Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 1 of 20 PageID #: 1250
`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 1 of 20 PageID #: 1250
`
`Exhibit 4
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 2 of 20 PageID #: 1251
`IDS/19 Page 2 of 2100f4agelD #: 1251
`EST
`
`U.S. District Court
`Northern District of West Virginia (Ciarksburg)
`
`CIVIL DOCKET FOR CASE #: 1:18-cv—00202—IMK
`
`Anacor Pharmaceuticals, Inc. V. Mylan Pharmaceuticals Inc. et
`al
`
`Assigned to: Senior Judge Irene M. Keeley
`Cause: 352271 Patent Infringement
`Plaintiff
`
`Anacor Pharmaceuticals, Inc.
`
`Date Filed: 10/30/2018
`
`Jury Demand: None
`Nature of Suit: 830 Patent
`
`Jurisdiction: Federal Question
`
`represented by Aaron P. Maurer
`Williams & Connolly LLP - Washington
`725 Twelfth St, NW
`Washington, DC 20005
`(202) 434—5000
`Fax: (202) 434-5029
`Email: a1naurer@wc.com
`LEAD ATTORNEY
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Anthony Sheh
`Williams & Connolly LLP ~ Washington
`725 Twelfth St, NW
`Washington, DC 20005
`(202) 434—6000
`Fax: (202) 434w5029
`Email: asheh@we.com
`LEAD ATTORNEY
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`David I. Berl
`
`Williams & Connolly LLP ~ Washington
`725 12th St, NW
`Washington, DC 20005
`(202) 434*5000
`Email: dberl@wc.00m
`LEAD A TTORNEY
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`David M. Horniak
`
`Williams & Connolly LLP - Washington
`725 Twelfth St, NW
`Washington, DC 20005
`(202) 434~5000
`Fax: (202) 434—5029
`Email: dhorniak@wg.eom
`LEAD ATTORNEY
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`James F. Companion
`Schrader Companion Duff & Law, PLLC
`401 Main Street
`
`Wheeling, WV 26003
`304~233~3390
`Fax: 304M233—2769
`
`Email: jfcfdlschraderlawcom
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`

`

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`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 3 of 20 PageID #: 1252
`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 3 of 20 PageID #: 1252
`Case: 1:18—cv-00202-IMK As of: 01/06/2019 05:14 PM EST 2 of 4
`
`V.
`
`Defendant
`
`Mylan Pharmaceuticals Inc.
`
`Defendant
`
`Mylan Inc.
`
`Counter Claimant
`
`Mylan Pharmaceuticals Inc.
`
`Counter Claimant
`
`Mylan Inc.
`
`V
`
`'
`Counter Defendant
`
`Anacor Pharmaceuticals, Inc.
`
`represented by William J O'Brien
`Steptoe & Johnson PLLC * Bridgeport
`400 White Oaks Blvd
`
`Bridgeport, WV 26330
`(304) 933—8181
`Fax: (304) 933w8183
`Email: William.Obrien@Steptoe-dohnsoncom
`ATTORNEY TO BENOTICED
`
`represented by William J O'Brien
`(See above for address)
`ATTORNEY T0 BENOTICED
`
`represented by Wiiliam J O'Brien
`(See above for address)
`ATTORNEYTO BENOTICED
`
`represented by William J O‘Brien
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Aaron P. Maurer
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Anthony Sheh
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`David I. Berl
`
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`David M. Horniak
`
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY T0 BE NOTICED
`
`James F. Companion
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`
`
`Date Filed
`
`10/30/2018
`
`Docket Text
`
`
`
`l COMPLAINT against Mylan Inc. and Mylan Pharmaceuticals Inc., filed by Anacor
`Pharmaceuticals, Inc. (Attachments: # _l_ Exhibit A - Patent Information, # 2 Exhibit B
`*- Patent Information, # 3‘ Exhibit C - Patent Information, # fl, Exhibit D ~ Patent
`
`

`

`Information, # i Civil Cover Sheet)(rnh) (Entered: 10/30/2018)
`
`
`l
`
`10/30/2018
`Supplemental Information for Patent Cases Involving An Abbreviated New Drug
`
`Application (ANDA) filed by Anacor Pharmaceuticals, Inc. (mh) (Entered:
`
`
`10/30/2018)
`10/30/2018
`
`REPORT to USPTO on the filing or determination of an action regarding re 1
`
`Complaint.(mh) (Entered: 10/30/2018)
`
`
`10/30/2018
`
`10/30/2018
`
`
`_5_ Corporate Disclosure Statement by Anacor Pharmaceuticals, Inc. identifying
`Corporate Parent Pfizer Inc. for Anacor Pharmaceuticals, Inc. (mh) (Entered:
`
`10/30/2018)
`
`
`
`Filing fee: $ 400.00, receipt number WVNW002018 (mh) (Entered: 10/30/2018)
`
`i
`
`_6_ VERIFICATION OF ATTORNEY ADMISSION to Attorneys Maurer, Sheh, Horniak
`10/30/2018
`
`and Berl. (mh) (Entered: 10/30/2018)
`
`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 4 of 20 PageID #: 1253
`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 4 of 20 PagelD #: 1253
`Case: 1:18-cv—00202-IMK As of: 01/06/2019 05:14 PM EST 3 of 4
`
`J
`
`
`
`
`
`1 1/09/2018
`ORDER granting _9_ Motion for Aaron P. Maurer to Appear Pro Hac Vice on behalf of
`the Plaintiff. Signed by Senior Judge Irene M. Keeley on 11/9/18. (mh) (Entered:
`
`
`11/09/2018)
`ll/09/2018
`
`
`11/30/2018
`
`SUMMONS Returned Executed as to Mylan Inc. served on 11/20/2018. (mh)
`
`(Entered: 11/30/2018)
`
`11/30/2018
`
`SUMMONS Returned Executed as to Mylan Pharmaceuticals Inc. served on
`
`1 1/20/2018. (mh) (Entered: 1 1/30/2018)
`
`
`
`2 MOTION for Leave to Appear pro hac vice ofDavid M HOI‘i’liak by Anacor
`Pharmaceuticals, Inc.. (Attachments: # 1 Exhibit A, # 2 Text of Proposed
`
`Order)(Companion, James) (Entered: 11/07/2018)
`Pi
`8 MOTION for Leave to Appear pro hac vice ofDavid I. Berl by Anacor
`1 1/07/2018
`Pharmaceuticals, Inc.. (Attachments: # _1_ Exhibit A, # 2 Text of Proposed
`
`Order)(Companion, James) (Entered: 1 1/07/2018)
`2 MOTION for Leave to Appear pro hac vice ofAaron P. Mai/rel: by Anacor
`rI 1/07/2018
`Pharmaceuticals, Inc.. (Attachments: # _1_ Exhibit A, # _2_ Text of Proposed
`
`Order)(Companion, James) (Entered: 11/07/2018)
`
`1 1/07/2018
`
`7
`
`1 1/07/2018
`
`10 MOTION for Leave to Appear pro hac vice ofAnt/zany She/2 by Anacor
`Pharmaceuticals, Inc.. (Attachments: # 1 Exhibit A, # _2 Text of Proposed
`
`OrderXCompanion, James) (Entered: 1 1/07/2018)
`
`1 1/08/2018 Q PHV Filing fee: 39 800.00, receipt number WVNC002403 re: Attorneys Sheh, Maurer,
`Berl and Horniak. (mh) (Entered: 11/08/2018)
`
`11/09/2018
`
`1; ORDER granting 1 Motion for David M. Horniak to Appear Pro Hac Vice on behalf of
`the Plaintiffs. Signed by Senior Judge Irene M. Keeley on 11/9/18. (mh) (Entered:
`
`1 1/09/2018)
`
`11/09/2018
`
`_1_; ORDER granting _8 Motion for David I. Berl to Appear Pro Hac Vice on behalf of the
`Plaintiff. Signed by Senior Judge Irene M. Keeley on 11/9/18. (mh) (Entered:
`
`1 1/09/2018)
`
`ORDER granting 10 Motion for Anthony Sheh to Appear Pro Hac Vice on behalf of
`the Plaintiff. Signed by Senior Judge Irene M. Keeley on 11/9/18. (mh) (Entered:
`1 1/09/2018)
`
`A
`
`12/04/2018
`
`20 FIRST ORDER AND NOTICE REGARDING DISCOVERY AND SCHEDULING:
`
`***NOTICE T ATTORNEYS*** : Pursuant to Rule 7.1 of the Federal Rules of
`
`
`Civil Procedure, ALL N0n~governmental CORPORATE parties must file a
`DISCLOSURE STATEMENT with the Court. Forms are available on the
`
`Court‘s Web Site at http:llwww.nwnd.uscourts.g0V/forms.htm
`
`Rule 26 Meeting to be held by 1/ 17/2019. Rule 26 Meeting Report due by 1/31/2019.
`Scheduling Conference set for 2/14/2019 01:30 PM in Clarksburg District Judge
`Courtroom, 2nd Floor before Senior Judge Irene M. Keeley. Discovery due by
`
`

`

`(11/04/2019 21 ANSWER to l Complaint, , COUNTERCLAIM against Anacor Pharmaceuticals, Inc.
`
`12/14/2018
`
`12/14/2018
`
`
`by Mylan Pharmaceuticals Inc, Mylan Inc.(O‘Brien, Wiliiam) (Entered: 12/14/2018)
`
`2; Corporate Disclosure Statement by Mylan Inc, Mylan Pharmaceuticals Inc.
`identifying Corporate Parent Mylan Inc, Corporate Parent Mylan N.V. for Mylan
`Pharmaceuticals Inc, Mylan Pharmaceuticals Inc; Corporate Parent Mylan NV. for
`Mylan Inc, Mylan Inc... (O'Brien, William) (Entered: 12/14/2018)
`
`22; Answer to Counterclaz'ms ofMylan Pharmaceuticals Inc. Other Document re 21
`Answer to Complaint, Counterclaim filed by Anacor Pharmaceuticals, Inc.
`(Companion, James) (Entered: 01/04/2019)
`
`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 5 of 20 PageID #: 1254
`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 5 of 20 PageID #: 1254
`
`Case: 1:18-CV—00202—1MK AS of: 01/06/2019 05:14 PM EST 4 Of 4
`
`2/22/2019. Signed by Senior Judge Irene M. Keeley on 12/4/18. (mh) (Entered:
`12/04/2018)
`
`
`
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`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 6 of 20 PageID #: 1255
`W‘Document 24-4 Filed 01/08/19 Page 6 of 20 PageID #: 1255
`Case 1:18~cvu00202-IMK Document 1 Filed 10/30/18 Page 1 of 15 PagelD #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`I
`)
`)
`
`ANACOR PHARMACEUTICALS, iNc,
`
`Plaintiff,
`
`FILED
`OCT
`
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`
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`
`v.
`
`MYLAN PHARMACEUTICALS INC, and
`MYLAN INC,
`
`Defendants.
`
`COMPLAINT
`
`Plaintiff Anacor Pharmaceuticals,
`
`Inc.
`
`(“Anacor”), by its attorneys,
`
`for
`
`its
`
`Complaint, alleges 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 US. 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 US. Patent No. 9,459,938 (“the ’938
`
`patent”); US. Patent No. 9,566,289 (“the ’289 patent”); US. Patent No. 9,566,290 (“the ’290
`
`patent”); and US. Patent No. 9,572,823 (“the ’823 patent”). These four patents are referred to
`
`collectively herein as “the patents-in~suit.”
`
`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
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 7 of 20 PageID #: 1256
`”Ease—1+18:6v@0202-|MK Document 24-4 Filed 01/08/19 Page 7 of 20 PageID #: 1256
`
`Case 1:18-cv-00202—IMK Document 1 Filed 10/30/18 Page 2 of 15 PagelD #2 2
`
`sale of a generic tavaborole topical solution (“Mylan’s ANDA Product”) prior to the expiration of
`
`the patents-in—suit.
`
`3.
`
`Upon information and belief, Mylan’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
`
`equivalent amounts.
`
`PARTIES
`
`4.
`
`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.
`
`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
`
`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 US. market.
`
`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.
`
`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.”
`
`
`
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`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 8 of 20 PageID #: 1257
`wGase—i‘ficvfifififiifm/IK "”"Document 24-4 Filed 01/08/19 Page 8 of 20 PageID #: 1257
`
`Case 1:18-cv-00202—lMK Document 1 Filed 10/30/18 Page 3 of15 PagelD #: 3
`
`JURISDICTION
`
`8.
`
`Jurisdiction is proper in this district pursuant to 28 U.S.C, §§ 1331, 1338(21),
`
`2201, and 2202.
`
`9.
`
`This Court has personal jurisdiction over Mylan.
`
`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,
`
`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
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 9 of 20 PageID #: 1258
`
`”Ease—1W- - - K’»-~'~Document24-4 Filed 01/08/19 Page90f 20 Page|D#: 1258
`
`
`Case 1:18~cv—00202—IMK Documentl Filed 10/30/18 Page4of 15 PageID#:4
`
`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.
`
`l2.
`
`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.
`
`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.
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`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 10 of 20 PageID #: 1259
`WWWcument 24-4 Filed 01/08/19 Page 10 of 20 PagelD #: 1259
`
`Case 1:18—cv—00202~ll\/ll< Document 1 Filed 10/30/18 Page 5 of15 PagelD #: 5
`
`THE PATENTS-IN-SUIT
`
`l4.
`
`Anacor incorporates each of the preceding paragraphs l~l3 as if fully set
`
`forth herein,
`
`15.
`
`The inventors named on each of the patents—in—suit are Stephen J. Baker,
`
`Tsutomu Alcarna, 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”).
`
`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.
`
`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 l,3-dihydro-5-fluoro-l~hydroxy~2,l-
`
`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
`
`l,3-dihydro—5-fluoro— l —hydroxy~2, l —benzoxaborole.
`
`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 l,3—dihydro-5-fluoro-1-hydrcxy-2,l-
`
`benzoxaborole or a pharmaceutically acceptable salt thereof in an amount sufficient to treat the
`
`infection, wherein the Tinea unguium infection is due to Tric/tophyton rubrum or TriChOp/ryton
`
`mentag'ophytes, and wherein the pharmaceutical composition is in the form of a solution
`
`comprising 5% w/w 1,3—dihydro-5—fluoro-l »hydroxy—2,l—benzoxaborole.
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 11 of 20 PageID #: 1260
`"WOZII’MK" Document 24-4 Filed 01/08/19 Page 11 of 20 PagelD #: 1260
`
`Case 1:18—cv—00202~IMK Document 1 Filed 10/30/18 Page 6 ot15 PagelD #: 6
`
`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 l,3—dihydro—5—fluoro-l-hydroxy—2,l—
`
`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 Trichophylon
`
`mentagrophytes, wherein the pharmaceutical composition is in the form of a solution comprising
`
`5% w/w l,3-dihydro-5—fluoro~l—hydroxy-2,l—benzoxaborole, and wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`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.
`
`21 .
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising
`
`l,3—dihydro-5-fluoro-lvhydroxy~2,l-benoxaborole, or a pharmaceutically acceptable salt thereof,
`
`a solvent system, and a chelating agent; wherein the l,3—dihydro~5-fluoro~l—hydroxy—2,l-
`
`benzoxaborole, or a pharmaceutically acceptable salt thereof, is present in a concentration of about
`
`5% w/w.
`
`22.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising
`
`about 5% w/w l,3—dihydro-5vfluoro-l—hydroxy~2,l-benoxaborole, or
`
`a pharmaceutically
`
`acceptable salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA)
`
`or a pharmaceutically acceptable salt thereof.
`
`23.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising
`
`about 5% w/w l,3-dihydro-5-fluoro—l~hydroxy—2,l-benoxaborole, or
`
`a pharmaceutically
`
`acceptable salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA)
`
`
`
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`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 12 of 20 PageID #: 1261
`Wfiozoz-IMK Document 24-4 Filed 01/08/19 Page 12 of 20 PagelD #: 1261
`Case 1:18—cv~00202~ll\/ll< Document 1 Filed 10/30/18 Page 7 of 15 PagelD #: 7
`
`or a pharmaceutically acceptable salt thereof; wherein the formulation is suitable for the treatment
`
`of onychomycosis of a toenail due to Tric/zophyton rubrum or Trichophyzon mentagmphytes by
`
`topical application of the formulation to the toenail.
`
`24.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising
`
`about 5% w/w l,3-dihydro-5-fluoro—l~hydroxy—2,l—benoxaborole, or
`
`a pharmaceutically
`
`acceptable salt thereof, propylene glycol, ethanol, and ethylene diamine tetraacetic acid (EDTA)
`
`or a phannaceutically 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.
`
`25.
`
`The ’289 patent claims, inter alia, a pharmaceutical formulation comprising
`
`about 5% w/w l,3—dihydro—5~fluoro~l~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 Trichophylon mentagrophytes by topical application
`
`of the formulation to the toenail.
`
`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.
`
`27.
`
`The ’290 patent claims, inter alia, a method of treating a human having
`
`onychornycosis of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the
`
`method comprising topically administering to the toenail a pharmaceutical composition
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 13 of 20 PageID #: 1262
`Wfiaserlrl8ucv-00202-IMK Document 24-4 Filed 01/08/19 Page 13 of 20 PagelD #: 1262
`
`Case 1:18~cv~00202—EMK Document 1 Filed 10/30/18 Page 8 of 15 PagelD #: 8
`
`comprising
`
`an
`
`amount
`
`of
`
`l,3—dihydro-5-fluoro-l-hydroxy—2,labenzoxaborole
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the
`
`Trichophyton rubrum or Trichophylon mentagrophytes; wherein the pharmaceutical composition
`
`is
`
`in the form of a solution comprising 5% w/w of l,3-dihydro-5~fluoro—l—hydroxy-Z,l-
`
`benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`28.
`
`The ”290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by TriC/iophytan 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,l~benzoxaborole
`
`or
`
`a
`
`phannaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the
`
`Trichophyton rubrum or Trichophytorz men/agrophytes; 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 l,3—dihydro-5—fluoro-l—hydroxy-2,l~benzoxaborole or a pharmaceutically
`
`acceptable salt thereof.
`
`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
`
`1,3odihydro—5-fluoro-l-hydroxy~2,l-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—l-hydroxy~2,1-benzoxaborole or a pharmaceutically
`
`WWW.”
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`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 14 of 20 PageID #: 1263
`W“D6€Ument
`24-4 Filed 01/08/19 Page 14 of 20 PageID #: 1263
`Case 1:18—cv-00202-lMK Document 1 Filed 10/30/18 Page 9 of 15 PagelD #: 9
`
`acceptable salt thereof; and wherein the pharmaceutical composition further comprises ethanol and
`
`propylene glycol.
`
`30.
`
`The ’290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Trichophyton rubrum or Trichophyton mentagrop/zytes, the
`
`method comprising topically administering to the toenail
`
`a pharmaceutical composition
`
`comprising
`
`an
`
`amount
`
`of
`
`l,3—dihydro-5-fluoro-l-hydroxy—2,l-benzoxaborole
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the
`
`Tric/zophyton 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 l,3—dihydro-5-fluoro-l-hydroxy-2,l—benzoxaborole or a pharmaceutically
`
`acceptable saltithereof; wherein the pharmaceutical composition further comprises ethanol and
`
`propylene glycol; and wherein the administering of the pharmaceutical composition occurs once a
`
`day.
`
`31.
`
`The ’290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Trichophylon 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,l—benzoxaborole
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the
`
`Trichophyton rubrum or Trichophyfon mentagrophyles; 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 l,3-dihydro~5-fluoro—l~hydroxy—2,l—benzoxaborole or a pharmaceutically
`
`acceptable salt thereof; wherein the pharmaceutical composition further comprises ethanol and
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 15 of 20 PageID #: 1264
`"WCéSe 1:18-CV-00202-IMK Document 24-4 Filed 01/08/19 Page 15 Of 20 PageID #: 1264
`Case 1:18—cv-00202—IMK Document 1 Filed 10/30/18 Page 10 of 15 PagelD #: 10
`
`propylene glycol; and wherein the method inhibits leucyl
`
`tRNA synthetase in Trichophyz‘on
`
`rubrum.
`
`32.
`
`The “290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Trichophyz‘on rubrum or Trichophyton mentagrophytes, the
`
`method comprising tepically administering to the toenail
`
`a pharmaceutical composition
`
`comprising
`
`an
`
`amount
`
`of
`
`1,3-dihydro—5—fluoro-l-hydroxy-2,l-benzoxaborole
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the
`
`Trichophyton rubrum or TriC/zophyton 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 l,3-dihydro-5—fluoro—l~hydroxy-2,l-benzoxaborole or a phannaceutically
`
`acceptable salt thereof; wherein the pharmaceutical composition further comprises ethanol and
`
`propylene glycol; and wherein the method inhibits leucyl tRNA synthetase in Trichophyton
`
`menlagrophytes.
`
`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.
`
`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 Trichophylon menragrop/zytes, the method comprising contacting the
`
`dorsal layer of the nail plate with a pharmaceutical composition comprising a compound that
`
`penetrates the nail plate, the compound being l,3—dihydro—S-fluoro—l~hydroxy—2,l—benzoxaborole
`
`or a pharmaceutically acceptable salt thereof, thereby treating onychomycosis due to Trichophyton
`
`rubrum or Trichophyron mentagrophyles; wherein the pharmaceutical composition is in the form
`
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`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 16 of 20 PageID #: 1265
`WZlMK Document 24-4 Filed 01/08/19 Page 16 of 20 PagelD #: 1265
`Case 1:18—cv~00202-lMK Document 1 Filed 10/30/18 Page 11 of 15 PagelD #: 11
`
`of a topical solution comprising 5% w/w of l,3—dihydro-5-fluoro-l-hydroxy-2,l—benzoxaborole,
`
`and wherein the pharmaceutical composition further comprises ethanol and propylene glycol.
`
`35.
`
`Anacor owns each of the patents~in—suit.
`
`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.
`
`37.
`
`Anacor will be substantially and irreparably damaged by infringement of
`
`the patentsdn-suit
`
`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.
`
`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 ofthe patents-in—suit.
`
`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 5050)(2)(A)(vii)(IV) of the FDCA,
`
`21 U.S.C. § 355 (j)(2)(A)(vii)(lV), with respect to each ofthe patents—in-suit, Upon information
`
`and belief, Mylan submitted its ANDA to the FDA containing a certification pursuant to 21 U.S.C.
`
`§ 3556)(2)(A)(vii)(lV) 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.
`
`11
`
`

`

`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 17 of 20 PageID #: 1266
`~€ase 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 17 of 20 PagelD #: 1266
`
`Case 1:18—cv-00202-lMK Document 1 Filed 10/30/18 Page 12 of 15 PagelD #: 12
`
`4t.
`
`Mylan’s ANDA Product, and the use of Mylan’s ANDA Product, are
`
`covered by one or more claims of each of the patents~in-suit, including at lieast the following:
`
`claims 3 and 5~6 ofthe ’938 patent; claims 10 and 12—45 ofthe ‘289 patent; claims 2, 5~6, 8, and
`
`l l-12 of the ’290 patent; and claim 2 of the ’823 patent.
`
`42.
`
`in its Notice Letter, Mylan did not contest infringement of the patents-in~
`
`suit.
`
`43.
`
`Mylan has knowledge of the each of the patents—in-suit.
`
`44.
`
`Mylan’s submission of its ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of its ANDA
`
`Product before the expiration of the patents~in-suit was an act of infringement of those patents
`
`under 35 U.S.C. § 27l(e)(2)(A).
`
`45.
`
`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
`
`and imminently upon approval of its ANDA.
`
`46.
`
`The manufacture, use, sale, offer for sale, or importation of Mylan’s ANDA
`
`Product would infringe one or more claims of each of the patents-in—suit, including at least the
`
`claims listed in above paragraph 41.
`
`47.
`
`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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`Case 1:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 18 of 20 PageID #: 1267
`Easel:18-cv-00202-IMK Document 24-4 Filed 01/08/19 Page 18 of 20 PagelD #: 1267
`Case 1:18—cv—00202‘IMK Document 1 Filed 10/30/18 Page 13 of 15 PagelD #: 13
`
`48.
`
`Upon information and belief, Mylan plans and intends t