UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`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 EXHIBITS
`
`
`
`

`

`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
`
`Preliminary 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 ten (10) business days of the Institution
`
`Decision issued by the Board on February 6, 2019, Paper No. 12. 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.
`
`Description
`Exhibit
`BGN 2001 Chapters 1 and 4 from Alastair Compston et al.,
`MCALPINE’S MULTIPLE SCLEROSIS (4th ed. 2006)
`
`Objection
`A, B, K, M,
`N, O
`
`
`
`- 1 -
`
`

`

`Exhibit
`BGN 2002
`
`BGN 2003
`
`BGN 2004
`
`BGN 2005
`
`BGN 2006
`
`BGN 2007
`
`Description
`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)
`FDA Clinical Review for NDA 204063 by
`Heather Fitter, M.D. (Review Completion Date:
`11/08/2012)
`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/usbiogenidec-
`results-idUSBRE93O0Q920130425 (last
`accessed Nov. 1, 2018)
`
`Objection
`A, B, 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
`
`A, B, C, D,
`E, F, I, K, M,
`N, O
`
`
`
`- 2 -
`
`

`

`Exhibit
`BGN 2008
`
`BGN 2009
`
`BGN 2010
`
`BGN 2011
`BGN 2012
`BGN 2013
`
`BGN 2014
`
`BGN 2015
`
`Description
`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)
`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/201
`80424005550/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)
`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)
`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)
`
`BGN 2016
`
`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)
`
`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, 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
`A, B, C, E, I,
`K, L, M, N,
`O, W, X
`A, B, C, E, I,
`K, L, M, N,
`O, W, X
`
`
`
`- 3 -
`
`

`

`Exhibit
`BGN 2018
`
`Description
`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
`
`BGN 2025
`
`BGN 2026
`BGN 2027
`
`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)
`
`Objection
`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
`P
`A, C, D, E, F,
`I, M, N, O,
`Q, S, U, W,
`X
`
`
`
`- 4 -
`
`

`

`Exhibit
`BGN 2028
`
`BGN 2029
`
`BGN 2030
`
`Description
`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)
`
`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
`
`BGN 2033
`
`BGN 2034
`
`BGN 2035
`
`BGN 2036
`BGN 2037
`
`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)
`
`Objection
`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, D, F,
`G, H, I, K, L,
`M, N, O, Q,
`S, T, U, W, X
`P
`A, C, E, I, K,
`M, N, O, W,
`X
`
`
`
`- 5 -
`
`

`

`Exhibit
`BGN 2038
`
`BGN 2039
`
`BGN 2040
`
`Description
`Final Written Decision (Paper 63) in Coalition
`for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR2015-01993 (“Coalition II”) (Mar. 21, 2017)
`
`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)
`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)
`
`Objection
`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
`
`Petitioner objects to paragraphs in the Patent Owner Preliminary Response
`
`that rely on exhibits objected to in this Petitioner’s Objection to Evidence.
`
`
`
`- 6 -
`
`

`

`Objection Key:
`
`A:
`
`B:
`
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`
`L:
`
`M:
`
`N:
`
`O:
`
`P:
`
`Q:
`
`
`
`FRE 801/802/803 (hearsay)
`
`FRE 901/902 (lacking authentication)
`
`FRE 402 (relevance) the document is not relevant to any issue in this IPR
`proceeding because the purported date of the document is after the filing
`date of the ’514patent or the prior art status is not clear
`
`FRE 402 (relevance) to the extent the document is relied upon for secondary
`considerations of nonobviousness, there is no nexus to the claimed
`compositions and methods
`
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document is
`after the filing date of the ’514 patent or the prior art status is not clear
`
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus to
`the claimed compositions and methods
`
`FRE 702 (improper expert testimony) expert testimony that relies on the
`document is not based on sufficient facts or data and/or is not the product of
`reliable principles and methods
`
`FRE 703 (bases of expert opinion) expert testimony that relies on the
`document is unreliable because the document is not of a type reasonably
`relied upon by experts in the field
`
`FRE 106 (completeness) the document is incomplete and includes only a
`select portion of a larger document that in fairness should be considered
`along with this document
`
`FRE 701, 702 (improper expert testimony) improper expert testimony by a
`lay witness
`
`FRE 1001-1003 (best evidence)
`
`FRE 403, 901 (improper compilation)
`
`FRE 403 (cumulative)
`
`FRE 402 (relevance) the document is not relevant to any issue in the IPR
`proceeding
`
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in the IPR proceeding
`
`No exhibit filed.
`
`Expert testimony fails to identify with particularity the underlying facts or
`data on which the opinion is based, violating 37 C.F.R. § 42.65(a)
`
`- 7 -
`
`

`

`R:
`
`S:
`
`T:
`
`U:
`
`FRE 602 (lack of personal knowledge)
`
`FRE 702/703 to the extent that the expert declarant relies on an exhibit
`objected to under grounds G and H, the testimony is (i) not based on
`sufficient facts or data and/or is not the product of reliable principles and
`methods and/or is (ii) is unreliable because the exhibit is not of a type
`reasonably relied upon by experts in the field
`
`FRE 1006 (improper summary)
`
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`
`V: FRE 403 (confusing, waste of time, unfair prejudice) the document is in a
`different forum with a different claim construction standard and its use
`would unfairly prejudice Petitioner, waste time and confuse the issues
`
`W: FRE 403 (confusing, waste of time, unfair prejudice) the paper, declaration,
`or opinion has been filed in a proceeding to which Petitioner is not a party
`and/or had no opportunity to cross-examine the witness in this proceeding
`and/or assess the basis or correctness of the opinions offered
`
`X:
`
`Petitioner was excluded from participation in proceeding, deposition or cross
`examination of the declarant or witness.
`
`
`
`February 20, 2019
`
`
`
`
`
`Respectfully submitted,
`
`Brandon M. White
`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W.
`Suite 600
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`
`
`- 8 -
`
`

`

`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OBJECTIONS TO PATENT
`
`OWNER’S EXHIBITS by email to the electronic service addresses for Patent
`
`Owner:
`
`Barbara C. McCurdy
`Erin M. Sommers
`Pier D. DeRoo
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`barbara.mccurdy@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`
`
`Dated: February 20, 2019
`
`Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`
`
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`