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
`____________________________
`
`Case No. IPR2018-014031
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`____________________________
`
`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
`____________________________
`
`Case No. IPR2018-014031
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`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 Sur-
`
`Reply 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 (5) business days of service of evidence
`
`to which the objections are directed. 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 -
`
`
`
`BGN 2208
`
`BGN 2207
`
`Description
`Exhibit
`BGN 2206 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)
`BGN 2209 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)
`BGN 2210 Multiple Sclerosis 2005-2020, Decision
`Resources, April 2007
`
`BGN 2211 Deposition of Joel W. Hay, IPR2014-00784,
`IPR2015-00518 (June 24, 2015)
`
`BGN 2212 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)
`BGN 2213 Gilenya (fingolimod) Go,
`https://www.facebook.com/GilenyaGO (last
`accessed October 17, 2019)
`BGN 2214 Aubagio (teriflunomide) 14mg tablets,
`https://www.facebook.com/AUBAGIOUS (last
`accessed October 17, 2019)
`
`
`
`- 2 -
`
`Objection
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, D, F,
`M, N, O, Y
`
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, C, D, E, F,
`I, M, N, O, Q,
`U, V, Y
`
`A, B, C, D, E,
`F, M, N, O,
`U, Y
`A, C, D, E, F,
`I, M, N, O, Q,
`U, V, Y
`A, C, D, E, F,
`M, N, O, Q,
`U, V, Y
`
`A, B, C, D, E,
`F, I, K, L, M,
`N, O, Y
`A, B, C, D, E,
`F, I, K, L, M,
`N, O, Y
`
`
`
`Exhibit
`BGN 2215
`
`Description
`Gilenya Patient Services Liaison - Gilenya,
`https://www.gilenyahcp.com/for-your-office
`(last accessed October 17, 2019)
`BGN 2216 MS Events Gilenya Events Gilenya (fingolimod),
`https://www.gilenya.com/c/living-with-ms/events
`(last accessed October 17, 2019)
`BGN 2217 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)
`BGN 2219 Data Chart based on mean number of new Gd+
`lesions (weeks 12-24)/4 scans
`
`BGN 2218
`
`BGN 2220
`
`Data Chart based on Koudriavtseva 1997 (Ex.
`1119)
`
`BGN 2221 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)
`BGN 2222 McFarland et al., Using Gadolinium-enhanced
`Magnetic Resonance Imaging Lesions to Monitor
`Disease Activity in Multiple Sclerosis, 32 ANN
`NEUROL 758 (1992)
`BGN 2223 Chapter 46 from Waldman et al.,
`PHARMACOLOGY AND THERAPEUTICS PRINCIPLES
`TO PRACTICE (2009)
`BGN 2224 Greenberg et al., Future Research Directions in
`Multiple Sclerosis Therapies, 28 SEMIN NEUROL
`121 (2008)
`
`
`
`- 3 -
`
`Objection
`A, B, C, D, E,
`F, I, K, M, N,
`O, Y
`A, B, C, D, E,
`F, I, K, M, N,
`O, Y
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, C, D, E,
`F, G, H, I, K,
`L, M, N, O,
`T, U, Y
`A, B, C, D, E,
`F, G, H, I, K,
`L, M, N, O,
`T, U, Y
`A, B, D, F,
`M, N, O, Y
`
`A, B, D, F,
`M, N, O, Y
`
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, C, D, E,
`F, M, N, O, Y
`
`
`
`Description
`Exhibit
`BGN 2225 Castro-Borrero et al., Current and emerging
`therapies in multiple sclerosis: a systematic
`review, 5 THER ADV NEUROL DISORD 205 (2012)
`BGN 2226 Hauser et al., B-Cell Depletion with Rituximab in
`Relapsing-Remitting Multiple Sclerosis, 358 N
`ENGL J MED 676 (2008)
`BGN 2227 Ayers et al., Modulation of immune function
`occurs within hours of therapy initiation for
`multiple sclerosis, 147 CLIN IMMUNOL. 105
`(2013)
`BGN 2228 Dr. Lindsey’s Multiple Sclerosis Website
`ECTRIMS Sept 2009,
`https://www.jwlindseymd.com/id69.html (last
`accessed September 16, 2019)
`BGN 2229 Dr. Lindsey’s Multiple Sclerosis Website
`ECTRIMS 2011,
`https://www.jwlindseymd.com/id77.html (last
`accessed September 16, 2019)
`Deposition of Joel Hay, Ph.D.
`Deposition of Benjamin Greenberg
`
`BGN 2230
`BGN 2231
`
`Objection
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, C, D, E,
`F, M, N, O, Y
`
`A, B, C, D, E,
`F, K, M, N,
`O, U, Y
`
`A, B, C, D, E,
`F, K, M, N,
`O, U, Y
`
`M
`M
`
`Petitioner objects to paragraphs in the Patent Owner Sur-Reply that rely on
`
`exhibits objected to in this Petitioner’s Objection to Evidence, as well as
`
`paragraphs in the Patent Owner Sur-Reply that rely on exhibits objected to in
`
`Petitioner’s Objections to Patent Owner’s Response Evidence (Paper 42).
`
`
`
`- 4 -
`
`
`
`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)
`
`- 5 -
`
`
`
`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 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
`Petitioner was excluded from participation in proceeding, deposition or cross
`examination of the declarant or witness.
`Y: Not cited in any paper in this proceeding.
`
`
`X:
`
`November 7, 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.
`
`
`
`- 6 -
`
`
`
`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: November 7, 2019
`
`Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`
`
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
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