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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC., ACTAVIS
`LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY'S
`LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner
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`Case IPR2016-013321
`Patent 8,822,438 B2
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`RESPONSE TO PATENT OWNER’S IDENTIFICATION OF NEW
`ARGUMENTS AND EVIDENCE IN PETITIONERS’ REPLY
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`1 Case IPR2017-00853 has been joined with this proceeding.
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`Petitioners respond to Paper 65 pursuant to Paper 64. For each category,
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`Petitioners’ citations apply to all items listed by Patent Owner within that category.
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`1. Arguments and Evidence Regarding Aminoglutethimide
`a. Prior Disclosure in the Petition
`i. Petition, p. 25:11-19
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`ii. Ex. 1002 (Garnick Declaration) ¶ 32
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`iii. Ex. 1003, pp. 2, 7-8, and Ex. 1021, abstract, p. 4
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`b. Material in PO’s Response to Which These Arguments Reply
`i. Response: p. 22:2-21; p. 23:8-15; see also p. 15:8-15; p. 17:11-18
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`ii. Ex. 2038 (Rettig Decl.) ¶¶ 61, 97-99, 106-109, 121-123, 130
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`iii. Ex. 2040 (Auchus Decl.) ¶¶ 30, 36-38
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`2. Arguments and Evidence Regarding Motivation to Combine Based on
`Adrenal Insufficiency and/or Low Adrenal Reserve
`a. Prior Disclosure in the Petition
`i. Petition: p. 28:9-19; p. 32:4-18; see also p. 5:1-10; pp. 26:11-27:1;
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`pp. 29:21-30:2; p. 40:2-7; pp. 40:20-41:15; p. 45:10-13
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`ii. Ex. 1002 ¶¶ 38-40, 58-59, 66-69, 78-80; see also ¶¶ 38-40
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`b. Material in PO’s Response to Which These Arguments Reply
`i. Response: pp. 13:18-26:20; see also p. 3:4-20; pp. 7:19-8:8; pp.
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`8:15-9:7; pp. 10:8-12:2; pp. 44:12-47:7
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`ii. Ex. 2040 (Auchus Decl.) ¶¶ 11-48
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`iii. Ex. 2038 (Rettig Decl.) ¶¶ 97-128, 143-53
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`3. Arguments and Evidence Regarding COU-AA-BE Study
`a. Material in PO’s Response to Which These Arguments Reply
`i. Response: p. 26:5-13
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`ii. Ex. 2038 (Rettig Decl.) ¶ 128
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`4. Arguments and Evidence Regarding Palliative Effects of Prednisone
`a. Prior Disclosure in the Petition
`i. Petition: pp. 13:19-14:6; pp. 58:15-59:2
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`ii. Ex. 1002 (Garnick Decl.) ¶¶ 33, 89
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`b. Material in PO’s Response to Which These Arguments Reply
`i. Response: pp. 30:7-34:7; p. 47:8-17; see also p. 4:1-12; pp. 6:13-
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`7:1; pp. 12:11-13:5; p. 37:19-39:8
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`ii. Ex. 2038 (Rettig Decl.) ¶¶ 131-42; see also ¶¶ 189-93
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`5. Arguments and Evidence Regarding Selection of Prednisone
`a. Prior Disclosure in the Petition
`i. Petition: p. 33:15-17; p. 34:4-6, 12-15; pp. 39:15-40:13; pp. 40:20-
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`41:18
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`ii. Ex. 1002 (Garnick Decl.) ¶¶ 33, 58-59, 89-90
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`b. Material in PO’s Response to Which These Arguments Reply
`i. Response: pp. 41:14-43:16; pp. 44:12-45:11; pp. 45:18-46:4
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`ii. Ex. 2038 (Rettig Decl.) ¶¶ 189-193
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`2
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`Dated: May 8, 2017
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`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
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`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6204
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
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`Attorney for Mylan Pharmaceuticals Inc.
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`3
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing Response to Patent
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`Owner’s Identification of New Arguments and Evidence in Petitioners’ Reply was
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`served electronically via email as follows:
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`Patent Owners:
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`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
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`Todd L. Krause
`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
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`Petitioners:
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`Samuel S. Park
`Jovial Wong
`Ryan B. Hauer
`Winston & Strawn LLP
`spark@winston.com
`jwong@winston.com
`rhauer@winston.com
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`Dated: May 8, 2017
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`/Brandon M. White/
`Brandon M. White
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`Attorney for Mylan Pharmaceuticals Inc.
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`1
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