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 | |
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 | |
12/7/2018 | 12-07-2018-Petitioner | |
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 | - Patent Owner Exhibit 2062: Supplemental Declaration of Dr. Bernhardt Trout (REDACTED Public Version)
- Patent Owner Exhibit 2062: Supplemental Declaration of Dr. Bernhardt Trout (UNREDACTED Confidential Version)
- Patent Owner Exhibit 2063: Declaration of Dr. Thomas Eichinger
- Patent Owner Exhibit 2064: The European Agency for the Evaluation of Medicinal Products, Committee For Proprietary Medicinal Products European Public Assessment Report (EPAR) for Lantus (June 6, 2000)
- Patent Owner Exhibit 2065: Internal Memorandum re FDA Contact And/Or Trip Report for Lantus (Insulin Glargine) on September 8, 1999, Document bates numbered SANOFI_01871544-84
- Patent Owner Exhibit 2066: March 30, 2000 Aventis Pharma memorandum regarding Minutes of 29th TSV Team Meeting on HOE901 Drug Product, Document bates numbered SANOFI_01875342-405
- Patent Owner Exhibit 2067: Hoeschst Marion Roussel presentation on HOE 901 ¿¿¿ Insulin Glargine, Document bates numbered SANOFI5_00012501-14
- Patent Owner Exhibit 2068: April 20, 2000 Response Letter to FDA re Lantus Application to Market a New Drug, Document bates numbered SANOFI_01870941-86
- Patent Owner Exhibit 2069: Draft Aventis RMC Strategy & Risk Assessment (RCMS SRA) For Development Activities for Lantus Reformulation, dated November 2003, Document bates numbered SANOFI_01628501-13
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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 1050: Walgreen Co. Recalls LANTUS¿¿ Insulin Glargine (rDNA) Injection, www.SafetyAlerts.com, Nov. 15, 2001, pp. 1-3
- 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: 1058A - 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
- Petitioner Exhibit 1065: U.S. SEC Form 20-F for Sanofi-Aventis FY 2004
- 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
- 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
- Petitioner Exhibit 1094: CDC About Diabetes June 1, 2017
- 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
- 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
- Petitioner Exhibit 1117: Manning et al. Stability of Protein Pharmaceuticals
- Petitioner Exhibit 1118: WO8300288
- Petitioner Exhibit 1119: CA1258427
- Petitioner Exhibit 1120: Hawley's Condensed Chemical Dictionary, 12th Ed.
- Petitioner Exhibit 1121: Wan et al. CMC of Polysorbates, J. of Pharma. Sciences
- Petitioner Exhibit 1122: WO0023098
- Petitioner Exhibit 1123: Farhadieh, Determination of CMC and Partial Specific Volume of Polysorbates
- Petitioner Exhibit 1124: K.L. Mittal Determination of CMC of Polysorbate 20 in Aqueous Solution by Surface Tension Method
- Petitioner Exhibit 1125: AU200072263 A1
- Petitioner Exhibit 1126: EP 1019022 B1
- Petitioner Exhibit 1127: U.S. Patent No. 6211144
- Petitioner Exhibit 1128: U.S. Patent No. 6335316
- 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
- Petitioner Exhibit 1131: U.S. Patent No. 6737401
- Petitioner Exhibit 1132: A. Martin et al. Physical Principles In the Pharmaceutical Sciences
- Petitioner Exhibit 1133: Affidavit of M.T. Lanterman - IPR2017-01526 and IPR2017-01528
- Petitioner Exhibit 1134: PDR 1997 Pgs. 1488-1490 Humalog insulin
- Petitioner Exhibit 1135: Physicians' Desk Reference 1997 Pgs. 1497-1498
- Petitioner Exhibit 1136: LANGER, R. et al. US 2015/0320837
- Petitioner Exhibit 1137: LANGER, Robert, et al. U.S. Publication No. 20150320837 Nov. 12 2015
- Petitioner Exhibit 1138: LANGER, Robert S. et al. U.S. Patent No. 9994615 B2
- Petitioner Exhibit 1139: 2001 PDR Entry for Etoposide p. 825
- Petitioner Exhibit 1140: 2001 PDR Entry for Limbitrol p1538
- Petitioner Exhibit 1141: 2001 PDR Entry for 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
- Petitioner Exhibit 1145: PROTECTIVE ORDER MATERIAL - Aventis LANTUS
- Petitioner Exhibit 1146: PROTECTIVE ORDER MATERIAL - Aventis Formulation Development Report Insulin Glargine
- Petitioner Exhibit 1147: PROTECTIVE ORDER MATERIAL - Aventis Lantus Multi Dose Vial (10 ml) Complaint Situation
- Petitioner Exhibit 1148: PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml Vials
- 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: Declaration of DeForest McDuff
- Petitioner Exhibit 1169: Ex. 1169E- Lantus Prescriptions
- Petitioner Exhibit 1169: Ex. 1169F - Lantus Market Shares
- 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. 1169D - Insulin Product Sales
- 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
- Petitioner Exhibit 1172: U.S. Patent No. 5,656,722
- 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: Ex. 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,
- 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: Physicians' Desk Reference - Venofer
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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 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)
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- Patent Owner Exhibit 2030: 2001 Physician¿¿¿s Desk Reference (Drugs)
- Patent Owner Exhibit 2031: Fife & Pujari, Metal Ion Catalysis, Bioorganic Chem. (2000)
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- Patent Owner Exhibit 2033: Pisano & Kostenbauder, Interaction of Preservatives with Macromolecules II (1957)
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- Patent Owner Exhibit 2035: Moore & Leppert, Role of Aggregated Human Growth-Hormone (hGH) (1980)
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- 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 CV
- 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: U.S. Patent No. 7,476,652, Acidic Insulin Preparations Having Improved Stability (filed March 25, 2005) (issued January 13, 2009)
- Petitioner Exhibit 1001: 1001A Part I - File History for U.S. Patent No. 7,476,652
- Petitioner Exhibit 1001: 1001A Part III - File History for U.S. Patent No. 7,476,652
- Petitioner Exhibit 1001: 1001A Part V - File History for U.S. Patent No. 7,476,652
- Petitioner Exhibit 1001: 1001A Part II - File History for U.S. Patent No. 7,476,652
- Petitioner Exhibit 1001: 1001A Part IV - File History for U.S. Patent No. 7,476,652
- Petitioner Exhibit 1001: 1001A Part VI - File History for U.S. Patent No. 7,476,652
- Petitioner Exhibit 1002: 1002A-File History for U.S. Patent No. 7,713,930
- Petitioner Exhibit 1002: U.S. Patent No. 7,713,930, Acidic Insulin Preparations Having Improved Stability (filed December 4, 2008) (issued May 11, 2010)
- Petitioner Exhibit 1003: 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky
- Petitioner Exhibit 1003: 1003B - Materials Reviewed by Professor Samuel H. Yalkowsky
- 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 1004: 1004A-Affidavit of Patricia van Skaik for December 1, 2000 date stamp of 2001 PDR received by the Lloyd Library and Museum (Cincinnati, Ohio)
- Petitioner Exhibit 1004: 2001 Physician's Desk Reference Entry for LANTUS
- 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)
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- Petitioner Exhibit 1017: K. Hallas-Moller, The Lente Insulins, Diabetes 5:7-14 (1956)
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- 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: 1033A - Certified Translation of Exh. 1033 (2001 Rote Liste-Entry for INISUMAN 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 1034: L. Gatlin and C. Gatlin, Minimizing Injection Pain & Damage in INJECTABLE DRUG DEVELOPMENT TECHNIQUES TO REDUCE PAIN AND IRRITATION CHAPTER 17 (eds. P.K. Gupta and G.A. Brazeau) (CRC Press) (1999)
- 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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