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Case number IPR2017-01912

FRESENIUS KABI USA, LLC v. AstraZeneca AB > Documents

Date Field Doc. No.PartyDescription
Feb 2, 2018 11 Notice of Refund Download
Jan 24, 2018 10 Petitioner's Refund Request Download
Dec 11, 2017 9 Decision - Denying Institution of Inter Partes Review Download
Dec 11, 2017 3002 Amendment to the Claims, Patent Appl. No. 12/285,887 Download
Nov 16, 2017 2170 Rowland Ch. 13 Download
Nov 16, 2017 2175 PTAB Order Download
Nov 16, 2017 2166 Oleksowicz Mylan Declaration Download
Nov 16, 2017 2172 FDA Guidance 1999 Download
Nov 16, 2017 2167 Burgess Amneal Declaration Download
Nov 16, 2017 2174 InnoPharma Petition Download
Nov 16, 2017 2173 InnoPharma Decision Download
Nov 16, 2017 2171 Shapiro 1965 Download
Nov 16, 2017 2169 PDR 1999 Inderal LA Download
Nov 16, 2017 8 Patent Owner's Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 8,466,139 Download
Nov 16, 2017 2168 D'Agostino 1990 Download
Nov 16, 2017 2041 Haarstad 1992 Download
Nov 16, 2017 2017 Jordan 1995 Download
Nov 16, 2017 2040 Howell 1997 Download
Nov 16, 2017 2160 Huynh 1993 Download
Nov 16, 2017 2044 Innovative Research Download
Nov 16, 2017 2152 Goss 1986 Download
Nov 16, 2017 2037 Hortobagyi 1997 Download
Nov 16, 2017 2136 Robertson Mylan Declaration Download
Nov 16, 2017 2140 Buzdar 2001 Download
Nov 16, 2017 2054 Beyea 1996 Download
Nov 16, 2017 2027 Dukes 1994 Download
Nov 16, 2017 2030 Robertson 2001 Download
Nov 16, 2017 2163 Dipippo 1997 Download
Nov 16, 2017 2039 Hayes 1995 Download
Nov 16, 2017 2119 Buzdar 1996 Download
Nov 16, 2017 2007 Pritchard 2010 Download
Nov 16, 2017 2009 Robertson 1996 Download
Nov 16, 2017 2032 Labrie 2004 Download
Nov 16, 2017 2135 Illum Mylan Declaration Download
Nov 16, 2017 2124 Huber 1965 Download
Nov 16, 2017 2110 Lundeen 1997 Download
Nov 16, 2017 2111 Buzdar 2003 Download
Nov 16, 2017 2149 Abrams 1990 Download
Nov 16, 2017 2014 Pritchard 1997 Download
Nov 16, 2017 2006 Ohno 2010 Download
Nov 16, 2017 2068 Baumann 1998 Download
Nov 16, 2017 2105 Porras 1999 Download
Nov 16, 2017 2008 Greenlee 2000 Download
Nov 16, 2017 2130 Levine 1966 Download
Nov 16, 2017 2147 Koyama 1999 Download
Nov 16, 2017 2096 Ansel Ch. 12 Download
Nov 16, 2017 2159 Martel 1998 Download
Nov 16, 2017 2056 Robertson 2012 Download
Nov 16, 2017 2108 Buzdar ASCO 2001 Download
Nov 16, 2017 2070 Stenbygaard 1993 Download
Nov 16, 2017 2022 Minton 1999 Download
Nov 16, 2017 2063 Johnston 2013 Download
Nov 16, 2017 2067 Cancer Weekly April 2004 Download
Nov 16, 2017 2129 Eagle 1949 Download
Nov 16, 2017 2117 Greenblatt 1978 Download
Nov 16, 2017 2019 Wiebe 1993 Download
Nov 16, 2017 2165 Al-Matubsi 1998 Download
Nov 16, 2017 2115 Ballard 1968 Download
Nov 16, 2017 2079 Gupta Ch. 2 Download
Nov 16, 2017 2144 Bonneterre 1985 Download
Nov 16, 2017 2045 PDR 1999 Nolvadex Download
Nov 16, 2017 2024 Hortobagyi New Eng. J. Med. 1998 Download
Nov 16, 2017 2101 Merck Index 1996 Download
Nov 16, 2017 2089 Vidal 1999 Download
Nov 16, 2017 2123 Gupta Ch. 17 Download
Nov 16, 2017 2093 Remington's Ch. 89 Download
Nov 16, 2017 2066 Pharma Marketletter 2004 Download
Nov 16, 2017 2077 Kuter 2012 Download
Nov 16, 2017 2081 Remington's Ch. 75 Download
Nov 16, 2017 2042 AACR Journals Online Download
Nov 16, 2017 2050 Bratherton 1984 Download
Nov 16, 2017 2155 Cristofanilli 2016 Download
Nov 16, 2017 2015 Buzdar Clin. Oncol. 1998 Download
Nov 16, 2017 2131 Yarinsky 1970 Download
Nov 16, 2017 2138 Jonat 1996 Download
Nov 16, 2017 2114 Zuidema 1994 Download
Nov 16, 2017 2082 Aulton Ch. 1 Download
Nov 16, 2017 2084 Remington's Ch. 84 Download
Nov 16, 2017 2106 Ansel Ch. 14 Download
Nov 16, 2017 2031 Robertson Clin. Ther. 2003 Download
Nov 16, 2017 2120 Lifschitz 1999 Download
Nov 16, 2017 2122 Chu 1960 Download
Nov 16, 2017 2088 Baselga 2003 Download
Nov 16, 2017 2139 Dombernowsky 1998 Download
Nov 16, 2017 2164 Sibonga 1998 Download
Nov 16, 2017 2146 Rose 1985 Download
Nov 16, 2017 2069 Pyrhonen 1994 Download
Nov 16, 2017 2062 Chia 2008 Download
Nov 16, 2017 2145 Hortobagyi 1985 Download
Nov 16, 2017 2035 Hortobagyi 1998 Download
Nov 16, 2017 2023 Grese 1998 Download
Nov 16, 2017 2002 Robertson Declaration Download
Nov 16, 2017 2100 Gao 1998 Download
Nov 16, 2017 2061 Bellmunt 1991 Download
Nov 16, 2017 2104 Aulton Ch. 6 Download
Nov 16, 2017 2109 Wade 1993 Download
Nov 16, 2017 2001 Illum Declaration Download
Nov 16, 2017 2003 Sawchuk Declaration Download
Nov 16, 2017 2078 Buzdar 2006 Download
Nov 16, 2017 2142 Goss 1998 Download
Nov 16, 2017 2121 Lavy 1999 Download
Nov 16, 2017 2157 Wright Ch. 4 Download
Nov 16, 2017 2073 Robertson Eur. J. Cancer 2005 Download
Nov 16, 2017 2092 Forrest Mylan Declaration Download
Nov 16, 2017 2154 Robertson 2016 Download
Nov 16, 2017 2150 Abrams 1999 Download
Nov 16, 2017 2076 Agrawal 2009 Download
Nov 16, 2017 2060 Robertson 2004 Download
Nov 16, 2017 2057 Robertson SABCS 2014 Download
Nov 16, 2017 2151 Jonat 2013 Download
Nov 16, 2017 2072 Barrios 2012 Download
Nov 16, 2017 2091 ABPI 1999-2000 Download
Nov 16, 2017 2102 Ansel Ch. 10 Download
Nov 16, 2017 2075 Vergote 2006 Download
Nov 16, 2017 2010 Fornier 1999 Download
Nov 16, 2017 2158 Strickley II 2000 Download
Nov 16, 2017 2034 Labrie 1999 Download
Nov 16, 2017 2086 Groves Ch. 2 Download
Nov 16, 2017 2148 Muss 1990 Download
Nov 16, 2017 2047 Rauschning 1994 Download
Nov 16, 2017 2118 Litchfield 1961 Download
Nov 16, 2017 2137 Buzdar 1997 Download
Nov 16, 2017 2025 Masamura 1994 Download
Nov 16, 2017 2052 Sweetana 1996 Download
Nov 16, 2017 2097 Ansel Ch. 13 Download
Nov 16, 2017 2095 Ansel Ch. 7 Download
Nov 16, 2017 2065 Johnston 2004 Download
Nov 16, 2017 2128 Skougaard 1966 Download
Nov 16, 2017 2125 Affidavit of Internet Archive Download
Nov 16, 2017 2156 Stenger 2017 Download
Nov 16, 2017 2051 Cohen 1995 Download
Nov 16, 2017 2080 Remington¿¿¿s Ch. 91 Download
Nov 16, 2017 2085 Buzdar 1994 Download
Nov 16, 2017 2098 Aulton Ch. 18 Download
Nov 16, 2017 2087 Gupta Ch. 1 Download
Nov 16, 2017 2059 Vergote 2003 Download
Nov 16, 2017 2016 Howell 1992 Download
Nov 16, 2017 2127 PDR 1999 Estrace Download
Nov 16, 2017 2012 Hortobagyi Cancer Investigation 1998 Download
Nov 16, 2017 2043 McLeskey Declaration Download
Nov 16, 2017 2036 Robertson 1999 Download
Nov 16, 2017 2055 Robertson 2009 Download
Nov 16, 2017 2134 Lachman's 1986 Download
Nov 16, 2017 2049 July 14 Trial Tr. Download
Nov 16, 2017 2112 Strickley I 1999 Download
Nov 16, 2017 2038 Dowsett 1995 Download
Nov 16, 2017 2028 Howell 2002 Download
Nov 16, 2017 2020 Jordan Supp. 1992 Download
Nov 16, 2017 2083 Buzdar 2002 Download
Nov 16, 2017 2099 Aulton Ch. 19 Download
Nov 16, 2017 2090 Vidal 1997 Download
Nov 16, 2017 2004 Di Leo 2010 Download
Nov 16, 2017 2005 Di Leo 2014 Download
Nov 16, 2017 2071 Robertson 2014 Download
Nov 16, 2017 2113 Avis Ch. 3 Download
Nov 16, 2017 2013 Johnston 1997 Download
Nov 16, 2017 2029 Osborne 2002 Download
Nov 16, 2017 2143 Hoffken 1992 Download
Nov 16, 2017 2064 Robertson 2005 Download
Nov 16, 2017 2153 Dowsett 1989 Download
Nov 16, 2017 2141 Dowsett Clin. Cancer Res. 1995 Download
Nov 16, 2017 2126 PDR 1999 Arimidex Download
Nov 16, 2017 2033 Van de Velde 1996 Download
Nov 16, 2017 2011 Jordan Supp. 1995 Download
Nov 16, 2017 2021 Jordan 1992 Download
Nov 16, 2017 2048 Thomas 1993 Download
Nov 16, 2017 2026 Kelloff 1998 Download
Nov 16, 2017 2132 Remington's Ch. 9 Download
Nov 16, 2017 2094 Aulton Ch. 13 Download
Nov 16, 2017 2161 Chatterjee 1993 Download
Nov 16, 2017 2116 Hirano 1981 Download
Nov 16, 2017 2107 Avis Ch. 2 Download
Nov 16, 2017 2162 Applied Biopharmaceutics 1999 Download
Nov 16, 2017 2018 Morrow 1993 Download
Nov 16, 2017 2053 Fallowfield 2006 Download
Nov 16, 2017 2133 Sawchuk Mylan Declaration Download
Nov 16, 2017 2074 Clinical Practice Guidelines 2003 Download
Nov 16, 2017 2103 Avis Ch. 4 Download
Nov 16, 2017 2058 Ellis 2015 Download
Nov 16, 2017 2046 PDR 1999 Femara Download
Nov 2, 2017 7 Order Denying Petitioner's Requests for Authorization to File a Motion to Withdraw the Petition And Motion for Joinder Download
Nov 2, 2017 3001 Ex. 3001 Download
Aug 25, 2017 6 Patent Owner's Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download
Aug 25, 2017 5 Patent Owner's Power of Attorney Pursuant to 37 C.F.R. 42.10(b) Download
Aug 16, 2017 4 Notice of Accord Filing Date Download
Aug 4, 2017 3 MOTION FOR JOINDER UNDER 35 U.S.C. 315(c) AND 37 C.F.R. 42.22 AND 42.122(b) Download
Aug 4, 2017 1107 Roberts, Investigation of Cosolvent Effects on the Solvation of AOT Reverse Micelles in Supercritical Ethane, 102 J. PHYS. CHEM. B 9074-80 (1998) Download
Aug 4, 2017 1097 Balant-Gorgia, Pharmacokinetic Optimisation of the Treatment of Psychosis, 25 CLIN. PHARMACOKINET. 217-36 (1993) Download
Aug 4, 2017 1087 Prosecution History for the U.S. Patent No. 8,466,139 Download
Aug 4, 2017 1088 Wunsche, Estrogenic Regulation of Clusterin mRNA in Normal and Malignant Endometrial Tissue, 76 INT. J. CANCER 684-88 (1998) Download
Aug 4, 2017 1079 Handbook of Pharmaceutical Excipients (Wade ed., 2d. ed. 1994) Download
Aug 4, 2017 1102 Nema, Excipients and Their Use in Injectable Products, 51 PDA J. PHARM. SCI. & TECH. 166-71 (1997) Download
Aug 4, 2017 1092 Lee, Standard Deviation and Standard Error of the Mean, 68 KOREAN J. ANESTHESIOLOGY 220-23 (2015) Download
Aug 4, 2017 1105 Powell, Compendium of Excipients for Parenteral Formulations, 52 PDA J. PHARM. SCI. & TECH. 238-311 (1998) Download
Aug 4, 2017 1096 August 21, 2008 Applicant Amendment and Response in Application No. 10 872,784 Download
Aug 4, 2017 1110 Ting, Solubility of Naproxen in Supercritical Carbon Dioxide with and without Cosolvents, 32 IND. ENG. CHEM. RES. 1471-81 (1993) Download
Aug 4, 2017 1078 Petition for Inter Partes Review in Mylan Pharms. Inc. v. AstraZeneca AB, Paper No. 2, IPR2016-01326 (P.T.A.B. June 29, 2016) Download
Aug 4, 2017 2 PETITIONER FRESENIUS KABI'S POWER OF ATTORNEY, U.S. PATENT NO. 8,466,139 Download
Aug 4, 2017 1094 Tse, Bioavailability of Parenteral Drugs I. Intravenous and Intramuscular Doses, 34 J. PARENTERAL DRUG ASSOCIATION 409-21 (1980) Download
Aug 4, 2017 1084 Fabian, Clinical Pharmacology of Tamoxifen in Patients with Breast Cancer: Correlation with Clinical Data, 48 CANCER 876-82 (1981) Download
Aug 4, 2017 1098 Chien, Solubilization of Steroids by Multiple Co-Solvent Systems, 23 CHEM. PHARM. BULL. 1085-90 (1975) Download
Aug 4, 2017 1111 Tse, Bioavailability of Parenteral Drugs II. Parenteral Doses Other Than Intravenous and Intramuscular Routes, 34 J. PARENTERAL DRUG ASSOCIATION 484-95 (1980) Download
Aug 4, 2017 1103 Ogasawara, Effects of Experimental Chemoendocrine Therapy with a Combination of a Pure Antiestrogen and 5-Fluorouracil on Human Breast Cancer Cells Implanted in Nude Mice, 29 SURGERY TODAY 149-56 (1999) Download
Aug 4, 2017 1100 Cunliffe-Beamer, "Biomethodology and Surgical Techniques," The Mouse in Biomedical Research, Volume III: Normative Biology, Immunology, and Husbandry 401-37 (Foster ed., 1983) Download
Aug 4, 2017 1093 Altman, Standard Deviations and Standard Errors, 331 BMJ 903 (2005) Download
Aug 4, 2017 1075 Robertson, J.F.R. et al., A Partially-Blind, Randomised, Multicentre Study Comparing the Anti-Tumor Effects of Single Doses (50, 125, 250 mg) Of Long-Acting (LA) 'Faslodex' (ICI 182,780) With Tamoxifen ... (Dec. 8-11, 1999) Download
Aug 4, 2017 1085 Goldenberg, Trastuzumab, a Recombinant DNA-Derived Humanized Monoclonal Antibody, a Novel Agent for the Treatment of Metastatic Breast Cancer, 21 CLINICAL THERAPEUTICS 309-18 (1999) Download
Aug 4, 2017 1104 Oldham, "Mass Transport to Electrodes," Chemical Kinetics 79-143 (Bamford ed., 1986) Download
Aug 4, 2017 1086 Wilkinson, Tamoxifen (Nolvadex*) Therapy - Rationale for Loading Dose Followed by Maintenance Dose for Patients with Metastatic Breast Cancer, 10 CANCER CHEMOTHERAPY PHARMACOLOGY 33-35 (1982) Download
Aug 4, 2017 1083 Baselga, Phase II Study of Weekly Intravenous Recombinant Humanized Anti-p185HER2 Monoclonal Antibody in Patients with HER2/neu-Overexpressing Metastatic Breast Cancer, 14 J. CLINICAL ONCOLOGY 737-44 Download
Aug 4, 2017 1080 FDA's Inactive Ingredient Database (1996) Download
Aug 4, 2017 1112 U.S. Patent No. 4,212,863 Download
Aug 4, 2017 1077 Jorgensen, Pharmacokinetic Studies in Volunteers of Intravenous and Oral Cis (Z)-Flupentixol and Intramuscular Cis (Z)-Flupentixol Decanoate in Viscoleo, 18 EUR. J. CLIN. PHARMACOL. 355-60 (1980) Download
Aug 4, 2017 1089 Chwalisz, Modulation of Oestrogenic Effects by Progesterone Antagonists in the Rat Uterus, 4 HUMAN REPRODUCTION UPDATE 570-83 (1998) Download
Aug 4, 2017 1113 USP 23 ¿¿¿ NF 18, The United States Pharmacopeia ¿¿¿ The National Formulary 13-14 (1995) Download
Aug 4, 2017 1095 Licciardi, Oral Versus Intramuscular Progesterone for In Vitro Fertilization: A Prospective Randomized Study, 71 FERTILITY & STERILITY 614-18 (1999) Download
Aug 4, 2017 1099 Ford, "Parenteral Products," Pharmaceutics: The Science of Dosage Form Design 359-80 (Aulton ed., 1988) Download
Aug 4, 2017 1108 Sawka, Physiological Consequences of Hypohydration: Exercise Performance and Thermoregulation, 24 MEDICINE & SCIENCE IN SPORTS & EXERCISE 657-70 (1992) Download
Aug 4, 2017 1091 Ansel, "Dosage Form Design: Biopharmaceutic and Pharmacokinetic Considerations," Pharmaceutical Dosage Forms and Drug Delivery Systems 101-41 (7th ed. 1999) Download
Aug 4, 2017 1101 Way, "Cosolvent Use in Injectable Formulations," Injectable Drug Development: Techniques to Reduce Pain and Irritation 215-66 (Gupta ed., 1999) Download
Aug 4, 2017 1109 Simmons, The Laboratory Mouse: Selection and Management 127-28 (1970) Download
Aug 4, 2017 1081 Drugs FDA Glossary of Terms, U.S. FOOD & DRUG ADMINISTRATION (last updated Feb. 2, 2012) Download
Aug 4, 2017 1106 Remington's Pharmaceutical Sciences 1538-39, 1545-50, 1686-88 (18th ed. 1990) Download
Aug 4, 2017 1090 Robertson, Fulvestrant (Faslodex)-How to Make a Good Drug Better, 12 ONCOLOGIST 774-84 (2007) Download
Aug 4, 2017 1082 Adam, "Pharmacokinetics of Agents in Relation to Response," Endocrine Management of Cancer: Biological Bases 112-24 (1988) Download
Aug 4, 2017 1076 Kohler, Plasma and Tissue Concentrations Following Intramuscular Administration of Etofenamat. Pharmacokinetics of Etofenamat and Flufenamic Acid in Plasma, Synovium, and Tissues of Patients with, 42 ARZNEIMITTEL-FORSCHUNG (English Abstract) (1992) Download
Aug 4, 2017 1005 RESERVED Download
Aug 4, 2017 1042 Prosecution History for U.S. Patent No. 8,329,680 (downloaded from PAIR) Download
Aug 4, 2017 1021 Faslodex Label Download
Aug 4, 2017 1003 RESERVED Download
Aug 4, 2017 1071 Smith, Analysis of Oil-Based Pharmaceuticals, 49 J. AMERICAN OIL CHEMISTS' SOCIETY 409-13 (1972) Download
Aug 4, 2017 1004 RESERVED Download
Aug 4, 2017 1040 Alan E. Wakeling & Jean Bowler, ICI 182,780: A New Antioestrogen with Clinical Potential, 43 J. STEROID BIOCHEM. MOLEC. BIOL. 173-177 (1992) Download
Aug 4, 2017 1010 Order, AstraZeneca Pharms. LP v. Sandoz Inc., No. 14-03547 (D.N.J. July 29, 2015), ECF No. 102 Download
Aug 4, 2017 1023 Qiu, Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice (2009) Download
Aug 4, 2017 1037 WO 03 006064 Download
Aug 4, 2017 1057 Dukes, Antiuterotrophic Effects of the Pure Antioestrogen ICI 182,780 in Adult Female Monkeys (Macaca nemestrina): Quantitative Magnetic Resonance Imaging, 138 J. ENDOCRINOLOGY 203-09 (1993) Download
Aug 4, 2017 1063 Equivalent Surface Area Dosage Conversion Factors (2007) Download
Aug 4, 2017 1073 Taucher, Sequential Steroid Hormone Receptor Measurements in Primary Breast Cancer with or without Intervening Primary Chemotherapy, 10 ENDOCRINE-RELATED CANCER 91-98 (2003) Download
Aug 4, 2017 1066 Johnston, Changes in Estrogen Receptor, Progesterone Receptor, and pS2 Expression in Tamoxifen-Resistant Human Breast Cancer, 55 CANCER RESEARCH 3331-38 (1995) Download
Aug 4, 2017 1017 AstraZeneca's Preliminary Response in Mylan Pharms. Inc. v. AstraZeneca AB, Paper No. 10, IPR2016-01325 (P.T.A.B. Oct. 6, 2016) Download
Aug 4, 2017 1030 White, Pharmacokinetic and Pharmacodynamic Considerations in Antimalarial Dose Optimization, 57 ANTIMICROBIAL AGENTS & CHEMOTHERAPY 5802 (2013) Download
Aug 4, 2017 1054 Santen, Use of Aromatase Inhibitors in Breast Carcinoma, 6 ENDOCRINE-RELATED CANCER 75-92 (1999) Download
Aug 4, 2017 1049 Anderson, Models of New Antioestrogen Action in Vivo: Primary Tumours, 5 THE BREAST 186-91 (1996) Download
Aug 4, 2017 1059 Selective Estrogen Receptor Modulators (SERMs), BREASTCANCER.ORG (last modified Nov. 5, 2015), http://www.breastcancer.org/treatment/hormonal/serms Download
Aug 4, 2017 1035 Uges, Plasma or Serum in Therapeutic Drug Monitoring and Clinical Toxicology, 10 PHARMACEUTISCH WEEKBLAD SCIENTIFIC EDITION 185-88 (1988) Download
Aug 4, 2017 1056 Howell, Response to a Specific Antioestrogen (ICI 182780) in Tamoxifen-Resistant Breast Cancer, 345 LANCET 29-30 (1995) Download
Aug 4, 2017 1068 Mackey, Tolerability of Intramuscular Injections of Testosterone Ester in Oil Vehicle, 10 HUMAN REPRODUCTION 862-65 (1995) Download
Aug 4, 2017 1009 O'Regan et al., Effects of the Antiestrogens Tamoxifen, Toremifene, and ICI 182,780 on Endometrial Cancer Growth, 90 J. NATL CANCER INST. 1552-1558 (1998) Download
Aug 4, 2017 1033 Riffkin, Castor Oil as a Vehicle for Parenteral Administration of Steroid Hormones, 53 J. PHARM. SCI. 891-895 (1964) Download
Aug 4, 2017 1069 Kern, "Role of Angiogenesis in the Transition to Hormone Independence and Acquisition of the Metastatic Phenotype," Endocrinology of Breast Cancer 169-86 (Manni ed., 1999) Download
Aug 4, 2017 1061 Thomas, The Effects of ICI 182,780, a Pure Anti-Oestrogen, on the Hypothalamic-Pituitary-Gonadal Axis and on Endometrial Proliferation in Pre-Menopausal Women, 9 HUMAN REPRODUCTION 1991-96 (1994) Download
Aug 4, 2017 1024 Tozer, Introduction to Pharmacokinetics and Pharmacodynamics: The Quantitative Basis of Drug Therapy (2006) Download
Aug 4, 2017 1012 Declaration of Diane Burgess, Ph.D. and Accompanying Exhibits Download
Aug 4, 2017 1045 Howell, Response to a Specific Antioestrogen (ICI 182780) in Tamoxifen-Resistant Breast Cancer, 345 LANCET 989-90 (1995) Download
Aug 4, 2017 1026 Wills, "Basic Pharmacodynamic Concepts and Models," Pharmacodynamics and Drug Development: Perspectives in Clinical Pharmacology (1994) Download
Aug 4, 2017 1008 McLeskey et al., Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in vivo to the antiestrogen ICI 182,780 and two aromatase inhibitors, 4 CLIN. CANCER RESEARCH 697-711 (1998) Download
Aug 4, 2017 1019 Declaration Under 37 C.F.R. 1.132 of Ronald J. Sawchuk in Application No. 12 285,887 Download
Aug 4, 2017 1022 DiPiro, Concepts in Clinical Pharmacokinetics (2010) Download
Aug 4, 2017 1046 Prosecution History for the U.S. Patent No. 7,456,160 Download
Aug 4, 2017 1001 U.S. Patent No. 8,466,139 Download
Aug 4, 2017 1011 Institution Decision in Mylan Pharms. Inc. v. AstraZeneca AB, Paper No. 11, IPR2016-01325 (P.T.A.B. Dec. 14, 2016) Download
Aug 4, 2017 1007 Howell et al., Pharmacokinetics, pharmacological and anti-tumour effects of the specific anti-oestrogen ICI 182780 in women with advanced breast cancer, 74 BRIT. J. CANCER 300-08 (1996) Download
Aug 4, 2017 1064 Clarke, Antiestrogen Resistance in Breast Cancer and the Role of Estrogen Receptor Signaling, 22 ONCOGENE 7316-39 (2003) Download
Aug 4, 2017 1038 DeFriend et al., Investigation of a New Pure Antiestrogen (ICI 182780) in Women with Primary Breast Cancer, 54 CANCER RESEARCH 408-414 (1994) Download
Aug 4, 2017 1027 Derendorf, Handbook of Pharmacokinetic Pharmacodynamic Correlation 53 (1995) Download
Aug 4, 2017 1020 Declaration Under 37 C.F.R. 1.132 of Paul Richard Gellert in Application No. 10 872,784 Download
Aug 4, 2017 1074 Turner, Administration of Substances to Laboratory Animals: Routes of Administration and Factors to Consider, 50 J. AMERICAN ASSOCIATION FOR LABORATORY ANIMAL SCIENCE 600-13 (2011) Download
Aug 4, 2017 1058 Wakeling, The Future of New Pure Antioestrogens in Clinical Breast Cancer, 25 BREAST CANCER RESEARCH & TREATMENT 1-9 (1993) Download
Aug 4, 2017 1052 Howell, The Definition of the 'No Change' Category in Patients Treated with Endocrine Therapy and Chemotherapy for Advanced Carcinoma of the Breast, 24 EUR. J. CANCER CLIN. ONCOL. 1567-72 (1988) Download
Aug 4, 2017 1055 EP 0 346 014 Download
Aug 4, 2017 1062 Freireich, Quantitative Comparison of Toxicity of Anticancer Agents in Mouse, Rat, Hamster, Dog, Monkey, and Man, 50 CANCER CHEMOTHERAPY REPORTS 219-44 (1966) Download
Aug 4, 2017 1 PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,466,139 UNDER 35 U.S.C. 311-319 AND 37 C.F.R. 42.100 ET SEQ. Download
Aug 4, 2017 1051 Howell, New Endocrine Therapies for Breast Cancer, 32A EUR. J. CANCER 576-88 (1996) Download
Aug 4, 2017 1014 Declaration of Dorraya El Ashry, Ph.D. and Accompanying Exhibits Download
Aug 4, 2017 1029 Colburn, Simultaneous Pharmacokinetic Pharmacodynamic Modeling, PHARMACODYNAMICS AND DRUG DEVELOPMENT: PERSPECTIVES IN CLINICAL PHARMACOLOGY (1994) Download
Aug 4, 2017 1039 Osborne et al., Comparison of the Effects of a Pure Steroidal Antiestrogen With Those of Tamoxifen in a Model of Human Breast Cancer, 87 J. NATL CANCER INST. 746-750 (1995) Download
Aug 4, 2017 1072 Spiegel & Noseworthy, Use of Nonaqueous Solvents in Parenteral Products, 52 J. PHARM. SCIS. 917-27 (1963) Download
Aug 4, 2017 1044 Robertson, Fulvestrant Versus Anastrozole for the Treatment of Advanced Breast Carcinoma in Postmenopausal Women: A Prospective Combined Analysis of Two Multicenter Trials, 98 CANCER 229-38 (2003) Download
Aug 4, 2017 1015 Declaration of Adrian Harris, Ph.D. and Accompanying Exhibits Download
Aug 4, 2017 1041 Howell, A. et al., Clinical Studies With The Specific 'Pure' Antiestrogen ICI 182780, THE BREAST, Vol. 5:192-195 (1996) Download
Aug 4, 2017 1043 Robertson, J.F.R. et al., Duration Of Remission To ICI 182,780 Compared To Megestrol Acetate In Tamoxifen Resistant Breast Cancer, THE BREAST, Vol. 6:186-189 (1997) Download
Aug 4, 2017 1013 Declaration of Richard Bergstrom, Ph.D. and Accompanying Exhibits Download
Aug 4, 2017 1048 Parczyk, K. et al., Progesterone Receptor Repression by Estrogens in Rat Uterine Epithelial Cells, 63 J. STEROID BIOCHEMISTRY & MOLECULAR BIOLOGY 309 (1997) Download
Aug 4, 2017 1070 Neubauer, Changes in Tumour Biological Markers during Primary Systemic Chemotherapy (PST), 28 ANTICANCER RESEARCH 1797-804 (2008) Download
Aug 4, 2017 1036 Dukes et al., Antiuterotrophic effects of a pure antioestrogen, ICI 182,780: magnetic resonance imaging of the uterus in ovariectomized monkeys, 135 J. ENDOCRINOLOGY 239-247 (1992) Download
Aug 4, 2017 1067 Waynforth, LASA Good Practice Guidelines: Administration of Substances (Rat, Mouse, Guinea Pig, Rabbit) (Oct. 1998), www.procedureswithcare.org.uk/lasa_administration.pdf Download
Aug 4, 2017 1025 Caldwell, An Introduction to Drug Disposition: The Basic Principles of Absorption, Distribution, Metabolism, and Excretion, 23 Toxicologic Pathology 102 (1995) Download
Aug 4, 2017 1060 Howell, Fulvestrant Revisited: Efficacy and Safety of the 500-mg Dose, 11 CLINICAL BREAST CANCER 204-10 (2011) Download
Aug 4, 2017 1006 Prosecution History for U.S. Patent No. 6,774,122 Download
Aug 4, 2017 1031 Wakeling et al., A Potent Specific Pure Antiestrogen with Clinical Potential, 51 CANCER RESEARCH 3867-3873 (1991) Download
Aug 4, 2017 1065 Gusterson, Do we now have a relevant animal model for breast cancer? 1 BREAST CANCER RESEARCH 2-4 (1999) Download
Aug 4, 2017 1002 RESERVED Download
Aug 4, 2017 1028 Mager, Scaling Pharmacodynamics from In Vitro and Preclinical Animal Studies to Humans, DRUG METAB. PHARMACOKINET. (2009) Download
Aug 4, 2017 1018 DeLuca, Formulation of Small Volume Parenterals, PHARMACEUTICAL DOSAGE FORMS: PARENTERAL MEDICATIONS VOLUME 1 (Avis ed., 2d ed. 1992) Download
Aug 4, 2017 1047 U.S. Patent No. 5,183,814 Download
Aug 4, 2017 1034 Finley, New Drug Being Tested in Breast Cancer Study, SAN ANTONIO EXPRESS-NEWS, Sept. 20, 1997 Download
Aug 4, 2017 1053 Nicholson, "Pure Antioestrogens in Breast Cancer: Experimental and Clinical Observations," Sex Hormones and Antihormones in Endocrine Dependent Pathology: Basic and Clinical Aspects, Proceedings of an International Symposium, Milano 347-60 (1994) Download
Aug 4, 2017 1016 U.S. Patent No. 4,659,516 Download
Aug 4, 2017 1050 Buzdar, Update on Endocrine Therapy for Breast Cancer, 4 CLINICAL CANCER RESEARCH 527-34 (1998) Download
Aug 4, 2017 1032 Nicholson, R.I. et al., Responses To Pure Antiestrogens (ICI 164384, ICI 82780) In Estrogen-Sensitive And - Resistant Experimental And Clinical Breast Cancer, ANNALS OF THE NEW YORK ACADEMY OF SCIENCES, Vol. 61:148-163 (1995) Download
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