Filed: February 28, 2024
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)1
`
`Before ULRIKE W. JENKS, ZHENYU YANG and TINA HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`PETITIONER’S UNOPPOSED MOTION FOR PRO HAC VICE
`ADMISSION OF DON J. MIZERK UNDER 37 C.F.R. 42.10(c)
`
`1 The identical paper is filed in each proceeding identified in the caption.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`IPR2023-00049 (Patent 7,713,947 B2)
`IPR2023-00050 (Patent 8,377,903 B2)1
`
`Before ULRIKE W. JENKS, ZHENYU YANG and TINA HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`PETITIONER’S UNOPPOSED MOTION FOR PRO HAC VICE
`ADMISSION OF DON J. MIZERK UNDER 37 C.F.R. 42.10(c)
`
`1 The identical paper is filed in each proceeding identified in the caption.
`
`
`
`
`
`EXHIBIT LIST
`
`EXHIBIT
`Ex. 1001
`
`DESCRIPTION
`US 7,713,947 B2.
`
`Ex. 1002
`
`Ex. 1003
`
`Ex. 1004
`
`Ex. 1005
`
`Ex. 1006
`
`US 8,377,903 B2.
`File History for Ser. No. 11/722,018, which
`issued as the ’947 patent.
`File History Ser. No. 12/766,173, which issued
`as the ’903 patent.
`Declaration of Dr. Benjamin M. Greenberg,
`M.D.
`Curriculum Vitae of Dr. Benjamin M.
`Greenberg, M.D.
`Ex. 1007 WO 2004/087101 A2.
`Ex. 1008
`Rice, George P.A., Massimo Filippi, and
`Giancarlo Comi. “Cladribine and progressive
`MS: clinical and MRI outcomes of a multicenter
`controlled trial.” Neurology Vol. 54, no. 5 (2000)
`pp. 1145–1155.
`Liliemark, Jan. “The clinical pharmacokinetics of
`cladribine.” Clinical pharmacokinetics Vol. 32,
`no. 2 (1997) pp. 120–131.
`Ex. 1010 Merck KGaA et al v. Accord Healthcare, Inc. et
`al 1-22-cv-00974 (DDE) Complaint.
`EMD Serano Inc., Mavenclad® (Cladribine)
`Package Insert, Mar. 2019
`Lublin FD, Reingold SC. Defining the clinical
`course of multiple sclerosis: results of an
`international survey. Neurology 1996;46:907–
`911.
`National Multiple Sclerosis Society, What is MS,
`Types of MS,
`https://www.nationalmssociety.org/What-is-
`MS/Types-of-MS, retrieved Sept. 20, 2022.
`National Multiple Sclerosis Society, What is MS,
`Types of MS, Secondary Progressive MS,
`https://www.nationalmssociety.org/What-is-
`
`Ex. 1009
`
`Ex. 1011
`
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`SHORT FORM
`’947 Patent
`
`’903 Patent
`’018 File
`Wrapper
`’173 File
`Wrapper
`Greenberg
`Decl.
`Greenberg CV
`
`Bodor ‘WO 101
`
`Rice 2000 or
`Rice
`
`Liliemark 1997
`
`Merck
`Complaint
`Mavenclad
`Package Insert
`
`Lublin 1996
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT
`
`Ex. 1015
`
`Ex. 1016
`
`Ex. 1017
`
`Ex. 1018
`
`Ex. 1019
`
`Ex. 1020
`
`Ex. 1021
`
`Ex. 1022
`
`Ex. 1023
`
`Ex. 1024
`
`Ex. 1025
`
`DESCRIPTION
`MS/Types-of-MS/Secondary-progressive-MS.
`Casanova, B., et al. “High clinical inflammatory
`activity prior to the development of secondary
`progression: a prospective 5-year follow-up
`study,” Multiple Sclerosis Journal, Feb. 2002,
`pp. 59-63, vol. 8.
`Romine, J. et al. “A Double-Blind, Placebo-
`Controlled, Randomized Trial of Cladribine in
`Relapsing-Remitting Multiple Sclerosis,”
`Proceedings of the Association of American
`Physicians, Jan./Feb. 1999, pp. 35-44, vol. 111,
`No. 1.
`Immunex Corporation, Novantrone®
`(Mixantrone) Package Insert, Oct. 13, 2000
`(“Novantrone® Package Insert”).
`Langtry, H. et al. “Cladribine: A Review of its
`Use in Multiple Sclerosis,” Biodrugs, May 1998,
`pp. 419-433, vol. 9, No. 3.
`Biogen Idec Inc., Tysarbi® (natazlizumab)
`Package Insert, Nov. 2004.
`Chiron Corporation, Betaseron® (Interferon
`beta- lb) Package Insert, 1993.
`Biogen, Inc., Avonex™ (Interferon Beta-1a)
`Package Insert, Nov. 1996.
`Teva Pharms USA, Copaxone® (glatiramer
`acetate for injection) Package Insert, 2001.
`Serano, Inc., Rebif® (Interferon Beta-1a)
`Package Insert, May 2003.
`Cursiefen, Simone, et al. “Escalating
`immunotherapy with mitoxantrone in patients
`with very active relapsing-remitting or
`progressive multiple sclerosis,” European
`neurology, Apr. 2000, pp. 186–187, vol. 43, No.
`3.
`Burt, Richard K., et al. “Treatment of
`autoimmune disease by intense
`immunosuppressive conditioning and autologous
`hematopoietic stem cell transplantation,” Blood,
`The Journal of the American Society of
`Hematology, Nov. 1998, pp. 3505–3514, vol.
`92, No. 10.
`
`SHORT FORM
`
`Casanova 2002
`
`Romine 1999
`
`Novantrone
`Package Insert
`
`Langtry 1998
`
`Tysabri Package
`Insert
`Betaseron
`Package Insert
`Avonex
`Package Insert
`Copaxone
`Package Insert
`Rebif Package
`Insert
`
`Cursiefen 2000
`
`Burt 1998
`
`
`
`
`
`DESCRIPTION
`Tortorella, Carla, et al. “Cladribine. Ortho
`Biotech Inc.” Current Opinion in Investigational
`Drugs, Dec. 2001, pp. 1751–1756, vol. 2, no. 12.
`Beutler, E. et al. “The treatment of chronic
`progressive multiple sclerosis with cladribine,”
`Proc. Natl. Acad. Sci. USA, Feb. 1996, pp.
`1716–1720, vol. 93.
`Coles, Alasdair, et al. “Campath-1H treatment of
`multiple sclerosis: lessons from the bedside for
`the bench,” Clinical neurology and
`neurosurgery, June 2004, pp. 270–274, vol. 106,
`no. 3.
`U.S. Patent No. 7,888,328
`Center for Disease Control, Office of Enterprise
`Communication, Press Release, Oct. 27, 2004,
`https://www.cdc.gov/media/pressrel/r041027.ht
`m.
`Selby, R. et al. “Safety and Tolerability of
`Subcutaneous Cladribine Therapy in Progressive
`Multiple Sclerosis,” Can. J. Neurol. Sci., 1998,
`pp. 295-299, vol. 25.
`Docket Navigator Printout of Case Activity for
`Merck KGaA et al v. Accord Healthcare, Inc. et
`al
`Food and Drug Administration, Orange Book:
`Approved Drug Products with Therapeutic
`Equivalence Evaluations, Patent and Exclusivity
`for: N022561,
`https://www.accessdata.fda.gov/scripts/cder/ob/p
`atent_info.cfm?Product_No=001&Appl_No=02
`2561&Appl_type=N, retrieved Oct. 5, 2022.
`Ex. 1034 Merck KGaA et al v. Accord Healthcare, Inc. et
`al 1-22-cv-00974 (DDE) Answer.
`Declaration of A. Lauren Hitchens
`(exhibit not filed)
`Declaration of Don J. Mizerk
`
`Ex. 1029
`Ex. 1030
`
`Ex. 1031
`
`Ex. 1032
`
`Ex. 1033
`
`Ex. 1035
`
`Ex. 1036
`
`
`
`EXHIBIT
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`SHORT FORM
`
`Tortorella 2001
`
`Beutler 1996
`
`Coles 2004
`
`Bodor ’328
`
`CDC Press
`Release
`
`Selby 1998
`
`
`
`
`
`Accord
`Complaint
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.10(c), Petitioner TWi Pharmaceuticals Inc.
`
`(“Petitioner”) respectfully requests that the Patent Trial and Appeal Board admit Don
`
`J. Mizerk pro hac vice in this proceeding. Petitioner has conferred with Patent Owner
`
`Merck Serono SA (“Patent Owner”) and Patent Owner does not object to Petitioner’s
`
`request.
`
`STATEMENT OF FACTS
`
`In accordance with 37 C.F.R. § 42.10(c),
`
`[t]he 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. For example, where the 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 showing that counsel is an
`experienced litigating attorney and has an established familiarity with
`the subject matter at issue in the proceeding.
`
`Good cause exists for the Board to recognize Don J. Mizerk pro hac vice in
`
`this proceeding. Petitioner’s lead counsel in this proceeding, Philip D. Segrest, Jr.,
`
`is a registered patent practitioner (Reg. No. 39,021). Accompanying the instant
`
`motion is the Declaration of Don J. Mizerk (Ex. 1036) attesting to the information
`
`required by “Order – Authorizing Motion for Pro Hac Vice Admission” in Unified
`
`Patents, Inc. v. Parallel Iron, LLC, Case No. IPR2013-00639, Paper No. 7 (October
`
`15, 2013). Mr. Mizerk is an experienced litigation attorney (Ex. 1036 at ¶¶ 1-3),
`
`– 1 –
`
`
`
`including 26 years of predominantly patent infringement litigation experience, and
`
`has established familiarity with the subject matter in this proceeding. Id. at ¶¶ 2, 10,
`
`11.
`
`Mr. Mizerk attests to the remaining matters set forth in Paper No. 7 of Unified
`
`Patents in paragraphs 3 to 11 of his Declaration. Id. at ¶¶ 3-11.
`
`Additional facts constitute good cause to grant the instant motion. Lead
`
`counsel and backup counsel, Nathan P. Sportel and Steven R. Howe, have conflicting
`
`litigation obligations that may present themselves during the pendency of the
`
`proceeding. Mr. Mizerk will support lead and backup counsel as scheduling conflicts
`
`arise in this proceeding.
`
`DECLARATION OF INDIVIDUAL SEEKING TO APPEAR
`
`This Unopposed Motion for Pro Hac Vice Admission is accompanied by the
`
`required Declaration of Don J. Mizerk (Ex. 1036).
`
`CONCLUSION
`
`For the foregoing reasons, Petitioner respectfully requests the Patent Trial
`
`and Appeal Board admit Don J. Mizerk pro hac vice in this proceeding.
`
`– 2 –
`
`
`
`February 28, 2024
`
`Respectfully submitted,
`/Philip D. Segrest, Jr./
`Philip D. Segrest ,Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`
`Nathan P. Sportel
`Steven R. Howe
`Backup Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`– 3 –
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.105, Petitioner certifies that the foregoing
`
`document was served via electronic mail to the attorneys of record in this proceeding
`
`at the following:
`
`Emily R. Whelan (Reg. No. 50,391)
`Emily.Whelan@wilmerhale.com
`Deric X. Geng, Ph.D. (Reg. No. 73,434)
`Deric.Geng@wilmerhale.com
`Cindy Kan (Reg. No. 76,385)
`Cindy.Kan@wilmerhale.com
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Counsel for Patent Owner
`
`February 28, 2024
`
`/Philip D. Segrest, Jr./
`Philip D. Segrest, Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`
`Nathan P. Sportel
`
`Steven R. Howe
`Backup Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`– 4 –
`
`
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