Pfizer Inc. vs Sanofi-Aventis Deutschland et al.

Trial Certificate Checklist

Other: fed circuit mandate

Other: other court decision

Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a)

Termination Decision Document

Petitioner's Reply In Support Of Petitioner's Motion To Exclude

Patent Owner's Updated Exhibit List

Record of Oral Hearing Held on 1.15.2020

Patent Owner's Opposition to Petitioner's Motion to Exclude

Transcript of Telephone Conference on 6.19.19

Email from Patent Owner to Petitioner re: Supplemental Evidence

Order - Conduct of the Proceeding - 37 CFR 42.5

Ex. 3001

EXPUNGED

Petitioner's Motion to Exclude Evidence

Patent Owner¿¿¿s Mandatory Notices Pursuant to 37 C.F.R. ¿¿ 42.8(b)(3

Granting Patent Owners Motion for Withdrawal of Counsel 37 C.F.R. sec 42.10(e)

PETITIONER'S MANDATORY CHANGE-OF-INFORMATION NOTICES

Patent Owner's Request for Oral Argument

PETITIONER'S NOTICE REGARDING ORAL ARGUMENT

PETITIONER'S OBJECTIONS TO EVIDENCE SUBMITTED WITH PATENT OWNER SUR-REPLY

Expert Opinion on Drug Delivery, Instructions for Authors

Patent Owner's Sur-Reply

Deposition of DeForest McDuff, dated October 9, 2019

Deposition of William C. Biggs, dated October 15, 2019

Transcript of Telephonic conference between Sanofi, the Board, Pfizer and Mylan, dated Nov. 18, 2019, in IPR2018-1670, -1676, -1678, -1679, -1680, and -1682

Patent Owner¿¿¿s Motion for Withdrawal of Counsel

ORDER Changing Due Date 8

SUBMISSION OF CORRECTED EXHIBIT

Ex. 1088 (corrected copy) Cowen and Co., ¿¿¿Diabetes: Many New Drugs, But Insulin Still Dominant¿¿¿, Therapeutic Categories Outlook, Feb. 2015, p.477-491

Ex. 1044 - Nat'l. Diabetes Statistic Report 2017, Estimates of Diabetes and Its Burden in the United States, CDC, p.1-20

Ex. 1046 - 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

Ex. 1045 - Teresa L. Pearson, "Practical Aspects of Insulin Pen Devices", Journal of Diabetes Science and Technology, Vol. 4, Issue 3, May 2010, p.522-531

Ex. 1049 - Curriculum Vitae of William Curtis Biggs

Ex. 1050 - Slocum Deposition Exhibit 1050: Annotations of EX2107 (Declaration of Alexander Slocum Ph.D.)

Ex. 1051 - Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism

Ex. 1052 - Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157

Ex. 1053 - Deposition of Alexander H. Slocum, Ph.D., August 27, 2019

Ex. 1059 - 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

Ex. 1060 - Declaration and c.v. of DeForrest McDuff, Ph.D.

Ex. 1061 - 2011 Orange Book (Excerpts)

Ex. 1063 - 2011-02-09 - Sanofi SA Earnings Conference Call

Ex. 1047 - 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

Ex. 1048 - Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply

Ex. 1054 - Deposition of Alexander H. Slocum, Ph.D., Vol II, August 28, 2019

Ex. 1055 - Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019

Ex. 1056 - Deposition of Robin Goland, Sep. 10, 2019

Ex. 1057 - Benita Lee, MPH, "How Much Does Insulin Cost? Here¿¿¿s How 23 Brands Compare", Good RX, Aug. 23, 2019, pp. 1-11,

Ex. 1058 - Certified English Translation of DE Patent 102 37 258A1, Dr. Roney Graf (Issued Mar. 18, 2004)

Ex. 1062 - 2019 Orange Book (Excerpt ¿¿¿ ADA 132 of 263)

Ex. 1065 - 2013-02-26 ¿¿¿ Sanofi SA at Citi Global HealthCare Conference

Ex. 1066 - 2014-02-06 ¿¿¿ Sanofi SA Earnings Conference Call

Ex. 1067 - 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

Ex. 1064 - 2012-02-08 ¿¿¿ Sanofi SA Earnings Conference Call

Ex. 1069 - Aventis 2034 20-F Form

Ex. 1070 - Sanofi-Aventis 2006 20 F Form

Ex. 1080 - Lewcock, Anna, "Sanofi¿¿¿s SoloStar Hits US Market Despite Patent Suit", in-Pharma Technologist.com, Jul. 20, 2007

Ex. 1085 - Nonaka, H., "FTO (Freedom to Operate) in the Pharmaceutical Industry", JSTOR, Pub. by Nomos Verlagsgesellschaft mbH (2018), p. 9-59

Ex. 1086 - 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

Ex. 1068 - Aventis 2002 20-F Form

Ex. 1071 - 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

Ex. 1072 - 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

Ex. 1073 - "About Diabetes", CDC Basics, p.1-2,

Ex. 1074 - David, J. et al. "Commercial Success: Economic Principles Applied to Patent Litigation", NERA Economic Consulting (copyrighted material), p. 159-160

Ex. 1075 - "Top Ten Tips on Writing Effectiveness Case Studies", By Design Business Association, May 23, 2016, p.1-5

DiMasi, J., et al. "Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs", J. of Health Economics 47 (2016), p. 20-33

Ex. 1077 - Grabowski, H., et al. "Returns on Research and Development for 1990s New Drug Introductions", Pharmacoeconomics 2002; 20 Suppl. 3: p. 11-29

Ex. 1078 - Pietrangelo, Ann "Levemir vs. Lantus: Similarities and Differences", Healthline, Oct. 19, 2016, p.1-14

Ex. 1079 - U.S. Patent 6,100,376

Ex. 1081 - Lantus, "Get to Know the Lantus SoloStar Insulin Pen, p. 1-7

Ex. 1082 - Lantus SoloStar Brochure: "High Blood Sugar, You¿¿¿re Going Down" (2012)

Ex. 1083 - Lantus SoloStar Brochure: "Your Guide to the Lantus SoloStar Insulin Pen" (2010)

Ex. 1084 - McDuff, et al., "Thinking Economically About Commercial Success", Landslide, March/April 2017, p. 37-40

Ex. 1087 - S.G. Cowen, "Perspectives", Pharmaceutical Therapeutic Categories Outlook, Oct. 2001, p.134-148

EXPUNGED

Ex. 1089 - UBS Large Cap Pharmaceuticals Handbook, "U.S. Pharmaceuticals", Apr. 6, 2018, p.45-53

Ex. 1091 - U.S. Patent 5,656,722

Ex. 1093 - U.S. Patent 7,713,930

Ex. 1094 - WebMD, "Types of Insulin for Diabetes Treatment", p.1-7

Ex. 1095 - Reply Declaration of Charles Clemens

PETITIONER¿¿¿S UPDATED EXHIBIT LIST (January 31, 2020)

Ex. 1090 - Campbell, K., "Insulin Costs Are Skyrocketing. This is Why", U.S. News and World Report, Jun. 29, 2018, p.1-7

Ex. 1092 - U.S. Patent 7,476,652

PETITIONER¿¿¿S REPLY TO PATENT OWNER RESPONSE

ORDER Granting Petitioner's Unopposed Motion for Admission Pro Hac Vice of Charles B. Klein and Dan H. Hoang

Petitioner's Objections to Evidence Submitted with Patent Owner Response

Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen, 957-967 (The Diabetes EDUCATOR)

Serpil Savas et al., The effects of the diabetes related soft tissue hand lesions and the reduced hand strength on functional disability of hand in type 2 diabetic patients

Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices

SoloSTAR Principles of Operation

Sanofi Patent Drive Sleeve and Piston Rod Animation

Deposition of Karl R. Leinsing

Deposition of Karl R. Leinsing, dated June 4, 2019

MP4 file of Sanofi¿¿¿s Patented Pen animation

Excerpts from McGraw Hill Dictionary of Scientific and Technical Terms (Sixth edition, McGraw-Hill 2003), p. 972 and 1873

Excerpts from Merriam-Webster¿¿¿s Collegiate Dictionary (10th edition, Merriam-Webster, Inc. 2001), p. 538

International Patent Application WO999038554A1

Patent Owner's Response

Opinion and Order regarding Claim Construction, Sanofi-Aventis U.S. LLC v. Mylan

Memorandum and Order regarding Claim Construction, Sanofi- Aventis U.S. LLC v. Merck

Giambattista Animation (1)

Animation depicting M¿¿ller¿¿¿s first embodiment

Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus

Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis

Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study

The New Oxford American Dictionary (Oxford University Press 2001), p. 789-90

Excerpt from Joint claim construction statement, Ex. A, dated October 8, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)

Giambattista Animation (2)

International Patent WO 99/38554

U.S. Patent No. 4,648,872

U.S. Patent No. 4,747,824

U.S. Patent No. 6,248,093

Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc.

Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel Syndrome in Patients With Diabetic Polyneuropathy

Animation depicting M¿¿ller¿¿¿s second embodiment

Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome

A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy

Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes

Considering Insulin Pens for Routine Hospital Use - Consider This... (ISMP article)

Trigger Finger Overview (Mayo Clinic)

Bone and joint problems associated with diabetes (Mayo Clinic)

Peripheral Neuropathy (Mayo Clinic)

Charles E. Buban, A pen that seeks to improve diabetes care

"Sanofi-aventis¿¿¿ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award"

U.S. New Prescriptions of LANTUS SoloSTAR

U.S. Total Prescriptions of LANTUS SoloSTAR

U.S. Share of Sales by Drugs in the LANTUS Franchise

Formulary Placement of Long-Acting Insulin Pen Products: Commercial Plans

Formulary Placement of Long-Acting Insulin Pen Products: Medicare Plans

Formulary Placement of Long-Acting Insulin Pen Products: Medicaid Plans

U.S. Total Prescriptions of Long-Acting Pens

2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design

U.S. Total Marketing Expenditure of Long Acting Insulin Franchises

U.S. Total Marketing Expenditures of Long-Acting Insulin Pens

U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs

M¿¿ller Second Embodiment Animation

Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction

Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions

Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs

Select Injectable Insulin Drugs Approved by the FDA in the U.S.

U.S. Dollar Sales of LANTUS SoloSTAR

Formulary Placement of Long-Acting Insulin Pen Products in Healthcare Exchanges

U.S. Share of Long-Acting Pens Among All Pens

U.S. Dollar Sales of Long-Acting Pens

U.S. New Prescriptions of Long-Acting Pens

U.S. Share of Long-Acting Pen Products

Yuzu Sato et al., Clinical Aspects of physical exercise for diabetes/metabolic syndrome

M¿¿ller First Embodiment Animation

Excerpts from Ernest Rabinowicz, Friction And Wear of Materials

Excerpts from Alexander H. Slocum, Precision Machine Design

Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An evaluation of prefilled insulin pens: a focuse on the Next Generation FlexPen¿¿, Med. Devices: Evidence & Research, 41- 50 (2010:3)

Collar Friction Model Demonstration 3

Leinsing Deposition Exhibit 2102: Hand drawings

SoloSTAR Dial Inject Video

Collar Friction Model Demonstrator Animation

Collar Friction Model Demonstration 1

Leinsing Deposition Exhibit 2100: Thomas van der Burg, 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, 150-155 (Jan. 2001)

Collar Friction Model Demonstration 2

Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of Burroughs

Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of the 486 Patent

SoloSTAR Wins 2008 Good Design Award

Leinsing Deposition Exhibit 2105: Hand drawings

Deposition of Charles E. Clemens (November 1, 2019)

Leinsing Deposition exhibit 2106: Annotations of Figures 11 and 12 of Giambattista

Declaration of Alexander Slocum, Ph.D.

Curriculum Vitae of Alexander Slocum, Ph.D.

Declaration of Henry R. Grabowski, Ph.D.

Curriculum Vitae of Henry R. Grabowski, Ph.D.

Curriculum Vitae of Dr. Robin S. Goland

Declaration of Dr. Robin S. Goland

Bradley M. Wright et al., A Review Of Insulin Pen Devices And Use In The Elderly Diabetic Population, 3 Clinical Medicine Insights: Endocrinology & Diabetes 54-63 (2010)

Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices, EMJ Diabet., 58-64 (2014:2)

Arthritis & Diabetes, What do diabetes and arthritis have in common? Plenty.,

Andreas Bode, Development of the SoloSTAR insulin pen device design verification and validation, 6 Expert Opinion on Drug Delivery 103-112 (2008)

Sanofi¿¿¿s Patented Pen animation

Sherwyn Schwartz, Correct Use of a New Reusable Insulin Injection Pen by Patients with Diabetes: A Design Validation Study, 4 J. Diabetes Sci. and Tech. 1229-1235 (2010)

Arnd Friedrichs et al., Dose Accuracy and Injection Force of Different Insulin Glargine Pens, 7 J. Diabetes Sci. and Tech. 1346- 1353 (2013)

Jerome S. Fischer et al., United States Patient Preference and Usability for the New Disposable Insulin Device Solostar¿¿ versus Other Disposable Pens, 2 JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY 1157-1160 (2008)

U.S. Provisional Patent Application 60/073820

John Carter, Usability, Participant Acceptance, and Safety of a Prefilled Insulin Injection Device in a 3-Month Observational Survey in Everyday Clinical Practice in Australia, J. Diabetes Sci & Tech., Vol. 3, Issue 6, 1425-1438 (Nov. 2009)

Estelle Davis, et. al., An evaluation of prefilled insulin pens: a focus on the Next Generation FlexPen, Med. Devices: Evidence & Research, 41-50 (2010:3)

DBA Design Effectiveness Awards 2009

SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22, 2009)

Stacey A. Seggelke et al., Effect of Glargine Insulin Delivery Method (Pen Device Versus Vial/Syringe) on Glycemic Control and Patient Preferences in Patients with Type 1 and Type 2 Diabetes, 20 ENDOCRINE PRACTICE, 536, 536, 538¿¿¿539 (2014)

Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated Patients with Type 1 and Type 2 Diabetes Mellitus, 5 J. Diabetes Sci. and Tech. 158-165 (2011)

Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-123 (2008)

Nicolae Hancu et al., A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction with the SoloSTAR Insulin Injection Device in Type 1 and Type 2 Diabetes, 5 J. Diabetes Sci. and Tech. 1224-1234 (2011)

Norbert Hermanns, Bernhard Kulzer & Thomas Haak, Dosing Accuracy with a Novel Pen Device (SoloSTAR) as Performed by Patients with Diabetes in a Clinical Setting, 10 Diabetes Tech. & Threapeutics 322-327 (2008)

ISO 11608-1, Pen-injectors for medical use (1st Ed. Dec. 15, 2000)

Meike Krzywon et al., Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens, 14 Diabetes Tech. & Therapeutics 804-809 (2012)

Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus, 3 J. Diabetic Complications 77-87 (1989)

Novo Nordisk Form 6-K (Feb. 9, 2009)

LANTUS SoloSTAR Pen Guide

Douglas Merritt et al., Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes, 4 J. Diabetes Sci. and Tech. 1438-1446 (2010)

Novo Nordisk History

Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn Between SoloSTAR and FlexPen at Three Different Dose Levels, 10 Diabetes Tech. & Therapeutics 359-362 (2008)

Riccardo Perfetti, Reusable and Disposable Insulin Pens for the Treatment of Diabetes: Understanding the Global Differences in User Preference and an Evaluation of Inpatient Insulin Pen Use, 12 Diabetes Tech. & Therapeutics 79-85 (2010)

John Shelmet et al., Preference and resource utilization in elderly patients: InnoLet versus vial/syringe, 63 Diabetes Res. and Clinical Prac. 27-35 (2004)

Prix Galien USA Announces 2009 Final Candidates (Prix Galien USA, August 7, 2009)

Thomas Haak et al., Comparison of Usability and Patient Preference for the New Disposable Insulin Device SoloStar Versus FlexPen, Lilly Disposable Pen, and a Prototype Pen: An Open- Label Study, 29 CLINICAL THERAPEUTICS, 650-660 (2007)

Alastair Clarke & Geralyn Spollett, Dose accuracy and injection force dynamics of a novel disposable insulin pen, 4 EXPERT OPINION ON DRUG DELIVERY 165-174 (2007)

US LANTUS SoloSTAR Launch Book, 2007, PTX-0705, Document bates stamped SANOFI_00232909-45

Part 1 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739, Document bates stamped SANOFI3_90330807-1025

Part 2 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739, Document bates stamped SANOFI3_90330807-1025

Steenfeldt-Jensen 5th Embodiment Animation

W. Schady et al, Observations on Severe Ulnar Neuropathy in Diabetes, 12 J Diabetes and Its Complications 128-132 (1998)

Steenfeldt-Jensen 2nd Embodiment Animation

Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Collar Friction Animation

Steenfeldt-Jensen 1st Embodiment Animation

Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation

Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Animation

Petitioner's Unopposed Motion for Pro Hac Vice Admission of Charles B. Klein and Dan. H. Hoang

Ex. 1036 - Declaration of Charles B. Klein in Support of Motion for Pro Hac Vice Admission

Ex. 1037 - Declaration of Dan H. Hoang in Support of Motion for Pro Hac Vice Admission

Patent Owner's Notice of Deposition of Charles E. Clemens

Patent Owner's Objections to Documents Served with the Petition

Trial Instituted Document

SCHEDULING ORDER

Order Conduct of the Proceeding

Reply in Support of Petitioner's Motion for Joinder

Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH

Waiver of Patent Owner's Preliminary Response

Patent Owner's Response to Petitioner's Motions for Joinder

Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH

Patent Owner¿¿¿s Mandatory Notices Pursuant to 37 C.F.R. 42.8

Notice of Accord Filing Date

Ex. 1002 - U.S. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013)

Ex. 1010 - File History for U.S. Patent. 9,604,008

Ex. 1013 - U.S. Patent 6,221,046 - A. Burroughs et al.

Ex. 1016 - U.S. Patent 6,932,794 B2 - L. Giambattista & A. Bendek

Ex. 1017 - U.S. Patent 6,582,404 B1 - P.C. Klitgaard et al

Ex. 1001 - U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)

Ex. 1003 - U.S. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015)

Ex. 1004 - U.S. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016)

Ex. 1005 - U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug Delivery Devices (issued Mar. 28, 2017)

Ex. 1006 - File History for U.S. Patent 8,679,069

Ex. 1007 - File History for U.S. Patent 8,603,044

Ex. 1008 - File History for U.S. Patent 8,992,486

Ex. 1009 - File History for U.S. Patent 9,526,844

Ex. 1014 - U.S. Patent 6,235,004 - S. Steenfeldt-Jensen & S. Hansen

Ex. 1015 - U.S. Patent Application US 2002/0052578 A1- C.S. Moller

Ex. 1018 - File History for U.S. Patent 6,582,404

Ex. 1019 - 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.)

Ex. 1020 - U.S. Patent 4,865,591 - B. Sams

Ex. 1021 - U.S. Patent 6,248,095 B1 - L. Giambattista et al.,

Ex. 1022 - U.S. Patent 5,921,966 B1 - A.A. Bendek et al

Ex. 1025 - Application as filed: U.S. Patent App. 14/946,203 -R.F. Veasey

Ex. 1026 - GB 0304822.0 - "improvements in and relating to a pen-type injector" (filed Mar. 3, 2003) ('844 Priority Doc.)

Ex. 1027 - WO 99/38554 - S.Steenfeldt-Jensen & S.Hansen

Ex. 1029 - Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018)

Ex. 1031 - N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, "Twenty Screw Devices" (3d ed., July 2, 2001)

Ex. 1033 - A.G. Erdman & G.N. Sandor, "Mechanical Advantage", section 3.7 in 1 Mechanism Design: Analysis and Synthesis (1984)

Ex. 1034 - WO 01/83008 - S. Hansen & T.D. Miller

Ex. 1023 - U.S. Patent 5,226,895 - D.C. Harris

Ex. 1024 - U.S. Patent 5,851,079 - R.L. Horstman et al.

Ex. 1028 - 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

Ex. 1030 - Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lilly and Co., No. 14-cv-113 (filed Jan. 20, 2015)

Ex. 1032 - EP 0 608 343 B1 - L. Petersen & N. A. Hansen

Ex. 1035 - K.J. Lipska et al., 320 J. Am. Med. Ass'n 53-62 (2018)

Ex. 1012 - Cirriculum Vitae of Charles E. Clemens

Petitioner's Power of Attorney

Ex. 1011 - Declaration of Mr. Charles E. Clemens

IPR Petition '069

MOTION FOR JOINDER