`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC. and,
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`PFIZER, INC.,
`Petitioner
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`PETITIONER’S UPDATED EXHIBIT LIST
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
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`Description
`U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)
`
`1001
`
`1002
`
`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`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)
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`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
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`File History for U.S. Patent 8,603,044
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`File History for U.S. Patent 8,992,486
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`File History for U.S. Patent 9,526,844
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`File History for U.S. Patent. 9,604,008
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`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)
`U.S. Patent 6,932,794 B2 – L. Giambattista & A. Bendek, “Medication
`Delivery Pen” (issued Aug. 23, 2005)
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`-2-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`Exhibit No.
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`Description
`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.)
`WO 99/38554 – S. Steenfeldt-Jensen & S. Hansen, “An Injection
`Syringe” (pub’d Aug. 5, 1999) (Steenfeldt-Jensen PCT)
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`-3-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`Exhibit No.
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`1028
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`1029
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`1030
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`1031
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`1032
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`1033
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`1034
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`1035
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`1036
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`1037
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`Description
`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)
`Transcript, Conference Call (January 15, 2019)
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`Redlined Petition Page 25
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`-4-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
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`Description
`Graph showing PTAB Days to Docketing for Review Proceedings filed
`between 2016-2018
`Transcript, Conference Call (February 13, 2019)
`
`1038
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`1039
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`1040
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`1041
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`1042
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`1043
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`1044
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`1045
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`1046
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`1047
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`1048
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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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`Reserved
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`Transcript of Telephone Conference on July 25, 2019.
`
`Nat’l. Diabetes Statistic Report 2017, “Estimates of Diabetes and Its
` Burden in the United States, CDC, p.1-20
`Teresa L. Pearson, “Practical Aspects of Insulin Pen Devices”, Journal
`of Diabetes Science and Technology, Vol. 4, Issue 3, May 2010,
`p.522-531
`Nancy J.V. Bohannon, “Insulin Delivery Using Pen Devices”,
`Postgraduate Medicine, Vol. 106, No.5, Oct. 15, 1999, p. 57-68,
`ISSN: 0032-5481 (Print) 1941-9260 – (Online) Journal homepage:
`https://www.tandfonline.com/loi/ipgm20
`Marilyn R. Graff, RN, CDE et al., “Assessment by Patients with
`Diabetes Mellitus of Two Insulin Pen Delivery Systems Versus a
`Vial and Syringe”, Clinical Therapeutics, Vol. 20, No. 3, 1998,
`p.486-196
`Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in
`Support of Mylan-Pfizer Reply
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`-5-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
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`Description
`Curriculum Vitae of William Curtis Biggs, M.D., FACE, ECNU
`
`1049
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`1050
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`1051
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`1052
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`1053
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`1054
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`1055
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`1056
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`1057
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`1058
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`1059
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`1060
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`1061
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`1062
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`Slocum Deposition Exhibit 1050: Annotations of EX2107 (Declaration
`of Alexander Slocum Ph.D.)
`Slocum Deposition Exhibit 1051: Hand drawing of modified drive
`mechanism
`Slocum Deposition Exhibit 1052: Annotations of excerpted figures
`from EX2157
`Deposition of Alexander H. Slocum, Ph.D., August 27, 2019
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`Deposition of Alexander H. Slocum, Ph.D., Vol II, August 28, 2019
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`Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019
`
`Deposition of Robin Goland, Sep. 10, 2019
`
`Benita Lee, MPH, “How Much Does Insulin Cost? Here’s How 23
`Brands Compare”, Good RX, Aug. 23, 2019, pp. 1-11,
`https:www.goodrx.com/glo/how-much-does-insuling-cost,compare-
`brands/
`Certified English Translation of DE Patent 102 37 258A1, Dr. Roney
`Graf (Issued Mar. 182004)
`M. Eledrisi, et al., “Twice-Daily Insulin Glargine for Patients with
`Uncontrolled Type 2 Diabetes Mellitus, Journal of Clinical &
`Translational Endocrinology 15 (2019), p. 35-36
`Declaration and c.v. of DeForrest McDuff, Ph.D.
`
`2011 Orange Book (Excerpts)
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`2019 Orange Book (Excerpt – ADA 132 of 263)
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`-6-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
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`Description
`2011-02-09 - Sanofi SA Earnings Conference Call
`
`1063
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`1064
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`1065
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`1066
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`1067
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`1068
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`1069
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`1070
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`1071
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`1072
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`1073
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`1074
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`1075
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`2012-02-08 – Sanofi SA Earnings Conference Call
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`2013-02-26 – Sanofi SA at Citi Global HealthCare Conference
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`2014-02-06 – Sanofi SA Earnings Conference Call
`
`Asamoah et al., “Insulin Pen – The “iPod” for Insulin Delivery (Why
`Pen Wins Over Syringe)”, J. of Diabetes Sci. and Technology, Vol.
`2, Issue 2, March 2008, p.292-296
`Aventis 2002 20-F Form
`
`Aventis 2003 20-F Form
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`Sanofi-Aventis 2006 20 F Form
`
`Correa, Carlos, “Ownership of Knowledge – the Role of Patents in
`Pharmaceutical R&D”, Round Table, Bulletin of World Health
`Org., 2004; 82; p.1-7
`Carter, Alan W., “Analysis of the Injection Force of Solostar®
`Compared with Other Disposable Insulin Pen Devices At Constant
`Volume Flow Rates”, J. of Diabetes Sci. and Tech., Vol. 5, Issue 1,
`Jan. 2011, p. 156-157
`“About Diabetes”, CDC Basics, p.1-2,
`https://www.cdc.gov/diabetes/bascis/diabetes
`David, J. et al. “Commercial Success: Economic Principles Applied to
`Patent Litigation”, NERA Economic Consulting (copyrighted
`material), p. 159-160
`“Top Ten Tips on Writing Effectiveness Case Studies”, By Design
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
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`1076
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`1077
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`1078
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`1079
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`1080
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`1081
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`1082
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`1083
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`Description
`Business Association, May 23, 2016, p.1-5,
`https://www.dba.org.uk/review-top-ten-tips-on-writing-
`effectiveness-case-studies/
`DiMasi, J., et al. “Innovation in the Pharmaceutical Industry: New
`Estimates of R&D Costs”, J. of Health Economics47 (2016), p. 20-
`33
`Grabowski, H., et al. “Returns on Research and Development for 1990s
`New Drug Introductions”, Pharmacoeconomics 2002; 20 Suppl. 3:
`p. 11-29
`Pietrangelo, Ann “Levemir vs. Lantus: Similarities and Differences”,
`Healthline, Oct. 19, 2016, p.1-14,
`https://www.healthline.com/health/deiabetes/levemir-lantus
`“A21, B30, Modified Insulin Derivatives having An Altered Action
`Profile”, M. Dörschug (issued Aug. 12, 1997)
`Lewcock, Anna, “Sanofi’s SoloStar Hits US Market Despite Patent
`Suit”, in-Pharma Technologist.com, Jul. 20, 2007, https://www.in-
`pharmatechnologist.com/Article/2007/07/31/Sanofi-s-SoloStar-hits-
`US-market-despite-patent-suit
`Lantus, “Get to Know the Lantus® SoloStar® Insulin Pen, p. 1-7,
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`Lantus SoloStar Brochure: “High Blood Sugar, You’re Going Down”
`(2012)
`Lantus SoloStar Brochure: “Your Guide to the Lantus SoloStar Insulin
`Pen” (2010)
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`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`Exhibit No.
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`Description
`McDuff, et al., “Thinking Economically About Commercial Success”,
`Landslide, March/April 2017, p. 37-40
`Nonaka, H., “FTO (Freedom to Operate) in the Pharmaceutical
`Industry”, JSTOR, Pub. by Nomos Verlagsgesellschaft mbH (2018),
`p. 9-59
`Senate Comm. On Finance Questions for the Record, “Drug Pricing in
`America”: A Prescription for Change Part II, Questions for Olivier
`Brandicourt, CEO Sanofi, Feb. 26, 2019, p. 1-460
`S.G. Cowen, “Perspectives”, Pharmaceutical Therapeutic Categories
`Outlook, Oct. 2001, p.134-148
`Cowen and Co., “Diabetes: Many New Drugs, But Insulin Still
`Dominant”, Therapeutic Categories Outlook, Feb. 2015, p.477-491
`UBS Large Cap Pharmaceuticals Handbook, “U.S. Pharmaceuticals”,
`Apr. 6, 2018, p.45-53
`Campbell, K., “Insulin Costs Are Skyrocketing. This is Why”, U.S.
`New and World Report, Jun. 29, 2018, p.1-7
`U.S. Patent 5,656,722, “A21, B30, Modified Insulin Derivatives having
`An Altered Action Profile”, M. Dörschug (issued Aug. 12, 1997)
`U.S. Patent 7,476,652, “Acidic Insulin Preparations Having Improved
`Stability”, Brunner-Schwarz (issued Jan. 13, 2009)
`U.S. Patent 7,713,930, “Acidic Insulin Preparations Having Improved
`Stability”, Brunner-Schwarz (issued May 11, 2010)
`WebMD, “Types of Insulin for Diabetes Treatment”, p.1-7
`https://www.webmd.com/diabetes/diabetes-types-insulin#1
`
`1084
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`1085
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`1086
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`1087
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`1088
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`1089
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`1090
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`1091
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`1092
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`1093
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`1094
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`-9-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
`
`Description
`Reply Declaration of Karl Leinsing
`
`1095
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`1096
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`1097
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`1098
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`1099
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`1100
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`1101
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`1102
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`1103
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`1104
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`1105
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`1106
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`1107
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`1108
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`1109
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`1110
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`1111
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`1112
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`Declaration of Karl R. Leinsing, MSME, PE, In Support of Petitioner’s
`Oppositions to Sanofi’s Motion to Amend
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`SUPPLEMENTAL – Reply Declaration of Karl R. Leinsing, MSME,
`PE (Served – not filed)
`SUPPLEMENTAL –Declaration of Karl R. Leinsing, MSME, PE in
`Support Of Petitioners’ Oppositions to Sanofi’s Motion to Amend
`(Served – not filed)
`Reserved
`
`Reserved
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`Transcript of Telephone Conference on Dec. 11, 2019
`
`Reserved
`
`Reserved
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`-10-
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`Exhibit No.
`
`Description
`
`1113
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`1114
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`1115
`
`Reserved
`
`Transcript, Slocum direct testimony in Sanofi-Aventis U.S. LLC v.
`Mylan GmbH, Case 2:17-cv-09105-SRC-CLW (D.N.J., Dec. 4,
`2019)
`Transcript, Slocum direct testimony in Sanofi-Aventis U.S. LLC v.
`Mylan GmbH, Case 2:17-cv-09105-SRC-CLW (D.N.J., Dec. 5,
`2019)
`
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`
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`Date 18 December 2019
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`Respectfully submitted,
`
`/Richard Torczon/
`Richard Torczon
`Reg. 34,448
`Counsel for Mylan
`
`-11-
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`
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`
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`CERTIFICATE OF SERVICE
`
`I certify that this Petitioner’s Updated Exhibit List and Exhibits 1110, 1114 and
`
`1115 were served today on the electronic service addresses of the Patent Owner
`
`specified as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`Sundip K. Kundu
`
`anish.desai@weil.com
`
`sundip.kundu@weil.com
`
`Kathryn M. Kantha
`
`kathryn.kantha@weil.com
`
`William S. Ansley
`
`Matthew D. Sieger
`
`Adrian C. Percer
`
`Brian C. Chang
`
`Robert T. Vlasis
`
`sutton.ansley@weil.com
`
`matthew.sieger@weil.com
`
`adrian.percer@weil.com
`
`brian.chang@weil.com
`
`robert.vlasis@weil.com
`
`WEIL, GOTSHAL & MANGES LLP
`
`Sanofi.IPR.Service@weil.com
`
`John S. Goetz, Joshua A. Griswold,
`Matthew S. Colvin, Kenneth W. Darby
`and W. Karl Renner
`
`PTABInbound@fr.com
`
`and on joinder counsel as follows:
`
`-12-
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`
`
`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`
`Jovial Wong
`Charles B. Klein
`Dan H. Hoang
`WINSTON & STRAWN LLP
`
`jwong@winston.com
`cklein@winston.com
`dhoang@winston.com
`PfizerIPRs@winston.com
`
`
`
`
`
`
`
`
`Date 18 December 2019
`
`
`
`
`
`Respectfully submitted,
`
`/Richard Torczon/
`Richard Torczon
`Reg. 34,448
`
`-13-
`
`
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