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`Filed: April 22, 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 APRIL 22, 2019
`
`
`
`
`
`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), available at
`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
`
`Exhibit
`2005
`
`Exhibit
`2006
`
`Exhibit
`2007
`
`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)
`
`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)
`
`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)
`
`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)
`
`Exhibit
`2008
`
`ViewPoints: Biogen Idec Struggling to Cope with Tecfidera
`Demand Suggests Analyst, FIRSTWORD PHARMA (June 12, 2013),
`
`2
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`EXHIBIT
`
`DESCRIPTION
`https://www.firstwordpharma.com/node/1105932?tsid=17 (last
`accessed Nov. 1, 2018)
`
`Exhibit
`2009
`
`Exhibit
`2010
`
`Exhibit
`2011
`
`Exhibit
`2012
`
`Exhibit
`2013
`
`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),
`available at
`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
`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
`
`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)
`
`3
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`EXHIBIT
`
`DESCRIPTION
`
`Exhibit
`2018
`
`Exhibit
`2019
`
`Exhibit
`2020
`
`Exhibit
`2021
`
`Exhibit
`2022
`
`Exhibit
`2023
`
`Exhibit
`2024
`
`Exhibit
`2025
`
`Exhibit
`2026
`
`Exhibit
`2027
`
`Exhibit
`2028
`
`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)
`
`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)
`
`4
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`EXHIBIT
`
`Exhibit
`2029
`
`Exhibit
`2030
`
`DESCRIPTION
`
`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
`2031
`
`Petition (Paper 1) in Coalition for Affordable Drugs V LLC v.
`Biogen MA Inc., IPR2015-01993 (“Coalition II”) (Sept. 28, 2015)
`
`Exhibit
`2032
`
`Exhibit
`2033
`
`Exhibit
`2034
`
`Exhibit
`2035
`
`Exhibit
`2036
`
`Exhibit
`2037
`
`Exhibit
`2038
`
`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)
`
`5
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`EXHIBIT
`
`DESCRIPTION
`
`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.
`
`Exhibit
`2042-2048
`
`RESERVED
`
`Exhibit
`2049
`
`Email from Emily Greb, counsel for Petitioner Mylan
`Pharmaceuticals, Inc., dated March 6, 2019
`
`Exhibit
`2050
`
`Result from URL in Mihail declaration,
`https://clinicaltrials.gov/archive/NCT00168701/2005_09_14 (last
`accessed April 22, 2019)
`
`
`
`
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`
`Respectfully submitted,
`
`Dated: April 22, 2019
`
`
`
`
`
`
`
`By: /Barbara C. McCurdy/
`
`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.
`
`6
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Biogen Exhibit List
`
`and Exhibits 2049 and 2050 were served electronically via e-mail on April 22,
`
`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: April 22, 2019
`
`
`
`
`
`By: / Catherine A. Sadler /
`Catherine A. Sadler
`Case Manager
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
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