UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`
`
`Case IPR2023-00050
`U.S. Patent 8,377,903
`
`PATENT OWNER’S MOTION FOR
`ADMISSION PRO HAC VICE OF
`H. RACHAEL MILLION-PEREZ
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`
`
`Case IPR2023-00050
`U.S. Patent 8,377,903
`
`PATENT OWNER’S MOTION FOR
`ADMISSION PRO HAC VICE OF
`H. RACHAEL MILLION-PEREZ
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`Statement of Precise Relief Requested
`Pursuant to 37 C.F.R. § 42.10(c) and Paper No. 3 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 H. Rachael Million-Perez pro hac vice in this proceeding, IPR2023-00050.
`
`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 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 a showing that counsel is an
`
`experienced litigating attorney and has an established familiarity with the subject
`
`matter at issue in the proceeding.” The facts here establish good cause for the
`
`Board to recognize Ms. Million-Perez pro hac vice in this proceeding.
`
`Lead counsel, Emily R. Whelan, is a registered practitioner. Backup
`
`counsel, Deric Geng and Cindy Kan, are also registered practitioners. Ms. Million-
`
`Perez is an experienced litigator and has established familiarity with the subject
`
`- 1 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`matter at issue in the proceeding.
`
`Accompanying this motion as Exhibit 2080 is the May 21, 2024, Declaration
`
`of H. Rachael Million-Perez in Support of this Motion for Admission Pro Hac
`
`Vice (“Million-Perez Decl.”). In her declaration, Ms. Million-Perez asserts:
`
`I am a member in good standing of the New York and Colorado
`
`Bars and am admitted to practice before the U.S. Court of Appeals
`
`for the Federal Circuit, the U.S. Court of Appeals for the Sixth
`
`Circuit, the U.S. District Court for the District of Colorado, and the
`
`U.S. District Court for the Western District of Tennessee.
`
`Million-Perez Decl. ¶ 2 (Ex. 2080).
`
`Ms. Million-Perez demonstrates that she has a detailed working knowledge
`
`of the relevant subject matter through her review of papers in the inter partes
`
`review matters challenging U.S. Patent No. 7,713,947 and U.S. Patent No.
`
`8,377,903 and participation in consolidated district court litigations. Id. ¶ 10 (Ex.
`
`2080). Ms. Million-Perez also has significant experience with patent litigation in a
`
`variety of jurisdictions, including in district court litigation. Id. ¶ 1 (Ex. 2080).
`
`Ms. Million-Perez will work in coordination and association with the designated
`
`lead counsel for this proceeding, Emily R. Whelan. Id. ¶ 11 (Ex. 2080).
`
`In her declaration, Ms. Million-Perez also attests to each of the listed items
`
`
`- 2 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`required by the “Order – Authorizing Motion for Pro Hac Vice Admission” in Case
`
`IPR2013-00639, Paper 7. See Million-Perez Decl. ¶¶ 1-12 (Ex. 2080). Ms.
`
`Million-Perez attests 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 37 C.F.R. §
`
`42. See id. ¶ 7 (Ex. 2080). Ms. Million-Perez further attests that she agrees to be
`
`subject to the United States Patent and Trademark Office’s Rules of Professional
`
`Conduct as set forth in 37 C.F.R. §§ 11.101 et seq. and disciplinary jurisdiction
`
`under 37 C.F.R. § 11.19(a). See id. ¶ 8 (Ex. 2080).
`
`III. Conclusion
`For the foregoing reasons, Patent Owner respectfully requests that the Board
`
`admit Ms. Million-Perez pro hac vice in this proceeding. The undersigned
`
`authorizes the Office to charge $250 to Deposit Account No. 08-0219 for the fees
`
`set forth in 37 C.F.R. § 42.15(e) for this pro hac vice motion. Please charge any
`
`shortage of fees or credit any overpayments to the above Deposit Account.
`
`
`
`Dated: May 22, 2024
`
`
`Respectfully Submitted,
`/Emily R. Whelan/
`Emily R. Whelan, Reg. No. 50,391
`Counsel for Patent Owner
`
`
`- 3 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`Description
`
`Exhibit
`No.
`2001 Declaration of David B. Bassett in Support of Motion for Admission
`Pro Hac Vice
`2002 Declaration of Vinita Ferrera in Support of Motion for Admission Pro
`Hac Vice
`2003 Declaration of Mary Pheng in Support of Motion for Admission Pro
`Hac Vice
`
`2004
`
`J. C. Sipe et al., Cladribine in Treatment of Chronic Progressive
`Multiple Sclerosis, 344 THE LANCET 9 (1994)
`
`2005
`
`2006
`
`B. M. Greenberg et al., Multiple Sclerosis, in PHARMACOLOGY AND
`THERAPEUTICS: PRINCIPLES TO PRACTICE 685 (S. A. Waldman & A.
`Terzic eds., 2009)
`
`C. Krishnan et al., Reduction of Disease Activity and Disability With
`High-Dose Cyclophosphamide in Patients With Aggressive Multiple
`Sclerosis, 65 ARCHIVES OF NEUROLOGY 1044 (2008)
`
`2007
`
`B. Greenberg & E. M. Frohman, Defining Success in Multiple
`Sclerosis: Treatment Failures and Nonresponders, 8 PROCEEDINGS,
`JOHNS HOPKINS ADVANCED STUDIES IN MEDICINE 274 (2008)
`2008 B. M. Greenberg et al., Current and Emerging Multiple Sclerosis
`Therapeutics, 16 CONTINUUM 58 (2010)
`
`2009 Transcript of Deposition of Benjamin Greenberg (Feb. 26, 2024)
`
`
`- 4 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Exhibit
`No.
`
`2010
`
`2011
`
`Description
`
`A. E. Miller & R. M. Herndon, Treatment Issues, in MULTIPLE
`SCLEROSIS: THE QUESTIONS YOU HAVE—THE ANSWERS YOU NEED 43
`(R. C. Kalb ed., 2nd Ed. 2000)
`
`J. Noseworthy et al., Disease-Modifying Treatments in Multiple
`Sclerosis, in MCALPINE’S MULTIPLE SCLEROSIS 729 (A. Compston et
`al. eds., 4th ed. 2005)
`
`2012
`
`H. El-Moslimany & A. E. Miller, Escape Therapies and Management
`of Multiple Sclerosis, in MULTIPLE SCLEROSIS: A COMPREHENSIVE
`TEXT 333 (C. S. Raine et al. eds., 2008)
`2013 F. Lublin, History of Modern Multiple Sclerosis Therapy, 252 JOURNAL
`OF NEUROLOGY III/3 (2005)
`2014 D. S. Goodin et al., Disease Modifying Therapies in Multiple Sclerosis,
`58 NEUROLOGY 169 (2002)
`
`2015
`
`2016
`
`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 MULTIPLE SCLEROSIS
`JOURNAL 719 (2023)
`
`M. Filippi et al., The Effect of Cladribine on T1 ‘Black Hole’ Changes
`in Progressive MS, 176 JOURNAL OF THE NEUROLOGICAL SCIENCES 42
`(2000)
`
`2017
`
`J. E. Joy & R. B. Johnston, Jr., MULTIPLE SCLEROSIS: CURRENT STATUS
`AND STRATEGIES FOR THE FUTURE 17 (2001)
`
`2018
`
`O. Neuhaus et al., Immunomodulation in Multiple Sclerosis: From
`Immunosuppression to Neuroprotection, 24 TRENDS IN
`PHARMACOLOGICAL SCIENCES 131 (2003)
`
`
`- 5 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Exhibit
`No.
`
`Description
`
`2019 Declaration of Fred Lublin, M.D.
`2020 L. Durelli, Dose and Frequency of Interferon Treatment Matter, 250
`JOURNAL OF NEUROLOGY IV/9 (2003)
`
`2021
`
`R. Rudick & A. Sandrock, Natalizumab: 4-Integrin Antagonist
`Selective Adhesion Molecule Inhibitors for MS, 4 EXPERT REVIEW OF
`NEUROTHERAPEUTICS 571 (2004)
`2022 D. S. Alberts et al., Disposition of Mitoxantrone in Cancer Patients, 45
`CANCER RESEARCH 1879 (1985)
`
`2023
`
`K. Rammohan et al., The Development of Cladribine Tablets for the
`Treatment of Multiple Sclerosis: A Comprehensive Review, 80 DRUGS
`1901 (2020)
`
`2024
`
`J. F. Kurtzke, Rating Neurologic Impairment in Multiple Sclerosis: An
`Expanded Disability Status Scale (EDSS), 33 NEUROLOGY 1444 (1983)
`
`M. J. Tullman et al., Immunotherapy of Multiple Sclerosis—Current
`Practice and Future Directions, 39 JOURNAL OF REHABILITATION
`RESEARCH AND DEVELOPMENT 273 (2002)
`
`G. Giovannoni et al., A Placebo-Controlled Trial of Oral Cladribine
`for Relapsing Multiple Sclerosis, 362 NEW ENGLAND JOURNAL OF
`MEDICINE 416 (2010)
`
`Supplementary Appendix to G. Giovannoni et al., A Placebo-
`Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis,
`362 NEW ENGLAND JOURNAL OF MEDICINE 416 (2010) (Exhibit 2026)
`
`
`- 6 -
`
`2025
`
`2026
`
`2027
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Exhibit
`No.
`
`2028
`
`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 MULTIPLE
`SCLEROSIS JOURNAL 1594 (2018)
`
`2029 US Patent No. 8,785,415
`2030 Serono Press Release, Serono and Ivax to Develop Oral Therapy for
`Multiple Sclerosis (Oct. 30, 2002)
`
`2031 Serono Form 20-F (2003)
`
`2032
`
`C. Sargent, Serono Purchases Rights to Experimental MS Drug, WALL
`STREET JOURNAL (Oct. 31, 2002),
`https://www.wsj.com/articles/SB1035995148253461151 (accessed
`Dec. 14, 2023)
`
`2033 Reserved
`
`2034
`
`P. S. Rommer et al., Requirement for Safety Monitoring for Approved
`Multiple Sclerosis Therapies: An Overview, 175 CLINICAL AND
`EXPERIMENTAL IMMUNOLOGY 397 (2013)
`
`2035 Reserved
`
`2036 LEUSTATIN® (cladribine) Package Insert (2002)
`
`2037
`
`Merck Receives Complete Response Letter from FDA on Cladribine
`Tablets New Drug Application, FIERCEBIOTECH.COM (Mar. 2, 2011),
`https://www.fiercebiotech.com/biotech/merck-receives-complete-
`response-letter-from-fda-on-cladribine-tablets-new-drug-application
`(accessed Mar. 12, 2024)
`
`
`- 7 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Exhibit
`No.
`
`Description
`
`2038
`
`M. Hoffman, Interview of K. Rammohan: Short-Term Dosing Regimen
`Gives Cladribine an Advantage in MS, NEUROLOGYLIVE.COM (Jul. 1,
`2020), https://www.neurologylive.com/view/short-commitment-
`dosing-regimen-gives-cladribine-an-advantage-in-ms (accessed Nov.
`10, 2023)
`2039 Transcript of Deposition of Nicholas Bodor in IPR2023-00480 &
`IPR2023-00481 (PROTECTIVE ORDER MATERIAL)
`
`2040
`
`J. C. Sipe et al., Development of Cladribine Treatment in Multiple
`Sclerosis, 1 MULTIPLE SCLEROSIS 343 (1996)
`2041 Transcript of Deposition of Nicholas Bodor in IPR2023-00480 &
`IPR2023-00481 [Public, Redacted]
`
`2042 Reserved
`
`2043
`
`FDA News Release: FDA Approves New Oral Treatment for Multiple
`Sclerosis (Mar. 29, 2019), https://www.fda.gov/news-events/press-
`announcements/fda-approves-new-oral-treatment-multiple-sclerosis
`(accessed on Nov. 25, 2023)
`
`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 Amendment and Reply to Rule 312 Communication (Jun. 12, 2014), in
`File History for U.S. Patent No. 8,785,415
`
`2048
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S. A. (PROTECTIVE
`ORDER MATERIAL)
`
`
`- 8 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Description
`
`Exhibit
`No.
`2049 December 17, 2003 Email and Cladribine Briefing Document
`(PROTECTIVE ORDER MATERIAL)
`2050 August 27, 2003 Minutes for the Oral Cladribine for MS Project Joint
`Meeting (PROTECTIVE ORDER MATERIAL)
`
`2051
`
`Video: A. E. Miller, What You Need to Know About Mavenclad®
`(https://www.nationalmssociety.org/Treating-
`MS/Medications/Mavenclad) (2019)
`2052 Transcript of Video: A. E. Miller, What You Need to Know About
`Mavenclad® (2019)
`
`2053 Declaration of Alain Munafo, Ph.D.
`
`2054 Declaration of Nicholas Bodor, Ph.D., D.Sc., d.h.c.
`
`2055 Declaration of Yogesh Dandiker, Ph.D.
`
`2056
`
`J. H. Noseworthy et al., Multiple Sclerosis, 343 THE NEW ENGLAND
`JOURNAL OF MEDICINE 938 (2000)
`2057 R. A. Rudick et al., Management of Multiple Sclerosis, 337 THE NEW
`ENGLAND JOURNAL OF MEDICINE 1604 (A. J. J. Wood ed., 1997)
`
`2058
`
`R. A. Rudick et al., Natalizumab plus Interferon Beta-1a for Relapsing
`Multiple Sclerosis, 354 THE NEW ENGLAND JOURNAL OF MEDICINE 911
`(2006)
`
`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 PREFERENCE AND ADHERENCE 1123
`(2014)
`
`
`- 9 -
`
`2059
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Exhibit
`No.
`
`Description
`
`2060 COPAXONE® (glatiramer acetate) Package Insert (2014)
`
`2061 Reserved
`
`2062
`
`2063
`
`A. Liu, Better 8 Years Late than Never: Merck KGaA Nabs FDA Nod
`for MS Drug Mavenclad, FIERCEBIOTECH.COM (Apr. 1, 2019),
`https://www.fiercepharma.com/pharma/better-8-years-late-than-never-
`merck-kgaa-nabs-fda-nod-for-ms-drug-mavenclad (accessed Dec. 18,
`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 Nov. 25, 2023)
`
`2064
`
`Safety & Side Effects: Learn About the Possible Risks of
`MAVENCLAD,
`https://web.archive.org/web/20231004232146/https://www.mavenclad.
`com/en/home/why-mavenclad/safety-and-side-effects.html (last
`updated Nov. 2022) (accessed Dec. 19, 2023)
`2065 M. Filippi et al., Whole Brain Volume Changes in Patients with
`Progressive MS Treated with Cladribine, 55 NEUROLOGY 1714 (2000)
`
`2066 Declaration of Asher S. McGuffin
`
`2067 Declaration of Willem de Weerd
`
`2068 Declaration of Cindy Kan
`
`2069 Reserved
`
`
`- 10 -
`
`
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`Exhibit
`No.
`
`2070 Reserved
`
`Description
`
`2071 Reserved
`2072 Reply and Amendment (Oct. 3, 2008), in File History for U.S. Patent
`No. 7,888,328
`2073 Declaration of Gillian Farrell in Support of Motion for Admission Pro
`Hac Vice
`
`2074 Supplemental Declaration of Cindy Kan (service only)
`
`2075
`
`J. C. Sipe et al., Cladribine in Treatment of Chronic Progressive
`Multiple Sclerosis, 344 THE LANCET 9 (1994) (service only)
`
`2076
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S.A. (PROTECTIVE
`ORDER MATERIAL) (service only)
`
`2077
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S. A. (REDACTED -
`PUBLIC)
`2078 December 17, 2003 Email and Cladribine Briefing Document
`(REDACTED - PUBLIC)
`2079 August 27, 2003 Minutes for the Oral Cladribine for MS Project Joint
`Meeting (REDACTED - PUBLIC)
`2080 Declaration of H. Rachael Million-Perez in Support of Motion for
`Admission Pro Hac Vice
`
`
`
`
`
`
`- 11 -
`
`
`
`IPR2023-00050
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael Million-Perez
`
`
`CERTIFICATE OF SERVICE
`
` hereby certify that on May 22, 2024, I caused a true and correct copy
`
` I
`
`of the foregoing materials:
`
`
`
`
`
`
`
`Patent Owner’s Motion for Admission Pro Hac Vice of H. Rachael
`
`Million-Perez
`
`Exhibit 2080
`
`Patent Owner’s Updated Exhibit List
`
`to be served via e-mail, as consented to by Petitioner, on the following
`
`attorneys of record:
`
`Philip.Segrest@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`Steve.Howe@huschblackwell.com
`Don.Mizerk@huschblackwell.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
`
`
`
`- 12 -
`
`
`
`
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