Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 1 of 15 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`FILED
`
`ANACOR PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`V. (cid:9)
`
`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`Defendants.
`
`OCT 3 0 2018
`
`
`u.s.
`DISTRICT COLIRT-WVND
`WHEELING,
`WV 26003
`
`Civil Action No. / :18-ciu-aoA
`
`COMPLAINT
`
`Plaintiff Anacor Pharmaceuticals, Inc. ("Anacor"), by its attorneys, for its
`
`Complaint, alleges as follows:
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`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
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`Drug Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") seeking
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`approval to manufacture and sell a generic version of Kerydin® (TAVABOROLE) TOPICAL
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`SOLUTION, 5% ("Kerydin"), prior to the expiration of U.S. Patent No. 9,459,938 ("the '938
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`patent"); U.S. Patent No. 9,566,289 ("the '289 patent"); U.S. Patent No. 9,566,290 ("the '290
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`patent"); and U.S. Patent No. 9,572,823 ("the '823 patent"). These four patents are referred to
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`collectively herein as "the patents-in-suit."
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`Mylan Pharmaceuticals Inc. notified Anacor by letter dated September 17,
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`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
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`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 2 of 15 PageID #: 2
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`sale of a generic tavaborole topical solution ("MyIan's ANDA Product") prior to the expiration of
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`the patents-in-suit.
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`3. (cid:9)
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`Upon information and belief, MyIan's ANDA Product is a drug product that
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`is a generic version of Kerydin, containing the same or equivalent ingredients in the same or
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`equivalent amounts.
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`PARTIES
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`Plaintiff Anacor is a corporation organized and existing under the laws of
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`the State of Delaware, having a principal place of business at 235 East 42nd Street, New York,
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`New York 10017.
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`Upon information and belief, defendant Mylan Pharmaceuticals Inc. is a
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`corporation organized and existing under the laws of the State of West Virginia, having its
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`principal place of business at 781 Chestnut Ridge Road, Morgantown, WV 26505. Upon
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`information and belief, Mylan Pharmaceuticals Inc. is in the business of, among other things,
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`manufacturing and selling generic versions of branded pharmaceutical drugs for the U.S. market.
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`Upon information and belief, defendant Mylan Inc. is a corporation
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`organized and existing under the laws of the State of Pennsylvania, having a principal place of
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`business at 1500 Corporate Drive, Canonsburg, PA 15317. Upon information and belief, Mylan
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`Inc. is in the business of, among other things, manufacturing and selling generic versions of
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`branded pharmaceutical products through various operating subsidiaries, including Mylan
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`Pharmaceuticals Inc.
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`Upon information and belief, Mylan Pharmaceuticals Inc. is a wholly
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`owned subsidiary of Mylan Inc. Mylan Pharmaceuticals Inc. and Mylan Inc. are collectively
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`referred to herein as "Mylan."
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`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 3 of 15 PageID #: 3
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`JURISDICTION
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`Jurisdiction is proper in this district pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`2201, and 2202.
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`This Court has personal jurisdiction over Mylan.
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`Mylan Pharmaceuticals Inc. is subject to personal jurisdiction in West
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`Virginia because, among other things, it has purposely availed itself of the benefits and protections
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`of West Virginia's laws such that it should reasonably anticipate being haled into court here.
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`Mylan Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of
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`West Virginia, is qualified to do business in West Virginia, and has appointed a registered agent
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`for service of process in West Virginia. It therefore has consented to general jurisdiction in West
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`Virginia. Upon information and belief, Mylan Pharmaceuticals Inc. develops, manufactures,
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`imports, markets, offers to sell, and/or sells generic drugs throughout the United States, including
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`in the State of West Virginia and therefore transacts business within the State of West Virginia
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`related to Anacor's claims, and/or has engaged in systematic and continuous business contacts
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`within the State of West Virginia.
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`Mylan Inc. is subject to personal jurisdiction in West Virginia because,
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`among other things, Mylan Inc., itself and through its wholly-owned subsidiary Mylan
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`Pharmaceuticals Inc., has purposefully availed itself of the benefits and protections of West
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`Virginia's laws such that it should reasonably anticipate being haled into court here. Upon
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`information and belief, Mylan Inc., itself and through its subsidiary Mylan Pharmaceuticals Inc.,
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`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the
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`United States, including in the State of West Virginia and therefore transacts business within the
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`State of West Virginia, and/or has engaged in systematic and continuous business contacts within
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`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 4 of 15 PageID #: 4
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`the State of West Virginia. In addition, Mylan Inc. is subject to personal jurisdiction in West
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`Virginia because, upon information and belief, it controls and dominates Mylan Pharmaceuticals
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`Inc. and therefore the activities of Mylan Pharmaceuticals Inc. in this jurisdiction are attributed to
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`Mylan Inc.
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`Upon information and belief, if Mylan's ANDA is approved, Mylan will
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`directly or indirectly manufacture, market, sell, and/or distribute Mylan's ANDA Product within
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`the United States, including in West Virginia, consistently with Mylan's practices for the
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`marketing and distribution of other generic pharmaceutical products. Upon information and belief,
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`Mylan regularly does business in West Virginia, and its practices with other generic
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`pharmaceutical products have involved placing those products into the stream of commerce for
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`distribution throughout the United States, including in West Virginia. Upon information and
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`belief, Mylan's generic pharmaceutical products are used and/or consumed within and throughout
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`the United States, including in West Virginia. Upon information and belief, Mylan's ANDA
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`Product will be prescribed by physicians practicing in West Virginia, dispensed by pharmacies
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`located within West Virginia, and used by patients in West Virginia. Each of these activities would
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`have a substantial effect within West Virginia and would constitute infringement of Anacor's
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`patents in the event that Mylan's ANDA Product is approved before the patents expire.
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`Upon information and belief, Mylan derives substantial revenue from
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`generic pharmaceutical products that are used and/or consumed within West Virginia, and which
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`are manufactured by Mylan and/or for which Mylan Pharmaceuticals Inc. or Mylan Inc. is the
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`named applicant on approved ANDAs. Upon information and belief, various products for which
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`Mylan Pharmaceuticals Inc. or Mylan Inc. is the named applicant on approved ANDAs are
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`available at retail pharmacies in West Virginia.
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`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 5 of 15 PageID #: 5
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`THE PATENTS-IN-SUIT
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`Anacor incorporates each of the preceding paragraphs 1-13 as if fully set
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`forth herein.
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`The inventors named on each of the patents-in-suit are Stephen J. Baker,
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`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").
`
`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.
`
`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 pharmaceutical composition is in the form of a solution comprising 5% w/w
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`1,3-dihydro-5-fluoro-l-hydroxy-2,1-benzoxaborole.
`
`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
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`comprising 5% w/w 1,3-dihydro-5-fluoro-l-hydroxy-2,1-benzoxaborole.
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`5
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`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 6 of 15 PageID #: 6
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`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.
`
`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.
`
`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.
`
`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.
`
`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)
`
`6
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`or a pharmaceutically acceptable salt thereof; wherein the formulation is suitable for the treatment
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`of onychomycosis of a toenail due to Trichophyton rubrum or Trichophyton mentagrophytes by
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`topical application of the formulation to the toenail.
`
`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.
`
`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; wherein the formulation is suitable for the treatment of onychomycosis
`
`of a toenail due to Trichophyton rubrum or Trichophyton mentagrophytes by topical application
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`of the formulation to the toenail.
`
`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.
`
`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
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`7
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`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 8 of 15 PageID #: 8
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`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 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.
`
`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; 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.
`
`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
`
`8
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`acceptable salt thereof; and wherein the pharmaceutical composition further comprises ethanol and
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`propylene glycol.
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`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-l-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.
`
`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
`
`9
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`propylene glycol; and wherein the method inhibits leucyl tRNA synthetase in Trichophyton
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`rubrum.
`
`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-l-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.
`
`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.
`
`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
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`Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising contacting the
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`dorsal layer of the nail plate with a pharmaceutical composition comprising a compound that
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`penetrates the nail plate, the compound being 1,3-dihydro-5-fluoro- 1 -hydroxy-2,1-benzoxaborole
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`or a pharmaceutically acceptable salt thereof, thereby treating onychomycosis due to Trichophyton
`
`rubrum or Trichophyton mentagrophytes; wherein the pharmaceutical composition is in the form
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`10
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`of a topical solution comprising 5% w/w of 1,3-dihydro-5-fluoro- 1 -hydroxy-2,1-benzoxaborole,
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`and wherein the pharmaceutical composition further comprises ethanol and propylene glycol.
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`Anacor owns each of the patents-in-suit.
`
`Kerydin, and methods of using Kerydin, are covered by one or more claims
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`of each of the patents-in-suit, and each of the patents-in-suit has been listed in connection with
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`Kerydin in the FDA's Orange Book.
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`Anacor will be substantially and irreparably damaged by infringement of
`
`the patents-in-suit.
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`COUNT I — MYLAN'S INFRINGEMENT OF THE PATENTS-IN-SUIT
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`Anacor incorporates each of the preceding paragraphs 1-37 as if fully set
`
`forth herein.
`
`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.
`
`In its Notice Letter, Mylan also notified Anacor that, as part of its ANDA,
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`Mylan had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA,
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`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.
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`§ 355(j)(2)(A)(vii)(IV) asserting that each of the patents-in-suit is invalid, unenforceable, ancUor
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`will not be infringed by the manufacture, use, offer for sale, sale, and/or importation of Mylan's
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`ANDA Product.
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`Mylan's ANDA Product, and the use of Mylan's ANDA Product, are
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`covered by one or more claims of each of the patents-in-suit, including at least the following:
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`claims 3 and 5-6 of the '938 patent; claims 10 and 12-15 of the '289 patent; claims 2,5-6,8, and
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`11-12 of the '290 patent; and claim 2 of the '823 patent.
`
`In its Notice Letter, Mylan did not contest infringement of the patents-in-
`
`suit.
`
`Mylan has knowledge of the each of the patents-in-suit.
`
`Mylan's submission of its ANDA for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of its ANDA
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`Product before the expiration of the patents-in-suit was an act of infringement of those patents
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`Upon information and belief, Mylan will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of its ANDA Product immediately
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`and imminently upon approval of its ANDA.
`
`The manufacture, use, sale, offer for sale, or importation of Mylan's ANDA
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`Product would infringe one or more claims of each of the patents-in-suit, including at least the
`
`claims listed in above paragraph 41.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Mylan's ANDA Product in accordance with, and as directed by Mylan's proposed
`
`product labeling would infringe one or more claims of each of the patents-in-suit, including at least
`
`the claims listed in above paragraph 41.
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`Upon information and belief, Mylan plans and intends to, and will, actively
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`induce infringement of the patents-in-suit when its ANDA is approved, and plans and intends to,
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`and will, do so immediately and imminently upon approval.
`
`Upon information and belief, Mylan knows that Mylan's ANDA Product
`
`and its proposed labeling are especially made or adapted for use in infringing the patents-in-suit,
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`that Mylan's ANDA Product is not a staple article or commodity of commerce, and that Mylan's
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`ANDA Product and its proposed labeling are not suitable for substantial noninfringing use. Upon
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`information and belief, Mylan plans and intends to, and will, contribute to infringement of the
`
`patents-in-suit immediately and imminently upon approval of Mylan's ANDA.
`
`Notwithstanding Mylan's knowledge of the claims of the patents-in-suit,
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`Mylan has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import
`
`Mylan's ANDA Product with its product labeling following upon FDA approval of Mylan's
`
`ANDA prior to the expiration of the patents-in-suit.
`
`The foregoing actions by Mylan constitute and/or will constitute
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`infringement of the patents-in-suit; active inducement of infringement of the patents-in-suit; and
`
`contribution to the infringement by others of the patents-in-suit.
`
`Upon information and belief, Mylan has acted with full knowledge of the
`
`patents-in-suit and without a reasonable basis for believing that it would not be liable for
`
`infringement of the patents-in-suit; active inducement of infringement of the patents-in-suit; and/or
`
`contribution to the infringement by others of the patents-in-suit.
`
`Unless Mylan is enjoined from infringing the patents-in-suit, actively
`
`inducing infringement of the patents-in-suit, and contributing to the infringement by others of the
`
`patents-in-suit, Anacor will suffer irreparable injury. Anacor has no adequate remedy at law.
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`COUNT II— DECLARATORY JUDGMENT OF INFRINGEMENT BY MYLAN OF
`THE PATENTS-IN-SUIT
`
`Anacor incorporates each of the preceding paragraphs 1-53 as if fully set
`
`forth herein.
`
`The Court may declare the rights and legal relations of the parties pursuant
`
`to 28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Anacor on
`
`the one hand and Mylan on the other regarding Mylan's infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the patents-in-suit.
`
`The Court should declare that the commercial manufacture, use, sale, offer
`
`for sale or importation of Mylan's ANDA Product, or any other drug product which is covered by
`
`or whose use is covered by one or more of the patents-in-suit, will infringe, induce the infringement
`
`of, and contribute to the infringement by others of, said patents.
`
`WHEREFORE, Anacor requests the following relief:
`
`A judgment that each of the patents-in-suit has been infringed under 35
`
`U.S.C. § 271(e)(2) by Mylan's submission to the FDA of Mylan's ANDA;
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`A judgment ordering that the effective date of any FDA approval of
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`commercial manufacture, use, or sale of Mylan's ANDA Product, or any other drug product that
`
`infringes or the use of which infringes one or more of the patents-in-suit, be not earlier than the
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`latest of the expiration dates of said patents, inclusive of any extension(s) and additional period(s)
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`of exclusivity;
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`A preliminary and permanent injunction enjoining Mylan, and all persons
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`acting in concert with Mylan, from the commercial manufacture, use, sale, offer for sale, or
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`importation into the United States of Mylan's ANDA Product, or any other drug product covered
`
`14
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`

`

`Case 1:18-cv-00202-IMK Document 1 Filed 10/30/18 Page 15 of 15 PageID #: 15
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`by or whose use is covered by one or more of the patents-in-suit, prior to the expiration of said
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`patents, inclusive of any extension(s) and additional period(s) of exclusivity;
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`A judgment declaring that the commercial manufacture, use, sale, offer for
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`sale or importation of Mylan's ANDA Product, or any other drug product which is covered by or
`
`whose use is covered by one-or-more of the patents-in-suit, prior to the expiration of said patents,
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`will infringe, induce the infringement of, and contribute to the infringement by others of, said
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`patents;
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`A declaration that this is an exceptional case and an award of attorneys' fees
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`pursuant to 35 U.S.C. § 285;
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`Costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`Respectfully submitted,
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`Dated: October 30, 2018
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`SCHRADER COMPANION DUFF & LAW, PLLC
`
`OF COUNSEL:
`
`Aaron P. Maurer
`David I. Berl
`David M. Horniak
`Anthony Sheh
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`(202) 434-5029 (Facsimile)
`amaurer wc.com
`dberl@wc.com
`dhorniak@wc.corn
`asheh@wc.com
`
`Is! James F. Companion
`James F. Companion
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.corn
`
`Attorneys for Plaintiff Anacor
`Pharmaceuticals, Inc.
`
`15
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`(cid:9)
`