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

Other: other court decision

Other: fed circuit mandate

Trial Certificate Checklist

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 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)

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 01-10-20

Petitioner's Reply In Support of Motion to Exclude

Patent Owner's Opposition to Petitioners' Motion to Exclude

ORDER Conduct of the Proceeding

Petitioners' Updated Exhibit List

Transcript of PTAB Telephone Conference January 13, 2020

Transcript of PTAB Telephone Conference January 13, 2020

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

Petitioners' Motion to Exclude

Oral Hearing 37 C.F.R. Section 42.70

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

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 2329: Annotations of M¿¿ller-1

Leinsing Deposition Exhibit 2330: Annotations of M¿¿ller-2

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.

Patent Owner's Responses to Petitioners' Observations

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

Transcript of the Cross-Examination of Karl Leinsing

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

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

Petitioner's Updated Exhibit List

Transcript of Telephone Conference on Dec. 13, 2019

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

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

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

Sanofi3-90098102

Petitioner's Mandatory Change-of-Information Notices

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

EXPUNGED

Revised Scheduling Order

IPR2018-1680 Objections - 2019-11-06

Deposition of David Plumptre Taken 04-26-2019

Patent Owner's Revised Contingent Motion to Amend

Declaration of John Moffat

EXPUNGED

EXPUNGED

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

2019-10-15 Biggs Transcript

2019-10-9 McDuff Transcript

EXPUNGED

Preliminary Guidance - Patent Owner's Motion to Amend

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

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

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

Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157

Deposition of Robin Goland, Sep. 10, 2019

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

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

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

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

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

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

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

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

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 2002 20-F Form

Aventis 2003 20-F Form

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

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

U.S. Patent 5,656,722, ¿¿¿A21, B30, Modified Insulin Derivatives having An Altered Action Profile¿¿¿, M. D¿¿rschug (issued Aug. 12, 1997)

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

¿¿¿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

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

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, ¿¿¿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: ¿¿¿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 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 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

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

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

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)

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

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

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

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

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

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

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

DECISION Instituting Inter Partes Review and Granting Motion for Joinder 35 U.S.C. 314, 315(c) (IPR2019-01022)

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

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

Declaration of Henry R. Grabowski, Ph.D. (CORRECTED)

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 37 C.F.R. 42.5(a)

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. 14/635,573 and related documents extracted from the USPTO file history

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

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

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

U.S. Patent Application No. 14/946,203 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. 13/909,681 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. 10/790,225 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

Patent Owner's Contingent Motion to Amend

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)

Leinsing Deposition Exhibit 2100: Thomas van der Burg, Injection Force of SoloSTAR¿¿ Compared with Other Disposable Insulin Pen Devices at Constant Volume Flow Rates

Patent Owner's Response

Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An evaluation of prefilled insulin pens: a focuse on the Next Generation FlexPen¿¿

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

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

Leinsing Deposition Exhibit 2105: Hand drawings

Leinsing Deposition Exhibit 2102: Hand drawings

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

Expert Report of Henry R. Grabowski, Ph.D.

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

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

Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices

Andreas Bode, Development of the SoloSTAR insulin pen device design verification and validation

Curriculum Vitae of Alexander Slocum, Ph.D.

Declaration of Dr. Robin S. Goland

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

Sherwyn Schwartz, Correct Use of a New Reusable Insulin Injection Pen by Patients with Diabetes: A Design Validation Study

DBA Design Effectiveness Awards 2009

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

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

Arnd Friedrichs et al., Dose Accuracy and Injection Force of Different Insulin Glargine Pens

Declaration of Alexander Slocum, Ph.D.

Jerome S. Fischer et al., United States Patient Preference and Usability for the New Disposable Insulin Device Solostar¿¿ versus Other Disposable Pens

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

Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated Patients with Type 1 and Type 2 Diabetes Mellitus

U.S. Provisional Patent Application 60/073820

Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens for the treatment of diabetes

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

Lantus SoloSTAR Pen Guide

Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus

Douglas Merritt et al., Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes

Novo Nordisk History, Part Two

Norbert Hermanns, Bernhard Kulzer & Thomas Haak, Dosing Accuracy with a Novel Pen Device (SoloSTAR) as Performed by Patients with Diabetes in a Clinical Setting

ISO 11608-1, Pen-injectors for medical use

Meike Krzywon et al., Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens

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

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

Novo Nordisk History, Part One

W. Schady et al, Observations on Severe Ulnar Neuropathy in Diabetes

Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn Between SoloSTAR and FlexPen at Three Different Dose Levels

John Shelmet et al., Preference and resource utilization in elderly patients: InnoLet versus vial/syringe

Prix Galien USA Announces 2009 Final Candidates

EXPUNGED

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

Alastair Clarke & Geralyn Spollett, Dose accuracy and injection force dynamics of a novel disposable insulin pen

Steenfeldt-Jensen 1st 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

Declaration of Chris Langley

Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen

SoloSTAR Principles of Operation

US Lantus SoloSTAR Launch Book

Lantus COMPASS Study Report, Part One

Lantus COMPASS Study Report, Part Two

Steenfeldt-Jensen 5th Embodiment Animation

Steenfeldt-Jensen 2nd Embodiment Animation

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

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

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)

Giambattista Animation (2)

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

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

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

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

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

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

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

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

Trigger Finger Overview (Mayo Clinic)

Bone and joint problems associated with diabetes (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. Dollar Sales of Lantus SoloSTAR

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

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

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

Considering Insulin Pens for Routine Hospital Use

Peripheral Neuropathy (Mayo Clinic)

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

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: Medicaid Plans

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

U.S. Dollar Sales of Long-Acting Pens

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

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

Collar Friction Model Demonstrator Animation

Collar Friction Model Demonstration 1

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 in Healthcare Exchanges

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

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

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

Excerpts from Ernest Rabinowicz, Friction And Wear of Materials, 2nd Edition

Excerpts from Alexander H. Slocum, Precision Machine Design

Collar Friction Model Demonstration 2

International Patent Application WO999038554A1

Collar Friction Model Demonstration 3

SoloSTAR Dial Inject Video

Prix Galien USA Announces 2009 Final Candidates

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

Scheduling Order

Exhibit 3001

Petitioner's Power of Attorney

Petitioner's Mandatory Change-Of-Information Notices

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

Expunging Duplicate Papers

Petitioners Updated Exhibit List

Transcript of Call 02.13.2019

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.)

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

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

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

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

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

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

Mylan Reply to Patent Owner's Preliminary Response

Order - 37 C.F.R. Sect. 42.108(c)

Patent Owner's Updated Mandatory Notices

Patent Owner's Preliminary Response

Press Release, ¿¿¿Mylan Enhances Partnership with Biocon through Strategic Collaboration for Insulin Products,¿¿¿ Feb. 13, 2013 (PR Newswire)

Press Release, ¿¿¿Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus¿¿ and Insulin Analog to Lantus¿¿,¿¿¿ Sept. 16, 2014 (PR Newswire)

Press Release, ¿¿¿Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association¿¿¿s 77th Scientific Sessions,¿¿¿ June 10, 2017 (PR Newswire)

First Amended and Supplemental Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie v. Merck Sharp & Dohme Corp., C.A. No. 1:16-cv-00812-RGA (D. Del)

Stipulation and Proposed Order, Sanofi-Aventis U.S. LLC v. Mylan, N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. Feb 5, 2018)

Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J. Oct. 24, 2017)

EXPUNGED

Excerpts from Defendants¿¿¿ Invalidity Contentions, dated Jan. 25, 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.)

Excerpts from Mylan GMBH¿¿¿s Amended Invalidity Contentions, dated April 25, 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.)

Updated Mandatory Notices

Notice of Accord Filing Date

Petitioner's Mandatory Change-of-Information Notices

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)

Petitioner Mylan Pharmaceuticals Inc. Power of Attorney

USP 8,603,044

USP 9,526,844

USP 9,604,008

USP 8,679,069

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

Curriculum Vitae of Karl Leinsing MSME,PE

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 6,921,995 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)

U.S. Patent 6,248,095 B1 ¿¿¿ L. Giambattista et al., ¿¿¿Low-cost Medication Delivery Pen¿¿¿ (issued June 19, 2001)

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

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)

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)

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)

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

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

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

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

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

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

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 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

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)

Petition for IPR of USP 9,526,844

EXPUNGED