UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SANOFI-AVENTIS U.S. LLC AND
`REGENERON PHARMACEUTICALS, INC,
`Petitioners
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`
`Case IPR2015-01624
`U.S. Patent No. 6,331,415
`
`_____________
`
`PETITIONERS' OBJECTION S TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioners sanofi-aventis U.S. LLC and
`
`Regeneron Pharmaceuticals, Inc. object to the admissibility of the following
`
`exhibits served by Patent Owners Genentech, Inc. and City of Hope on May 16,
`
`2016.
`
`I.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`
`Evidence
`Exhibit 2003
`Expert Declaration of
`John Fiddes, Ph.D.
`(Second Declaration
`of Steven Lanier
`McKnight,
`Reexamination Nos.
`90/007,542 and
`90/007,859 (June 3,
`2008))
`Exhibit 2019
`(Expert Declaration of
`John Fiddes)
`Exhibit 2020 (Foote
`Deposition)
`Exhibit 2021 (Expert
`Declaration of Reiner
`Gentz)
`
`Exhibit 2023
`(Expert Report of
`Gregory Winter, Eli
`Lilly v. Genentech)
`Exhibit 2024
`(Transcript of Gregory
`Winter Deposition,
`
`Objections
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20)
`
`See Appendix A, attached hereto.
`
`Previously objected to on April 28, 2016. See Paper 26 .
`
`Opinion testimony by a lay witness (FRE 701). E.g.,
`Dr. Gentz lacked a Ph.D. in molecular biology as of April
`8, 1983.
`See objections to specific paragraphs in Appendix B,
`attached hereto.
`Previously objected to. See Paper 26
`
`Previously objected to. See Paper 26
`
`1
`
`

`
`Eli Lilly v. Genentech)
`Exhibit 2026 (Arthur
`Riggs Declaration)
`
`Exhibit 2027 (Ronald
`Wetzel Declaration)
`
`Exhibit 2028 (Jeanne
`Perry Declaration)
`
`Exhibit 2029
`(William Holmes
`Declaration)
`
`Exhibit 2030
`(Michael Rey
`Declaration)
`
`Exhibit 2031
`(Michael Mumford
`Declaration)
`
`Exhibit 2032 (Shmuel
`Cabilly Declaration)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20).
`
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20).
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20).
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20).
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20).
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op.. (P.T.A.B. April 1, 2014)
`(Paper 20).
`Not Made Available for Deposition: Object to
`admission of this declaration unless this witness is made
`available for a deposition. See Ikaria, Inc. v. Geno LLC,
`Case IPR2013-00253, slip. op. (P.T.A.B. April 1, 2014)
`(Paper 20).
`
`Exhibit 2033 (Julie
`
`See Appendix C, attached hereto.
`
`2
`
`

`
`Davis Declaration)
`Exhibit 2035 (U.S.
`Patent No. 4,495,280
`File History)
`Exhibit 2040 (U.S.
`Patent No. 4,299,916)
`Exhibit 2041 (U.S.
`Patent No. 3,996,345)
`Exhibit 2057 (U.S.
`Patent No. 4,208,479)
`Exhibit 2059 (U.S.
`Patent No. 4,193,983)
`Exhibit 2060 (Gentz
`et al. Publication)
`
`Exhibit 2072 (Expert
`Report of Carlo M.
`Croce, M.D.)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`
`Previously objected to. See Paper 26.
`
`Previously objected to. See Paper 26.
`
`Previously objected to. See Paper 26.
`
`Previously objected to. See Paper 26.
`
`Previously objected to. See Paper 26.
`
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`
`Exhibit 2090
`(Deposition Transcript
`of James H. Sabry,
`M.D.)
`
`Relevance (FRE 402): This exhibit contains the
`statements of a different expert in a district court litigation
`concerning, inter alia, the Cabilly III Patent and therefore
`is irrelevant to the § 103 invalidity grounds currently
`instituted in the instant proceeding.
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Exhibit 2093 (Expert Hearsay (FRE 801, 802, 803): The exhibit sets forth
`
`Exhibit 2091
`(Deposition Transcript
`of Timothy R.
`Schwartz)
`
`3
`
`

`
`Report of Robert C.
`Rickert, Ph.D.)
`
`Exhibit 2116 (Davis
`Declaration Appendix
`C)
`
`Exhibit 2117 (Davis
`Declaration Appendix
`D)
`
`Exhibit 2122
`(Feldman et al.
`Publication)
`
`Exhibit 2123
`(Gibbons Publication)
`
`Exhibit 2124 (Nelsen
`Publication)
`
`Exhibit 2125 (Scherer
`Publication)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Insufficient Basis for Opinion (FRE 702, 703 and 705,
`37 C.F.R. §42.65). Fails to provide underlying data
`sufficient to support opinion.
`Summaries to Prove Content (FRE 1006). Fails to
`provide underlying data.
`Demonstrative Exhibit: “Demonstrative exhibits are not
`evidence.” EMC Corp. v. Personalweb Tech., LLC,
`IPR2013-00082, Paper 66 at 3 (P.T.A.B. Dec. 13, 2013).
`Insufficient Basis for Opinion (FRE 702, 703 and 705,
`37 C.F.R. §42.65). Fails to provide underlying data
`sufficient to support opinion.
`Summaries to Prove Content (FRE 1006). Fails to
`provide underlying data.
`Demonstrative Exhibit: “Demonstrative exhibits are not
`evidence.” EMC Corp. v. Personalweb Tech., LLC,
`IPR2013-00082, Paper 66 at 3 (P.T.A.B. Dec. 13, 2013).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`
`4
`
`

`
`Exhibit 2126 (Waltz
`Publication)
`
`Exhibit 2128
`(Lorenzetti
`Publication)
`
`Exhibit 2129
`(Hirschler Article)
`
`Exhibit 2131 (Cabilly
`Settlement
`Agreements)
`
`Exhibit 2132 (Cabilly
`Royalty Statements)
`
`Exhibit 2135
`(Transcript of BMS v.
`Genentech District
`Court Foote
`Deposition)
`Exhibit 2139
`(Schwartz Deposition
`Exhibit 17)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Objections limited to pages 293-382
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Summaries to Prove Content (FRE 1006). Fails to
`provide underlying data.
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`Summaries to Prove Content (FRE 1006). Fails to
`provide underlying data.
`Previously objected to. See Paper 26.
`
`Hearsay (FRE 801, 802, 803): The exhibit sets forth
`inadmissible hearsay offered for the truth of the matters
`asserted therein and is not subject to any exceptions.
`Furthermore, the exhibit does not contain any non-hearsay
`statements under Fed. R. Evid. 801(d).
`
`5
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`Summaries to Prove Content (FRE 1006). Fails to
`provide underlying data.
`
`II.
`
`CONCLUSION
`
`To the extent Patent Owners fail to correct the defects identified above,
`
`Petitioners may file a motion to exclude under 37 C.F.R. § 42.64(c) pursuant to the
`
`Scheduling Order (Paper 16) in this case.
`
`Dated: May 20, 2016
`
`Respectfully submitted,
`
`By:
`Richard McCormick (Reg. No. 55,902)
`Lisa M. Ferri (pro hac vice)
`Brian W. Nolan (Reg. No. 45,821)
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Attorneys for Petitioners sanofi-aventis U.S.
`LLC and Regeneron Pharmaceuticals, Inc.
`
`6
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`APPENDIX A
`OBJECTIONS TO IPR DECLARATION OF JOHN FIDDLES
`
`Fiddes ¶1
`¶¶ 58-80
`
`¶¶ 87-91
`
`¶¶ 93-95
`
`¶ 101
`
`¶ 104
`
`¶ 107
`
`¶ 120
`
`¶ 121
`
`123-126
`
`Objection(s)
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705;37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705;; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Hearsay (FRE 802): Recites out of court statements of Sir Winter.
`
`Relevance (FRE 402, 403): Relies on statements of a different
`expert in a prior litigation concerning, inter alia, the '415 patent and
`therefore is irrelevant to the § 103 invalidity grounds currently
`instituted in the instant proceeding. Fed. R. Evid. 402. More
`specifically, the statements of Dr. Winter concern the invalidity of
`the '415 patent primarily for non-enablement and lack of written
`description, with an obviousness-type double patenting argument that
`
`1 To the extent a separate paragraph relies upon a paragraph listed below, Petitioner incorporates the listed objection
`for the separate paragraph too.
`
`720559682
`
`7
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`is irrelevant to the § 103 invalidity grounds currently instituted in the
`instant proceeding. Secondly, any of the exhibit's probative value to
`the § 103 invalidity grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair prejudice, confusing
`the issues, misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed. R. Evid.
`403.
`
`¶ 128
`
`¶ 138
`
`Prejudice, Confusion, Waste of Time or Other Reason (FRE
`403): Misleadingly characterizes Sir Winter testimony.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`¶¶ 130-137 Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Hearsay (FRE 802): Recites out of court statements of Dr.
`McKnight.
`
`¶ 141
`
`¶ 144
`
`Relevance (FRE 402, 403): Relies on statements of a different
`expert in a prior proceeding concerning, inter alia, the '415 patent
`and therefore is irrelevant to the § 103 invalidity grounds currently
`instituted in the instant proceeding. Fed. R. Evid. 402. Secondly, any
`of the exhibit's probative value to the § 103 invalidity grounds
`instituted in the instant proceeding is substantially outweighed by the
`danger of unfair prejudice, confusing the issues, misleading the
`Board as trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403.
`
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 CFR
`§42.65). Outside area of expertise.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`
`8
`
`¶ 155
`
`720559682
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`Hearsay (FRE 802): Recites out of court statements by inventors of
`Bujard.
`
`Completeness (FRE 102): Relies on selected statements made
`during prosecution of patent at issue, the remainder of which is
`necessary to explain the information or data, to place the information
`or data in context, to avoid misleading the Board as trier of fact,
`and/or to insure a fair and impartial understanding of the exhibit.
`Fed. R. Evid. 106
`
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Completeness (FRE 102): Relies on selected statements made
`during prosecution of patent at issue, the remainder of which is
`necessary to explain the information or data, to place the information
`or data in context, to avoid misleading the Board as trier of fact,
`and/or to insure a fair and impartial understanding of the exhibit.
`Fed. R. Evid. 106.
`Completeness (FRE 102): Relies on selected statements made
`during prosecution of patent at issue, the remainder of which is
`necessary to explain the information or data, to place the information
`or data in context, to avoid misleading the Board as trier of fact,
`and/or to insure a fair and impartial understanding of the exhibit.
`Fed. R. Evid. 106.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Hearsay (FRE 802): Recites out of court statements of Sir Winter.
`
`Relevance (FRE 402, 403): Relies on statements of a different
`expert in a prior litigation concerning, inter alia, the '415 patent and
`therefore is irrelevant to the § 103 invalidity grounds currently
`instituted in the instant proceeding. Fed. R. Evid. 402. More
`9
`
`¶ 161
`
`¶ 164
`
`¶ 166
`
`¶ 186
`
`¶ 189
`
`¶ 195
`
`¶ 195
`
`¶ 205
`
`720559682
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`specifically, the statements of Dr. Winter concern the invalidity of
`the '415 patent primarily for non-enablement and lack of written
`description, with an obviousness-type double patenting argument that
`is irrelevant to the § 103 invalidity grounds currently instituted in the
`instant proceeding. Secondly, any of the exhibit's probative value to
`the § 103 invalidity grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair prejudice, confusing
`the issues, misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed. R. Evid.
`403.
`
`Lack of Personal Knowledge (FRE 602). Fails to establish
`personal knowledge of matter related to Dr. Milstein and Sir Winter.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Relevance (FRE 402, 403): Recites prior art patents that do not have
`any nexus with any instituted grounds of the proceeding and does not
`establish that any fact in issue in the proceeding is either more or less
`likely to be true, and is therefore irrelevant. Fed. R. Evid. 402.
`Secondly, any of the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is substantially
`outweighed by the danger of unfair prejudice, confusing the issues,
`misleading the Board as trier of fact, undue delay, wasting time, and
`needlessly presenting cumulative evidence. Fed. R. Evid. 403.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Relevance (FRE 402, 403): Recites statement from the '415 patent
`reexamination that do not have any nexus with any instituted grounds
`of the proceeding and does not establish that any fact in issue in the
`proceeding is either more or less likely to be true, and is therefore
`irrelevant. Fed. R. Evid. 402. Secondly, any of the exhibit's
`probative value to the § 103 invalidity grounds instituted in the
`instant proceeding is substantially outweighed by the danger of
`unfair prejudice, confusing the issues, misleading the Board as trier
`of fact, undue delay, wasting time, and needlessly presenting
`cumulative evidence. Fed. R. Evid. 403.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`
`10
`
`¶ 206
`
`¶ 219
`
`¶ 219
`
`¶ 238
`
`¶ 247
`
`720559682
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`
`¶ 250
`
`¶ 252
`
`¶ 253
`
`¶ 259
`
`¶ 260
`
`¶ 261
`
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Prejudice, Confusion, Waste of Time or Other Reason (FRE
`403): Misleadingly characterizes the Boards findings.
`Prejudice, Confusion, Waste of Time or Other Reason (FRE
`403): Misleadingly characterizes the Bujard Publication.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Prejudice, Confusion, Waste of Time or Other Reason (FRE
`403): Misleadingly characterizes the Falkner & Zavhau, Rice &
`Baltimore, Oi, and Ochi Publications.
`¶¶ 265-267 Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`¶¶ 289-290 Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Prejudice, Confusion, Waste of Time or Other Reason (FRE
`403): Misleadingly characterizes Southern's teachings.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`Insufficient fact and information (FRE 702, 703, and 705; 37 §
`CFR 42.65): Fails to provide sufficient support on which the opinion
`is based.
`
`¶ 273
`
`¶ 298
`
`¶ 300
`
`¶ 304
`
`720559682
`
`11
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`APPENDIX B
`OBJECTIONS TO IPR DECLARATION OF REINER GENTZ
`Objection(s)
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony.
`Hearsay (FRE 802). Relies on unsworn out of court statements for
`the truth of the matter asserted. Dr. Bujard has not submitted
`declarations in this proceeding.
`Prejudice, Confusion, Waste of Time or Other Reason (FRE
`403). Misleading and fails to establish no one was contemplating
`expressing two different eukaryotic proteins using one plasmid.
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony.
`Lack of Personal Knowledge (FRE 602). Fails to establish that Dr.
`Gentz had personal knowledge ascribed to third-parties.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony.
`Relevance (FRE 402, 403): Relies on non-prior-art and as such
`cannot prove the state of the art as of the priority date of the Cabilly
`II patent, has no nexus with any instituted grounds of the proceeding
`
`Gentz ¶2
`¶ 9
`
`¶ 23
`
`¶ 24-26
`
`¶ 28
`
`¶ 33
`
`¶ 39-41
`
`¶ 43
`
`¶ 45
`
`2 To the extent a separate paragraph relies upon a paragraph listed below, Petitioner incorporates the listed objection
`for the separate paragraph too.
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`Petitioners’ Objections to Evidence
`and does not establish that any fact in issue in the proceeding is either
`more or less likely to be true, and is therefore irrelevant. Secondly,
`any of the exhibit's probative value to the invalidity grounds
`instituted in the instant proceeding is substantially outweighed by the
`danger of unfair prejudice, confusing the issues, misleading the
`Board as trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence.
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony concerning his
`interpretation.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`Lack of Personal Knowledge (FRE 602) & Prejudice, Confusion,
`Waste of Time or Other Reason (FRE 403). Misleading and fails to
`establish Dr. Gentz possessed knowledge ascribed to third parties.
`Insufficient Basis for opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide support for testimony.
`
`¶ 49
`
`¶ 53
`
`¶ 55
`
`¶ 59-60
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`Davis ¶3
`¶ 27
`
`¶ 30
`
`¶ 32
`
`¶ 33
`
`¶ 34
`
`¶ 37
`
`¶ 38
`
`¶ 39
`
`¶ 43
`
`¶ 44
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`APPENDIX C
`OBJECTIONS TO IPR DECLARATION OF JULIE DAVIS
`Objection(s)
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide sufficient support for her testimony and
`outside her area of expertise.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide sufficient support for her testimony and
`outside her area of expertise.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide sufficient support for her testimony and
`outside her area of expertise.
`Hearsay (FRE 802). Recites out of court statements of Dr. Sabry
`and Dr. Croce from district court proceedings. Dr. Sabry and Dr.
`Croce have not submitted declarations in this proceeding.
`Hearsay (FRE 802). Recites out of court statements of Dr. Croce
`from a district court proceeding. Dr. Croce has not submitted
`declarations in this proceeding.
`Hearsay (FRE 802). Recites unsworn out of court statements of Dr.
`Schwartz. Dr. Schwartz has not submitted declarations in this
`proceeding.
`Lack of Personal Knowledge (FRE 602). Fails to establish that Dr.
`Schwartz has personal knowledge concerning motivates ascribed to
`third-parties.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide sufficient support for her testimony and
`outside her area of expertise.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide sufficient support for her testimony and
`outside her area of expertise.
`Prejudice, Confusion, Waste of Time or Other Reason (FRE 403)
`– Licensee under Ilex license challenged patent and that license is not
`in effect.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`
`3 To the extent a separate paragraph relies upon a paragraph listed below, Petitioner incorporates the listed objection
`for the separate paragraph too.
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`¶ 45
`
`¶ 46
`
`¶ 47
`
`¶ 49
`
`¶ 51
`
`¶ 52
`
`¶ 53
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`IPR2015-01624
`Petitioners’ Objections to Evidence
`
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide sufficient basis to support basis for
`rationale why the MedImmune rates are lower.
`Lack of Personal Knowledge (FRE 602). Fails to establish any
`basis for why the MedImmune rates are lower..
`Hearsay (FRE 802). Seeks to put into evidence quotes from articles
`without establishing reliability of the article
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to establish expert in this particular field would
`reasonably rely on thiskKind of information.
`Hearsay (FRE 802). Seeks to put into evidence quotes from articles
`without establishing reliability of the article
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to establish expert in this particular field would
`reasonably rely on thiskKind of information.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion for financial information concerning Cabilly patents and
`Cohen-Boyer patents.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to establish expert in this particular field would
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`¶ 54
`
`¶ 55
`
`¶ 56
`
`¶ 57
`
`¶ 58
`
`¶ 59
`
`¶ 60
`
`¶ 61
`
`¶ 62
`
`¶ 65
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`reasonably rely on this kind of information.
`Conclusion of Law (FRE 702 and 704). Legal conclusion as to
`what is sufficient to show commercial success
`Conclusion of Law (FRE 702 and 704). Legal conclusion as to
`what is sufficient to show commercial success
`Hearsay (FRE 802). Recites out of court statements of Dr. Rickert
`from a district court proceeding. Dr. Rickert has not submitted
`declarations in this proceeding.
`Hearsay (FRE 802). Recites out of court statements of Dr. Sabry
`from a district court proceeding. Dr. Sabry has not submitted
`declarations in this proceeding.
`Hearsay (FRE 802). Recites out of court statements of Dr. Rickert
`from a district court proceeding. Dr. Rickert has not submitted
`declarations in this proceeding.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Hearsay (FRE 802). Seeks to put into evidence quotes from articles
`without establishing reliability of the article
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to establish expert in this particular field would
`reasonably rely on thiskKind of information.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
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`¶ 66
`
`¶ 67
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
`Insufficient Basis for Opinion (FRE 702, 703 and 705, 37 C.F.R.
`§42.65). Fails to provide underlying data sufficient to support
`opinion.
`Summaries to Prove Content (FRE 1006). Fails to provide
`underlying data.
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`Petitioners’ Objections to Evidence
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing was served on
`May 20, 2016, via electronic mail to counsel for Patent Owners at the following
`addresses:
`
`David L. Cavanaugh (No. 36,476)
`David.Cavanaugh@wilmerhale.com
`
`Jeffrey P. Kushan (No. 43,401)
`jkushan@sidley.com
`
`Adam R. Brausa (No. 60,287)
`abrausa@durietangri.com
`
`/Richard J. McCormick/
`Richard J. McCormick, (No. 55,902)
`rmccormick@mayerbrown.com
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Telephone: (212) 506-2382
`Fax: (212) 849 5682
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