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Case number IPR2017-01526

Mylan Pharmaceuticals Inc., v. Sanofi Aventis Deutschland GmbH > Documents

Date Field Doc. No.PartyDescription
Nov 6, 2020 100 petitioner Petitioner's Mandatory Change-of-Information Notices Download
Apr 15, 2020 99 Download
Feb 19, 2020 98 Download
Feb 5, 2020 97 Download
Jan 29, 2020 96 Patent Owner's Motion for Withdrawal of Counsel Download
Jan 8, 2019 95 Order Granting Patent Owner's Motion to Seal Download
Jan 4, 2019 94 Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a) Download
Dec 20, 2018 93 Patent Owner's Motion to Seal Download
Dec 19, 2018 91 Patent Owner's Updated Exhibit List - Public Download
Dec 19, 2018 90 Petitioner's Reply (Redacted Public Version Submitted by Patent Owner) Download
Dec 19, 2018 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 Download
Dec 12, 2018 89 Termination Decision Document Download
Oct 24, 2018 87 Petitioner's Motion to Seal Download
Oct 24, 2018 88 REDACTED - Paper 86 - Mylan Pharmaceutical Inc.'s Sur-Surreply Download
Oct 16, 2018 85 Mylan Pharmaceuticals' Objections Download
Oct 11, 2018 84 Petitioner's Mandatory Change-of-Information Notices Download
Oct 9, 2018 78 Patent Owner's Motion to Seal Download
Oct 9, 2018 82 Patent Owner's Updated Exhibit List Download
Oct 9, 2018 80 Patent Owner's Surreply - Public Download
Oct 9, 2018 2062 Supplemental Declaration of Dr. Bernhardt Trout - Public Download
Oct 9, 2018 2064 Lantus EPAR June 2000 Download
Sep 27, 2018 77 Hearing Transcript Download
Sep 25, 2018 75 Authorizing Sur-reply and Sur-sur-reply Download
Sep 25, 2018 76 Mylan Pharmaceutical Inc.'s Updated Exhibit List Download
Sep 25, 2018 1186 Exhibit 1186A - Final Transcript of Telephonic Conference held September 24, 2018 in IPR-2017-01526 and IPR2017-01528 Download
Sep 24, 2018 74 Mylan Pharmaceutical Inc.'s Updated Exhibit List Download
Sep 24, 2018 1186 RoughtTranscript of Telephone Conference held 09-24-2018 Download
Sep 24, 2018 1186 RoughtTranscript of Telephone Conference held 09-24-2018 Download
Aug 29, 2018 73 Order Adjusting Oral Hearing Time Download
Aug 27, 2018 72 Trial Hearing 37 C.F.R § 42.70 Download
Aug 24, 2018 71 Patent Owner's Reply to Motion to Exclude Download
Aug 24, 2018 70 Mylan Pharmaceutical Inc.'s Reply In Support of Its Motion to Exclude Download
Aug 22, 2018 69 Corrected Paper 57- Mylan_Pharmaceutical's_Request_For_Oral_Argument Download
Aug 21, 2018 66 Mylan Pharmaceutical Inc.'s Motion Requesting Acceptance Download
Aug 21, 2018 63 Patent Owner's Motion Requesting Acceptance of Submission Pursuant to 37 C.F.R. 42.6(b) Download
Aug 21, 2018 1184 Download
Aug 21, 2018 1185 Download
Aug 21, 2018 64 Patent Owner's Opposition to Petitioner's Motion to Exclude Download
Aug 21, 2018 65 Mylan's Updated Exhibit List Download
Aug 21, 2018 67 Mylan Pharmaceutical Inc.'s Opposition to Sanofi's Motion to Exclude Download
Aug 21, 2018 68 Mylan Pharmaceutical Inc.'s Response to Sanofi's Observations on Cross Examination Download
Aug 10, 2018 58 Mylan Pharmaceutical's Request For Oral Argument Download
Aug 10, 2018 61 Patent Owner's Motion to Exclude Download
Aug 10, 2018 62 Patent Owner's Updated Exhibit List Download
Aug 10, 2018 57 Mylan Pharmaceutical's Motion to Exclude Download
Aug 10, 2018 60 Patent Owner's Observations on the Cross Examination of Petitioner's Reply Declarants Download
Aug 10, 2018 59 Patent Owner's Request for Oral Argument Download
Aug 10, 2018 2057 Annex 1, Summary of Product Characteristics Download
Aug 10, 2018 2059 July 30, 2018, Deposition Transcript of Dr. William C. Biggs Download
Aug 10, 2018 2061 August 7, 2018, Deposition Transcript of Dr. Robert S. Langer Download
Aug 10, 2018 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) Download
Aug 10, 2018 2060 August 2, 2018, Deposition Transcript of Dr. Robert D. McDuff Download
Aug 10, 2018 2058 July 31, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky, Volume II Download
Aug 3, 2018 56 Mylan Pharmaceutical Inc.'s Updated Exhibit Download
Jul 30, 2018 54 Mylan Pharmaceuticals' Objections Download
Jul 30, 2018 55 Patent Owner's Notice of Deposition of Dr. Robert S. Langer Download
Jul 27, 2018 51 Patent Owner's Notice of Deposition of Dr. William C. Biggs Download
Jul 27, 2018 53 Mylan Pharmaceuticals Updated Exhibit List Download
Jul 27, 2018 52 Petitioner's Opposition to Patent Owner's Motion to Strike Download
Jul 27, 2018 1183 Transcript of Telephone Conference held on July 26th, 2018, in IPR2017-01526 and IPR2017-01528 Download
Jul 27, 2018 1183 Transcript of Telephone Conference held on July 26th, 2018, in IPR2017-01526 and IPR2017-01528 Download
Jul 26, 2018 50 Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky Download
Jul 24, 2018 49 Patent Owner's Updated Exhibit List Download
Jul 24, 2018 48 Patent Owner's Notice of Deposition of DeForest McDuff, Ph.D. Download
Jul 24, 2018 2055 Transcript of 7/17/2018 Telephonic Conference (IPR2017-01526, IPR2017-01528) Download
Jul 23, 2018 46 Patent Owner Surreply Download
Jul 23, 2018 47 Patent Owner's Motion to Strike Download
Jul 23, 2018 2051 Judge Andrews' Order, Dkt. 287 (Sanofi v. Merck, 16-812-RGA) Download
Jul 23, 2018 2052 Trial Transcript Excerpts (Sanofi v. Merck, 16-812-RGA) Download
Jul 23, 2018 2053 Petitioner's Reply - Public, Redacted Download
Jul 20, 2018 45 Patent Owner's Supplemental Motion to Seal Download
Jul 20, 2018 44 PATENT OWNER¿¿¿S OBJECTIONS TO ADMISSIBILITY OF EVIDENCE SERVED BY PETITIONER MYLAN PHARMACEUTICAL INC. IN INTER PARTES REVIEW Download
Jul 13, 2018 41 Petitioner's Motion To Seal And For Entry Of Proposed Protective Order Download
Jul 13, 2018 42 Mylan Pharmaceutical Inc.'s Updated Exhibit List Download
Jul 13, 2018 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) Download
Jul 13, 2018 1167 U.S. Patent No. 6,656,499 (¿¿¿Foldvari¿¿¿) Download
Jul 13, 2018 1109 Sanofi Press Releases 2006 Download
Jul 13, 2018 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) Download
Jul 13, 2018 1110 Sanofi Press Releases 2005 Download
Jul 13, 2018 1162 Gerhard Wenske, Dictionary of Chemistry German/English (1st ed. 1994) Download
Jul 13, 2018 1124 AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿) Download
Jul 13, 2018 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 Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 1104 SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2006) Download
Jul 13, 2018 1112 Baynes et al., ¿¿¿Role of Arginine in the Stabilization of Proteins Against Aggregation¿¿¿, Biochemistry, Vol. 44, No. 12, pp. 4919-4925 (2005) Download
Jul 13, 2018 1136 LANGER, Robert S. et al. U.S. Publication No. 2015/0025005A1, Jan. 22, 2015 Download
Jul 13, 2018 1142 LANGER, Robert S. et al. WO2013123492 A1, Aug. 22, 2013 Download
Jul 13, 2018 1101 UBS Equities ¿¿¿ Sanofi-Aventis Q205, Sep. 1, 2005 Download
Jul 13, 2018 1143 2001 PDR Entry for ¿¿¿Novoline¿¿¿¿¿, pp. 2238-2242 Download
Jul 13, 2018 1139 2001 PDR Entry for ¿¿¿Etoposide¿¿¿, p. 825 Download
Jul 13, 2018 1081 LANTUS¿¿ About (Current) Download
Jul 13, 2018 1119 CA Patent No. 1,258,427 (¿¿¿CA ¿¿¿427¿¿¿) Download
Jul 13, 2018 1179 Velosulin¿¿ BR Buffered Regular Human Insulin Injection (rDNA origin), Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 2435 Download
Jul 13, 2018 1092 Cowen and Company, ¿¿¿Therapeutic Categories Outlook¿¿¿, Comprehensive Study (Oct. 2006) Download
Jul 13, 2018 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 Download
Jul 13, 2018 1080 LANTUS¿¿ Home Page (October 2006) Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 1180 Novolin¿¿ R Regular, Human Insulin Injection (recombinant DNA origin), Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 2423 Download
Jul 13, 2018 1087 FDA Approval Letter ¿¿¿ LANTUS¿¿ Reformulation March 2005 Download
Jul 13, 2018 1125 AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿) Download
Jul 13, 2018 1121 Wan, et al., ¿¿¿CMC of Polysorbates¿¿¿, J. of Pharma. Sciences, Vol. 63, No. 1, pp. 136-137 (Jan. 1974) Download
Jul 13, 2018 1129 Safety Alerts Internet Archive ¿¿¿Walgreen Co. Recalls Lantus Insulin Glargine (rDNA origin) Injection¿¿¿ (Nov. 15, 2001) Download
Jul 13, 2018 1113 Baynes et al., ¿¿¿Rational Design of Solution Additives for the Prevention of Protein Aggregation¿¿¿, Biophysical J., Vol. 87, pp.1631-1639 (Sept. 2004) Download
Jul 13, 2018 1111 1111A - Curriculum Vitae of Professor Robert Langer Download
Jul 13, 2018 1127 U.S. Patent No. 6,211,144 (¿¿¿Havelund¿¿¿) Download
Jul 13, 2018 1084 LANTUS¿¿ - Home Page (Current) Download
Jul 13, 2018 1094 CDC, ¿¿¿About Diabetes¿¿¿, June 1, 2017, (http://www.cdc.gov/biabetes/data) Download
Jul 13, 2018 1128 U.S. Patent No. 6,335,316 (¿¿¿Hughes¿¿¿) Download
Jul 13, 2018 1105 SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (Oct. 2005) Download
Jul 13, 2018 1122 WO 00/23098 (¿¿¿¿¿¿098 application¿¿¿) Download
Jul 13, 2018 1171 U.S. Patent No. 6,100,376 (¿¿¿the ¿¿¿376 patent¿¿¿) Download
Jul 13, 2018 1118 WO 83/00288 A1 (¿¿¿¿¿¿288 application¿¿¿) Download
Jul 13, 2018 1131 U.S. Patent No. 6,737,401 (¿¿¿Kim¿¿¿) Download
Jul 13, 2018 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 Download
Jul 13, 2018 1140 2001 PDR Entry for ¿¿¿Limbitrol¿¿¿¿¿, p. 1538 Download
Jul 13, 2018 1182 Vanofor¿¿ Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 580-581 Download
Jul 13, 2018 1083 LANTUS¿¿ - How to Inject Lantus With a Vial and Syringe Download
Jul 13, 2018 1174 Declaration of William Curtis Biggs Download
Jul 13, 2018 1095 U.S. SEC Form 20-F for Sanofi-Aventis FY 2003 Download
Jul 13, 2018 1172 U.S. Patent No. 5,656,722 (¿¿¿the ¿¿¿722 patent¿¿¿) Download
Jul 13, 2018 1166 U.S. Patent No. 6,306,440 (¿¿¿Backstrom 2001¿¿¿) Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 1163 U.S. Patent No. 4,783,441 (¿¿¿Thurow 1998¿¿¿) Download
Jul 13, 2018 1097 ABN AMRO ¿¿¿ Pharmaceutical Market Share Report (Oct. 2001) Download
Jul 13, 2018 1082 LANTUS¿¿ - Your Diabetes Treatment Routine (Current) Download
Jul 13, 2018 1116 Shao, et al. ¿¿¿ ¿¿¿Differential Effects of Anionic, Cationic, Nonionic, and Physiologic Surfactants on the Dissociation, ¿¿-Chymotryptic Degradation, and Enteral Absorption if Insulin Download
Jul 13, 2018 1178 Phys. Desk Ref., ¿¿¿Iletin¿¿ II¿¿¿, 1997, pp. 1507-1509 Download
Jul 13, 2018 1117 Manning et al., ¿¿¿Stability of Protein Pharmaceuticals¿¿¿, Pharm. Research, Vol. 6, No. 11, pp. 903-918 (1989) Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 1124 AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿) Download
Jul 13, 2018 1135 1997 PDR Entry for ¿¿¿Humulin¿¿R¿¿¿, pp. 1497-1498 Download
Jul 13, 2018 1085 LANTUS¿¿ - Explore Diabetes Treatment Options (Current) Download
Jul 13, 2018 1177 Phys. Desk Ref., ¿¿¿Iletin¿¿¿¿¿, 1997, pp. 1503-1504 Download
Jul 13, 2018 1106 SG Cowen ¿¿¿Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2005) Download
Jul 13, 2018 1175 Diabetes Complications and Control Trial (DCCT) (1993) Download
Jul 13, 2018 1111 1111A - Curriculum Vitae of Professor Robert Langer Download
Jul 13, 2018 1089 FDA ¿¿¿ 25th Orange Book (2005) Download
Jul 13, 2018 1165 U.S. Patent No. 5,518,998 (¿¿¿Backstrom¿¿¿) Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 1174 Declaration of William Curtis Biggs Download
Jul 13, 2018 1169 Ex. 1169D - Insulin Product Sales Download
Jul 13, 2018 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) Download
Jul 13, 2018 1108 SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook , pp. 134-148 (Oct. 2001) Download
Jul 13, 2018 1102 UBS Equities ¿¿¿ Sanofi-Aventis Q105, May 13, 2005 Download
Jul 13, 2018 1099 UBS Equities ¿¿¿ Sanofi-Aventis Q405, Jan. 24, 2006 Download
Jul 13, 2018 1090 DiMasietal, et al. ¿¿¿Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs¿¿¿, J. of Health Eco., 37 (2016) pp. 20-33 Download
Jul 13, 2018 1137 LANGER, Robert S. et al. U.S. Publication No. 2015/0320837, Nov. 12, 2015 Download
Jul 13, 2018 1098 WebMD ¿¿¿ ¿¿¿Types of Insulin for Diabetes Treatment¿¿¿ (accessed May 3, 2018) Download
Jul 13, 2018 1114 Neuprogen¿¿ (Filgratim), Amgen Inc. Product label, April 2, 1998 Download
Jul 13, 2018 1164 U.S. Patent No. 4,849,227 (¿¿¿Cho¿¿¿) Download
Jul 13, 2018 1091 David et al., ¿¿¿Commercial Success Economic Principles Applied to Patent Litigation¿¿¿, Economics of Pat. Damages, Chap. 9, pp. 159-160 Download
Jul 13, 2018 1093 CDC, ¿¿¿Long-Term Trends in Diabetes¿¿¿, April 2017, (http://www.cdc.gov/biabetes/data) Download
Jul 13, 2018 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) Download
Jul 13, 2018 1100 UBS Equities ¿¿¿ Sanofi-Aventis Q305, Nov. 3, 2005 Download
Jul 13, 2018 1181 Declaration of Professor Samuel H. Yalkowsky Download
Jul 13, 2018 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 Download
Jul 13, 2018 1088 FDA ¿¿¿ 27th Orange Book (2007) Download
Jul 13, 2018 1141 2001 PDR Entry fro ¿¿¿Norditropin¿¿¿¿¿, p. 2236 Download
Jul 13, 2018 1173 Susan Budavari et al., The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals (12th ed. 1996) Download
Jul 13, 2018 1126 EP 1019022 B1 (¿¿¿EP ¿¿¿022¿¿¿) Download
Jul 13, 2018 1120 Hawley¿¿¿s Condensed Chemical Dictionary, 12th Ed. ¿¿¿ Strong acid reference¿¿¿, pp. 890-891 (1993) Download
Jul 13, 2018 1138 LANGER, Robert S. et al. U.S. Patent No. 9,994,615 B2, Jun. 12, 2018 Download
Jul 13, 2018 1096 U.S. SEC Form 20-F for Sanofi-Aventis FY 2002 Download
Jul 13, 2018 1134 1997 PDR Entry for ¿¿¿Humalog¿¿¿¿¿, pp. 1488-1490 Download
Jul 13, 2018 1103 St. Louis Federal Reserve Economic Data, Consumer Price Index for All Urban Consumers¿¿¿ CPI Monthly (accessed May 24, 2018) Download
Jul 13, 2018 1107 SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook, pp. 136-156 (March 2002) Download
Jul 13, 2018 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 Download
Jul 13, 2018 1068 Q2 2005 Sanofi-Aventis Earnings Conference Call Download
Jul 13, 2018 1058 Affidavit of Marlene S. Bobka (July 3, 2018) Download
Jul 13, 2018 1064 U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - Part 2 Download
Jul 13, 2018 1074 LANTUS¿¿ Using Lantus ¿¿¿How to Use the Lantus¿¿ SoloSTAR¿¿ Pen¿¿¿ (Current) Download
Jul 13, 2018 1066 Q4 2005 Sanofi-Aventis Earnings Conference Call Download
Jul 13, 2018 1057 Affidavit of Marlene S. Bobka (July 3, 2018) Download
Jul 13, 2018 1056 Campbell, Kevin; ¿¿¿Insulin Costs Are Skyrocketing. This is Why.¿¿¿, U.S. News and World Report, June 29, 2018, pp.1-3 Download
Jul 13, 2018 1076 LANTUS¿¿ Resources (Current) Download
Jul 13, 2018 1079 LANTUS¿¿ Home Page (Current) Download
Jul 13, 2018 1064 U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - Part 2 Download
Jul 13, 2018 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) Download
Jul 13, 2018 1078 LANTUS¿¿ Support ¿¿¿LANTUS¿¿ Tips and Support¿¿¿ (October 2006) Download
Jul 13, 2018 1051 EP Pub. 0368187 A2 Download
Jul 13, 2018 1057 Affidavit of Marlene S. Bobka (July 3, 2018) Download
Jul 13, 2018 1069 Q1 2005 Sanofi-Aventis Earnings Conference Call Download
Jul 13, 2018 1070 LANTUS¿¿ (NDA 21-081 S-024) ¿¿¿ Labeling-Container Carton Labels, Labeling-Package Insert, Rev. Mar. 2007 Download
Jul 13, 2018 1075 LANTUS¿¿ Savings Card (Current) Download
Jul 13, 2018 1073 LANTUS¿¿ Why Lantus Page ¿¿¿ Ask Your Healthcare Provider About Switching to LANTUS¿¿¿¿¿ (October 16, 2006) Download
Jul 13, 2018 1063 U.S. SEC Form 20-F for Sanofi-Aventis FY 2006 Download
Jul 13, 2018 1072 Mestre-Ferrandiz, et al., ¿¿¿The R&D Cost of a New Medicine¿¿¿, Office of Health Economics, pp. 1-100 (Dec. 2012) Download
Jul 13, 2018 1065 U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 2 Download
Jul 13, 2018 1053 Center for Drug Evaluation and Research, Approval for ¿¿¿NUTROPIN AQ¿¿¿ (App. 20-522/S-10), Apr. 10, 2000 Download
Jul 13, 2018 1052 Amgen, Inc. profile of ¿¿¿NEUPOGEN¿¿¿ (Filgrastim), Apr. 2, 1998, pp. 1-27pp. 1-27 Download
Jul 13, 2018 1055 Deposition of Dr. Laurence Baker, Ph.D. (June 22, 2018) Download
Jul 13, 2018 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) Download
Jul 13, 2018 1054 Deposition of Dr. Berhard Trout (June 21, 2018) Download
Jul 13, 2018 1077 LANTUS¿¿ New to Lantus Page (October 2006) Download
Jul 13, 2018 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) Download
Jul 13, 2018 1071 NDA 21-081 S-005 ¿¿¿ Efficacy-New Dosing Regimen ¿¿¿ Label, Apr. 30, 2003 Download
Jul 13, 2018 1058 Affidavit of Marlene S. Bobka (July 3, 2018) Download
Jul 13, 2018 1067 Q3 2005 Sanofi-Aventis Earnings Conference Call Download
Jul 13, 2018 1065 U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 2 Download
Jul 13, 2018 1057 Download
Jul 13, 2018 1058 Download
Jul 13, 2018 1064 U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - part 1 Download
Jul 13, 2018 1065 U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 1 Download
Jul 13, 2018 1111 Ex. 1111B - References Considered by Professor Robert Langer Download
Jul 13, 2018 1124 Download
Jul 13, 2018 1132 Download
Jul 13, 2018 1169 Ex. 1169F - Lantus Market Shares Download
Jul 13, 2018 1169 Ex. 1169B - Revenues by Product Download
Jul 13, 2018 1169 Ex. 1169E - Lantus Prescriptions Download
Jul 13, 2018 1169 Ex. 1169C - Diabetes Patient Population Download
Jul 13, 2018 1169 Ex. 1169A - Curriculum Vitae of DeForest McDuff Download
Jul 13, 2018 1169 Declaration of DeForest McDuff Download
Jul 13, 2018 1174 1174A- Curriculum Vitae of William Curtis Biggs Download
Jul 13, 2018 1183 References Considered by Professor Robert Langer Download
Jul 11, 2018 40 Mylan Pharmaceutical Inc.'s Updated Exhibit List Download
Jul 11, 2018 1059 Transcript of Telephone Conference Held July 5, 2018 in IPR2017-01526 and IPR2017-01528 Download
Jun 13, 2018 39 Mylan Pharmaceuticals Inc. Revised Power of Attorney Download
Jun 13, 2018 38 Mylan Pharmaceuticals Inc. Updated Mandatory Notices Download
Jun 6, 2018 37 Granting Petitioner's Unopposed Motions for Pro Hac Vice Recognition Download
May 29, 2018 36 Mylan Pharmaceutical's Unopposed Motion for Pro Hac Vice Recognition Download
May 29, 2018 35 Notice of Deposition of Dr. Laurence baker Download
May 29, 2018 33 Joint Stipulation to Modify the Scheduling Order Download
May 29, 2018 34 Notice Of Deposition of Dr. Bernhardt Trout Download
May 29, 2018 1049 Biography of Elham Firouzi Steiner Download
May 29, 2018 1048 Declaration of ElhamSteiner Download
May 8, 2018 32 Supplemental Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Download
May 8, 2018 31 Patent Owner's Updated Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download
May 3, 2018 30 Order Granting Patent Owner's Pro Hac Vice Motions to Admit Robert Vlasis Download
Apr 18, 2018 2049 Declaration of Robert Vlasis Download
Apr 18, 2018 2050 Biography of Robert Vlasis Download
Apr 18, 2018 29 Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10 Download
Apr 3, 2018 28 Mylan Pharmaceutical's Objections Download
Mar 27, 2018 2036 Ratner et al., Persistent Cutaneous Insulin Allergy, Diabetes (1990) Download
Mar 27, 2018 2023 Brange et al., Chemical Stability of Insulin. 2, Pharm. Res. (1992) Download
Mar 27, 2018 2035 Moore & Leppert, Role of Aggregated Human Growth-Hormone (hGH) (1980) Download
Mar 27, 2018 2021 Kreilgaard et al., Effects of Additives on the Stability, Pharm. Sci. (1999) Download
Mar 27, 2018 2026 Fisher & Porter, Stability of Bovine Insulin, J. Pharm. Pharmacol (1981) Download
Mar 27, 2018 2009 Campbell et al., Insulin glargine, Clinical Therapeutics (December 2001) Download
Mar 27, 2018 2040 Curriculum Vitae of Dr. Laurence C. Baker Download
Mar 27, 2018 2016 Banga, Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems (1995) Download
Mar 27, 2018 2022 Darrington, Effects of Insulin Concentration, Pharm. Res. (1995) Download
Mar 27, 2018 2027 Ingram, Gene Mutations in Human Hemoglobin, Nature (Aug. 17, 1957) Download
Mar 27, 2018 2015 Rosskamp & Park, Long-acting Insulin Analogs, Diabetes Care (March 1999) Download
Mar 27, 2018 2048 U.S. Price per Insulin Unit of Long-Acting Insulin Products Download
Mar 27, 2018 2008 March 12, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky Download
Mar 27, 2018 2010 FDA¿¿¿s Office of Clinical Pharmacology and Biopharmaceutics Review 2005 Download
Mar 27, 2018 2019 Nelson & Cox, Lehninger Principles of Biochemistry (3rd ed. 2000) (2 of 2) Download
Mar 27, 2018 2041 Dr. Laurence C. Baker¿¿¿s Prior Testimony Download
Mar 27, 2018 2042 Dr. Laurence C. Baker¿¿¿s Documents Relied On Download
Mar 27, 2018 2030 2001 Physician¿¿¿s Desk Reference (Drugs) Download
Mar 27, 2018 2046 U.S. Formulary Placement of Long-Acting Insulin Products Download
Mar 27, 2018 27 Patent Owner's Response to Petition for Inter Partes Review of U.S. Patent No. 7,476,652 Download
Mar 27, 2018 2017 Jaeger et al., Peroxide Accumulation, J. Biochem. & Biophys. Methods (1994) Download
Mar 27, 2018 2044 U.S. Share of Lantus Vial Among Long-Acting Injectable Insulin Products Download
Mar 27, 2018 2033 Pisano & Kostenbauder, Interaction of Preservatives with Macromolecules II (1957) Download
Mar 27, 2018 2032 Patel & Foss, Interaction of Some Pharmaceuticals with Macromolecules I (1964) Download
Mar 27, 2018 2007 Curriculum Vitae of Dr. Bernhardt Trout Download
Mar 27, 2018 2011 Brange et al., Chemical Stability of Insulin 1, Pharm. Res. (1992) Download
Mar 27, 2018 2013 Clodfelter et al., Effects of Non-Covalent Self-Association, Pharm. Res. (1998) Download
Mar 27, 2018 2024 Maislos, The Source of the Circulating Aggregate of Insulin, J. Clin. Invest. (1986) Download
Mar 27, 2018 2037 Dische, et al., Insulin as an Amyloid-Fibril Protein, Diabetologia (1988) Download
Mar 27, 2018 2006 Declaration of Dr. Bernhardt Trout Download
Mar 27, 2018 2020 Wang, Instability, Stabilization, and Formulation, Int¿¿¿l J. Pharm. (1999) Download
Mar 27, 2018 2012 Sluzky et al., Kinetics of Insulin Aggregation, Proc. Natl. Acad. Sci. (1991) Download
Mar 27, 2018 2028 Owens et al., ¿¿¿Insulins Today and Beyond,¿¿¿ The Lancet (September 1, 2001) Download
Mar 27, 2018 2029 Roberts & Urey, The Mechanisms of Acid, J. Am. Chem. Soc. (1939) Download
Mar 27, 2018 2043 U.S. Dollar Sales of Long-Acting Insulin Products Download
Mar 27, 2018 2047 U.S. Total Marketing Expenditures of Long-Acting Insulin Products Download
Mar 27, 2018 2019 Nelson & Cox, Lehninger Principles of Biochemistry (3rd ed. 2000) (2 of 2) Download
Mar 27, 2018 2038 Summary of Claim Constructions from Related Cases Download
Mar 27, 2018 2014 Techniques of Solubilization of Drugs 15-89 (Samuel H. Yalkowsky ed., 1981) Download
Mar 27, 2018 2045 U.S. Total Prescriptions of Long-Acting Insulin Products Download
Mar 27, 2018 2018 Hoogwerf, Advances in the Treatment of Diabetes Mellitus in the Elderly (1996) Download
Mar 27, 2018 2039 Dr. Laurence C. Baker¿¿¿s Declaration Download
Mar 27, 2018 2034 Donbrow et al., Autoxidation of Polysorbates (December 1978) Download
Mar 27, 2018 2025 2001 Physician¿¿¿s Desk Reference (Insulin) Download
Mar 27, 2018 2005 Canadian Patent No. 1,258,427 Download
Mar 27, 2018 2031 Fife & Pujari, Metal Ion Catalysis, Bioorganic Chem. (2000) Download
Mar 27, 2018 2019 Nelson & Cox, Lehninger Principles of Biochemistry (3rd ed. 2000) (1 of 2) Download
Feb 28, 2018 25 Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky Download
Feb 28, 2018 26 Patent Owner's Objections to Admissibility of Supplemental Evidence Served by Petitioner Mylan Pharmaceutical Inc. in Inter Partes Review Download
Feb 21, 2018 22 Order Conduct of the Proceeding Extending Due Date 1 and Due Date 2 of the Scheduling Order Download
Feb 21, 2018 24 Mylan Pharmaceuticals's Updated Exhibit List Download
Feb 21, 2018 23 Order Granting-in-part and Denying-in-part Petitioner's Motion for Supplemental Information Download
Feb 21, 2018 1036 Affidavit of Christopher Butler (April 4, 2017) Download
Feb 21, 2018 1037 Aventispharma-us.com, Lantus Prescribing Information (Jan. 10, 2001) Download
Feb 5, 2018 21 Patent Owner's Opposition to Petitioner's Motion for Supplemental Information Download
Jan 29, 2018 19 Mylan Pharmaceuticals Motion For Supplemental Information Download
Jan 29, 2018 20 Mylan Pharmaceutical's Updated Exhibit List Download
Jan 29, 2018 1046 Exhibit 1046 - Board Email Download
Jan 29, 2018 1047 Exhibit 1047 Download
Jan 26, 2018 18 Mylan Pharmaceutical's Updated Exhibit List Download
Dec 28, 2017 17 Mylan's Objecjections Download
Dec 28, 2017 16 Patent Owner's Objections to Admissibility of Evidence Served with Petitioner Mylan Pharmaceutical Inc.'s Petition for Inter Partes Review Download
Dec 15, 2017 15 SCHEDULING ORDER 37 C.F.R. ¿¿ 42.5(a) Download
Dec 14, 2017 14 PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES Download
Dec 13, 2017 13 Trial Instituted Document Download
Dec 12, 2017 12 PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES Download
Oct 11, 2017 11 Declaration of Clark Lin Download
Oct 11, 2017 10 Mylan Pharmaceuticals Inc.'s Updated Exhibit List Download
Oct 11, 2017 1004 Corrected Exhibit 1004 Download
Oct 6, 2017 9 Conduct of the Proceeding 37 C.F.R ¿¿ 42.5 Download
Sep 14, 2017 8 Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 7,476,652 Download
Sep 14, 2017 2004 U.S. Patent No. 5,656,722 Download
Sep 14, 2017 2002 Formulation-Related Problems Associated with Intravenous Drug Delivery Download
Sep 14, 2017 2001 2001 Physicians Desk Reference (PDR) Download
Sep 14, 2017 2003 Physical Biochemistry of Protein Drugs, in Protein and Peptide Delivery Download
Aug 24, 2017 7 Patent Owner's Updated Mandatory Notices Download
Jun 20, 2017 5 Patent Owner's Power of Attorney Download
Jun 20, 2017 6 Patent Owner's Mandatory Notice Download
Jun 20, 2017 6 Patent Owner's Mandatory Notice Download
Jun 20, 2017 4 Patent Owner's Mandatory Notices Download
Jun 15, 2017 3 Notice of Accord Filing Date Download
Jun 5, 2017 2 PETITION FOR INTER PARTES REVIEW U.S. PATENT NO. 7,476,652 Download
Jun 5, 2017 1031 R. Jones, Insulin Glargine Aventis Pharma, IDrugs 3:1081-87 (2000) Download
Jun 5, 2017 1012 U. Derewenda et al. Phenol Stabilizes More Helix in a New Symmetrical Zinc Insulin Hexamer, Nature 338:594-6 (April 1989) Download
Jun 5, 2017 1018 W.D. Lougheed et al., Insulin Aggregation in Artificial Delivery Systems, Diabetologia 19:1-9 (July 1980) Download
Jun 5, 2017 1007 1007A - Certified English translation for Ex. 1007 (FASS Entry for INSUMAN INFUSAT) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 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) Download
Jun 5, 2017 1010 FDA Drug Approval for LANTUS (NDA 02-1081) (April 20, 2000) Download
Jun 5, 2017 1015 J. Brange et al., Toward Understanding Insulin Fibrillation, J. Pharm. Sci. 86:517-25 (May 1997) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1024 U.S. Patent No. 4,839,341 Stabilized Insulin Formulations (Issued June 13, 1989) Download
Jun 5, 2017 1017 K. Hallas-Moller, The Lente Insulins, Diabetes 5:7-14 (1956) Download
Jun 5, 2017 1029 M. Heile and D. Schneider, The Evolution of Insulin Therapy in Diabetes Mellitus, J. Fam. Pract. 61 (5 Suppl.: S6-12 (May 2012) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1013 H. Berchtold and R. Hilgenfeld, Binding of Phenol to R6 Insulin Hexamers, Biopolymers 51:165-72 (1999) Download
Jun 5, 2017 1003 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky Download
Jun 5, 2017 1007 1007A - Certified English translation for Ex. 1007 (FASS Entry for INSUMAN INFUSAT) Download
Jun 5, 2017 1009 EMEA Public Statement on INSUMAN INFUSAT (February 14, 2000) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 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 Download
Jun 5, 2017 1011 P. Gillies et al., Insulin Glargine, Drugs 59:253-60 (February 2000) Download
Jun 5, 2017 1006 W.D. Lougheed et al., Physical Stability of Insulin Formulations, Diabetes 32:424-32 (May 1983) Download
Jun 5, 2017 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 Download
Jun 5, 2017 1005 D.R. Owens et al., Pharmacokinetics of 125I-Labeled Insulin Glargine (HOE 901) in Healthy Men, Diabetes Care 23:813-19 (June 2000) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 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 Download
Jun 5, 2017 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) Download
Jun 5, 2017 1002 1002A - FH US 7713930 Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1008 U. Grau and C.D. Saudek, Stable Insulin Preparation for Implanted Insulin Pumps, Diabetes 36:1453-59 (December 1987) Download
Jun 5, 2017 1003 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1003 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1002 1002A - FH US 7713930 Download
Jun 5, 2017 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 Download
Jun 5, 2017 1032 I.R. Schmolka, Poloxamers in the Pharmaceutical Industry, in POLYMERS FOR CONTROLLED DRUG DELIVERY, CHAPTER 10 (CRC Press) (1991) Download
Jun 5, 2017 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 Download
Jun 5, 2017 1034 L. Gatlin and C. Gatlin, Minimizing Injection Pain & Damage in INJECTABLE DRUG DEVELOPMENT TECHNIQUES TO REDUCE PAIN AND IRRITATION CHAPTER 17 Download
Jun 5, 2017 1026 A. Chawla et al. Aggregation of Insulin, Containing Surfactants, in Contact with Different Materials, Diabetes 34:420-24 (May 1985) Download
Jun 5, 2017 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) Download
Jun 5, 2017 1023 U.S. Patent No. 4,153,689 Stable Iinsulin Preparation for Nasal Administration (Issued May 8, 1979) Download
Jun 5, 2017 1007 1007A - Certified English translation for Ex. 1007 (FASS Entry for INSUMAN INFUSAT) Download
Jun 5, 2017 1020 W.R. Ashford and S. Landi, Stabilizing Properties of Tween 80 in Dilute Protein Solutions, Bull. Parenteral Drug Assoc. 20:74-81 (1966) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1003 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky Download
Jun 5, 2017 1004 1004A - Notarized Affidavit Lloyd Library Download
Jun 5, 2017 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) Download
Jun 5, 2017 1 Power of Attorney Download
Jun 5, 2017 1030 ADIS R&D Profile Insulin Glargine: Glargine, HOE 71GT15, HOE 71GT80, HOE 901, Drugs R&D 2:107-09 (August 1999) Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1021 H. Thurow and K. Geisen, Stabilisation of Dissolved Proteins Against Denaturation at Hydrophobic Interfaces, Diabetologia 27:212-18 (1984) Download
Jun 5, 2017 1025 E.P. Publication No. 0200383 An Improved Method for Administering Insulin (Issued November 5, 1986) Download
Jun 5, 2017 1004 1004A - Notarized Affidavit Lloyd Library Download
Jun 5, 2017 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 Download
Jun 5, 2017 1003 1003A - Curriculum Vitae of Professor Samuel H. Yalkowsky Download
Jun 5, 2017 1001 1001A Part III - FH US 7476652 Download
Jun 5, 2017 1004 1004A - Notarized Affidavit Lloyd Library Download
Jun 5, 2017 1001 1001A Part IV - FH US 7476652 Download
Jun 5, 2017 1001 1001A Part II - FH US 7476652 Download
Jun 5, 2017 1001 1001A Part V - FH US 7476652 Download
Jun 5, 2017 1001 1001A Part VI - FH US 7476652 Download
Jun 5, 2017 1001 U.S. Patent No. 7,476,652 Download
Jun 5, 2017 1001 1001A Part I - FH US 7476652 Download
Jun 5, 2017 1002 U.S. Patent No. 7,713,930 Download
Jun 5, 2017 1003 1003B - Materials Reviewed by Professor Samuel H. Yalkowsky Download
Jun 5, 2017 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 Download
Jun 5, 2017 1004 Physicians Desk Reference Download
Jun 5, 2017 1007 2000 FASS Entry for INSUMAN INFUSAT (January 2000) Download
Jun 5, 2017 1033 1033A -Certified Translation of Exh. 1033 (2001 Rote Liste; Entry for INISUMAN INFUSAT) Download
Jun 5, 2017 1033 2001 Rote Liste; Entry for INSUMAN INFUSAT Download
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