`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Filed: May 31, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`IPR2018-01403
`Patent No. 8,399,514
`
`BIOGEN EXHIBIT LIST AS OF MAY 31, 2019
`
`
`
`US. 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, MD.
`(Review Completion Date: 11/08/2012)
`
`E3333“
`
`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 Treatmentfor
`Multiple Sclerosis aseb. 3, 2014) (published by BUSINESS WIRE)
`
`Exhibit
`2006
`
`Exhibit
`2007
`
`Exhibit
`2008
`
`Douglas Quenqua, Existential Animal News and the World ’s Lightest
`Solid, NY. 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-idUSBRE9300Q920130425 (last accessed Nov. 1,
`2018)
`
`ViewPoints: Biogen Idec Struggling to Cope with Tecfidera Demand
`Suggests Analyst, FIRSTWORD PHARMA (June 12, 2013),
`https://www.f1rstwordpharma.com/node/ 1 105932?tsid=17 (last
`accessed Nov. 1, 2018)
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`
`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
`
`Exhibit
`2205
`
`Dated: May 31, 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
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`Counsel for Patent Owner
`Biogen MA Inc.
`
`19
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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 MAY 31, 2019 and Exhibits 2051, 2053-2058, 2060-2071, 2073-
`
`2074, 2077, 2083-2125, 2130-2163, 2165-2185, and 2188-2205 were served
`
`electronically via the PTAB electronic filing system and via e-mail on May 31, 2019,
`
`in their entirety on the following:
`
`Brandon M. White
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`David L. Anstaett
`Emily Greb
`Perkins Coie LLP
`One East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`Email: danstaett@perkinscoie.com
`E-mail: egreb@perkinscoie.com
`Petitioner has agreed to electronic service.
`
`Dated: May 31, 2019
`
`By: / Catherine A. Sadler /
`Catherine A. Sadler
`Case Manager
`
`
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
