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`
`Paper No. __
`
`
`
`
`
`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
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`Coalition For Affordable Drugs V LLC
`Petitioner
`v.
`
`Biogen MA Inc.
`Patent Owner
`____________
`
`Case IPR2015-01993
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
` 
`
`
`
`PETITIONER’S EXHIBIT LIST
`
` 
`
` 
`
`
`
`1
`
`

`

`37 CFR 42.63(e) states that:
`
`(e) Exhibit list. Each party must maintain an exhibit list with the exhibit
`number and a brief description of each exhibit. If the exhibit is not filed,
`the exhibit list should note that fact. A current exhibit list must be
`served whenever evidence is served and the current exhibit list must be
`filed when filing exhibits.
`
`
`
`Description of Marks in the Date Served, and Date Filed columns:
`
`A date in the "Date Served" column indicates the exhibit has been served on
`
`the specified date.
`
`A date in the "Date Filed" column indicates the exhibit has been filed on the
`
`Date Filed
`Date Served
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`specified date.
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1001 US Patent No. 8,399,514, titled “Treatment for Multiple
`
`Sclerosis” to Lukashev et al. (‘514 patent).
`
`1002 Wakkee M et al., “Drug evaluation: BG-12, an
`
`immunomodulatory dimethylfumarate.” Curr. Opin.
`
`Investig. Drugs. 2007 Nov; 8(11):955-62.
`
`
`
`2
`
`

`

`Date Filed
`Date Served
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1003
`
` Kappos et al., “Efficacy of a novel single-agent
`
`fumarate, BG00012, in patients with relapsing-remitting
`
`multiple sclerosis: results of a phase 2 study”, J Neurol
`
`(2006) 253 [Suppl 2]: II/1–II/170; pg. II/27 O108.
`
`1004
`
`International Conference on Harmonization of
`
`Technical Requirements for Registration of
`
`Pharmaceuticals for Human Use, ICH Harmonized
`
`Tripartite Guideline, Dose-Response Information to
`
`Support Drug Registration E4, Current Step 4 version,
`
`dated 10 March 1994.
`
`
`
`1005 Declaration of Dr. Steven E. Linberg.
`
`1006
`
`European Medicines Agency, Assessment Report,
`
`Tecfidera, 26 November 2013.
`
`
`
`3
`
`

`

`Date Filed
`Date Served
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1007
`
`“Preliminary Amendment Under 37 C.F.R. § 1.115, In
`
`re application of: LUKASHEV et al.”, Application No.
`
`13/372,426 that issued into US Patent 8,399,514.
`
`1008
`
`“Amendment and Reply Under 37 C.ER. § 1.111, In re
`
`application of: LUKASHEV et al., Appl. No.
`
`13/372,426” that issued into US Patent 8,399,514.
`
`1009 Office Action with mail date of 05/03/2012 for
`
`Application No. 13/372,426 that issued into US Patent
`
`8,399,514.
`
`1010
`
`Paper 178, Interference 106,023.
`
`1011
`
`PCT Application No. PCT/US2008/001602
`
`1012
`
`Certified copy of US Provisional Application No.
`
`601888,921.
`
`
`
`4
`
`

`

`Date Filed
`Date Served
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1013 Assignment Record for US Patent No. 8,399,514 from
`
`USPTO’s Assignments on the Web.
`
`1014
`
`Paper 179, Interference 106,023.
`
`1015 Unassigned.
`
`1016 D. Werdenberg, et al., “Presystemic Metabolism and
`
`
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`Intestinal Absorption of Antipsoriatic Fumaric Acid
`
`Esters”, 2003, BIOPHARMACEUTICS & DRUG
`
`DISPOSITION, Biopharm. Drug Dispos. 24: 259–273
`
`(2003), Published online in Wiley InterScience
`
`(www.interscience.wiley.com). DOI: 10.1002/bdd.364.
`
`1017
`
`CV of Dr. Steven E. Linberg
`
`
`
`5
`
`

`

`Date Filed
`Date Served
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1018 US Application 13/372,426, as filed on February 13,
`
`2012
`
`1019 Nieboer et al., “Fumaric Acid Therapy in Psoriasis: A
`
`Double-Blind Comparison between Fumaric Acid
`
`Compound Therapy and Monotherapy with
`
`Dimethylfumaric Acid Ester” Dermatologica 1990;
`
`181:33- 37
`
`1020 Declaration of Scott Bennett
`
`1021 Unassigned.
`
`1022
`
`“View of NCT00168701 on 2005_09_14”, from URL
`
`
`
`https://clinicaltrials.gov/archive/NCT00168701/2005_0
`
`9/28/2015
`
`9/28/2015
`
`9_14.
`
`
`
`
`
`6
`
`

`

`Date Filed
`Date Served
`
`
`
`9/28/2015
`
`10/29/2015
`
`9/28/2015
`
`10/29/2015
`
`
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1023 Unassigned.
`
`1024 Declaration of Robert Mihail.
`
`1024A Declaration of Robert Mihail (Corrected as per Board
`
`email of 10/29/2015)
`
`1025 Unassigned.
`
`1026 Unassigned.
`
`1027
`
`Begleiter et al., “Dietary induction of NQO1 increases
`
`
`
`9/28/2015
`
`9/28/2015
`
`
`
`the antitumour activity of mitomycin C in human colon
`
`tumours in vivo”, 2004, British Journal of Cancer, 1624
`
`– 1631.
`
`1028 Unassigned.
`
`
`
`7
`
`

`

`Date Filed
`Date Served
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`
`
`
`
`
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`
`
`
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1029 Hartung et al., “The cost of multiple sclerosis drugs in
`
`the US and the pharmaceutical industry”, American
`
`Academy of Neurology, 2015.
`
`1030 US Patent No. 7,320,999, titled “Dimethyl Fumarate
`
`For The Treatment Of Multiple Sclerosis” to Joshi et al.
`
`1031 US Patent Application 2003/0018072 to Joshi et al.
`
`1032 Unassigned.
`
`1033 Unassigned.
`
`1034 Unassigned.
`
`1035
`
`IPR2015-01136, Paper 23, Decision Denying Institution
`
`of Inter Partes Review
`
`1036 US Patent No. 6,436,992, titled “Use Of Fumaric Acid
`
`Derivatives” to Joshi et al.
`
`1037 Unassigned.
`
`1038 Unassigned.
`
`
`
`8
`
`

`

`Date Filed
`Date Served
`
`
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`9/28/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1039 Unassigned.
`
`1040
`
`Current view of ClinicalTrials NCT00168701 on URL
`
`https://clinicaltrials.gov/show/NCT00168701
`
`1041 History of Changes and the ClinicalTrials.gov Archive
`
`Site on URL
`
`https://clinicaltrials.gov/ct2/archive/NCT00168701
`
`1042 History of ClinicalTrials NCT00168701 on URL
`
`https://clinicaltrials.gov/archive/NCT00168701
`
`1043
`
`ClinicalTrials.gov Background on URL
`
`https://www.clinicaltrials.gov/ct2/about%ADsite/backgr
`
`ound
`
`1044 Hendricks, Steve, “The Rise of Bib Generic: Why
`
`Knockoff Prescriptions Now Cost $1,200,” 08/08/2015,
`
`on URL http://www.truth-out.org/news/item/32182-the-
`
`rise-of-big-generic-why-knockoff-prescriptions-now-
`
`cost-1-200
`
`
`
`9
`
`

`

`
`
`/RobertMihail/
`Robert Mihail, Reg. No. 66,021
`Back-up Counsel for the Petitioner
`Neifeld IP Law, PC
`4813-B Eisenhower Avenue
`Alexandria, VA 22304
`Tel: 1-703-415-0012 Ext. 107
`Fax: 1-703-415-0013
`Email: rmihail@neifeld.com
`
`
`
`10
`
`

`

`42.6(e) CERTIFICATE OF SERVICE
`
`I certify that this document was served or simultaneously is being served on
`
`each opposing party with the filing of this document. I certify that the following
`exhibits being filed along with this document, if any, have been or simultaneously
`are being served on each opposing party:
`
`
`Description
`
`Exhibit
`Number
`1024A Declaration of Robert Mihail (Corrected as per Board email of
`10/29/2015)
`
`
`
`42.6(e)(4) (iii)(A) The date and manner of service:
`
`Manner of service (Per Patent Owner’s Mandatory Notice of 10/16/2015,
`“Patent Owner consents to electronic service by e-mail to
`michael.flibbert@finnegan.com and maureen.queler@finnegan.com.”):
`Email to: michael.flibbert@finnegan.com; maureen.queler@finnegan.com
`42.6(e)(4)(iii)(B) The name and address of every person served are:
`Lead Counsel for patent owner, telephone and email: Michael J. Flibbert (Reg.
`No. 33,234); Tel: 202.408.4493
`Backup Counsel for patent owner, telephone and email: Maureen D. Queler (Reg.
`No. 61,879); Tel: 202.408.4294
`Postal Address for lead and backup counsel for patent owner: Finnegan,
`Henderson, Farabow, Garrett & Dunner, LLP, 901 New York Avenue, NW,
`Washington, DC 20001.
`Fax Address for lead and backup counsel for patent owner: 202-408-4000
`
`Date of Service: 10/29/2015
`
`
`/RobertMihail/
`Robert Mihail, Reg. No. 66,021
`Back-up Counsel for the Petitioner
`Neifeld IP Law, PC
`4813-B Eisenhower Avenue
`Alexandria, VA 22304
`
`
`
`11
`
`

`

`Tel: 1-703-415-0012 Ext. 107
`Fax: 1-703-415-0013
`Email: rmihail@neifeld.com
`
`
`
`
`
`
`12
`
`

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