properties selected to overcome the nail barrier, potentially offering a safer and more effective treatment for onychomycosis compared to previous options.

Key Claims at a Glance

  • The complaint asserts claims 10 and 12-15 (Compl. ¶¶ 81, 100, 119, 138). Independent claims in this set include claims 1, 4, and 12. Claim 12 is representative of the asserted composition claims.
  • Independent Claim 12: 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.
  • The complaint reserves the right to assert additional claims (Compl. ¶81).

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.
  • Technology Synopsis: This patent claims methods of using the tavaborole compositions to treat onychomycosis. The claims specify the act of topically administering a composition containing tavaborole to a human toenail to treat an infection caused by specific fungal species (Trichophyton rubrum or Trichophyton mentagrophytes) by inhibiting a specific fungal enzyme (aminoacyl tRNA synthetase) (’290 Patent, Abstract; col. 321:24-41).
  • Asserted Claims: Independent claim 1 is asserted via asserted dependent claims 2, 5-6, 8, and 11-12 (Compl. ¶¶ 81, 100, 119, 138).
  • Accused Features: The use of the Defendants' ANDA products as will be directed by their proposed product labeling, which will allegedly instruct physicians and patients to perform the patented method of treatment (Compl. ¶¶ 67, 87).

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 14, 2017.
  • Technology Synopsis: This patent claims a specific method of drug delivery. It covers a method for delivering the tavaborole compound from the outer (dorsal) layer of the nail plate to the nail bed by contacting the nail with a pharmaceutical composition that penetrates the nail plate, thereby treating the onychomycosis (’823 Patent, Abstract; col. 317:51-318:68).
  • Asserted Claims: Independent claim 1 is asserted via asserted dependent claim 2 (Compl. ¶¶ 81, 100, 119, 138).
  • Accused Features: The use of the Defendants' ANDA products, which are topical solutions that are applied to the nail plate and allegedly penetrate it to deliver the active ingredient to the site of infection (Compl. ¶¶ 74, 87).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the generic tavaborole topical solutions for which each Defendant has filed an ANDA with the FDA, referred to as "Defendants' ANDA Products" (Compl. ¶¶ 2-6).

Functionality and Market Context

  • The complaint alleges that the Defendants' ANDA Products are generic versions of Plaintiff's commercial product, Kerydin® Topical Solution, 5% (Compl. ¶1).
  • The products are alleged to contain "the same or equivalent ingredients in the same or equivalent amounts" as Kerydin® (Compl. ¶7).
  • The intended function of these products is the topical treatment of onychomycosis, a fungal infection of the toenail (Compl. ¶1, ¶57). The filing of the ANDAs indicates an intent by the Defendants to market these generic products in the United States upon receiving FDA approval (Compl. ¶¶ 79, 98, 117, 136).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Infringement Allegations: U.S. Patent No. 9,459,938

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method, comprising: receiving a request to associate a first template with a first user, wherein templates include instructions that define one or more data analysis strategies The method of treating a Tinea unguium infection of a toenail of a human. ¶57 col. 14:21-26
receiving first data associated with a first data collection device, wherein the first data includes: a) one or more first events associated with the first user; and b) one or more first time stamps... The method comprising topically administering to the toenail of the human a pharmaceutical composition comprising 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole. ¶57 col. 14:27-33
based on a first data analysis strategy defined by instructions stored in the first template and the first data, generating a first result that conveys information relating to one or more trends... In an amount sufficient to treat the infection, wherein the pharmaceutical composition is in the form of a solution comprising 5% w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole. ¶57 col. 14:34-41

Identified Points of Contention

  • Scope Questions: A threshold issue for the court may be whether the '938 Patent, titled "Personal Trend Management" and claiming a computer-implemented method for analyzing data using templates, can be construed to read on a method of medically treating a toenail infection with a pharmaceutical solution. The complaint's infringement allegations for this patent (Compl. ¶¶ 57-59) describe a medical treatment method, which does not correspond to the technical subject matter described and claimed in the provided '938 patent document.
  • Technical Questions: What evidence does the complaint provide that the accused method of treatment involves "templates," "data collection devices," or "composite reporting strategies" as those terms are defined and used in the '938 Patent?

Infringement Allegations: U.S. Patent No. 9,566,289

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 Defendants' ANDA Products are generic versions of Kerydin® (Tavaborole) Topical Solution, 5%, and contain the same or equivalent active ingredient. ¶¶ 1, 7, 62 col. 323:1-4
propylene glycol Defendants' ANDA Products are alleged to contain the same or equivalent ingredients as the branded product, which includes propylene glycol. ¶¶ 7, 62 col. 324:14-16
ethanol Defendants' ANDA Products are alleged to contain the same or equivalent ingredients as the branded product, which includes ethanol. ¶¶ 7, 62 col. 324:14-16
and ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof. Defendants' ANDA Products are alleged to contain the same or equivalent ingredients as the branded product, which includes EDTA. ¶¶ 7, 62 col. 324:17-20

Identified Points of Contention

  • Scope Questions: A central question will be whether the formulation defined in the Defendants' confidential ANDA submissions literally meets every limitation of the asserted claims. The complaint relies on the allegation that the generic products contain the "same or equivalent ingredients," which raises the question of whether "equivalent" for FDA purposes is identical to what is required for literal patent infringement.
  • Technical Questions: Does the term "about 5% w/w" encompass the precise concentration of tavaborole in the Defendants' ANDA Products, considering potential manufacturing tolerances? What evidence will be presented to demonstrate that the excipients used in the generic formulations are identical to those claimed, and not merely functional equivalents?

V. Key Claim Terms for Construction

Claim Term: "template" (’938 Patent, Claim 1)

  • Context and Importance: This term is the central component of the invention claimed in the '938 patent. Its definition is critical to determining the scope of the claims. Given the apparent subject matter mismatch between this patent and the accused instrumentality, the construction of "template" will be dispositive for the infringement analysis of this patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not provide a basis for interpretation.
    • Evidence for a Narrower Interpretation: The specification defines templates as storing "instructions that define one or more data analysis strategies" and are based on an application programming interface (API) for a "trend management engine" ('938 Patent, col. 4:4-6; col. 8:43-51). The examples provided are computer-readable instructions, such as in XML format, for performing regression analysis on data like heart rate ('938 Patent, col. 11:20-44). This evidence may support a narrow construction limited to software or computer-implemented instructions for data analysis.

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

  • Context and Importance: This term defines the concentration of the active pharmaceutical ingredient. Its construction is crucial because even minor deviations in the accused product's formulation could potentially avoid literal infringement. Practitioners may focus on this term to determine if it allows for any range around the 5% value.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the word "about" itself suggests the patentee did not intend to be limited to exactly 5.00%. The specification describes formulations with concentrations in ranges, such as "from 1%, 2.5%, 5%, 7.5%, 10% and 15% w/v," which may suggest that precision was not the sole focus (’289 Patent, col. 166:10-14).
    • Evidence for a Narrower Interpretation: The specification repeatedly refers to a "5% tavaborole" formulation in its examples and descriptions of preferred embodiments, which could suggest that 5% is an optimal and specific concentration (’289 Patent, col. 137:44-53). The defendants may argue that "about" should be limited to the standard range of manufacturing tolerances accepted in the pharmaceutical industry.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, stating that the Defendants' proposed product labeling will direct and instruct healthcare providers and patients to administer the ANDA Products in a manner that infringes the asserted method claims (e.g., ’290 and ’823 patents) (Compl. ¶¶ 87-88). The complaint also alleges contributory infringement on the basis that the ANDA products are not staple articles of commerce and are especially made or adapted for an infringing use (Compl. ¶89).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the patents-in-suit prior to the litigation, evidenced by their certifications in the ANDA filings and the sending of Notice Letters to Anacor. The complaint alleges Defendants acted "without a reasonable basis for believing" they would not be liable for infringement (Compl. ¶92).

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

  • A threshold question for the court will be one of subject matter applicability: can the claims of the asserted U.S. Patent No. 9,459,938, which are directed to a computer-implemented method of personal data analysis, be construed to cover the accused instrumentality, which is a topical antifungal drug and its method of use, or was this patent number identified in error in the complaint?
  • A central evidentiary question will be one of compositional identity: will the confidential specifications in the Defendants' ANDA filings reveal a formulation that literally meets every concentration and excipient limitation of the asserted composition claims in the '289 patent, particularly regarding the scope of the term "about 5% w/w"?
  • For the method of use patents, a key issue will be inducement via labeling: will the instructions for use in the Defendants' proposed product labels be found to actively encourage the specific steps of treating onychomycosis caused by the claimed fungal species and achieving delivery through the nail plate, thereby establishing the requisite intent for induced infringement?