Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 1 of 21 PageID #: 1229
`Case 1:18-cv-OO202-IMK Document 24-3 Filed 01/08/19 Page 1 of 21 PageID #: 1229
`
`Exhibit 3
`
`

`

`0 men
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 2 of 21 PageID #: 1230
`Case: 1: 8-cv-01698-RGAt 4-s 31‘: riioisrrrlalrsaear zaagem 1230
`Case 1: 18-CV-OOZOE-I M K D
`
`US. District Court
`District of Delaware (Wilmington)
`CiVlL DOCKET FOR CASE #: 1:18-cv-O1699—RGA
`
`PATENT
`
`Anacor Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et
`a1
`
`Assigned to: Judge Richard G. Andrews
`Related Cases:
`1 Zlg—CV“01606—RGA
`1:18-cv~01673—RGA
`
`Cause: 351271 Patent Infringement
`Plaintiff
`
`Anacor Pharmaceuticals, Inc.
`
`represented by
`
`V.
`
`Defendant
`
`Mylan Pharmaceuticals Inc.
`
`represented by
`
`Date Filed: 10/29/2018
`
`Jury Demand: None
`Nature of Suit: 835 Patth - Abbreviated
`
`New Drug Application(ANDA)
`Jurisdiction: Federal Question
`
`Jack B. Blumenfeld
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`PO. Box 1347
`
`Wilmington, DE 19899
`(302) 658—9200
`Email: jbbefilingfiflmnatcom
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Megan Elizabeth Dellinger
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`PO. Box 1347
`
`Wilmington, DE 19899
`302~351—9366
`
`Email: mdellingerfiflmnatcom
`ATTORNEY TO BE NOTICED
`
`David Ellis Moore
`Potter Anderson & Corroon, LLP
`1313 N. Market St, Hercules Plaza, 6th
`Flr.
`PO. Box 951
`
`Wilmington, DE 19899—0951
`(302) 984—6000
`Email: dmoore@potteranderson.Com
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Bindu Ann George Palapura
`Potter Anderson & Corroon, LLP
`1313 N. Market St., Hercules Plaza, 6th
`Flr.
`RC). Box 951
`
`Wilmington, DE 19899-0951
`302-984—6000
`Fax: 302*778~6000
`
`Email: bpalaguraaflpotterandersoncom
`ATTORNEY TO BE NOTICED
`
`Wendy L. Devine
`Email: wdevine®wscrcom
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 3 of 21 PageID #: 1231
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 3 of 21 PagelD #: 1231
`Case: 1:18—cv—01699—RGA As of: 01/06/2019 05:13 PM EST 2 of 4
`
`Defendant
`
`Mylan Inc.
`
`represented by David Ellis Moore
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOT/CED
`
`Bindu Ann George Palapura
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Wendy L. Devine
`(See above for address)
`PRO HAC VICE
`ATTORNEYTO BE NOTICED
`
`i Date Filed
`
`
`#
`Docket Text
`
`10/29/2018
`
`1, COMPLAINT * filed against Mylan Inc., Mylan Pharmaceuticals Inc. - Magistrate
`Consent Notice to Pitf. ( Filing fee $ 400, receipt number 0311—2492018.) - filed by
`Anacor Phannaceuticais, Inc. (Attachments: # 1 Exhibit A ~ D, # 2 Civil Cover
`
`Sheet)(rwc) (Entered: 10/30/2018)
`
`10/29/2018
`
`Wuwmmwm
`lm Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (rwc)
`(Entered: 10/30/2018)
`[LA Report to the Commissioner of Patents and Trademarks for Patent/Trademark
`WM
`Number(s) 9,459,938 B2 ;9,566,289 BZ ;9,566,290 B2 ;9,572,823 B2. (rwc) (Entered:
`10/30/2018)
`
`10/29/2018
`
`10/29/2018
`
`14>-
`
`Supplemental information for patent cases involving an Abbreviated New Drug
`Application (ANDA) — Date Patentee(s) Received Notice: 9/18/18. Date of Expiration
`of Patent: 2/ 16/26.Thirty Month Stay Deadline: 3/18/2021. (rwc) (Entered:
`
`10/30/2018)
`
`
`
`NMWW
`
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`E
`i
`
`E
`i
`‘
`
`i
`%
`
`;
`i
`
`
`
`10/29/2018
`
`10/30/2018
`
`IUI Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Pfizer Inc. for
`Anacor Pharmaceuticals, Inc. filed by Anacor Pharmaceuticals, Inc. (rwc) (Entered:
`10/30/2018)
`
`mwmm
`
`Summons Issued with Magistrate Consent Notice attached as to Mylan Inc. on
`10/30/2018; Mylan Pharmaceuticals Inc. on 10/30/2018. Requesting party or attorney
`should pick up issued summons at the Help Desk, Room 4209, or call 302-573*6170
`and ask the Clerk to mail the summons to them. (rwc) (Entered: 10/30/2018)
`
`10/31/2018
`
`10/31/2018
`
`Case Assigned to Judge Leonard P. Stark. Please include the initials of the Judge
`(LPS) after the case number on all documents filed. Associated Cases:
`1:18ficv—01673-LPS, 1:18~cv~01699~LPS (rjb) (Entered: 10/31/2018)
`Return of Service Executed by Anacor Pharmaceuticals, Inc.. Mylan Pharmaceuticals
`Inc. served on 10/30/2018, answer due 11/20/2018. (Dellinger, Megan) (Entered:
`
`10/31/2018)
`
`10/31/2018
`
`l\1
`
`MOTION for Pro Hac Vice Appearance of Attorney Aaron P. Maurer, David 1. Ber],
`David M. Horniak and Anthony Sheh of Williams & Connolly LLP _. filed by Anacor
`
`Pharmaceuticals, Inc.. (Dellinger, Megan) (Entered: 10/31/2018)
`
`11/01/2018
`loo
`DECLARATION of Mailing to Mylan Inc, by Anacor Pharmaceuticals, Inc..
`
`(Dellinger, Megan) Modified on 11/28/2018 (rims). (Entered: 11/01/2018)
`
`11/01/2018
`
`SO ORDERED, re 1 MOTION for Pro Hac Vice Appearance of Attorney Aaron P.
`Maurer, David I. Berl, David M. Horniak and Anthony Sheh of Williams & Connolly
`LLP, filed by Anacor Phannaceuticals, Inc. Signed by Judge Leonard P. Stark on
`11/1/18. Associated Cases: 1218“CV‘“OI606~LPS, 1318“CV”01673“LPS,
`1218*cv~01699~LPS (ntl) Modified on 11/28/2018 (nms). (Entered: 11/01/2018)
`
` 11/07/2018 1
`
`lxo
`
`MOTION for Pro Hac Vice Appearance of Attorney T.O. Kong and Wendy Lynn
`Devine of Wilson Sonsini Goodrich & Rosati - filed by Mylan Inc, Mylan
`
`
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 4 of 21 PageID #: 1232
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 4 of 21 PagelD #: 1232
`Case: 1:18—cv—01699-RGA As of: 01/06/2019 05:13 PM EST 3 of 4
`
`
`
`Pharmaceuticals Inc.. (Palapura, Bindu) (Entered: 11/07/2018)
`
`i
`
`1
`
`11/09/2018
`
`SO ORDERED, re _9_ MOTION for Pro Hac Vice Appearance of Attorney T.O. Kong
`and Wendy Lynn Devine of Wilson Sonsini Goodrich & Rosati filed by Mylan Inc,
`Mylan Pharmaceuticals Inc. Signed by Judge Leonard P. Stark on 1 1/9/18. (ntl)
`
`(Entered: 11/09/2018)
`
`10 NOTICE of Appearance by David Ellis Moore on behalf of Mylan 1nc., Mylan
`1 1/12/2018
`
`Pharmaceuticals Inc. (Moore, David) (Entered: 11/12/2018)
`
`11/13/2018
`1 1
`STIPULATION TO EXTEND TIME to answer, move or otherwise respond to the
`Complaint to December 11, 2018 — filed by Mylan Inc, Mylan Pharmaceuticals Inc..
`
`(Palapura1 Bindu) (Entered: 11/13/2018)
`
`,1
`
`1 1/15/2018
`
`SO ORDERED, re 11 STIPULATION TO EXTEND TIME to answer, move or
`otherwise respond to the Complaint to December 113 2018 filed by Mylan Inc, Mylan
`Pharmaceuticals Inc. Signed by Judge Leonard P. Stark on 11/15/18. (ntl) (Entered:
`
`11/15/2018)
`
`11/16/2018
`
`Case Reassigned to Judge Richard G. Andrews. Please include the initials of the Judge
`(RGA) after the case number on all documents filed. Associated Cases:
`1:18—cv—01606‘RGA, 1:18~cv-01673—RGA, 1:18-cv~01699~RGA (rjb) (Entered:
`
`1 1/16/2018)
`L
`Pro Hac Vice Attorney Wendy L. Devine for Mylan Inc.,Wendy L. Devine for Mylan
`Pharmaceuticals Inc. added for electronic noticing. Pursuant to Local Rule 83.5 (d),
`Delaware counsel shall be the registered users of CM/ECF and shall be required to file
`all papers. (lak) (Entered: 11/19/2018)
`
`1 1/ 19/2018
`
`12/ 10/2018
`
`l
`12 Cross-M0tion to Stay All Cases Against All Defendants and Response to Defendant
`Flatwing's Motion to Stay Case 1 filed by Anacor Pharmaceuticals, Inc.. (Dellinger,
`
`Megan) Modified on 12/1 1/2018 (nrns). (Entered: 12/10/2018)
`
`12/10/2018
`
`Set Answering Brief Deadline re 12 Cross~Motion to Stay All Cases Against All
`Defendants and Response to Defendant Flatwing's Motion to Stay Case. Answering
`
`
`Brief/Response due date per Local Rules is 12/24/2018. (nms) (Entered: 12/11/2018)
`
`12/11/2018
`
`13 STIPULATION TO EXTEND TIME for Mylan to answer, move or otherwise respond
`to the Complaint to December 21, 2018 and for Mylan to respond to the Cross—Motion
`
`to Stay to January 9, 2019 — filed by Mylan Inc., Mylan Pharmaceuticals Inc..
`
`
`(Palapura, Bindu) (Entered: 12/1 1/2018)
`
`J
`
`12/12/2018
`
`SO ORDERED, re 1; STIPULATION TO EXTEND TIME for Mylan to answer,
`move or otherwise respond to the Complaint to December 21, 2018, and for Mylan to
`respond to the Cross-Motion to Stay to January 9, 2019. Signed by Judge Richard G.
`
`Andrews on 12/11/2018. (runs) (Entered: 12/12/2018)
`
`12/21/2018
`
`12/21/2018
`
`filed by
`MOTION to Dismiss for Improper Venue and Failure to State a Claim -
`Mylan Inc., Mylan Pharmaceuticals Inc.. (Attachments: # 1 Text of Proposed
`
`Order)(Palapura, Bindu) Modified on 12/28/2018 (rims). (Entered: 12/21/2018)
`
`[SEALED] OPENING BRIEF in Support re 11 MOTION to Dismiss for Improper
`Venue and Failure to State a Claim, filed by Mylan Inc., Mylan Pharmaceuticals
`Inc..Answering Brief/Response due date per Local Rules is 1/4/2019. (Palapura,
`
`Bindu) Modified on 12/28/2018 (nms). (Entered: 12/21/2018)
`
`
`
`
`
`
`
`12/21/2018
`
`16
`
`[SEALED] DECLARATION of Keith Meckstroth re 14 MOTION to Dismiss for
`Improper Venue and Failure to State a Claim, by Mylan Inc, Mylan Pharmaceuticals
`Inc.. (Attachments: # 1 Exhibits A—C)(Pa1apura, Bindu) Modified on 12/28/2018
`
`(nms). (Attachment 1 replaced on 1/4/2019) (nms). (Entered: 12/21/2018)
`
`12/21/2018
`
`12 Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Mylan N.V.
`for Mylan Inc.; Corporate Parent Mylan Inc. for Mylan Pharmaceuticals Inc. filed by
`Mylan Inc” Mylan Pharmaceuticals Inc.. (Palapura, Bindu) (Entered: 12/21/2018)
`
`12/31/2018
`
`18 STIPULATION and Order — filed by Anacor Pharmaceuticals, Inc.. (Blumenfeld,
`Jack) Modified on 1/2/2019 (rims). (Entered: 12/31/2018)
`
`I
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 5 of 21 PageID #: 1233
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 5 of 21 PagelD #: 1233
`Case: 1:18—cv-01699—RGA As of: 01/06/2019 05:13 PM EST 4 of 4
`
`
`
`
`01/02/2019
`
`SO ORDERED, re 1§ STIPULATION and Order (Reset Briefing Scheduie: re 13
`MOTION to Dismiss for Improper Venue and Failure to State a Claim. Answering
`Brief due 1/18/2019). Signed by Judge Richard G. Andrews on 1/2/2019. (nrns)
`
`(Entered: 01/02/2019)
`
`
`
`
`
`
`(11/04/2019
`20 REDACTED VERSION of_1_6_Declaration, ofKeiz‘hAlec/{strait by My1an Inc, Mylan T
`
`(11/04/2019
`
`(11/04/2019
`
`[
`
`L
`
`CORRECTING ENTRY: The pdf for the exhibits found at 13.1. 16 has been replaced
`per counsel's request. Exhibit B has been corrected. (runs) (Entered: (11/04/2019)
`
`12 REDACTED VERSION of_1_§ Opening Brief in Support, by Mylan Inc, Mylan
`
`Pharmaceuticals Inc.. (Palapura, Bindu) (Entered: 01/04/2019)
`
`Pharmaceuticals Inc.. (Attachments: # 1 Exhibit A~C)(Palapura, Bindu) (Entered:
`01/04/2019)
`
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`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 6 of 21 PageID #: 1234
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 6 of 21 PageID #: 1234
`Case 1:18-cv—01699—UNA Document 1 Filed 10/29/18 Page 1 of 16 PagelD #: 1
`
`IN THE UNITED STATES DISTRlCT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ANACOR PHARMACEUTICALS, INC.,
`
`)
`
`Plaintiff,
`
`v.
`MYLAN PHARIVIACEUTICALS INC. and
`
`MYLAN INC,
`
`Defendants.
`
`)
`) CA. No.
`i
`
`)
`
`)
`
`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 I7, 2018 (“Mylan’s Notice Letter”) that it had submitted to the FDA ANDA No.
`
`2l2065 (“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.
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 7 of 21 PageID #: 1235
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 7 of 21 PagelD #: 1235
`Case 1:18-0v—01699-UNA Document 1 Filed 10/29/18 Page 2 of 16 PagelD #: 2
`
`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.
`
`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 24-3 Filed 01/08/19 Page 8 of 21 PageID #: 1236
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 8 of 21 PagelD #: 1236
`Case 1:18~cv—01699-UNA Document 1 Filed 10/29/18 Page 3 of 16 PagetD #: 3
`
`JURISDICTION
`
`8.
`
`Jurisdiction is proper in this district pursuant
`
`to 28 USC. §§ I33],
`
`1338(a), 2201, and 2202.
`
`9.
`
`This Court has personal jurisdiction over Mylan.
`
`10.
`
`Mylan Pharmaceuticals Inc. is subject to personal jurisdiction in Delaware
`
`because, among other things, it has purposely availed itself of the benefits and protections of
`
`Delaware’s laws such that it should reasonably anticipate being haled into court here. 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
`
`Delaware and therefore transacts business within the State of Delaware related to Anacor’s
`
`claims, and/or has engaged in systematic and continuous business contacts within the State of
`
`Delaware.
`
`ll.
`
`Mylan Inc. is subject to personal jurisdiction in Delaware 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 Delaware’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 Delaware and therefore transacts business within the State of Delaware, and/or has
`
`engaged in systematic and continuous business contacts within the State of Delaware.
`
`In
`
`addition, Mylan Inc. is subject to personal jurisdiction in Delaware because, upon information
`
`and beiief, it controls and dominates Mylan Pharmaceuticals Inc. and therefore the activities of
`
`Mylan Pharmaceuticals Inc. in this jurisdiction are attributed to Mylan inc.
`
`U.)
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 9 of 21 PageID #: 1237
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 9 of 21 PagelD #: 1237
`Case 1:18-cv-01699-UNA Document 1 Filed 10/29/18 Page 4 of 16 Page“) #2 4
`
`l2.
`
`Mylan has previously used the process contemplated by the Hatch»
`
`Waxman Act to challenge branded pharmaceutical companies’ patents by filing a certification of
`
`the
`
`type
`
`described
`
`in
`
`Section
`
`5050)(2)(A)(vii)(lV)
`
`of
`
`the
`
`FDCA,
`
`21 U.S.C.
`
`§355(j)(2)(A)(vii)(lV), serving a notice letter on those companies, and engaging in patent
`
`litigation arising from the process contemplated by the Hatch—Waxman Act.
`
`13.
`
`Upon information and belief, Mylan, with knowledge of the Hatch—
`
`Waxman Act process, directed Mylan’s Notice Letter
`
`to,
`
`inter alia, Anacor, an entity
`
`incorporated in Delaware, and alleged in Mylan’s Notice Letter that Anacor’s patents are invalid.
`
`Upon information and belief, Mylan knowingly and deliberately challenged Anacor’s patent
`
`rights, and knew when it did so that it was triggering a forty—five day period for Anacor to bring
`
`an action for patent infringement under the Hatch—Waxman Act.
`
`14.
`
`Because Anacor is a corporation incorporated in Delaware, Anacor suffers
`
`injury and consequences from Mylan’s filing of Mylan’s ANDA, challenging Anacor’s patent
`
`rights,
`
`in Delaware. Upon information and belief, Mylan knew that
`
`it was deliberately
`
`challenging the patent rights of a Delaware entity and seeking to invalidate intellectual property
`
`held in Delaware. Mylan has been a litigant in connection with other infringement actions under
`
`the Hatch—Waxman Act, and reasonably should have anticipated that by sending Mylan’s Notice
`
`Letter to Anacor, a Delaware corporation,
`
`that
`
`it would be sued in Delaware for patent
`
`infringement.
`
`15.
`
`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 Delaware, consistently with Mylan’s practices for the marketing
`
`and distribution of other generic pharmaceutical products. Upon information and belief, Mylan
`
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`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 10 of 21 PageID #: 1238
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 10 of 21 PagelD #: 1238
`Case 1:18-cv—01699—UNA Document 1 Filed 10/29/18 Page 5 of 16 PagelD #: 5
`
`regularly does business in Delaware, 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 Delaware.
`
`Upon information and belief, Mylan’s generic
`
`pharmaceutical products are used and/or consumed within and throughout the United States,
`
`including in Delaware. Upon information and belief, Mylan’s ANDA Product will be prescribed
`
`by physicians practicing in Delaware, dispensed by pharmacies located within Delaware, and
`
`used by patients in Delaware. Each of these activities would have a substantial effect within
`
`Delaware and would constitute infringement of Anacor’s patents in the event that Mylan’s
`
`ANDA Product is approved before the patents expire.
`
`16.
`
`Upon information and belief, Mylan derives substantial revenue from
`
`generic pharmaceutical products that are used and/or consumed within Delaware, 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 Delaware.
`
`THE PATENTS—IN—SUIT
`
`l7.
`
`Anacor incorporates each of the preceding paragraphs l—~16 as if fully set
`
`forth herein.
`
`18.
`
`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”).
`
`

`

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`Case 1:18—cv—01699-UNA Document 1 Filed 10/29/18 Page 6 of 16 PagelD #: 6
`
`19.
`
`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.
`
`20.
`
`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.
`
`21.
`
`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 Tric/mphyton rubrum or Tz'ichophyton
`
`mentagrophytes, and 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.
`
`22.
`
`The ’938 patent claims, inter alia, a method of treating a Tinea zmguium
`
`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 Trichophyion rubrum or Trichophyton
`
`mentagrophyfes, wherein the pharmaceutical composition is in the form of a solution comprising
`
`
`
`WWWWM‘mawwmm
`
`WWW“
`
`New“.
`
`mmwmu
`
`
`
`WWW»mnmwwm
`
`MWWWW
`
`MWWWW.
`
`

`

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`Case 1:18—cv-01699—UNA Document 1 Filed 10/29/18 Page 7 of 16 PagelD #: 7
`
`5% w/w l,3—dihydro—5—fluoro~l~hydroxy—2,l—benzoxaborole, and wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`23.
`
`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
`
`lnventors.
`
`24.
`
`The
`
`’289 patent
`
`claims,
`
`inter alia,
`
`a pharmaceutical
`
`formulation
`
`comprising l,3-dihydro—5—fluoro—l—hydroxy-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.
`
`25.
`
`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 pharmaceutically acceptable salt thereof.
`
`26.
`
`The
`
`’289 patent claims,
`
`inter alia,
`
`a pharmaceutical
`
`formulation
`
`comprising
`
`about
`
`5% w/w l,3—dihydro-5-fluoro~1~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; wherein the formulation is
`
`suitable for the treatment of onychomycosis of a toenail due to Yi‘ichophylon rubrum or
`
`Trichophylon mentagrophytes by topical application of the formulation to the toenail.
`
`27,
`
`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
`
`

`

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`Case 1:18-CV—01699-UNA Document 1 Filed 10/29/18 Page 8 of 16 PagelD #: 8
`
`tetraacetic acid (BDTA) 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.
`
`28.
`
`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 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 TriC/iophyton rubrum or Trichophyton
`
`mentagmphytes by topical application of the formulation to the toenail.
`
`29.
`
`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.
`
`30.
`
`The ’290 patent claims, inter alia, a method of treating a human having
`
`onychornycosis of a toenail caused by Trickophyton rubrum or Trichophyton mentagmphyles,
`
`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 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-iluoro—l~hydroxy~
`
`2,l -benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`mmmwm
`
`
`
`WWWmemmWmmm
`
`Wm
`
`WVWWWY
`
`Mwlmmm
`
`mmama-m
`
`

`

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`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 14 of 21 PagelD #: 1242
`Case 1:18~cv-01699—UNA Document 1 Filed 10/29/18 Page 9 of 16 PagelD #: 9
`
`31.
`
`The 5290 patent claims; inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Trickop/iyton rubrum or Yi‘ic/iop/iyton mentagrop/zytesg
`
`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 Ti'ichophyton rubrum or
`
`fi‘ichophyl‘on mentagrophyfes; 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.
`
`32.
`
`The ”290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Zl‘ichophyton rub/“um or Yi’iC/mp/Iyton mentagrop/iytes,
`
`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 Trio/70171021017 rubrul'n or Trichophyton men/agrophyfes; 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; and wherein the pharmaceutical composition further
`
`comprises ethanol and propylene glycol.
`
`33.
`
`The ’290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Trichophyton rubrmn or Tl'z'c/iophylan memagrophytes,
`
`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
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 15 of 21 PageID #: 1243
`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 15 of 21 PagelD #: 1243
`Case 1:18-cv~01699-UNA Document 1 Filed 10/29/18 Page 10 of 16 PagelD it: 10
`
`mmwmvm
`
`mmwm
`
`i
`
`Ei
`
`Wmvwqu
`
`t
`E
`
`memvm
`
`E
`
`
`
`W,w‘ru‘rawmw
`
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in
`
`the Tricitophyton rat/3mm or Trichop/iyl'on men/agrophyles; wherein the aminoacyl
`
`tRNA
`
`synthetase is leucyi 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 propylene glycol; and wherein the administering of the pharmaceutical
`
`composition occurs once a day.
`
`34.
`
`The ”290 patent claims, inter alia, a method of treating a human having
`
`onychomycosis of a toenail caused by Trickophylon rubrum or Trio/zophylon menlagrophytes,
`
`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/tophyton rubrum or Trichophyz‘on menlagmphytes; 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 prepylene glycol; and wherein the method inhibits leucyl
`tRNA
`
`synthetase in Tz‘ichophylon rubrum.
`
`35.
`
`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
`
`l,3—dihydro~5—fluoro~l~hydroxy-2,l-benzoxaborole
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in
`
`10
`
`

`

`Case 1:18-cv-00202-IMK Document 24-3 Filed 01/08/19 Page 16 of 21 PageID #: 1244
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`Case 1:18-cv—01699-UNA Document 1 Filed 10/29/18 Page 11 of 16 PagelD #: 11
`
`the Tric/rophyfon rubrum or Trickop/ryton 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 salt
`
`thereof; wherein the pharmaceutical composition further
`
`comprises ethanol and propylene glycol; and wherein the method inhibits
`
`leucyl
`
`tRNA
`
`synthetase in Trichophyton mentagmphytes.
`
`36.
`
`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.
`
`37.
`
`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 Yi‘z'chophyton 111entag7‘0phyl'es, 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 1,3-dihydro—5-fluoro-l -hydroxy—2,l —benzoxaborole
`
`or
`
`a pharmaceutically acceptable salt
`
`thereof,
`
`thereby treating onychomycosis due to
`
`Trickop/iyton rubrum or Tric/tophyton mentagrophyt’es; wherein the pharmaceutical composition
`
`is in the form of a topical solution comprising 5% w/w of l,3—dihydro—5—fiuoro—l~hydroxy—2,l—
`
`benzoxaborole, and wherein the pharmaceutical composition further comprises ethanol and
`
`prop