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

Petitioner's Mandatory Change-of-Information Notices

Patent Owner Sanofi-Aventis Deutschland GmbH¿¿¿s Notice of Extension of Time to File Petition for Writ of Certiorari

Patent Owner Sanofi-Aventis Deutschland GmbH¿¿¿s Notice of Filing Petition for Writ of Certiorari Within the Time Allowed

ORDER Granting Patent Owner¿¿¿s Motions to Withdraw Counsel 37 C.F.R. ¿¿ 42.10(e)

Patent Owner's Motion for Withdrawal of Counsel

Order Granting Patent Owner's Motion to Seal

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

Patent Owner's Motion to Seal

Patent Owner's Updated Exhibit List - Confidential

Petitioner's Reply (Redacted Public Version Submitted by Patent Owner)

Patent Owner's Updated Exhibit List - Public

Expert Declaration of Professor Robert S. Langer in Support of Petition for IPR of Patent Nos. 7,476,652 and 7,713,930 - Public

Termination Decision Document

Petitioner's Motion to Seal and For Entry of Proposed Protective Order

Petitioner's Motion to Seal

REDACTED - Paper 83 - Mylan Pharmaceutical Inc.'s Sur-Surreply

Mylan Pharmaceutical Inc.'s Sur-Surreply

Mylan Pharmaceuticals' Objections

Petitioner's Mandatory Change-of-Information Notices

Patent Owner's Motion to Seal

Patent Owner Surreply

Patent Owner Surreply (REDACTED Public Version)

Supplemental Declaration of Dr. Bernhardt Trout (REDACTED Public Version)

The European Agency for the Evaluation of Medicinal Products, Committee For Proprietary Medicinal Products European Public Assessment Report (EPAR) for Lantus (June 6, 2000)

Supplemental Declaration of Dr. Bernhardt Trout (UNREDACTED Confidential Version)

Declaration of Dr. Thomas Eichinger

March 30, 2000 Aventis Pharma memorandum regarding Minutes of 29th TSV Team Meeting on HOE901 Drug Product, Document bates numbered SANOFI_01875342-405

April 20, 2000 Response Letter to FDA re Lantus Application to Market a New Drug, Document bates numbered SANOFI_01870941-86

Draft Aventis RMC Strategy & Risk Assessment (RCMS SRA) For Development Activities for Lantus Reformulation, dated November 2003, Document bates numbered SANOFI_01628501-13

Patent Owner's Updated Exhibit List (REDACTED Public Version)

Internal Memorandum re FDA Contact And/Or Trip Report for Lantus (Insulin Glargine) on September 8, 1999, Document bates numbered SANOFI_01871544-84

Hoeschst Marion Roussel presentation on HOE 901 ¿¿¿ Insulin Glargine, Document bates numbered SANOFI5_00012501-14

Patent Owner's Updated Exhibit List (UNREDACTED Confidential Version)

Hearing Transcript

Authorizing Sur-reply and Sur-sur-reply

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Exhibit 1186A - Final Transcript of Telephonic Conference held September 24, 2018 in IPR-2017-01526 and IPR2017-01528

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Rough Transcript of Telephone Conference held 09-24-2018

Order Adjusting Oral Hearing Time

Trial Hearing 37 C.F.R § 42.70

Patent Owner's Reply to Motion to Exclude

Mylan Pharmaceutical Inc.'s Reply In Support of Its Motion to Exclude

Corrected Paper 56 - Mylan_Pharmaceutical's_Request_For_Oral_Argument

EXPUNGED

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

Mylan's Updated Exhibit List

August 17, 2018, email serving Mylan's Response to Sanofi's Observations & Mylan¿¿¿s Opposition to Sanofi¿¿¿s Motion to Exclude[

Copy of August 17, 2018, email notifying Board of service of Mylan's Response to Sanofi's Observations & Mylan¿¿¿s Opposition to Sanofi¿¿¿s Motion to Exclude

EXPUNGED

Mylan Pharmaceutical Inc.'s Opposition to Sanofi's Motion to Exclude

Mylan Pharmaceutical Inc.'s Response to Sanofi's Observations on Cross Examination

Mylan Pharmaceutical's Motion to Exclude

Mylan Pharmaceutical's Request For Oral Argument

Patent Owner's Request for Oral Argument

Patent Owner's Observations on Cross Examination of Petitioner's Reply Declarants

Annex 1, Summary of Product Characteristics

July 31, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky, Volume II

July 30, 2018, Deposition Transcript of Dr. William C. Biggs

August 7, 2018, Deposition Transcript of Dr. Robert S. Langer

Patent Owner's Motion to Exclude

Patent Owner's Updated Exhibit List

S. Simpson & E. Toth, ¿¿¿Expanding the Options in Insulin Therapy: A Review of Insulin Analogues,¿¿¿ 26(3) Canadian Journal of Diabetes, 195-205 (2002)

August 2, 2018, Deposition Transcript of Dr. Robert D. McDuff

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Mylan Pharmaceuticals' Objections

Patent Owner's Notice of Deposition of Dr. Robert S. Langer

Patent Owner's Notice of Deposition of Dr. William C. Biggs

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

Mylan Pharmaceutical's Updated Exhibit List

Transcript of Telephone Conference held on July 26, 2018, in IPR2017-01526 and IPR2017-01528

Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky

Patent Owner's Notice of Deposition of DeForest McDuff, Ph.D.

Transcript of 7/17/2018 Telephonic Conference (IPR2017-01526, IPR2017-01528)

Patent Owner's Updated Exhibit List

Patent Owner Surreply

Judge Andrews' Order, Dkt. 287 (Sanofi v. Merck, 16-812-RGA)

Trial Transcript Excerpts (Sanofi v. Merck, 16-812-RGA)

Patent Owner's Motion to Strike

Petitioner's Reply Brief - Public, Redacted

Petitioner's Reply Brief - Under Seal

PATENT OWNER'S OBJECTIONS TO ADMISSIBILITY OF EVIDENCE SERVED BY PETITIONER MYLAN PHARMACEUTICAL INC. IN INTER PARTES REVIEW

Patent Owner's Supplemental Motion to Seal

Amgen, Inc. profile of ¿¿¿NEUPOGEN¿¿¿ (Filgrastim), Apr. 2, 1998, pp. 1-27pp. 1-27

Campbell, Kevin; ¿¿¿Insulin Costs Are Skyrocketing. This is Why.¿¿¿, U.S. News and World Report, June 29, 2018, pp.1-3

Sanofi Press Release, ¿¿¿LANTUS¿¿ Add-on to Oral Monotherapy Therapy Showed Improved Glycemic Control in Type 2 Diabetes Patients Compared to oral Actos Add-on to Oral Therapy¿¿¿ (June 13, 2005)

Sanofi Press Release, ¿¿¿Data Presented at ADA Showed That Basal Insulin Therapy with LANTUS¿¿ Achieved Target Glycemic Control In Poorly Controlled Type 2 Diabetes¿¿¿ (June 13, 2005)

Walgreen Co. Recalls LANTUS¿¿ Insulin Glargine (rDNA) Injection, www.SafetyAlerts.com, Nov. 15, 2001, pp. 1-3

EP Pub. 0368187 A2

Center for Drug Evaluation and Research, Approval for ¿¿¿NUTROPIN AQ¿¿¿ (App. 20-522/S-10), Apr. 10, 2000

Deposition of Dr. Berhard Trout (June 21, 2018)

Deposition of Dr. Laurence Baker, Ph.D. (June 22, 2018)

MEDWATCH, FDA Medical Products Reporting Program, Report on LANTUS¿¿, Case ID 376724, Apr. 05, 2002

Affidavit of Marlene S. Bobka (July 3, 2018)

Aventis Pharmaceuticals, Inc., Individual Safety Report for ¿¿¿LANTUS¿¿¿¿¿, Case 4054424-5-00-01, Feb. 06, 2003

1058A - Affidavit of Marlene S. Bobka (July 3, 2018)

Sanofi Press Release, ¿¿¿Prospective Study Published in Diabetes Care Confirms Basal Therapy with LANTUS¿¿ Improves Glycemic Control In Patients with Type 2 Diabetes Poorly Controlled on Prior Insulin Regimens¿¿¿ (June 8, 2005)

U.S. SEC Form 20-F for Sanofi-Aventis FY 2006

U.S. SEC Form 20-F for Sanofi-Aventis FY 2004

Q4 2005 Sanofi-Aventis Earnings Conference Call

U.S. SEC Form 20-F for Sanofi-Aventis FY 2005

Q2 2005 Sanofi-Aventis Earnings Conference Call

FDA Approval Letter ¿¿¿ LANTUS Reformulation March 2005

Q3 2005 Sanofi-Aventis Earnings Conference Call

Q1 2005 Sanofi-Aventis Earnings Conference Call

LANTUS (NDA 21-081 S-024) ¿¿¿ Labeling-Container Carton Labels, Labeling-Package Insert Rev. Mar. 2007

NDA 21-081 S-005 ¿¿¿ Efficacy-New Dosing Regimen ¿¿¿ Label, Apr. 30, 2003

Mestre-Ferrandiz, et al. The R&D Cost of a New Medicine, Office of Health Economics, pp. 1-100 (Dec. 2012)

LANTUS Why Lantus Page "Ask Your Healthcare Provider About Switching to LANTUS" (October 16, 2006)

LANTUS Using Lantus "How to Use the Lantus SoloSTAR¿¿ Pen" (Current)

LANTUS Savings Card

LANTUS Resources (Current)

LANTUS New to Lantus Page (October 2006)

LANTUS Support "LANTUS Tips and Support" (October 2006)

LANTUS Home Page (Current)

LANTUS Home Page (October 2006)

LANTUS About (Current)

LANTUS - Your Diabetes Treatment Routine (Current)

LANTUS - How to Inject Lantus With a Vial and Syringe

LANTUS - Home Page (Current)

LANTUS - Explore Diabetes Treatment Options (Current)

PROTECTIVE ORDER MATERIAL- IQVIA ¿¿¿ Diabetes Data

FDA ¿¿¿ 25th Orange Book (2005)

DiMasietal, et al. Innovation in the Pharmaceutical Industry New Estimates of R&D Costs J. of Health Eco., 37 (2016) pp. 20-33

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Cowen and Company, Therapeutic Categories Outlook, Comprehensive Study Oct. 2006

CDC Long-Term Trends in Diabetes April 2017

FDA ¿¿¿ 27th Orange Book (2007)

UBS Equities Sanofi-Aventis Q105 May 13 2005

SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook, pp. 136-156 (March 2002)

SG Cowen Perspectives Pharmaceutical Therapeutic Categories Outlook pp. 134-148 Oct. 2001

Neuprogen Filgratim Amgen Inc. Product label April 2 1998

Shao et al Differential Effects of Anionic, Cationic, Nonionic, and Physiologic Surfactants on

Wan et al. CMC of Polysorbates, J. of Pharma. Sciences

Safety Alerts Internet Archive Walgreen Co. Recalls Lantus Insulin Glargine (rDNA origin) Injection Nov. 15 2001

A. Martin et al. Physical Principles In the Pharmaceutical Sciences

CDC About Diabetes June 1, 2017

U.S. SEC Form 20-F for Sanofi-Aventis FY 2003

U.S. SEC Form 20-F for Sanofi-Aventis FY 2002

ABN AMRO Pharmaceutical Market Share Report Oct. 2001

WebMD Types of Insulin for Diabetes Treatment accessed May 3, 2018

UBS Equities ¿¿¿ Sanofi-Aventis Q405, Jan. 24, 2006

UBS Equities Sanofi-Aventis Q305, Nov. 3, 2005

UBS Equities ¿¿¿ Sanofi-Aventis Q205, Sep. 1, 2005

St. Louis Federal Reserve Economic Data, Consumer Price Index for All Urban Consumers CPI Monthly accessed May 24, 2018

SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2006)

SG Cowen Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study Oct. 2005

SG Cowen Pharmaceutical Therapeutic Categories Outlook Comprehensive Study March 2005

Sanofi Press Releases 2006

Sanofi Press Releases 2005

1111A - Curriculum Vitae of Professor Robert Langer

Baynes et al. Role of Arginine in the Stabilization of Proteins Against Aggregation Biochemistry

Baynes et al. Rational Design of Solution Additives for the Prevention of Protein Aggregation Biophysical J. Vol. 87 pp.1631-1639, Sept. 2004

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K.L. Mittal Determination of CMC of Polysorbate 20 in Aqueous Solution by Surface Tension Method

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Affidavit of M.T. Lanterman - IPR2017-01526 and IPR2017-01528

PDR 1997 Pgs. 1488-1490 Humalog insulin

Physicians' Desk Reference 1997 Pgs. 1497-1498

LANGER, Robert, et al. U.S. Publication No. 20150320837 Nov. 12 2015

2001 PDR Entry for Etoposide p. 825

2001 PDR Entry for Limbitrol p1538

2001 PDR Entry for Norditropin p. 2236

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2001 PDR Entry for Novoline, pp. 2238-2242

PROTECTIVE ORDER MATERIAL- Aventis, NDA 21-081 Formulation Optimization

PROTECTIVE ORDER MATERIAL - Aventis LANTUS

PROTECTIVE ORDER MATERIAL - Aventis Formulation Development Report Insulin Glargine

PROTECTIVE ORDER MATERIAL - Aventis Lantus Multi Dose Vial (10 ml) Complaint Situation

PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml Vials

LANGER, R. et al. US 2015/0320837

LANGER, Robert S. et al. U.S. Patent No. 9994615 B2

PROTECTIVE ORDER MATERIAL - Aventis Summary Report Lantus mL Vials ¿¿¿ Complaints Turbidity Description and Measurements, Aug. 19, 2002, SANOFI_01594042

PROTECTIVE ORDER MATERIAL- Aventis Formulation Optimization Decision to Submit for 10-ml Vials, PPRC, June 17, 2004, SANOFI_01665660

PROTECTIVE ORDER MATERIAL- Aventis Reformulation LANTUS IO QO View, Nov. 7, 2014, SANOFI_01747290

U.S. Patent No. 6,656,499 Foldvari

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Declaration of DeForest McDuff

Ex. 1169E- Lantus Prescriptions

Ex. 1169F - Lantus Market Shares

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U.S. Patent No. 5,656,722

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Petitioner's Reply (Protective Order Material)

PROTECTIVE ORDER MATERIAL- SANOFI Insulin Glargine ¿¿¿ Solution for Injection Container Closure System Injection Vial 5 and 10 mL May 2013 SANOFI_00430764

PROTECTIVE ORDER MATERIAL - Aventis Response to Agency Request Insulin Glargine Solution for Injection, 100 IU/ml, Jan. 13, 2005, SANOFI_01593692

PROTECTIVE ORDER MATERIAL - Aventis Development Status Report, HOE 901 In-use Stability of HOE 901 Solution for Injection May 2001 SANOFI_01594032

PROTECTIVE ORDER MATERIAL-- Aventis LANTUS HOE 901D - Formulation Improvement Strategy GPT/MAX Team Meeting, June 14, 2003, SANOFI_01628810

PROTECTIVE ORDER MATERIAL- Aventis Formulation Optimization Decision to Submit PROC June 2, 2004, SANOFI_01664827

PROTECTIVE ORDER MATERIAL- Aventis Comparative in Use of Stability of Lantus and Other Insulins, SANOFI_01666332

PROTECTIVE ORDER MATERIAL- Aventis Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml. Vials, Complaints Concerning Turbidity, July 24, 2001, SANOFI_01667979

PROTECTIVE ORDER MATERIAL- E-mail Contact Report from FDA to M. Lutz, Regulatory Affairs, for proposed FDA Revision, April 28, 2003 SANOFI_01815531

PROTECTIVE ORDER MATERIAL- Aventis Pharma Lantus Injectable 10 ml. Vial Insulin Glargine NDA 21-081 Field Alert July 12, 2001 SANOFI_70006138

PROTECTIVE ORDER MATERIAL- Aventis Pharma, Formulation Development Report Insulin Glargine, Lantus Formulation HOE 901 (30) R, SANOFI3_90297269

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Ex. 1169A - Curriculum Vitae of DeForest McDuff

Ex. 1169B - Revenues by Product

Ex. 1169C - Diabetes Patient Population

Ex. 1169D - Insulin Product Sales

U.S. Patent No. 6,100,376

Susan Budavari et al., The Merck Index An Encyclopedia of Chemicals Drugs and Biologicals 12th ed. 1996

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Declaration of William Curtis Biggs

Ex. 1174A - Curriculum Vitae of William Curtis Biggs

Diabetes Complications and Control Trial (DCCT) (1993)

March 2, 2003 Usenet forum post by William Biggs, Preloading Lantus in syringes, misc.health.diabetes,

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Declaration of Professor Samuel H. Yalkowsky

Physicians' Desk Reference - Venofer

PROTECTIVE ORDER MATERIAL - Declaration of Professor Robert Langer

Ex. 1111B - References Considered by Professor Robert Langer

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Transcript of Telephone Conference Held July 5, 2018, in IPR2017-01526 and IPR2017-01528

Mylan Pharmaceuticals Inc. Updated Mandatory Notices

Mylan Pharmaceuticals Inc. Revised Power Of Attorney

Granting Petitioner's Unopposed Motions for Pro Hac Vice Recognition

Joint Stipulation to Modify the Scheduling Order

Notice of Deposition of Dr. Bernhardt Trout

Notice of Deposition of Dr. Laurence Baker

Mylan Pharmaceutical's Unopposed Motion for Pro Hac Vice Recognition

Declaration of Elham Steiner

Biography of Elham Firouzi Steiner

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

Supplemental Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH

Order Granting Patent Owner's Pro Hac Vice Motions to Admit Robert Vlasis

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

Declaration of Robert Vlasis

Biography of Robert Vlasis

Mylan Pharmaceutical's Objections

Patent Owner's Response to Petition for Inter Partes Review of U.S. Patent No. 7,713,930

Declaration of Dr. Bernhardt Trout

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

Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky

Patent Owner's Objections to Admissibility of Supplemental Evidence Served by Petitioner Mylan Pharmaceutical Inc. in Inter Partes Review

Order Conduct of the Proceeding Extending Due Date 1 and Due Date 2 of the Scheduling Order

Order Granting-in-part and Denying-in-part Petitioner's Motion for Supplemental Information

Affidavit of Christopher Butler (April 4, 2017)

Mylan Pharmaceuticals's Updated Exhibit List

Aventispharma-us.com, Lantus Prescribing Information (Jan. 10, 2001)

Patent Owner's Opposition to Petitioner's Motion for Supplemental Information

Exhibit 1047

Mylan Pharmaceuticals Inc. Motion for Supplemental Information

Mylan Pharmaceuticals Updated Exhibit List

Exhibit 1045 - Board Email

Mylan Pharmaceutical's Updated Exhibit List

Exhibit 1045 - call Transcript

Patent Owner's Objections to Admissibility of Evidence Served with Petitioner Mylan Pharmaceutical Inc.'s Petition for Inter Partes Review

Mylan's Objections

SCHEDULING ORDER 37 C.F.R. sec 42.5(a)

PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES

Trial Instituted Document

PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES

Mylan Pharmaceuticals Inc.¿¿¿s Updated Exhibit List

Declaration of Clark Lin

Corrected Exhibit 1004

Conduct of the Proceeding 37 C.F.R sec 42.5

Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 7,713,930

2001 Physicians Desk Reference (PDR)

Formulation-Related Problems Associated with Intravenous Drug Delivery

Physical Biochemistry of Protein Drugs, in Protein and Peptide Delivery

U.S. Patent No. 5,656,722

Canadian Patent No. 1,258,427

Patent Owner's Updated Mandatory Notices

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

Notice of Accord Filing Date

U.S. Patent No. 7,476,652, Acidic Insulin Preparations Having Improved Stability (filed March 25, 2005) (issued January 13, 2009)

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1001A Part III - File History for U.S. Patent No. 7,476,652

1001A Part V - File History for U.S. Patent No. 7,476,652

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1001A Part IV - File History for U.S. Patent No. 7,476,652

1001A Part VI - File History for U.S. Patent No. 7,476,652

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1007A - Certified English translation for Ex. 1007 (FASS Entry for INSUMAN INFUSAT)

Power of Attorney

1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky

1003B - Materials Reviewed by Professor Samuel H. Yalkowsky

2000 FASS Entry for INSUMAN INFUSAT (January 2000)

W.D. Lougheed et al., Insulin Aggregation in Artificial Delivery Systems, Diabetologia 19:1-9 (July 1980)

Expert Declaration of Professor Samuel H. Yalkowsky in Support of Petition for Inter Partes Review of Patent No. 7,476,652 and U.S. Patent No. 7,713,930

PETITION FOR INTER PARTES REVIEW U.S. PATENT NO. 7,713,930