`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, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGENBERG,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`____________________________________________
`
`Case: IPR2015-01993
`U.S. Patent No. 8,399,514
`____________________________________________
`
`BIOGEN’S EXHIBIT LIST AS OF JUNE 22, 2016
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`Exhibit
`
`Description
`
`Exhibit 2001 Hayman Capital Management, L.P. Form ADV Part 2A
`Brochure, June 1, 2015
`
`Exhibit 2002
`
`First Amended Petition in IPR2015-01136 (Paper No. 9)
`
`Exhibit 2003 Biogen’s Preliminary Response in IPR2015-01136 (Paper No.
`21)
`
`Exhibit 2004 Declaration of Dr. Linberg in IPR2015-01136 (Exhibit 1005A)
`
`Exhibit 2005
`
`Exhibit 2006
`
`Exhibit 2007
`
`Exhibit 2008
`
`Ludwig Kappos et al.,“A Randomized, Placebo-Controlled
`Phase 2 Trial of a Novel Oral Fumarate, BG00012, in Patients
`With Relapsing-Remitting Multiple Sclerosis,” from the 15th
`meeting of the European Neurological Society, Vienna Austria
`(June 18-22, 2005) (presented on June 20, 2005)
`
`Final Program for Fifteenth Meeting of the European
`Neurological Society, June 18-22, 2005, Vienna Austria
`(http://www.congrex.ch/2005/ens2005/)
`
`Scientific Program from Fifteenth Meeting of the European
`Neurological Society, June 18-22, 2005
`(http://registration.akm.ch/einsicht.php?XNKONGRESS_ID=1
`8&XNSPRACHE_ID=2)
`
`Program from Wednesday, June 22, 2005 from Fifteenth
`Meeting of the European Neurological Society
`(http://registration.akm.ch/einsicht.php?XNKONGRESS_ID=1
`8&XNSPRACHE_ID=2&XNMASKEN_ID=200&XSDATU
`M=2005-06-20)
`
`Exhibit 2009
`
`Final Office Action dated October 12, 2012, in U.S. Patent
`Application No. 13/372,426
`
`Exhibit 2010 Reply to Final Office Action filed December 12, 2012, in U.S.
`Patent Application No. 13/372,426
`
`Exhibit 2011 Declaration of Richard A. Rudick, M.D. Under 37 C.F.R.
`§ 1.132 filed on August 3, 2012 in U.S. Patent Application No.
`
`
`
`2
`
`
`
`
`
`Exhibit
`
`Description
`13/372,426
`
`Exhibit 2012 Notice of Allowance and Fees Due dated December 26, 2012
`in U.S. Patent Application No. 13/372,426
`
`Exhibit 2013
`
`Poster Session 5, Multiple Sclerosis, Wednesday, June 22,
`2005 from Fifteenth Meeting of the European Neurological
`Society
`(http://registration.akm.ch/einsicht.php?XNMASKEN_ID=300
`&XNKONGRESS_ID=18&XNSPRACHE_ID=2&XNSESSI
`ON_ID=748)
`
`Exhibit 2014 Declaration of Gilmore O’Neill, M.D.
`
`Exhibit 2015 Declaration of Richard Brudnick
`
`Exhibit 2016 Redacted License Agreement between Fumapharm AG and
`Biogen, Inc. dated September 25, 2003
`
`Exhibit 2016A License Agreement between Fumapharm AG and Biogen, Inc.
`dated September 25, 2003 (PROTECTIVE ORDER
`MATERIAL)
`
`Exhibit 2017 Redacted Stock Purchase Agreement dated May 26, 2006
`
`Exhibit 2017A Stock Purchase Agreement dated May 26, 2006
`(PROTECTIVE ORDER MATERIAL)
`
`Exhibit 2018
`
`SEC’Y OF THE COMMW. OF MASS., CORPS. DIV., BUSINESS
`ENTITY SUMMARY FOR BIOGEN MA INC. dated May 25, 2016
`
`Exhibit 2019
`
`Biogen Idec to Acquire Fumapharm AG; Consolidates
`Ownership of Oral Compound BG-12 Being Studied for
`Multiple Sclerosis, BUSINESS WIRE (May 31, 2006, 7:00 AM
`EDT),
`http://www.businesswire.com/news/home/20060531005276/en
`/Biogen-Idec-Acquire-Fumapharm-AG-Consolidates-
`Ownership
`
`Exhibit 2020 Biogen Idec Inc., Quarterly Report (Form 10-Q) (Nov. 9,
`
`
`
`3
`
`
`
`
`
`Exhibit
`
`Description
`2006)
`
`Exhibit 2021 Certified copy of Patent Assignment, Reel/Frame 018556-0294
`(Executed Dec. 20, 2000)
`
`Exhibit 2022 Certified copy of Patent Assignment, Reel/Frame 018556-0364
`(Executed June 24, 2003)
`
`Exhibit 2023 Curriculum Vitae of Richard Brudnick
`
`Exhibit 2024
`
`Petition in IPR2015-01993 (Paper No. 1)
`
`Exhibit 2025 Ralf Gold et al., Placebo-Controlled Phase 3 Study of Oral
`BG-12 for Relapsing Multiple Sclerosis, 367 N. ENGL. J. MED.
`1098 (2012)
`
`Exhibit 2026 Robert J. Fox et al., Placebo-Controlled Phase 3 Study of Oral
`BG-12 or Glatiramer in Multiple Sclerosis, 367 N. ENGL. J.
`MED. 1087 (2012)
`
`Exhibit 2027 Hillel S. Panitch et al., Randomized, Controlled Trial of
`Dextromethorphan/Quinidine for Pseudobulbar Affect in
`Multiple Sclerosis, 59 ANNALS OF NEUROL. 780 (2006)
`
`Exhibit 2028
`
`Exhibit 2029
`
`Exhibit 2030
`
`Exhibit 2031
`
`
`
`Erik P. Pioro et al., Dextromethorphan Plus Ultra Low-Dose
`Quinidine Reduces Pseudobulbar Affect, 68 ANNALS OF
`NEUROL. 693 (2010)
`
`Employee’s Proprietary Information and Inventions Agreement
`between Gilmore O’Neill and Biogen, Inc. (executed Apr. 28,
`2003)
`
`Employee Proprietary Information and Inventions and Dispute
`Resolution Agreement between Gilmore O’Neill and Biogen
`Idec Inc. (executed Mar. 29, 2004)
`
`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.com/press-
`
`4
`
`
`
`
`
`Exhibit
`
`Description
`release/multiple-sclerosis-ms/biogen-idec-announces-positive-
`top-line-results-first-phase-3-tr
`
`Exhibit 2032
`
`Employee Proprietary Information and Inventions and Dispute
`Resolution Agreement between Matvey Lukashev and Biogen
`Idec Inc. (executed Apr. 13, 2004)
`
`Exhibit 2033 Daily Dosing Date Ranges Chart
`
`Exhibit 2034
`
`SEC’Y OF THE COMMW. OF MASS., CORPS. DIV., BUSINESS
`ENTITY SUMMARY FOR BIOGEN INC. dated May 25, 2016
`
`Exhibit 2035 Rui Wang et al., Statistics in Medicine — Reporting of
`Subgroup Analyses in Clinical Trials, 357 N. ENGL. J. MED.
`2189 (2007)
`
`Exhibit 2036
`
`Peter M. Rothwell, Subgroup Analysis in Randomised
`Controlled Trials: Importance, Indications, and Interpretation,
`365 LANCET 176 (2005)
`
`Exhibit 2037 Andrew D. Oxman et al., A Consumer’s Guide to Subgroup
`Analyses, 116 ANNALS OF INTERNAL MED. 78 (1992)
`
`Exhibit 2038 Declaration of Ronald A. Thisted, Ph.D.
`
`Exhibit 2039 Curriculum Vitae of Ronald A. Thisted, Ph.D.
`
`Exhibit 2040 Declaration of Jose Miranda, Ph.D.
`
`Exhibit 2041 Curriculum Vitae of Jose Miranda, Ph.D.
`
`Exhibit 2042 Declaration of Richard C. Brundage, Pharm.D., Ph.D.
`
`Exhibit 2043 Curriculum Vitae of Richard C. Brundage, Pharm.D., Ph.D.
`
`Exhibit 2044 Declaration of Richard A. Rudick, M.D.
`
`Exhibit 2045 Curriculum Vitae of Richard A. Rudick, M.D.
`
`Exhibit 2046 Declaration of Daniel Wynn, M.D. FACNS FAASM
`
`
`
`5
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2047 Curriculum Vitae of Daniel Wynn, M.D. FACNS FAASM
`
`Exhibit 2048
`
`Erin McCallister, Tecfidera Cleans Up, BIOCENTURY, (Apr. 1,
`2013), http://www.biocentury.com/biotech-pharma-
`news/finance/2013-04-01/clean-label-for-biogen-ms-drug-
`tecfidera-translates-into-37b-market-cap-bump-a31a
`
`Exhibit 2049 Biogen, Inc., Current Report (Form 8-K) (June 23, 2003)
`
`Exhibit 2050 Certified copy of Patent Assignment, Reel/Frame 028146-0980
`
`Exhibit 2051 Biogen’s Daily Diligence Chart
`
`Exhibit 2052 BG-12 Program Chart
`
`Exhibit 2053 STEDMAN’S MEDICAL DICTIONARY (28th ed. 2006)
`
`Exhibit 2054 BLAKISTON’S GOULD MEDICAL DICTIONARY (Arthur Osol et al.
`eds., 3rd ed. 1972)
`
`Exhibit 2055
`
`Exhibit 2056
`
`Stuart E. Starr et al., Combination Therapy with Efavirenz,
`Nelfinavir, and Nucleoside Reverse-Transcriptase Inhibitors in
`Children Infected with Human Immunodeficiency with Virus
`Type 1, 341 N. ENGL. J. MED. 1874 (1999)
`
`Excerpt of Obligationenrecht [OR], [Code of Obligations] Mar.
`30, 1911, SR 220, RS 220 (Switz.) (English translation),
`available at https://www.admin.ch/opc/en/classified-
`compilation/19110009/201507010000/220.pdf.
`
`Exhibit 2057 Oral Compound BG-12 Achieves Primary Endpoint in Phase II
`Study of Relapsing-Remitting Multiple Sclerosis; Treatment
`with BG-12 Led to Statistically Significant Reductions in MRI
`Measures, BUSINESS WIRE (May 30, 2006, 10:00 AM EDT),
`http://www.businesswire.com/news/home/20060530005548/en
`/Oral-Compound-BG-12-Achieves-Primary-Endpoint-Phase
`
`Exhibit 2058
`
`Ludwig Kappos et al., Efficacy and Safety of Oral Fumarate in
`Patients with Relapsing-Remitting Multiple Sclerosis: A
`Multicentre, Randomised, Double-Blind, Placebo-Controlled
`
`
`
`6
`
`
`
`
`
`Exhibit
`
`Description
`Phase IIb Study, 372 LANCET 1463 (2008)
`
`Exhibit 2059
`
`International Conference on Harmonisation; Dose-Response
`Information to Support Drug Registration; Guideline;
`Availability, 59 Fed. Reg. 55972 (Nov. 9, 1994)
`
`Exhibit 2060
`
`Ezekiel J. Emanuel at al., What Makes Clinical Research
`Ethical?, 283 JAMA 2701 (2000)
`
`Exhibit 2061 DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (26th ed.
`1981)
`
`Exhibit 2062
`
`L. Kappos et al., Abstract, A Randomised, Placebo-Controlled
`Phase II Trial of a Novel Oral Single-Agent Fumarate
`Therapy, BG00012, in Patients with Relapsing-Remitting
`Multiple Sclerosis, 252 J. NEUROL. II/95 (2005)
`
`Exhibit 2063 Biogen MA Inc. v. Forward Pharma A/S, Interference No.
`106,023, Paper 611
`
`Exhibit 2064
`
`File Wrapper for U.S. Provisional Application No. 60/888,921,
`filed February 8, 2007
`
`Exhibit 2065 Chapters 1 and 4 from ALASTAIR COMPSTON ET AL.,
`MCALPINE’S MULTIPLE SCLEROSIS (4th ed. 2006)
`
`Exhibit 2066 Chapter 1 from MULTIPLE SCLEROSIS THERAPEUTICS (Jeffrey
`A. Cohen & Richard A. Rudick eds., 4th ed. 2011)
`
`Exhibit 2067 Brie Zeltner, Cleveland Clinic Announces Its Top 10 Medical
`Innovations of the Year, CLEVELAND.COM (Nov. 3, 2010, 10:53
`AM EDT),
`http://www.cleveland.com/healthfit/index.ssf/2010/11/2010_in
`novations_summit_clevel.html
`
`Exhibit 2068 Douglas Quenqua, Existential Animal News and the World’s
`Lightest Solid, N.Y. TIMES, Apr. 1, 2013, available at
`http://www.nytimes.com/2013/04/02/science/existential-
`animal-news-and-the-worlds-lightest-solid.html?_r=0
`
`
`
`7
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2069
`
`Exhibit 2070
`
`Biogen Idec Struggling to Cope with Tecfidera Demand
`Suggests Analyst, FIRSTWORD PHARMA (June 12, 2013),
`https://www.firstwordpharma.com/node/1105932?tsid=17
`
`Toni Clarke, U.S. FDA Approves Biogen’s Oral MS Drug,
`Tecfidera, REUTERS (Mar. 27, 2013, 5:10 PM EDT),
`http://www.reuters.com/article/us-biogen-tecfidera-
`idUSBRE92Q19820130327
`
`Linberg Dep., June 13, 2016
`Exhibit 2071
`Exhibit 2072 Gilenya® Prescribing Info., rev. Feb. 2016
`Exhibit 2073 Aubagio® Prescribing Info., rev. Oct. 2014
`Tecfidera® Prescribing Info., rev. Feb. 2016
`
`Exhibit 2074
`
`Exhibit 2075 Bill Berkrot, Biogen Profit Beats Estimates, Raises 2013
`Forecast, REUTERS (Apr. 25, 2013, 10:08 AM EDT),
`http://www.reuters.com/article/us-biogenidec-results-
`idUSBRE93O0Q920130425
`
`Exhibit 2076
`
`Second Declaration of Gilmore O’Neill, M.D.
`
`Exhibit 2077 Declaration of Katherine Dawson, M.D.
`
`Exhibit 2078 Declaration of Carmen Bozic, M.D.
`
`Exhibit 2079 Declaration of Cara Lansden
`
`Exhibit 2080 Declaration of Tammy Sarnelli
`Exhibit 2081 New Data Show Strong, Sustained 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.com/press-
`release/neurology/new-data-show-strong-sustained-effects-
`tecfidera-dimethyl-fumarate-newly-dia
`
`Exhibit 2082
`
`Excerpts from Clinical Study Report Study Number:
`
`
`
`8
`
`
`
`
`
`Exhibit
`
`Description
`109MS301 (Report Date: 1/14/2012)
`
`Exhibit 2083
`
`Excerpts from Clinical Study Report Study Number:
`109MS302 (Report Date: 1/14/2012)
`
`Exhibit 2084
`
`Standard Acknowledgment for Access to Protective Order
`Material signed June 21, 2016 by Carol A. Spiegel
`
`Exhibit 2085 CDER Pharmacology Review(s) (Submission Date 2/27/2012)
`
`Exhibit 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
`
`Exhibit 2087
`
`Letter to Russell Katz (dated April 20, 2007) re: IND 73,061:
`BG00012 (Dimethyl Fumarate): Multiple Sclerosis Submission
`of Clinical Trial Protocols Serial No. 0017
`
`Exhibit 2088 Biogen Idec Inc., Annual Report (Form 10-K) (Mar. 10, 2004)
`
`Exhibit 2089 Biogen Idec Inc., Quarterly Report (Form 10-Q) (Nov. 9,
`2006)
`
`Exhibit 2090 Cover Page of Clinical Study Report Study Number: 109-HV-
`101 (Report Date: 4/16/2007)
`
`Exhibit 2091 Biogen Inc., Annual Report (Form 10-K) (Feb. 3, 2016)
`
`Exhibit 2092 Excerpts from Clinical Study Report Study Number: C-1900
`(Report Date: 5/12/2008)
`
`Exhibit 2093
`
`Standing Protective Order
`
`Exhibit 2094
`
`Standard Acknowledgment for Access to Protective Order
`Material signed June 22, 2016 by James T. Carmichael
`
`Exhibit 2095 Reserved
`
`Exhibit 2096
`
`Email (dated 4/25/2006) with attached presentation on
`CDT/SMT Charters (dated 5/11/2004)
`
`
`
`9
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2097 –
`Exhibit 2104
`
`Exhibit 2105
`
`Reserved
`
`Email (dated 6/28/2006) providing information on BG-12
`Country Selection in preparation for an upcoming meeting
`
`Exhibit 2106 BG12 Phase III SMT Minutes from July 20, 2006 Meeting
`
`Exhibit 2107–
`Exhibit 2114
`
`Reserved
`
`Exhibit 2115 BG00012 SMT Kick-Off Meeting Minutes on May 24, 2006
`
`Exhibit 2116 BG00012 SMT Meeting Minutes on June 1, 2006
`
`Exhibit 2117 Reserved
`
`Exhibit 2118
`
`Letter to Russell Katz regarding submitting the Initial
`Investigational New Drug Application BG00012 (dated
`2/22/2006)
`
`Exhibit 2119 –
`Exhibit 2121
`
`Reserved
`
`Exhibit 2122 BG-12 Program Team Meeting Minutes from May 18, 2006
`Meeting
`
`Exhibit 2123 Reserved
`
`Exhibit 2124 BG-12 Program Team Meeting Minutes from May 25, 2006
`Meeting
`
`Exhibit 2125
`
`Email (dated 6/21/2006) regarding BG12 protocol review
`
`Exhibit 2126
`
`Email (dated 6/29/2006) regarding request to review BG12
`protocols
`
`Exhibit 2127 BG00012 SMT Meeting Minutes from July 6, 2006 Meeting
`
`Exhibit 2128
`
`
`
`Email (dated 6/26/2006) requesting review of the 109MS301
`and 109MS302 BG12 protocols
`10
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2129 Reserved
`
`Exhibit 2130 BG-12 Phase 3 Data DEFINE First Look (dated 4/8/2011)
`
`Exhibit 2131 BG-12 MS Clinical Development Team Minutes from May 17,
`2006 Meeting
`Exhibit 2132 BG-12 MS Clinical Development Team Minutes from July 12,
`2006 Meeting
`
`Exhibit 2133 Reserved
`Exhibit 2134 BG-12 MS Clinical Development Team Minutes from July 19,
`2006 Meeting
`
`Reserved
`
`Exhibit 2135 –
`Exhibit 2195
`Exhibit 2196 BG00012 SMT Meeting Minutes from January 18, 2007
`meeting
`
`Exhibit 2197 Reserved
`Exhibit 2198 BG00012 SMT Meeting Minutes from February 8, 2007
`meeting
`
`Reserved
`
`Exhibit 2199 –
`Exhibit 2202
`Exhibit 2203 BG00012 SMT Meeting Minutes from February 22, 2007
`meeting
`
`Exhibit 2204 –
`Exhibit 2205
`
`Reserved
`
`Exhibit 2206 BG12 SMT Meeting Minutes from November 9, 2006 meeting
`
`Exhibit 2207 –
`Exhibit 2209
`
`Exhibit 2210
`
`
`
`Reserved
`
`Email from Kate Dawson (dated 11/21/2006) regarding
`11
`
`
`
`
`
`Exhibit
`
`Description
`BG00012 Phase 3 Clinical Trials
`
`Exhibit 2211
`
`Email (dated 12/21/2006) attaching MRI Minutes and Agenda
`from December 18, 2006 meeting
`
`Exhibit 2212
`
`109MS301 Advisory Committee Minutes from February 2,
`2007 Meeting
`
`Exhibit 2213
`
`109MS301 Advisory Committee Minutes from January 19,
`2007 Meeting
`
`Exhibit 2214 BG00012 SMT Minutes from November 2, 2006 Meeting
`
`Exhibit 2215
`
`Exhibit 2216
`
`Email to bg00012 phase 3 smt (dated November 8, 2006)
`attaching Project Startup Summary: 109MS301 (dated
`November 7, 2006)
`
`Email to bg00012 phase 3 smt (dated December 6, 2006)
`attaching BG00012 SMT Minutes from November 30, 2006
`Meeting
`
`Exhibit 2217 BG00012 SMT Minutes from December 7, 2006 Meeting
`
`Exhibit 2218 BG00012 SMT Minutes from December 14, 2006 Meeting
`
`Exhibit 2219 BG00012 SMT Minutes from January 4, 2007 Meeting
`
`Exhibit 2220 BG00012 SMT Minutes from January 11, 2007 Meeting
`
`Exhibit 2221 BG00012 SMT Minutes from January 25, 2007 Meeting
`Exhibit 2222 BG-12 MS Clinical Development Team Minutes from
`November 15, 2006 Meeting
`
`Exhibit 2223 BG00012 SMT Minutes from January 18, 2011 Meeting
`
`Exhibit 2224 Reserved
`
`Exhibit 2225
`
`Letter to Russell Katz (dated September 11, 2006) re: IND
`73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`
`
`
`12
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2226
`
`Letter to Russell Katz (dated September 25, 2006) re: IND
`73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`
`Exhibit 2227
`
`Letter to Russell Katz (dated October 27, 2006) re: IND
`73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Serial No. 0012 Request for Special Protocol Assessment -
`Clinical Protocol
`
`Exhibit 2228 BG-12 MS Clinical Development Team Minutes from
`September 6, 2006 Meeting
`
`Exhibit 2229
`
`Exhibit 2230
`
`Protocol 109MS301: Safety and Efficacy of BG00012 in
`RRMS (Version 1) (Report Date: 9/21/2006; Signed by
`Carmen Bozic 9/21/2006)
`
`Protocol 109MS301: Efficacy and Safety of BG00012 in
`RRMS (Version 2) (Report Date: 10/24/2006; Signed by
`Carmen Bozic 10/25/2006)
`
`Exhibit 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)
`Exhibit 2232 BG-12 MS Clinical Development Team Minutes from October
`11, 2006 Meeting
`Exhibit 2233 BG-12 MS Clinical Development Team Minutes from October
`4, 2006 Meeting
`
`Exhibit 2234 BG00012 SMT Minutes from September 7, 2006 Meeting
`
`Exhibit 2235
`
`Email (dated 8/10/2006) regarding BG-12 PK/Potential for
`BID Bioequivalence
`Exhibit 2236 BG-12 MS Clinical Development Team Minutes from
`September 27, 2006 Meeting
`
`Exhibit 2237
`
`Email (dated 8/9/2006) regarding an information update for a
`BG12 SMT meeting
`
`
`
`13
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2238
`
`Email (dated 9/5/2006) regarding CRF Review for 109MS301
`
`Exhibit 2239
`
`Email (dated 8/8/2006) regarding CRO selection for
`109MS301 and 109MS302
`
`Exhibit 2240
`
`Email (dated 8/11/2006) regarding Lab and IVRS/IXRS
`Selection for 109MS301 and 109MS302
`
`Exhibit 2241 BG00012 SMT Minutes from September 21, 2006 Meeting
`
`Exhibit 2242 BG00012 SMT Minutes from September 28, 2006 Meeting
`
`Exhibit 2243 Reserved
`
`Exhibit 2244
`
`Fox et al. NEJM: Placebo-Controlled Phase 3 Study of Oral
`BG-12 or Glatiramer in Multiple Sclerosis (dated September
`20, 2012); Supplementary Protocol and SAP; Supplementary
`Appendix
`
`Exhibit 2245
`
`Gold et al. NEJM: Placebo-Controlled Phase 3 Study of Oral
`BG-12 for Relapsing MS (dated September 20, 2012);
`Protocol; Supplementary Appendix
`
`Exhibit 2246 –
`Exhibit 2249
`
`Reserved
`
`Exhibit 2250
`
`Email (dated 3/27/2006) regarding the BG12 MS IND 73,061
`
`Exhibit 2251 Reserved
`
`Exhibit 2252 BG-12 MS Clinical Development Team Minutes from
`May 3, 2006 Meeting
`
`Exhibit 2253 –
`Exhibit 2254
`
`Reserved
`
`Exhibit 2255
`
`Email (dated 5/1/2006) regarding the BG12 MS IND
`
`Exhibit 2256 –
`Exhibit 2257
`
`Reserved
`
`
`
`14
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2258 Neurology R&D Committee Minutes from June 19, 2007
`Meeting
`
`Exhibit 2259 –
`Exhibit 2261
`
`Reserved
`
`Exhibit 2262 BG00012 MS Clinical Development Team Minutes from
`September 7, 2005 Meeting
`
`Exhibit 2263 –
`Exhibit 2272
`
`Exhibit 2273
`
`Reserved
`
`Excerpts from Study of Dimethyl Fumarate in CD®IGS Rats
`(Date Study Completed: 5/12/2006)
`
`Exhibit 2274
`
`Excerpts from Final Report from Testing Facility EBA00009,
`for P00012-04-11 (dated February 28, 2008)
`
`Exhibit 2275
`
`Excerpts from Final Report from Testing Facility EBA00066,
`for P00012-05-05 (dated April 9, 2007)
`
`Exhibit 2276
`
`Excerpts from Final Report from Testing Facility EBA00176,
`for P00012-05-08 (Study completed 6/21/2007)
`
`Exhibit 2277
`
`Email (dated 6/10/2006) regarding update on BG12 feasibility
`
`Exhibit 2278 Reserved
`
`Exhibit 2279
`
`Email (dated 6/14/2006) discussing the BG-12 MS IND
`
`Exhibit 2280 Reserved
`
`Exhibit 2281
`
`Email (dated 5/25/2007) forwarding FDA request and
`attaching BG00012 End-Of-Phase 2 Meeting Information
`Package (dated 7/28/2006)
`
`Exhibit 2282 Reserved
`
`Exhibit 2283
`
`Letter to Russell Katz regarding P00012-04-11 for IND 73,061
`(dated 3/11/ 2008)
`
`
`
`15
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2284
`
`Letter to Russell Katz regarding P00012-05-03 for IND 73,061
`(dated 02/12/2009)
`
`Exhibit 2285
`
`Letter to Russell Katz regarding IND 73,061 and the
`submission of two revised Phase 3 clinical protocols (dated
`04/20/2007)
`
`Exhibit 2286
`
`Letter to Russell Katz regarding IND 73,061 submitting a 1
`year monkey toxicology report (dated 07/03/2007)
`
`Exhibit 2287
`
`Letter to Russell Katz regarding IND 73,061 submitting the
`final CSR for C-1900 (dated 06/23/2008)
`
`Exhibit 2288
`
`Letter to Sandy Childs submitting the BG00012 Type B
`Briefing document (dated 10/21/2004)
`
`Exhibit 2289
`
`Fax from FDA regarding draft reviewer comments from the
`11/23/2004 meeting concerning BG00012 (dated 11/19/2004)
`
`Exhibit 2290
`
`Letter from FDA regarding meeting minutes from 11/23/2004
`for PIND 69,852 (dated 12/23/2004)
`
`Exhibit 2291
`
`Email (dated 07/26/2005) from FDA regarding PIND 73,061
`meeting request and schedule of the type B meeting
`
`Exhibit 2292 Reserved
`
`Exhibit 2293
`
`Letter from FDA acknowledging IND 73,061 submission
`(dated 03/10/2006)
`
`Exhibit 2294
`
`Letter from FDA regarding IND 73,061 and protocol
`assessment of 109MS301 and submitting questions regarding
`same (dated 12/11/2006)
`
`Exhibit 2295 Reserved
`
`Exhibit 2296
`
`Letter from FDA regarding IND 73,061 setting up a meeting
`time for an EOP2/type B meeting on August 30, 2006 (dated
`08/10/2006)
`
`
`
`16
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2297
`
`Letter from Russell Katz enclosing the meeting minutes from
`the EOP2 meeting from Aug. 30, 2006 (dated 9/29/2006 and
`received 10/04/2006)
`
`Exhibit 2298 Reserved
`
`Exhibit 2299 Agency Phone Contact Report regarding receipt of request for
`SPA for studies 301 and 302 (contact dates 10/27/2006,
`11/2/2006, and 11/3/2006)
`
`Exhibit 2300 –
`Exhibit 2307
`
`Exhibit 2308
`
`Reserved
`
`Final Protocol Study Number: 109HV101 (Report Date:
`6/29/2006; Signed 7/5/2006)
`
`Exhibit 2309
`
`Email chain attaching slides for Ad Hoc CTRB Meeting –
`BG12 MS on 02/19/2004
`
`Exhibit 2310 CTRB Draft Meeting Minutes from February 19, 2004 meeting
`
`Exhibit 2311
`
`Email (dated 7/15/2005) providing draft pre-IND meeting
`package
`
`Exhibit 2312 –
`Exhibit 2315
`
`Exhibit 2316
`
`Reserved
`
`Email from Cara Lansden (dated 7/6/2006) forwarding BG-
`12 MS Clinical Development Team Minutes from
`July 5, 2006 Meeting
`
`Exhibit 2317 Reserved
`
`Exhibit 2318
`
`Email (dated 10/10/2003) discussing the development of
`BG00012
`
`Exhibit 2319 –
`Exhibit 2320
`
`Reserved
`
`Exhibit 2321
`
`Email (dated 6/14/2006) discussing the BG-12 MS IND
`
`
`
`17
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2322
`
`Email from Ratna Lingamaneni (dated 12/27/2005) Re: BG12
`MS IND - Cross functional review- Comments due 12/28/2005
`
`Exhibit 2323
`
`Email to Carmen Bozic (dated 3/18/2005) forwarding Official
`Pre-IND Meeting Minutes for PIND 69,852, BG00012 from
`FDA
`
`Exhibit 2324 –
`Exhibit 2325
`
`Exhibit 2326
`
`Reserved
`
`Letter to Russell Katz, requesting revisions to minutes from the
`EOP2 meeting held on Aug. 30, 2006 (dated 10/06/2006); fax
`from FDA (dated 9/29/2006) enclosing minutes from EOP2
`meeting
`
`Exhibit 2327
`
`Exhibit 2328
`
`Letter to Russell Katz regarding the upcoming EOP2 meeting
`and submitting Type B briefing package for same (dated
`07/28/2006)
`
`Letter to Russell Katz submitting the final CSR for C-1903 as
`well as new investigator information for 109HV101 (dated
`09/13/2006)
`
`Exhibit 2329 Reserved
`
`Exhibit 2330 BG12 IND Modules 1-3 submitted to Russell Katz on
`02/22/2006
`
`Exhibit 2331
`
`Letter to Russell Katz requesting a type B or pre-IND meeting
`to discuss BG00012 for treatment of RRMS (dated
`07/08/2005)
`
`Exhibit 2332
`
`Letter to Russell Katz regarding a request for end-of-phase 2
`meeting (Type B) (dated 06/23/06)
`
`Exhibit 2333
`
`Letter from FDA to Biogen regarding IND (dated 12/11/2006)
`
`Exhibit 2334 –
`Exhibit 2338
`
`Reserved
`
`
`
`18
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2339
`
`Email (dated 7/7/2006) providing Dial-In information for
`upcoming BG-12 MS CDT meeting; Potential Ph 3 Protocol
`Modifications
`
`Exhibit 2340 Reserved
`
`Exhibit 2341
`
`Email to Gilmore O'Neill (dated 6/8/2006) providing feasibility
`data for BG12
`
`Exhibit 2342 Reserved
`
`Exhibit 2343
`
`Email (dated 5/12/2006) regarding submission to FDA
`concerning the BG12 MS IND
`
`Exhibit 2344
`
`Email (dated 7/17/2006) regarding the EOP2 document,
`specifically safety data from C-1900
`
`Exhibit 2345 BG00012 SMT Meeting Minutes from June 8, 2006 Meeting
`
`Exhibit 2346
`
`Fumapharm (BG12) Monthly ADCI: MS (June 2006)
`
`Exhibit 2347 –
`Exhibit 2349
`
`Exhibit 2350
`
`Reserved
`
`Email (dated 5/8/2006) regarding BG00012 EU briefing
`document for VP review
`
`Exhibit 2351
`
`Email (dated 6/5/2006) regarding information update for BG12
`MS MOCK regulatory authority meeting
`
`Exhibit 2352
`
`Email (dated 6/29/2006) sending BG12 EOP2 meeting
`package draft for review
`
`Exhibit 2353 –
`Exhibit 2359
`
`Exhibit 2360
`
`Reserved
`
`Email from Ratna Lingamaneni (dated 7/31/2006) regarding
`copy of BG12 EOP2 meeting package submitted to FDA
`
`Exhibit 2361
`
`Email (dated 8/14/2006) discussing estimate regarding
`
`
`
`19
`
`
`
`
`
`Exhibit
`
`Exhibit 2362 –
`Exhibit 2363
`
`Exhibit 2364
`
`Description
`cost/timeline of adding 480 mg BG-12
`
`Reserved
`
`Email (dated 7/3/2006) providing second draft of BG12 IB
`revision
`
`Exhibit 2365
`
`Email (dated 7/10/2006) regarding BG12 EOP2 briefing
`document (requesting authors edits)
`
`Exhibit 2366 BG00012 Proposed End of Phase 2 Briefing Document
`
`Exhibit 2367
`
`Email (dated 6/29/2006) regarding review of BG12 EOP2
`meeting package
`
`Exhibit 2368
`
`Email (dated 7/21/2006) requesting urgent review of the BG12
`Phase 3 protocols
`
`Exhibit 2369
`
`Protocol 109MS301 (Version 1): Safety and Efficacy of
`BG00012 in RRMS (Report Date: 9/21/2006; signed by
`Carmen Bozic 9/21/2006)
`
`Exhibit 2370 Neurology TA Committee Minutes from March 1, 2007
`Meeting
`
`Exhibit 2371 Neurology R&D Committee Minutes from August 15, 2007
`Meeting
`
`Exhibit 2372 Clinical Review for NDA 204063 by Heather Fitter (Review
`Completion Date: 11/08/2012) (Public)
`
`Exhibit 2373
`
`Exhibit 2374
`
`Initial Quality Assessment, Branch I, Division of New Drug
`Quality Assessment I, NDA: 204-063, Stamp Date February
`27, 2012
`
`Summary Review of Application No. 204063Orig1s000 by
`Center for Drug Evaluation and Research, Ref. ID 3282328
`(dated 3/25/2013)
`
`
`
`20
`
`
`
`
`
`Exhibit
`
`Description
`
`Exhibit 2375 CDER Statistical Review and Evaluation of Carcinogenicity
`Studies (Submission Date: 2/27/2012)
`
`Exhibit 2376 CDER Statistical Review and Evaluation of Clinical Studies
`(Submission Date: 2/27/2012)
`
`Exhibit 2377
`
`Two-Year Oral (Gavage) Carcinogenicity Study in Mice with
`BG00012, Excerpts from Final Report (dated 12/30/2008)
`
`Exhibit 2378 –
`Exhibit 2380
`
`Reserved
`
`Dated: June 22, 2016
`
`Exhibit 2381 Agency Telephone Contact Report dated April 26, 2006,
`regarding submission of an EOP2 Meeting Request
`
`Respectfully submitted,
`
` By: /Erin M. Sommers/
`Michael J. Flibbert, Reg. No. 33,234
`Erin M. Sommers, Reg. No. 60,974
`Finnegan, Henderson, Farabow, Garrett
`& Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2015-01993
`
`
`
`
`
`21
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that copies of the foregoing BIOGEN’S
`
`EXHIBIT LIST AS OF JUNE 22, 2016 as well as the Exhibits cited in the
`
`foregoing list except Exhibits 2001-2014 were served on June 22, 2016, via
`
`Federal Express directed to counsel of record for the Petitioner at the following:
`
`James T. Carmichael
`Carol A. Spiegel
`Carmichael IP, PLLC
`8000 Towers Crescent Drive, 13th Floor
`Tysons Corner, VA 22182
`jim@carmichaelip.com
`carol@carmichaelip.com
`
`Petitioner has agreed to electronic service.
`
`
`Dated: June 22, 2016
`
`
`
`
`
`
`
`
`
` By: /Erin M. Sommers/
`Erin M. Sommers, Reg. No. 60,974
`
`
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
`
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