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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`————————————————
`Case No. IPR2018-01676
`Patent No. 8,603,044
`————————————————
`
`
`MYLAN PHARMACEUTICALS INC.
`UNOPPOSED MOTION FOR PRO HAC VICE RECOGNITION
`37 CFR §42.10(c)
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`I.
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` PRECISE RELIEF REQUESTED
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`Petitioner (Mylan) moves for Elham F. Steiner to be recognized pro hac vice
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`for this proceeding. 37 CFR §42.10(c); Paper 6, citing Unified Patents, Inc. v.
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`Parallel Iron, LLC, IPR2013-00639, Paper 7 (2013) (representative). Patent Owner
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`(Sanofi) has indicated that it will not oppose. A Declaration (EX1040) from Ms.
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`Steiner accompanies this Motion.
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`II. STATEMENT OF FACTS
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`1. Ms. Steiner is a member in good standing of the state bars of New York
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`and California, of the United States Court of Appeals for the Federal Circuit, and of
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`numerous United States District Courts. EX1040, ¶1.
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`2. Ms. Steiner has not been suspended or disbarred from practice before any
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`court or administrative body. Id., ¶2.
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`3.
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`No court or administrative body has denied an application for admission
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`from Ms. Steiner. Id., ¶3.
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`4.
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`No court or administrative body has imposed sanctions or contempt
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`citations imposed on Ms. Steiner. Id., ¶4.
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`5. Ms. Steiner has read and will comply with the Office Patent Trial
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`Practice Guide (and update) and the Board’s Rules of Practice for Trials set forth in
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`part 42 of title 37 of the Code of Federal Regulations. Id., ¶5.
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`6. Ms. Steiner agrees to be subject to the USPTO Rules of Professional
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`Conduct set forth in 37 C.F.R. §§ 11.101 et seq. and to disciplinary jurisdiction under
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`37 C.F.R. § 11.19(a). Id., ¶6.
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`7. Within the last three years, Ms. Steiner only appeared pro hac vice before
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`the Board in Mylan Technologies, Inc. v. MonoSol RX, LLC (IPR2017-00200) and in
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`related proceedings for Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland
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`GmbH (IPR2017-01526 and IPR2017-01528). Id., ¶7.
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`8. Ms. Steiner is counsel for Mylan GmbH in the related district court
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`litigation with Sanofi-Aventis U.S. LLC, et al. v. Mylan GmbH, et al., No. 2:17-cv-
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`09105 (D.N.J.), filed October 24, 2017. As a result, Ms. Steiner has particular
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`experience and familiarity with the substantive and technical issues involved in these
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`proceedings from that representation, and from coordination in these proceedings. Id.,
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`¶8.
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`9. Ms. Steiner is a patent litigation attorney with experience representing
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`clients in multiple jurisdictions, including United States District Courts and the
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`Federal Circuit Court of Appeals. Ms. Steiner has experience in all stages of litigation,
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`from preliminary injunction through trial and appeal, and across a wide range of
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`technologies, including pharmaceutical-related technologies. Her pertinent
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`biographical background appears in an addendum to her declaration. Id., ¶9 (citing
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`EX1041 (Elham F. Steiner, Attorney Biography)).
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`10. Ms. Steiner has reviewed in detail U.S. Patent No. 8,603,044 and the
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`parties’ submissions in the present proceeding. EX1040, ¶10.
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`III. REASONS FOR THE REQUESTED RELIEF
`Through Ms. Steiner’s representation in these and related matters, Mylan has
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`
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`developed a relationship with Ms. Steiner, which Mylan wants to continue for the
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`purpose of these proceedings. Sanofi has asserted a large number of patents and
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`claims against Mylan, making Ms. Steiner’s active involvement in all proceedings for
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`purposes of coordination invaluable. Her educational background, general litigation
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`experience, successful admission before other tribunals, and experience with this
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`proceeding in particular make her well suited for pro hac vice admission in these
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`proceedings.
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`IV. DECLARATION OF MS. STEINER
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`A declaration from Ms. Steiner (EX1040) accompanies this motion.
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`V. CONCLUSION
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`Good cause warrants the recognition of Ms. Steiner pro hac vice. Mylan
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`respectfully requests that the Board grant this unopposed motion.
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`
`
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`Date: 28 February 2019
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`
`
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`Respectfully submitted,
`
`/ Wesley E. Derryberry /
`Wesley E. Derryberry, Back-up Counsel
`Reg. No. 71,594
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`UPDATED EXHIBIT LIST
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`
`Exhibit No.
`1001
`
`Description
`U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
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`1008
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`1009
`
`1010
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`1011
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`1012
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`1013
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`1014
`
`1015
`
`U.S. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013)
`U.S. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015)
`
`U.S. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016)
`
`U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug
`Delivery Devices (issued Mar. 28, 2017)
`File History for U.S. Patent 8,679,069
`
`File History for U.S. Patent 8,603,044
`
`File History for U.S. Patent 8,992,486
`
`File History for U.S. Patent 9,526,844
`
`File History for U.S. Patent. 9,604,008
`
`Expert Declaration of Karl Leinsing MSME, PE in Support of Petition
`for Inter Partes Review of U.S. Patent Nos. 8,679,069; 8,603,044;
`8,992,486; 9,526,844 and 9,604,008
`Curriculum Vitae of Karl Leinsing MSME,PE
`
`U.S. Patent 6,221,046 - A. Burroughs et al., “Recyclable Medication
`Dispensing Device” (issued Apr. 24, 2001)
`U.S. Patent 6,235,004 – S. Steenfeldt-Jensen & S. Hansen, “Injection
`Syringe” (issued May 22, 2001)
`U.S. Patent Application US 2002/0053578 A1 – C.S. Møller, “Injection
`Device” (pub’d May 2, 2002)
`
`-5-
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`
`
`Case No. IPR2018-01676
`Patent No. 8,603,044
`
`Exhibit No.
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`Description
`U.S. Patent 6,932,794 B2 – L. Giambattista & A. Bendek, “Medication
`Delivery Pen” (issued Aug. 23, 2005)
`U.S. Patent 6,582,404 B1 – P.C. Klitgaard et al., “Dose Setting Limiter”
`(issued June 24, 2003)
`File History for U.S. Patent 6,582,404
`
`Plaintiffs’ Preliminary Claim Constructions and Preliminary
`Identification of Supporting Intrinsic and Extrinsic Evidence,
`Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105
`(D.N.J.) (filed Sep. 5 2018)
`U.S. Patent 4,865,591 – B. Sams, “Measured Dose Dispensing Device”
`(issued Sep. 12, 1989)
`U.S. Patent 6,248,095 B1 – L. Giambattista et al., “Low-cost
`Medication Delivery Pen” (issued June 19, 2001)
`U.S. Patent 6,921,995 B1 – A.A. Bendek et al., “Medication Delivery
`Pen Having An Improved Clutch Assembly” (issued July 13, 1999)
`U.S. Patent 5,226,895 – D.C. Harris, “Multiple Dose Injection Pen”
`(issued July 13, 1993)
`U.S. Patent 5,851,079 – R.L. Horstman et al., “Simplified
`Unidirectional Twist-Up Dispensing Device With Incremental
`Dosing” (issued Dec. 22, 1998)
`Application as filed: U.S. Patent App. 14/946,203 – R.F. Veasey,
`“Relating to a Pen-Type Injector” (filed Nov. 19, 2015)
`GB 0304822.0 – “Improvements in and relating to a pen-type injector”
`(filed Mar. 3, 2003) (‘844 Priority Doc.)
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`-6-
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`Exhibit No.
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`1027
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`1028
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`1029
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`1030
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`1031
`
`1032
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`1033
`
`1034
`
`1035
`
`Description
`WO 99/38554 – S.Steenfeldt-Jensen & S.Hansen, “An Injection
`Syringe” (pub’d Aug. 5, 1999) (Steenfeldt-Jensen PCT)
`Mylan GmbH and Biocon’s Preliminary Claim Constructions and
`Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis U.S.,
`LLC v. Mylan N.V., C.A. No. 17-cv-09105 (filed Sep. 5, 2018)
`Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp &
`Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018)
`Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lilly and Co.,
`No. 14-cv-113 (filed Jan. 20, 2015)
`N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices
`Sourcebook 191-95, “Twenty Screw Devices” (3d ed., July 2, 2001)
`EP 0 608 343 B1 – L. Petersen & N.-A. Hansen, “Large Dose Pen”
`(pub’d Oct. 18, 1991)
`A.G. Erdman &G.N. Sandor, “ Mechanical Advantage”, §3.7 in
`1 Mechanism Design: Analysis and Synthesis (1984)
`WO 01/83008 – S. Hansen & T.D. Miller., “An Injection Device, A
`Preassembled Dose Setting And Injection Mechanism For An
`Injection Device, And A Method Of Assembling An Injection Device”
`(pub’d Nov. 8, 2001)
`K.J. Lipska et al., Association of Initiation of Basal Insulin Analogs vs
`Neutral Protamine Hagedorn Insulin With Hypoglycemia-Related
`Emergency Department Visits or Hospital Admissions and With
`Glycemic Control in Patients With Type 2 Diabetes, 320 J. Am.
`Med. Ass’n 53-62 (2018)
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`-7-
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`Exhibit No.
`1036
`
`Description
`Transcript, Conference Call (January 15, 2019)
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`1037
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`1038
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`1039
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`1040
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`1041
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`Reserved
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`Graph showing PTAB Days to Docketing for Review Proceedings filed
`between 2016-2018
`Reserved
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`Declaration of Elham F. Steiner in Support of Petitioner’s Motion for
`Pro Hac Vice Admission
`Elham F. Steiner, Attorney Biography
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`-8-
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`Case No. IPR2018-01676
`Patent No. 8,603,044
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`CERTIFICATE OF SERVICE
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`I certify that on 28 February 2019 a true and correct copy of Unopposed
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`Motion for Pro Hac Vice Recognition, EX1040, and EX1041 were served on the
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`patent owner at the email correspondence addresses of the patent owner as follows:
`
`
`Elizabeth Stotland Weiswasser
`Anish R. Desai
`Kathryn M. Kantha
`William S. Ansley
`Matthew D. Sieger
`WEIL, GOTSHAL & MANGES LLP
`
`
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`kathryn.kantha@weil.com
`sutton.ansley@weil.com
`matthew.sieger@weil.com
`Sanofi.IPR.Service@weil.com
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`Respectfully submitted,
`
`
`
`
`Date: 28 February 2019
`
`
`
`
`/ Wesley E. Derryberry /
`Wesley E. Derryberry, Back-up Counsel
`Reg. No. 71,594
`
`
`
`-9-
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`
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