DCT

1:19-cv-00632

Anacor Pharma Inc v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00632, N.D.W. Va., 10/30/2018
  • Venue Allegations: Venue is based on Defendant Mylan Pharmaceuticals Inc. being a West Virginia corporation with its principal place of business in the district, and Defendant Mylan Inc. conducting business in the district through its subsidiary.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Kerydin® (tavaborole) constitutes an act of infringement of four patents related to antifungal chemical compounds and methods of their use.
  • Technical Context: The technology concerns boron-containing small molecules, specifically tavaborole, formulated into a topical solution for treating onychomycosis, a common fungal infection of the toenails and fingernails.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to a Paragraph IV notice letter from Mylan indicating its intent to market a generic drug prior to patent expiration. Plaintiff asserts the patents-in-suit are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for Kerydin®. The complaint notes that Mylan’s notice letter did not contest infringement. Subsequent to the filing of the complaint, Inter Partes Review (IPR) proceedings at the Patent Trial and Appeal Board resulted in the cancellation of all claims of U.S. Patent Nos. 9,566,289, 9,566,290, and 9,572,823, which may render the infringement allegations for those patents moot.

Case Timeline

Date Event
2005-02-16 Earliest Priority Date ('289', '290', '823' Patents)
2010-12-09 Priority Date ('938' Patent)
2016-10-04 U.S. Patent No. 9,459,938 Issues
2017-01-24 U.S. Patent No. 9,459,938 Issues (per Complaint ¶16)*
2017-02-14 U.S. Patent Nos. 9,566,289 and 9,566,290 Issue
2017-02-21 U.S. Patent No. 9,572,823 Issues
2018-09-17 Mylan sends Notice Letter to Anacor
2018-10-30 Complaint Filed

*Note: A discrepancy exists between the issue date stated in the complaint for the '938' patent (January 24, 2017) and the issue date on the provided patent document (October 4, 2016).

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 a market where consumers use various data collection devices (e.g., fitness trackers, mobile phones) but are limited to the data analysis tools provided by each device's manufacturer. This prevents users from performing customized analysis or combining data from different devices to identify broader personal trends ('938' Patent, col. 1:50-2:19).
  • The Patented Solution: The invention is a "trend management system" that can receive data from numerous, disparate data collection devices. It uses third-party-developed "templates" that define specific data analysis strategies. By applying a selected template to a user's collected data, the system can generate customized reports and visualizations of personal trends, such as correlating heart-rate data from one device with location data from another ('938' Patent, Abstract; col. 4:1-19).
  • Technical Importance: The described solution aimed to create a centralized, customizable platform for the growing "quantified self" movement, decoupling data analysis from the specific hardware that collects the data. ('938' Patent, col. 3:1-18).

Key Claims at a Glance

The complaint asserts claims 3 and 5-6 of the '938' patent (Compl. ¶41). However, the provided '938' patent document contains only four claims in total. This analysis is based on the provided document.

  • Independent Claim 1:
    • Receiving a request to associate a first "template" with a user, where templates define data analysis strategies.
    • Receiving first data (events and timestamps) from a first data collection device.
    • Generating a first result based on the first template and first data.
    • Receiving a request to associate a second template and receiving second data of a different type from the first data.
    • Generating a second result based on the second template and second data.
    • Receiving user input defining a "composite reporting strategy," including relationships between templates in a "trend hierarchy" and associated "weight metrics."
    • Generating a composite report with a "trend category metric" based on the user-defined strategy.

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

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of treating onychomycosis (fungal nail infection). It notes that systemic oral antifungal drugs can have significant side effects, while topical treatments often fail because they cannot effectively penetrate the dense keratin of the nail plate to reach the site of infection in the nail bed ('289' Patent, col. 2:1-18).
  • The Patented Solution: The invention claims specific pharmaceutical formulations containing a boron-based compound, 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole (tavaborole). This compound is described as having antifungal properties and physicochemical characteristics that facilitate penetration through the nail plate to treat the underlying infection ('289' Patent, Abstract; col. 135:20-40).
  • Technical Importance: The invention provided a novel topical antifungal agent and formulation designed specifically to overcome the nail penetration barrier, offering a potential alternative to oral therapies. ('289' Patent, col. 2:55-67).

Key Claims at a Glance

  • The complaint asserts claims 10 and 12-15 (Compl. ¶41). Claim 12 is independent.
  • 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.

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

  • Technology Synopsis: This patent claims methods of treating onychomycosis in a human. The claimed method involves topically administering a pharmaceutical composition containing tavaborole, which is alleged to be effective by inhibiting an essential fungal enzyme, aminoacyl tRNA synthetase. (Compl. ¶¶27-28).
  • Asserted Claims: Independent claims 6, 11, and 12 are asserted, along with several dependent claims. (Compl. ¶41).
  • Accused Features: The future use of Mylan's generic product by patients and doctors as directed by its labeling is alleged to infringe these method claims. (Compl. ¶47).

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

  • Technology Synopsis: This patent claims a method of delivering the tavaborole compound to treat onychomycosis. The claimed method specifically involves contacting the dorsal (top) layer of the nail plate with a composition containing the compound, which then penetrates the nail plate to treat the infection. (Compl. ¶34).
  • Asserted Claims: Claim 2 (dependent on claim 1) is asserted. (Compl. ¶41).
  • Accused Features: The use of Mylan's generic topical solution, which is applied to the toenail, is alleged to infringe this delivery method claim. (Compl. ¶¶34, 41).

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 product is a drug intended for the topical treatment of onychomycosis (Compl. ¶1). The complaint alleges that Mylan's product contains the "same or equivalent ingredients in the same or equivalent amounts" as the branded Kerydin® product (Compl. ¶3). The act of infringement alleged under the Hatch-Waxman Act is Mylan's submission of the ANDA to the FDA for the purpose of commercially manufacturing and selling this generic product before the expiration of the patents-in-suit (Compl. ¶44).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Mylan's notice letter did not contest infringement of the patents-in-suit, suggesting Mylan's defense will focus on invalidity (Compl. ¶42).

9,459,938 Infringement Allegations

The complaint's infringement allegations for the '938' Patent describe a method of treating a toenail infection with a specific chemical composition (Compl. ¶¶17-19). These allegations do not correspond to the subject matter of the provided U.S. Patent No. 9,459,938, which is directed to "Personal Trend Management" technology. The complaint appears to reference a different patent than the one provided in the case materials. Therefore, a claim chart mapping the allegations to the provided patent cannot be constructed.

9,566,289 Infringement Allegations

Claim Element (from Independent Claim 12) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical formulation, comprising: Mylan's ANDA Product is alleged to be a pharmaceutical formulation. ¶3, ¶22 col. 139:1-2
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 generic "TAVABOROLE) TOPICAL SOLUTION, 5%" alleged to contain the same active ingredient in the same amount as Kerydin. ¶1, ¶3, ¶22 col. 4:50-56
propylene glycol; The complaint alleges Mylan's product contains equivalent ingredients to Kerydin, and the '289' patent identifies propylene glycol as a component of the Kerydin formulation. ¶3, ¶22 col. 166:10
ethanol; and The complaint alleges Mylan's product contains equivalent ingredients to Kerydin, and the '289' patent identifies ethanol as a component of the Kerydin formulation. ¶3, ¶22 col. 166:10
ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof. The complaint alleges Mylan's product contains equivalent ingredients to Kerydin, and the '289' patent identifies EDTA as a component of the Kerydin formulation. ¶3, ¶22 col. 170:10-20

Identified Points of Contention

  • Scope Questions: The primary contention regarding the '938' patent is the fundamental mismatch between the patent's subject matter (data trend management) and the complaint's allegations (topical fungal treatment). This raises the question of whether this is a clerical error in the complaint or if the count is facially deficient as pleaded.
  • Technical Questions: For the '289', '290', and '823' patents, the complaint's assertion that Mylan did not contest infringement suggests that the technical operation and composition of Mylan's ANDA product falls within the scope of the asserted claims (Compl. ¶42). The central dispute would therefore have been validity, an issue that appears to have been subsequently resolved by the PTAB's cancellation of all asserted claims for these three patents.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of claim construction disputes, particularly as it alleges infringement was not contested. However, based on the claim language, certain terms could become focal points. The analysis below is for the '289' Patent.

  • The Term: "about 5% w/w"
  • Context and Importance: This term defines the concentration of the active ingredient, tavaborole. Its construction is critical to determining the literal scope of the claim. While Mylan’s product is labeled as 5%, disputes could arise over manufacturing tolerances and whether they fall within the range implied by "about."
  • 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 teaches that formulations can contain the active ingredient in a concentration "which is a member selected from 1%, 2.5%, 5%, 7.5%, 10% and 15% w/w" ('289' Patent, col. 166:11-15), which could be used to argue for a range of acceptable concentrations around the 5% point.
    • Evidence for a Narrower Interpretation: The patent provides an exemplary formulation in Example 13 that lists "Tavaborole, 5.0%" ('289' Patent, col. 166:3-10). A defendant could argue this specific example, without the modifier "about," suggests a more precise value was contemplated and that "about" should be construed narrowly to cover only minor variations inherent in measurement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement on the basis that Mylan plans to market its product with labeling that will instruct physicians and patients to use the product in an infringing manner (Compl. ¶¶47-48). It also alleges contributory infringement, stating Mylan's product is not a staple article of commerce and is especially adapted for infringing use (Compl. ¶49).
  • Willful Infringement: Willfulness is alleged based on Mylan having "full knowledge of the patents-in-suit" and proceeding with its ANDA filing "without a reasonable basis for believing that it would not be liable" (Compl. ¶52). This knowledge is predicated on the Orange Book listing and Mylan's own Paragraph IV certification (Compl. ¶¶36, 40).

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

This case presents several fundamental issues, with post-filing events likely being dispositive for most of the asserted patents.

  • A primary threshold issue is one of pleading sufficiency: does the complaint's assertion of U.S. Patent No. 9,459,938, a patent for personal data management, against a topical antifungal drug represent a fatal clerical error, and if so, how will it be rectified or resolved?
  • The central question for the remaining three patents ('289', '290', '823') is one of mootness: given that all asserted claims (and all other claims) of these patents were cancelled in subsequent IPR proceedings, what, if any, justiciable controversy remains for the court to decide regarding these patents?
  • A final question concerns case viability: assuming the '938' patent issue is resolved and acknowledging the cancellation of the other patents' claims, the case, which would have been centered on Mylan's validity challenges, appears to have been largely decided outside of the district court, raising the question of what legal or factual issues could remain.