Case number IPR2017-01913
Fresenius Kabi USA, LLC v. AstraZeneca AB > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Feb 1, 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 17, 2017 | 2167 | Burgess Amneal Declaration Download | |
| Nov 17, 2017 | 2172 | FDA Guidance 1999 Download | |
| Nov 17, 2017 | 2160 | Huynh 1993 Download | |
| Nov 17, 2017 | 2171 | Shapiro 1965 Download | |
| Nov 17, 2017 | 2164 | Sibonga 1998 Download | |
| Nov 17, 2017 | 2159 | Martel 1998 Download | |
| Nov 17, 2017 | 2168 | D'Agostino 1990 Download | |
| Nov 17, 2017 | 8 | Patent Owner's Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 8,329,680 Download | |
| Nov 17, 2017 | 2161 | Chatterjee 1993 Download | |
| Nov 17, 2017 | 2173 | InnoPharma Decision Download | |
| Nov 17, 2017 | 2175 | PTAB Order Download | |
| Nov 17, 2017 | 2166 | Oleksowicz Mylan Declaration Download | |
| Nov 17, 2017 | 2165 | Al-Matubsi 1998 Download | |
| Nov 17, 2017 | 2158 | Strickley II 2000 Download | |
| Nov 17, 2017 | 2174 | InnoPharma Petition Download | |
| Nov 17, 2017 | 2162 | Applied Biopharmaceutics 1999 Download | |
| Nov 17, 2017 | 2170 | Rowland Ch. 13 Download | |
| Nov 17, 2017 | 2169 | PDR 1999 Inderal LA Download | |
| Nov 17, 2017 | 2163 | Dipippo 1997 Download | |
| Nov 17, 2017 | 2096 | Ansel Ch. 12 Download | |
| Nov 17, 2017 | 2098 | Aulton Ch. 18 Download | |
| Nov 17, 2017 | 2129 | Eagle 1949 Download | |
| Nov 17, 2017 | 2104 | Aulton Ch. 6 Download | |
| Nov 17, 2017 | 2024 | Hortobagyi New Eng. J. Med. 1998 Download | |
| Nov 17, 2017 | 2156 | Stenger 2017 Download | |
| Nov 17, 2017 | 2047 | Rauschning 1994 Download | |
| Nov 17, 2017 | 2093 | Remington's Ch. 89 Download | |
| Nov 17, 2017 | 2001 | Illum Declaration Download | |
| Nov 17, 2017 | 2059 | Vergote 2003 Download | |
| Nov 17, 2017 | 2132 | Remington's Ch. 9 Download | |
| Nov 17, 2017 | 2154 | Robertson 2016 Download | |
| Nov 17, 2017 | 2028 | Howell 2002 Download | |
| Nov 17, 2017 | 2117 | Greenblatt 1978 Download | |
| Nov 17, 2017 | 2099 | Aulton Ch. 19 Download | |
| Nov 17, 2017 | 2070 | Stenbygaard 1993 Download | |
| Nov 17, 2017 | 2126 | PDR 1999 Arimidex Download | |
| Nov 17, 2017 | 2140 | Buzdar 2001 Download | |
| Nov 17, 2017 | 2046 | PDR 1999 Femara Download | |
| Nov 17, 2017 | 2089 | Vidal 1999 Download | |
| Nov 17, 2017 | 2066 | Pharma Marketletter 2004 Download | |
| Nov 17, 2017 | 2036 | Robertson 1999 Download | |
| Nov 17, 2017 | 2144 | Bonneterre 1985 Download | |
| Nov 17, 2017 | 2031 | Robertson Clin. Ther. 2003 Download | |
| Nov 17, 2017 | 2149 | Abrams 1990 Download | |
| Nov 17, 2017 | 2065 | Johnston 2004 Download | |
| Nov 17, 2017 | 2061 | Bellmunt 1991 Download | |
| Nov 17, 2017 | 2121 | Lavy 1999 Download | |
| Nov 17, 2017 | 2131 | Yarinsky 1970 Download | |
| Nov 17, 2017 | 2062 | Chia 2008 Download | |
| Nov 17, 2017 | 2147 | Koyama 1999 Download | |
| Nov 17, 2017 | 2072 | Barrios 2012 Download | |
| Nov 17, 2017 | 2134 | Lachman's 1986 Download | |
| Nov 17, 2017 | 2150 | Abrams 1999 Download | |
| Nov 17, 2017 | 2097 | Ansel Ch. 13 Download | |
| Nov 17, 2017 | 2108 | Buzdar ASCO 2001 Download | |
| Nov 17, 2017 | 2105 | Porras 1999 Download | |
| Nov 17, 2017 | 2053 | Fallowfield 2006 Download | |
| Nov 17, 2017 | 2064 | Robertson 2005 Download | |
| Nov 17, 2017 | 2094 | Aulton Ch. 13 Download | |
| Nov 17, 2017 | 2005 | Di Leo 2014 Download | |
| Nov 17, 2017 | 2073 | Robertson Eur. J. Cancer 2005 Download | |
| Nov 17, 2017 | 2045 | PDR 1999 Nolvadex Download | |
| Nov 17, 2017 | 2085 | Buzdar 1994 Download | |
| Nov 17, 2017 | 2013 | Johnston 1997 Download | |
| Nov 17, 2017 | 2023 | Grese 1998 Download | |
| Nov 17, 2017 | 2101 | Merck Index 1996 Download | |
| Nov 17, 2017 | 2044 | Innovative Research Download | |
| Nov 17, 2017 | 2002 | Robertson Declaration Download | |
| Nov 17, 2017 | 2008 | Greenlee 2000 Download | |
| Nov 17, 2017 | 2050 | Bratherton 1984 Download | |
| Nov 17, 2017 | 2151 | Jonat 2013 Download | |
| Nov 17, 2017 | 2130 | Levine 1966 Download | |
| Nov 17, 2017 | 2135 | Illum Mylan Declaration Download | |
| Nov 17, 2017 | 2004 | Di Leo 2010 Download | |
| Nov 17, 2017 | 2095 | Ansel Ch. 7 Download | |
| Nov 17, 2017 | 2074 | Clinical Practice Guidelines 2003 Download | |
| Nov 17, 2017 | 2026 | Kelloff 1998 Download | |
| Nov 17, 2017 | 2025 | Masamura 1994 Download | |
| Nov 17, 2017 | 2016 | Howell 1992 Download | |
| Nov 17, 2017 | 2092 | Forrest Mylan Declaration Download | |
| Nov 17, 2017 | 2137 | Buzdar 1997 Download | |
| Nov 17, 2017 | 2040 | Howell 1997 Download | |
| Nov 17, 2017 | 2003 | Sawchuk Declaration Download | |
| Nov 17, 2017 | 2138 | Jonat 1996 Download | |
| Nov 17, 2017 | 2037 | Hortobagyi 1997 Download | |
| Nov 17, 2017 | 2118 | Litchfield 1961 Download | |
| Nov 17, 2017 | 2103 | Avis Ch. 4 Download | |
| Nov 17, 2017 | 2139 | Dombernowsky 1998 Download | |
| Nov 17, 2017 | 2006 | Ohno 2010 Download | |
| Nov 17, 2017 | 2115 | Ballard 1968 Download | |
| Nov 17, 2017 | 2027 | Dukes 1994 Download | |
| Nov 17, 2017 | 2043 | McLeskey Declaration Download | |
| Nov 17, 2017 | 2127 | PDR 1999 Estrace Download | |
| Nov 17, 2017 | 2107 | Avis Ch. 2 Download | |
| Nov 17, 2017 | 2054 | Beyea 1996 Download | |
| Nov 17, 2017 | 2057 | Robertson SABCS 2014 Download | |
| Nov 17, 2017 | 2068 | Baumann 1998 Download | |
| Nov 17, 2017 | 2038 | Dowsett 1995 Download | |
| Nov 17, 2017 | 2146 | Rose 1985 Download | |
| Nov 17, 2017 | 2035 | Hortobagyi 1998 Download | |
| Nov 17, 2017 | 2055 | Robertson 2009 Download | |
| Nov 17, 2017 | 2033 | Van de Velde 1996 Download | |
| Nov 17, 2017 | 2106 | Ansel Ch. 14 Download | |
| Nov 17, 2017 | 2034 | Labrie 1999 Download | |
| Nov 17, 2017 | 2078 | Buzdar 2006 Download | |
| Nov 17, 2017 | 2051 | Cohen 1995 Download | |
| Nov 17, 2017 | 2090 | Vidal 1997 Download | |
| Nov 17, 2017 | 2083 | Buzdar 2002 Download | |
| Nov 17, 2017 | 2114 | Zuidema 1994 Download | |
| Nov 17, 2017 | 2119 | Buzdar 1996 Download | |
| Nov 17, 2017 | 2113 | Avis Ch. 3 Download | |
| Nov 17, 2017 | 2100 | Gao 1998 Download | |
| Nov 17, 2017 | 2048 | Thomas 1993 Download | |
| Nov 17, 2017 | 2116 | Hirano 1981 Download | |
| Nov 17, 2017 | 2075 | Vergote 2006 Download | |
| Nov 17, 2017 | 2152 | Goss 1986 Download | |
| Nov 17, 2017 | 2030 | Robertson 2001 Download | |
| Nov 17, 2017 | 2112 | Strickley I 1999 Download | |
| Nov 17, 2017 | 2060 | Robertson 2004 Download | |
| Nov 17, 2017 | 2080 | Remington's Ch. 91 Download | |
| Nov 17, 2017 | 2076 | Agrawal 2009 Download | |
| Nov 17, 2017 | 2120 | Lifschitz 1999 Download | |
| Nov 17, 2017 | 2124 | Huber 1965 Download | |
| Nov 17, 2017 | 2017 | Jordan 1995 Download | |
| Nov 17, 2017 | 2067 | Cancer Weekly April 2004 Download | |
| Nov 17, 2017 | 2109 | Wade 1993 Download | |
| Nov 17, 2017 | 2056 | Robertson 2012 Download | |
| Nov 17, 2017 | 2019 | Wiebe 1993 Download | |
| Nov 17, 2017 | 2069 | Pyrhonen 1994 Download | |
| Nov 17, 2017 | 2141 | Dowsett Clin. Cancer Res. 1995 Download | |
| Nov 17, 2017 | 2077 | Kuter 2012 Download | |
| Nov 17, 2017 | 2086 | Groves Ch. 2 Download | |
| Nov 17, 2017 | 2052 | Sweetana 1996 Download | |
| Nov 17, 2017 | 2123 | Gupta Ch. 17 Download | |
| Nov 17, 2017 | 2010 | Fornier 1999 Download | |
| Nov 17, 2017 | 2155 | Cristofanilli 2016 Download | |
| Nov 17, 2017 | 2087 | Gupta Ch. 1 Download | |
| Nov 17, 2017 | 2102 | Ansel Ch. 10 Download | |
| Nov 17, 2017 | 2071 | Robertson 2014 Download | |
| Nov 17, 2017 | 2039 | Hayes 1995 Download | |
| Nov 17, 2017 | 2032 | Labrie 2004 Download | |
| Nov 17, 2017 | 2058 | Ellis 2015 Download | |
| Nov 17, 2017 | 2136 | Robertson Mylan Declaration Download | |
| Nov 17, 2017 | 2041 | Haarstad 1992 Download | |
| Nov 17, 2017 | 2145 | Hortobagyi 1985 Download | |
| Nov 17, 2017 | 2063 | Johnston 2013 Download | |
| Nov 17, 2017 | 2079 | Gupta Ch. 2 Download | |
| Nov 17, 2017 | 2011 | Jordan Supp. 1995 Download | |
| Nov 17, 2017 | 2133 | Sawchuk Mylan Declaration Download | |
| Nov 17, 2017 | 2148 | Muss 1990 Download | |
| Nov 17, 2017 | 2009 | Robertson 1996 Download | |
| Nov 17, 2017 | 2125 | Affidavit of Internet Archive Download | |
| Nov 17, 2017 | 2018 | Morrow 1993 Download | |
| Nov 17, 2017 | 2029 | Osborne 2002 Download | |
| Nov 17, 2017 | 2153 | Dowsett 1989 Download | |
| Nov 17, 2017 | 2042 | AACR Journals Online Download | |
| Nov 17, 2017 | 2111 | Buzdar 2003 Download | |
| Nov 17, 2017 | 2091 | ABPI 1999-2000 Download | |
| Nov 17, 2017 | 2082 | Aulton Ch. 1 Download | |
| Nov 17, 2017 | 2049 | July 14 Trial Tr. Download | |
| Nov 17, 2017 | 2007 | Pritchard 2010 Download | |
| Nov 17, 2017 | 2143 | Hoffken 1992 Download | |
| Nov 17, 2017 | 2012 | Hortobagyi Cancer Investigation 1998 Download | |
| Nov 17, 2017 | 2022 | Minton 1999 Download | |
| Nov 17, 2017 | 2088 | Baselga 2003 Download | |
| Nov 17, 2017 | 2157 | Wright Ch. 4 Download | |
| Nov 17, 2017 | 2142 | Goss 1998 Download | |
| Nov 17, 2017 | 2081 | Remington's Ch. 75 Download | |
| Nov 17, 2017 | 2021 | Jordan 1992 Download | |
| Nov 17, 2017 | 2128 | Skougaard 1966 Download | |
| Nov 17, 2017 | 2122 | Chu 1960 Download | |
| Nov 17, 2017 | 2020 | Jordan Supp. 1992 Download | |
| Nov 17, 2017 | 2015 | Buzdar Clin. Oncol. 1998 Download | |
| Nov 17, 2017 | 2110 | Lundeen 1997 Download | |
| Nov 17, 2017 | 2084 | Remington's Ch. 84 Download | |
| Nov 17, 2017 | 2014 | Pritchard 1997 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 | 5 | Patent Owner's Power of Attorney Pursuant to 37 C.F.R. 42.10(b) Download | |
| Aug 25, 2017 | 6 | Patent Owner's Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download | |
| Aug 17, 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 | 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 | 1106 | Remington's Pharmaceutical Sciences 1538-39, 1545-50, 1686-88 (18th ed. 1990) 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 | 1113 | USP 23 - NF 18, The United States Pharmacopeia - The National Formulary 13-14 (1995) Download | |
| Aug 4, 2017 | 1099 | Ford, "Parenteral Products," Pharmaceutics: The Science of Dosage Form Design 359-80 (Aulton ed., 1988) 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 | 1068 | Mackey, Tolerability of Intramuscular Injections of Testosterone Ester in Oil Vehicle, 10 HUMAN REPRODUCTION 862-65 (1995) 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 | 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 | 1094 | Tse, Bioavailability of Parenteral Drugs I. Intravenous and Intramuscular Doses, 34 J. PARENTERAL DRUG ASSOCIATION 409-21 (1980) 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 | 2 | PETITIONER FRESENIUS KABI'S POWER OF ATTORNEY U.S. PATENT NO. 8,329,680 Download | |
| Aug 4, 2017 | 1076 | Kohler 1992 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 | 1102 | Nema, Excipients and Their Use in Injectable Products, 51 PDA J. PHARM. SCI. & TECH. 166-71 (1997) 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 | 1087 | Copy of Prosecution History for the U.S. Patent No. 8,466,139 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 | 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 | 1089 | Chwalisz, Modulation of Oestrogenic Effects by Progesterone Antagonists in the Rat Uterus, 4 HUMAN REPRODUCTION UPDATE 570-83 (1998) 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 | 1095 | Licciardi, Oral Versus Intramuscular Progesterone for In Vitro Fertilization: A Prospective Randomized Study, 71 FERTILITY & STERILITY 614-18 (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 | 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 | 1079 | Handbook of Pharmaceutical Excipients (Wade ed., 2d. ed. 1994) 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 | 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 | 1097 | Balant-Gorgia, Pharmacokinetic Optimisation of the Treatment of Psychosis, 25 CLIN. PHARMACOKINET. 217-36 (1993) Download | |
| Aug 4, 2017 | 1090 | Robertson, Fulvestrant (Faslodex) - How to Make a Good Drug Better, 12 ONCOLOGIST 774-84 (2007) Download | |
| Aug 4, 2017 | 1081 | Drugs@FDA Glossary of Terms, U.S. FOOD & DRUG ADMINISTRATION (last updated Feb. 2, 2012) Download | |
| Aug 4, 2017 | 1093 | Altman, Standard Deviations and Standard Errors, 331 BMJ 903 (2005) Download | |
| Aug 4, 2017 | 1080 | FDA's Inactive Ingredient Database (1996) 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 | 1082 | Adam, "Pharmacokinetics of Agents in Relation to Response," Endocrine Management of Cancer: Biological Bases 112-24 (1988) Download | |
| Aug 4, 2017 | 1071 | Smith, Analysis of Oil-Based Pharmaceuticals, 49 J. AMERICAN OIL CHEMISTS SOCIETY 409-13 (1972) 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 | 1072 | Spiegel & Noseworthy, Use of Nonaqueous Solvents in Parenteral Products, 52 J. PHARM. SCIS. 917-27 (1963) 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 | 1112 | U.S. Patent No. 4,212,863 Download | |
| Aug 4, 2017 | 1078 | Petition for Inter Partes Review in Mylan Pharms. Inc. v. AstraZeneca AB, Paper No. 2, IPR2016-01325 (P.T.A.B. June 29, 2016) 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 | 1067 | Waynforth, LASA Good Practice Guidelines: Administration of Substances (Rat, Mouse, Guinea Pig, Rabbit) (Oct. 1998) 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 | 1075 | Robertson, J.F.R. et al., (1999) Download | |
| Aug 4, 2017 | 1104 | Oldham, "Mass Transport to Electrodes," Chemical Kinetics 79-143 (Bamford ed., 1986) 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 | 1096 | August 21, 2008 Applicant Amendment and Response in Application No. 10/872,784 Download | |
| Aug 4, 2017 | 1109 | Simmons, The Laboratory Mouse: Selection and Management 127-28 (1970) 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 | 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 | 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 | 1049 | Anderson, Models of New Antioestrogen Action in Vivo: Primary Tumours, 5 THE BREAST 186-91 (1996) 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 | 1028 | Mager, Scaling Pharmacodynamics from In Vitro and Preclinical Animal Studies to Humans, DRUG METAB. PHARMACOKINET. (2009) 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 | 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 | 1059 | Selective Estrogen Receptor Modulators (SERMs), BREASTCANCER.ORG (last modified Nov. 5, 2015) Download | |
| Aug 4, 2017 | 1003 | Exhibit Reserved Download | |
| Aug 4, 2017 | 1047 | U.S. Patent No. 5,183,814 Download | |
| Aug 4, 2017 | 1014 | Declaration of Dorraya El-Ashry, Ph.D. and Accompanying Exhibits 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 | 1024 | Tozer, Introduction to Pharmacokinetics and Pharmacodynamics: The Quantitative Basis of Drug Therapy (2006) 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 | 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 | 1033 | Riffkin, Castor Oil as a Vehicle for Parenteral Administration of Steroid Hormones, 53 J. PHARM. SCI. 891-895 (1964) Download | |
| Aug 4, 2017 | 1002 | Exhibit Reserved Download | |
| Aug 4, 2017 | 1054 | Santen, Use of Aromatase Inhibitors in Breast Carcinoma, 6 ENDOCRINE-RELATED CANCER 75-92 (1999) 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. NAT'L CANCER INST. 1552-1558 (1998) 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 | 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 | 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 | 1050 | Buzdar, Update on Endocrine Therapy for Breast Cancer, 4 CLINICAL CANCER RESEARCH 527-34 (1998) 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 | 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 | 1004 | Exhibit Reserved 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 | 1030 | White, Pharmacokinetic and Pharmacodynamic Considerations in Antimalarial Dose Optimization, 57 ANTIMICROBIAL AGENTS & CHEMOTHERAPY 5802 (2013) 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. NAT'L CANCER INST. 746-750 (1995) 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 | |
| Aug 4, 2017 | 1055 | EP 0 346 014 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 | 1037 | WO 03/006064 Download | |
| Aug 4, 2017 | 1021 | Faslodex Label Download | |
| Aug 4, 2017 | 1013 | Declaration of Richard Bergstrom, Ph.D. and Accompanying Exhibits 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 | 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 | 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 | 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 | 1042 | Copy of Prosecution History for U.S. Patent No. 8,329,680 (downloaded from PAIR) Download | |
| Aug 4, 2017 | 1016 | U.S. Patent No. 4,659,516 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 | 1060 | Howell, Fulvestrant Revisited: Efficacy and Safety of the 500-mg Dose, 11 CLINICAL BREAST CANCER 204-10 (2011) Download | |
| Aug 4, 2017 | 1029 | Colburn, Simultaneous Pharmacokinetic/Pharmacodynamic Modeling, PHARMACODYNAMICS AND DRUG DEVELOPMENT: PERSPECTIVES IN CLINICAL PHARMACOLOGY (1994) 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 | 1023 | Qiu, Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice (2009) 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 | 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 | 1063 | Equivalent Surface Area Dosage Conversion Factors (2007) 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 | 1010 | Order, AstraZeneca Pharms. LP v. Sandoz Inc., No. 14-03547 (D.N.J. July 29, 2015), ECF No. 102 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 | 1046 | Copy of Prosecution History for the U.S. Patent No. 7,456,160 Download | |
| Aug 4, 2017 | 1051 | Howell, New Endocrine Therapies for Breast Cancer, 32A EUR. J. CANCER 576-88 (1996) Download | |
| Aug 4, 2017 | 1 | PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,329,680 UNDER 35 U.S.C. 311-319 AND 37 C.F.R. 42.100 ET SEQ Download | |
| Aug 4, 2017 | 1027 | Derendorf, Handbook of Pharmacokinetic/Pharmacodynamic Correlation 53 (1995) 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 | 1026 | Wills, "Basic Pharmacodynamic Concepts and Models," Pharmacodynamics and Drug Development: Perspectives in Clinical Pharmacology (1994) 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 | 1064 | Clarke, Antiestrogen Resistance in Breast Cancer and the Role of Estrogen Receptor Signaling, 22 ONCOGENE 7316-39 (2003) Download | |
| Aug 4, 2017 | 1012 | Declaration of Diane Burgess, Ph.D. and Accompanying Exhibits Download | |
| Aug 4, 2017 | 1015 | Declaration of Adrian Harris, Ph.D. and Accompanying Exhibits Download | |
| Aug 4, 2017 | 1001 | U.S. Patent No. 8,329,680 Download | |
| Aug 4, 2017 | 1005 | Exhibit Reserved Download | |
| Aug 4, 2017 | 1006 | Copy of Prosecution History for U.S. Patent No. 6,774,122 Download | |
| Aug 4, 2017 | 1022 | DiPiro, Concepts in Clinical Pharmacokinetics (2010) Download |
