For the Petitioner
`Lead counsel: James T. Carmichael, Reg. No. 45,306
`Backup counsel: Carol A. Spiegel, Reg. No. 68,033
`Carmichael IP, PLLC
`
`
`
`Paper No. __
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT FUND, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGENBERG,
`Petitioners,
`v.
`BIOGEN MA INC.,
`Patent Owner.
`____________________
`
`Case IPR2015-01993
`Patent 8,399,514 B2
`____________________
`
`PETITIONER OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`
`
`Lead counsel: James T. Carmichael, Reg. No. 45,306
`Backup counsel: Carol A. Spiegel, Reg. No. 68,033
`Carmichael IP, PLLC
`
`
`
`Paper No. __
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT FUND, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGENBERG,
`Petitioners,
`v.
`BIOGEN MA INC.,
`Patent Owner.
`____________________
`
`Case IPR2015-01993
`Patent 8,399,514 B2
`____________________
`
`PETITIONER OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b), Petitioner objects under the Federal Rules
`
`of Evidence (“FRE”) and 37 C.F.R. § 42.62 to the following exhibits cited in
`
`Biogen’s Opposition to the Petition (Paper 38), Patent Owner’s Motion to Antedate
`
`(Paper 40), O’Neill Declaration II (Ex. 2076), Dawson Declaration (Ex. 2077),
`
`Lansden Declaration (Ex. 2079), and Sarnelli Declaration (Ex. 2080). Petitioner’s
`
`Objections to Evidence are timely filed under 37 C.F.R. § 42.64(b)(1).
`
`
`
`Petitioner serves Patent Owner (“PO”) with these objections to provide
`
`notice that Petitioner may move to exclude the challenged exhibits under 37 C.F.R.
`
`§ 42.64(c) unless Patent Owner cures the defects associated with the challenged
`
`exhibits defined herein.
`
`Exhibit
`2031
`
`PO Description
`Biogen Idec
`Announces Positive
`Top Line Results from
`the
`First Phase 3 Trial
`Investigating Oral BG-
`12 (DIMETHYL
`FUMARATE) in
`Multiple Sclerosis,
`BIOGEN MEDIA (Apr.
`11,
`2011, 7:00 AM EDT),
`http://media.biogen.co
`m/press-
`release/multiple-
`sclerosis-ms/biogen-
`idec-announces-
`positivetop-
`
`
`
`Cited at
`O’Neill Dec. II
`(Ex. 2076) at ¶43
`
`Objection(s)
`This exhibit is confusing,
`lacks authentication, is
`not available at the cited
`url location, and
`constitutes and/or
`contains hearsay.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`FRE 801(c) (hearsay)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`FRE 901 (lacking
`authentication)
`
`2
`
`
`
`
`
`2033
`
`line-results-first-
`phase-3-tr
`Daily Dosing Date
`Ranges Chart
`
`Motion to
`Antedate, Paper
`40 at 9, 13 and 14.
`
`2051
`
`Biogen’s Daily
`Diligence Chart
`
`Motion to
`Antedate, Paper
`40 at 8.
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 902 (evidence is not
`self-authenticating)
`It is unclear what “a
`given range” is and how
`it relates to the claimed
`invention for any of the
`six studies, including one
`human clinical. Exs.
`2375 and 2092, at the
`pages cited in the chart,
`fail to describe the
`asserted start and end
`dates of study C-1900.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`This exhibit is confusing,
`lacks authentication and
`constitutes and/or
`contains hearsay.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the rule
`against hearsay)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`
`3
`
`
`
`
`
`2052
`
`BG-12 Program Chart Motion to
`Antedate, Paper
`40 at 9-11.
`
`Biogen’s
`Opposition to the
`Petition, Paper 38
`at 54.
`
`2075
`
`Bill Berkrot, Biogen
`Profit Beats Estimates,
`Raises 2013
`Forecast, REUTERS
`(Apr. 25, 2013, 10:08
`AM EDT),
`http://www.reuters.co
`m/article/us-
`biogenidec-
`resultsidUSBRE93O0
`Q920130425
`
`2081
`
`New Data Show
`Strong, Sustained
`
`Biogen’s
`Opposition to the
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 902 (evidence is not
`self-authenticating)
`This exhibit is confusing,
`lacks authentication and
`constitutes and/or
`contains hearsay.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the rule
`against hearsay)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`This exhibit lacks
`authentication and
`constitutes and/or
`contains hearsay.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the rule
`against hearsay)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`This exhibit is confusing,
`lacks authentication, is
`
`4
`
`
`
`Effects of
`TECFIDERA®
`(Dimethyl Fumarate)
`in Newly-Diagnosed
`and Early Disease
`Course Multiple
`Sclerosis Patients,
`BIOGEN MEDIA (Oct. 7,
`2015, 6:00 AM EDT),
`http://media.biogen.co
`m/pressrelease/
`neurology/new-data-
`show-strong-
`sustained-
`effectstecfidera-
`dimethyl-fumarate-
`newly-dia
`
`Excerpts from Clinical
`Study Report Study
`Number: 109MS301
`(Report Date:
`1/14/2012)
`
`2082
`
`Petition, Paper 38
`at 64.
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 40;
`Dawson Dec. (Ex.
`2077) at ¶¶ 6, 7
`and 31.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`not available at the cited
`url location, and
`constitutes and/or
`contains hearsay.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 801(c)
`(hearsay)FRE 802 (not an
`exception to the rule
`against hearsay)
`
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the rule
`against hearsay)FRE
`803(6) (document has not
`been shown to be a
`business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`
`5
`
`
`
`
`
`2083
`
`Excerpts from Clinical
`Study Report Study
`Number:
`109MS302 (Report
`Date: 1/14/2012)
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 40;
`Dawson Dec. (Ex.
`2077) at ¶¶ 6, 7
`and 31.
`
`2086
`
`Letter to Russell Katz
`(dated October 27,
`2006) re: IND
`73,061: BG00012
`(Dimethyl Fumarate):
`Multiple Sclerosis
`Serial No. 0013
`Request for Special
`Protocol Assessment -
`Clinical Protocol
`
`Motion to
`Antedate, Paper
`40 at 21;
`Dawson Dec. (Ex.
`2077) at ¶¶6, 7
`and 56; Sarnelli
`Dec. (Ex. 2080) at
`¶¶15, 16, 20 and
`68.
`
`2087
`
`Letter to Russell Katz
`(dated October 27,
`2006) re: IND
`
`Motion to
`Antedate, Paper
`40 at 13;
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`This exhibit lacks
`authentication and
`constitutes and/or
`contains hearsay.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the rule
`against hearsay)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`
`6
`
`
`
`73,061: BG00012
`(Dimethyl Fumarate):
`Multiple Sclerosis
`Serial No. 0013
`Request for Special
`Protocol Assessment -
`Clinical Protocol
`
`Dawson Dec. (Ex.
`2077) at ¶¶6, 7
`and 15; Sarnelli
`Dec. (Ex. 2080) at
`¶¶20 and 69.
`
`2090
`
`Cover Page of Clinical
`Study Report Study
`Number: 109-HV-
`101 (Report Date:
`4/16/2007)
`
`Motion to
`Antedate, Paper
`40 at 16;
`Dawson Dec. (Ex.
`2077) at ¶¶6, 7,
`52, 56 and 59.
`
`2106
`
`BG12 Phase III SMT
`Minutes from July 20,
`2006 Meeting
`
`Motion to
`Antedate, Paper
`40 at 20 and 22;
`Dawson Dec. (Ex.
`2077) at ¶¶6, 7,
`37, 39, and 40.
`
`2115
`
`BG00012 SMT Kick-
`Off Meeting Minutes
`on May 24, 2006
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 51; Lansden
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 802 (not an
`exception to the rule
`against hearsay)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`
`7
`
`
`
`Dec. (Ex. 2079) at
`¶¶9, 10, and 42.
`
`2116
`
`BG00012 SMT
`Meeting Minutes on
`June 1, 2006
`
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 44; Sarnelli
`Dec. (Ex. 2080) at
`¶¶20 and 52.
`
`2122
`
`BG-12 Program Team
`Meeting Minutes from
`May 18, 2006
`Meeting
`
`2124
`
`BG-12 Program Team
`Meeting Minutes from
`May 25, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 17; O’Neill
`Dec. II (Ex. 2076)
`at ¶¶9 and 50;
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 41; Sarnelli
`Dec. (Ex. 2080) at
`¶¶20 and 52.
`
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 43; Sarnelli
`Dec. (Ex. 2080) at
`¶¶20 and 52.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`
`8
`
`
`
`2125
`
`Email (dated
`6/21/2006) regarding
`BG12 protocol review
`
`Motion to
`Antedate, Paper
`40 at 18; O’Neill
`Dec. II (Ex. 2076)
`at ¶¶9 and 54;
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 45.
`
`2127
`
`BG00012 SMT
`Meeting Minutes from
`July 6, 2006 Meeting
`
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 49.
`
`2130
`
`BG-12 Phase 3 Data
`DEFINE First Look
`(dated 4/8/2011)
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 43.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`All but three sentences
`are redacted from this 56-
`page document which
`provides no actual data.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`
`9
`
`
`
`2131
`
`BG-12 MS Clinical
`Development Team
`Minutes from May 17,
`2006 Meeting
`
`2132
`
`BG-12 MS Clinical
`Development Team
`Minutes from July 12,
`2006 Meeting
`
`Motion to
`Antedate, Paper
`40 at 18 and 22;
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 51; Lansden
`Dec. (Ex. 2079) at
`¶¶9, 10, and 41;
`Sarnelli Dec. (Ex.
`2080) at ¶¶20 and
`52.
`Motion to
`Antedate, Paper
`40 at 19; Dawson
`Dec. (Ex. 2077) at
`¶¶6, 7, and 35.
`
`2134
`
`BG-12 MS Clinical
`Development Team
`Minutes from July 19,
`2006 Meeting
`
`Motion to
`Antedate, Paper
`40 at 20 and 22;
`Dawson Dec. (Ex.
`2077) at ¶¶6, 7,
`37, and 39.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`
`10
`
`
`
`
`
`2196
`
`BG00012 SMT
`Meeting Minutes from
`January 18, 2007
`meeting
`
`Motion to
`Antedate, Paper
`40 at 21, 23, and
`24; Dawson Dec.
`(Ex. 2077) at ¶¶6,
`7, and 67-69.
`
`2198
`
`BG00012 SMT
`Meeting Minutes from
`February 8, 2007
`meeting
`
`Motion to
`Antedate, Paper
`40 at 21, 23, and
`24; Dawson Dec.
`(Ex. 2077) at ¶¶6,
`7, 71, 73, and 74.
`
`2203
`
`BG00012 SMT
`Meeting Minutes from
`February 22, 2007
`meeting
`
`Motion to
`Antedate, Paper
`40 at 21, 23, and
`24; Dawson Dec.
`(Ex. 2077) at ¶¶6,
`7, and 71-74.
`
`2206
`
`BG12 SMT Meeting
`Minutes from
`November 9, 2006
`meeting
`
`Motion to
`Antedate, Paper
`40 at 23; Dawson
`Dec. (Ex. 2077) at
`¶¶6, 7, 59, and 60.
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`
`11
`
`
`
`
`
`
`
`2212
`
`109MS301 Advisory
`Committee Minutes
`from February 2,
`2007 Meeting
`
`Motion to
`Antedate, Paper
`40 at 21 and 23;
`Dawson Dec. (Ex.
`2077) at ¶¶71 and
`73.
`
`2213
`
`109MS301 Advisory
`Committee Minutes
`from January 19,
`2007 Meeting
`
`Motion to
`Antedate, Paper
`40 at 21 and 24;
`Dawson Dec. (Ex.
`2077) at ¶¶68 and
`69.
`
`2214
`
`BG00012 SMT
`Minutes from
`November 2, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 23; Dawson
`Dec. (Ex. 2077) at
`¶¶59 and 60.
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Document lacks
`authentication; Advisory
`Committee members are
`unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. Advisory
`Committee members are
`unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. SMT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`
`12
`
`
`
`2215
`
`Email to bg00012
`phase 3 smt (dated
`November 8, 2006)
`attaching Project
`Startup Summary:
`109MS301 (dated
`November 7, 2006)
`
`Motion to
`Antedate, Paper
`40 at 23; Dawson
`Dec. (Ex. 2077) at
`¶58.
`
`2216
`
`Email to bg00012
`phase 3 smt (dated
`December 6, 2006)
`attaching BG00012
`SMT Minutes from
`November 30, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 23; Dawson
`Dec. (Ex. 2077) at
`¶¶59 and 61.
`
`2217
`
`BG00012 SMT
`Minutes from
`December 7, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 23-24;
`Dawson Dec. (Ex.
`2077) at ¶¶64 and
`65.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. [S]mt
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. [S]mt
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. SMT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`13
`
`
`
`2218
`
`BG00012 SMT
`Minutes from
`December 14, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 23-24;
`Dawson Dec. (Ex.
`2077) at ¶¶64 and
`65.
`
`2219
`
`BG00012 SMT
`Minutes from January
`4, 2007 Meeting
`
`Motion to
`Antedate, Paper
`40 at 23-24;
`Dawson Dec. (Ex.
`2077) at ¶¶61, 63,
`67, and 68.
`
`2220
`
`BG00012 SMT
`Minutes from January
`11, 2007 Meeting
`
`Motion to
`Antedate, Paper
`40 at 24; Dawson
`Dec. (Ex. 2077) at
`¶68.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. SMT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. SMT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. SMT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`
`14
`
`
`
`
`
`2221
`
`BG00012 SMT
`Minutes from January
`25, 2007 Meeting
`
`Motion to
`Antedate, Paper
`40 at 24; Dawson
`Dec. (Ex. 2077) at
`¶68.
`
`2222
`
`BG-12 MS Clinical
`Development Team
`Minutes from
`November 15, 2006
`Meeting
`
`Dawson Dec. (Ex.
`2077) at ¶60.
`
`
`2223
`
`BG00012 SMT
`Minutes from January
`18, 2011 Meeting
`
`Dawson Dec. (Ex.
`2077) at ¶67.
`
`
`2228
`
`BG-12 MS Clinical
`Development Team
`Minutes from
`
`Motion to
`Antedate, Paper
`40 at 21 and 23;
`Dawson Dec. (Ex.
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Document lacks
`authentication. SMT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. CDT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Document lacks
`authentication.
`Hearsay under FRE
`801(c).
`
`15
`
`
`
`September 6, 2006
`Meeting
`
`2077) at ¶7;
`Sarnelli Dec. (Ex.
`2080) at ¶20
`
`2229
`
`Protocol 109MS301:
`Safety and Efficacy of
`BG00012 in
`RRMS (Version 1)
`(Report Date:
`9/21/2006; Signed by
`Carmen Bozic
`9/21/2006)
`
`Motion to
`Antedate, Paper
`40 at 21; Dawson
`Dec. (Ex. 2077) at
`¶49.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`The entire 94-page
`document is redacted but
`for its cover sheet and
`lacks authentication.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`16
`
`
`
`
`
`
`
`Dawson Dec. (Ex.
`2077) at ¶55.
`
`2230
`
`Protocol 109MS301:
`Efficacy and Safety of
`BG00012 in
`RRMS (Version 2)
`(Report Date:
`10/24/2006; Signed by
`Carmen Bozic
`10/25/2006)
`
`Motion to
`Antedate, Paper
`40 at 21; Dawson
`Dec. (Ex. 2077) at
`¶55.
`
`2231
`
`Protocol 109MS302:
`Efficacy and Safety of
`BG00012 in
`RRMS with Active
`Reference (Version 1)
`(Report Date:
`10/16/2006; Signed by
`Carmen Bozic
`10/16/2006)
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 802 (not an
`exception to the rule
`against hearsay)
`
`The entire 92-page
`document is redacted but
`for its cover sheet and
`lacks authentication.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`The entire 94-page
`document is redacted but
`for its cover sheet and
`lacks authentication.
`FRE 403 (excluding
`relevant evidence for
`prejudice, confusion,
`waste of time, or other
`reasons)
`
`17
`
`
`
`2232
`
`BG-12 MS Clinical
`Development Team
`Minutes from October
`11, 2006 Meeting
`
`Motion to
`Antedate, Paper
`40 at 21; Dawson
`Dec. (Ex. 2077) at
`¶¶55 and 56.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. CDT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`
`18
`
`
`
`
`
`2233
`
`BG-12 MS Clinical
`Development Team
`Minutes from October
`4, 2006 Meeting
`
`Motion to
`Antedate, Paper
`40 at 21; Dawson
`Dec. (Ex. 2077) at
`¶¶55 and 56.
`
`2234
`
`BG00012 SMT
`Minutes from
`September 7, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 21-23;
`Dawson Dec. (Ex.
`2077) at ¶¶49-51.
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Document lacks
`authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`19
`
`
`
`2236
`
`BG-12 MS Clinical
`Development Team
`Minutes from
`September 27, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 21; Dawson
`Dec. (Ex. 2077) at
`¶49.
`
`2239
`
`Email (dated 8/8/2006)
`regarding CRO
`selection for
`109MS301 and
`109MS302
`
`Motion to
`Antedate, Paper
`40 at 22; Dawson
`Dec. (Ex. 2077) at
`¶45.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. CDT
`members are unknown.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication. Hearsay
`under FRE 801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`
`20
`
`
`
`
`
`
`
`2240
`
`Email (dated
`8/11/2006) regarding
`Lab and IVRS/IXRS
`Selection for
`109MS301 and
`109MS302
`
`Motion to
`Antedate, Paper
`40 at 22; Dawson
`Dec. (Ex. 2077) at
`¶45.
`
`2241
`
`BG00012 SMT
`Minutes from
`September 21, 2006
`Meeting
`
`Motion to
`Antedate, Paper
`40 at 21-23;
`Dawson Dec. (Ex.
`2077) at ¶¶49-51.
`
`2242
`
`BG00012 SMT
`Minutes from
`
`Motion to
`Antedate, Paper
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Document lacks
`authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an
`exception to the rule
`against hearsay)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Hearsay under FRE
`801(c).
`
`21
`
`
`
`September 28, 2006
`Meeting
`
`40 at 22-23;
`Dawson Dec. (Ex.
`2077) at ¶¶. 6, 7,
`and 50-51.
`
`2250
`
`Email (dated
`3/27/2006) regarding
`the BG12 MS IND
`73,061
`
`Motion to
`Antedate, Paper
`40 at 16; Sarnelli
`Dec. (Ex. 2080) at
`¶¶20 and 50.
`
`2252
`
`BG-12 MS Clinical
`Development Team
`Minutes from
`May 3, 2006 Meeting
`
`Motion to
`Antedate, Paper
`40 at 18; O’Neill
`Dec. II (Ex. 2076)
`at ¶¶9, 36, and 51;
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 41; Sarnelli
`Dec. (Ex. 2080) at
`¶¶20 and 52.
`
`2258
`
`Neurology R&D
`Committee Minutes
`from June 19, 2007
`Meeting
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9,
`40, and 63.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`
`22
`
`
`
`2262
`
`BG00012 MS Clinical
`Development Team
`Minutes from
`September 7, 2005
`Meeting
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 25.
`
`2273
`
`Excerpts from Study
`of Dimethyl Fumarate
`in CD®IGS Rats
`(Date Study
`Completed: 5/12/2006)
`
`O’Neill Dec. II
`(Ex. 2076) at ¶¶9
`and 26; Dawson
`Dec. (Ex. 2077) at
`¶¶6 and 7; Sarnelli
`Dec. (Ex. 2080) at
`¶¶15, 16, 23, and
`24.
`
`
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the hearsay
`rule)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`23
`
`
`
`
`
`2274
`
`Excerpts from Final
`Report from Testing
`Facility EBA00009,
`for P00012-04-11
`(dated February 28,
`2008)
`
`2275
`
`Excerpts from Final
`Report from Testing
`Facility EBA00066,
`for P00012-05-05
`(dated April 9, 2007)
`
`
`
`Motion to
`Antedate, Paper
`40 at 12; O’Neill
`Dec. II (Ex. 2076)
`at ¶¶9, 52, 57, and
`61; Dawson Dec.
`(Ex. 2077) at ¶¶6,
`7, and 18; Sarnelli
`Dec. (Ex. 2080) at
`¶¶ 15, 16, 25, and
`26.
`
`Motion to
`Antedate, Paper
`40 at 14; O’Neill
`Dec. II (Ex. 2076)
`at ¶¶9, 26, 57, and
`61; Dawson Dec.
`(Ex. 2077) at ¶¶6,
`7, 16, 34, 36, 43,
`and 48; Sarnelli
`Dec. (Ex. 2080) at
`¶¶15, 16, and 30-
`32.
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the hearsay
`rule)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the hearsay
`rule)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`24
`
`
`
`
`
`2276
`
`Excerpts from Final
`Report from Testing
`Facility EBA00176,
`for P00012-05-08
`(Study completed
`6/21/2007)
`
`Motion to
`Antedate, Paper
`40 at15; O’Neill
`Dec. II (Ex. 2076)
`at ¶¶9, 26, 53, 58,
`and 62; Dawson
`Dec. (Ex. 2077) at
`¶¶6, 7, 19, 34, 36,
`43, 48, 54, 58, 63,
`and 67; Sarnelli
`Dec. (Ex. 2080) at
`¶¶15, 16, and 33-
`35.
`
`2277
`
`Email (dated
`6/10/2006) regarding
`update on BG12
`feasibility
`
`Lansden Dec. (Ex.
`2079) at ¶¶9, 10,
`and 44; Sarnelli
`Dec. (Ex. 2080) at
`¶20.
`
`
`
`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the hearsay
`rule)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`Lacks authentication.
`Hearsay under FRE
`801(c).
`FRE 802 (not an
`exception to the hearsay
`rule)
`FRE 803(6) (document
`has not been shown to be
`a business record “by the
`testimony of the
`custodian or another
`qualified witness”)
`FRE 807 (no required
`showing of residual
`exception requirements)
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`
`25
`
`
`
`
`
`2279
`
`Email (dated
`6/14/2006) discussing
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