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IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMERIGEN PHARMACEUTICALS LIMITED
`
`and
`
`ARGENTUM PHARMACEUTICALS LLC
`
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner
`_______________
`
`Case IPR2016-002861
`
`Patent 8,822,438 B2
`_______________
`
`
`
`PETITIONERS’ REPLY TO PATENT OWNER’S IDENTIFICATION OF
`NEW ARGUMENTS AND EVIDENCE IN PETITIONERS’ REPLY
`
`
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`
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`1 Case IPR2016-01317 has been joined with this proceeding.
`
`

`

`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
`
`
`
`In response to Patent Owner’s identification of allegedly new arguments and
`
`evidence in Petitioners’ Reply, Petitioners submit the following reply.
`
`As an initial matter, Petitioner objects to the Patent Owner’s end run around
`
`the Rules as well as the Board’s Scheduling Order. The relief being requested by
`
`the Patent Owner, and the basis therefor, are obviously no more than a second
`
`Motion to Exclude.
`
`The Patent Owner is attempting to expand the limits of a permitted Motion
`
`to Exclude in terms of length and timing. Further, the Patent Owner ignored the
`
`Board’s Order and provided argument via the incorporation of substantive
`
`headings. Petitioners objects to these headings as mischaracterizing the content of
`
`the cited passages. Patent Owner’s “Request” should be denied on these bases
`
`alone. Nonetheless, Petitioners respond that each of the arguments and evidence
`
`identified by Patent Owner are proper and respond substantively to Patent Owner’s
`
`Response and expert declarations, as follows.
`
`1. New Argument and Evidence Regarding Motivation to Combine
`
`based on “Combined Congenital CYP 17 Deficiency”
`
`a.
`
`JSN 2040, ¶¶ 49, 51-58; AMG 1026; AMG 1027; AMG 1025
`
`b.
`
`P.O. Response p. 29, l. 15 - p. 32, l. 4; JSN 2038, ¶¶ 151, 153
`
`2
`
`

`

`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
`
`c.
`
`P.O. Response p. 20, l. 4-16; JSN 2040, ¶28, 52, 58
`
`
`
`2. New Arguments and Evidence Regarding Motivation to Combine
`
`Based on Adrenal Insufficiency, Concurrent Stress, or Adrenal Crisis
`
`a.
`
`JSN 2040, ¶¶ 29, 33, 34, 54
`
`b.
`
`P.O. Response p. 18, l. 3 – p. 19, l. 7; JSN 2040, ¶¶ 31, 33, 107-111
`
`c.
`
`P.O. Response p. 43, l. 11- p. 44, l. 12; JSN 2038, ¶¶ 49-50, 154; JSN
`
`2040, ¶¶ 31-35, 59-62
`
`d.
`
`P.O. Response p. 43, l. 11 - p. 44, l. 12; JSN 2040, ¶¶ 31-34; JSN
`
`2038 ¶¶ 105, 107, 111-112
`
`e.
`
`P.O. Response p. 43, l. 11 - p. 44, l. 12; JSN 2040, ¶¶ 31-33
`
`3. New Argument Regarding Prednisone’s Safety Profile
`
`a.
`
`P.O. Response p. 30, l. 3 - p. 32, l. 4; JSN 2038 ¶¶ 49-50, 114-115,
`
`124-135, 155-156; JSN 2040 ¶¶ 13-15, 32-33, 43-45, 59-62
`
`b.
`
`JSN 2040 ¶¶ 59-62
`
`4. New Argument Regarding Glucocorticoids as Effective Anti-Cancer
`
`Agents
`
`a.
`
`P.O. Response, p. 55, l. 13 - p. 56, l. 15
`
`3
`
`

`

`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
`
`Petition, p. 21, l. 10 – p. 22, l. 8
`
`P.O. Response, p. 55, l. 13 - p. 56, l. 15
`
`P.O. Response, p. 55, l. 13 - p. 56, l. 15
`
`P.O. Response, p. 59, ll. 1-6; JSN 2038 ¶188
`
`P.O. Response, p. 48, l. 1 – p. 49, l. 8; p. 55, l. 13 - p. 56, l. 15
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`
`
`
`
`Dated: February 3, 2017
`
`
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`
`
`Respectfully Submitted,
`
`/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
`
`4
`
`

`

`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
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the Petitioners’ Reply To Patent
`
`
`
`
`
`Owner’s Identification of Patent Owner’s Identification of New Arguments and
`
`Evidence in Petitioners’ Reply was served on February 3, 2017 by delivering
`
`copies via electronic mail on the following attorneys of record for the Patent
`
`Owner:
`
`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
`
`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
`
`Jennifer H. Roscetti
`Anthony C. Tridico
`
`5
`
`

`

`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
`
`jennifer.roscetti@finnegan.com
`anthony.tridico@finnegan.com
`FINNEGAN HENDERSON FARABOW GARRETT & DUNNER
`
`
`
`Teresa Stanek Rea
`Shannon M. Lentz
`TRea@Crowell.com
`SLentz@Crowell.com
`CROWELL & MORING LLP
`
`
`
`
`
`
`Date: February 3, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/William D. Hare/
`William D. Hare
`
`6
`
`

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