`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`AMERIGEN PHARMACEUTICALS LIMITED
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`and
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`ARGENTUM PHARMACEUTICALS LLC
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`Petitioners
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`v.
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner
`_______________
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`Case IPR2016-002861
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`Patent 8,822,438 B2
`_______________
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`PETITIONERS’ REPLY TO PATENT OWNER’S IDENTIFICATION OF
`NEW ARGUMENTS AND EVIDENCE IN PETITIONERS’ REPLY
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`Petitioners’ Reply to Patent Owner’s Identification of Patent Owner’s Identification of New
`Arguments and Evidence in Petitioners’ Reply
`Petition for Inter Partes Review 2016-00286
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`In response to Patent Owner’s identification of allegedly new arguments and
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`evidence in Petitioners’ Reply, Petitioners submit the following reply.
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`As an initial matter, Petitioner objects to the Patent Owner’s end run around
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`the Rules as well as the Board’s Scheduling Order. The relief being requested by
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`the Patent Owner, and the basis therefor, are obviously no more than a second
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`Motion to Exclude.
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`The Patent Owner is attempting to expand the limits of a permitted Motion
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`to Exclude in terms of length and timing. Further, the Patent Owner ignored the
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`Board’s Order and provided argument via the incorporation of substantive
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`headings. Petitioners objects to these headings as mischaracterizing the content of
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`the cited passages. Patent Owner’s “Request” should be denied on these bases
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`alone. Nonetheless, Petitioners respond that each of the arguments and evidence
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`identified by Patent Owner are proper and respond substantively to Patent Owner’s
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`Response and expert declarations, as follows.
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`1. New Argument and Evidence Regarding Motivation to Combine
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`based on “Combined Congenital CYP 17 Deficiency”
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`a.
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`JSN 2040, ¶¶ 49, 51-58; AMG 1026; AMG 1027; AMG 1025
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`b.
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`P.O. Response p. 29, l. 15 - p. 32, l. 4; JSN 2038, ¶¶ 151, 153
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`2
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`Petitioners’ Reply to Patent Owner’s Identification of Patent Owner’s Identification of New
`Arguments and Evidence in Petitioners’ Reply
`Petition for Inter Partes Review 2016-00286
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`c.
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`P.O. Response p. 20, l. 4-16; JSN 2040, ¶28, 52, 58
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`2. New Arguments and Evidence Regarding Motivation to Combine
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`Based on Adrenal Insufficiency, Concurrent Stress, or Adrenal Crisis
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`a.
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`JSN 2040, ¶¶ 29, 33, 34, 54
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`b.
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`P.O. Response p. 18, l. 3 – p. 19, l. 7; JSN 2040, ¶¶ 31, 33, 107-111
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`c.
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`P.O. Response p. 43, l. 11- p. 44, l. 12; JSN 2038, ¶¶ 49-50, 154; JSN
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`2040, ¶¶ 31-35, 59-62
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`d.
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`P.O. Response p. 43, l. 11 - p. 44, l. 12; JSN 2040, ¶¶ 31-34; JSN
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`2038 ¶¶ 105, 107, 111-112
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`e.
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`P.O. Response p. 43, l. 11 - p. 44, l. 12; JSN 2040, ¶¶ 31-33
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`3. New Argument Regarding Prednisone’s Safety Profile
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`a.
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`P.O. Response p. 30, l. 3 - p. 32, l. 4; JSN 2038 ¶¶ 49-50, 114-115,
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`124-135, 155-156; JSN 2040 ¶¶ 13-15, 32-33, 43-45, 59-62
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`b.
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`JSN 2040 ¶¶ 59-62
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`4. New Argument Regarding Glucocorticoids as Effective Anti-Cancer
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`Agents
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`a.
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`P.O. Response, p. 55, l. 13 - p. 56, l. 15
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`3
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`Petitioners’ Reply to Patent Owner’s Identification of Patent Owner’s Identification of New
`Arguments and Evidence in Petitioners’ Reply
`Petition for Inter Partes Review 2016-00286
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`Petition, p. 21, l. 10 – p. 22, l. 8
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`P.O. Response, p. 55, l. 13 - p. 56, l. 15
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`P.O. Response, p. 55, l. 13 - p. 56, l. 15
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`P.O. Response, p. 59, ll. 1-6; JSN 2038 ¶188
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`P.O. Response, p. 48, l. 1 – p. 49, l. 8; p. 55, l. 13 - p. 56, l. 15
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`b.
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`c.
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`d.
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`e.
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`f.
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`Dated: February 3, 2017
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`Respectfully Submitted,
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`/William D. Hare/
`William D. Hare
`Reg. No. 44,739
`McNeely Hare & War, LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(202) 640-1801
`bill@miplaw.com
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`4
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`Petitioners’ Reply to Patent Owner’s Identification of Patent Owner’s Identification of New
`Arguments and Evidence in Petitioners’ Reply
`Petition for Inter Partes Review 2016-00286
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the Petitioners’ Reply To Patent
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`Owner’s Identification of Patent Owner’s Identification of New Arguments and
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`Evidence in Petitioners’ Reply was served on February 3, 2017 by delivering
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`copies via electronic mail on the following attorneys of record for the Patent
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`Owner:
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`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`delderkin@akingump.com
`bmullin@akingump.com
`rmunoz@akingump.com
`JANS-ZYTIGA@akingump.com
`AKIN GUMP STRAUSS HAUER & FELD LLP
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`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Todd Krause
`Isaac Olson
`Alyssa B. Monsen
`dpritikin@sidley.com
`bdonovan@sidley.com
`pzegger@sidley.com
`tkrause@sidley.com
`iolson@sidley.com
`amonsen@sidley.com
`ZytigaIPRTeam@sidley.com
`SIDLEY AUSTIN LLP
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`Jennifer H. Roscetti
`Anthony C. Tridico
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`5
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`Petitioners’ Reply to Patent Owner’s Identification of Patent Owner’s Identification of New
`Arguments and Evidence in Petitioners’ Reply
`Petition for Inter Partes Review 2016-00286
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`jennifer.roscetti@finnegan.com
`anthony.tridico@finnegan.com
`FINNEGAN HENDERSON FARABOW GARRETT & DUNNER
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`
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`Teresa Stanek Rea
`Shannon M. Lentz
`TRea@Crowell.com
`SLentz@Crowell.com
`CROWELL & MORING LLP
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`Date: February 3, 2017
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`/William D. Hare/
`William D. Hare
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`6
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