Case 1:18-cv-00202-IMK Document 21 Filed 12/14/18 Page 1 of 24 PageID #: 1032
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINA
`
`ANACOR PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`MYLAN PHARMACEUTICALS INC. and
`MYLAN INC.,
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`Defendants.
`
`v.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 1:18-CV-00202-IMK
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`DEFENDANTS’ ANSWER TO PLAINTIFF’S COMPLAINT AND COUNTERCLAIMS
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`Defendants Mylan Pharmaceuticals Inc. (“MPI”) and Mylan, Inc., (collectively, “the
`
`Mylan Defendants”), by and through their counsel, hereby answer Plaintiff Anacor
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`Pharmaceuticals, Inc.’s (“Anacor” or “Plaintiff”) Complaint. The Mylan Defendants deny each
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`and every allegation contained in Anacor’s Complaint (“Complaint”) that is not expressly
`
`admitted below. The Mylan Defendants answer each paragraph of Anacor’s Complaint in the
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`order set forth therein as follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the United States, Title
`35, United States Code that arises out of Defendants' filing of an Abbreviated New Drug
`Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking
`approval to manufacture and sell a generic version of Kerydin® (TAVABOROLE)
`TOPICAL SOLUTION, 5% (“Kerydin”), prior to the expiration of U.S. Patent No.
`9,459,938 (“the ’938 patent”); U.S. Patent No. 9,566,289 (“the ’289 patent”); U.S. Patent
`No. 9,566,290 (“the ’290 patent”); and U.S. Patent No. 9,572,823 (“the ’823 patent”).
`These four patents are referred to collectively herein as “the patents-in-suit.”
`
`ANSWER: Paragraph 1 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, the Mylan Defendants admit that MPI filed Abbreviated New Drug
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`Application (“ANDA”) No. 212065 with United States Food and Drug Administration (“FDA”)
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`seeking approval for its Tavaborole 5% topical solution product. The Mylan Defendants deny
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`Case 1:18-cv-00202-IMK Document 21 Filed 12/14/18 Page 2 of 24 PageID #: 1033
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`that Mylan Inc. is a proper party to this action. To the extent there are allegations not expressly
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`admitted above, such allegations are denied.
`
`2.
`
`Mylan Pharmaceuticals Inc. notified Anacor by letter dated September 17, 2018
`(“Mylan's Notice Letter”) that it had submitted to the FDA ANDA No. 212065 (“Mylan's
`ANDA”), seeking approval from the FDA to engage in the commercial manufacture, use
`and/or sale of a generic tavaborole topical solution (“Mylan's ANDA Product”) prior to
`the expiration of the patents-in-suit.
`
`ANSWER: The Mylan Defendants admit that MPI sent Anacor a notice letter dated
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`September 17, 2018 pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”) stating
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`that MPI had submitted ANDA No. 212065 to FDA. To the extent there are allegations not
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`expressly admitted, such allegations are denied.
`
`3.
`
`Upon information and belief, Mylan’s ANDA Product is a drug product that is a generic
`version of Kerydin, containing the same or equivalent ingredients in the same or
`equivalent amounts.
`
`ANSWER: The Mylan Defendants admit that the product that is the subject of ANDA No.
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`212065 (“MPI’s ANDA Product”) contains the active ingredient Tavaborole in 5% dosage
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`strength intended for topical administration. The Mylan Defendants lack sufficient knowledge
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`and information to form a belief as to the truth of the remaining allegations contained in
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`paragraph 3 of the Complaint and, on that basis, deny them.
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`PARTIES
`
`4.
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`Plaintiff Anacor is a corporation organized and existing under the laws of the State of
`Delaware, having a principal place of business at 235 East 42nd Street, New York, New
`York 10017.
`
`ANSWER: The Mylan Defendants lack sufficient knowledge and information to form a belief
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`as to the truth of the allegations contained in paragraph 4 of the Complaint and, on that basis,
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`deny them.
`
`5.
`
`Upon information and belief, defendant Mylan Pharmaceuticals Inc. is a corporation
`organized and existing under the laws of the State of West Virginia, having its principal
`place of business at 781 Chestnut Ridge Road, Morgantown, WV 26505. Upon
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`2
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`information and belief, Mylan Pharmaceuticals Inc. is in the business of, among other
`things, manufacturing and selling generic versions of branded pharmaceutical drugs for
`the U.S. market.
`
`ANSWER: MPI admits that it is incorporated in West Virginia and has its principal place of
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`business at 781 Chestnut Ridge Road, Morgantown, WV 26505. MPI further admits that it is in
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`the business of, among other things, manufacturing and selling generic medicines.
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`6.
`
`Upon information and belief, defendant Mylan Inc. is a corporation organized and
`existing under the laws of the State of Pennsylvania, having a principal place of business
`at 1500 Corporate Drive, Canonsburg, PA 15317. Upon information and belief, Mylan
`Inc. is in the business of, among other things, manufacturing and selling generic versions
`of branded pharmaceutical products through various operating subsidiaries, including
`Mylan Pharmaceuticals Inc.
`
`ANSWER: Mylan Inc. admits that it is incorporated in Pennsylvania and has its principal
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`place of business at 1000 Mylan Boulevard, Robert J. Coury Global Center, Canonsburg,
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`Pennsylvania 15317. The Mylan Defendants deny that Mylan Inc. is a proper party to this
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`action. To the extent there are allegations not expressly admitted above, such allegations are
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`denied.
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`7.
`
`Upon information and belief, Mylan Pharmaceuticals Inc. is a wholly owned subsidiary
`of Mylan Inc. Mylan Pharmaceuticals Inc. and Mylan Inc. are collectively referred to
`herein as “Mylan.”
`
`ANSWER: The Mylan Defendants admit that MPI is wholly-owned by Mylan Inc. The
`
`Mylan Defendants deny that Mylan Inc. is a proper party to this action. To the extent there are
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`allegations not expressly admitted above, such allegations are denied.
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`JURISDICTION
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`8.
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`Jurisdiction is proper in this district pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and
`2202.
`
`ANSWER: Paragraph 8 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, the Mylan Defendants deny that this Court has subject matter
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`jurisdiction over allegations related to any alleged infringement under 35 U.S.C. §§ 271(a), (b),
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`3
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`(c), and/or (g). The Mylan Defendants deny that Mylan Inc. is a proper party to this action. To
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`the extent there are allegations not expressly admitted above, such allegations are denied.
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`9.
`
`This Court has personal jurisdiction over Mylan.
`
`ANSWER: Paragraph 9 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, for the purposes of this litigation, the Mylan Defendants do not
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`contest personal jurisdiction in West Virginia.
`
`10. Mylan Pharmaceuticals Inc. is subject to personal jurisdiction in West Virginia because,
`among other things, it has purposely availed itself of the benefits and protections of West
`Virginia's laws such that it should reasonably anticipate being haled into court here.
`Mylan Pharmaceuticals Inc. is a corporation organized and existing under the laws of the
`State of West Virginia, is qualified to do business in West Virginia, and has appointed a
`registered agent for service of process in West Virginia. It therefore has consented to
`general jurisdiction in West Virginia. Upon information and belief, Mylan
`Pharmaceuticals Inc. develops, manufactures, imports, markets, offers to sell, and/or sells
`generic drugs throughout the United States, including in the State of West Virginia and
`therefore transacts business within the State of West Virginia related to Anacor's claims,
`and/or has engaged in systematic and continuous business contacts within the State of
`West Virginia.
`
`ANSWER:
`
` Paragraph 10 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, for the purposes of this litigation, the Mylan Defendants do not
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`contest personal jurisdiction in West Virginia. To the extent there are allegations not expressly
`
`admitted above, such allegations are denied.
`
`11. Mylan Inc. is subject to personal jurisdiction in West Virginia because, among other
`things, Mylan Inc., itself and through its wholly-owned subsidiary Mylan
`Pharmaceuticals Inc., has purposefully availed itself of the benefits and protections of
`West Virginia's laws such that it should reasonably anticipate being haled into court here.
`Upon information and belief, Mylan Inc., itself and through its subsidiary Mylan
`Pharmaceuticals Inc., develops, manufactures, imports, markets, offers to sell, and/or
`sells generic drugs throughout the United States, including in the State of West Virginia
`and therefore transacts business within the State of West Virginia, and/or has engaged in
`systematic and continuous business contacts within the State of West Virginia. In
`addition, Mylan Inc. is subject to personal jurisdiction in West Virginia because, upon
`information and belief, it controls and dominates Mylan Pharmaceuticals Inc. and
`therefore the activities of Mylan Pharmaceuticals Inc. in this jurisdiction are attributed to
`Mylan Inc.
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`ANSWER: Paragraph 11 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, for the purposes of this litigation, the Mylan Defendants do not
`
`contest personal jurisdiction in West Virginia. The Mylan Defendants deny that Mylan Inc. is a
`
`proper party to this action. To the extent there are allegations not expressly admitted above, such
`
`allegations are denied.
`
`12.
`
`Upon information and belief, if Mylan's ANDA is approved, Mylan will directly or
`indirectly manufacture, market, sell, and/or distribute Mylan's ANDA Product within the
`United States, including in West Virginia, consistently with Mylan's practices for the
`marketing and distribution of other generic pharmaceutical products. Upon information
`and belief, Mylan regularly does business in West Virginia, and its practices with other
`generic pharmaceutical products have involved placing those products into the stream of
`commerce for distribution throughout the United States, including in West Virginia.
`Upon information and belief, Mylan's generic pharmaceutical products are used and/or
`consumed within and throughout the United States, including in West Virginia. Upon
`information and belief, Mylan's ANDA Product will be prescribed by physicians
`practicing in West Virginia, dispensed by pharmacies located within West Virginia, and
`used by patients in West Virginia. Each of these activities would have a substantial effect
`within West Virginia and would constitute infringement of Anacor's patents in the event
`that Mylan's ANDA Product is approved before the patents expire.
`
`ANSWER: For purposes of this litigation, the Mylan Defendants do not contest personal
`
`jurisdiction or venue in West Virginia. The Mylan Defendants deny that Mylan Inc. is a proper
`
`party to this action. To the extent there are allegations not expressly admitted above, such
`
`allegations are denied.
`
`13.
`
`Upon information and belief, Mylan derives substantial revenue from generic
`pharmaceutical products that are used and/or consumed within West Virginia, and which
`are manufactured by Mylan and/or for which Mylan Pharmaceuticals Inc. or Mylan Inc.
`is the named applicant on approved ANDAs. Upon information and belief, various
`products for which Mylan Pharmaceuticals Inc. or Mylan Inc. is the named applicant on
`approved ANDAs are available at retail pharmacies in West Virginia.
`
`ANSWER: For purposes of this litigation, the Mylan Defendants do not contest personal
`
`jurisdiction or venue in West Virginia. The Mylan Defendants deny that Mylan Inc. is a proper
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`party to this action. To the extent there are allegations not expressly admitted above, such
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`allegations are denied.
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`5
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`

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`Case 1:18-cv-00202-IMK Document 21 Filed 12/14/18 Page 6 of 24 PageID #: 1037
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`THE PATENTS-IN-SUIT
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`14.
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`Anacor incorporates each of the preceding paragraphs 1–13 as if fully set forth herein.
`
`ANSWER: The Mylan Defendants incorporate by reference their responses to the preceding
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`paragraphs as if fully set forth herein.
`
`15.
`
`The inventors named on each of the patents-in-suit are Stephen J. Baker, Tsutomu
`Akama, Vincent S. Hernandez, Karin M. Hold, Kirk Maples, Jacob J. Plattner, Virginia
`Sanders, Yong-Kang Zhang, Gregory T. Fieldson, and James J. Leyden (collectively,
`“the Named Inventors”).
`
`ANSWER: The Mylan Defendants admit that, on their face, the patents-in-suit name Stephen
`
`J. Baker, Tsutomu Akama, Vincent S. Hernandez, Karin M. Hold, Kirk Maples, Jacob J. Plattner,
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`Virginia Sanders, Yong-Kang Zhang, Gregory T. Fieldson, and James J. Leyden as the inventors.
`
`The Mylan Defendants lack sufficient knowledge and information to form a belief as to the truth
`
`of the remaining allegations contained in paragraph 15 of the Complaint, and on that basis, deny
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`them.
`
`16.
`
`The ’938 patent, entitled “Boron-Containing Small Molecules” (Exhibit A hereto), was
`duly and legally issued on January 24, 2017, to Anacor, as assignee of the Named
`Inventors.
`
`ANSWER: The Mylan Defendants admit that, on its face, the ’938 patent indicates that it is
`
`entitled “Boron-Containing Small Molecules,” issued on January 24, 2017, and lists the assignee
`
`as “Anacor Pharmaceuticals, Inc.” The Mylan Defendants deny that the ʼ938 patent was duly
`
`and legally issued by the United States Patent and Trademark Office on January 24, 2017. The
`
`Mylan Defendants lack sufficient knowledge and information to form a belief as to the truth of
`
`the remaining allegations contained in paragraph 16 of the Complaint, and on that basis, deny
`
`them.
`
`17.
`
`The ’938 patent claims, inter alia, a method of treating a Tinea unguium infection of a
`toenail of a human, 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 or a pharmaceutically acceptable salt thereof in an amount sufficient to
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`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.
`
`ANSWER: Paragraph 17 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`18.
`
`The ’938 patent claims, inter alia, a method of treating a Tinea unguium infection of a
`toenail of a human, 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 or a pharmaceutically acceptable salt thereof in an amount sufficient to
`treat the infection, wherein the Tinea unguium infection is due to Trichophyton rubrum or
`Trichophyton mentagrophytes, and 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.
`
`ANSWER: Paragraph 18 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`19.
`
`The ’938 patent claims, inter alia, a method of treating a Tinea unguium infection of a
`toenail of a human, 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 or a pharmaceutically acceptable salt thereof in an amount sufficient to
`treat the infection, wherein the Tinea unguium infection is due to Trichophyton rubrum or
`Trichophyton mentagrophytes, 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, and
`wherein the pharmaceutical composition further comprises ethanol and propylene glycol.
`
`ANSWER: Paragraph 19 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`20.
`
`The ’289 patent, entitled “Boron-Containing Small Molecules” (Exhibit B hereto), was
`duly and legally issued on February 14, 2017, to Anacor, as assignee of the Named
`Inventors.
`
`ANSWER: The Mylan Defendants admit that, on its face, the ’289 patent indicates that it is
`
`entitled “Boron-Containing Small Molecules,” issued on February 14, 2017, and lists the assignee
`
`as “Anacor Pharmaceuticals, Inc.” The Mylan Defendants deny that the ʼ289 patent was duly
`
`and legally issued by the United States Patent and Trademark Office on February 14, 2017. The
`
`Mylan Defendants lack sufficient knowledge and information to form a belief as to the truth of
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`the remaining allegations contained in paragraph 20 of the Complaint, and on that basis, deny
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`them.
`
`21.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising 1,3-
`dihydro-5-fluoro-1-hydroxy-2,1-benoxaborole, or a pharmaceutically acceptable salt
`thereof, a solvent system, and a chelating agent; wherein the 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof, is present in a
`concentration of about 5% w/w.
`
`ANSWER: Paragraph 21 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`22.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising about 5%
`w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benoxaborole, or a pharmaceutically acceptable
`salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA) or a
`pharmaceutically acceptable salt thereof.
`
`ANSWER: Paragraph 22 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`23.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising about 5%
`w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benoxaborole, or a pharmaceutically acceptable
`salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA) or a
`pharmaceutically acceptable salt thereof; wherein the formulation is suitable for the
`treatment of onychomycosis of a toenail due to Trichophyton rubrum or Trichophyton
`mentagrophytes by topical application of the formulation to the toenail.
`
`ANSWER: Paragraph 23 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`24.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising about 5%
`w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benoxaborole, or a pharmaceutically acceptable
`salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA) or a
`pharmaceutically acceptable salt thereof; wherein the ethylene diamine tetraacetic acid
`(EDTA) or a pharmaceutically acceptable salt thereof, is present in a concentration of
`from about 0.005% to about 2.0% w/w.
`
`ANSWER: Paragraph 24 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`25.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising about 5%
`w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benoxaborole, or a pharmaceutically acceptable
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`salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA) or a
`pharmaceutically acceptable salt thereof; wherein the ethylene diamine tetraacetic acid
`(EDTA) or a pharmaceutically acceptable salt thereof, is present in a concentration of
`from about 0.005% to about 2.0% w/w; wherein the formulation is suitable for the
`treatment of onychomycosis of a toenail due to Trichophyton rubrum or Trichophyton
`mentagrophytes by topical application of the formulation to the toenail.
`
`ANSWER: Paragraph 25 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`26.
`
`The ’290 patent, entitled “Boron-Containing Small Molecules” (Exhibit C hereto), was
`duly and legally issued on February 14, 2017, to Anacor, as assignee of the Named
`Inventors.
`
`ANSWER: The Mylan Defendants admit that, on its face, the ’290 patent indicates that it is
`
`entitled “Boron-Containing Small Molecules,” issued on February 14, 2017, and lists the assignee
`
`as “Anacor Pharmaceuticals, Inc.” The Mylan Defendants deny that the ʼ290 patent was duly and
`
`legally issued by the United States Patent and Trademark Office on February 14, 2017. The
`
`Mylan Defendants lack sufficient knowledge and information to form a belief as to the truth of
`
`the remaining allegations contained in paragraph 26 of the Complaint, and on that basis, deny
`
`them.
`
`27.
`
`The ’290 patent claims, inter alia, a method of treating a human having onychomycosis
`of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method
`comprising topically administering to the toenail a pharmaceutical composition
`comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA
`synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes; wherein the
`pharmaceutical composition is in the form of a solution comprising 5% w/w of 1,3-
`dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt
`thereof.
`
`ANSWER: Paragraph 27 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`28.
`
`The ’290 patent claims, inter alia, a method of treating a human having onychomycosis
`of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method
`comprising topically administering to the toenail a pharmaceutical composition
`comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a
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`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA
`synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes; wherein the
`aminoacyl tRNA synthetase is leucyl tRNA synthetase; and wherein the pharmaceutical
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`ANSWER: Paragraph 28 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`29.
`
`The ’290 patent claims, inter alia, a method of treating a human having onychomycosis
`of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method
`comprising topically administering to the toenail a pharmaceutical composition
`comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA
`synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes; wherein the
`aminoacyl tRNA synthetase is leucyl tRNA synthetase; wherein the pharmaceutical
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof; and wherein
`the pharmaceutical composition further comprises ethanol and propylene glycol.
`
`ANSWER: Paragraph 29 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`30.
`
`The ’290 patent claims, inter alia, a method of treating a human having onychomycosis
`of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the
`method comprising topically administering to the toenail a pharmaceutical composition
`comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA
`synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes; wherein the
`aminoacyl tRNA synthetase is leucyl tRNA synthetase; wherein the pharmaceutical
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof; wherein the
`pharmaceutical composition further comprises ethanol and propylene glycol; and
`wherein the administering of the pharmaceutical composition occurs once a day.
`
`ANSWER: Paragraph 30 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`31.
`
`The ’290 patent claims, inter alia, a method of treating a human having onychomycosis
`of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method
`comprising topically administering to the toenail a pharmaceutical composition
`comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA
`synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes; wherein the
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`aminoacyl tRNA synthetase is leucyl tRNA synthetase; wherein the pharmaceutical
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof; wherein the
`pharmaceutical composition further comprises ethanol and propylene glycol; and wherein
`the method inhibits leucyl tRNA synthetase in Trichophyton rubrum.
`
`ANSWER: Paragraph 31 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`32.
`
`The ’290 patent claims, inter alia, a method of treating a human having onychomycosis
`of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method
`comprising topically administering to the toenail a pharmaceutical composition
`comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA
`synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes; wherein the
`aminoacyl tRNA synthetase is leucyl tRNA synthetase; wherein the pharmaceutical
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof; wherein the
`pharmaceutical composition further comprises ethanol and propylene glycol; and wherein
`the method inhibits leucyl tRNA synthetase in Trichophyton mentagrophytes.
`
`ANSWER: Paragraph 32 contains legal conclusions to which no answer is required. To the
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`extent there are allegations not expressly admitted above, such allegations are denied.
`
`33.
`
`The ’823 patent, entitled “Boron-Containing Small Molecules” (Exhibit D hereto), was
`duly and legally issued on February 14, 2017, to Anacor, as assignee of the Named
`Inventors.
`
`ANSWER: The Mylan Defendants admit that, on its face, the ’823 patent indicates that it is
`
`entitled “Boron-Containing Small Molecules,” issued on February 14, 2017, and lists the assignee
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`is “Anacor Pharmaceuticals, Inc.” The Mylan Defendants deny that the ʼ823 patent was duly
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`and legally issued by the United States Patent and Trademark Office on February 14, 2017. The
`
`Mylan Defendants lack sufficient knowledge and information to form a belief as to the truth of
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`the remaining allegations contained in paragraph 33 of the Complaint, and on that basis, deny
`
`them.
`
`34.
`
`The ’823 patent claims, inter alia, a method of delivering a compound, in a human, from
`a dorsal layer of a nail plate to a nail bed to treat onychomycosis caused by Trichophyton
`rubrum or Trichophyton mentagrophytes, the method comprising contacting the dorsal
`
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`Case 1:18-cv-00202-IMK Document 21 Filed 12/14/18 Page 12 of 24 PageID #: 1043
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`layer of the nail plate with a pharmaceutical composition comprising a compound that
`penetrates the nail plate, the compound being 1,3-dihydro-5-fluoro-1-hydroxy-2,1-
`benzoxaborole or a pharmaceutically acceptable salt thereof, thereby treating
`onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes; wherein
`the pharmaceutical composition is in the form of a topical solution comprising 5% w/w of
`1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, and wherein the pharmaceutical
`composition further comprises ethanol and propylene glycol.
`
`ANSWER: Paragraph 34 contains legal conclusions to which no answer is required. To the
`
`extent there are allegations not expressly admitted above, such allegations are denied.
`
`35.
`
`Anacor owns each of the patents-in-suit.
`
`ANSWER: The Mylan Defendants lack sufficient knowledge and information to form a belief
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`as to the truth of the allegations contained in paragraph 35 of the Complaint and, on that basis,
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`deny them.
`
`36.
`
`Kerydin, and methods of using Kerydin, are covered by one or more claims of each of the
`patents-in-suit, and each of the patents-in-suit has been listed in connection with Kerydin
`in the FDA’s Orange Book.
`
`ANSWER: Paragraph 36 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, the Mylan Defendants admit that FDA’s Orange Book lists the
`
`patents-in-suit in connection with Kerydin. The Mylan Defendants lack sufficient knowledge
`
`and information to form a belief as to the truth of the remaining allegations contained in
`
`paragraph 36 of the Complaint and, on that basis, deny them.
`
`37.
`
`Anacor will be substantially and irreparably damaged by infringement of the patents-in-
`suit.
`
`ANSWER: Denied.
`
`COUNT I – MYLAN’S INFRINGEMENT OF THE PATENTS-IN-SUIT
`
`38.
`
`Anacor incorporates each of the preceding paragraphs 1–37 as if fully set forth herein.
`
`ANSWER: The Mylan Defendants incorporate by reference their responses to the preceding
`
`paragraphs as if fully set forth herein.
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`Case 1:18-cv-00202-IMK Document 21 Filed 12/14/18 Page 13 of 24 PageID #: 1044
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`39.
`
`In Mylan’s Notice Letter, Mylan notified Anacor of the submission of Mylan’s ANDA to
`the FDA. The purpose of that submission was to obtain approval under the FDCA to
`engage in the commercial manufacture, use, offer for sale, sale and/or importation of
`Mylan’s ANDA Product prior to the expiration of the patents-in-suit.
`
`ANSWER: The Mylan Defendants admit that MPI filed ANDA No. 212065 with FDA for
`
`MPI’s ANDA Product. The Mylan Defendants admit that MPI sent a Notice Letter to Anacor
`
`regarding the patent certifications contained in MPI’s ANDA No. 212065. To the extent there
`
`are allegations not expressly admitted above, such allegations are denied.
`
`40.
`
`In its Notice Letter, Mylan also notified Anacor that, as part of its ANDA, Mylan had
`filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21
`U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to each of the patents-in-suit. Upon
`information and belief, Mylan submitted its ANDA to the FDA containing a certification
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that each of the patents-in-suit is
`invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for
`sale, sale, and/or importation of Mylan’s ANDA Product.
`
`ANSWER: The Mylan Defendants admit that MPI’s Notice Letter states that MPI’s ANDA
`
`No. 212065 contains certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (paragraph IV
`
`certifications) with respect to U.S. Patent Nos. 7,582,621, 9,549,938, 9,566,289, 9,566,290, and
`
`9,572,