`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`
`
`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`
`PATENT OWNER’S MOTION FOR
`ADMISSION PRO HAC VICE OF
`DAVID MLAVER
`
`
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`I.
`
`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`Statement of Precise Relief Requested
`Pursuant to 37 C.F.R. § 42.10(c) and Paper No. 7 authorizing the
`
`parties to file motions for pro hac vice admissions under 37 C.F.R. §
`
`42.10(c), Patent Owner Merck Serono SA requests that the Patent Trial and
`
`Appeal Board (the “Board”) admit David Mlaver pro hac vice in this
`
`proceeding, IPR2023-00481. The parties have met and conferred, and
`
`Petitioner does not oppose this motion.
`
`II.
`
`Statement of Facts Showing Good Cause for the Board to
`Recognize Counsel Pro Hac Vice During the Proceeding
`In accordance with 37 C.F.R. § 42.10(c), the Board may recognize
`
`counsel pro hac vice during a proceeding upon a showing of good cause,
`
`subject to the condition that lead counsel be a registered practitioner and to
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`any other conditions as the Board may impose. Section 42.10(c) indicates
`
`that “where lead counsel is a registered practitioner, a motion to appear pro
`
`hac vice by counsel who is not a registered practitioner may be granted upon
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`a showing that counsel is an experienced litigating attorney and has an
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`established familiarity with the subject matter at issue in the proceeding.”
`
`The facts here establish good cause for the Board to recognize Mr. Mlaver
`
`pro hac vice in this proceeding.
`
`Lead counsel, Emily R. Whelan, is a registered practitioner. Backup
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`counsel, Deric Geng and Cindy Kan, are also registered practitioners. Mr.
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`Mlaver is an experienced litigator and has established familiarity with the
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`subject matter at issue in the proceeding. Accompanying this motion as
`
`Exhibit 2075 is the February 7, 2024, Declaration of David Mlaver in
`
`Support of this Motion for Admission Pro Hac Vice (“Mlaver Decl.”). In his
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`declaration, Mr. Mlaver asserts: “I am a member in good standing of the Bars
`
`of the District of Columbia, Maryland, and Massachusetts.” Mlaver Decl. ¶ 2
`
`(Ex. 2075).
`
`Mr. Mlaver demonstrates that he has a detailed working knowledge of
`
`the relevant subject matter through his participation in the inter partes
`
`review matters challenging U.S. Patent No. 8,377,903 and U.S. Patent No.
`
`7,713,947 and in consolidated district court litigations. Id. ¶ 10 (Ex. 2075).
`
`Mr. Mlaver also has significant experience with litigation involving
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`pharmaceuticals, methods of treatment, and small molecule therapeutics. Id.
`
`¶ 11 (Ex. 2075)
`
`In his declaration, Mr. Mlaver also attests to each of the listed items
`
`required by the “Order – Authorizing Motion for Pro Hac Vice Admission”
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`in Case IPR2013-00639, Paper 7. See Mlaver Decl. ¶¶ 1-12 (Ex. 2075). Mr.
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`Mlaver attests that he has read and will comply with the Office Patent Trial
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Practice Guide and the Board’s Rules of Practice for Trials set forth in 37
`
`C.F.R. § 42. See id. ¶ 7 (Ex. 2075). Mr. Mlaver further attests that he agrees
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`to be subject to the United States Patent and Trademark Office’s Rules of
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`Professional Conduct as set forth in 37 C.F.R. §§ 11.101 et seq. and
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`disciplinary jurisdiction under 37 C.F.R. § 11.19(a). See id. ¶ 8 (Ex. 2075).
`
`III. Conclusion
`For the foregoing reasons, Patent Owner respectfully requests that the
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`Board admit Mr. Mlaver pro hac vice in this proceeding. The undersigned
`
`authorizes the Office to charge $250 to Deposit Account No. 08-0219 for the
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`fees set forth in 37 C.F.R. § 42.15(e) for this pro hac vice motion. Please
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`charge any shortage of fees or credit any overpayments to the above Deposit
`
`Account.
`
`
`
`Dated: February 9, 2024
`
`
`Respectfully Submitted,
`/Emily R. Whelan/
`Emily R. Whelan, Reg. No. 50,391
`Counsel for Patent Owner
`
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
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`
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`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`Exhibit
`No.
`
`Description
`
`2001 MAVENCLAD® (cladribine) Package Insert (2022)
`2002 Declaration of David B. Bassett in Support of Motion for Admission
`Pro Hac Vice
`2003 Declaration of Vinita Ferrera in Support of Motion for Admission Pro
`Hac Vice
`
`2004
`
`H. El-Moslimany et al., Escape Therapies and Management of
`Multiple Sclerosis in C. S. Raine MULTIPLE SCLEROSIS A
`COMPREHENSIVE TEXT 333 (2008) (Excerpt)
`
`2005
`
`A. E. Miller et al., Treatment Issues in R. C. Kalb MULTIPLE
`SCLEROSIS: THE QUESTION YOU HAVE – THE ANSWERS
`YOU NEED 43 (2d ed. 2000) (Excerpt)
`2006 M. J. Tullman et al., Immunotherapy of Multiple Sclerosis – Current
`Practice and Future Directions, 39 J. REHAB. RES. DEV. 273 (2002)
`
`2007
`
`Video: A. Miller, What You Need to Know About Mavenclad®
`(https://www.nationalmssociety.org/Treating-
`MS/Medications/Mavenclad) (2019); image of USB Drive containing
`video
`2008 Transcript of Video, A. Miller, What You Need to Know About
`Mavenclad® (2019)
`
`2009 Deposition Transcript of Dr. Aaron Miller (December 12, 2023)
`
`2010
`
`J. E. Joy et al., Multiple Sclerosis: Current Status and Strategies for the
`Future, 17 (2001) (Excerpt)
`
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`- 4 -
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Exhibit
`No.
`2011 F. Lublin, History of Modern Multiple Sclerosis Therapy, 252 (SUPPL
`3) J. NEUROL. III/3 (2005)
`
`Description
`
`2012 Reserved
`2013 D. S. Goodin et al., Disease Modifying Therapies in Multiple Sclerosis,
`58 NEUROLOGY 169 (2002)
`
`2014 Betaseron® (Interferon beta-1b) Package Insert (1993)
`
`2015 Avonex™ (Interferon beta-1a) Package Insert (1996)
`
`2016 Rebif® (Interferon beta-1a) Package Insert (2003)
`
`2017 Copaxone® (glatiramer acetate) Package Insert (2001)
`
`2018 Novantrone® (mitoxantrone) Package Insert (2000)
`
`2019 Tysabri® (natalizumab) Package Insert (2004)
`
`2020
`
`R. A. Rudick et al., Natalizumab: 4-Integrin Antagonist Selective
`Adhesion Molecule Inhibitors for MS, 4 EXPERT REV.
`NEUROTHER. 571 (2004)
`2021 R. A. Rudick et al., Natalizumab plus Interferon Beta-1a for Relapsing
`Multiple Sclerosis, 354 NEW ENG. J. MED. 911 (2006)
`
`2022 Reserved
`
`2023 Reserved
`2024 L. Durelli, Dose and Frequency of Interferon Treatment Matter, 250 J.
`NEUROL. (SUPPL 4) IV/9 (2003)
`
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`- 5 -
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Exhibit
`No.
`2025 D. S. Alberts et al., Disposition of Mitoxantrone in Cancer Patients, 45
`CANCER RES. 1879 (1985)
`
`Description
`
`2026
`
`M. Caporro et al., Two Decades of Subcutaneous Glatiramer Acetate
`Injection: Current Role of the Standard Dose, and New High-Dose
`Low-Frequency Glatiramer Acetate in Relapsing-Remitting Multiple
`Sclerosis Treatment, 8 PATIENT PREFER. ADHERENCE 1123
`(2014)
`
`2027 Reserved
`
`2028 Reserved
`
`2029 U.S. Patent No. 8,785,415
`
`2030
`
`J. C. Sipe et al., Development of Cladribine Treatment in Multiple
`Sclerosis, 1 MULT. SCLER. 343 (1996)
`
`2031
`
`J. Noseworthy et al., Disease-Modifying Treatments in Multiple
`Sclerosis in A. Compston MCALPINE’S MULTIPLE SCLEROSIS
`729 (4th ed. 2005) (Excerpt)
`
`2032
`
`K. Rammohan et al., The Development of Cladribine Tablets for the
`Treatment of Multiple Sclerosis: A Comprehensive Review, 80 DRUGS
`1901 (2020)
`2033 G. Giovannoni et al., A Placebo-Controlled Trial of Oral Cladribine
`for Relapsing Multiple Sclerosis, 362 NEW ENG. J. MED. 416 (2010)
`
`2034
`
`G. Giovannoni et al., Supplementary Appendix to A Placebo-
`Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis,
`362 NEW ENG. J. MED. 416 (2010)
`
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`- 6 -
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Description
`
`G. Giovannoni et al., Safety and Efficacy of Cladribine Tablets in
`Patients with Relapsing-Remitting Multiple Sclerosis: Results from the
`Randomized Extension Trial of the CLARITY Study, 24 MULT.
`SCLER. J. 1594 (2018)
`
`G. Giovannoni et al., Long-Term Follow-Up of Patients with Relapsing
`Multiple Sclerosis from the CLARITY/CLARITY Extension Cohort of
`CLASSIC-MS: An Ambispective Study, 29 MULT. SCLER. J. 719
`(2023)
`
`A. Miller et al., Current and Investigational Therapies Used to Alter
`the Course of Disease in Multiple Sclerosis, 90 SOUTH. MED. J. 367
`(1997)
`
`Merck Receives Complete Response Letter From FDA on Cladribine
`Tablets New Drug Application, FIERCEBIOTECH.COM (March 2,
`2011) (https://www.fiercebiotech.com/biotech/merck-receives-
`complete-response-letter-from-fda-on-cladribine-tablets-new-drug-
`application), accessed on December 20, 2023
`
`Exhibit
`No.
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039 Reserved
`
`FDA News Release: FDA Approves New Oral Treatment For Multiple
`Sclerosis (March 29, 2019) (https://www.fda.gov/news-events/press-
`announcements/fda-approves-new-oral-treatment-multiple-sclerosis),
`accessed on November 25, 2023
`
`ClinicalTrials.gov publication and Record History, NCT00213135 A
`Safety and Efficacy Study of Oral Cladribine in Subjects With
`Relapsing-Remitting Multiple Sclerosis (RRMS) (CLARITY) (2014)
`(https://clinicaltrials.gov/study/NCT00213135;
`https://clinicaltrials.gov/study/NCT00213135?tab=history&a=13),
`accessed on November 25, 2023
`
`
`- 7 -
`
`2040
`
`2041
`
`
`
`
`
`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Description
`
`M. Hoffman, K. Rammohan Interview: Short-Term Dosing Regimen
`Gives Cladribine an Advantage in MS, NEUROLOGYLIVE (July 1,
`2020) (https://www.neurologylive.com/view/shortcommitment-dosing-
`regimen-gives-cladribine-an-advantage-in-ms), accessed on November
`10, 2023
`
`Exhibit
`No.
`
`2042
`
`2043
`
`J. Liliemark et al., On the Bioavailability of Oral and Subcutaneous 2-
`Chloro-2’-Deoxydenosine in Humans: Alternative Routes of
`Administration, 10 J. CLIN. ONCOL. 1514 (1992)
`
`2044 U.S. Provisional Patent Application No. 60/458,922
`
`2045 U.S. Provisional Patent Application No. 60/484,756
`
`2046 U.S. Provisional Patent Application No. 60/541,247
`2047 U.S. Patent No. 8,785,415 File History, Response to Rule 312
`Communication Post Allowance, filed on June 12, 2014
`
`2048
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S.A. (PROTECTIVE
`ORDER MATERIAL)
`2049 December 17, 2003 email and Cladribine Briefing Document
`(PROTECTIVE ORDER MATERIAL)
`2050 August 27, 2003 Meeting Minutes for the Oral Cladribine for MS
`Project Joint Meeting (PROTECTIVE ORDER MATERIAL)
`
`2051 Declaration of Fred D. Lublin, M.D.
`
`2052 Declaration of Bernd Meibohm, Dr.rer.nat.
`
`2053 Declaration of Alain Munafo, Ph.D.
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`- 8 -
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Exhibit
`No.
`
`Description
`
`2054 Declaration of Nicholas Bodor, Ph.D., D.Sc., d.h.c.
`
`2055 Declaration of Yogesh Dandiker, Ph.D.
`2056 Serono Press Release, Serono and IVAX to Develop Oral Therapy for
`Multiple Sclerosis (October 30, 2002)
`
`2057 Serono S.A. Form 20F (2003)
`
`2058
`
`C. Sargent, Serono Purchases Rights to Experimental MS Drug, Wall
`Street Journal (October 31, 2002)
`(https://www.wsj.com/articles/SB1035995148253461151), accessed on
`December 14, 2023
`
`2059 Copaxone® (glatiramer acetate) Package Insert (2014)
`
`A. Liu, Better 8 Years Late Than Never: Merck KGaA Nabs FDA Nod
`for MS Drug Mavenclad, FIERCEPHARMA.COM (April 1, 2019)
`(https://www.fiercepharma.com/pharma/better-8-years-late-than-never-
`merck-kgaa-nabs-fda-nod-for-ms-drug-mavenclad), accessed on
`December 18, 2023
`
`The Canadian Cooperative Multiple Sclerosis Study Group, The
`Canadian Cooperative Trial of Cyclophosphamide and Plasma
`Exchange in Progressive Multiple Sclerosis, 337 LANCET 441 (1991)
`
`J. W. Hainer et al., Dosing in Heavy-Weight/Obese Patients with the
`LMWH, Tinzaparin: A pharmacodynamic Study, 87 THROMB
`HAEMOST. 817 (2002) (Excerpt)
`
`B. Meibohm et al., Clinical Pharmacodynamics & Pharmacokinetics,
`In: R. A. Helms, RA et al. TEXTBOOK OF THERAPEUTICS: DRUG
`AND DISEASE MANAGEMENT 1 (8th ed. 2006) (Excerpt)
`
`
`- 9 -
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`2060
`
`2061
`
`2062
`
`2063
`
`
`
`
`
`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Exhibit
`No.
`
`2064 Reserved
`
`2065 Reserved
`
`Description
`
`2066 Reserved
`2067 Declaration of Asher S. McGuffin in Support of Exhibits 2056, 2057,
`and 2058
`2068 Declaration of Cindy Kan in Support of Exhibits 2038, 2040, 2041,
`2042, 2060, and 2070
`
`2069 U.S. Patent No. 7,888,328
`
`2070
`
`SAFETY & SIDE EFFECTS Learn about the possible risks of
`MAVENCLAD (https://www.mavenclad.com/en/home/why-
`mavenclad/safety-and-side-effects.html#:~:text=It) (last updated
`November 2022), accessed on December 18, 2023
`2071 Declaration of Willem de Weerd in Support of Exhibits 2048, 2049,
`and 2050
`
`2072 Supplemental Declaration of Fred D. Lublin, M.D. (SERVICE ONLY)
`
`2073
`
`D. S. Goodin et al., Disease Modifying Therapies in Multiple Sclerosis,
`58 NEUROLOGY 169, Supplementary Material (2002) (SERVICE
`ONLY)
`2074 The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S.A. (SERVICE ONLY)
`2075 Declaration of David Mlaver in Support of Motion for Admission Pro
`Hac Vice
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`- 10 -
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`Exhibit
`No.
`2076 Declaration of Mary Pheng in Support of Motion for Admission Pro
`Hac Vice
`
`Description
`
`
`- 11 -
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`IPR2023-00481
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`
`CERTIFICATE OF SERVICE
`
` hereby certify that on February 9, 2024, I caused a true and correct
`
` I
`
`copy of the foregoing materials:
`
`
`
`
`
`
`
`Patent Owner’s Motion for Admission Pro Hac Vice of David Mlaver
`
`Exhibit 2075
`
`Patent Owner’s Updated Exhibit List
`
`to be served via e-mail, as consented to by Petitioner, to:
`
`eellison-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`cvira-PTAB@sternekessler.com
`jcrozendaal-PTAB@sternekessler.com
`cdashe-PTAB@sternekessler.com
`PTAB@sternekessler.com
`
`
`
`By: /Cindy Kan/
`Cindy Kan (Reg. No. 76,385)
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: (212) 295-6470
`E-mail: cindy.kan@wilmerhale.com
`
`
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