IPR2016-00286
`Patent 8,822,438 B2
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`Paper No. ___
`Date Filed: December 7, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`AMERIGEN PHARMACEUTICALS LIMITED, ARGENTUM
`PHARMACEUTICALS LLC,
`Petitioners
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`Case IPR2016-002861
`Patent 8,822,438 B2
`________________
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`PETITIONERS’ REPLY TO PATENT OWNER’S
`MOTION TO FILE EVIDENCE
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`Patent 8,822,438 B2
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`Paper No. ___
`Date Filed: December 7, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`AMERIGEN PHARMACEUTICALS LIMITED, ARGENTUM
`PHARMACEUTICALS LLC,
`Petitioners
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`Case IPR2016-002861
`Patent 8,822,438 B2
`________________
`
`
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`PETITIONERS’ REPLY TO PATENT OWNER’S
`MOTION TO FILE EVIDENCE
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`IPR2016-00286
`Patent 8,822,438 B2
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`
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`Petitioners Amerigen Pharmaceuticals Limited and Argentum
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`Pharmaceuticals LLC (collectively, “Petitioners”) hereby respectfully object to the
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`filing of exhibits 2033, 2034 and 2035 identified in Patent Owner’s Motion to File
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`Exhibits (“PO MTF”) filed December 2, 2016.
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`In addition to having a significant in-house legal department, Patent Owner
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`has retained three national law firms to represent them in this proceeding.
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`Petitioner is a small generic start up. Petitioner’s business model and objective is
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`to make and provide to American healthcare consumers low cost bioequivalent
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`generic drugs. Each expenditure by Petitioner on extraneous motion practice
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`needlessly diverts limited resources from Petitioner’s core business.
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`Notwithstanding this disparity in resources, Petitioner has acquiesced to all
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`of Patent Owner’s several requests to extend filing deadlines, first agreeing on June
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`29, 2016, then again on September 12, 2016, to two extensions of the original
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`August 31, 2016 date set in the Scheduling Order for Patent Owner’s Response,
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`providing Patent Owner with an additional five (5) weeks to file its Response. See
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`AMG 1078, 1079, 1080; see also Paper 22 (Joint Notice of Change to Due Dates)
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`and Paper 29 (Second Joint Notice of Change to Due Date).
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`Petitioners would be especially prejudiced by Patent Owner’s late filing of
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`the exhibits in question because Petitioners have little, if any, leeway to obtain
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`additional time to submit their Reply in view of the February 17, 2017 trial date.
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`IPR2016-00286
`Patent 8,822,438 B2
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`Mindful of the inelastic deadline for filing a Reply, Petitioners’ counsel and
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`experts began to analyze Patent Owner’s voluminous Response, including the
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`expert declarations, shortly after these were filed and served on October 4, 2016.
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`On October 7, 2016, Patent Owner’s counsel, Mr. Olson, contacted Petitioner’s
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`counsel, Mr. Hare, advising that the calculations in Appendices C, C-1, D and D-1
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`to the declaration of Patent Owner’s expert on secondary considerations, Dr.
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`Vellturo (“Vellturo Decl.”), JSN 2044, were incorrect and requesting permission
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`from Petitioners to file a replacement exhibit. After confirming that a redline of
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`the proposed replacement for these appendices did not appear to include additional
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`information other than the revised calculations, Petitioners agreed to Patent
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`Owner’s request. See AMG 1081. Both the original and replacement versions of
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`JSN 2044 cite to the exhibits at issue in footnotes to Appendix B, but they do not
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`describe what the exhibits are. In the absence of any description of the underlying
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`data for Appendix B, and with no guidance from Patent Owner’s October 4, 2016
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`Updated Exhibit List as to the identity of JSN 2033, 2034 and 2035, which are
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`merely described as “reserved” therein, see Paper 35, Petitioners’ experts were
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`unable to conduct any meaningful analysis of this information. Petitioners
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`objected on a timely basis to JSN 2044 in their Objections to Evidence. See Paper
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`36, ¶ 11. In addition, as Patent Owner acknowledges, Petitioners separately wrote
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`to Patent Owner’s counsel advising that these exhibits were missing. Cf. PO MTF
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`IPR2016-00286
`Patent 8,822,438 B2
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`at 2. Although Patent Owner was on express notice of their omissions at least as of
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`when Petitioners served their Objections to Evidence, it was not until October 18,
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`2016, two weeks after the Patent Owner’s Response was filed and apparently only
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`in response to Petitioners’ email, that Patent Owner’s counsel attached the exhibits
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`in an email to Petitioner’s counsel. By this time, Petitioners’ counsel and experts
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`had already spent substantial time and effort in preparing Petitioners’ Reply,
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`including preparing for Dr. Vellturo’s deposition.
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`Neither when the original version of the Vellturo Decl. was filed October 4,
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`2016, nor when the replacement was filed on October 12, 2016, did Patent Owner
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`make any effort to ascertain whether or not the underlying data for its appendices
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`had been filed as well. Whether or not Patent Owner’s mistakes were inadvertent,
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`the failure to identify and supply the underlying data on which its expert’s
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`calculations and opinions are based is hardly a harmless clerical error. There is no
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`way to meaningfully rebut Dr. Vellturo’s testimony regarding Appendix B or the
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`portions in the body of the Vellturo Decl. that cite to it in the absence of this
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`underlying data. Cf. FRCP 26(a)(2)(B); FRE 702. Petitioners should not be
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`required to expend additional limited resources to make up for Patent Owner’s
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`mistakes and omissions. For at least these reasons, Patent Owner’s motion should
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`be denied.
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`Dated: December 7, 2016
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`
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`Respectfully submitted,
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`
`
`/William D. Hare/
`William D. Hare
`Reg. No. 44,739
`Gabriela Materassi
`Reg. No. 47,774
`MCNEELY HARE & WAR LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`Counsel for Petitioner Amerigen
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`Teresa Stanek Rea
`Reg. No. 30,427
`Shannon Lentz
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`Counsel for Petitioner Argentum
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`IPR2016-00286
`Patent 8,822,438 B2
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`IPR2016-00286
`Patent 8,822,438 B2
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing Petitioners’ Reply to
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`Patent Owner’s Motion to File Evidence were served on December 7, 2016 by
`delivering copies via electronic mail on the following attorneys of record for the
`Patent Owner:
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`Diane B. Elderkin
`Barbara L. Mullin
`Ruben Munoz
`JANS-ZYTIGA@akingump.com
`David T. Pritikin
`Bindu Donovan
`Isaac Olson
`Alyssa B. Monsen
`ZytigaIPRTeam@sidley.com
`Jennifer H. Roscetti
`jennifer.roscetti@finnegan.comn
`Anthony C. Tridico
`anthony.tridico@finnegan.com
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`Date: December 7, 2016
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`Respectfully submitted,
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`/William D. Hare/
`William D. Hare
`Reg. No. 44,739
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(202) 640-1801
`bill@miplaw.com
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