Mylan Pharmaceuticals Inc. et al. vs Sanofi-Aventis Deutschland GmbH 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)

JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable Denying Petitioner’s Motion to Exclude 35 U.S.C. § 318(a)

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

Petitioners' Mandatory Change-of-Information Notices

ORDER Granting Patent Owner's Motion for Withdrawal of Counsel

ORDER Adjusting One-Year Pendency Due to Joinder 35 U.S.C. ¿¿ 316(a)(11); 37 C.F.R ¿¿ 42.100(c)

Petitioners' Updated Exhibit List

Sanofi-Aventis U.S. LLC v. Mylan GmbH, Case 2:17-cv-09105 (SRC), slip op. (D.N.J. entered Mar. 9, 2020) (collateral opinion on infringement and validity)

Hearing Transcript

EXPUNGED

Patent Owner¿¿¿s Motion for Withdrawal of Counsel

Patent Owner's Objections to Petitioners' Demonstratives

Petitioners' Demonstratives

Patent Owner's Demonstratives

Petitioners¿¿¿ Response to Patent Owner¿¿¿s Observations on Testimony of Mr. Karl Leinsing

Patent Owner's Responses to Petitioners' Observations

Petitioner's reply in Support of Petitioner's Motion to Exclude

Patent Owner's Observations on the Cross-Examination of Mr. Karl Leinsing

Transcript of Cross-Examination of Karl Leinsing

Petitioner's Observations Regarding the Testimony of Alexander Slocum, Ph.D.

Transcript of Telephone Conference on Dec. 11, 2019

Petitioner's Updated Exhibit List

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)

Order Conduct of the Proceeding

Patent Owner's Opposition to Petitioners' Motion to Exclude

Email of Patent Owner's Supplemental Evidence

Petitioner Motion to Exclude

ORDER Oral Hearing

Petitioner's Updated Exhibit List

Transcript of Telephone Conference on November 18, 2019

Order Conduct of the Proceeding

Email

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Argument

Petitioner's Mandatory Change-of-Information Notices

IPR2018-1676 Objections - 2019-11-06

Patent Owner's Sur-Reply

SoloStar Wins Good Design Award

Excerpt from Merck Trial Transcript

2019-10-10 Leinsing Transcript

2019-10-15 Biggs Transcript

Expert Opinion on Drug Delivery

2019-10-9 McDuff Transcript

EXPUNGED

Petitioner's Updated Exhibit List

Patent Owner's Notice of Deposition of Karl R. Leinsing

Patent Owner's Notice of Deposition of William Curtis Biggs

Patent Owner's Notice of Deposition of DeForest McDuff

Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH

Patent Owner's Updated Mandatory Notices

Petitioner's Mandatory Change-of-Information Notices

Patent Owner's Objections to Documents Served By Petitioner

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

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

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., Vol II, August 28, 2019

Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019

2011-02-09 - Sanofi SA Earnings Conference Call

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

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

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...¿¿¿, Clinical Therapeutics, Vol. 20, No. 3, 1998, p.486-196

Curriculum Vitae of William Curtis Biggs, M.D., FACE, ECNU

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

Deposition of Alexander H. Slocum, Ph.D., August 27, 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. 18, 2004)

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)

2019 Orange Book (Excerpt ¿¿¿ ADA 132 of 263)

2012-02-08 ¿¿¿ Sanofi SA Earnings Conference Call

Sanofi-Aventis 2006 20-F Form

Carter, Alan W., ¿¿¿Analysis of the Injection Force of Solostar¿¿ Compared with Other Disposable Insulin...¿¿¿, 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 Business Association, May 23, 2016, p.1-5, https://www.dba.org.uk/review-top-ten-tips-on-writing-effectiveness-case-studies/

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

Aventis 2002 20-F Form

Aventis 2003 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

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

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 SoloStar Brochure: ¿¿¿High Blood Sugar, You¿¿¿re Going Down¿¿¿ (2012)

Lantus SoloStar Brochure: ¿¿¿Your Guide to the Lantus SoloStar Insulin Pen¿¿¿ (2010)

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 Ques.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

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. D¿¿rschug (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

Pietrangelo, Ann ¿¿¿Levemir vs. Lantus: Similarities and Differences¿¿¿, Healthline, Oct. 19, 2016, p.1-14, https://www.healthline.com/health/deiabetes/levemir-lantus

U.S. Patent 6,100,376, ¿¿¿A21, B30 Modified Insulin Derivatives having An Altered Action Profile¿¿¿, M. D¿¿rschug (issued Aug. 8, 2000)

Lantus, ¿¿¿Get to Know the Lantus¿¿ SoloStar¿¿ Insulin Pen, p. 1-7, https://www.lantus.com/get-to-know-the-lantus-solostar-pen

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

Reply Declaration of Karl Leinsing

Petitioner's Reply to Patent Owner Response

Petitioner's Updated Exhibit List

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

Order - Granting Patent Owner's Motions for Pro Hac Vice Admission of Anna E. Dwyer - 37 CFR 42.10

Notice of Deposition for Robin S. Goland, M.D.

Notice of Deposition for Henry Grabowski

Declaration of Anna E. Dwyer in Support of Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10

Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10

Biography of Anna E. Dwyer

Order Granting Motion for Joinder

Notice of Joint Stipulation to Modify Due Dates 2, 3, 5, and 6

Notice of Deposition of Alexander Slocum, Ph.D.

Order - 37 C.F.R. 42.5

ORDER - Granting Patent Owner¿¿¿s Motions for Pro Hac Vice Admission of Robert Vlasis 37 C.F.R. 42.10

Petitioner's Updated Exhibit List

Transcript of Telephone Conference on July 25, 2019

Motion for Pro Hac Vice Admission Under 37 C.F.R. ¿¿ 42.10

Declaration of Robert T. Vlasis

Biography of Robert T. Vlasis

Petitioner's Mandatory Change-of-Information Notices

Mylan Pharmaceuticals Inc. Objections To Evidence Submitted With Patent Owner Response

Petitioner's Updated Exhibit List

Transcript of Telephone Conference on 6.19.19

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

Patent Owner's Response

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)

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)

Leinsing Deposition Exhibit 2102: Hand drawings

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

Leinsing Deposition Exhibit 2105: Hand drawings

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

Curriculum Vitae of Alexander Slocum, Ph.D.

Curriculum Vitae of Dr. Robin S. Goland

Declaration of Alexander Slocum, Ph.D., Part 1

Declaration of Alexander Slocum, Ph.D. Part 2

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., https://www.arthritis.org/living-witharthritis/comorbidities/diabetes-and-arthritis/

DBA Design Effectiveness Awards 2009

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

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)

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)

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)

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

U.S. Provisional Patent Application 60/073820

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

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

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)

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)

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)

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

Lantus SoloSTAR Pen Guide

Novo Nordisk Form 6-K (Feb. 9, 2009), Part 1

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)

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

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

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 Form 6-K (Feb. 9, 2009), Part 5

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

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)

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

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

Novo Nordisk Form 6-K (Feb. 9, 2009), Part 2

Novo Nordisk Form 6-K (Feb. 9, 2009), Part 3

Novo Nordisk Form 6-K (Feb. 9, 2009), Part 4

Novo Nordisk History

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

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)

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)

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

Steenfeldt-Jensen 2nd Embodiment Animation

Steenfeldt-Jensen 5th Embodiment Animation

Steenfeldt-Jensen 1st Embodiment Animation

Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation

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, 77 Diabetes Res. and Clinical Prac. 77-83 (2007)

Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices, 4 J. Diabetes Sci. and Tech. 505-513 (2010)

Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Animation

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

International Patent Application WO999038554A1

SoloSTAR Principles of Operation, PTX-0553, Document bates stamped SANOFI_00406383-94

Sanofi Patent Drive Sleeve and Piston Rod Animation

Deposition of Karl R. Leinsing, dated June 3, 2019 for IPR2018- 01675, -01676, -01678, -01680

Deposition of Karl R. Leinsing, dated June 4, 2019 for IPR2018- 01675, -01676, -01678, -01680

Opinion and Order regarding Claim Construction, Sanofi-Aventis U.S. LLC v. Mylan, N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. May 9, 2019), Dkt. No. 319

Memorandum and Order regarding Claim Construction, Sanofi- Aventis U.S. LLC v. Merck, No. 16-812-RGA (D. Del. Jan. 12, 2018), Dkt. No. 192

Giambattista Animation (1)

Giambattista Animation (2)

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

Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309

Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome, 113 Clinical Neurophysiology 1429-1434 (2002)

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

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

Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel Syndrome in Patients With Diabetic Polyneuropathy, 25 Diabetes Care 565-569 (2002)

A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy, 24 Current Med. Res. and Opinion 2545-2549 (2008)

Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus, Diabetes Res. and Clinical Prac. 1-9 (2005)

Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes, 23 J. Diabetes and Its Complications 32-99 (2009)

Peripheral Neuropathy (Mayo Clinic), https://www.mayoclinic.org/diseases-conditions/peripheralneuropathy/ symptoms-causes/syc-20352061

U.S. Dollar Sales of Lantus SoloSTAR

U.S. New Prescriptions of Lantus SoloSTAR

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

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

Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis, 61 Annals of Physical and Rehabilitation Med. 99-104 (2018)

Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study, 65 Metabolism Clinical and Experimental 883-892 (2016)

Considering Insulin Pens for Routine Hospital Use - Consider This... (ISMP article), https://www.ismp.org/resources/consideringinsulin- pens-routine-hospital-use-consider

Trigger Finger Overview (Mayo Clinic), https://www.mayoclinic.org/diseases-conditions/triggerfinger/ symptoms-causes/syc-20365100

Bone and joint problems associated with diabetes (Mayo Clinic), https://www.mayoclinic.org/diseases-conditions/diabetes/indepth/ diabetes/art-20049314

Charles E. Buban, A pen that seeks to improve diabetes care, INQUIRER.NET (2008), Document Bates stamped SANOFI_00006282-84

"Sanofi-aventis¿¿¿ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award", (PR Newswire Feb. 14), Document Bates stamped SANOFI_00006299-301

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

U.S. Total Prescriptions of Lantus SoloSTAR

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

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

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

U.S. New Prescriptions of Long-Acting Pens

U.S. Total 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, 77S Diabetes Research and Clinical Practice S87 (2007)

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

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

U.S. Dollar Sales of Long-Acting Pens

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

Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs, 357 N. Engl. J. Med. 673 (2007)

Collar Friction Model Demonstrator Animation

Excerpts from Ernest Rabinowicz, Friction And Wear of Materials, 2nd Edition, 68-70 (John Wiley & Sons, Inc. 1995)

Collar Friction Model Demonstration 3

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

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

M¿¿ller First Embodiment Animation

M¿¿ller Second Embodiment Animation

Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction (June 27, 2011), Document bates stamped SANOFI_00179886-88

Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions, 20 Pharmacoeconomics 15 (2002)

Excerpts from Alexander H. Slocum, Precision Machine Design, 706-709 (Prentice-Hall, Inc. 1992)

Collar Friction Model Demonstration 1

Collar Friction Model Demonstration 2

SoloSTAR Dial Inject Video

ORDER Conduct of the Proceeding 35 C.F.R. ¿¿ 42.5(a)

PATENT OWNER¿¿¿S UPDATED MANDATORY NOTICES PURSUANT TO 37 C.F.R. 42.8

Patent Owner's Power of Attorney

Patent Owner's Updated Notice of Deposition of Karl R. Leinsing

PATENT OWNER¿¿¿S UPDATED MANDATORY NOTICES PURSUANT TO 37 C.F.R. 42.8

PATENT OWNER¿¿¿S NOTICE OF DEPOSITION OF KARL R. LEINSING

PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5

Mylan Pharmacetucials Inc. Objections to Evidence

Patent Owner's Objections to Documents Served with the Petition

Trial Instituted Document

Exhibit 3001

SCHEDULING ORDER

Petitioner's Mandatory Change-Of-Information Notices

Petitioner's Power of Attorney

Order - 37 C.F.R. 42.10

Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognition

Declaration of Elham F. Steiner ISO Unopposed Motion for Pro Hac Vice Recognition

Elham F. Steiner, Attorney Biography

Patent Owner's Sur-Reply in Support of Patent Owner's Preliminary Response

Letter from A. Calmann to Judge Waldor dated Apr. 24, 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.), Dkt. No. 90

Report of the Local Patent Rules Committee, Explanatory Notes for 2016 Amendments

Defendants¿¿¿ Opposition to Plaintiffs¿¿¿ Motion to Stay dated Nov. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 44

Joint Proposed Discovery Plan dated Dec. 14, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRCCLW (D.N.J.)

Motion to Expedite Defendants¿¿¿ Motion Requesting an Expedited Scheduling Conference dated Nov. 22, 2017 , Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 46

Initial Planning Meeting Report and Discovery Proposals dated Dec. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 61

Transcript of Motion / Scheduling Conference dated Jan. 3, 2018,Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 64

Excerpts from Transcript, Conference Call dated Aug. 2, 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.)

Transcript, Conference Call for Case IPR2018-01675, -01676, -01678, -01680 (P.T.A.B. Feb. 5, 2019)

Order - 37 CFR 42.5

Mylan Reply to Patent Owner's Preliminary Response

Graph showing PTAB Days to Docketing for Review Proceedings filed between 2016-2018

ORDER 37 C.F.R. ¿¿ 42.108(c)

Petitioner's Updated Exhibit List

Transcript of Telephone Conference - 01.15.19

Patent Owner's Updated Mandatory Notices

Patent Owner's Preliminary Response

Ex. 2001 - 2013.02.13 press release

Ex. 2004 - Sanofi v. Eli Lilly - 2014-01-30 [01] Complaint for Patent Infringement

Ex. 2006 - [DI-45] 2018-02-05 Letter enclosing stip of Dismissal for Mylan

Ex. 2008 - 2018-01-25 Invalidity Contentions, Excerpted

Ex. 2009 - m-Invalidity Contentions - Amended Cover Pleading - All Patents, Excerpted p. 268-9

Ex. 2010 - Amended Invalidity Contentions, Ex. C - Excerpted

Ex. 2017 - Embodiment_One_compressed.mp4

Ex. 2002 - 2014.09.16 press release

Ex. 2003 - 2017.06.10 press release

Ex. 2005 - Sanofi v. Merck - 2016-09-16 Complaint [DI 1]

Ex. 2007 - Sanofi v. Mylan - [DI-1] 2017-10-24 Complaint without exhibits

Ex. 2011 - 2018.08.13 Service of Sanofi's Responses to Mylan's Amended Contentions_Redacted

Ex. 2012 - SanofiPatentPen_compressed.mp4

Ex. 2013 - Defendants Opening Claim Construction Brief (EXCERPTED)

Ex. 2014 - 2018-01-12 [DI 192] Memo and Opinion re claim construction

Ex. 2015 - WO9938554A1

Ex. 2016 - Joint Claim construction, Ex. A, Excerpted p. 65

Ex. 2018 - Embodiment_Two_compressed2.mp4

Updated Mandatory Notices

Petitioner's Mandatory Change-of-Information Notices

Notice of Accord Filing Date

Power of Attorney

Patent Owner's Mandatory Notices Pursuant To 37 C.F.R. 42.8

Petitioner¿¿¿s Mandatory Change-of-Information Notices Under 37 C.F.R. ¿¿42.8(A)(3)

USP 9,526,844

Petitioner Mylan Pharmaceuticals Inc. Power of Attorney

USP 8,679,069

USP 8,603,044

USP 8,992,486

USP 9,604,008

U.S. Patent 4,865,591 ¿¿¿ B. Sams, ¿¿¿Measured Dose Dispensing Device¿¿¿ (issued Sep. 12, 1989)

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. M¿¿ller, ¿¿¿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)

U.S. Patent 6,582,404 B1 ¿¿¿ P.C. Klitgaard et al., ¿¿¿Dose Setting Limiter¿¿¿ (issued June 24, 2003)

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)

WO 99/38554 ¿¿¿ S.Steenfeldt-Jensen & S.Hansen, ¿¿¿An Injection Syringe¿¿¿ (pub¿¿¿d Aug. 5, 1999) (Steenfeldt-Jensen PCT)

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

A.G. Erdman &G.N. Sandor, ¿¿¿ Mechanical Advantage¿¿¿, ¿¿3.7 in 1 Mechanism Design: Analysis and Synthesis (1984)

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 Lily and Co., No. 14-cv-113 (filed Jan. 20, 2015)

EP 0 608 343 B1 ¿¿¿ L. Petersen & N.-A. Hansen, ¿¿¿Large Dose Pen¿¿¿ (pub¿¿¿d Oct. 18, 1991)

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. 9,604,008

Application as filed: U.S. Patent App. 14/946,203 ¿¿¿ R.F. Veasey, ¿¿¿Relating to a Pen-Type Injector¿¿¿ (filed Nov. 19, 2015)

File History for U.S. Patent 9,526,844

File History for U.S. Patent 6,582,404

GB 0304822.0 ¿¿¿ ¿¿¿Improvements in and relating to a pen-type injector¿¿¿ (filed Mar. 3, 2003) (¿¿¿844 Priority Doc.)

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 ... 320 J. Am. Med. Ass¿¿¿n 53-62 (2018).

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

Petition for Inter Partes Review of USP 8,603,044

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)