UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`
`Exhibit No.
`
`Description
`
`U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug
`
`1005
`Delivery Devices (issued Mar. 28, 2017)
`
`
`1006
`
`1007
`
`1008
`
`1009
`
`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
`1010
`
`
`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 2002/0053 578 A1 — C.S. Moller, “Injection
`
`Device” (pub’d May 2, 2002)
`
`U.S. Patent 6,932,794 B2 — L. Giambattista & A. Bendek, “Medication
`
`Delivery Pen” (issued Aug. 23, 2005)
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`
`Exhibit No.
`
`Description
`
`US. Patent 6,582,404 B1 — P.C. Klitgaard et al., “Dose Setting Limiter”
`
`(issued June 24, 2003)
`
`1018
`
`File History for US. Patent 6,582,404
`
`Plaintiffs’ Preliminary Claim Constructions and Preliminary
`
`1019
`
`Identification of Supporting Intrinsic and Extrinsic Evidence,
`Sanofi-Aventis US. LLC v. Mylan GmbH, N0. 2:17-cv-09105
`
`(D.N.J.) (filed Sep. 5 2018)
`
`US. Patent 4,865,591 — B. Sams, “Measured Dose Dispensing Device”
`
`
`
`(issued Sep. 12, 1989)
`
`US. Patent 6,248,095 B1 — L. Giambattista et al., “Low-cost
`
`Medication Delivery Pen” (issued June 19, 2001)
`
`US. Patent 6,921,995 B1 — A.A. Bendek et al., “Medication Delivery
`
`Pen Having An Improved Clutch Assembly” (issued July 13, 1999)
`
`US. Patent 5,226,895 — D.C. Harris, “Multiple Dose Injection Pen”
`
`(issued July 13, 1993)
`
`US. Patent 5,851,079 — R.L. Horstman et al., “Simplified
`
`1024
`
`Unidirectional Twist-Up Dispensing Device With Incremental
`
`Dosing” (issued Dec. 22, 1998)
`
`1025
`
`Application as filed: US. Patent App. 14/946,203 — R.F. Veasey,
`“Relating to a Pen-Type Injector” (filed Nov. 19, 2015)
`
`1026
`
`1027
`
`GB 03 04822.0 — “Improvements in and relating to a pen-type injector”
`(filed Mar. 3, 2003) (‘844 Priority Doc.)
`
`W0 99/3 8554 — S.Steenfeldt-Jensen & S.Hansen, “An Injection
`Syringe” (pub’d Aug. 5, 1999) (Steenfeldt—Jensen PCT)
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`
`Exhibit No.
`
`Description
`
`Mylan GmbH and Biocon’s Preliminary Claim Constructions and
`
`Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis US,
`
`LLC v. Mylan N. V., CA. No. 17-cv-09105 (filed Sep. 5, 2018)
`
`
`1029
`
`1030
`
`Memorandum Opinion, Sanofi-Aventis US. LLC v. Merck Sharp &
`
`Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018)
`
`Memorandum Opinion, Sanofi -Aventis US. 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)
`
`1031
`
`
`
`1032
`
`1033
`
`1034
`
`EP 0 608 343 B1 — L. Petersen & N.-A. Hansen, “Large Dose Pen”
`(pub’d Oct. 18, 1991)
`
`AG. 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 OfAssembling An Injection Device”
`
`(pub’d Nov. 8, 2001)
`
`K.J. Lipska et al., Association ofInitiation ofBasal 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)
`
`103 6
`
`Transcript, Conference Call (January 15, 2019)
`
`103 7
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`
`Exhibit No.
`
`Description
`
`1038
`
`Graph showing PTAB Days to Docketing for Review Proceedings filed
`between 2016-2018
`
`Declaration of Elham F. Steiner in Support of Petitioner’s Motion for Pro Hac Vice Admission
`
`Elham F. Steiner — Attorney Biography
`
`Transcript of Telephone Conference on June 19, 2019.
`
`Date: 1 July 2019
`
`Respectfully submitted,
`
`/ Richard Torczon/
`Richard Torczon, Lead Counsel
`
`Reg. No. 34,448
`
`
`
`Case No. IPR2018-01676
`
`Patent No. 8,603,044
`
`CERTIFICATE OF SERVICE
`
`I certify that the foregoing Petitioner’s Updated Exhibit List and EX.1042 were
`
`served on 1 July 2019, on the Patent Owner at the email correspondence address of the
`
`Patent Owner as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`anish.desai@weil.com
`
`Sundip K. Kundu
`
`sundip_.kundu@weil.com
`
`Kathryn M. Kantha
`
`kat
`
`n.kantha weil.com
`
`William S. Ansley
`
`sutton.ansley@weil.com
`
`Matthew D. Sieger
`
`matthew.sieger@weil.com
`
`Adrian C. Percer
`
`Brian C. Chang
`
`adrian.p_ercer@weil.com
`
`brian.chan weil.com
`
`WEIL, GOTSHAL & MANGES LLP
`
`Sanof1.IPR.Service@weil.com
`
`FISH & RICHARDSON
`
`PTABInbound@fr.com
`
`Date: 1 July 2019
`
`Respectfully submitted,
`
`/ Richard Torczon/
`Richard Torczon, Lead Counsel
`
`Reg. No. 34,448
`
`
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