11/6/2020 | 11-06-2020-Petitioner | |
4/15/2020 | 04-15-2020-Patent_Owner | |
2/19/2020 | 02-19-2020-Patent_Owner | |
2/5/2020 | 02-05-2020-Board | |
1/29/2020 | 01-29-2020-Patent_Owner | |
6/21/2019 | 06-21-2019-Patent_Owner | |
1/8/2019 | 01-08-2019-Board | |
1/4/2019 | 01-04-2019-Patent_Owner | |
12/20/2018 | 12-20-2018-Patent_Owner | |
12/19/2018 | 12-19-2018-Patent_Owner | |
12/12/2018 | 12-12-2018-Board | |
10/24/2018 | 10-24-2018-Petitioner | |
10/23/2018 | 10-23-2018-Petitioner | |
10/16/2018 | 10-16-2018-Petitioner | |
10/11/2018 | 10-11-2018-Petitioner | |
10/9/2018 | 10-09-2018-Patent_Owner | |
9/27/2018 | 09-27-2018-Board | |
9/25/2018 | 09-25-2018-Petitioner | |
9/25/2018 | 09-25-2018-Board | |
9/24/2018 | 09-24-2018-Petitioner | |
8/29/2018 | 08-29-2018-Board | |
8/27/2018 | 08-27-2018-Board | |
8/24/2018 | 08-24-2018-Petitioner | |
8/24/2018 | 08-24-2018-Patent_Owner | |
8/22/2018 | 08-22-2018-Petitioner | |
8/21/2018 | 08-21-2018-Patent_Owner | |
8/21/2018 | 08-21-2018-Petitioner | |
8/10/2018 | 08-10-2018-Petitioner | |
8/10/2018 | 08-10-2018-Patent_Owner | - 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
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8/3/2018 | 08-03-2018-Petitioner | |
7/30/2018 | 07-30-2018-Patent_Owner | |
7/30/2018 | 07-30-2018-Petitioner | |
7/27/2018 | 07-27-2018-Petitioner | |
7/27/2018 | 07-27-2018-Patent_Owner | |
7/26/2018 | 07-26-2018-Patent_Owner | |
7/24/2018 | 07-24-2018-Patent_Owner | |
7/23/2018 | 07-23-2018-Patent_Owner | |
7/20/2018 | 07-20-2018-Patent_Owner | |
7/13/2018 | 07-13-2018-Petitioner | - 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
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7/11/2018 | 07-11-2018-Petitioner | |
6/13/2018 | 06-13-2018-Petitioner | |
6/6/2018 | 06-06-2018-Board | |
5/29/2018 | 05-29-2018-Petitioner | |
5/8/2018 | 05-08-2018-Patent_Owner | |
5/3/2018 | 05-03-2018-Board | |
4/18/2018 | 04-18-2018-Patent_Owner | |
4/3/2018 | 04-03-2018-Petitioner | |
3/27/2018 | 03-27-2018-Patent_Owner | - 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
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2/28/2018 | 02-28-2018-Patent_Owner | |
2/21/2018 | 02-21-2018-Board | |
2/21/2018 | 02-21-2018-Petitioner | |
2/5/2018 | 02-05-2018-Patent_Owner | |
1/29/2018 | 01-29-2018-Petitioner | |
1/26/2018 | 01-26-2018-Petitioner | |
12/28/2017 | 12-28-2017-Patent_Owner | |
12/28/2017 | 12-28-2017-Petitioner | |
12/15/2017 | 12-15-2017-Board | |
12/14/2017 | 12-14-2017-Petitioner | |
12/13/2017 | 12-13-2017-Board | |
12/12/2017 | 12-12-2017-Petitioner | |
10/11/2017 | 10-11-2017-Petitioner | |
10/6/2017 | 10-06-2017-Board | |
9/14/2017 | 09-14-2017-Patent_Owner | |
8/24/2017 | 08-24-2017-Patent_Owner | |
6/20/2017 | 06-20-2017-Patent_Owner | |
6/15/2017 | 06-15-2017-Board | |
6/5/2017 | 06-05-2017-Petitioner | - 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
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- 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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