Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 1 of 43 PageID #: 1093
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 1 of 43 PageID #: 1093
`
`Exhibit 1
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 2 of 43 PageID #: 1094
`Case 1:18-cv-00202-IMK Document 24-1 Flled 01/08/19 Page 2 of 43 PageID #: 1094
`Case: 1218~CV-01606~RGA AS Of: 01/06 2019 05:11 P EST 1 Of 8
`
`U.S. District Court
`District of Delaware (Wilmington)
`CIVIL DOCKET FOR CASE #: 1:18—cv-O1606—RGA
`
`PATENT
`
`Anacor Pharmaceuticals, Inc. V. Lupin Limited et al
`Assigned to: Judge Richard G. Andrews
`Related Cases: 1:] 8~cv-Ol 673—RGA
`1:18~cv~01699—RGA
`Cause: 35 2271 Patent Infringement
`Plaintiff
`
`Date Filed: 10/17/2018
`Jury Demand: None
`Nature of Suit: 835 Patent - Abbreviated
`New Drug Application(ANDA)
`Jurisdiction: Federal Question
`
`Anacor Pharmaceuticals, Inc.
`
`represented by Jack B. Blumenfeld
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`PO. Box 1347
`
`Wilmington, DE 19899
`(302) 658-9200
`,mnat.com
`Email:'bbefilin
`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: mdellingerdflmnatcom
`ATTORNEY TO BE NOTICED
`
`V.
`
`Defendant
`
`Lupin Limited
`
`1
`
`represented by Andrea L. Cheek
`
`Email: andrea.cheek@knobbe.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Aryeh N. Feinstein
`Email: Ari.Feinstein@knobbe.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Carol M. Pitzel Cruz
`
`Email: carolpitzel.cruz@knobbe.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`William R. Zimmerman
`Email: 2wrz@knobbe.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Katharine Lester Mowery
`Richards, Layton & Finger, PA
`One Rodney Square
`Suite 600
`
`920 N. King Street
`Wilmington, DE 19801
`302-651—7623
`
`Email: mowery@rlf.com
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 3 of 43 PageID #: 1095
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 3 of 43 PageID #: 1095
`Case: 1:18-ev~01606—RGA As of: 01/06/2019 05:11 PM EST 2 of 8
`
`Defendant
`
`Lupin Pharmaceuticals, Inc.
`
`ATTORNEY TO BE NOTICED
`
`represented by Andrea L. Cheek
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Aryeh N. Feinstein
`(See above for address)
`PRO I-IAC VICE
`ATTORNEY TO BE NOTICED
`
`Carol M. Pitzel Cruz
`
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`William R. Zimmerman
`
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Katharine Lester Mowery
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Defendant
`
`Encube Ethicals Pvt. Ltd.
`
`represented by
`
`Gary J. Speier
`Email: gspeiercharlsoncasperseom
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Renee Marie Mosley
`Richards, Layton & Finger, PA
`One Rodney Square
`Suite 600
`
`920 N. King Street
`Wilmington, DE 19801
`(302) 651~7641
`Email: inosleyézlrlficom
`ATTORNEY TO BE NOTICED
`
`Samuel T. Lockner
`
`Email: slockner@carlsoncasgerseom
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Kelly E. Farnan
`Richards, Layton & Finger, PA
`One Rodney Square
`Suite 600
`
`920 N. King Street
`Wilmington, DE 19801
`(302) 651-7705
`
`Email: faman@rlf.com
`ATTORNEY TO BE NOTICED
`
`Defendant
`
`Glasshouse Pharmaceuticals Limited
`Canada
`
`represented by Karen Elizabeth Keller
`Shaw Keller LLP
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`
`”WWW.
`
`miwtwmm
`
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`WWW
`
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`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 4 of 43 PageID #: 1096
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 4 of 43 PageID #: 1096
`Case: 1:18-cv-01606—RGA As of: 01/06/2019 05:11 PM EST 3 of 8
`
`Defendant
`
`FlatWing Pharmaceuticals, LLC
`
`302-298—0700
`
`Email: kkellernghawkellercom
`ATTORNEY TO BE NOTICED
`
`represented by John C. Phillips , Jr.
`Phillips, Goldman, McLaughlin & Hall,
`RA.
`1200 North Broom Street
`
`Wilmington, DE 19806
`(302) 655—4200
`Email: jcp®pgmhlawcom
`LEAD A TTORNEY
`ATTORNEY TO BE NOTICED
`
`Megan C. Haney
`Phillips, Goldman, McLaughlin & Hall,
`PA.
`1200 North Broom Street
`
`Wilmington, DE 19806
`302- 655—4200
`
`Email: mchfcbpgmhlaweom
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`David A. Gerasimow
`
`Email: david.gerasimowKizlhuschblackwell.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Don J. Mizerk
`Email: don.mizerkfdlhuschblackwell.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Marc R. Wezowski
`Email: marewezowski@husohblackwelLoom
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Counter Claimant
`
`Lupin Limited
`
`Counter Claimant
`
`Lupin Pharmaceuticals, Inc.
`
`V.
`
`Counter Defendant
`
`Anacor Pharmaceuticals, Inc.
`
`represented by Katharine Lester Mowery
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Katharine Lester Mowery
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Jack B. Blumenfeld
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Megan Elizabeth Dellinger
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 5 of 43 PageID #: 1097
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 5 of 43 PagelD #: 1097
`Case: lilB-CV—Ol606-RGA AS Of: 01/06/2019 05:11 PM EST 4 018
`
`Counter Claimant
`
`Encube Ethicals Pvt. Ltd.
`
`represented by Kelly E. Farnan
`(See above for address)
`ATTORNEY TO BE NOT/CED
`
` Date Filed
`Docket Text
`
`
`COMPLAINT for PATENT INFRINGEMENT filed against Encube Ethicals Pvt.
`Ltd., FlatWing Pharmaceuticals, LLC, Glasshouse Pharmaceuticals Limited Canada,
`Lupin Limited, Lupin Pharmaceuticals, Inc. - Magistrate Consent Notice to Pltf. (
`Filing fee 33 400, receipt number 031 1-2483254.) “ filed by Anacor Pharmaceuticals,
`Inc.. (Attachments: # _1_ Exhibit A-D, # 21 Civil Cover Sheet)(nmg) (Entered:
`10/17/2018)
`
`
`
`
`Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (nmg)
`10/17/2018
`(Entered: 10/17/2018)
`
`
`
`10/17/2018
`
`
`
`10/17/2018
`
`Supplemental information for patent cases involving an Abbreviated New Drug
`Application (ANDA) — Date Patentee(s) Received Notice: See Attached. Date of
`Expiration of Patent: 2/16/2026. Thirty Month Stay Deadline: See Attached. (nmg)
`(Entered: 10/ 17/2018)
`
`Report to the Commissioner of Patents and Trademarks for Patent/Trademark
`Number(s) 9,459,938 B2; 9,566,289 B2; 9,566,290 B2; 9,572,823 B2. (nmg) (Entered:
`
`10/ 17/2018)
`
`Summons Issued with Magistrate Consent Notice attached as to Encube Ethicals Pvt.
`Ltd. on 10/17/2018; FlatWing Pharmaceuticals, LLC on 10/ 17/2018; Glasshouse
`Pharmaceuticals Limited Canada on 10/17/2018; Lupin Limited on 10/17/2018; Lupin
`Pharmaceuticals, Inc. on 10/ 17/2018. 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. (11mg) (Entered: 10/ 17/2018)
`
`
`
`
`
`
`10/17/2018
`
`10/ 17/2018
`
`10/17/2018
`
`10/ 19/2018
`
`
`
`
`Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Pfizer Inc. for
`Anacor Pharmaceuticals, Inc. filed by Anacor Pharmaceuticals, Inc.. (nmg) (Entered:
`10/17/2018)
`
`
`
`
`10/18/2018
`Return of Service Executed by Anacor Pharmaceuticals, Inc.. Lupin Pharmaceuticals,
`Inc. served on 10/18/2018, answer due 11/8/2018. (Blumenfeld, Jack) (Entered:
`
`
`10/ 18/2018)
`
`10/19/2018
`Return of Service Executed by Anacor Pharmaceuticals, Inc.. FlatWing
`Pharmaceuticals, LLC served on 10/18/2018, answer due 1 1/8/2018. (Blumenfeld,
`
`Jack) (Entered: 10/ 19/2018)
`
`
`Return of Service Executed by Anacor Pharmaceuticals, Inc.. Glasshouse
`Pharmaceuticals Limited Canada served on 10/18/2018, answer due 11/8/2018.
`
`(Blumenfeld, Jack) (Entered: 10/19/2018)
`
`10/23/2018
`
`SUMMONS Returned Executed by Anacor Pharmaceuticals, Inc.. Encube Ethicals
`Pvt. Ltd. served on 10/18/2018, answer due 11/8/2018. (Blumenfeld, Jack) (Entered:
`
`
`10/23/2018)
`
`10/24/2018
`
`10/31/2018
`
`MOTION for Pro Hac Vice Appearance of Attorney Aaron P. Maurer, David I. Berl,
`David M. Homiak and Anthony Sheh of Williams & Connolly LLP ~ filed by Anacor
`
`
`Pharmaceuticals, Inc.. (Dellinger, Megan) (Entered: 10/31/2018)
`10/31/2018
`
`
`
`10/31/2018
`WAIVER OF SERVICE returned executed by Anacor Pharmaceuticals, Inc: For
`Lupin Limited waiver sent on 10/29/2018, answer due 12/28/2018. (Blumenfeld, Jack)
`
`
`(Entered: 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. (rjb) (Entered: 10/24/2018)
`
`REQUEST FOR WAIVER of Service sent to Lupin Limited on 10/29/2018 by Anacor
`
`Pharmaceuticals, Inc.. (Blumenfeld, Jack) (Entered: 10/31/2018)
`
`
`
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`
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`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 6 of 43 PageID #: 1098
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Pa e 6 of 43 PageID #: 1098
`Case: 1:18—cv—01606—RGA As of: 01/06/2019 05:11 P EST 5 of 8
`
`7
`
`11/01/2018
`
`SO ORDERED, re (7 in 1:18~cv~01699—LPS, 15 in 1:18-cv—01673-LPS, 10 in
`1:18hcv—01606—LPS) MOTION for Pro Hac Vice Appearance of Attorney Aaron P.
`Maurer, David I. Ber], David M. Horniak and Anthony Sheh of Williams & Connolly
`LLP filed by Anacor Pharmaceuticals, Inc. Signed by Judge Leonard P. Stark on
`11/1/18. Associated Cases: 1:18—cv-01606—LPS, 1:18wcv-01673~LPS,
`
`1218*cv~01699”LPS (ntl) (Entered: 11/01/2018)
`1.__1
`11/05/2018
`
`STIPULATION TO EXTEND TIME for Flatwing to answer, plead or otherwise
`respond to the Complaint (D.I. 1) to December 10, 2018 - filed by FlatWing
`
`Pharmaceuticals, LLC. (Phillips, John) (Entered: 11/05/2018)
`
`
`
`
`
` Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by
`
`11/06/2018
`
`STIPULATION TO EXTEND TIME to Respond to the Complaint to December 10,
`2018 - filed by Glasshouse Pharmaceuticals Limited Canada. (Keller, Karen)
`
`(Entered: 11/06/2018)
`
`11/06/2018
`
`1
`
`STIPULATION TO EXTEND TIME for defendant Encube Ethicals Pvt. Ltd. to
`respond to the Complaint to December 10, 2018 - filed by Anacor Pharmaceuticals,
`
`
`Inc. (Dellinger, Megan) (Entered: 11/06/2018)
`
`11/08/2018
`
`11/08/2018
`
`11/08/2018
`
`ANSWER to _1_ Complaint, and COUNTERCLAIM of Lupin Ltd. against Anacor
`Pharmaceuticals, Inc, by Lupin Limited, Lupin Pharmaceuticals, Inc..(Mowery,
`
`Katharine) Modified on 1 1/19/201 8 (nms). (Entered: 11/08/2018)
`
`Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Lupin Atlantis
`Holdings S.A. for Lupin Limited; Corporate Parent Lupin Ltd, Corporate Parent
`Lupin Inc. for Lupin Pharmaceuticals, Inc. filed by Lupin Limited, Lupin
`
`Pharmaceuticals, Inc.. (Mowery, Katharine) (Entered: 1 1/08/2018)
`
`MOTION for Pro Hac Vice Appearance ofAttorney William R. Zimmerman, Carol
`
`l
`
`Pitzel Cruz and Andrea L. Cheek - filed by Lupin Limited, Lupin Pharmaceuticals,
`
`Inc.. (Mowery, Katharine) (Entered: 11/08/2018)
`
`11/09/2018
`
`SO ORDERED, re 18 MOTION for Pro Hac Vice Appearance of Attorney William R.
`Zimmerman, Carol Pitzel Cruz and Andrea L. Cheek filed by Lupin Limited, Lupin
`Pharmaceuticals, Inc. Signed by Judge Leonard P. Stark on 11/9/18. (ntl) (Entered:
`
`1 1/09/2018)
`
`11/14/2018
`
`Pro Hac Vice Attorney Andrea L. Cheek, Carol M. Pitzel Cruz, and William R.
`Zimmerman for Lupin Limited and Lupin 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. (ceg) (Entered: 11/14/2018)
`
`11/14/2018
`
`SO ORDERED, re 1; STIPULATION TO EXTEND TIME for defendant Encube
`Ethicals Pvt. Ltd. to respond to the Complaint to December 10, 2018 filed by Anacor
`Pharmaceuticals, Inc., JA STIPULATION TO EXTEND TIME to Respond to the
`Complaint to December 10, 2018 filed by Glasshouse Pharmaceuticals Limited
`Canada, 1; STIPULATION TO EXTEND TIME for Flatwing to answer, plead or
`otherwise respond to the Complaint (D.I. 1) to December 10, 2018 filed by FlatWing
`Pharmaceuticals, LLC. Signed by Judge Leonard P. Stark on 11/8/18. (ntl) (Entered:
`
`11/14/2018)
`——i
`11/15/2018
`
`ANSWER to 1 Complaint, Defenses and, COUNTERCLAIM against Anacor
`Pharmaceuticals, Inc. by Encube Ethicals Pvt. Ltd..(Faman, Kelly) (Entered:
`
`11/15/2018)
`
`11/15/2018
`
`11/15/2018
`
`
`Encube Ethicals Pvt. Ltd. (Farnan, Kelly) (Entered: 11/15/2018)
`
`MOTION for Pro Hac Vice Appearance of Attorney Gary J. Speier and Samuel T.
`
`Lockner - filed by Encube Ethicals Pvt. Ltd.. (Farnan, Kelly) (Entered: 1 1/ 15/2018)
`
`11/16/2018
`
`SO ORDERED, re 2_1_ MOTION for Pro Hac Vice Appearance of Attorney Gary J.
`Speier and Samuel T. Lockner filed by Encube Ethicals Pvt. Ltd. Signed by Judge
`
`Leonard P. Stark on 1 1/ 16/ 18. (ntl) (Entered: 1 1/ 16/2018)
`
`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)
`
`
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 7 of 43 PageID #: 1099
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 7 of 43 PagelD #: 1099
`Case: lilB—CV—OlBOG-RGA AS of: 01/06/2019 05:11 PM EST 6 018
`
`
`22 NOTICE of Appearance by Renee Marie Mosley on behalf of Encube Ethicals Pvt.
`_4
`Ltd. (Mosley, Renee) (Entered: 1 1/ 16/2018)
`Pro Hac Vice Attorney Samuel T. Lockner and Gary J. Speier for Encube Ethicals Pvt.
`Ltd. 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. (ceg)
`
`(Entered: 11/20/2018)
`
`2?; MOTIONto Stay Case PendingResolution ofInterPartes Review ..filed by FlatWingj
`
`Pharmaceuticals, LLC. (Attachments: # 1 Proposed Order)(Phillips, John) Modified on
`1 1/27/2018 (inns). (Entered: 1 1/26/2018)
`
`22 OPENING BRIEF in Support re 23; MOTION to Stay Case Pending Resolution of
`Inter Partes Review, filed by FlatWing Pharmaceuticals, LLC.Answering
`Brief/Response due date per Local Rules is 12/10/2018. (Phillips, John) Modified on
`
`11/27/2018 (nms). (Entered: 11/26/2018)
`
`_2_5 DECLARATION of David A. Gerasimow re Li MOTION to Stay Case Pending
`Resolution of Inter Partes Review, by FlatWing Pharmaceuticals, LLC. (Attachments:
`# _1_ Exhibit A, # 2 Exhibit B, # 2 Exhibit C, # & Exhibit D, # i Exhibit E, # _6_ Exhibit F,
`# 1 Exhibit G, # 8 Exhibit H, # _9_ Exhibit I, # _l_Q Exhibit J, # fl Exhibit K, # 12 Exhibit
`L)(Phillips, John) Modified on 11/27/2018 (runs). (Entered: 11/26/2018)
`
`26 MOTION for Pro Hac Vice Appearance of Attorney Marc R. Wezowski and David
`Gerasimow ~ filed by FlatWing Pharmaceuticals, LLC. (Haney, Megan) (Entered:
`1 1/26/2018)
`
`SO ORDERED, re 26 MOTION for Pro Hac Vice Appearance of Attorney Marc R.
`Wezowski and David Gerasimow, filed by FlatWing Pharmaceuticals, LLC. Signed by
`Judge Richard G. Andrews on 11/27/2018. (nms) (Entered: 1 1/27/2018)
`
`11/16/2018
`
`11/20/2018
`
`11/26/2018
`
`11/26/2018
`
`11/26/2018
`
`1 1/26/2018
`
`1 1/27/2018
`
`11/27/2018
`
`11/27/2018
`
`__J
`
`
`
`
`2] Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Wicker
`Pharmaceuticals, LLC for FlatWing Pharmaceuticals, LLC filed by FlatWing
`Pharmaceuticals, LLC. (Phillips, John) (Entered: 11/27/2018)
`
`
`
`Pro Hac Vice Attorney Marc R. Wezowski and David A. Gerasimow for FlatWing
`Pharmaceuticals, LLC 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. (ceg) (Entered: 11/27/2018)
`
`1 1/27/2018
`
`1 1/27/2018
`
`MOTION for Pro Hac Vice Appearance of Attorney Don J. Mizerk - filed by
`FlatWing Pharmaceuticals, LLC. (Haney, Megan) (Entered: 11/27/2018)
`
`SO ORDERED, re 28 MOTION for Pro Hac Vice Appearance of Attorney Don J.
`Mizerk, filed by FlatWing Pharmaceuticals, LLC. Signed by Judge Richard G.
`
`Andrews on 11/27/2018. (nms) (Entered: 11/27/2018)
`
`11/28/2018
`
`Pro Hac Vice Attorney Don J. Mizerk for FlatWing Pharmaceuticals, LLC 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:
`
`11/28/2018)
`
`11/29/2018
`
`29_ ANSWER to 16 Answer to Complaint, and Counterclaims, by Anacor
`Pharmaceuticals, Inc..(Blumenfeld, Jack) Modified on 11/30/2018 (nms). (Entered:
`
`11/29/2018)
`12/06/2018
`
`30 ANSWER to _l_9_ Answer to Complaint, and Counterclairns, by Anacor
`Pharmaceuticals, Inc..(Blumenfeld, Jack) Modified on 12/7/2018 (rims). (Entered:
`
`12/06/2018)
`
`12/07/2018
`
`STIPULATION TO EXTEND TIME to Respond to Complaint to January 9, 2019 -
`filed by Glasshouse Pharmaceuticals Limited Canada. (Keller, Karen) (Entered:
`
`12/07/2018)
`_1
`12/07/2018
`
`STIPULATION TO EXTEND TIME to Respond to FlatWing‘s Motion to Stay and
`Opening Brief to December 26, 2018 ~ filed by Encube Ethicals Pvt. Ltd. (Farnan,
`
`Kelly) (Entered: 12/07/2018)
`
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`
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`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 8 of 43 PageID #: 1100
`Case 1:18-cv-00202-IMK Document24-1 Fil d
`1 8
`P
`:
`Case: 1:18-cv~01606—RGA As of: 01756/ 0/10913911 $61283? 47301Peage'D# 1100
`‘5
`
`12/ 10/2018
`
`SO ORDERED, re §__1_ STIPULATION TO EXTEND TIME to Respond to Complaint
`to January 9, 2019 (*Reset Answer Deadlines: Glasshouse Pharmaceuticals Limited
`Canada answer due 1/9/2019). Signed by Judge Richard G. Andrews on 12/7/2018.
`
`(nms) (Entered: 12/ 1 0/201 8)
`
`12/10/2018
`
`SO ORDERED, re _3_2 STIPULATION TO EXTEND TIME to Respond to Motion to
`Stay to December 26, 2018 (*Reset Briefing Schedule: re _2_3_ MOTION to Stay Case
`Pending Resolution of Inter Partes Review. Answering Brief due 12/26/2018). Signed
`4m
`by Judge Richard G. Andrews on 12/10/2018. (nms) (Entered: 12/ 10/2018)
`
`
`
`12/10/2018
`
`183
`
`”1"“
`
`12/10/2018
`
`1::
`
`ANSWER to I Complaint, and Defenses, by FlatWing Pharmaceuticals,
`LLC.(Phillips, John) Modified on 12/11/2018 (runs). (Entered: 12/ 10/2018)
`RESPONSE to 2; MOTION to Stay Case Pending Resolution of Inter Partes Review l
`and Cross—Motion to Stay All Cases Against All Defendants, filed by Anacor
`Pharmaceuticals, Inc.. (Dellinger, Megan) Modified on 12/11/2018 (nms). Modified on
`
`
`
`
`
`
`
`
`
`V!
`
`12/11/2018 (nms). (Entered: 12/10/2018)
`
`12/ 10/2018
`
`Set Answering Brief Deadline re 34 Cross-Motion to Stay All Cases Against All
`Defendants. Answering Brief/Response due date per Local Rules is 12/24/2018. (nms)
`
`(Entered: 12/11/2018)
`
`+
`
`CORRECTING ENTRY: D1. 34 has been re—coded to reflect the filing is a motion.
`12/11/2018
`
`(nms) (Entered: 12/11/2018)
`P!
`
`__ STIPULATION TO EXTEND TIME Defendant Encube Ethical's Response to Cross
`Motion to Stay All Cases Against All Defendants DI.23 to and including January 9,
`2019 — filed by Encube Ethicals Pvt. Ltd.. (Parnan, Kelly) (Entered: 12/18/2018)
`
`12/18/2018
`
`"
`
`12/19/2018
`
`SO ORDERED, re 3;: STIPULATION TO EXTEND TIME for Defendant Encube
`Ethical's Response to Cross Motion to Stay All Cases Against All Defendants D123 to
`and including January 9, 2019. Signed by Judge Richard G. Andrews on 12/19/2018.
`
`(rims) (Entered: 12/19/2018)
`
`12/20/2018
`
`___ STIPULATION TO EXTEND TIME to Respond to Plaintiff Anacor's Cross~Motion
`to Stay to January 9, 2019 — filed by Lupin Limited, Lupin Pharmaceuticals, Inc..
`(Mowery, Katharine) (Entered: 12/20/2018)
`
`12/20/2018
`
`__ STIPULATION TO EXTEND TIME to Respond to Flawting Pharmaceuticals, LLC's
`Motion to Stay to January 9, 2019 m filed by Lupin Limited, Lupin Pharmaceuticals,
`
`
`12/21/2018
`
`12/21/2018
`
`12/21/2018
`
`01/02/2019
`
`01/02/2019
`
`01/03/2019
`
`Inc.. (Mowery, Katharine) (Entered: 12/20/2018)
`
`SO ORDERED, re _3_7 STIPULATION TO EXTEND TIME to Respond to Flawting
`Pharmaceuticals, LLC's Motion to Stay to Januaiy 9, 2019. Signed by Judge Richard
`
`G. Andrews on 12/21/2018. (nms) (Entered: 12/21/2018)
`
`j
`
`SO ORDERED, re 3__6_ STIPULATION TO EXTEND TIME to Respond to Anacor's
`Cross-Motion to Stay to January 9, 2019. Signed by Judge Richard G. Andrews on
`
`12/21/2018. (nms) (Entered: 12/21/2018)
`
`__ STIPULATION TO EXTEND TIME to Respond to Anacor Pharmaceuticals, Inc.‘s
`Cross~Motion to Stay to January 16, 2019 ~ filed by FlatWing Pharmaceuticals, LLC.
`(Phillips, John) (Entered: 12/21/2018)
`
`SO ORDERED, re 38, STIPULATION TO EXTEND TIME to Respond to Anacor
`Pharmaceuticals, 1nc.‘s Cross-Motion to Stay to January 16, 2019. Signed by Judge
`Richard G. Andrews on 1/2/2019. (nms) (Entered: 01/02/2019)
`
`__ MOTION for Pro Hac Vice Appearance of Attorney Aryeh N. Feinstein - filed by
`Lupin Limited, Lupin Pharmaceuticals, Inc.. (Mowery, Katharine) (Entered:
`
`01/02/2019)
`
`SO ORDERED, re :19 MOTION for Pro Hac Vice Appearance of Attorney Aryeh N.
`Feinstein, filed by Lupin Limited, Lupin Pharmaceuticals, Inc.. Signed by Judge
`Richard G. Andrews on 1/3/2019. (nms) (Entered: 01/03/2019)
`
`01/03/2019
`
`Pro Hac Vice Attorney Aryeh N. Peinstein for Lupin Limited and Lupin
`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
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 9 of 43 PageID #: 1101
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 9 of 43 PageID #: 1101
`Case: 1:18~cv~01606—RGA As of: 01/06/2019 05:11 PM EST 8 of 8
`
`t
`
`1 all papers. (ceg) (Entered: 01/03/2019)
`
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`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 10 of 43 PageID #: 1102
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 10 of 43 Pa eID #: 1102
`Case 1:18-cv-01606—UNA Document 1 Filed 10/17/18 Page 1 of 34 Page!
`#: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ANACOR PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`LUPIN LIMITED, LUPIN
`PHARMACEUTICALS, INC, ENCUBE
`
`ETHICALS PVT. LTD., GLASSHOUSE
`PHARMACEUTICALS LIMITED CANADA,
`
`and PLATWING PHARMACEUTICALS,
`
`LLC,
`
`Defendants.
`
`vvvvvvvvvvvvvv
`
`CA. No.
`
`COMPLAINT
`
`Plaintiff Anacor Pharmaceuticals,
`
`Inc.
`
`(“Anacor”), by its attorneys,
`
`for
`
`its
`
`Complaint, alleges as follows:
`
`I.
`
`This is an action for patent infringement under the patent laws of the
`
`United States, Title 35, United States Code that arises out of each Defendant’s filing of an
`
`Abbreviated New Drug Applications (“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.
`
`Lupin Limited notified Anacor by letter dated September 4, 2018
`
`(“Lupin’s Notice Letter”) that
`
`it had submitted to the FDA ANDA No. 212168 (“Lupin’s
`
`ANDA”), seeking approval from the FDA to engage in the commercial manufacture, use and/or
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 11 of 43 PageID #: 1103
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 11 of 43 PageID #: 1103
`Case 1:18-cv—01606-UNA Document 1 Filed 10/17/18 Page 2 of 34 PagelD #: 2
`
`sale of a generic tavaborole topical solution (“Lupin’s ANDA Product”) prior to the expiration of
`
`the patents—in~suit.
`
`3.
`
`Encube Ethicals Pvt. Ltd. (“Encube”) notified Anacor by letters dated
`
`September 4, 2018, and September 11, 2018 (“Eneube’s Notice Letters”) that it had submitted to
`
`the FDA ANDA No. 21 1297 (“Encube’s ANDA”), seeking approval from the FDA to engage in
`
`the commercial manufacture, use and/or sale of a generic tavaborole topical solution (“Encube’s
`
`ANDA Product”) prior to the expiration of the patents—in—suit.
`
`4.
`
`Glasshouse Pharmaceuticals Limited Canada (“Glasshouse”) notified
`
`Anacor by letter dated September 6, 2018 (“Glasshouse’s Notice Letter”) that it had submitted to
`
`the FDA ANDA No. 2121 16 (“Glasshouse’s ANDA”), seeking approval from the FDA to
`
`engage in the commercial manufacture, use and/or sale of a generic tavaborole topical solution
`
`(“Glasshouse’s ANDA Product”) prior to the expiration of the patents—in-suit.
`
`5.
`
`FlatWing Pharmaceuticals, LLC (“FlatWing”) notified Anacor by letter
`
`dated September 7, 2018 (“FlatWing’s Notice Letter”) that it had submitted to the FDA ANDA
`
`No. 21 1963 (“FlatWing’s ANDA”), seeking approval from the FDA to engage in the commercial
`
`manufacture, use and/or sale of a generic tavaborole topical solution (“FlatWing’s ANDA
`
`Product”) prior to the expiration of the patents—in—suit.
`
`6.
`
`Lupin’s Notice Letter, Encube’s Notice Letters, Glasshouse’s Notice
`
`Letter, and FlatWing’s Notice Letter are collectively referred to herein as “Defendants’ Notice
`
`Letters.” Lupin’s ANDA, Encube’s ANDA, Glasshouse’s ANDA, and FlatWing’s ANDA are
`
`collectively referred to herein as “Defendants” AND/XS,” Lupin’s ANDA Product, Encube’s
`
`ANDA Product, Glasshouse’s ANDA Product, and FlatWing’s ANDA Product, are collectively
`
`referred to herein as “Defendants’ ANDA Products.”
`
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`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 12 of 43 PageID #: 1104
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 12 of 43 PagelD #: 1104
`Case 1:18-cv—01606—UNA Document 1 Filed 10/17/18 Page 3 of 34 Page!
`#1 3
`
`7.
`
`Upon information and belief, Defendants’ ANDA Products are all drug
`
`products that are generic versions of Kerydin, containing the same or equivalent ingredients in
`
`the same or equivalent amounts.
`
`PARTIES
`
`8.
`
`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.
`
`9.
`
`Upon information and belief, defendant Lupin Limited is a corporation
`
`organized and existing under the laws of India, with a principal place of business at 8/4 Laxmi
`
`Towers, Bandra—Kurla Complex, Bandra (E), Mumbai 400 051, India. Upon information and
`
`belief, Lupin Limited is in the business of, among other things, manufacturing and selling
`
`generic versions of branded pharmaceutical drugs through various operating subsidiaries,
`
`including Lupin Pharmaceuticals, Inc.
`
`10.
`
`Upon information and belief, defendant Lupin Pharmaceuticals,
`
`Inc.
`
`(“Lupin Pharmaceuticals”) is a corporation organized and existing under the laws of the State of
`
`Delaware, with a principal place of business at 111 South Calvert Street, Harbor-place Tower,
`
`21 st Floor, Baltimore, Maryland 21202. Upon information and belief, Lupin Pharmaceuticals is
`
`in the business of, among other things, manufacturing and selling generic versions of branded
`
`pharmaceutical products for the US. market.
`
`11.
`
`Upon information and belief, Lupin Pharmaceuticals is an indirect,
`
`wholly-owned subsidiary of Lupin Limited. Lupin Limited and Lupin Pharmaceuticals are
`
`collectively referred to herein as “Lupin."
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 13 of 43 PageID #: 1105
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 13 of 43 PagelD #: 1105
`Case 1:18-cv—01606-UNA Document 1 Filed 10/17/18 Page 4 of 34 PagelD #: 4
`
`12.
`
`Upon information and belief, Lupin Limited and Lupin Pharmaceuticals
`
`acted in concert to prepare and submit Lupin’s ANDA to the FDA.
`
`13.
`
`Upon information and belief, Lupin Limited and Lupin Pharmaceuticals
`
`know and intend that upon approval of Lupin’s ANDA, Lupin Limited will manufacture Lupin’s
`
`ANDA Product and Lupin Pharmaceuticals will directly or indirectly market, sell, and distribute
`
`Lupin’s ANDA Product throughout the United States, including in Delaware. Upon information
`
`and belief, Lupin Limited and Lupin Pharmaceuticals are agents of each other and/or operate in
`
`concert as integrated parts of the same business group, including with respect to Lupin’s ANDA
`
`Product, and enter into agreements with each other that are nearer than arm’s length. Upon
`
`information and belief, Lupin Pharmaceuticals participated in, assisted, and cooperated with
`
`Lupin Limited in the acts complained of herein.
`
`14.
`
`Upon information and belief, following any FDA approval of Lupin’s
`
`ANDA, Lupin Limited and Lupin Pharmaceuticals will act
`
`in concert to distribute and sell
`
`Lupin’s ANDA Product throughout the United States, including within Delaware.
`
`15.
`
`Upon information and belief, defendant Encube is a corporation organized
`
`and existing under the laws of India, with a principal place of business at Unit 24, Steelmade
`
`Industrial Estate, Andheri (E), Mumbai, 400 069 India. Upon information and belief, Encube is
`
`in the business of, among other things, manufacturing and selling generic versions of branded
`
`pharmaceutical drugs.
`
`16.
`
`Upon information and belief, Encube prepared and submitted Encube’s
`
`ANDA to the FDA.
`
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`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 14 of 43 PageID #: 1106
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 14 of 43 PageID #: 1106
`Case 1:18—cv—01606—UNA Document 1 Filed 10/17/18 Page 5 of 34 PagelD #: 5
`
`l7.
`
`Upon information and belief, Encube knows and intends that upon
`
`approval of Encube’s ANDA, Encube will manufacture and directly or indirectly market, sell,
`
`and distribute Encube’s ANDA Product throughout the United States, including in Delaware.
`
`18.
`
`Upon information and belief, following any FDA approval of Encube’s
`
`ANDA, Encube will distribute and sell Encube’s ANDA Product throughout the United States,
`
`including within Delaware.
`
`19.
`
`Upon information and belief, defendant Glasshouse is a corporation
`
`organized and existing under the laws of Canada, with a principal place of business at
`
`2145 Meadowpine Blvd, Mississauga, Ontario LSN 658 Canada. Upon information and belief,
`
`Glasshouse is in the business of, among other things, manufacturing and selling generic versions
`
`of branded pharmaceutical drugs.
`
`20.
`
`Upon information and belief, Glasshouse prepared and submitted
`
`Glasshouse’s ANDA to the FDA.
`
`2].
`
`Upon information and belief, Glasshouse knows and intends that upon
`
`approval of Glasshouse’s ANDA, Glasshouse will manufacture and directly or indirectly market,
`
`sell, and distribute Glasshouse’s ANDA Product throughout the United States,
`
`including in
`
`Delaware.
`
`22.
`
`Upon
`
`information
`
`and
`
`belief,
`
`following any FDA approval of
`
`Glasshouse’s ANDA, Glasshouse will distribute and sell Glasshouse’s ANDA Product
`
`throughout the United States, including within Delaware.
`
`23.
`
`Upon information and belief, defendant FlatWing is a limited liability
`
`company organized and existing under the laws of Delaware, with a principal place of business
`
`at 833 W 15th Pl, Unit 901, Chicago,
`
`lllinois 60608-1429. Upon information and belief,
`
`

`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 15 of 43 PageID #: 1107
`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 15 of 43 PagelD #: 1107
`Case 1:18-cv-01606-UNA Document 1 Filed 10/17/18 Page 6 of 34 PagelD #: 6
`
`FlatWing is in the business of, among other things, manufacturing and selling generic versions of
`
`branded pharmaceutical drugs.
`
`24.
`
`Upon information and belief, FlatWing prepared
`
`and
`
`submitted
`
`FlatWing’s ANDA to the FDA.
`
`25.
`
`Upon information and belief, FlatWing knows and intends that upon
`
`approval of F latWing’s ANDA, FlatWing wili manufacture and directly or indirectly market,
`
`sell, and distribute FlatWing’s ANDA Product
`
`throughout
`
`the United States,
`
`including in
`
`Delaware.
`
`26.
`
`Upon information and belief, following any FDA approval of FlatWing’s
`
`ANDA, FlatWing will distribute and sell FlatWing’s ANDA Product throughout the United
`
`States, including within Delaware.
`
`JURISDICTION
`
`27.
`
`Jurisdiction is proper in this district pursuant
`
`to 28 U.S.C, §§133l,
`
`1338(a), and 2201 and 2202.
`
`28.
`
`This Court has personal jurisdiction over each of the Defendants.
`
`Ma
`
`29.
`
`Lupin Limited is subject to personal jurisdiction in Delaware because,
`
`among other things, Lupin Limited,
`
`itself and through its wholly-owned subsidiary Lupin
`
`Pharmaceuticals, 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, Lupin Limited, itself and through its wholly-owned subsidiary Lupin Pharmaceuticals,
`
`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
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`

`Case 1:18-cv-00202-IMK Document 24-1 Filed 01/08/19 Page 16 of 43 PageID #: 1108
`Case 1:18-cv-00202-IMK Docu