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. IPR2018-01675
`
`Patent No. 8,603,044
`
`PETITIONER MYLAN’S MOTION TO CORRECT
`
`37 CFR §42.104(c)
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`Case No. IPR2018-01675
`
`Patent No. 8,603,044
`
`PETITIONER MYLAN’S MOTION TO CORRECT
`
`37 CFR §42.104(c)
`
`
`
`1. Statement of requested relief
`
`Petitioner (“Mylan”) requests correction of the petition (Paper 2) at page 25
`
`to reflect that the citation “EX1011, 11165; cf. EX1002, 3 :42-44 (describing threads
`
`may include part threads).” should read “EX1011, 11165; cf. EX1002, 3 :62-64
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`(describing threads may include part threads).” That is, the “42-44” should be “62-
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`64”. Mylan believes that the accompanying exhibit (EX1037) provides adequate
`
`clarification for the record, but will submit a corrected petition if the Board prefers.
`
`2. Reasons for relief
`
`This motion is timely filed pursuant to an email authorization from Andrew
`
`Kellogg. 37 CFR §42.2(“Board”)(1). The petition contains a typographical error
`
`that substitutes “42-44” for “62-64”. The accompanying parenthetical and textual
`
`context make the nature of the error self-evident: the citation identifies a sentence
`
`“In the illustrated embodiment the second thread 24 comprises a series of part
`
`threads rather than a complete thread.” in EX1002 (the involved patent of Patent
`
`Owner (“Sanofi”)) to support a discussion of a discontinuous helical rib in the
`
`petition. Mylan regrets the error, but does not believe citing the wrong lines in the
`
`correct column for parenthetically described text in Sanofi’s own patent creates
`
`any significant prejudice for Sanofi. Pursuant to the Board’s instruction (EX1036,
`
`16:14-17-7), the parties conferred on filing a correction exhibit or paper, but
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`despite discussing a variety of options could not agree on the scope of Sanofi’s
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`-1-
`
`
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`response to the correction. To the extent a further Sanofi response to the correction
`
`is deemed appropriate, the Board can set its own limits on the response.
`
`3. Conclusion
`
`Mylan requests the Board to grant this motion and accept EX1037 as
`
`sufficient correction of the petition.
`
`Date: 30 January 2019
`
`/ Richard Torczon/
`Richard Torczon, Lead Counsel
`
`Reg. No. 34,448
`
`
`
`UPDATED EXHIBIT LIST
`
`Description
`Exhibit No.
`
`
`1001
`
`US. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)
`
`1002
`
`US. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013)
`
`1003
`
`US. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015)
`
`1004
`
`US. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016)
`
`
`
`1005
`
`US. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug
`
`Delivery Devices (issued Mar. 28, 2017)
`
`1006
`
`File History for US. Patent 8,679,069
`
`1007
`
`File History for US. Patent 8,603,044
`
`
`
`1008
`
`File History for US. Patent 8,992,486
`
`
`
`1009
`
`File History for US. Patent 9,526,844
`
`1010
`
`File History for US. Patent. 9,604,008
`
`Expert Declaration of Karl Leinsing MSME, PE in Support of
`
`Petition for Inter Partes Review of US. Patent Nos. 8,679,069;
`
`8,603,044; 8,992,486; 9,526,844 and 9,604,008
`
`
`
`
`
`Exhibit No.
`
`Description
`
`1012
`
`Curriculum Vitae of Karl Leinsing MSME,PE
`
`1013
`
`1014
`
`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)
`
`
`1015
`
`U.S. Patent Application US 2002/0053 578 A1 — C.S. Muller, “Injection
`
`Device” (pub’d May 2, 2002)
`
`1016
`
`U.S. Patent 6,932,794 B2 — L. Giambattista & A. Bendek,
`“Medication Delivery Pen” (issued Aug. 23, 2005)
`
`
`
`1017
`
`U.S. Patent 6,582,404 B1 — P.C. Klitgaard et al., “Dose Setting
`Limiter” (issued June 24, 2003)
`
`
`1018
`
`File History for U.S. Patent 6,582,404
`
`Plaintiffs’ Preliminary Claim Constructions and Preliminary
`
`1019
`
`Identification of Supporting Intrinsic and Extrinsic Evidence,
`
`Sanofi-Aventis U.S. LLC v. Mylan GmbH, N0. 2:17-cv-09105
`
`(D.N.J.) (filed Sep. 5 2018)
`
`1020
`
`U.S. Patent 4,865,591 — B. Sams, “Measured Dose Dispensing
`
`Device” (issued Sep. 12, 1989)
`
`1021
`
`U.S. Patent 6,248,095 B1 — L. Giambattista et al., “Low-cost
`Medication Delivery Pen” (issued June 19, 2001)
`
`
`
`
`
`Exhibit No.
`
`Description
`
`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
`
`Unidirectional Twist-Up Dispensing Device With Incremental
`
`Dosing” (issued Dec. 22, 1998)
`
`Application as filed: US. Patent App. 14/946,203 — R.F. Veasey,
`
`“Relating to a Pen-Type Injector” (filed Nov. 19, 2015)
`
`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)
`
`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)
`
`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)
`
`
`
`
`
`Exhibit No.
`
`Description
`
`N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices
`
`1031
`
`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)
`
`1033
`
`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
`
`1 034
`
`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-
`
`1035
`
`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)
`
`1037
`
`Redlined copy of page 25 of the petition (Paper 2) showing
`
`correction of typographical error.
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that this Motion with Updated Exhibit List and EX1037 were served
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`on 30 January 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
`
`Kathryn M. Kantha
`
`kat
`
`n.kantha weil.com
`
`William S. Ansley
`
`sutton.ansley@weil.com
`
`Matthew D. Sieger
`
`matthew.sieger@weil.com
`
`WEIL, GOTSHAL & MANGES LLP Sanof1.IPR.Service@weil.com
`
`Date: 30 January 2019
`
`Respectfully submitted,
`
`/ Richard Torczon/
`Richard Torczon, Lead Counsel
`
`Reg. No. 34,448
`
`
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