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`Paper No. ____
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`For the Petitioner:
`Lead counsel: Robert W. Hahl, Reg. No. 33,893
`Backup counsel: Robert Mihail, Reg. No. 66,021
`Backup counsel: John K. Pike, Reg. No. 41,253
`NEIFELD IP LAW, PC
`
`James T. Carmichael, Reg. No. 45,306
`CARMICHAEL IP, LLC
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT FUND, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGEBERG,
`Petitioners,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________
`
`Case IPR2015-01993
`Patent 8,399,514 B2
`____________________
`
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`Pursuant to 37 C.F.R. § 42.64(b), Petitioner objects under the Federal Rules
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`of Evidence (“FRE”) and 37 C.F.R. § 42.62 to the following exhibits cited in
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`Patent Owner’s Preliminary Response (“POPR”), dated January 6, 2016.
`
`Petitioner’s Objections to Evidence are timely filed under 37 C.F.R. § 42.64.(b)(1).
`
`
`
`Petitioner serves Patent Owner (“PO”) with these objections to provide
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`notice that Petitioner may move to exclude the challenged exhibits under 37 C.F.R.
`
`§ 42.64(c) unless Patent Owner cures the defects associated with the challenged
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`exhibits defined herein.
`
`Exhibit PO Description
`
`Declaration under 37 CFR
`1.132 of Dr. Katherine
`Dawson filed in U.S. Patent
`Application No. 13/372,426
`
`Con-
`tained
`within
`1007 at
`pages
`14-35.
`
`Page(s)
`of POPR
`citing
`31-38
`
`
`
`Objection(s)
`
`To the extent the Dawson
`declaration is relied upon for
`secondary considerations of
`non-obviousness, there is no
`nexus to the claimed
`methods. The unexpected
`results evidence presented in
`an ex parte examination is
`not binding in a subsequent
`inter partes cases involving
`the same application.
`
`FRE 401 (Relevance “has
`any tendency to make a fact
`more or less probable than it
`would be without the
`evidence” and “is of
`consequence in determining
`the action”).
`
`2
`
`
`
`
`
`
`24
`
`2005
`
`Ludwig Kappos et al., “A
`Randomized, Placebo-
`Controlled Phase 2 Trial of
`a Novel Oral Fumarate,
`BG00012, in Patients With
`Relapsing-Remitting
`Multiple Sclerosis,” from
`the 15th meeting of the
`European Neurological
`Society, Vienna Austria
`(June 18-22, 2005)
`(presented on June 20,
`2005)
`
`
`
`
`
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 402 (Irrelevant
`evidence is not admissible)
`FRE 403 (excluding relevant
`evidence for prejudice,
`confusion, waste of time, or
`other reasons)
`This exhibit is confusing,
`lacks authentication, and
`constitutes and/or contains
`hearsay. Specifically, a first
`petition based, in part, on a
`Kappos 2005 reference was
`denied. This IPR trial was
`instituted, in part, based on a
`Kappos 2006 reference. As
`stated in the POPR (see e.g.,
`POPR at 7), Kappos 2006
`provides the results of a
`Phase II study. Exhibit 2005
`is purportedly dated June 18-
`22, 2005, contains no results,
`and, at a minimum, confuses
`which Kappos reference is
`being referred to. In
`addition, Exhibit 2005 lacks
`authentication and, thus,
`constitutes and/or contains
`hearsay. To the extent PO
`might rely on Exhibit 2013
`for authentication, that
`exhibit refers to “P 574,” an
`identification not found on
`Exhibit 2005.
`
`FRE 403 (excluding relevant
`evidence for prejudice,
`confusion, waste of time, or
`other reasons)
`
`3
`
`
`
`
`
`
`24
`
`2006
`
`Final Program for the
`Fifteenth Meeting of the
`European Neurological
`Society, June 18-22, 2005,
`Vienna Austria
`(http://www.congrex.ch/200
`5/ens/2005/)
`
`
`2007
`
`24
`
`Scientific Program from
`Fifteenth Meeting of the
`European Neurological
`Society, June 18-22, 2005
`(http://registration.akm.ch/ei
`nsicht.php?XNKONGRESS
`_ID=18&XNSPRACHE_ID
`=2)
`
`
`
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`FRE 901 (lacking
`authentication)
`FRE 902 (evidence is not
`self-authenticating)
`FRE 802 (not an exception
`to the rule against hearsay)
`
`This exhibit is confusing and
`irrelevant to the trial as
`instituted. PO has failed to
`explain why the exhibit is
`being relied upon. Further,
`the supplied URL link is
`defective.
`
`FRE 401 (Relevance “has
`any tendency to make a fact
`more or less probable than it
`would be without the
`evidence” and “is of
`consequence in determining
`the action”).
`FRE 402 (Irrelevant
`evidence is not admissible)
`FRE 403 (excluding relevant
`evidence for prejudice,
`confusion, waste of time, or
`other reasons)
`
`This exhibit is confusing and
`irrelevant to the trial as
`instituted. PO has failed to
`explain why the exhibit is
`being relied upon.
`
`FRE 401 (Relevance “has
`any tendency to make a fact
`more or less probable than it
`would be without the
`
`4
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
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`evidence” and “is of
`consequence in determining
`the action”).
`FRE 402 (Irrelevant
`evidence is not admissible)
`FRE 403 (excluding relevant
`evidence for prejudice,
`confusion, waste of time, or
`other reasons)
`
`This exhibit is confusing and
`irrelevant to the trial as
`instituted. PO has failed to
`explain why the exhibit is
`being relied upon.
`
`FRE 401 (Relevance “has
`any tendency to make a fact
`more or less probable than it
`would be without the
`evidence” and “is of
`consequence in determining
`the action”).
`FRE 402 (Irrelevant
`evidence is not admissible)
`FRE 403 (excluding relevant
`evidence for prejudice,
`confusion, waste of time, or
`other reasons)
`
`To the extent the document
`is relied upon for secondary
`considerations of non-
`obviousness, there is no
`nexus to the claimed
`methods. The unexpected
`results evidence presented in
`an ex parte examination is
`not binding in a subsequent
`
`5
`
`2008
`
`24
`
`Program from Wednesday,
`June 22, 2005 from
`Fifteenth Meeting of the
`European Neurological
`Society
`(http://registration.akm.ch/ei
`nsicht.php?XNKONGRESS
`_ID=18&XNSPRACHE_ID
`=2&XNMASKEN_ID=200
`&XSDATUM=2005-06-20)
`
`
`31-38
`
`2011
`
`Declaration of Richard A.
`Rudick, M.D. Under 37
`C.F.R. §1.132 filed on
`August 3, 2012 in U.S.
`Patent Application No.
`13/372,426
`
`
`
`
`
`
`
`
`
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`
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
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`2013
`
`24
`
`Poster Session 5, Multiple
`Sclerosis, Wednesday, June
`22, 2005 from Fifteenth
`Meeting of the European
`Neurological Society
`(http:registration.akm.ch/ein
`sicht.php?XNMASKEN_ID
`=300&XNKONGRESS_ID
`=18&XNSPRACHE_ID=2
`&XNSESSION_ID=748)
`
`
`inter partes cases involving
`the same application.
`
`FRE 401 (Relevance “has
`any tendency to make a fact
`more or less probable than it
`would be without the
`evidence” and “is of
`consequence in determining
`the action”).
`FRE 402 (Irrelevant
`evidence is not admissible)
`FRE 403 (excluding relevant
`evidence for prejudice,
`confusion, waste of time, or
`other reasons)
`
`This exhibit is confusing and
`irrelevant to the trial as
`instituted. PO has failed to
`explain why the exhibit is
`being relied upon. To the
`extent PO might rely on
`Exhibit 2013 to authenticate
`Exhibit 2005, the former
`refers to “P 574,” while the
`latter does not.
`
`FRE 401 (Relevance “has
`any tendency to make a fact
`more or less probable than it
`would be without the
`evidence” and “is of
`consequence in determining
`the action”).
`FRE 402 (Irrelevant
`evidence is not admissible)
`FRE 403 (excluding relevant
`evidence for prejudice,
`
`6
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`Dated: 5 April 2016
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
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`confusion, waste of time, or
`other reasons)
`
`
`Respectfully submitted,
`
`/James T. Carmichael/
`By:
`James T. Carmichael, Reg. No. 45,306
`CARMICHAEL IP, LLC
`8000 Towers Crescent Drive, Ste. 1350
`Tysons Corner, VA 22182
`Tel: (703) 646-9246
`Fax: (703) 877-812-8563
`Counsel for Petitioner
`
`
`
`
`
`
`7
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`Case No. IPR2015-01993
`U.S. Patent 8,399,514 B2
`
`37 C.F.R. §42.6(e) CERTIFICATE OF SERVICE
`
`§42.6(e)(1): “Under 37 C.F.R. § 42.6(e), Patent Owner consents to electronic
`service by e-mail to michael.flibbert@finnegan.com and
`maureen.queler@finnegan.com.” Patent Owner Mandatory Notice dated 10/16/15.
`
` I
`
` certify that this document was served or simultaneously is being served on each
`opposing party with the filing of this document.
`
`§42.6(e)(4)(iii)(A): The date and manner of service:
`Email to michael.flibbert@finnegan.com and maureen.queler@finnegan.com.
`Date: 5 April 2016
`
`§42.6(e)(4)(iii)(B): The name and address of every person served:
`Michael J. Flibbert (Reg. No. 33, 234)
`Finnegan, Henderson, Farrabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`Fax: (202) 408-4000
`
`Tel:
`(202) 408-4493
`Email:
`michael.flibbert@finnegan.com
`
`Maureen D. Queler (Reg. No. 61.879)
`Finnegan, Henderson, Farrabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`Fax: (202) 408-4000
`
`Tel:
`(202) 408-4294
`Email:
`maureen.queler@finnegan.com
`
`
` /
`
` James T. Carmichael /
`James T. Carmichael, Reg. No. 45,306
`CARMICHAEL IP, LLC
`8000 Towers Crescent Drive, Ste. 1350
`Tysons Corner, VA 22182
`Tel:
`(703) 646-9246
`
`jim@carmichaelip.com
`Counsel for Petitioner
`
`
`
`
`
`Fax: (877) 812-8463
`
`
`
`8
`
`
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