Case No. IPR2015-00644
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`
`
`____________________________
`
`Case No. IPR2015-00644
`Patent No. 8,399,413
`____________________________
`
`
`
`PETITIONER’S OBJECTIONS UNDER 37 C.F.R. § 42.62
`TO EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`
`
`____________________________
`
`Case No. IPR2015-00644
`Patent No. 8,399,413
`____________________________
`
`
`
`PETITIONER’S OBJECTIONS UNDER 37 C.F.R. § 42.62
`TO EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`Case No. IPR2015-00644
`
`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 Yeda Research and Development Co. Ltd.
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’413 patent”
`
`means U.S. Patent No. 8,399,413. All objections under FRE 802 (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 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.
`
`Exhibit
`
`Description
`
`Objection
`
`2001
`
`Teva Provides Update on Forte Trial (July 7,
`2008)
`
`A, B, D, F, G, H, I, J,
`N, O, K, T
`
`2002
`
`2003
`
`Francisco J. Quintana, et al., Systems Biology
`Approaches for the Study of Multiple
`Sclerosis, J. CELL. MOL. MED. Vol 12, No
`4, 1087-93 (2008)
`
`David J. Virley, Developing Therapeutics for
`the treatment of multiple sclerosis, 2 J. AM.
`SOC. EXP. NEUROTHERAPEUTICS, 638-
`49 (Oct. 2005)
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, M, N, O
`
`1
`
`
`
`
`Exhibit
`
`Description
`
`2004
`
`Manuel A. Friese, The value of animal models
`for drug development in multiple sclerosis,
`129 BRAIN, 1940-52 (2006)
`2005 Copaxone Prescribing Information (January
`2014)
`
`2006
`
`Dvora Teitelbaum et al., Suppression of
`experimental allergic encephalomyelitis by a
`synthetic polypeptide, 1 EUR. J. IMMUNOL.,
`242-248 (Aug. 1971)
`
`2007
`
`Jill Conner, Glatiramer acetate and
`therapeutic peptide vaccines for multiple
`sclerosis,1 J. Autoimmunity and Cell
`Responses 3 (2014)
`2008 Copaxone, Physicians Desk Reference 62ed.
`(2008)
`
`2009
`
`2010
`
`2011
`
`Wiebke Schrempf and Tjalf Ziemssen,
`Glatiramer acetate: Mechanisms of action in
`multiple sclerosis, 6 AUTOIMMUN. REV.,
`469–475 (2007)
`
`V.Wee Yong, Differential mechanisms of
`action of interferon-β and glatiramer acetate
`in MS, 59 NEUROLOGY, 802-8 (April 2002)
`
`Suhayl Dhib-Jalbut, Mechanisms of action of
`interferons and glatiramer acetate in multiple
`sclerosis, 58 NEUROLOGY (8 Suppl 4) S3–9
`(2002)
`
`Case No. IPR2015-00644
`
`
`Objection
`
`A, D, F, G, H, M, N, O
`
`A, C, D, E, F, G, H, M,
`N, O
`
`A, B, D, F, G, H, I, K,
`M, N, O
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, I, M, N,
`O
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, M, N, O
`
`2
`
`
`
`
`Exhibit
`
`Description
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`Oliver Neuhaus et al., Pharmacokinetics and
`pharmacodynamics of the interferon-betas,
`glatiramer acetate, and mitoxantrone in
`multiple sclerosis, 259 J. NEUROL. SCI., 27–
`37 (2007)
`
`Oded Abramsky et al., Effect Of A Synthetic
`Polypeptide (COP 1) On Patients With
`Multiple Sclerosis and With Acute
`Disseminated Encephalomyelitis. Preliminary
`Report, 31 J. NEUROL. SCI., 433-38 (1977)
`
`Murray B. Bornstein et al., Treatment of
`Multiple Sclerosis with a Synthetic
`Polypeptide: Preliminary Results, 105 TRAN.
`AM. NEUROL. ASSOC., 348-50 (1980)
`
`Murray B. Bornstein et al., Multiple Sclerosis:
`Trial of a Synthetic Polypeptide, 11 ANN.
`NEUROL., 317-19 (Mar. 1982)
`
`Murray B. Bornstein et al., A Pilot Trial of
`COP 1 in Exacerbating-Remitting Multiple
`Sclerosis, 13 N. ENGL. J. MED., 408-14
`(Aug. 13, 1987)
`
`Case No. IPR2015-00644
`
`
`Objection
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, I, M, N,
`O
`
`A, D, F, G, H, M, N, O
`
`A, D, F, G, H, M, N, O
`
`Sage Journals,
`http://msj.sagepub.com/content/14/1_suppl.toc
`(Sept. 2008)
`
`A, B, C, D, E, F, G, H,
`I, K, L, N, O
`
`Massimo Filippi et al., Effects of oral
`glatiramer acetate on clinical and MRI
`monitored disease activity in patients with
`relapsing multiple sclerosis: a multicentre,
`double-blind, randomised, placebo-controlled
`study, http://neurology.thelancet.com (Jan. 20,
`2006)
`
`A, D, F, G, H, M, N, O
`
`3
`
`
`
`
`Exhibit
`
`Description
`
`2019
`
`Yuval Ramot et al., Comparative Long-Term
`Preclinical Safety Evaluation of Two
`Glatiramoid Compounds (Glatiramer Acetate,
`Copaxone1, and TV-5010, Protiramer) in Rats
`and Monkeys, 40 TOXICOL. PATH., 40-54
`(2012)
`2020 U.S. Patent Application No. 2007/0161566 A1
`(“Pinchasi”)
`
`2021
`
`Tjalf Ziemssen et al., Risk-Benefit Assessment
`of Glatiramer Acetate in Multiple Sclerosis,
`24 DRUG SAFETY, 13, 979-90 (2001)
`
`Case No. IPR2015-00644
`
`
`Objection
`
`A, D, F, G, H, K, M, N,
`O
`
`A, D, F, G, H, K, M, N,
`O
`
`A, D, F, G, H, M, N, O
`
`Teva News Release, Phase III Data Published
`in Annals of Neurology Show That a Higher
`Concentration Dose of Glatiramer Acetate
`Given Three Times a Week Reduced
`Annualized Relapse Rates in the Treatment of
`Relapsing-Remitting Multiple Sclerosis (July
`1, 2013)
`
`Omar Khan et al., Three Times Weekly
`Glatiramer Acetate in Relapsing–Remitting
`Multiple Sclerosis, 73 ANN. NEUROL., 705–
`13 (2013)
`
`A, B, C, D, E, F, G, H,
`M, N, O, T
`
`A, C, D, E, F, G, H, M,
`N, O
`
`Teva Press Release, Teva Reports First
`Quarter 2015 Results (April 30, 2015)
`
`A, B, C, D, E, F, G, H,
`L, M, N, O, T
`
`Kate McKeage, Glatiramer Acetate 40 mg/mL
`in Relapsing-Remitting Multiple Sclerosis: A
`Review, CNS DRUGS (April 24, 2015)
`
`A, C, D, E, F, G, H, I,
`M, N, O
`
`2022
`
`2023
`
`2024
`
`2025
`
`4
`
`
`
`
`Case No. IPR2015-00644
`
`
`Objection
`
`A, D, F, G, H, M, N, O
`
`Exhibit
`
`Description
`
`K.P. Johnson et al., Copolymer 1 reduces
`relapse rate and improves disability in
`relapsing-remitting multiple sclerosis: Results
`of a phase I11 multicenter, double-blind,
`placebo-controlled trial, 45 Neurology, 1268-
`76 (1995)
`
`
`
`2026
`
`
`
`5
`
`
`
`
`Case No. IPR2015-00644
`
`
`Objection Key:
`
`A:
`B:
`C:
`
`FRE 802 (hearsay)
`FRE 901 (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 ’413 patent 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 ’413 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
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`L:
`M:
`N:
`
`O:
`
`P:
`Q:
`
`6
`
`
`
`
`Case No. IPR2015-00644
`
`
`data on which the opinion is based violating 37 C.F.R. § 42.65(a)
`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)
`
`
`
`R:
`S:
`
`T:
`
`
`
`7
`
`
`
`
`
`Dated: September 9, 2015
`
`
`
`Case No. IPR2015-00644
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6204
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
`
`Attorneys for Mylan Pharmaceuticals Inc.
`
`
`8
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Case No. IPR2015-00644
`
`
`The undersigned hereby certifies that the foregoing “PETITIONER’S
`
`
`
`OBJECTIONS UNDER 37 C.F.R. § 42.62 TO EVIDENCE SUBMITTED BY
`
`PATENT OWNER” was served electronically via email as follows:
`
`Patent Owners:
`
`Elizabeth Holland
`Goodwin Procter LLP
`eholland@goodwinprocter.com
`
`William James
`Goodwin Procter LLP
`wjames@goodwinprocter.com
`
`Eleanor Yost
`Goodwin Procter LLP
`eyost@goodwinprocter.com
`
`
`Dated: September 9, 2015
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
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