`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner
`v.
`MERCK SERONO S.A.,
`Patent Owner
`
`___________________
`
`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`___________________
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`PETITIONER HOPEWELL PHARMA VENTURES, INC.’S MOTION FOR
`PRO HAC VICE ADMISSION OF CHRISTINA E. DASHE UNDER 37
`C.F.R. § 42.10(c)
`
`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`TABLE OF CONTENTS
`
`INTRODUCTION .......................................................................................... 1
`I.
`STATEMENT OF FACTS ............................................................................. 2
`II.
`III. GOOD CAUSE EXISTS FOR THIS MOTION ............................................ 4
`IV. DECLARATION OF INDIVIDUAL SEEKING TO APPEAR .................... 4
`V.
`CONCLUSION ............................................................................................... 5
`
`
`
`
`
`
`- i -
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`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`PETITIONER’S UPDATED EXHIBIT LIST
`
`Description
`
`De Luca, G., et al., “Cladribine Regimen for Treating Multiple
`Sclerosis,” U.S. Patent No. 7,713,947 B2 (filed June 18, 2007; issued
`May 11, 2010)
`Declaration of Aaron Miller, M.D.
`Curriculum Vitae for Aaron Miller, M.D.
`File History for U.S. Patent No. 7,713,947
`Intentionally Left Blank
`Noseworthy, J.H., et al., “Multiple Sclerosis,” The New England
`Journal of Medicine, 343(13):938-952 (2000)
`Neuhaus, O., et al., “Immunomodulation in multiple sclerosis: from
`immunosuppression to neuroprotection,” TRENDS in
`Pharmaceutical Sciences, 24(3):131-138 (2003)
`Weiner, H.L., et al., “Immunotherapy of Multiple Sclerosis,” Annals
`of Neurology, 23(3):211-222 (1988)
`Wingerchuk, D.M., et al., “Biology of Disease, Multiple Sclerosis:
`Current Pathophysiological Concepts,” Laboratory Investigation,
`81(3):263-281 (2001)
`Kurtzke, J.F., “Rating neurologic impairment in multiple sclerosis:
`An expanded disability status scale (EDSS),” Neurology, 33:1444-
`1452 (1983)
`Intentionally Left Blank
`Whitaker, J.N., “Rationale for Immunotherapy in Multiple
`Sclerosis,” Annals of Neurology, 36:S103-S107 (1994)
`Stelmasiak, Z., et al., “A pilot trial of cladribine (2-
`chlorodeoxyadenosine) in remitting-relapsing multiple sclerosis,”
`Medical Science Monitor, 4(1):4-8 (1998)
`Beutler, E., et al., “The treatment of chronic progressive multiple
`sclerosis with cladribine,” Proceedings of the National Academy of
`Sciences, USA 93:1716-1720 (1996)
`Tortorella, C., et al., “Cladribine Ortho Biotech Inc,” Current
`Opinion in Investigational Drugs, 2(12):1751-1756 (2001)
`Langtry, H.D., et al., “Cladribine, A Review of its Use in Multiple
`Sclerosis,” BioDrugs, 9(5):419-433 (1998)
`
`Exhibit #
`
`1001
`
`1002
`1003
`1004
`1005
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`- ii -
`
`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`
`Description
`
`Rudick, R.A., et al., “Management of Multiple Sclerosis,” The New
`England Journal of Medicine, 337(22):1604-1611 (1997)
`Rice, G.P.A., et al., “Cladribine and progressive MS, Clinical and
`MRI outcomes of a multicenter controlled trial,” Neurology,
`54:1145-1155 (2000)
`Barkhof, R., et al., “Limited duration of the effect of
`methylprednisolone on changes on MRI in multiple sclerosis,”
`Neuroradiology, 36:382-387 (1994)
`Pirko, I. and Rodriguez, M., “Pulsed Intravenous
`Methylprednisolone Therapy in Progressive Multiple Sclerosis: Need
`for a Controlled Trial,” Archives of Neurology, 61:1148-1149 (2004)
`Weiner, H.L., et al., “Intermittent cyclophosphamide pulse therapy in
`progressive multiple sclerosis: Final report of the Northeast
`Cooperative Multiple Sclerosis Treatment Group,” Neurology,
`43:910-918 (1993)
`Bodor, N. and Dandiker, Y., “Oral Formulations of Cladribine,”
`International Publication No. WO 2004/087101 A2 (filed March 26,
`2004; published October 14, 2004)
`Grieb, P., et al., “Effect of Repeated Treatments with Cladribine (2-
`Chlorodeoxyadenosine) on Blood Counts in Multiple Sclerosis
`Patients,” Archivum Immunologiae Experimentalis, 43:323-327
`(1995)
`Schultz, T.W., et al., “Cyclodextrine Cladribine Formulations,” U.S.
`Patent No. 6,194,395 B1 (filed February 25, 1999; issued February
`27, 2001)
`File History for U.S. Patent No. 8,377,903
`Beutler, E., “Use of Substituted Adenine Derivatives for Treating
`Multiple Sclerosis,” U.S. Patent No. 5,506,214 B2 (filed February
`18, 1993; issued April 9, 1996)
`Docket Report, Merck KGaA et al. v. Hopewell Pharma Ventures,
`Inc., Case No. 1:22-cv-01365-GBW (D.Del.)
`Docket Report, Merck KGaA et al. v. Accord Healthcare, Inc., Case
`No. 1:22-cv-00974-GBW (D.Del.)
`United States District Courts - National Judicial Caseload Profile,
`June 2022
`Curriculum Vitae for Nancy E. Adams, Ed.D.
`
`Exhibit #
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`1030
`
`- iii -
`
`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`
`Description
`
`Romine, J. S., et al., “A Double-Blind, Placebo-Controlled,
`Randomized Trial of Cladribine in Relapsing-Remitting Multiple
`Sclerosis,” Proceedings of the Association of American Physicians,
`111(1):35-44 (1999)
`Docket Report, Merck KGaA et al. v. Aurobindo Pharma USA, Inc.,
`et al., Case No. 1:23-cv-00039-GBW (D.Del.)
`Bloom, P.M., “Treatment of Multiple Sclerosis with
`Lymphocytapheresis and Chemo-Immunosuppression,” U.S. Patent
`No. 4,964,848 (filed June 27, 1988; issued October 23, 1990)
`Intentionally Left Blank
`Intentionally Left Blank
`Lassmann, H., et al., “Heterogeneity of multiple sclerosis
`pathogenesis: implications for diagnosis and therapy,” TRENDS in
`Molecular Medicine, 7(3):115-121 (March 2001)
`Lublin, F. D., et al., “Defining the clinical course of multiple
`sclerosis: Results of an international survey,” Neurology, 46:907-911
`(1996)
`Casanova, B., et al., “High clinical inflammatory activity prior to the
`development of secondary progression: a prospective 5-year follow-
`up study,” Multiple Sclerosis, 8:59-63 (2002)
`Publisher's Record for Stelmasiak (EX1013)
`Declaration of Nancy E. Adams, Ed.D.
`Intentionally Left Blank
`Shurkovich, S., et al., “Randomized study of antibodies to INF-γ and
`TNF-α in secondary progressive multiple sclerosis,” Multiple
`Sclerosis, 7:277-84 (2001)
`Khoury, S. J., “Multiple Sclerosis: What Have We Learned From
`Magnetic Resonance Imaging Studies?,” Archives of Internal
`Medicine, 158:565-73 (1998)
`Roitt, I. M., “Essential Immunology, Sixth Edition,” Blackwell
`Scientific Publications, 1-29 (1988) (Excerpt)
`Filippi, M., et al., “The effect of cladribine on T1 'black hole'
`changes in progressive MS,” Journal of Neurological Sciences,
`176:42-44 (2000)
`Romine, J. S., et al., “Cladribine: Use in Therapy of Multiple
`Sclerosis,” Biodrugs, 7(5):386-93 (1997)
`
`Exhibit #
`
`1031
`
`1032
`
`1033
`
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`- iv -
`
`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`
`Description
`
`Selby, R., et al., “Safety and Tolerability of Subcutaneous Cladribine
`Therapy in Progressive Multiple Sclerosis,” Canadian Journal of
`Neurological Sciences, 25:295-99 (1998)
`Liliemark, J., “The Clinical Pharmacokinetics of Cladribine,”
`Clinical Pharmacokinetics, 32(2):120-31 (1997)
`Barkhof, F., et al., “Limited duration of the effect of
`methylprednisolone on changes on MRI in multiple sclerosis,”
`Neuroradiology, 36:382-387 (1994)
`Chumlea, W.C., “Total body water data for white adults 18 to 64
`years of age: The Fels Longitudinal Study,” Kidney International,
`56:244-252 (1999)
`U.S. Patent and Trademark Office, Memorandum, Interim Procedure
`for Discretionary Denials in AIA Post-Grant Proceedings with
`Parallel District Court Litigation (June 21, 2022)
`Supplemental Declaration of Aaron Miller, M.D. (served not filed)
`Declaration of Christina E. Dashe in Support of Motion for Pro Hac
`Vice Admission
`Declaration of John Christopher Rozendaal in Support of Motion for
`Pro Hac Vice Admission
`
`Exhibit #
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`1053
`
`1054
`
`
`
`
`
`- v -
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`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.10(c) and the Notice of Filing Date Accorded to
`
`Petition (Paper 7), Petitioner Hopewell Pharma Ventures, Inc. (“Petitioner”),
`
`respectfully requests that the Board recognize Christina E. Dashe as counsel pro
`
`hac vice in this proceeding. Petitioner is not seeking to replace either its current
`
`lead or back-up lead counsel with Ms. Dashe. Patent Owner does not oppose this
`
`motion.
`
`Where the lead counsel is a registered practitioner, a non-registered
`
`practitioner may be permitted to appear pro hac vice “upon a showing that counsel
`
`is an experienced litigating attorney and has established familiarity with the subject
`
`matter at issue in the proceeding.” 37 C.F.R. § 42.10(c); Unified Patents, Inc. v.
`
`Parallel Iron, LLC, Case IPR2013-00639 (P.T.A.B. Oct. 15, 2013) (Paper 7)
`
`(setting forth requirements for pro hac vice admission).
`
`As set forth in the accompanying Declaration (EX1053), Christina E. Dashe
`
`is Counsel at Sterne, Kessler, Goldstein & Fox PLLC and an experienced patent
`
`litigation attorney with significant experience representing clients in patent matters
`
`before the courts. Based on the facts detailed below and in her declaration,
`
`Christina E. Dashe has significant familiarity with the particular subject matter in
`
`this IPR proceeding.
`
`This motion is authorized by the Notice of Filing Date Accorded that was
`
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`

`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`mailed on March 27, 2023. See Paper 7, 2.
`
`II.
`
`STATEMENT OF FACTS
`As detailed in her declaration, Ms. Dashe has focused her practice on patent
`
`law throughout her career as an attorney—since 2013—and has extensive
`
`experience representing clients in patent matters before courts and agencies,
`
`including U.S. District Courts and the U.S. Court of Appeals for the Federal
`
`Circuit. EX1053, ¶8.
`
`Ms. Dashe has significant knowledge and experience in patent litigation,
`
`including through litigating invalidity defenses, defending and deposing witnesses,
`
`handling evidentiary issues, and arguing issues of claim construction. Id., ¶9.
`
`Ms. Dashe has previously been involved in proceedings before the Board,
`
`and has worked on such matters since 2016. Id., ¶10. This experience includes:
`
`assisting with the preparation of petitions and other submissions; preparing
`
`witnesses for deposition; and assisting with oral argument and related
`
`presentations. Id.
`
`Based on her involvement to date, Ms. Dashe has developed an established
`
`familiarity with the subject matter of this proceeding, including a close familiarity
`
`with the arguments and evidence in the petition. Id., ¶11. She has gained this
`
`familiarity through review and analysis of the challenged patent, the prosecution
`
`history of the challenged patent, technical literature, the expert declaration, and
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`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`other sources of information. Id.
`
`Petitioner is concurrently filing a motion for pro hac vice admission of Ms.
`
`Dashe in related proceeding IPR2023-00481.
`
`Ms. Dashe is a member in good standing of the bars of California, the
`
`District of Columbia, U.S. Court of Appeals for the Federal Circuit, U.S. District
`
`Court for the Central District of California, U.S. District Court for the Eastern
`
`District of California, U.S. District Court for the Northern District of California,
`
`and U.S. District Court for the Southern District of California. Id., ¶2.
`
`Ms. Dashe has never been suspended or disbarred from practice before any
`
`court or administrative body (id., ¶3), has never been denied admission to practice
`
`before any court or administrative body (id., ¶4), and has never received sanctions
`
`or contempt citations from any court or administrative body (id., ¶5).
`
`Ms. Dashe certifies that she has read and will comply with the Office Patent
`
`Trial Practice Guide and the Board’s Rules of Practice for Trials set forth in part 42
`
`of 37 C.F.R. EX1053, ¶6. Ms. Dashe certifies that she understands that she will be
`
`subject to the Rules of Professional Conduct under 37 C.F.R. §§ 11.101 et seq. and
`
`disciplinary jurisdiction under 37 C.F.R. § 11.19(a). EX1053, ¶7.
`
`Ms. Dashe certifies that in this proceeding she will work in coordination
`
`with lead counsel Eldora L. Ellison, who is a registered practitioner. Id., ¶12.
`
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`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`III. GOOD CAUSE EXISTS FOR THIS MOTION
`The Board may recognize counsel pro hac vice during a proceeding upon a
`
`showing of good cause. Based on the facts above, as supported by Ms. Dashe’s
`
`declaration (EX1053), there is good cause to admit Ms. Dashe pro hac vice in this
`
`proceeding given her extensive experience and qualifications (id., ¶¶2, 8-10) and
`
`established familiarity with the subject matter at issue in this proceeding (id., ¶11).
`
`In addition, Ms. Dashe has significant knowledge and experience in patent
`
`litigation, including defending and deposing witnesses, handling evidentiary issues,
`
`and arguing issues of claim construction. Id., ¶8-10. These skills are readily
`
`applicable to post-grant proceedings and favor admitting Ms. Dashe to represent
`
`Petitioner.
`
`Petitioner will maintain a registered practitioner as lead counsel for at least
`
`as long as Ms. Dashe is admitted pro hac vice. Ms. Dashe certifies that she will
`
`coordinate and associate with the designated lead counsel for Petitioner, Eldora L.
`
`Ellison, who is a registered practitioner, for the duration of her involvement. Id.,
`
`¶12.
`
`IV. DECLARATION OF INDIVIDUAL SEEKING TO APPEAR
`This motion is accompanied by the declaration required by Unified Patents,
`
`Inc. v. Parallel Iron, LLC, Case IPR2013-00639 (P.T.A.B. Oct. 15, 2013) (Paper
`
`7).
`
`
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`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`V. CONCLUSION
`Petitioner submits that there is good cause under 37 C.F.R. § 42.10(c) for the
`
`Board to recognize Christina E. Dashe as counsel pro hac vice during this
`
`proceeding.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`/Eldora L. Ellison/
`
`Eldora L. Ellison, Ph.D., Esq.
`Registration No. 39,967
`Lead Attorney for Petitioner
`
`Date: January 5, 2024
`1101 K Street, NW, 10th Floor
`Washington, DC 20005
`(202) 371-2600
`
`
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`

`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`I certify that the above-captioned PETITIONER HOPEWELL PHARMA
`
`VENTURES, INC.’S MOTION FOR PRO HAC VICE ADMISSION OF
`
`CHRISTINA E. DASHE UNDER 37 C.F.R. § 42.10(c) and Exhibit 1053 was
`
`served in its entirety on January 5, 2024, upon the following parties via electronic
`
`mail:
`
`Emily R. Whelan (Lead Counsel)
`Deric Geng (Back-up Counsel)
`Cindy Kan (Back-up Counsel)
`David B. Bassett (Back-up Counsel)
`Vinita Ferrera (Back-up Counsel)
`WILMER CUTLER PICKERING HALE AND DORR LLP
`Emily.Whelan@wilmerhale.com
`Deric.Geng@wilmerhale.com
`Cindy.Kan@wilmerhale.com
`David.Bassett@wilmerhale.com
`Vinita.Ferrera@wilmerhale.com
`WHMerckMavencladIPRs@wilmerhale.com
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`/Eldora L. Ellison/
`
`Eldora L. Ellison, Ph.D., Esq.
`Registration No. 39,967
`Lead Attorney for Petitioner
`
`Date: January 5, 2024
`1101 K Street, NW, 10th Floor
`Washington, DC 20005
`(202) 371-2600
`21029670.1
`
`
`
`