`Date Filed: Aug. 24, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`
`________________
`
`Case IPR2016-01317
`Patent 8,822,438
`
`________________
`
`
`
`JANSSEN ONCOLOGY, INC.’S WAIVER OF PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. §42.107(b)
`
`
`
`
`
`IPR2016-01317
`Patent 8,822,438
`
`
`
`Pursuant to 37 C.F.R. §42.107(b), Patent Owner Janssen Oncology, Inc.
`
`(“Janssen”) hereby elects to waive its Patent Owner Preliminary Response to the
`
`Petition for inter partes review. This waiver is being filed within three months of
`
`July 12, 2016, the date of the Notice of Filing Date accorded to the Petition.
`
`As indicated in the Trial Practice Guide, no adverse inference should be
`
`taken by this election. Office Patent Trial Practice Guide, 77 Fed. Reg. 48756,
`
`48764 (August 14, 2012). Janssen reserves all rights to submit a Patent Owner
`
`Response and/or a Motion to Amend pursuant to 37 C.F.R. §§42.120 and 42.121,
`
`respectively. This election should not be deemed a waiver or admission on the part
`
`of Janssen of any material presented in the Petition.
`
`By filing this waiver pursuant to C.F.R. §42.107(b), Janssen does not waive
`
`the arguments that it raised in IPR2016-00286 regarding: 1) the exclusion of the
`
`expert declaration addressing “commercial success” related to U.S. Patent No.
`
`8,882,438 submitted by Petitioner Amerigen Pharmaceuticals Limited
`
`(“Amerigen”) in IPR2016-00286; or 2) the alternative relief sought by Janssen in
`
`IPR2016-00286, namely, submitting a new declaration in support of its preliminary
`
`response to address Amerigen’s commercial success arguments. See IPR2016-
`
`00286, Paper 11 (PTAB Feb. 22, 2016).
`
`
`
`
`
`
`
`1
`
`
`
`IPR2016-01317
`Patent 8,822,438
`
`Date: Aug. 24, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`Barbara L. Mullin (Reg. No. 38,250)
`Ruben H. Munoz (Reg. No. 66,998)
`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
`JANS-ZYTIGA@akingump.com
`
`Counsel for Patent Owner
`
`
`
`2
`
`
`
`IPR2016-01317
`Patent 8,822,438
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing JANSSEN
`
`ONCOLOGY INC.’S WAIVER OF PRELIMINARY RESPONSE
`
`PURSUANT TO 37 C.F.R. §42.107(b) was served on counsel of record on Aug.
`
`24, 2016 by filing this document through the End-to-End System, as well as
`
`delivering a copy via electronic mail to counsel of record for the Petitioner at the
`
`following addresses:
`
`Teresa Stanek Rea – TRea@Crowell.com
`Shannon M. Lentz – SLentz@Crowell.com
`
`
`
`Date: Aug. 24, 2016
`
`
`
`
`
`
`
`/s/ Dianne B. Elderkin /
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`3