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 IPR2015-01136
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
`
`PETITIONER’S EXHIBIT LIST OF 5/27/2015
`
`1
`
`Page 1 of 28
`
`Biogen Exhibit 2025
`Mylan v. Biogen
`IPR2018-01403
`
`
`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 IPR2015-01136
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
`
`PETITIONER’S EXHIBIT LIST OF 5/27/2015
`
`1
`
`Page 1 of 28
`
`Biogen Exhibit 2025
`Mylan v. Biogen
`IPR2018-01403
`
`
`
`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
`
`5/1/2015
`
`5/1/2015
`
`
`
`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 Unassigned
`
`
`
`2
`
`Page 2 of 28
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1003 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.
`
`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 Unassigned
`
`
`
`3
`
`Page 3 of 28
`
`
`
`Date Filed
`Date 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
`
`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.F.R. § 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 Unassigned
`
`1011
`
`PCT Application No. PCT/US2008/001602
`
`
`
`1012
`
`Certified copy of US Provisional Application No.
`
`601888,921
`
`1013 Assignment Record for US Patent No. 8,399,514 from
`
`USPTO’s Assignments on the Web.
`
`
`
`4
`
`Page 4 of 28
`
`
`
`Date Filed
`Date 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
`
`Exhibit Number
`
`1014
`
`IFW of PCT/US2008/001602.
`
`
`
`1015
`
`Certified Copy of US Provisional 60/888,921 as
`
`received by the International Bureau on March 26,
`
`2008.
`
`1016 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.
`
`1017
`
`CV of Dr. Steven E. Linberg
`
`
`
`1018 US Application 13/372,426, as filed on February 13,
`
`2012
`
`
`
`5
`
`Page 5 of 28
`
`
`
`Date Filed
`Date 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
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`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
`
`“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.
`
`1022
`
`“View of NCT00168701 on 2005_09_14”, from URL
`
`https://clinicaltrials.gov/archive/NCT00168701/2005_0
`
`9_14
`
`6
`
`Page 6 of 28
`
`
`
`Date Filed
`Date 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
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1023
`
`“Galenic development”, Fumapharm AG archival page
`
`located at
`
`http://web.archive.org/web/20050803080203/http://ww
`
`w.fumapharm.ch/EN/Research/Galenical_Development/
`
`index.php
`
`1024 Declaration of Robert Mihail
`
`
`
`1025 Declaration of Christopher Butler
`
`
`
`1026
`
`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.
`
`
`
`7
`
`Page 7 of 28
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`5/1/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1027
`
`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.
`
`1001A US Patent No. 8,399,514, titled “Treatment for Multiple
`
`Sclerosis” to Lukashev et al. (‘514 patent)
`
`
`
`1003A 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
`
`
`
`8
`
`Page 8 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1004A 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
`
`
`
`1005A Declaration of Dr. Steven E. Linberg
`
`
`
`
`
`9
`
`Page 9 of 28
`
`
`
`1007A “Preliminary Amendment Under 37 C.F.R. § 1.115, In
`
`5/27/2015
`
`5/27/2015
`
`re application of: LUKASHEV et al.”, Application No.
`
`13/372,426 that issued into US Patent 8,399,514
`
`Table of Contents For Ex. 1007A
`
`Amendment -------------------------------- pages 2 - 13
`
`Exhibit 1 (Declaration of Katherine T. Dawson,
`
`M.D. Under 37 C.F.R. § 1.132) --------- pages 14 – 35
`
`Exhibit A (Curriculum Vitae for
`
`Katherine T. Dawson --------------------- pages 38 - 43
`
`Exhibit B (Kappos, L., el al., "Efficacy and safety of
`
`oral fumarate in patients with relapsing-remitting
`
`multiple sclerosis: a multicenter, randomised, double--
`
`blind, placebo--controlled phase IIIb study,"
`
`Lancet 372: 1463-72 (2008) -------------- pages 44 - 54
`
`Exhibit C (Kappos, L., et al., "Efficacy of a novel oral
`
`single-agent fumarate, BG00012, in patients with
`
`relapsing-remitting multiple sclerosis: results of a phase
`
`2 study* 16th Meeting of the European Neurological
`
`Society
`
`(May 30, 2006) (Slide Presentation)) -- pages 56 - 57
`
`
`
`10
`
`Page 10 of 28
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`Exhibit D (Kappos, L., et al., "Efficacy of a novel oral
`
`single-agent Fumarate, BG00012, in patients with
`
`relapsing-remitting multiple sclerosis: results of a phase
`
`II study,"
`
`16th Meeting of the European Neurological
`
`Society (May 30, 2006)
`
`(Abstract to the Presentation) ------------ pages 78 - 79
`
`Exhibit E ("Oral Compound BG-12 Achieves Primary
`
`Endpoint
`
`in Phase II Study of Relapsing-Remitting MS with BG-
`
`12 Led to Statistically Significant Reductions in MRI
`
`Measures,"Biogen Idec News Release (May 30, 2006))
`
`------------------------------------------------ pages 80 - 82
`
`Exhibit 2 (Press Release Details) --------pages 83 - 86
`
`Transmittal letter -------------------------- page 87
`
`
`
`11
`
`Page 11 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1008A “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
`
`
`
`
`
`12
`
`Page 12 of 28
`
`
`
`5/27/2015
`
`5/27/2
`
`5/27/2015
`
`5/27/2
`
`1009A Office Action with mail date of 05/03/2012 for
`
`Application No. 13/372,426 that issued into US Patent
`
`8,399,514
`
`Table of Contents For Ex. 1009A
`
`Office Action of 05/03/2012 for
`
`Application No. 13/372,426 ------------- pages 2 - 12
`
`First Supplemental Information Disclosure Statement
`
`by Applicant ------------------------------- pages 13 - 42
`
`Information Disclosure Statement
`
`by Application ---------------------------- page 43
`
`Second Supplemental Information Disclosure Statement
`
`by Applicant ------------------------------ pages 44 - 47
`
`First Supplemental Information Disclosure
`
`Statement by Applicant ------------------ pages 48 - 54
`
`Second Supplemental Information Disclosure Statement
`
`by Applicant ------------------------------ pages 55 - 56
`
`Third Supplemental Information Disclosure
`
`Statement by Applicant ------------------ page 57
`
`1011A PCT Application No. PCTIUS2008/001602
`
`13
`
`Page 13 of 28
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`Table of Contents For Ex. 1011A
`
`PCT Publication no. 2008/097596 A2
`
`Front page --------------------------- page 2
`
`Specification ------------------------ pages 3 - 36
`
`Claims ------------------------------- pages 37 - 39
`
`Drawings ---------------------------- pages 40 - 43
`
`
`
`
`
`
`
`
`
`
`
`
`
`14
`
`Page 14 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1012A Certified copy of US Provisional Application No.
`
`601888,921
`
`Table of Contents For Ex. 1012A
`
`Certified Copy of US Provisional 60/888,921
`
`Questel Cover Letter--------------- page 2
`
`Front page --------------------------- page 3
`
`Electronic Acknowledgment
`
`Receipt ------------------------------ page 4 – 6
`
`Provisional Application
`
`Cover Sheet ------------------------- page 7
`
`Specification ------------------------ pages 8 - 43
`
`Claims ------------------------------- pages 44 - 46
`
`Abstract ------------------------------ page 47
`
`Drawings ---------------------------- pages 48 - 49
`
`
`
`
`
`15
`
`Page 15 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1013A Assignment Record for US Patent No. 8,399,514 from
`
`USPTO’s Assignments on the Web
`
`
`
`
`
`16
`
`Page 16 of 28
`
`
`
`1014A IFW of PCT/US2008/001602
`
`Table of Contents For Ex. 1014A
`
`File Wrapper of PCT Application No.
`
`PCT/US2008/001602
`
`5/27/2015
`
`5/27/2015
`
`Incoming ISA/202 – Notification of Receipt of
`
`Search Copy ------------------------------- page 2
`
`RO/102 – Notification Concerning Payment of
`
`Prescribed Fees and Annex -------------- pages 3 - 4
`
`RO/105 – Notification of the IA Number and of the
`
`International Filing Date ----------------- page 5
`
`RO/101 – Annex
`
`(fee calculation sheet) --------------------- page 6
`
`RO/101 - Request form for new IA
`
`– Conventional ----------------------------- pages 7 – 10
`
`Specification -------------------------------- pages 11 - 44
`
`Claims --------------------------------------- pages 45 – 47
`
`Abstract -------------------------------------- page 48
`
`Drawings ------------------------------------ pages 49 - 52
`
`Miscellaneous Internal Document ------- page 53
`
`PCT Transmittal Letter -------------------- page 54
`
`
`
`17
`
`Page 17 of 28
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`RO/102(b) - Chapter I Fee
`
`Recordation Sheet -------------------------- page 55
`
`Placeholder sheet indicating presence of supplemental
`
`content in SCORE -------------------------- page 56
`
`
`
`18
`
`Page 18 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1015A Certified Copy of US Provisional 60/888,921 as
`
`received by the International Bureau on March 26, 2008
`
`Table of Contents For Ex. 1015A
`
`Certified Copy of US Provisional 60/888,921 as
`
`received by the International Bureau
`
`WIPO Cover Letter------------------------ page 2
`
`Front page ---------------------------------- page 3
`
`Provisional Application Cover Sheet --- page 4
`
`Specification -------------------------------- pages 5 - 40
`
`Claims --------------------------------------- pages 41 - 43
`
`Abstract -------------------------------------- page 44
`
`Drawings ------------------------------------ pages 45 - 46
`
`Electronic Acknowledgment Receipt --- pages 47 - 49
`
`
`
`
`
`19
`
`Page 19 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1016A 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
`
`1017A CV of Dr. Steven E. Linberg
`
`
`
`
`
`20
`
`Page 20 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1018A US Application 13/372,426, as filed on February 13,
`
`2012
`
`Table of Contents For Ex. 1018A
`
`US Application 13/372,426, as filed on February 13,
`
`2012
`
`Face of application ------------------------ page 2
`
`Specification ------------------------------- pages 3 - 36
`
`Claims --------------------------------------- pages 37 - 39
`
`Drawings ------------------------------------ pages 40 - 43
`
`
`
`1019A 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
`
`
`
`21
`
`Page 21 of 28
`
`
`
`5/27/2015
`
`5/27/2015
`
`1020A Declaration of Scott Bennett
`
`Table of Contents For Ex. 1020A
`
`
`
`Declaration of Scott Bennett
`
`Declaration of Scott Bennett --------------- pages 1 - 3
`
`Attachment 1: Program cover of the Fifteenth Meeting
`
`of the European Neurological
`
`Society (ENS) -------------------------------- page 4
`
`Attachment 2: ENS Meeting Program
`
`entry for Item 1 ------------------------------- page 5
`
`Attachment 3: Cover of the Journal of Neurology, 22,
`
`Supplement 2 (June 2005) from the University of
`
`Maryland -------------------------------------- page 6
`
`Attachment 4: Item 1 from the Journal of Neurology,
`
`22, Supplement 2
`
`(June 2005), p. II/148 ------------------------ page 7
`
`Attachment 5: Index entry for Item 1 from the Journal
`
`of Neurology, 22, Supplement 2
`
`(June 2005), p. II/164 ------------------------ page 8
`
`Attachment 6: University of Maryland Library catalog
`
`record for the
`
`
`
`22
`
`Page 22 of 28
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`Journal of Neurology ------------------------- page 9
`
`Attachment 7: OCLC WorldCat record for the Journal
`
`of Neurology ---------------------------------- page 10
`
`Attachment 8: Web of Science entry for
`
`Item 1 ------------------------------------------- page 11
`
`Attachment 9: SpringerLink entry for
`
`Item 1 download ------------------------------- page 12
`
`
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`1021A “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
`
`1022A “View of NCT00168701 on 2005_09_14”, from URL
`
`https://clinicaltrials.gov/archive/NCT00168701/2005_0
`
`9_14
`
`
`
`23
`
`Page 23 of 28
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1023A “Galenic development”, Fumapharm AG archival page
`
`located at
`
`http://web.archive.org/web/20050803080203/http://ww
`
`w.fumapharm.ch/EN/Research/Galenical_Development/
`
`index.php
`
`1024A Declaration of Robert Mihail
`
`
`
`1025A Declaration of Christopher Butler
`
`Table of Contents For Ex. 1025A
`
`
`
`Declaration of Christopher Butler
`
`Affidavit of Christopher Butler ----------------- page 2
`
`Exhibit A (Webpage Galenic development) --- page 4
`
`
`
`
`
`24
`
`Page 24 of 28
`
`
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1026A 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.
`
`1027A 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
`
`
`
`25
`
`
`
`/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:
`Neifeld IP Law, PC, 4813-B Eisenhower Avenue, Alexandria, VA 22304
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Page 25 of 28
`
`
`
`42.6(e) CERTIFICATE OF SERVICE
`
`Agreements on Service: “Under 37 C.F.R. § 42.6(e), Patent Owner consents to
`electronic service by email at michael.flibbert@finnegan.com and
`maureen.queler@finnegan.com.” Patent Owner’s Mandatory Notice of 5/22/2015.
`
`
`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
`1001A US Patent No. 8,399,514, titled “Treatment for Multiple Sclerosis” to
`Lukashev et al. (‘514 patent)
`1003A 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
`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
`1005A Declaration of Dr. Steven E. Linberg
`1007A
`“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.ER. § 1.111, In re application of:
`LUKASHEV et al., Appl. No. 13/372,426” that issued into US Patent
`8,399,514
`1009A Office Action with mail date of 05/03/2012 for Application No.
`13/372,426 that issued into US Patent 8,399,514
`
`1004A
`
`1008A
`
`1011A
`
`PCT Application No. PCTIUS2008/001602
`
`1012A Certified copy of US Provisional Application No. 601888,921
`26
`
`
`
`Page 26 of 28
`
`
`
`1013A Assignment Record for US Patent No. 8,399,514 from USPTO’s
`Assignments on the Web
`IFW of PCT/US2008/001602
`1014A
`1015A Certified Copy of US Provisional 60/888,921 as received by the
`International Bureau on March 26, 2008
`1016A 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
`1017A CV of Dr. Steven E. Linberg
`1018A US Application 13/372,426, as filed on February 13, 2012
`
`1023A
`
`1022A
`
`1019A 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
`1020A Declaration of Scott Bennett
`1021A
`“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/NCT00168701/2005_09_14
`“Galenic development”, Fumapharm AG archival page located at
`http://web.archive.org/web/20050803080203/http://www.fumapharm.c
`h/EN/Research/Galenical_Development/index.php
`1024A Declaration of Robert Mihail
`1025A Declaration of Christopher Butler
`1026A 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
`1027A 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
`
`27
`
`Page 27 of 28
`
`
`
`42.6(e)(4) (iii)(A) The date and manner of service:
`
`Date of Service: 5/27/2015
`
`Manner of service: 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
`
`/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
`
`28
`
`Page 28 of 28
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
