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Patent Owner

Sanofi Aventis Deutschland GmbH

Petitioner

Mylan Pharmaceuticals Inc.

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Mylan Pharmaceuticals Inc. v. Sanofi Aventis Deutschland GmbH

IPR2017-01526 | Patent Trial and Appeal Board

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Filed June 5, 2017

Terminated Dec. 12, 2018

Judges Erica Franklin, Michelle Ankenbrand, and Robert Pollock

Case Type Inter Partes Review

Status Final Written Decision

Challenged Patent 11/89,777

Patent No. 7,476,652 assignments

Tech Center 1600

Art Unit 1654

Inventors Anette Brunner-Schwarz, Norbert Lill

Last Updated: 5 months ago

Filing Date	#	Filing and Exhibits
Entries matching. Show All.
11/6/2020	11-06-2020-Petitioner	Petitioner Notice 100: Petitioner's Mandatory Change-of-Information Notices
4/15/2020	04-15-2020-Patent_Owner	Patent Owner Notice 99: Patent Owner Sanofi-Aventis Deutschland GmbH¿¿¿s Notice of Extension of Time to File Petition for Writ of Certiorari
2/19/2020	02-19-2020-Patent_Owner	Patent Owner Notice 98: Patent Owner Sanofi-Aventis Deutschland GmbH¿¿¿s Notice of Filing Petition for Writ of Certiorari Within the Time Allowed
2/5/2020	02-05-2020-Board	Board Order 97: ORDER Granting Patent Owner¿¿¿s Motions to Withdraw Counsel 37 C.F.R. ¿¿ 42.10(e)
1/29/2020	01-29-2020-Patent_Owner	Patent Owner Motion 96: Patent Owner's Motion for Withdrawal of Counsel
6/21/2019	06-21-2019-Patent_Owner	Patent Owner Exhibit 2071: EXPUNGED
1/8/2019	01-08-2019-Board	Board Order 95: Order Granting Patent Owner's Motion to Seal
1/4/2019	01-04-2019-Patent_Owner	Event: Notice of Appeal Patent Owner Notice of Appeal 94: Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a)
12/20/2018	12-20-2018-Patent_Owner	Patent Owner Motion 93: Patent Owner's Motion to Seal
12/19/2018	12-19-2018-Patent_Owner	Patent Owner Other (Not for motions) 90: Petitioner's Reply (Redacted Public Version Submitted by Patent Owner) Patent Owner Exhibit List 91: Patent Owner's Updated Exhibit List - Public Patent Owner Exhibit List 92: Patent Owner's Updated Exhibit List - Confidential Patent Owner Exhibit 2070: Expert Declaration of Professor Robert S. Langer in Support of Petition for IPR of Patent Nos. 7,476,652 and 7,713,930 - Public
12/12/2018	12-12-2018-Board	Board Termination Decision Document 89: Termination Decision Document
10/24/2018	10-24-2018-Petitioner	Petitioner Motion 87: Petitioner's Motion to Seal Petitioner Reply 88: REDACTED - Paper 86 - Mylan Pharmaceutical Inc.'s Sur-Surreply
10/23/2018	10-23-2018-Petitioner	Petitioner Reply 86: Mylan Pharmaceutical Inc.'s Sur-Surreply
10/16/2018	10-16-2018-Petitioner	Petitioner Objection 85: Mylan Pharmaceuticals' Objections
10/11/2018	10-11-2018-Petitioner	Petitioner Notice 84: Petitioner's Mandatory Change-of-Information Notices
10/9/2018	10-09-2018-Patent_Owner	Patent Owner Motion 78: Patent Owner's Motion to Seal Patent Owner Reply 79: Patent Owner's Surreply Patent Owner Reply 80: Patent Owner's Surreply - Public Patent Owner Exhibit List 81: Patent Owner's Updated Exhibit List Patent Owner Exhibit List 82: Patent Owner's Updated Exhibit List Patent Owner Exhibit List 83: Patent Owner's Updated Exhibit List Patent Owner Exhibit 2062: Supplemental Declaration of Dr. Bernhardt Trout Patent Owner Exhibit 2062: Supplemental Declaration of Dr. Bernhardt Trout - Public Patent Owner Exhibit 2063: Declaration of Dr. Thomas Eichinger Patent Owner Exhibit 2064: Lantus EPAR June 2000 Patent Owner Exhibit 2065: Internal Memorandum re FDA Contact And/Or Trip Report for Lantus (Insulin Glargine) on September 8, 1999 Patent Owner Exhibit 2066: March 30, 2000 Aventis Pharma memorandum regarding Minutes of 29th TSV Team Meeting on HOE901 Drug Product Patent Owner Exhibit 2067: Hoeschst Marion Roussel presentation on HOE 901 ¿¿¿ Insulin Glargine Patent Owner Exhibit 2068: April 20, 2000 Response Letter to FDA re Lantus Application to Market a New Drug Patent Owner Exhibit 2069: Draft Aventis RMC Strategy & Risk Assessment (RCMS SRA) For Development Activities for Lantus Reformulation
9/27/2018	09-27-2018-Board	Board Hearing Transcript 77: Hearing Transcript
9/25/2018	09-25-2018-Petitioner	Petitioner Exhibit List 76: Mylan Pharmaceutical Inc.'s Updated Exhibit List Petitioner Exhibit 1186: Exhibit 1186A - Final Transcript of Telephonic Conference held September 24, 2018 in IPR-2017-01526 and IPR2017-01528
9/25/2018	09-25-2018-Board	Board Order Conduct of Proceeding 75: Authorizing Sur-reply and Sur-sur-reply
9/24/2018	09-24-2018-Petitioner	Petitioner Exhibit List 74: Mylan Pharmaceutical Inc.'s Updated Exhibit List Petitioner Exhibit 1186: RoughtTranscript of Telephone Conference held 09-24-2018
8/29/2018	08-29-2018-Board	Board Order 73: Order Adjusting Oral Hearing Time
8/27/2018	08-27-2018-Board	Board Order 72: Trial Hearing 37 C.F.R § 42.70
8/24/2018	08-24-2018-Petitioner	Petitioner Response 70: Mylan Pharmaceutical Inc.'s Reply In Support of Its Motion to Exclude
8/24/2018	08-24-2018-Patent_Owner	Patent Owner Reply 71: Patent Owner's Reply to Motion to Exclude
8/22/2018	08-22-2018-Petitioner	Petitioner Oral Hearing Request 69: Corrected Paper 57- Mylan_Pharmaceutical's_Request_For_Oral_Argument
8/21/2018	08-21-2018-Patent_Owner	Patent Owner Motion 63: EXPUNGED Patent Owner Opposition 64: Patent Owner's Opposition to Petitioner's Motion to Exclude
8/21/2018	08-21-2018-Petitioner	Petitioner Exhibit List 65: Mylan's Updated Exhibit List Petitioner Motion 66: EXPUNGED Petitioner Motion 67: Mylan Pharmaceutical Inc.'s Opposition to Sanofi's Motion to Exclude Petitioner Motion 68: Mylan Pharmaceutical Inc.'s Response to Sanofi's Observations on Cross Examination Petitioner Exhibit 1184: August 17, 2018, email serving Mylan's Response to Sanofi's Observations & Mylan¿¿¿s Opposition to Sanofi¿¿¿s Motion to Exclude[ Petitioner Exhibit 1185: 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
8/10/2018	08-10-2018-Petitioner	Petitioner Motion 57: Mylan Pharmaceutical's Motion to Exclude Petitioner Oral Hearing Request 58: Mylan Pharmaceutical's Request For Oral Argument
8/10/2018	08-10-2018-Patent_Owner	Patent Owner Oral Hearing Request 59: Patent Owner's Request for Oral Argument Patent Owner Other (Not for motions) 60: Patent Owner's Observations on the Cross Examination of Petitioner's Reply Declarants Patent Owner Motion 61: Patent Owner's Motion to Exclude Patent Owner Exhibit List 62: Patent Owner's Updated Exhibit List Patent Owner Exhibit 2056: S. Simpson & E. Toth, ¿¿¿Expanding the Options in Insulin Therapy: A Review of Insulin Analogues,¿¿¿ 26(3) Canadian Journal of Diabetes, 195-205 (2002) Patent Owner Exhibit 2057: Annex 1, Summary of Product Characteristics Patent Owner Exhibit 2058: July 31, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky, Volume II Patent Owner Exhibit 2059: July 30, 2018, Deposition Transcript of Dr. William C. Biggs Patent Owner Exhibit 2060: August 2, 2018, Deposition Transcript of Dr. Robert D. McDuff Patent Owner Exhibit 2061: August 7, 2018, Deposition Transcript of Dr. Robert S. Langer
8/3/2018	08-03-2018-Petitioner	Petitioner Exhibit List 56: Mylan Pharmaceutical Inc.'s Updated Exhibit
7/30/2018	07-30-2018-Patent_Owner	Patent Owner Notice of Deposition 55: Patent Owner's Notice of Deposition of Dr. Robert S. Langer
7/30/2018	07-30-2018-Petitioner	Petitioner Objection 54: Mylan Pharmaceuticals' Objections
7/27/2018	07-27-2018-Petitioner	Petitioner Opposition 52: Petitioner's Opposition to Patent Owner's Motion to Strike Petitioner Exhibit List 53: Mylan Pharmaceuticals Updated Exhibit List Petitioner Exhibit 1183: Transcript of Telephone Conference held on July 26th, 2018, in IPR2017-01526 and IPR2017-01528
7/27/2018	07-27-2018-Patent_Owner	Patent Owner Notice of Deposition 51: Patent Owner's Notice of Deposition of Dr. William C. Biggs
7/26/2018	07-26-2018-Patent_Owner	Patent Owner Notice of Deposition 50: Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky
7/24/2018	07-24-2018-Patent_Owner	Patent Owner Notice of Deposition 48: Patent Owner's Notice of Deposition of DeForest McDuff, Ph.D. Patent Owner Exhibit List 49: Patent Owner's Updated Exhibit List Patent Owner Exhibit 2055: Transcript of 7/17/2018 Telephonic Conference (IPR2017-01526, IPR2017-01528)
7/23/2018	07-23-2018-Patent_Owner	Patent Owner Reply 46: Patent Owner Surreply Patent Owner Motion 47: Patent Owner's Motion to Strike Patent Owner Exhibit 2051: Judge Andrews' Order, Dkt. 287 (Sanofi v. Merck, 16-812-RGA) Patent Owner Exhibit 2052: Trial Transcript Excerpts (Sanofi v. Merck, 16-812-RGA) Patent Owner Exhibit 2053: Petitioner's Reply - Public, Redacted Patent Owner Exhibit 2054: Petitioner's Reply - Under Seal
7/20/2018	07-20-2018-Patent_Owner	Patent Owner Objection 44: PATENT OWNER¿¿¿S OBJECTIONS TO ADMISSIBILITY OF EVIDENCE SERVED BY PETITIONER MYLAN PHARMACEUTICAL INC. IN INTER PARTES REVIEW Patent Owner Motion 45: Patent Owner's Supplemental Motion to Seal
7/13/2018	07-13-2018-Petitioner	Petitioner Motion 41: Petitioner's Motion To Seal And For Entry Of Proposed Protective Order Petitioner Exhibit List 42: Mylan Pharmaceutical Inc.'s Updated Exhibit List Petitioner Reply 43: Petitioner's Reply (Protective Order Material) Petitioner Exhibit 1051: EP Pub. 0368187 A2 Petitioner Exhibit 1052: Amgen, Inc. profile of ¿¿¿NEUPOGEN¿¿¿ (Filgrastim), Apr. 2, 1998, pp. 1-27pp. 1-27 Petitioner Exhibit 1053: Center for Drug Evaluation and Research, Approval for ¿¿¿NUTROPIN AQ¿¿¿ (App. 20-522/S-10), Apr. 10, 2000 Petitioner Exhibit 1054: Deposition of Dr. Berhard Trout (June 21, 2018) Petitioner Exhibit 1055: Deposition of Dr. Laurence Baker, Ph.D. (June 22, 2018) Petitioner Exhibit 1056: Campbell, Kevin; ¿¿¿Insulin Costs Are Skyrocketing. This is Why.¿¿¿, U.S. News and World Report, June 29, 2018, pp.1-3 Petitioner Exhibit 1057: MEDWATCH, FDA Medical Products Reporting Program, Report on LANTUS¿¿, Case ID 376724, Apr. 05, 2002 Petitioner Exhibit 1057: Affidavit of Marlene S. Bobka (July 3, 2018) Petitioner Exhibit 1058: Aventis Pharmaceuticals, Inc., Individual Safety Report for ¿¿¿LANTUS¿¿¿¿¿, Case 4054424-5-00-01, Feb. 06, 2003 Petitioner Exhibit 1058: Affidavit of Marlene S. Bobka (July 3, 2018) Petitioner Exhibit 1060: 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) Petitioner Exhibit 1061: 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) Petitioner Exhibit 1062: 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) Petitioner Exhibit 1063: U.S. SEC Form 20-F for Sanofi-Aventis FY 2006 Petitioner Exhibit 1064: U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - part 1 Petitioner Exhibit 1064: U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - Part 2 Petitioner Exhibit 1065: U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 1 Petitioner Exhibit 1065: U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 2 Petitioner Exhibit 1066: Q4 2005 Sanofi-Aventis Earnings Conference Call Petitioner Exhibit 1067: Q3 2005 Sanofi-Aventis Earnings Conference Call Petitioner Exhibit 1068: Q2 2005 Sanofi-Aventis Earnings Conference Call Petitioner Exhibit 1069: Q1 2005 Sanofi-Aventis Earnings Conference Call Petitioner Exhibit 1070: LANTUS¿¿ (NDA 21-081 S-024) ¿¿¿ Labeling-Container Carton Labels, Labeling-Package Insert, Rev. Mar. 2007 Petitioner Exhibit 1071: NDA 21-081 S-005 ¿¿¿ Efficacy-New Dosing Regimen ¿¿¿ Label, Apr. 30, 2003 Petitioner Exhibit 1072: Mestre-Ferrandiz, et al., ¿¿¿The R&D Cost of a New Medicine¿¿¿, Office of Health Economics, pp. 1-100 (Dec. 2012) Petitioner Exhibit 1073: LANTUS¿¿ Why Lantus Page ¿¿¿ Ask Your Healthcare Provider About Switching to LANTUS¿¿¿¿¿ (October 16, 2006) Petitioner Exhibit 1074: LANTUS¿¿ Using Lantus ¿¿¿How to Use the Lantus¿¿ SoloSTAR¿¿ Pen¿¿¿ (Current) Petitioner Exhibit 1075: LANTUS¿¿ Savings Card (Current) Petitioner Exhibit 1076: LANTUS¿¿ Resources (Current) Petitioner Exhibit 1077: LANTUS¿¿ New to Lantus Page (October 2006) Petitioner Exhibit 1078: LANTUS¿¿ Support ¿¿¿LANTUS¿¿ Tips and Support¿¿¿ (October 2006) Petitioner Exhibit 1079: LANTUS¿¿ Home Page (Current) Petitioner Exhibit 1080: LANTUS¿¿ Home Page (October 2006) Petitioner Exhibit 1081: LANTUS¿¿ About (Current) Petitioner Exhibit 1082: LANTUS¿¿ - Your Diabetes Treatment Routine (Current) Petitioner Exhibit 1083: LANTUS¿¿ - How to Inject Lantus With a Vial and Syringe Petitioner Exhibit 1084: LANTUS¿¿ - Home Page (Current) Petitioner Exhibit 1085: LANTUS¿¿ - Explore Diabetes Treatment Options (Current) Petitioner Exhibit 1086: PROTECTIVE ORDER MATERIAL - IQVIA ¿¿¿ Diabetes Data Petitioner Exhibit 1087: FDA Approval Letter ¿¿¿ LANTUS¿¿ Reformulation March 2005 Petitioner Exhibit 1088: FDA ¿¿¿ 27th Orange Book (2007) Petitioner Exhibit 1089: FDA ¿¿¿ 25th Orange Book (2005) Petitioner Exhibit 1090: DiMasietal, et al. ¿¿¿Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs¿¿¿, J. of Health Eco., 37 (2016) pp. 20-33 Petitioner Exhibit 1091: David et al., ¿¿¿Commercial Success Economic Principles Applied to Patent Litigation¿¿¿, Economics of Pat. Damages, Chap. 9, pp. 159-160 Petitioner Exhibit 1092: Cowen and Company, ¿¿¿Therapeutic Categories Outlook¿¿¿, Comprehensive Study (Oct. 2006) Petitioner Exhibit 1093: CDC, ¿¿¿Long-Term Trends in Diabetes¿¿¿, April 2017, (http://www.cdc.gov/biabetes/data) Petitioner Exhibit 1094: CDC, ¿¿¿About Diabetes¿¿¿, June 1, 2017, (http://www.cdc.gov/biabetes/data) Petitioner Exhibit 1095: U.S. SEC Form 20-F for Sanofi-Aventis FY 2003 Petitioner Exhibit 1096: U.S. SEC Form 20-F for Sanofi-Aventis FY 2002 Petitioner Exhibit 1097: ABN AMRO ¿¿¿ Pharmaceutical Market Share Report (Oct. 2001) Petitioner Exhibit 1098: WebMD ¿¿¿ ¿¿¿Types of Insulin for Diabetes Treatment¿¿¿ (accessed May 3, 2018) Petitioner Exhibit 1099: UBS Equities ¿¿¿ Sanofi-Aventis Q405, Jan. 24, 2006 Petitioner Exhibit 1100: UBS Equities ¿¿¿ Sanofi-Aventis Q305, Nov. 3, 2005 Petitioner Exhibit 1101: UBS Equities ¿¿¿ Sanofi-Aventis Q205, Sep. 1, 2005 Petitioner Exhibit 1102: UBS Equities ¿¿¿ Sanofi-Aventis Q105, May 13, 2005 Petitioner Exhibit 1103: St. Louis Federal Reserve Economic Data, Consumer Price Index for All Urban Consumers¿¿¿ CPI Monthly (accessed May 24, 2018) Petitioner Exhibit 1104: SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2006) Petitioner Exhibit 1105: SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (Oct. 2005) Petitioner Exhibit 1106: SG Cowen ¿¿¿Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2005) Petitioner Exhibit 1107: SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook, pp. 136-156 (March 2002) Petitioner Exhibit 1108: SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook , pp. 134-148 (Oct. 2001) Petitioner Exhibit 1109: Sanofi Press Releases 2006 Petitioner Exhibit 1110: Sanofi Press Releases 2005 Petitioner Exhibit 1111: 1111A - Curriculum Vitae of Professor Robert Langer Petitioner Exhibit 1111: PROTECTIVE ORDER MATERIAL - Declaration of Professor Robert Langer Petitioner Exhibit 1111: Ex. 1111B - References Considered by Professor Robert Langer Petitioner Exhibit 1112: Baynes et al., ¿¿¿Role of Arginine in the Stabilization of Proteins Against Aggregation¿¿¿, Biochemistry, Vol. 44, No. 12, pp. 4919-4925 (2005) Petitioner Exhibit 1113: Baynes et al., ¿¿¿Rational Design of Solution Additives for the Prevention of Protein Aggregation¿¿¿, Biophysical J., Vol. 87, pp.1631-1639 (Sept. 2004) Petitioner Exhibit 1114: Neuprogen¿¿ (Filgratim), Amgen Inc. Product label, April 2, 1998 Petitioner Exhibit 1115: Nielsen, et al., ¿¿¿Effect of Environmental Factors On the Kinetics of Insulin Fibril Formation: Elucidation of the Molecular Mechanism¿¿¿, Biochemistry 2001, 40, pp. 6036-6046 (2001) Petitioner Exhibit 1116: Shao, et al. ¿¿¿ ¿¿¿Differential Effects of Anionic, Cationic, Nonionic, and Physiologic Surfactants on the Dissociation, ¿¿-Chymotryptic Degradation, and Enteral Absorption if Insulin Petitioner Exhibit 1117: Manning et al., ¿¿¿Stability of Protein Pharmaceuticals¿¿¿, Pharm. Research, Vol. 6, No. 11, pp. 903-918 (1989) Petitioner Exhibit 1118: WO 83/00288 A1 (¿¿¿¿¿¿288 application¿¿¿) Petitioner Exhibit 1119: CA Patent No. 1,258,427 (¿¿¿CA ¿¿¿427¿¿¿) Petitioner Exhibit 1120: Hawley¿¿¿s Condensed Chemical Dictionary, 12th Ed. ¿¿¿ Strong acid reference¿¿¿, pp. 890-891 (1993) Petitioner Exhibit 1121: Wan, et al., ¿¿¿CMC of Polysorbates¿¿¿, J. of Pharma. Sciences, Vol. 63, No. 1, pp. 136-137 (Jan. 1974) Petitioner Exhibit 1122: WO 00/23098 (¿¿¿¿¿¿098 application¿¿¿) Petitioner Exhibit 1123: B. Farhadieh, ¿¿¿Determination of CMC and Partial Specific Volume of Polysorbates 20, 60 and 80 from Densities of Their Aqueous Solutions¿¿¿, J. of Pharma. Sciences, Vol. 62, No. 10, pp.1685-1688 (Oct. 1973) Petitioner Exhibit 1124: AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿) Petitioner Exhibit 1124: Corrected Ex. 1124 - K.L. Mittal, ¿¿¿Determination of CMC of Polysorbate 20 in Aqueous Solution by Surface Tension Method¿¿¿, J. of Pharma. Sciences, Vol. 51, No. 8, pp. 1134-1135 (Aug. 1972) Petitioner Exhibit 1125: AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿) Petitioner Exhibit 1126: EP 1019022 B1 (¿¿¿EP ¿¿¿022¿¿¿) Petitioner Exhibit 1127: U.S. Patent No. 6,211,144 (¿¿¿Havelund¿¿¿) Petitioner Exhibit 1128: U.S. Patent No. 6,335,316 (¿¿¿Hughes¿¿¿) Petitioner Exhibit 1129: Safety Alerts Internet Archive ¿¿¿Walgreen Co. Recalls Lantus Insulin Glargine (rDNA origin) Injection¿¿¿ (Nov. 15, 2001) Petitioner Exhibit 1130: Conway-Jacobs, et al., ¿¿¿Isoelectric Focusing in Acrylamide Gels¿¿¿ Use of Amphoteric Dyes As Internal markers For Determination of Isoelectric Points¿¿¿, Analytical BioChem. 43, 394-400 ( 1971) Petitioner Exhibit 1131: U.S. Patent No. 6,737,401 (¿¿¿Kim¿¿¿) Petitioner Exhibit 1132: Part 1 - A. Martin, et al., ¿¿¿Physical Principles In the Pharmaceutical Sciences¿¿¿ Phys. Pharmacy, Drug Dynamics Inst., Col. Of Pharma., Univ. of Texas, 1983 Petitioner Exhibit 1132: Part 2 - A. Martin, et al., ¿¿¿Physical Principles In the Pharmaceutical Sciences¿¿¿ Phys. Pharmacy, Drug Dynamics Inst., Col. Of Pharma., Univ. of Texas, 1983 Petitioner Exhibit 1133: Expert Declaration of Mark Lanterman In Support of Petitioner¿¿¿s Reply For Inter Partes Review of U.S. Pat. No. 7,476,652 and 7,713,930 Petitioner Exhibit 1134: 1997 PDR Entry for ¿¿¿Humalog¿¿¿¿¿, pp. 1488-1490 Petitioner Exhibit 1135: 1997 PDR Entry for ¿¿¿Humulin¿¿R¿¿¿, pp. 1497-1498 Petitioner Exhibit 1136: LANGER, Robert S. et al. U.S. Publication No. 2015/0025005A1, Jan. 22, 2015 Petitioner Exhibit 1137: LANGER, Robert S. et al. U.S. Publication No. 2015/0320837, Nov. 12, 2015 Petitioner Exhibit 1138: LANGER, Robert S. et al. U.S. Patent No. 9,994,615 B2, Jun. 12, 2018 Petitioner Exhibit 1139: 2001 PDR Entry for ¿¿¿Etoposide¿¿¿, p. 825 Petitioner Exhibit 1140: 2001 PDR Entry for ¿¿¿Limbitrol¿¿¿¿¿, p. 1538 Petitioner Exhibit 1141: 2001 PDR Entry fro ¿¿¿Norditropin¿¿¿¿¿, p. 2236 Petitioner Exhibit 1142: LANGER, Robert S. et al. WO2013123492 A1, Aug. 22, 2013 Petitioner Exhibit 1143: 2001 PDR Entry for ¿¿¿Novoline¿¿¿¿¿, pp. 2238-2242 Petitioner Exhibit 1144: PROTECTIVE ORDER MATERIAL - Aventis, NDA 21-081 Formulation Optimization, Lantus (Insulin Glargine Injection), ¿¿¿ Description and Composition of the Drug Product¿¿¿, Nov. 1, 2004, SANOFI_00003665 Petitioner Exhibit 1145: PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿LANTUS (HOE 901 D) Formulation Improvement¿¿¿ Summit Meeting, Bridgewater, June 18, 2002, SANOFI_00321284 Petitioner Exhibit 1146: PROTECTIVE ORDER MATERIAL - Aventis, Formulation Development Report, Insulin Glargine, Lantus Reformulation (HOE 901 (30) R), June 4, 2004, SANOFI_00410543 Petitioner Exhibit 1147: PROTECTIVE ORDER MATERIAL - Aventis ¿¿¿Lantus Multi Dose Vial (10 ml) Complaint Situation¿¿¿, Oct. 27, 2001, SANOFI_00413048 Petitioner Exhibit 1148: PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml Vials, Complaints Concerning Turbidity¿¿¿, July 19, 2001, SANOFI_00413346 Petitioner Exhibit 1149: PROTECTIVE ORDER MATERIAL - SANOFI, ¿¿¿Insulin Glargine ¿¿¿ Solution for Injection, Container Closure System, Injection Vial, 5 and 10 mL¿¿¿, May 2013, SANOFI_00430764 Petitioner Exhibit 1150: PROTECTIVE ORDER MATERIAL - Aventis, Response to Agency Request ¿¿¿Insulin Glargine Solution for Injection, 100 IU/ml¿¿¿, Jan. 13, 2005, SANOFI_01593692 Petitioner Exhibit 1151: PROTECTIVE ORDER MATERIAL - Aventis, Development Status Report, HOE 901, ¿¿¿In-use Stability of HOE 901 Solution for Injection¿¿¿, May 2001, SANOFI_01594032 Petitioner Exhibit 1152: PROTECTIVE ORDER MATERIAL - Aventis, Summary Report ¿¿¿Lantus¿¿ mL Vials ¿¿¿ Complaints Turbidity Description and Measurements¿¿¿, Aug. 19, 2002, SANOFI_01594042 Petitioner Exhibit 1153: PROTECTIVE ORDER MATERIAL - Aventis, LANTUS (HOE 901D) ¿¿¿Formulation Improvement Strategy¿¿¿ GPT/MAX Team Meeting, June 14, 2003, SANOFI_01628810 Petitioner Exhibit 1154: PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿Formulation Optimization Decision to Submit¿¿¿, PROC, June 2, 2004, SANOFI_01664827 Petitioner Exhibit 1155: PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿Formulation Optimization Decision to Submit for 10-ml Vials¿¿¿, PPRC, June 17, 2004, SANOFI_01665660 Petitioner Exhibit 1156: PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿Comparative in Use of Stability of Lantus and Other Insulins¿¿¿, SANOFI_01666332 Petitioner Exhibit 1157: 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 Petitioner Exhibit 1158: PROTECTIVE ORDER MATERIAL - Aventis Reformulation LANTUS¿¿ IO QO View, Nov. 7, 2014, SANOFI_01747290 Petitioner Exhibit 1159: PROTECTIVE ORDER MATERIAL - E-mail Contact Report from FDA to M. Lutz, Regulatory Affairs, for proposed FDA Revision, April 28, 2003, SANOFI_01815531 Petitioner Exhibit 1160: PROTECTIVE ORDER MATERIAL - Aventis Pharma , Lantus Injectable, 10 ml. Vial (Insulin Glargine) NDA 21-081, Field Alert, July 12, 2001, SANOFI_70006138 Petitioner Exhibit 1161: PROTECTIVE ORDER MATERIAL - Aventis Pharma, Formulation Development Report ¿¿¿Insulin Glargine, Lantus Formulation (HOE 901 (30) R), SANOFI3_90297269 Petitioner Exhibit 1162: Gerhard Wenske, Dictionary of Chemistry German/English (1st ed. 1994) Petitioner Exhibit 1163: U.S. Patent No. 4,783,441 (¿¿¿Thurow 1998¿¿¿) Petitioner Exhibit 1164: U.S. Patent No. 4,849,227 (¿¿¿Cho¿¿¿) Petitioner Exhibit 1165: U.S. Patent No. 5,518,998 (¿¿¿Backstrom¿¿¿) Petitioner Exhibit 1166: U.S. Patent No. 6,306,440 (¿¿¿Backstrom 2001¿¿¿) Petitioner Exhibit 1167: U.S. Patent No. 6,656,499 (¿¿¿Foldvari¿¿¿) Petitioner Exhibit 1168: Z. Strickley, ¿¿¿Stability of Human Insulin Effect of Water Content and Added Excipients on the Degradation of Lyophilized Insulin at Acidic pH¿¿¿, Thesis, Dept. of Pharm. and Pharmaceutical Chem. , U. of Utah, Dec. 1995 Petitioner Exhibit 1169: Ex. 1169D - Insulin Product Sales Petitioner Exhibit 1169: Declaration of DeForest McDuff Petitioner Exhibit 1169: Ex. 1169A - Curriculum Vitae of DeForest McDuff Petitioner Exhibit 1169: Ex. 1169B - Revenues by Product Petitioner Exhibit 1169: Ex. 1169C - Diabetes Patient Population Petitioner Exhibit 1169: Ex. 1169E - Lantus Prescriptions Petitioner Exhibit 1169: Ex. 1169F - Lantus Market Shares Petitioner Exhibit 1170: Pak, et al. ¿¿¿A Simple Apparatus For Measurement of Protein Monofilm Expansion At Air-Water Interface in Response to Soluble Reactants in the Subsolution¿¿¿, J. of Colloid Sci., 16, pp. 513-530 (1961) Petitioner Exhibit 1171: U.S. Patent No. 6,100,376 (¿¿¿the ¿¿¿376 patent¿¿¿) Petitioner Exhibit 1172: U.S. Patent No. 5,656,722 (¿¿¿the ¿¿¿722 patent¿¿¿) Petitioner Exhibit 1173: Susan Budavari et al., The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals (12th ed. 1996) Petitioner Exhibit 1174: Declaration of William Curtis Biggs Petitioner Exhibit 1174: 1174A- Curriculum Vitae of William Curtis Biggs Petitioner Exhibit 1175: Diabetes Complications and Control Trial (DCCT) (1993) Petitioner Exhibit 1176: March 2, 2003 Usenet forum post by William Biggs, Preloading Lantus in syringes, misc.health.diabetes, https://groups.google.com/forum/#!msg/misc.health.diabetes/ZNfvSjSwISI/vlNR48z2ME4J Petitioner Exhibit 1177: Phys. Desk Ref., ¿¿¿Iletin¿¿¿¿¿, 1997, pp. 1503-1504 Petitioner Exhibit 1178: Phys. Desk Ref., ¿¿¿Iletin¿¿ II¿¿¿, 1997, pp. 1507-1509 Petitioner Exhibit 1179: Velosulin¿¿ BR Buffered Regular Human Insulin Injection (rDNA origin), Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 2435 Petitioner Exhibit 1180: Novolin¿¿ R Regular, Human Insulin Injection (recombinant DNA origin), Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 2423 Petitioner Exhibit 1181: Declaration of Professor Samuel H. Yalkowsky Petitioner Exhibit 1182: Vanofor¿¿ Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 580-581 Petitioner Exhibit 1183: References Considered by Professor Robert Langer
7/11/2018	07-11-2018-Petitioner	Petitioner Exhibit List 40: Mylan Pharmaceutical Inc.'s Updated Exhibit List Petitioner Exhibit 1059: Transcript of Telephone Conference Held July 5, 2018 in IPR2017-01526 and IPR2017-01528
6/13/2018	06-13-2018-Petitioner	Petitioner Other (Not for motions) 38: Mylan Pharmaceuticals Inc. Updated Mandatory Notices Petitioner Power of Attorney 39: Mylan Pharmaceuticals Inc. Revised Power of Attorney
6/6/2018	06-06-2018-Board	Board Order 37: Granting Petitioner's Unopposed Motions for Pro Hac Vice Recognition
5/29/2018	05-29-2018-Petitioner	Petitioner Other (Not for motions) 33: Joint Stipulation to Modify the Scheduling Order Petitioner Notice of Deposition 34: Notice Of Deposition of Dr. Bernhardt Trout Petitioner Notice of Deposition 35: Notice of Deposition of Dr. Laurence baker Petitioner Motion 36: Mylan Pharmaceutical's Unopposed Motion for Pro Hac Vice Recognition Petitioner Exhibit 1048: Declaration of ElhamSteiner Petitioner Exhibit 1049: Biography of Elham Firouzi Steiner
5/8/2018	05-08-2018-Patent_Owner	Patent Owner Notice 31: Patent Owner's Updated Mandatory Notices Pursuant to 37 C.F.R. 42.8 Patent Owner Power of Attorney 32: Supplemental Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH
5/3/2018	05-03-2018-Board	Board Order 30: Order Granting Patent Owner's Pro Hac Vice Motions to Admit Robert Vlasis
4/18/2018	04-18-2018-Patent_Owner	Patent Owner Motion 29: Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10 Patent Owner Exhibit 2049: Declaration of Robert Vlasis Patent Owner Exhibit 2050: Biography of Robert Vlasis
4/3/2018	04-03-2018-Petitioner	Petitioner Objection 28: Mylan Pharmaceutical's Objections
3/27/2018	03-27-2018-Patent_Owner	Patent Owner Response 27: Patent Owner's Response to Petition for Inter Partes Review of U.S. Patent No. 7,476,652 Patent Owner Exhibit 2005: Canadian Patent No. 1,258,427 Patent Owner Exhibit 2006: Declaration of Dr. Bernhardt Trout Patent Owner Exhibit 2007: Curriculum Vitae of Dr. Bernhardt Trout Patent Owner Exhibit 2008: March 12, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky Patent Owner Exhibit 2009: Campbell et al., Insulin glargine, Clinical Therapeutics (December 2001) Patent Owner Exhibit 2010: FDA¿¿¿s Office of Clinical Pharmacology and Biopharmaceutics Review 2005 Patent Owner Exhibit 2011: Brange et al., Chemical Stability of Insulin 1, Pharm. Res. (1992) Patent Owner Exhibit 2012: Sluzky et al., Kinetics of Insulin Aggregation, Proc. Natl. Acad. Sci. (1991) Patent Owner Exhibit 2013: Clodfelter et al., Effects of Non-Covalent Self-Association, Pharm. Res. (1998) Patent Owner Exhibit 2014: Techniques of Solubilization of Drugs 15-89 (Samuel H. Yalkowsky ed., 1981) Patent Owner Exhibit 2015: Rosskamp & Park, Long-acting Insulin Analogs, Diabetes Care (March 1999) Patent Owner Exhibit 2016: Banga, Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems (1995) Patent Owner Exhibit 2017: Jaeger et al., Peroxide Accumulation, J. Biochem. & Biophys. Methods (1994) Patent Owner Exhibit 2018: Hoogwerf, Advances in the Treatment of Diabetes Mellitus in the Elderly (1996) Patent Owner Exhibit 2019: Nelson & Cox, Lehninger Principles of Biochemistry (3rd ed. 2000) (1 of 2) Patent Owner Exhibit 2019: Nelson & Cox, Lehninger Principles of Biochemistry (3rd ed. 2000) (2 of 2) Patent Owner Exhibit 2020: Wang, Instability, Stabilization, and Formulation, Int¿¿¿l J. Pharm. (1999) Patent Owner Exhibit 2021: Kreilgaard et al., Effects of Additives on the Stability, Pharm. Sci. (1999) Patent Owner Exhibit 2022: Darrington, Effects of Insulin Concentration, Pharm. Res. (1995) Patent Owner Exhibit 2023: Brange et al., Chemical Stability of Insulin. 2, Pharm. Res. (1992) Patent Owner Exhibit 2024: Maislos, The Source of the Circulating Aggregate of Insulin, J. Clin. Invest. (1986) Patent Owner Exhibit 2025: 2001 Physician¿¿¿s Desk Reference (Insulin) Patent Owner Exhibit 2026: Fisher & Porter, Stability of Bovine Insulin, J. Pharm. Pharmacol (1981) Patent Owner Exhibit 2027: Ingram, Gene Mutations in Human Hemoglobin, Nature (Aug. 17, 1957) Patent Owner Exhibit 2028: Owens et al., ¿¿¿Insulins Today and Beyond,¿¿¿ The Lancet (September 1, 2001) Patent Owner Exhibit 2029: Roberts & Urey, The Mechanisms of Acid, J. Am. Chem. Soc. (1939) Patent Owner Exhibit 2030: 2001 Physician¿¿¿s Desk Reference (Drugs) Patent Owner Exhibit 2031: Fife & Pujari, Metal Ion Catalysis, Bioorganic Chem. (2000) Patent Owner Exhibit 2032: Patel & Foss, Interaction of Some Pharmaceuticals with Macromolecules I (1964) Patent Owner Exhibit 2033: Pisano & Kostenbauder, Interaction of Preservatives with Macromolecules II (1957) Patent Owner Exhibit 2034: Donbrow et al., Autoxidation of Polysorbates (December 1978) Patent Owner Exhibit 2035: Moore & Leppert, Role of Aggregated Human Growth-Hormone (hGH) (1980) Patent Owner Exhibit 2036: Ratner et al., Persistent Cutaneous Insulin Allergy, Diabetes (1990) Patent Owner Exhibit 2037: Dische, et al., Insulin as an Amyloid-Fibril Protein, Diabetologia (1988) Patent Owner Exhibit 2038: Summary of Claim Constructions from Related Cases Patent Owner Exhibit 2039: Dr. Laurence C. Baker¿¿¿s Declaration Patent Owner Exhibit 2040: Curriculum Vitae of Dr. Laurence C. Baker Patent Owner Exhibit 2041: Dr. Laurence C. Baker¿¿¿s Prior Testimony Patent Owner Exhibit 2042: Dr. Laurence C. Baker¿¿¿s Documents Relied On Patent Owner Exhibit 2043: U.S. Dollar Sales of Long-Acting Insulin Products Patent Owner Exhibit 2044: U.S. Share of Lantus Vial Among Long-Acting Injectable Insulin Products Patent Owner Exhibit 2045: U.S. Total Prescriptions of Long-Acting Insulin Products Patent Owner Exhibit 2046: U.S. Formulary Placement of Long-Acting Insulin Products Patent Owner Exhibit 2047: U.S. Total Marketing Expenditures of Long-Acting Insulin Products Patent Owner Exhibit 2048: U.S. Price per Insulin Unit of Long-Acting Insulin Products
2/28/2018	02-28-2018-Patent_Owner	Patent Owner Notice of Deposition 25: Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky Patent Owner Objection 26: Patent Owner's Objections to Admissibility of Supplemental Evidence Served by Petitioner Mylan Pharmaceutical Inc. in Inter Partes Review
2/21/2018	02-21-2018-Board	Board Order Conduct of Proceeding 22: Order Conduct of the Proceeding Extending Due Date 1 and Due Date 2 of the Scheduling Order Board Order 23: Order Granting-in-part and Denying-in-part Petitioner's Motion for Supplemental Information
2/21/2018	02-21-2018-Petitioner	Petitioner Exhibit List 24: Mylan Pharmaceuticals's Updated Exhibit List Petitioner Exhibit 1036: Affidavit of Christopher Butler (April 4, 2017) Petitioner Exhibit 1037: Aventispharma-us.com, Lantus Prescribing Information (Jan. 10, 2001)
2/5/2018	02-05-2018-Patent_Owner	Patent Owner Opposition 21: Patent Owner's Opposition to Petitioner's Motion for Supplemental Information
1/29/2018	01-29-2018-Petitioner	Petitioner Motion 19: Mylan Pharmaceuticals Motion For Supplemental Information Petitioner Exhibit List 20: Mylan Pharmaceutical's Updated Exhibit List Petitioner Exhibit 1046: Exhibit 1046 - Board Email Petitioner Exhibit 1047: Exhibit 1047
1/26/2018	01-26-2018-Petitioner	Petitioner Exhibit List 18: Mylan Pharmaceutical's Updated Exhibit List Petitioner Exhibit 1045: Exhibit 1045 - Call Transcript
12/28/2017	12-28-2017-Patent_Owner	Patent Owner Objection 16: Patent Owner's Objections to Admissibility of Evidence Served with Petitioner Mylan Pharmaceutical Inc.'s Petition for Inter Partes Review
12/28/2017	12-28-2017-Petitioner	Petitioner Objection 17: Mylan's Objecjections
12/15/2017	12-15-2017-Board	Board Order 15: SCHEDULING ORDER 37 C.F.R. ¿¿ 42.5(a)
12/14/2017	12-14-2017-Petitioner	Petitioner Notice 14: PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES
12/13/2017	12-13-2017-Board	Event: Petition Institution (Granted and Denied) Board Institution Decision 13: Trial Instituted Document
12/12/2017	12-12-2017-Petitioner	Petitioner Other (Not for motions) 12: PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES
10/11/2017	10-11-2017-Petitioner	Petitioner Exhibit List 10: Mylan Pharmaceuticals Inc.'s Updated Exhibit List Petitioner Declaration 11: Declaration of Clark Lin Petitioner Exhibit 1004: Corrected Exhibit 1004
10/6/2017	10-06-2017-Board	Board Order Conduct of Proceeding 9: Conduct of the Proceeding 37 C.F.R ¿¿ 42.5
9/14/2017	09-14-2017-Patent_Owner	Event: Preliminary Response Patent Owner Preliminary Response 8: Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 7,476,652 Patent Owner Exhibit 2001: 2001 Physicians Desk Reference (PDR) Patent Owner Exhibit 2002: Formulation-Related Problems Associated with Intravenous Drug Delivery Patent Owner Exhibit 2003: Physical Biochemistry of Protein Drugs, in Protein and Peptide Delivery Patent Owner Exhibit 2004: U.S. Patent No. 5,656,722
8/24/2017	08-24-2017-Patent_Owner	Patent Owner Notice 7: Patent Owner's Updated Mandatory Notices
6/20/2017	06-20-2017-Patent_Owner	Patent Owner Power of Attorney 5: Patent Owner's Power of Attorney Patent Owner Mandatory Notice 6: Patent Owner's Mandatory Notice
6/15/2017	06-15-2017-Board	Board Notice of Filing Date Accorded to Petition 3: Notice of Accord Filing Date
6/5/2017	06-05-2017-Petitioner	Petitioner Power of Attorney 1: Power of Attorney Event: Petition Petitioner Petition 2: PETITION FOR INTER PARTES REVIEW U.S. PATENT NO. 7,476,652 Petitioner Exhibit 1001: 1001A Part I - FH US 7476652 Petitioner Exhibit 1001: 1001A Part II - FH US 7476652 Petitioner Exhibit 1001: 1001A Part III - FH US 7476652 Petitioner Exhibit 1001: U.S. Patent No. 7,476,652 Petitioner Exhibit 1001: 1001A Part IV - FH US 7476652 Petitioner Exhibit 1001: 1001A Part V - FH US 7476652 Petitioner Exhibit 1001: 1001A Part VI - FH US 7476652 Petitioner Exhibit 1002: U.S. Patent No. 7,713,930 Petitioner Exhibit 1002: 1002A - FH US 7713930 Petitioner Exhibit 1003: 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 Petitioner Exhibit 1003: 1003B - Materials Reviewed by Professor Samuel H. Yalkowsky Petitioner Exhibit 1003: 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky Petitioner Exhibit 1004: Physicians Desk Reference Petitioner Exhibit 1004: 1004A - Notarized Affidavit Lloyd Library Petitioner Exhibit 1005: D.R. Owens et al., Pharmacokinetics of 125I-Labeled Insulin Glargine (HOE 901) in Healthy Men, Diabetes Care 23:813-19 (June 2000) Petitioner Exhibit 1006: W.D. Lougheed et al., Physical Stability of Insulin Formulations, Diabetes 32:424-32 (May 1983) Petitioner Exhibit 1007: 1007A - Certified English translation for Ex. 1007 (FASS Entry for INSUMAN INFUSAT) Petitioner Exhibit 1007: 2000 FASS Entry for INSUMAN INFUSAT (January 2000) Petitioner Exhibit 1008: U. Grau and C.D. Saudek, Stable Insulin Preparation for Implanted Insulin Pumps, Diabetes 36:1453-59 (December 1987) Petitioner Exhibit 1009: EMEA Public Statement on INSUMAN INFUSAT (February 14, 2000) Petitioner Exhibit 1010: FDA Drug Approval for LANTUS (NDA 02-1081) (April 20, 2000) Petitioner Exhibit 1011: P. Gillies et al., Insulin Glargine, Drugs 59:253-60 (February 2000) Petitioner Exhibit 1012: U. Derewenda et al. Phenol Stabilizes More Helix in a New Symmetrical Zinc Insulin Hexamer, Nature 338:594-6 (April 1989) Petitioner Exhibit 1013: H. Berchtold and R. Hilgenfeld, Binding of Phenol to R6 Insulin Hexamers, Biopolymers 51:165-72 (1999) Petitioner Exhibit 1014: J. Brange and L. Langkjaer, Insulin Structure and Stability, in STABILITY AND CHARACTERIZATION OF PROTEIN AND PEPTIDE DRUGS, CASE HISTORIES CHAPTER 11, 315-50 Petitioner Exhibit 1015: J. Brange et al., Toward Understanding Insulin Fibrillation, J. Pharm. Sci. 86:517-25 (May 1997) Petitioner Exhibit 1016: L.S. Jones et al., Surfactant-Stabilized Protein Formulations: A Review of Protein-Surfactant Interactions and Novel Analytical Methodologies, in THERAPEUTIC PROTEIN AND PEPTIDE FORMULATION AND DELIVERY, ACS SYMPOSIUM SERIES Petitioner Exhibit 1017: K. Hallas-Moller, The Lente Insulins, Diabetes 5:7-14 (1956) Petitioner Exhibit 1018: W.D. Lougheed et al., Insulin Aggregation in Artificial Delivery Systems, Diabetologia 19:1-9 (July 1980) Petitioner Exhibit 1019: Excerpts from Handbook of Pharmaceutical Excipients 2nd Edition (eds. A. Wade and P.J. Weller) (American Pharmaceutical Association, Washington) (The Pharmaceutical Press, London) (1994) Petitioner Exhibit 1020: W.R. Ashford and S. Landi, Stabilizing Properties of Tween 80 in Dilute Protein Solutions, Bull. Parenteral Drug Assoc. 20:74-81 (1966) Petitioner Exhibit 1021: H. Thurow and K. Geisen, Stabilisation of Dissolved Proteins Against Denaturation at Hydrophobic Interfaces, Diabetologia 27:212-18 (1984) Petitioner Exhibit 1022: M. Katakam et al., Effect of Surfactants on the Physical Stability of Recombinant Human Growth Hormone, J. Pharm. Sci. 84:713-16 (June 1995) Petitioner Exhibit 1023: U.S. Patent No. 4,153,689 Stable Iinsulin Preparation for Nasal Administration (Issued May 8, 1979) Petitioner Exhibit 1024: U.S. Patent No. 4,839,341 Stabilized Insulin Formulations (Issued June 13, 1989) Petitioner Exhibit 1025: E.P. Publication No. 0200383 An Improved Method for Administering Insulin (Issued November 5, 1986) Petitioner Exhibit 1026: A. Chawla et al. Aggregation of Insulin, Containing Surfactants, in Contact with Different Materials, Diabetes 34:420-24 (May 1985) Petitioner Exhibit 1027: Y-C Lee et al., Effect of Brij-78 on Systemic Delivery of Insulin from an Ocular Device J. Pharm. Sci. 86:430-33 (April 1997) Petitioner Exhibit 1028: Y-C Lee et al., Review on the Systemic Delivery of Insulin via the Ocular Route, International J. Pharmaceutics 233:1-18 (February 2002) Petitioner Exhibit 1029: M. Heile and D. Schneider, The Evolution of Insulin Therapy in Diabetes Mellitus, J. Fam. Pract. 61 (5 Suppl.: S6-12 (May 2012) Petitioner Exhibit 1030: ADIS R&D Profile Insulin Glargine: Glargine, HOE 71GT15, HOE 71GT80, HOE 901, Drugs R&D 2:107-09 (August 1999) Petitioner Exhibit 1031: R. Jones, Insulin Glargine Aventis Pharma, IDrugs 3:1081-87 (2000) Petitioner Exhibit 1032: I.R. Schmolka, Poloxamers in the Pharmaceutical Industry, in POLYMERS FOR CONTROLLED DRUG DELIVERY, CHAPTER 10 (CRC Press) (1991) Petitioner Exhibit 1033: 2001 Rote Liste; Entry for INSUMAN INFUSAT Petitioner Exhibit 1033: 1033B - Declaration of Hans-Peter Krieger (Deutsche National Bibliothek Librarian) for receipt of 2001 Rote Liste by Deutsche National Bibliothek on February 16, 2001 Petitioner Exhibit 1033: 1033A -Certified Translation of Exh. 1033 (2001 Rote Liste; Entry for INISUMAN INFUSAT) Petitioner Exhibit 1034: L. Gatlin and C. Gatlin, Minimizing Injection Pain & Damage in INJECTABLE DRUG DEVELOPMENT TECHNIQUES TO REDUCE PAIN AND IRRITATION CHAPTER 17 Petitioner Exhibit 1035: 2004 CNN Money article regarding Aventis Pharma merger with Sanofi-Synthelabo to create Sanofi-Aventis, the parent corporation of '930 patent assignee Sanofi-Aventis Deutschland GmbH

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Mylan Pharmaceuticals Inc. v. Sanofi Aventis Deutschland GmbH

IPR2017-01526 | Patent Trial and Appeal Board

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