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 Patent Owner’s Motion to Amend Denying-in-Part, Dismissing-in-Part 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)

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)

Petitioners' Updated Exhibit List

EXPUNGED

Hearing Transcript

Patent Owner¿¿¿s Motion for Withdrawal of Counsel

Petitioners' Demonstratives

Patent Owner's Demonstratives

Patent Owner's Objections to Petitioners' Demonstratives

Petitioners' Surreply to the Revised Motion to Amend

Petitioners' Updated Exhibit List

Deposition of Alexander Slocum taken 1-10-20

Petitioner's Reply In Support of Motion to Exclude

Patent Owner's Opposition to Petitioners' Motion to Exclude

ORDER Conduct of the Proceeding

Transcript of PTAB Telephone Conference on January 13, 2020

Petitioners' Updated Exhibit List

Petitioners' Objections to Evidence Sanofi Reply - Revised Motion to Amend

Petitioners' Motion to Exclude

Oral Hearing 37 C.F.R. Section 42.70

Leinsing Deposition Exhibit 2329: Annotations of Moller-1

Animation of Dr. Slocum's "Stinger" Model plus Externally Threaded Nut

Patent Owner's Reply to Petitioner's Opposition to Patent Owner's Revised Motion to Amend

Leinsing Deposition Exhibit 2330: Annotations of Moller-2

Deposition of Karl R. Leinsing, dated December 20, 2019 for IPR2018-01679, -01680, -01682

Declaration of Alexander Slocum, Ph.D. in Support of Sanofi's Reply to Mylan's Opposition to Sanofi's Revised Motion to Amend

Animation of Dr. Slocum's "Stinger" Model

Notice of Deposition of Alexander Slocum, Ph.D.

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

Patent Owner's Responses to Petitioners' Observations

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

Transcript of the Cross-Examination of Karl Leinsing

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

Patent Owner's Request for Oral Argument

Petitioner's Request for Oral Argument

Order Conduct of the Proceeding

Transcript of Telephone Conference on Dec. 13, 2019

Petitioner's Opposition to Patent Owner's Revised Motion to Amend

Petitioner's Updated Exhibit List

Deposition of Alexander Slocum (Dec. 10, 2019)

Transcript of Telephone Conference on Dec. 11, 2019

US 2004/026728 A1 ¿¿¿ Veasey, ¿¿¿Pen Type Injector¿¿¿ (pub¿¿¿d. Dec. 30, 2004)

Declaration of Karl R. Leinsing, MSME, PE, In Support of Petitioner¿¿¿s Oppositions to Sanofi¿¿¿s Revised Motion to Amend

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

Notice of Depositions of Alexander Slocum, Ph.D.

Joint Stipulation to Modify Due Dates in Revised Scheduling Order

Transcript of Telephone Conference on November 18, 2019

Petitioner's Updated Exhibit List

Order Conduct of the Proceeding

Email

Patent Owner's Corrected Revised Contingent Motion to Amend

Declaration of Alexander Slocum, Ph.D. in Support of Sanofi¿¿¿s Revised Motions to Amend

Supplemental Disclosure Pursuant to 37 C.F.R. ¿¿ 42.11

Sanofi3-90098102

Table of Equivalent Disclosure in U.S. Applications 13/909,681 (486 Patent) and 15/156,616 (844 Patent) and Related Applications for Revised Motions to Amend

Petitioner's Mandatory Change-of-Information Notices

ORDER - Conduct of the Proceeding 37 C.F.R. 42.5

EXPUNGED

REVISED SCHEDULING ORDER

IPR2018-1679 Objections - 2019-11-06

EXPUNGED

EXPUNGED

Deposition of David Plumptre Taken 04-26-2019

Patent Owner's Revised Contingent Motion to Amend

Declaration of John Moffat

EXPUNGED

EXPUNGED

DCA0000436-DCA0000440

DCA0000559-DCA0000564

Novo Nordisk A/S Annual Financial Report 2003

Deposition of Andreas Bode Taken 05-03-2019

SoloStar Wins Good Design Award

Patent Owner's Sur-Reply

Expert Opinion on Drug Delivery

Excerpt from Merck Trial Transcript

2019-10-10 Leinsing Transcript

2019-10-9 McDuff Transcript

EXPUNGED

2019-10-15 Biggs Transcript

Preliminary Guidance - Patent Owner's Motion to Amend

Petitioner's Updated Exhibit List

Order Granting Patent Owner's Motion for Pro Hac Vice Admission of Robert Vlasis

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

Patent Owner's Updated Mandatory Notices

Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH

Petitioner's Mandatory Change-of-Information Notices

Patent Owner's Objections to Documents Served By Petitioner

CORRECTED - Declaration of Karl Leinsing ISO Petitioner's Opposition to Sanofi's Motion to Amend

Patent Owner's Updated Exhibit List

Transcript of 09-09-2019 Teleconference between Board and Parties

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

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

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

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

Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism

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

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

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

Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157

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

Certified English Translation of DE Patent 102 37 258A1, Dr. Roney Graf (Issued Mar. 182004)

Declaration and c.v. of DeForrest McDuff, Ph.D.

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

Aventis 2002 20-F Form

¿¿¿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

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

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

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/

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

2011 Orange Book (Excerpts)

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

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

Aventis 2003 20-F Form

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

¿¿¿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/

DiMasi, J., et al. ¿¿¿Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs¿¿¿, J. of Health Economics47 (2016), p. 20-33

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

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

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

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

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)

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

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

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)

WebMD, ¿¿¿Types of Insulin for Diabetes Treatment¿¿¿, p.1-7 https://www.webmd.com/diabetes/diabetes-types-insulin#1

Declaration of Karl Leinsing in Support of Support of Mylan-Pfizer Reply

WO 02/092153, Atterbury et al., ¿¿¿Medication Injector Apparatus with Drive Assembly that Facilitates Reset¿¿¿ (Pub¿¿¿d. Nov. 21, 2002)

EP 0 937 471, Walters et al., ¿¿¿Medication Delivery Pen¿¿¿ (Pub¿¿¿d. Aug. 25, 1999)

GB 2 064 012, Lorscheidt, ¿¿¿Dose Dispenser for Pastes and Liquids¿¿¿ (Pub¿¿¿d. Jun 10. 1981)

U.S. Patent 4,083,288, ¿¿¿Split Nuts¿¿¿, Williams (issued Apr. 11, 1978)

U.S. Patent 5,725,508 ¿¿¿Quick Connect Medication Delivery Pen¿¿¿, Chanoch, et al. (issued Mar. 10, 1998)

EP 0 667 469, Akram, ¿¿¿Ratchet mechanism Exploiting Both Strakes of the Ratchet Motion¿¿¿ (Pub¿¿¿d. Aug. 16, 1995)

GB 2 384 431, Stamp, ¿¿¿Needleless Injection having an Audible Does Indicator¿¿¿ (Pub¿¿¿d. Jul. 30, 2003)

U.S. Patent 5,000,650, ¿¿¿Split Nut¿¿¿, Haas, Jr. (issued Mar. 19, 1991)

U.S. Patent 6,277,099, ¿¿¿Medication Delivery Pen¿¿¿, Strowe, et al. (issued Aug. 21, 2001)

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

Petitioner's Opposition to Patent Owner's Contingent Motion to Amend

Declaration of Karl Leinsing ISO Petitioner's Opposition to Sanofi's Motion to Amend

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

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

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

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

Biography of Anna E. Dwyer

EXPUNGED

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

Petitioner's Updated Exhibit List

Transcript of Telephone Conference on July 25, 2019

Declaration of Robert T. Vlasis

Biography of Robert T. Vlasis

Petitioner's Mandatory Change-of-Information Notices

Mylan Pharmaceuticals Inc. Objections To Sanofi's Motion To Amend Evidence

Petitioner's Updated Exhibit List

Transcript of Telephone Conference on 6.19.19

Mylan Pharmaceuticals Inc. Objections to Evidence Submitted with Patent Owner Response

Order Conduct of the Proceeding Information and Guidance on Patent Owner¿¿¿s Proposed Motion to Amend

Declaration of Alexander Slocum, Ph.D. in Support of Sanofi¿¿¿s Motions to Amend

Patent Owner's Contingent Motion to Amend

Disclosure Pursuant to 37 C.F.R. ¿¿ 42.11

Table of Equivalent Disclosure in U.S. Applications 13/909,681 (¿¿¿486 Patent) and 15/156,616 (¿¿¿844 Patent) and Related Applications

U.S. Patent Application No. 15/156,616 and related documents extracted from the USPTO file history

U.S. Patent Application No. 14/635,573 and related documents extracted from the USPTO file history

U.S. Patent Application No. 13/919,251 and related documents extracted from the USPTO file history

U.S. Patent Application No. 13/040,198 and related documents extracted from the USPTO file history

U.S. Patent Application No. 11/483,546 and related documents extracted from the USPTO file history

U.S. Patent Application No. 10/790,225 and related documents extracted from the USPTO file history

U.S. Patent Application No. 13/909,681 and related documents extracted from the USPTO file history

U.S. Patent Application No. 12/944,544 and related documents extracted from the USPTO file history

Declaration of Chris Langley and Exhibit A, including an as-filed copy of GB 0304822.0 and related correspondence

U.S. Patent Application No. 14/946,203 and related documents extracted from the USPTO file history

Patent Owner's Updated Exhibit List

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)

Patent Owner's Response

Leinsing Deposition Exhibit 2105: Hand drawings

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

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 2104: Annotations of Figures 5-8 of the 486 Patent

Curriculum Vitae of Alexander Slocum, Ph.D.

Declaration of Dr. Robin S. Goland

Curriculum Vitae 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-with-arthritis/comorbidities/diabetes-and-arthritis/

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, Paticipant 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)

DBA Design Effectiveness Awards 2009

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

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)

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

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)

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

Novo Nordisk History Part 1

Novo Nordisk History Part 2

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)

Lantus SoloSTAR Pen Guide

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)

Declaration of Alexander Slocum, Ph.D.

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

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

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

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

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)

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

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

Steenfeldt-Jensen 1st Embodiment Animation

Steenfeldt-Jensen 2nd Embodiment Animation

International Patent Application WO999038554A1

Declaration of Chris Langley

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

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

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

Steenfeldt-Jensen 5th Embodiment Animation

Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation

Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Animation

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

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

Giambattista Animation (1)

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., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309 Part 2

Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309 Part 3

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)

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)

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)

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 (2)

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

Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309 Part 1

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)

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)

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

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

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

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

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

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

U.S. Dollar Sales of Lantus SoloSTAR

U.S. New Prescriptions of Lantus SoloSTAR

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

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

M¿¿ller First Embodiment Animation

Moller 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)

U.S. Dollar Sales of Long-Acting 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

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)

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

Collar Friction Model Demonstration 1

Collar Friction Model Demonstration 2

Collar Friction Model Demonstration 3

SoloSTAR Dial Inject Video

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

Patent Owner's Objections to Documents Served with the Petition

Trial Instituted Document

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 Updated Mandatory Notices Pursuant to 37 C.F.R. 42.8

Notice of Accord Filing Date

Updated Mandatory Notices

Petitioner's Mandatory Change-of-Information Notices

Power of Attorney for Patent Owner

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)

Petitioner Mylan Pharmaceuticals Inc. Power of Attorney

USP 8,679,069

USP 9,526,844

USP 9,604,008

USP 8,603,004

USP 8,992,486

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)

Curriculum Vitae of Karl Leinsing MSME,PE

U.S. Patent 6,932,794 B2 ¿¿¿ L. Giambattista & A. Bendek, ¿¿¿Medication Delivery Pen¿¿¿ (issued Aug. 23, 2005)

U.S. Patent 5,226,895 ¿¿¿ D.C. Harris, ¿¿¿Multiple Dose Injection Pen¿¿¿ (issued July 13, 1993)

U.S. Patent Application US 2002/0053578 A1 ¿¿¿ C.S. M¿¿ller, ¿¿¿Injection Device¿¿¿ (pub¿¿¿d May 2, 2002)

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

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 5,851,079 ¿¿¿ R.L. Horstman et al., ¿¿¿Simplified Unidirectional Twist-Up Dispensing Device With Incremental Dosing¿¿¿ (issued Dec. 22, 1998)

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

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 99/38554 ¿¿¿ 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 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. Eli Lily and Co., No. 14-cv-113 (filed Jan. 20, 2015)

File History for U.S. Patent 8,679,069

File History for U.S. Patent 8,992,486

File History for U.S. Patent. 9,604,008

File History for U.S. Patent 8,603,044

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

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

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 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).

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)

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 8,992,486