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`Paper No. ___
`Date Filed: May 3, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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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.,
`Patent Owner.
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`________________
`Case IPR2016-013321
`Patent 8,822,438 B2
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`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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`IPR2016-01332
`U.S. Patent 8,822,438
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`Pursuant to the Board’s April 28, 2017 Order (Paper 64), Patent Owner Janssen
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`Oncology, Inc. hereby submits an itemized list of what Patent Owner considers to
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`be new arguments and evidence raised in Petitioners’ Reply (Paper 55), including
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`paragraphs of the declarations of Drs. Garnick (Ex. 1104) and Bantle (Ex. 1097), as
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`specifically identified below.
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`1. New Arguments and Evidence Regarding Aminoglutethimide
`a. Pet. Reply, p. 2, ll. 3-6, 7-10, 12-15
`b. Pet. Reply, p. 4, l. 20 – p. 5, l. 4
`c. Pet. Reply, p. 6, ll. 5-9
`d. Pet. Reply, p. 10, l. 8 – p. 11, l. 5
`e. Ex. 1104, ¶¶ 5, 16-17, 22-23, 26-27, 48, 52, 68
`f. Ex. 1097, ¶¶ 46, 49, 50, 67, 94
`2. New Arguments and Evidence Regarding Motivation to Combine Based
`on Adrenal Insufficiency and/or Low Adrenal Reserve
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`a. Pet. Reply, p. 1, ll. 5-6
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`b. Pet. Reply, p. 3, ll. 2-4
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`c. Pet. Reply, p. 5, ll. 5-9
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`d. Pet. Reply, p. 10, l. 6 – p. 11, l. 5
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`e. Pet. Reply, p. 11, l. 9 - p. 12, l. 2
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`f. Pet. Reply, p. 13, ll. 4-11
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`g. Pet. Reply, footnote 7, ll. 3-6
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`h. Ex. 1097, ¶¶ 12-13, 15, 32-40, 43-44, 48-54, 58-60, 63-67, 69-82, 84,
`88, 93, 99
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`1
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`IPR2016-01332
`U.S. Patent 8,822,438
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`i. Ex. 1104, ¶¶ 18, 33, 42-48, 51, 68
`3. New Arguments and Evidence Regarding COU-AA-BE Study
`a. Pet. Reply, p. 14, ll. 5-9
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`b. Ex. 1104, ¶¶ 56-58
`4. New Arguments and Evidence Regarding Purported Palliative Effects of
`Prednisone
`a. Pet. Reply, p. 1, ll. 8-9, 14-16
`b. Pet. Reply, p. 3, ll. 7-9
`c. Pet. Reply, p. 8, ll. 7-9
`d. Pet. Reply, p. 18, ll. 16-19
`e. Pet. Reply, p. 20, ll. 7-8
`f. Ex. 1104, ¶¶ 24, 60, 70, 80-87
`g. Ex. 1097, ¶ 96
`5. New Arguments and Evidence Regarding Selection of Prednisone from
`Among Glucocorticoids
`a. Pet. Reply, p. 8, ll. 3-13
`b. Ex. 1104, ¶¶ 5, 24
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`Respectfully submitted,
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`
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`/Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
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`Dated: May 3, 2017
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`2
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`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
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`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`Paul J. Zegger (Reg. No. 33,821)
`Todd L. Krause (Reg. No. 48,860)
`Alyssa B. Monsen (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
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`Counsel for Patent Owner
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`3
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`IPR2016-01332
`U.S. Patent 8,822,438
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`IPR2016-01332
`U.S. Patent 8,822,438
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Identification of New Arguments and Evidence in Petitioners’ Reply was
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`served on counsel of record on May 3, 2017 by filing this document through the
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`End-to-End System, as well as delivering a copy via electronic mail to counsel of
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`record for the Petitioners at the following addresses:
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`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
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`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`Respectfully submitted,
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`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`Date: May 3, 2017
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