UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: June 7, 2019
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`BIOGEN MA INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`
`
`
`
`
`Filed: June 7, 2019
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`BIOGEN MA INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owner Biogen MA Inc. (“Biogen” or “Patent Owner”) in the Patent Owner’s
`
`Response in the above-captioned inter partes review.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because they
`
`are being filed and served within five business days. Petitioner’s objections provide
`
`notice to Biogen that Petitioner may move to exclude these exhibits under 37 C.F.R.
`
`§ 42.64(c).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’514 patent”
`
`means U.S. Patent No. 8,399,514. All objections under FRE 801-803 (hearsay)
`
`apply to the extent Patent Owner relies on the exhibits identified in connection with
`
`that objection for the truth of the matter asserted therein.
`
`Exhibit descriptions provided in this table are from Patent Owner’s exhibit list
`
`and are used for identification purposes only. The use of the description does not
`
`indicate that Petitioner agrees with the descriptions or characterizations of the
`
`documents.
`
`
`
`
`
`- 1 -
`
`
`
`Description
`Exhibit
`BGN 2001 Chapters 1 and 4 from Alastair Compston et al.,
`MCALPINE’S MULTIPLE SCLEROSIS (4th ed.
`2006)
`BGN 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),
`available at
`https://www.ema.europa.eu/documents/scientific
`-guideline/guideline-clinical-investigation-
`medicinal-productstreatment-multiple-
`sclerosis_en.pdf (last accessed Nov. 1, 2018)
`BGN 2003 FDA Clinical Review for NDA 204063 by
`Heather Fitter, M.D. (Review Completion Date:
`11/08/2012)
`
`BGN 2004 Australian Government, Department of Health,
`Therapeutic Goods Administration, Australian
`Public Assessment Report for Dimethyl
`Fumarate, Proprietary Product Name: Tecfidera
`(October 2013), available at
`https://www.tga.gov.au/sites/default/files/auspar
`-dimethyl-fumarate-131022.pdf (last accessed
`Nov. 1, 2018)
`BGN 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)
`BGN 2006 Douglas Quenqua, Existential Animal News and
`the World’s Lightest Solid, N.Y. TIMES, April
`2, 2013, available at
`http://www.nytimes.com/2013/04/02/science/
`existential-animal- news-and-the-worlds-
`lightest-solid.html?_r=0 (last accessed Nov. 1,
`2018)
`
`Objection
`A, B, C, K,
`M, N, O
`
`A, B, C, D,
`F, M, N, O
`
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`U
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`U
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`L, M, N, O
`
`- 2 -
`
`
`
`Description
`Exhibit
`BGN 2007 Bill Berkrot, Biogen Profit Beats Estimates,
`Raises 2013 Forecast, REUTERS (Apr. 25,
`2013),
`http://www.reuters.com/article/usbiogenidec-
`results-idUSBRE93O0Q920130425 (last
`accessed Nov. 1, 2018)
`BGN 2008 ViewPoints: Biogen Idec Struggling to Cope
`with Tecfidera Demand Suggests Analyst,
`FIRSTWORD PHARMA (June 12, 2013),
`https://www.firstwordpharma.com/node/110593
`2?tsid=17 (last accessed Nov. 1, 2018)
`BGN 2009 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)
`BGN 2010 News Release, Biogen, Biogen Reports
`Quarterly Revenues of $3.1 Billion (Apr. 24,
`2018) (published by BUSINESS WIRE),
`available at
`https://www.businesswire.com/news/home/201
`80424005550/en/ (last accessed Nov. 7, 2018)
`BGN 2011 RESERVED
`BGN 2012 RESERVED
`BGN 2013 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)
`BGN 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)
`BGN 2015 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)
`
`Objection
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`T
`
`P
`P
`C, E, M, N,
`O, V
`
`C, E, M, N,
`O, V
`
`A, B, C, D,
`E, F, G, H,
`I, K, L, M,
`N, O, Q, R,
`S, T, U, W,
`X
`
`- 3 -
`
`
`
`Exhibit
`BGN 2016
`
`Description
`Information Disclosure Statement in U.S. Appl.
`No. 13/372,426 (Feb. 13, 2012)
`
`BGN 2017 First Supplemental Information Disclosure
`Statement in U.S. Appl. No. 13/372,426 (Feb.
`13, 2012)
`BGN 2018 Non-Final Office Action in U.S. Appl. No.
`13/372,426 (May 3, 2012)
`
`BGN 2019 Amendment and Reply Under 37 C.F.R. § 1.111
`in U.S. Appl. No. 13/372,426 (August 3, 2012)
`
`BGN 2020 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)
`
`BGN 2021 Final Office Action in U.S. Appl. No.
`13/372,426 (October 12, 2012)
`
`BGN 2022 Reply to Final Office Action Under 37 C.F.R. §
`1.116 in U.S. Appl. No. 13/372,426 (December
`12, 2012)
`
`BGN 2023 Notice of Allowance in U.S. Appl. No.
`13/372,426 (December 26, 2012)
`
`BGN 2024 First Amended Petition (Paper 9) in Coalition
`for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR2015-01136 (“Coalition I”) (May 27, 2015)
`BGN 2025 Petitioner’s Exhibit List (Paper 10) in Coalition
`for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR2015-01136 (“Coalition I”) (May 27, 2015)
`
`- 4 -
`
`Objection
`A, B, C, E,
`I, K, L, M,
`N, O, W, X
`A, B, C, E,
`I, K, L, M,
`N, O, W, X
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`W, X
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`Q, S, T, U,
`W, X
`A, B, C, D,
`E, F, G, H,
`I, K, L, M,
`N, O, Q, S,
`T, U, W, X
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`W, X
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`W, X
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`W, X
`A, C, E, I,
`M, N, O, Q,
`S, U, W, X
`A, C, E, I,
`K, M, N, O,
`W, X
`
`
`
`Description
`
`Exhibit
`BGN 2026 RESERVED
`BGN 2027 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)
`BGN 2028 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)
`BGN 2029 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)
`BGN 2030 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)
`
`BGN 2031 Petition (Paper 1) in Coalition for Affordable
`Drugs V LLC v. Biogen MA Inc., IPR2015-
`01993 (“Coalition II”) (Sept. 28, 2015)
`
`BGN 2032 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)
`BGN 2033 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)
`BGN 2034 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)
`BGN 2035 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)
`
`Objection
`P
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, B, C, D,
`F, G, H, I,
`K, L, M, N,
`O, Q, S, T,
`U, W, X
`
`- 5 -
`
`
`
`Description
`
`Exhibit
`BGN 2036 RESERVED
`BGN 2037 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)
`BGN 2038 Final Written Decision (Paper 63) in Coalition
`for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR2015-01993 (“Coalition II”) (Mar. 21, 2017)
`
`BGN 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)
`BGN 2040 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)
`BGN 2041 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.
`RESERVED
`
`BGN
`2042-2048
`BGN 2049 Email from Emily Greb, counsel for Petitioner
`Mylan Pharmaceuticals, Inc., dated March 6,
`2019
`
`BGN 2050 Result from URL in Mihail declaration,
`https://clinicaltrials.gov/archive/NCT00168701/
`2005_09_14 (last accessed April 22, 2019)
`
`BGN 2051 Gilbert et al., Comparison of HIV-1 and HIV-2
`Infectivity from a Prospective Cohort Study in
`Senegal, 22 STATISTICAL MED. 573 (2003)
`BGN 2052 RESERVED
`
`Objection
`P
`A, C, E, I,
`K, M, N, O,
`W, X
`
`A, C, D, E,
`F, G, H, I,
`K, M, N, O,
`Q, S, U, W,
`X
`C, E, M, N,
`O, V
`
`C, E, I, K,
`M, N, O, V
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`P
`
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`T
`A, B, C, D,
`E, F, K, M,
`N, O, R, V,
`W, X
`A, B, D, F,
`M, N, O
`
`P
`
`- 6 -
`
`
`
`Description
`Exhibit
`BGN 2053 Chapter 39 from DiPiro et al.,
`PHARMACOTHERAPY: A PATHOPHYSIOLOGIC
`APPROACH (9th ed. 2014)
`BGN 2054 Vollmer et al., Oral Simvastatin Treatment in
`Relapsing-Remitting Multiple Sclerosis, 363
`LANCET 1607 (2004)
`BGN 2055 Corboy & Coyle, Fresh Approaches to MS
`Care: New Treatment Options Encourage a
`Fresh Approach to Patients, PRACTICAL
`NEUROLOGY (2013)
`BGN 2056 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)
`BGN 2057 Declaration of Richard C. Brundage, Pharm. D.,
`Ph.D.
`
`BGN 2058 Declaration of Martin Duddy, M.D.
`
`BGN 2059 RESERVED
`BGN 2060 Declaration of Ronald A. Thisted, Ph.D.
`
`BGN 2061 Declaration of Daniel Wynn, M.D. FACNS
`FAASM
`
`BGN 2062 Deposition of Leslie Benet, Ph.D.
`
`Objection
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, D, F,
`I, K, M, N,
`O
`
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`P
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`A, C, D, E,
`F, G, H, M,
`N, O, Q, S,
`U
`
`- 7 -
`
`
`
`Description
`Exhibit
`BGN 2063 Deposition of John R. Corboy, M.D.
`
`BGN 2064 Deposition of Ian McKeague, Ph.D.
`
`BGN 2065 Deposition of Jennifer Rock
`
`BGN 2066 FDA, Center for Drug Evaluation and Research,
`Summary Review (2013)
`https://www.accessdata.fda.gov/drugsatfda_docs/n
`da/2013/204063ori g1s000sumr.pdf (last accessed
`April 8, 2019)
`BGN 2067 Tecfidera® Prescribing Information (December
`2017)
`
`BGN 2068 D’Agostino et al., Non-Inferiority Trials: Design
`Concepts and Issues — The Encounters of
`Academic Consultants in Statistics, 22
`STATISTICS IN MED. 169 (2003)
`BGN 2069 Oxman et al., A Consumer’s Guide to Subgroup
`Analyses, 116 ANNALS INTERNAL MED. 78
`(1992)
`BGN 2070 Rothwell, Subgroup Analysis in Randomized
`Controlled Trials: Importance, Indications, and
`Interpretation, 365 LANCET 176 (2005)
`BGN 2071 Wang et al., Statistics in Medicine—Reporting of
`Subgroup Analyses in Clinical Trials, 357 NEW
`ENGL. J. MED. 2189 (2007)
`BGN 2072 RESERVED
`BGN 2073 Kappos et al., Oral Fingolimod (FTY720) for
`Relapsing Multiple Sclerosis, 355 N. ENG. J.
`MED. 11 (2006)
`
`Objection
`A, C, D, E,
`F, G, H, M,
`N, O, Q, S,
`U
`A, C, D, E,
`F, G, H, M,
`N, O, Q, S,
`U
`A, C, D, E,
`F, J, M, N,
`O, R
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`
`A, B, D, F,
`I, K, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, C, D,
`F, I, K, M,
`N, O
`P
`A, B, C, D,
`F, I, K, M,
`N, O
`
`- 8 -
`
`
`
`Description
`Exhibit
`BGN 2074 Kappos et al., Ocrelizumab in Relapsing-
`Remitting Multiple Sclerosis: A Phase 2,
`Randomized, Placebo-Controlled, Multicentre
`Trial, 378 LANCET 1779 (2011)
`BGN 2075 RESERVED
`BGN 2076 RESERVED
`BGN 2077 Mancardi et al., Effect of Copolymer-1 on Serial
`Gadolinium- Enhanced MRI in Relapsing
`Remitting Multiple Sclerosis, 50. NEUROLOGY
`1127 (1998)
`BGN 2078 RESERVED
`BGN 2079 RESERVED
`BGN 2080 RESERVED
`BGN 2081 RESERVED
`BGN 2082 RESERVED
`BGN 2083 Rumrill, Multiple Sclerosis: Medical and
`Psychosocial Aspects, Etiology, Incidence, and
`Prevalence, 31 J. VOCATIONAL REHABILITATION
`75 (2009)
`BGN 2084 De Stefano et al., Assessing Brain Atrophy Rates
`in a Large Population of Untreated Multiple
`Sclerosis Subtypes, 74 NEUROLOGY 1868 (2010)
`BGN 2085 Fisniku et al., Gray Matter Atrophy is Related to
`Long-Term Disability in Multiple Sclerosis, 64
`ANNALS NEUROLOGY 247 (2008)
`BGN 2086 Wynn et al., A Reappraisal of the Epidemiology
`of Multiple Sclerosis in Olmsted County,
`Minnesota, 40 NEUROLOGY 780 (1990)
`BGN 2087 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)
`BGN 2088 Clinical Trial Review Board Agenda Item
`Meeting Minutes (February 19, 2004)
`
`Objection
`A, B, C, D,
`F, I, K, M,
`N, O
`
`P
`P
`A, B, D, F,
`I, K, M, N,
`O
`
`P
`P
`P
`P
`P
`A, B, C, D,
`F, I, K, M,
`N, O
`
`A, B, C, D,
`F, I, K, M,
`N, O
`A, B, C, D,
`F, I, K, M,
`N, O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`
`A, B, D, F,
`I, K, M, N,
`O, T, W, X
`
`- 9 -
`
`
`
`Description
`Exhibit
`BGN 2089 Email from Rebecca Conaghan and Gilmore
`O’Neill, M.D. (August 16, 2004)
`
`BGN 2090 Email from Cara Lansden with Attachment
`(October 25, 2005)
`
`BGN 2091 Presentation by Dr. Gilmore O’Neill, M.D.,
`titled “BG00012 in RRMS: Update From Phase
`2 Study,” presented in February 2006
`BGN 2092 Email from Gilmore O’Neill, M.D. with
`Attachment (February 1, 2006)
`
`BGN 2093 Emails between Gilmore O’Neill, M.D., and
`Ludwig Kappos, M.D., with Attachments
`(January 31, 2006)
`
`BGN 2094 Prosecution History, U.S. Patent Application
`No. 12/526,296, Preliminary Amendment (June
`20, 2011)
`BGN 2095 Prosecution History, U.S. Patent Application
`No. 12/526,296, Supplemental Amendment and
`Reply (October 28, 2011)
`BGN 2096 Prosecution History, U.S. Patent Application
`No. 12/526,296, Request to Add Inventor in a
`Nonprovisional Patent Application (October 28,
`2011)
`BGN 2097 Declaration of Gilmore O’Neill, M.D.
`
`BGN 2098 Declaration of Rebecca Conaghan
`
`Objection
`A, B, D, F,
`I, K, L, M,
`N, O, T, W,
`X
`A, B, C, D,
`F, I, K, L,
`M, N, O, T,
`W, X
`A, B, D, F,
`I, M, N, O
`
`A, B, D, F,
`G, I, K, L,
`M, N, O, T,
`W, X
`A, B, D, F,
`G, I, K, L,
`M, N, O, T,
`W, X
`A, I, M, N,
`O
`
`A, I, M, N,
`O
`
`A, I, M, N,
`O
`
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`A, B, C, D,
`E, F, K, M,
`N, O
`
`- 10 -
`
`
`
`Description
`Exhibit
`BGN 2099 Declaration of Eva Havrdova, M.D., Ph.D.
`
`BGN 2100 Declaration of Matvey Lukashev, Ph.D.
`
`BGN 2101 U.S. Provisional Application No. 60/888,921
`
`BGN 2102
`
`International Publication No. WO 2008/097596
`A2
`BGN 2103 Decision on Biogen Motion 6 (Paper 611) in
`Biogen MA Inc. v. Forward Pharma A/S, Interf.
`No. 106,023, (PTAB Feb. 5, 2016)
`
`BGN 2104 File Wrapper for U.S. Provisional Application
`No. 60/888,921
`BGN 2105 Prosecution History, U.S. Patent Application
`No. 12/526,296, Claims (February 7, 2008)
`BGN 2106 Prosecution History, U.S. Patent Application
`No. 12/526,296, Combined Declaration and
`Power of Attorney (December 6, 2010)
`BGN 2107 Prosecution History, U.S. Patent Application
`No. 13/372,426, Amendment and Reply (August
`3, 2012)
`BGN 2108 Sales Data from Symphony Health, Part 1
`
`BGN 2109 Sales Data from Symphony Health, Part 2
`
`BGN 2110 Prosecution History, U.S. Patent Application
`No. 12/526,296, Amendment to Specification
`(July 20, 2015)
`
`Objection
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`A, B, C, D,
`E, F, G, H,
`K, M, N, O,
`Q, S, U
`A, I, M, N,
`O
`A, I, M, N,
`O
`A, C, D, E,
`F, I, M, N,
`O, Q, S, U,
`W, X
`A, I, M, N,
`O
`A, I, M, N,
`O
`A, I, M, N,
`O
`
`A, C, E, I,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`R, T
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`R, T
`A, C, E, I,
`M, N, O
`
`- 11 -
`
`
`
`Description
`Exhibit
`BGN 2111 Sales Data from Symphony Health, Part 3
`
`BGN 2112 Sales Data from Symphony Health, Part 4
`
`BGN 2113 Biogen, 10-K (2013)
`
`BGN 2114 De Keyser, Autoimmunity in Multiple Sclerosis,
`38 NEUROLOGY 371 (1988)
`
`BGN 2115 Broadley et al., Autoimmune Disease in First-
`Degree Relatives of Patients with Multiple
`Sclerosis: A UK Survey, 123 BRAIN 1102 (2000)
`BGN 2116 Titelbaum et al., Anti-Tumor Necrosis Factor
`Alpha-Associated Multiple Sclerosis, 26 AM. J.
`NEURORADIOL. 1548 (2005)
`BGN 2117 Sicotte & Voskuhl, Onset of Multiple Sclerosis
`Associated with Anti- TNF Therapy, 57
`NEUROLOGY 1885 (2001)
`BGN 2118 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)
`BGN 2119 Papp, The Safety of Etanercept for the Treatment
`of Plaque Psoriasis, 3(2) THERAPEUTICS &
`CLINICAL RISK MANAG. 245 (2007)
`BGN 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)
`
`Objection
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`R, T
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`R, T
`A, B, C, D,
`E, F, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`A, B, D, F,
`I, K, M, N,
`O
`
`A, B, C, D,
`F, I, K, M,
`N, O
`A, B, C, D,
`F, I, K, M,
`N, O
`
`- 12 -
`
`
`
`BGN 2123
`
`Description
`Exhibit
`BGN 2121 Kister & Corboy, Reducing Costs While
`Enhancing Quality of Care in MS, 87
`NEUROLOGY 1617 (2016)
`BGN 2122 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/comme
`rcial/multiple-
`sclerosis/tecfidera/hcp/en_us/pdf/TEC-US-
`0298_StartForm- web_150713.pdf (last accessed
`April 8, 2019)
`BGN 2124 Presentation by Martin Duddy, M.D., titled
`“Emerging Therapies in Multiple Sclerosis,”
`presented in September 2009
`BGN 2125 Presentation by Martin Duddy, M.D., titled
`“G2G 2011,” presented in November 2011
`
`BGN 2126 Email from Emily Greb, Counsel for Petitioner
`Mylan Pharmaceuticals, Inc. (May 6, 2019)
`
`BGN 2127
`
`Internet Archive: Legal: Requests Website, (last
`accessed May 16, 2019)
`
`BGN 2128 Result from Wayback Machine,
`http://www.fumapharm.ch/pdf/BG-
`12_Schimrigk_Poster_Final.pdf (last accessed
`May 16, 2019)
`BGN 2129 Deposition of Christopher Butler, IPR2016-
`00541 (October 6, 2016)
`
`BGN 2130 Search Results for Patent Number: 8399514,
`https://www.accessdata.fds.gov/Scripts/cder/ob/sea
`rch—patent.cfm (last accessed April 8, 2019)
`
`Objection
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, D, F,
`I, K, M, N,
`O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`F, I, M, N,
`O
`A, B, C, D,
`F, I, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`L, M, N, O,
`T
`A, B, C, D,
`E, F, I, M,
`N, O
`A, B, C, D,
`E, F, I, M,
`N, O
`
`A, B, C, D,
`F, G, H, I,
`K, L, M, N,
`O, Q, S, T,
`U, W, X
`A, B, C, D,
`E, F, I, M,
`N, O
`
`- 13 -
`
`
`
`Description
`Exhibit
`BGN 2131 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)
`BGN 2132 NDA 204063 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/a
`ppletter/2013/2040 63Orig1s000ltr.pdf (last
`accessed April 15, 2019)
`BGN 2133 Tecfidera® Prescribing Information (March
`2013)
`
`BGN 2134 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)
`BGN 2135 NDA 209884 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/a
`ppletter/2019/2098 84Orig1s000ltr.pdf (last
`accessed April 8, 2019)
`BGN 2136 NDA 22561 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/a
`ppletter/2019/0225 61Orig1s000ltr.pdf (last
`accessed April 8, 2019)
`BGN 2137 Gilenya® Prescribing Information (September
`2010)
`BGN 2138 Gilenya® Prescribing Information (October
`2018)
`
`Objection
`A, B, C, D,
`F, I, K, M,
`N, O
`
`A, B, C, D,
`E, F, I, K,
`L, M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`F, M, N, O
`A, B, C, D,
`E, F, M, N,
`O
`
`- 14 -
`
`
`
`Description
`Exhibit
`BGN 2139 FDA Approved Drug Products, NDA 022527,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=022527 (last accessed
`April 16, 2019)
`BGN 2140 Aubagio® Prescribing Information (September
`2012)
`
`BGN 2141 FDA Approved Drug Products, NDA 202992,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=202992 (last accessed
`April 15, 2019)
`BGN 2142 Sanofi, Form 20-F (2018)
`
`Objection
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`BGN 2143 Mayzent® Prescribing Information (March 2019) A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`BGN 2144 FDA Approved Drug Products, NDA 209884,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=Bas icSearch.process (last
`accessed April 16, 2019)
`BGN 2145 Mavenclad® Prescribing Information (March
`2019)
`
`BGN 2146 FDA Approves New Oral Treatment for Multiple
`Sclerosis (March 29, 2019),
`https://www.fda.gov/NewsEvents/Newsroom/Press
`Announcements/uc m634837.htm (last accessed
`April 17, 2019)
`BGN 2147 FDA Approved Drug Products, NDA 022561,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=022561 (last accessed
`April 16, 2019)
`
`- 15 -
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`
`
`Description
`Exhibit
`BGN 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)
`BGN 2149 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)
`BGN 2150 AVONEX® Prescribing Information (February
`2012)
`
`BGN 2151 FDA Approved Drug Products, BLA 103628,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=103628 (last accessed
`April 16, 2019)
`BGN 2152 Rebif® Prescribing Information (March 2002)
`
`BGN 2153 FDA Approved Drug Products, BLA 103780,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=103780 accessed April
`16, 2019)
`BGN 2154 PlegridyTM Prescribing Information (August
`2014)
`
`BGN 2155 FDA Approved Drug Products, BLA 125499,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=125499 (last accessed
`April 16, 2019)
`
`Objection
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`F, M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`- 16 -
`
`
`
`Description
`Exhibit
`BGN 2156 Betaseron® Prescribing Information (August
`2018)
`
`BGN 2157 FDA Approved Drug Products, BLA 103471,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=Bas icSearch.process (last
`accessed April 16, 2019)
`BGN 2158 Extavia® Prescribing Information (July 2009)
`
`BGN 2159 FDA Approved Drug Products, BLA 125290,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=125290 (last accessed
`April 16, 2019)
`BGN 2160 COPAXONE® Prescribing Information
`(September 2018)
`
`BGN 2161 Letter Regarding ANDA 090218,
`https://www.accessdata.fda.gov/drugsatfda_docs/a
`ppletter/2015/0902 18Orig1s000ltr.pdf (last
`accessed April 8, 2019)
`BGN 2162 ANDA 091646 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/a
`ppletter/2017/0916 46Orig1s000ltr.pdf (last
`accessed April 8, 2019)
`BGN 2163 ZINBRYTATM Prescribing Information (May
`2016)
`
`BGN 2164 RESERVED
`BGN 2165 FDA Approved Drug Products, BLA 761029,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=Bas icSearch.process (last
`accessed April 16, 2019)
`BGN 2166 NDA 21-120 Approval Letter,
`https://www.accessdata.fda.gov/drugsatfda_docs/n
`da/2000/21120.pdf
`_Novantrone_Approv.pdf (last accessed April 8,
`2019)
`
`Objection
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`F, M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`P
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`- 17 -
`
`
`
`Description
`Exhibit
`BGN 2167 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)
`BGN 2168 FDA Approved Drug Products, ANDA 077356,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=077356 (last accessed
`April 8, 2019)
`BGN 2169 LEMTRADA® Prescribing Information
`(December 2017)
`
`BGN 2170 FDA Approved Drug Products, BLA 103948,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=ove
`rview.process&ApplNo=103948 (last accessed
`April 16, 2019)
`BGN 2171 Tysabri® Prescribing Information (November
`2004)
`BGN 2172 FDA Approved Drug Products, BLA 125104,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=Bas icSearch.process (last
`accessed April 16, 2019)
`BGN 2173 OcrevusTM Prescribing Information (March
`2017)
`
`BGN 2174 FDA Approved Drug Products, BLA 761053,
`https://www.accessdata.fda.gov/scripts/cder/daf/ind
`ex.cfm?event=Bas icSearch.process (last
`accessed April 16, 2019)
`BGN 2175 Thomas, Secondary Considerations in
`Nonobviousness Analysis: The Use of Objective
`Indicia Following KSR v. Teleflex, 86 N.Y.
`UNIV. LAW REV. 2070 (2011)
`
`Objection
`A, B, C, D,
`F, K, M, N,
`O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`F, M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`F, I, K, M,
`N, O
`
`- 18 -
`
`
`
`Description
`Exhibit
`BGN 2176 Samuelson & Nordhaus, ECONOMICS at 49 (17th
`ed.) (2001)
`
`BGN 2177 Comprehensive, reliable pharmaceutical market
`analysis delivered wherever and whenever you
`need them, SYMPHONYHEALTH,
`https://symphonyhealth.com/product/pharmaceut
`ical-audit-suite- phast/ (last accessed April 9,
`2019)
`BGN 2178 Hampp et al., Use of Antidiabetic Drugs in the
`U.S., 2003–2012, 37 DIABETES CARE 1367
`(2014)
`BGN 2179 Maron et al., Occurrence of Clinically
`Diagnosed Hypertrophic Cardiomyopathy in the
`United States, 117 AM. J. CARDIOLOGY 1651
`(2016)
`BGN 2180 Pinkerton & Santoro, Compounded Bioidentical
`Hormone Therapy: Identifying Use Trends and
`Knowledge Gaps Among US Women, 22
`MENOPAUSE 926 (2015)
`BGN 2181 Quigley et al., Genmab A/S (GEN DC), J.P.
`MORGAN (September 20, 2017)
`
`BGN 2182 Nachman et al., August Exparel Sales Up From
`July, but Still Tracking Well Below 3Q
`Consensus, BMO CAPITAL MARKETS,
`(September 19, 2017)
`BGN 2183 Smith et al, Bullish on Intrarosa as the Next
`AMAG Value Driver Following Survey; Initiate
`OW, $26 PT, MORGAN STANLEY (September 8,
`2017)
`BGN 2184 PHASTTM Integrated,
`https://symphonyhealth.com/wp-
`content/uploads/2017/01/phast_integrated_sales
`_sheet.pdf (last accessed April 8, 2019)
`
`Objection
`A, B, D, F,
`I, K, M, N,
`O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`- 19 -
`
`
`
`Description
`Exhibit
`BGN 2185 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)
`BGN 2186 RESERVED
`BGN 2187 RESERVED
`BGN 2188 Pollock et al., Appropriate Prescribing of
`Medications: An Eight-Step Approach, 75 AM.
`FAM. PHYSICIAN 231 (2007)
`BGN 2189 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)
`BGN 2190 TECFIDERA Clinical Trials,
`https://www.tecfiderahcp.com/en_us/home/efficac
`y/clinical-trials.html (last accessed April 8, 2019)
`BGN 2191 DEFINE* Trial Efficacy,
`https://www.tecfiderahcp.com/en_us/efficacy/de
`fine-trial.html (last accessed April 8, 2019)
`BGN 2192 CONFIRM* Trial Efficacy,
`https://www.tecfiderahcp.com/en_us/home/efficac
`y/confirm-trial.html (last accessed April 8, 2019)
`BGN 2193 TOLERABILITY MANAGEMENT,
`https://www.tecfiderahcp.com/en_us/home/toler
`ability-and- safety/tolerability-management.html
`(last accessed April 8, 2019)
`BGN 2194 Ahlawat et al., The Secret of Successful Drug
`Launches, MCKINSEY & COMPANY (March
`2014),
`https://www.mckinsey.com/industries/pharmaceuti
`cals-and-medical- products/our-insights/the-
`secret-of-successful-drug-launches (last
`accessed April 8, 2019)
`
`Objection
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`P
`P
`A, B, C, D,
`F, I, K, M,
`N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`A, B, C, D,
`E, F, I, K,
`M, N, O
`
`- 20 -
`
`
`
`Description
`Exhibit
`BGN 2195 Safety & Monitoring: Demonstrated Safety
`Profile,
`https://www.tecfiderahcp.com/en_us/home/tolerabi
`lity-and- safety/safety.html (last accessed April
`9, 2019)
`BGN 2196 Bagwell, The Economic Analysis of Advertising,
`Discussion Paper No.: 0506-01, Department of
`Economics, Columbia University (August 2005)
`BGN 2197 Ching & Ishihara, Measuring the Informative
`and Persuasive Roles of Detailing on
`Prescribing Decisions, 58 MANAG. SCI. 1374
`(2012)
`BGN 2198 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)
`
`BGN 2200
`
`BGN 2199 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-Respo
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