throbber
For the Patent Owner
`Backup counsel: Robert W. Hahl, Reg. No. 33,893
`Backup counsel: Robert Mihail, Reg. No. 66,021
`Neifeld IP Law, PC
`
`
`
`Paper No. __
`
`
`
`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 IPR Unassigned
`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
`specified date.
`
`Date Filed
`
`5/1/2015
`
`Not Filed
`
`
`
`Date Served
`
`5/1/2015
`
`Not Served
`
`
`
`
`
`
`
`
`
`
`
`5/1/2015
`
`
`
`5/1/2015
`
`
`
`Exhibit
`Description of
`
`US Patent No. 8,399,514, titled “Treatment
`for Multiple Sclerosis” to Lukashev et al.
`(‘514 patent)
`Unassigned
`
`Kappos et al., “A randomised, placebo-
`controlled phase II trial of a novel oral
`single-agent fumarate therapy, BG00012, in
`patients with relapsing-remitting multiple
`sclerosis”, 2005, J Neurol (2005) 252 [Suppl
`2]: II/95–II/170, pII/148, P574.
`
`Exhibit Number
`
`1001
`
`1002
`
`1003
`
`
`
`2
`
`

`
`Date Filed
`
`Not Filed
`
`Date Served
`
`Not Served
`
`5/1/2015
`
`5/1/2015
`
`
`
`
`
`5/1/2015
`
`5/1/2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`
`
`
`
`
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`
`
`
`
`
`
`Exhibit
`Description of
`
`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.
`
`Exhibit Number
`
`1004
`
`1005
`
`Declaration of Dr. Steven E. Linberg.
`
`1006
`
`Unassigned
`
`1007
`
`1008
`
`1009
`
`
`
`“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.
`
`“Amendment and Reply Under 37 C.F.R. §
`1.111, In re application of: LUKASHEV et
`al., Appl. No. 13/372,426” that issued into
`US Patent 8,399,514.
`
`Office Action with mail date of 05/03/2012
`for Application No. 13/372,426 that issued
`into US Patent 8,399,514.
`
`3
`
`

`
`Date Filed
`
`Not Filed
`
`Date Served
`
`Not Served
`
`
`
`
`
`
`
`
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`
`
`
`
`
`
`
`
`
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`
`
`
`
`
`
`
`
`
`
`5/1/2015
`
`
`
`5/1/2015
`
`
`
`Exhibit
`Description of
`
`Exhibit Number
`
`1010
`
`Unassigned
`
`1011
`
`PCT Application No. PCT/US2008/001602
`
`1012
`
`1013
`
`Certified copy of US Provisional Application
`No. 601888,921
`
`Assignment Record for US Patent No.
`8,399,514 from USPTO’s Assignments on
`the Web.
`
`1014
`
`IFW of PCT/US2008/001602.
`
`1015
`
`1016
`
`
`
`Certified Copy of US Provisional
`60/888,921 as received by the International
`Bureau on March 26, 2008.
`D. Werdenberg, et al., “Presystemic
`Metabolism and 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.
`
`4
`
`

`
`Date Filed
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`Not Filed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Date Served
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`Not Served
`
`
`
`
`
`Exhibit
`Description of
`
`Exhibit Number
`
`1017
`
`CV of Dr. Steven E. Linberg
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`
`
`US Application 13/372,426, as filed on
`February 13, 2012
`
`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
`Declaration of Scott Bennett
`
`“BG 12 BG 00012, BG 12/Oral Fumarate,
`FAG-201, Second-Generation Fumarate
`Derivative – Fumapharm/ Biogen Idec”,
`2005, Drugs R D 2005; 6 (4): 229-230.
`
`“View of NCT00168701 on 2005_09_14”,
`from URL
`https://clinicaltrials.gov/archive/NCT001687
`01/2005_09_14
`“Galenic development”, Fumapharm AG
`archival page located at
`http://web.archive.org/web/20050803080203
`/http://www.fumapharm.ch/EN/Research/Ga
`lenical_Development/index.php
`
`
`
`
`
`
`
`
`
`5
`
`

`
`Not Served
`
`
`
`
`
`
`
`
`
`Exhibit
`Description of
`
`Exhibit Number
`
`1024
`
`Declaration of Robert Mihail
`
`1025
`
`Declaration of Christopher Butler
`
`1026
`
`1027
`
`Talalay et al., “Identification of a common
`chemical signal regulating the induction of
`enzymes that protect against chemical
`carcinogenesis”, November 1998, Proc. Nati.
`Acad. Sci. USA, Vol. 85, pp. 8261-8265,
`Medical Sciences.
`Begleiter et al., “Dietary induction of NQO1
`increases the antitumour activity of
`mitomycin C in human colon tumours in
`vivo”, 2004, British Journal of Cancer, 1624
`– 1631.
`
`
`/RobertHahl#33,893/
`Robert W. Hahl, Reg. No. 33,893
`Lead Counsel for the Petitioner
`Tel: 1-703-415-0012 Ext. 103
`Email: rhahl@neifeld.com
`Backup Counsel for Petitioner
`Robert Mihail, Reg. No. 66,021
`Tel: 1-703-415-0012 Ext. 107
`Email: rmihail@neifeld.com
`Fax for lead and backup counsel for the Petitioner: 1-703-415-0013
`Postal address for lead and backup counsel:
`6
`
`
`
`Date Filed
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`Not Filed
`
`
`
`
`
`
`
`
`
`Date Served
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`
`

`
`Neifeld IP Law, PC, 4813-B Eisenhower Avenue, Alexandria, VA 22304
`
`
`
`
`
`7
`
`

`
`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 foregoing
`exhibits being filed along with this document, if any, have been or simultaneously
`are being served on each opposing party.
`
`42.6(e)(4) (iii)(A) The date and manner of service:
`
`Manner of service: Priority Mail Express and email to the following firm of record
`as listed on PAIR:
`
`Jones Day
`222 East 41st St.
`New York, NY 10017
`
`Date of Service: 5/1/2015
`
`
`
`/RobertHahl#33,893/
`Robert W. Hahl, Reg. No. 33,893
`Lead Counsel for the Petitioner
`Neifeld IP Law, PC
`4813-B Eisenhower Avenue
`Alexandria, VA 22304
`Tel: 1-703-415-0012 Ext. 103
`Fax: 1-703-415-0013
`Email: rhahl@neifeld.com
`
`
`
`
`8

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