`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`SAWAI USA, INC., AND
`SAWAI PHARMACEUTICAL CO., LTD.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`IPR2018-014031
`Patent No. 8,399,514
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BIOGEN EXHIBIT LIST AS OF NOVEMBER 6, 2019
`
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`EXHIBIT
`
`DESCRIPTION
`
`Exhibit
`2001
`
`Chapters 1 and 4 from Alastair Compston et al., MCALPINE’S
`MULTIPLE SCLEROSIS (4th ed. 2006)
`
`Exhibit
`2002
`
`European Medicines Agency, Guideline on Clinical Investigation of
`Medicinal Products for the Treatment of Multiple Sclerosis, Doc Ref.
`CPMP/EWP/561/98 Rev. 1 (Nov. 16, 2006),
`https://www.ema.europa.eu/documents/scientific- guideline/guideline-
`clinical-investigation-medicinal-products- treatment-multiple-
`sclerosis_en.pdf (last accessed Nov. 1, 2018)
`
`Exhibit
`2003
`
`FDA Clinical Review for NDA 204063 by Heather Fitter, M.D.
`(Review Completion Date: 11/08/2012)
`
`Exhibit
`2004
`
`Australian Government, Department of Health, Therapeutic Goods
`Administration, Australian Public Assessment Report for Dimethyl
`Fumarate, Proprietary Product Name: Tecfidera (October 2013),
`https://www.tga.gov.au/sites/default/files/auspar- dimethyl-fumarate-
`131022.pdf (last accessed Nov. 1, 2018)
`
`Exhibit
`2005
`
`Press Release, Biogen, TECFIDERA® (Dimethyl Fumarate)
`Approved in the European Union as a First-Line Oral Treatment for
`Multiple Sclerosis (Feb. 3, 2014) (published by BUSINESS WIRE)
`
`Exhibit
`2006
`
`Exhibit
`2007
`
`Exhibit
`2008
`
`Douglas Quenqua, Existential Animal News and the World’s Lightest
`Solid, N.Y. TIMES, April 1, 2013,
`http://www.nytimes.com/2013/04/02/science/existential-animal-
`news-and-the-worlds-lightest-solid.html?_r=0 (last accessed Nov. 1,
`2018)
`
`Bill Berkrot, Biogen Profit Beats Estimates, Raises 2013 Forecast,
`REUTERS (Apr. 25, 2013), http://www.reuters.com/article/us-
`biogenidec-results-idUSBRE93O0Q920130425 (last accessed Nov. 1,
`2018)
`
`ViewPoints: Biogen Idec Struggling to Cope with Tecfidera Demand
`Suggests Analyst, FIRSTWORD PHARMA (June 12, 2013),
`https://www.firstwordpharma.com/node/1105932?tsid=17 (last
`accessed Nov. 1, 2018)
`
`2
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`News Release, Biogen, Biogen Highlights at ECTRIMS 2018 Data on
`Its Industry-Leading Multiple Sclerosis Portfolio and a Range of
`Initiatives Aimed at Transforming Patient Care (Oct. 4, 2018)
`(published by ENP Newswire)
`
`News Release, Biogen, Biogen Reports Quarterly Revenues of $3.1
`Billion (Apr. 24, 2018) (published by BUSINESS WIRE),
`https://www.businesswire.com/news/home/20180424005550/en/ (last
`accessed Nov. 7, 2018)
`
`RESERVED
`
`RESERVED
`
`Defendant Mylan Pharmaceuticals Inc.’s Answer, Separate Defenses
`and Counterclaims to Complaint, Biogen Int’l GmbH & Biogen MA
`Inc. v. Mylan Pharm. Inc., No. 1:17-cv-116, Dkt. 25 (N.D.W. Va.
`Aug. 7, 2017)
`
`Exhibit
`2009
`
`Exhibit
`2010
`
`Exhibit
`2011
`
`Exhibit
`2012
`
`Exhibit
`2013
`
`Exhibit
`2014
`
`Scheduling Order, Biogen Int’l GmbH & Biogen MA Inc. v. Mylan
`Pharm. Inc., No. 1:17-cv-116, Dkt. 56 (N.D.W. Va. Nov. 6, 2017)
`
`Exhibit
`2015
`
`Exhibit
`2016
`
`Exhibit
`2017
`
`Exhibit
`2018
`
`Exhibit
`2019
`
`Preliminary Amendment and Declaration of Katherine T. Dawson,
`M.D. Under 37 C.F.R. § 1.132 in U.S. Appl. No. 13/372,426 (Feb. 14,
`2012) (cover page from Coalition II)
`
`Information Disclosure Statement in U.S. Appl. No. 13/372,426 (Feb.
`13, 2012)
`
`First Supplemental Information Disclosure Statement in U.S. Appl.
`No. 13/372,426 (Feb. 13, 2012)
`
`Non-Final Office Action in U.S. Appl. No. 13/372,426 (May 3, 2012)
`
`Amendment and Reply Under 37 C.F.R. § 1.111 in U.S. Appl. No.
`13/372,426 (August 3, 2012)
`
`3
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Declaration of Richard A. Rudick, M.D. Under 37 C.F.R. § 1.132,
`submitted with Response to Non-Final Office Action in U.S. Appl.
`No. 13/372,426 (August 3, 2012)
`
`Final Office Action in U.S. Appl. No. 13/372,426 (October 12, 2012)
`
`Reply to Final Office Action Under 37 C.F.R. § 1.116 in U.S. Appl.
`No. 13/372,426 (December 12, 2012)
`
`Notice of Allowance in U.S. Appl. No. 13/372,426 (December 26,
`2012)
`
`First Amended Petition (Paper 9) in Coalition for Affordable Drugs V
`LLC v. Biogen MA Inc., IPR2015-01136 (“Coalition I”) (May 27,
`2015)
`
`Petitioner’s Exhibit List (Paper 10) in Coalition for Affordable Drugs
`V LLC v. Biogen MA Inc., IPR2015-01136 (“Coalition I”) (May 27,
`2015)
`
`RESERVED
`
`Decision Denying Institution of Inter Partes Review (Paper 23) in
`Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-
`01136 (“Coalition I”) (Sept. 22, 2015)
`
`Biogen Motion 1 (Lack of written description and enablement) in
`Biogen MA Inc. v. Forward Pharma A/S, Intf. 106,023 (“FP
`Interference”) (Aug. 6, 2015)
`
`Biogen Motion 4 (for judgment based on priority) in Biogen MA Inc.
`v. Forward Pharma A/S, Intf. 106,023 (“FP Interference”) (Dec. 30,
`2015)
`
`Decision - Motions - 37 C.F.R. § 41.125(a) in Biogen MA Inc. v.
`Forward Pharma A/S, Intf. 106,023 (“FP Interference”) (Mar. 31,
`2017)
`
`Exhibit
`2020
`
`Exhibit
`2021
`
`Exhibit
`2022
`
`Exhibit
`2023
`
`Exhibit
`2024
`
`Exhibit
`2025
`
`Exhibit
`2026
`
`Exhibit
`2027
`
`Exhibit
`2028
`
`Exhibit
`2029
`
`Exhibit
`2030
`
`Exhibit
`2031
`
`Petition (Paper 1) in Coalition for Affordable Drugs V LLC v. Biogen
`MA Inc., IPR2015-01993 (“Coalition II”) (Sept. 28, 2015)
`
`4
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Decision - Institution of Inter Partes Review (Paper 20) in Coalition
`for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01993
`(“Coalition II”) (Mar. 22, 2016)
`
`Biogen’s Opposition to the Petition (Paper 38) in Coalition for
`Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01993
`(“Coalition II”) (June 22, 2016)
`
`Biogen’s Motion to Antedate (Paper 40) in Coalition for Affordable
`Drugs V LLC v. Biogen MA Inc., IPR2015-01993 (“Coalition II”)
`(June 22, 2016)
`
`Declaration of Ronald A. Thisted, Ph.D. in Coalition for Affordable
`Drugs V LLC v. Biogen MA Inc., IPR2015-01993 (“Coalition II”)
`(June 20, 2016)
`
`RESERVED
`
`Corrected Petitioner’s Exhibit List (Paper 48) in Coalition for
`Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01993
`(“Coalition II”) (Sept. 28, 2016)
`
`Final Written Decision (Paper 63) in Coalition for Affordable Drugs V
`LLC v. Biogen MA Inc., IPR2015-01993 (“Coalition II”) (Mar. 21,
`2017)
`
`Exhibit
`2032
`
`Exhibit
`2033
`
`Exhibit
`2034
`
`Exhibit
`2035
`
`Exhibit
`2036
`
`Exhibit
`2037
`
`Exhibit
`2038
`
`Exhibit
`2039
`
`Proof of Service, Biogen Int’l GmbH & Biogen MA Inc. v. Mylan
`Pharm. Inc., No. 1:17-cv-116, Dkt. 24 (N.D.W. Va. July 20, 2017)
`
`Exhibit
`2040
`
`Exhibit
`2041
`
`Complaint for Patent Infringement, Biogen Int’l GmbH & Biogen MA
`Inc. v. Mylan Pharm. Inc., No. 1:17-cv-116, Dkt. 1 (N.D.W. Va. June
`30, 2017)
`
`Transcript of April 12, 2019 teleconference with APJs Sheridan K.
`Sneeden and Jacqueline T. Harlow, counsel for Patent Owner Biogen
`MA Inc. and counsel for Petitioner Mylan Pharmaceuticals, Inc.
`
`Exhibits
`2042-2048 RESERVED
`
`5
`
`
`
`
`
`
`
`Exhibit
`2049
`
`Email from Emily Greb, counsel for Petitioner Mylan
`Pharmaceuticals, Inc., dated March 6, 2019
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Exhibit
`2050
`
`Exhibit
`2051
`
`Exhibit
`2052
`
`Exhibit
`2053
`
`Exhibit
`2054
`
`Exhibit
`2055
`
`Exhibit
`2056
`
`Exhibit
`2057
`
`Exhibit
`2058
`
`Exhibit
`2059
`
`Exhibit
`2060
`
`Exhibit
`2061
`
`Result from URL in Mihail declaration,
`https://clinicaltrials.gov/archive/NCT00168701/2005_09_14 (last
`accessed April 22, 2019)
`
`Gilbert et al., Comparison of HIV-1 and HIV-2 Infectivity from a
`Prospective Cohort Study in Senegal, 22 STATISTICAL MED. 573
`(2003)
`
`RESERVED
`
`Chapter 39 from DiPiro et al., PHARMACOTHERAPY: A
`PATHOPHYSIOLOGIC APPROACH (9th ed. 2014)
`
`Vollmer et al., Oral Simvastatin Treatment in Relapsing-Remitting
`Multiple Sclerosis, 363 LANCET 1607 (2004)
`
`Corboy & Coyle, Fresh Approaches to MS Care: New Treatment
`Options Encourage a Fresh Approach to Patients, PRACTICAL
`NEUROLOGY (2013)
`
`Frohman et al., The Utility of MRI in Suspected MS: Report of the
`Therapeutics and Technology Assessment Subcommittee of the
`American Academy of Neurology, 61 AM. ACAD. NEUROLOGY 602
`(2003)
`
`Declaration of Richard C. Brundage, Pharm. D., Ph.D.
`
`Declaration of Martin Duddy, M.D.
`
`RESERVED
`
`Declaration of Ronald A. Thisted, Ph.D.
`
`Declaration of Daniel Wynn, M.D. FACNS FAASM
`
`6
`
`
`
`
`
`
`
`Exhibit
`2062
`
`Exhibit
`2063
`
`Exhibit
`2064
`
`Exhibit
`2065
`
`Exhibit
`2066
`
`Exhibit
`2067
`
`Exhibit
`2068
`
`Exhibit
`2069
`
`Exhibit
`2070
`
`Exhibit
`2071
`
`Exhibit
`2072
`
`Exhibit
`2073
`
`Exhibit
`2074
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Deposition of Leslie Benet, Ph.D.
`
`Deposition of John R. Corboy, M.D.
`
`Deposition of Ian McKeague, Ph.D.
`
`Deposition of Jennifer Rock
`
`FDA, Center for Drug Evaluation and Research, Summary Review
`(2013)
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063ori
`g1s000sumr.pdf (last accessed April 8, 2019)
`
`Tecfidera® Prescribing Information (December 2017)
`
`D’Agostino et al., Non-Inferiority Trials: Design Concepts and Issues
`— The Encounters of Academic Consultants in Statistics, 22
`STATISTICS IN MED. 169 (2003)
`
`Oxman et al., A Consumer’s Guide to Subgroup Analyses, 116
`ANNALS INTERNAL MED. 78 (1992)
`
`Rothwell, Subgroup Analysis in Randomized Controlled Trials:
`Importance, Indications, and Interpretation, 365 LANCET 176 (2005)
`
`Wang et al., Statistics in Medicine—Reporting of Subgroup Analyses
`in Clinical Trials, 357 NEW ENGL. J. MED. 2189 (2007)
`
`RESERVED
`
`Kappos et al., Oral Fingolimod (FTY720) for Relapsing Multiple
`Sclerosis, 355 N. ENG. J. MED. 11 (2006)
`
`Kappos et al., Ocrelizumab in Relapsing-Remitting Multiple Sclerosis:
`A Phase 2, Randomized, Placebo-Controlled, Multicentre Trial, 378
`LANCET 1779 (2011)
`
`7
`
`
`
`Exhibit
`2075
`
`Exhibit
`2076
`
`Exhibit
`2077
`
`Exhibit
`2078
`
`Exhibit
`2079
`
`Exhibit
`2080
`
`Exhibit
`2081
`
`Exhibit
`2082
`
`Exhibit
`2083
`
`Exhibit
`2084
`
`Exhibit
`2085
`
`Exhibit
`2086
`
`Exhibit
`2087
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`RESERVED
`
`RESERVED
`
`Mancardi et al., Effect of Copolymer-1 on Serial Gadolinium-
`Enhanced MRI in Relapsing Remitting Multiple Sclerosis, 50.
`NEUROLOGY 1127 (1998)
`
`RESERVED
`
`RESERVED
`
`RESERVED
`
`RESERVED
`
`RESERVED
`
`Rumrill, Multiple Sclerosis: Medical and Psychosocial Aspects,
`Etiology, Incidence, and Prevalence, 31 J. VOCATIONAL
`REHABILITATION 75 (2009)
`
`De Stefano et al., Assessing Brain Atrophy Rates in a Large
`Population of Untreated Multiple Sclerosis Subtypes, 74 NEUROLOGY
`1868 (2010)
`
`Fisniku et al., Gray Matter Atrophy is Related to Long-Term
`Disability in Multiple Sclerosis, 64 ANNALS NEUROLOGY 247 (2008)
`
`Wynn et al., A Reappraisal of the Epidemiology of Multiple Sclerosis
`in Olmsted County, Minnesota, 40 NEUROLOGY 780 (1990)
`
`The Lenercept Multiple Sclerosis Study Group & The University of
`British Columbia MS/MRI Analysis Group, TNF Neutralization in
`MS: Results of a Randomized, Placebo-Controlled Multicenter Study,
`53 NEUROLOGY 457 (1999)
`
`8
`
`
`
`Exhibit
`2088
`
`Exhibit
`2089
`
`Exhibit
`2090
`
`Exhibit
`2091
`
`Exhibit
`2092
`
`Exhibit
`2093
`
`Exhibit
`2094
`
`Exhibit
`2095
`
`Exhibit
`2096
`
`Exhibit
`2097
`
`Exhibit
`2098
`
`Exhibit
`2099
`
`Exhibit
`2100
`
`Exhibit
`2101
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Clinical Trial Review Board Agenda Item Meeting Minutes (February
`19, 2004)
`
`Email from Rebecca Conaghan and Gilmore O’Neill, M.D. (August
`16, 2004)
`
`Email from Cara Lansden with Attachment (October 25, 2005)
`
`Presentation by Dr. Gilmore O’Neill, M.D., titled “BG00012 in
`RRMS: Update From Phase 2 Study,” presented in February 2006
`
`Email from Gilmore O’Neill, M.D. with Attachment (February 1,
`2006)
`
`Emails between Gilmore O’Neill, M.D., and Ludwig Kappos, M.D.,
`with Attachments (January 31, 2006)
`
`Prosecution History, U.S. Patent Application No. 12/526,296,
`Preliminary Amendment (June 20, 2011)
`
`Prosecution History, U.S. Patent Application No. 12/526,296,
`Supplemental Amendment and Reply (October 28, 2011)
`
`Prosecution History, U.S. Patent Application No. 12/526,296, Request
`to Add Inventor in a Nonprovisional Patent Application (October 28,
`2011)
`
`Declaration of Gilmore O’Neill, M.D.
`
`Declaration of Rebecca Conaghan
`
`Declaration of Eva Havrdova, M.D., Ph.D.
`
`Declaration of Matvey Lukashev, Ph.D.
`
`U.S. Provisional Application No. 60/888,921
`
`9
`
`
`
`Exhibit
`2102
`
`Exhibit
`2103
`
`Exhibit
`2104
`
`Exhibit
`2105
`
`Exhibit
`2106
`
`Exhibit
`2107
`
`Exhibit
`2108
`
`Exhibit
`2109
`
`Exhibit
`2110
`
`Exhibit
`2111
`
`Exhibit
`2112
`
`Exhibit
`2113
`
`Exhibit
`2114
`
`Exhibit
`2115
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`International Publication No. WO 2008/097596 A2
`
`Decision on Biogen Motion 6 (Paper 611) in Biogen MA Inc. v.
`Forward Pharma A/S, Interf. No. 106,023, (PTAB Feb. 5, 2016)
`
`File Wrapper for U.S. Provisional Application No. 60/888,921
`
`Prosecution History, U.S. Patent Application No. 12/526,296, Claims
`(February 7, 2008)
`
`Prosecution History, U.S. Patent Application No. 12/526,296,
`Combined Declaration and Power of Attorney (December 6, 2010)
`
`Prosecution History, U.S. Patent Application No. 13/372,426,
`Amendment and Reply (August 3, 2012)
`
`Sales Data from Symphony Health, Part 1
`
`Sales Data from Symphony Health, Part 2
`
`Prosecution History, U.S. Patent Application No. 12/526,296,
`Amendment to Specification (July 20, 2015)
`
`Sales Data from Symphony Health, Part 3
`
`Sales Data from Symphony Health, Part 4
`
`Biogen, 10-K (2013)
`
`De Keyser, Autoimmunity in Multiple Sclerosis, 38 NEUROLOGY 371
`(1988)
`
`Broadley et al., Autoimmune Disease in First-Degree Relatives of
`Patients with Multiple Sclerosis: A UK Survey, 123 BRAIN 1102
`(2000)
`
`10
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Titelbaum et al., Anti-Tumor Necrosis Factor Alpha-Associated
`Multiple Sclerosis, 26 AM. J. NEURORADIOL. 1548 (2005)
`
`Sicotte & Voskuhl, Onset of Multiple Sclerosis Associated with Anti-
`TNF Therapy, 57 NEUROLOGY 1885 (2001)
`
`van Oosten et al., Increased MRI Activity and Immune Activation in
`Two Multiple Sclerosis Patients Treated with the Monoclonal Anti-
`Tumor Necrosis Factor Antibody cA2, 47 NEUROLOGY 1531 (1996)
`
`Exhibit
`2116
`
`Exhibit
`2117
`
`Exhibit
`2118
`
`Exhibit
`2119
`
`Papp, The Safety of Etanercept for the Treatment of Plaque Psoriasis,
`3(2) THERAPEUTICS & CLINICAL RISK MANAG. 245 (2007)
`
`Exhibit
`2120
`
`Ulzheimer et al., Therapeutic Approaches to Multiple Sclerosis: An
`Update on Failed, Interrupted, or Inconclusive Trials of
`Immunomodulatory Treatment Strategies, 24(4) BIODRUGS 249 (2010)
`
`Exhibit
`2121
`
`Kister & Corboy, Reducing Costs While Enhancing Quality of Care in
`MS, 87 NEUROLOGY 1617 (2016)
`
`Exhibit
`2122
`
`Exhibit
`2123
`
`Exhibit
`2124
`
`Exhibit
`2125
`
`Exhibit
`2126
`
`Exhibit
`2127
`
`Exhibit
`2128
`
`Wiendl & Hohlfeld, Therapeutic Approaches in Multiple Sclerosis:
`Lessons from Failed and Interrupted Treatment Trials, 16(3)
`BIODRUGS 183 (2002)
`
`Instructions for Healthcare Providers (2018),
`https://www.tecfiderahcp.com/content/dam/commercial/multiple-
`sclerosis/tecfidera/hcp/en_us/pdf/TEC-US-0298_StartForm-
`web_150713.pdf (last accessed April 8, 2019)
`
`Presentation by Martin Duddy, M.D., titled “Emerging Therapies in
`Multiple Sclerosis,” presented in September 2009
`
`Presentation by Martin Duddy, M.D., titled “G2G 2011,” presented in
`November 2011
`
`Email from Emily Greb, Counsel for Petitioner Mylan
`Pharmaceuticals, Inc. (May 6, 2019)
`
`Internet Archive: Legal: Requests Website, (last accessed May 16,
`2019)
`
`Result from Wayback Machine, http://www.fumapharm.ch/pdf/BG-
`12_Schimrigk_Poster_Final.pdf (last accessed May 16, 2019)
`11
`
`
`
`
`
`
`
`Exhibit
`2129
`
`Exhibit
`2130
`
`Exhibit
`2131
`
`Exhibit
`2132
`
`Exhibit
`2133
`
`Exhibit
`2134
`
`Exhibit
`2135
`
`Exhibit
`2136
`
`Exhibit
`2137
`
`Exhibit
`2138
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Deposition of Christopher Butler, IPR2016-00541 (October 6, 2016)
`
`Search Results for Patent Number: 8399514,
`https://www.accessdata.fds.gov/Scripts/cder/ob/search—patent.cfm
`(last accessed April 8, 2019)
`
`Biogen Idec Announces Positive Top-Line Results from the First
`Phase 3 Trial Investigating Oral BG-12 (DIMETHYL FUMARATE) in
`Multiple Sclerosis, BIOGEN.COM (April 11, 2011),
`http://media.biogen.com/news-releases/news-release-details/biogen-
`idec-announces-positive-top-line-results-first-phase-3 (last accessed
`April 8, 2019)
`
`NDA 204063 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/2040
`63Orig1s000ltr.pdf (last accessed April 15, 2019)
`
`Tecfidera® Prescribing Information (March 2013)
`
`Biogen Idec Total Revenues Increased 10% to $1.4 Billion in First
`Quarter 2013, BIOGEN.COM (April 25, 2013),
`http://investors.biogen.com/news-releases/news-release-
`details/biogen-idec-total-revenues-increased-10-14-billion-first-
`quarter (last accessed April 15, 2019)
`
`NDA 209884 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/2098
`84Orig1s000ltr.pdf (last accessed April 8, 2019)
`
`NDA 22561 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/0225
`61Orig1s000ltr.pdf (last accessed April 8, 2019)
`
`Gilenya® Prescribing Information (September 2010)
`
`Gilenya® Prescribing Information (October 2018)
`
`12
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Exhibit
`2139
`
`Exhibit
`2140
`
`Exhibit
`2141
`
`Exhibit
`2142
`
`FDA Approved Drug Products, NDA 022527,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=022527 (last accessed April 16, 2019)
`
`Aubagio® Prescribing Information (September 2012)
`
`FDA Approved Drug Products, NDA 202992,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=202992 (last accessed April 15, 2019)
`
`Sanofi, Form 20-F (2018)
`
`Exhibit
`2143 Mayzent® Prescribing Information (March 2019)
`FDA Approved Drug Products, NDA 209884,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Bas
`icSearch.process (last accessed April 16, 2019)
`
`Exhibit
`2144
`
`Exhibit
`2145 Mavenclad® Prescribing Information (March 2019)
`FDA Approves New Oral Treatment for Multiple Sclerosis (March 29,
`2019),
`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc
`m634837.htm (last accessed April 17, 2019)
`
`Exhibit
`2146
`
`Exhibit
`2147
`
`FDA Approved Drug Products, NDA 022561,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=022561 (last accessed April 16, 2019)
`
`Exhibit
`2148
`
`Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal
`of Marketing Authorizations for ZINBRYTA® (daclizumab) for
`Relapsing Multiple Sclerosis (March 2, 2018),
`http://investors.biogen.com/news-releases/news-release-
`details/biogen-and-abbvie-announce-voluntary-worldwide-withdrawal
`(last accessed April 16, 2019)
`
`13
`
`
`
`
`
`
`
`Exhibit
`2149
`
`Exhibit
`2150
`
`Exhibit
`2151
`
`Exhibit
`2152
`
`Exhibit
`2153
`
`Exhibit
`2154
`
`Exhibit
`2155
`
`Exhibit
`2156
`
`Exhibit
`2157
`
`Exhibit
`2158
`
`Exhibit
`2159
`
`Exhibit
`2160
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`FDA Approves Zinbryta to Treat Multiple Sclerosis (May 27, 2016),
`https://www.fda.gov/news-events/press-announcements/fda-approves-
`zinbryta-treat-multiple-sclerosis (last accessed April 17, 2019)
`
`AVONEX® Prescribing Information (February 2012)
`
`FDA Approved Drug Products, BLA 103628,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=103628 (last accessed April 16, 2019)
`
`Rebif® Prescribing Information (March 2002)
`
`FDA Approved Drug Products, BLA 103780,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=103780 accessed April 16, 2019)
`
`PlegridyTM Prescribing Information (August 2014)
`
`FDA Approved Drug Products, BLA 125499,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=125499 (last accessed April 16, 2019)
`
`Betaseron® Prescribing Information (August 2018)
`
`FDA Approved Drug Products, BLA 103471,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Bas
`icSearch.process (last accessed April 16, 2019)
`
`Extavia® Prescribing Information (July 2009)
`
`FDA Approved Drug Products, BLA 125290,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=125290 (last accessed April 16, 2019)
`
`COPAXONE® Prescribing Information (September 2018)
`
`14
`
`
`
`Exhibit
`2161
`
`Exhibit
`2162
`
`Exhibit
`2163
`
`Exhibit
`2164
`
`Exhibit
`2165
`
`Exhibit
`2166
`
`Exhibit
`2167
`
`Exhibit
`2168
`
`Exhibit
`2169
`
`Exhibit
`2170
`
`Exhibit
`2171
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Letter Regarding ANDA 090218,
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0902
`18Orig1s000ltr.pdf (last accessed April 8, 2019)
`
`ANDA 091646 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0916
`46Orig1s000ltr.pdf (last accessed April 8, 2019)
`
`ZINBRYTATM Prescribing Information (May 2016)
`
`RESERVED
`
`FDA Approved Drug Products, BLA 761029,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Bas
`icSearch.process (last accessed April 16, 2019)
`
`NDA 21-120 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21120.pdf
`_Novantrone_Approv.pdf (last accessed April 8, 2019)
`
`Determination That NOVANTRONE (Mitoxantrone Hydrochloride)
`Injection, Equivalent to 25 Milligrams Base/12.5 Milliliter and
`Equivalent to 30 Milligrams Base/15 Milliliter, Was Not Withdrawn
`From Sale for Reasons of Safety or Effectiveness (April 13, 2011)
`
`FDA Approved Drug Products, ANDA 077356,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=077356 (last accessed April 8, 2019)
`
`LEMTRADA® Prescribing Information (December 2017)
`
`FDA Approved Drug Products, BLA 103948,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=103948 (last accessed April 16, 2019)
`
`Tysabri® Prescribing Information (November 2004)
`
`15
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Exhibit
`2172
`
`Exhibit
`2173
`
`Exhibit
`2174
`
`Exhibit
`2175
`
`Exhibit
`2176
`
`Exhibit
`2177
`
`FDA Approved Drug Products, BLA 125104,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Bas
`icSearch.process (last accessed April 16, 2019)
`
`OcrevusTM Prescribing Information (March 2017)
`
`FDA Approved Drug Products, BLA 761053,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Bas
`icSearch.process (last accessed April 16, 2019)
`
`Thomas, Secondary Considerations in Nonobviousness Analysis: The
`Use of Objective Indicia Following KSR v. Teleflex, 86 N.Y. UNIV.
`LAW REV. 2070 (2011)
`
`Samuelson & Nordhaus, ECONOMICS at 49(17th ed.) (2001)
`
`Comprehensive, reliable pharmaceutical market analysis delivered
`wherever and whenever you need them, SYMPHONYHEALTH,
`https://symphonyhealth.com/product/pharmaceutical-audit-suite-
`phast/ (last accessed April 9, 2019)
`
`Exhibit
`2178
`
`Hampp et al., Use of Antidiabetic Drugs in the U.S., 2003–2012, 37
`DIABETES CARE 1367 (2014)
`
`Exhibit
`2179
`
`Exhibit
`2180
`
`Maron et al., Occurrence of Clinically Diagnosed Hypertrophic
`Cardiomyopathy in the United States, 117 AM. J. CARDIOLOGY 1651
`(2016)
`
`Pinkerton & Santoro, Compounded Bioidentical Hormone Therapy:
`Identifying Use Trends and Knowledge Gaps Among US Women, 22
`MENOPAUSE 926 (2015)
`
`Exhibit
`2181
`
`Quigley et al., Genmab A/S (GEN DC), J.P. MORGAN (September 20,
`2017)
`
`Exhibit
`2182
`
`Nachman et al., August Exparel Sales Up From July, but Still
`Tracking Well Below 3Q Consensus, BMO CAPITAL MARKETS,
`(September 19, 2017)
`
`16
`
`
`
`
`
`
`
`Exhibit
`2183
`
`Exhibit
`2184
`
`Exhibit
`2185
`
`Exhibit
`2186
`
`Exhibit
`2187
`
`Exhibit
`2188
`
`Exhibit
`2189
`
`Exhibit
`2190
`
`Exhibit
`2191
`
`Exhibit
`2192
`
`Exhibit
`2193
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Smith et al, Bullish on Intrarosa as the Next AMAG Value Driver
`Following Survey; Initiate OW, $26 PT, MORGAN STANLEY
`(September 8, 2017)
`
`PHASTTM Integrated, https://symphonyhealth.com/wp-
`content/uploads/2017/01/phast_integrated_sales_sheet.pdf (last
`accessed April 8, 2019)
`
`Lorenzetti, 7 New Blockbuster Drugs to Watch in 2016, FORTUNE
`(March 25, 2016), http://fortune.com/2016/03/25/new-blockbuster-
`drugs-to-watch/ (last accessed April 8, 2019)
`
`RESERVED
`
`RESERVED
`
`Pollock et al., Appropriate Prescribing of Medications: An Eight-Step
`Approach, 75 AM. FAM. PHYSICIAN 231 (2007)
`
`Gold et al., Long-Term Effects of Delayed-Release Dimethyl Fumarate
`in Multiple Sclerosis: Interim Analysis of ENDORSE, A Randomized
`Extension Study, 23 MULTIPLE SCLEROSIS J. 253 (2017)
`
`TECFIDERA Clinical Trials,
`https://www.tecfiderahcp.com/en_us/home/efficacy/clinical-trials.html
`(last accessed April 8, 2019)
`
`DEFINE* Trial Efficacy,
`https://www.tecfiderahcp.com/en_us/efficacy/define-trial.html (last
`accessed April 8, 2019)
`
`CONFIRM* Trial Efficacy,
`https://www.tecfiderahcp.com/en_us/home/efficacy/confirm-trial.html
`(last accessed April 8, 2019)
`
`TOLERABILITY MANAGEMENT,
`https://www.tecfiderahcp.com/en_us/home/tolerability-and-
`safety/tolerability-management.html (last accessed April 8, 2019)
`
`17
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Ahlawat et al., The Secret of Successful Drug Launches, MCKINSEY &
`COMPANY (March 2014),
`https://www.mckinsey.com/industries/pharmaceuticals-and-medical-
`products/our-insights/the-secret-of-successful-drug-launches (last
`accessed April 8, 2019)
`
`Safety & Monitoring: Demonstrated Safety Profile,
`https://www.tecfiderahcp.com/en_us/home/tolerability-and-
`safety/safety.html (last accessed April 9, 2019)
`
`Bagwell, The Economic Analysis of Advertising, Discussion Paper
`No.: 0506-01, Department of Economics, Columbia University
`(August 2005)
`
`Exhibit
`2194
`
`Exhibit
`2195
`
`Exhibit
`2196
`
`Exhibit
`2197
`
`Ching & Ishihara, Measuring the Informative and Persuasive Roles of
`Detailing on Prescribing Decisions, 58 MANAG. SCI. 1374 (2012)
`
`Exhibit
`2198
`
`Exhibit
`2199
`
`Exhibit
`2200
`
`Exhibit
`2201
`
`Exhibit
`2202
`
`Exhibit
`2203
`
`Exhibit
`2204
`
`Declaration of Richard C. Brundage, Pharm. D., Ph.D., in Coalition
`for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01993
`(“Coalition II”) (June 21, 2016)
`
`Starr et al., Combination Therapy With Efavirenz, Nelfinavir, and
`Nucleoside Reverse-Transcriptase Inhibitors in Children Infected with
`Human Immunodeficiency Virus Type 1, 341 NEW ENGL. J. MED. 1874
`(1999)
`
`International Conference on Harmonisation; Dose-Response
`Information to Support Drug Registration; Guideline; Availability, 59
`Fed. Reg. 55972 (Nov. 9, 1994)
`
`Emanuel et al., What Makes Clinical Research Ethical, 283 JAMA
`2701 (2000)
`
`Declaration of John C. Jarosz
`
`U.S. Patent Application No. 12/526,296
`
`U.S. Patent Application No. 13/372,426
`
`18
`
`
`
`
`
`
`
`Exhibit
`2205
`
`Exhibit
`2206
`
`Exhibit
`2207
`
`Exhibit
`2208
`
`Exhibit
`2209
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`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
`Hay et al., Good Research Practices for Measuring Drug Costs in
`Cost Effectiveness Analyses: Issues and Recommendations: The
`ISPOR Drug Cost Task Force Report - Part I, 13 VALUE HEALTH 3
`(2010)
`Zhang et al., Cost-Effectiveness Analysis of Rizatriptan and
`Sumatriptan versus Cafergot® in the Acute Treatment of Migraine, 19
`CNS DRUGS 635 (2005)
`Zhang et al., Cost Effectiveness of Fingolimod, Teriflunomide,
`Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-
`Remitting Multiple Sclerosis, 29 CNS DRUGS 71 (2015)
`Declaration of Joel W. Hay in Torrent Pharmaceuticals Limited,
`Apotex, Inc. & Mylan Pharmaceuticals Inc. v. Novartis AG &
`Mitsubishi Pharma Corp., IPR2014-00784, IPR2015-00518 (June 5,
`2015)
`Exhibit
`2210 Multiple Sclerosis 2005-2020, Decision Resources, April 2007
`Exhibit
`Deposition of Joel W. Hay, IPR2014-00784, IPR2015-00518 (June
`2211
`24, 2015)
`Declaration of Joel W. Hay in Mylan Pharmaceuticals Inc. & Amneal
`Pharmaceuticals LLC v. Yeda Research and Development Co. Ltd.,
`IPR2015-00643, IPR2015-00644, IPR2015-00830 (Mar. 9, 2016)
`Gilenya (fingolimod) Go, https://www.facebook.com/GilenyaGO (last
`accessed October 17, 2019)
`Aubagio (teriflunomide) 14mg tablets,
`https://www.facebook.com/AUBAGIOUS (last accessed October 17,
`2019)
`Gilenya Patient Services Liaison - Gilenya,
`https://www.gilenyahcp.com/for-your-office (last accessed October
`17, 2019)
`MS Events Gilenya Events Gilenya (fingolimod),
`https://www.gilenya.com/c/living-with-ms/events (last accessed
`October 17, 2019)
`
`Exhibit
`2212
`
`Exhibit
`2213
`
`Exhibit
`2214
`
`Exhibit
`2215
`
`Exhibit
`2216
`
`19
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`Hay, Competition, Market Power and Pricing in Brand Name
`Pharmaceutical Markets, 14 HARV. HEALTH POL’Y REV. 6 (2013)
`Frohman et al., Addressing the Challenges in Risk Assessment and
`Risk management in Multiple Sclerosis, 12 JOHNS HOPKINS
`ADVANCED STUDIES IN MEDICINE 6 (2012)
`Data Chart based on mean number of new Gd+ lesions (weeks 12-
`24)/4 scans
`
`Data Chart based on Koudriavtseva 1997 (Ex. 1119)
`
`Harris et al., Serial Gadolinium-enhanced Magnetic Resonance
`Imaging Scans in Patients with Early, Relapsing-Remitting Multiple
`Sclerosis: Implications for Clinical Trials and Natural History, 29
`ANN NEUROL 548 (1991)
`McFarland et al., Using Gadolinium-enhanced Magnetic Resonance
`Imaging Lesions to Monitor Disease Activity in Multiple Sclerosis, 32
`ANN NEUROL 758 (1992)
`Chapter 46 from Waldman et al., PHARMACOLOGY AND THERAPEUTICS
`PRINCIPLES TO PRACTICE (2009)
`
`Greenberg et al., Future Research Directions in Multiple Sclerosis
`Therapies, 28 SEMIN NEUROL 121 (2008)
`Castro-Borrero et al., Current and emerging therapies in multiple
`sclerosis: a systematic review, 5 THER ADV NEUROL DISORD 205
`(2012)
`Hauser et al., B-Cell Depletion with Rituximab in Relapsing-Remitting
`Multiple Sclerosis, 358 N ENGL J MED 676 (2008)
`Ayers et al., Modulation of immune function occurs within hours of
`therapy initiation for multiple sclerosis, 147 CLIN IMMUNOL. 105
`(2013)
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`2019)
`Dr. Lindsey’s Multiple Sclerosis Website ECTRIMS 2011,
`https://www.jwlindseymd.com/id77.html (last accessed September 16,
`2019)
`
`Exhibit
`2217
`
`Exhibit
`2218
`
`Exhibit
`2219
`
`Exhibit
`2220
`
`Exhibit
`2221
`
`Exhibit
`2222
`
`Exhibit
`2223
`
`Exhibit
`2224
`
`Exhibit
`2225
`
`Exhibit
`2226
`
`Exhibit
`2227
`
`Exhibit
`2228
`
`Exhibit
`2229
`
`20
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Exhibit
`2230
`
`Exhibit
`2231
`
`Exhibit
`2232
`
`Deposition of Joel Hay, Ph.D.
`
`Deposition of Benjamin Greenberg
`
`Deposition of Emily Greb
`
`Dated: November 6, 2019
`
`By: /Barbara C. McCurdy/
`
`
`
`Respectfully submitted,
`
`Barbara C. McCurdy, Reg. No. 32,120
`Mark J. Feldstein, Reg. No. 46,693
`Erin M. Sommers, Reg. No. 60,974
`Pier D. DeRoo, Reg. No. 69,340
`Cora R. Holt, Reg. No. 68,332
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`Counsel for Patent Owner
`Biogen MA Inc.
`
`21
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing BIOGEN EXHIBIT
`
`LIST AS OF NOVEMBER 6, 2019 and Exhibit 2232 were served electronically
`
`via the PTAB electronic filing system and via e-mail on November 6, 2019, in their
`
`entirety on the following:
`
`Brandon M. White
`Shannon M. Bloodworth
`Michael A. Chajon
`Maria A. Stubbings
`Nathan Kelley
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`Email: bmwhite@perkinscoie.com
`Email: sbloodworth@perkinscoie.com
`Email: mchajon@perkinscoie.com
`Email: mstubbings@perkinscoie.com
`Email: nkelley@perkinscoie.com
`
`David L. Anstaett
`Emily J. Greb
`Perkins Coie LLP
`One East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`Email: danstaett@perkinscoie.com
`Email: egreb@perkinscoie.com
`
`Courtney M. Prochnow
`Perkins Coie LLP
`633 W. 5th St., Suite 5850
`Los Angeles, CA 90071
`Telephone: (310) 788-3284
`Email: cprochnow@perkinscoie.com
`
`
`
`
`
`
`
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Brian Sodikoff