IPR2019-00459 - Csl Behring GMBH v. Shire ViroPharma IncReport Error
Details
PATENT NUMBER
APPL. NUMBER
15837677
STATUS
Not Instituted - Procedural § 325(d)
FILING DATE
2018-12-21
INSTITUTION DATE
2019-07-02
TERMINATION DATE
2019-07-02
AUTHOR JUDGE
Timeline
Petition
Notice of Filing Date
Preliminary Response
Institution Decision
Dec
2019
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
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Nov
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2020
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Docket
| 1 | 2018-12-21 | Petitioner | Power of Attorney | Petitioner, CSL Behring GmbH's, Power of Attorney |
| 2 | 2018-12-21 | Petitioner | Power of Attorney | Petitioner, CSL Behring LLC's, Power of Attorney |
| 3 | 2018-12-21 | Petitioner | Petition | Petition for Inter Partes Review |
| 1001 | 2018-12-21 | Petitioner | CSL Exhibit 1001 | |
| 1002 | 2018-12-21 | Petitioner | CSL Exhibit 1002 | |
| 1003 | 2018-12-21 | Petitioner | CSL Exhibit 1003 | |
| 1004 | 2018-12-21 | Petitioner | CSL Exhibit 1004 | |
| 1005 | 2018-12-21 | Petitioner | CSL Exhibit 1005 | |
| 1006 | 2018-12-21 | Petitioner | CSL Exhibit 1006 | |
| 1007 | 2018-12-21 | Petitioner | CSL Exhibit 1007 | |
| 1008 | 2018-12-21 | Petitioner | CSL Exhibit 1008 | |
| 1009 | 2018-12-21 | Petitioner | CSL Exhibit 1009 | |
| 1010 | 2018-12-21 | Petitioner | CSL Exhibit 1010 | |
| 1011 | 2018-12-21 | Petitioner | CSL Exhibit 1011 | |
| 1012 | 2018-12-21 | Petitioner | CSL Exhibit 1012 | |
| 1013 | 2018-12-21 | Petitioner | CSL Exhibit 1013 | |
| 1014 | 2018-12-21 | Petitioner | CSL Exhibit 1014 | |
| 1015 | 2018-12-21 | Petitioner | CSL Exhibit 1015 | |
| 1016 | 2018-12-21 | Petitioner | CSL Exhibit 1016 | |
| 1017 | 2018-12-21 | Petitioner | CSL Exhibit 1017 | |
| 1018 | 2018-12-21 | Petitioner | CSL Exhibit 1018 | |
| 1019 | 2018-12-21 | Petitioner | CSL Exhibit 1019 | |
| 1020 | 2018-12-21 | Petitioner | CSL Exhibit 1020 | |
| 1021 | 2018-12-21 | Petitioner | CSL Exhibit 1021 | |
| 1022 | 2018-12-21 | Petitioner | CSL Exhibit 1022 | |
| 1023 | 2018-12-21 | Petitioner | CSL Exhibit 1023 | |
| 1024 | 2018-12-21 | Petitioner | CSL Exhibit 1024 | |
| 1025 | 2018-12-21 | Petitioner | CSL Exhibit 1025 | |
| 1026 | 2018-12-21 | Petitioner | CSL Exhibit 1026 | |
| 1027 | 2018-12-21 | Petitioner | CSL Exhibit 1027 | |
| 1028 | 2018-12-21 | Petitioner | CSL Exhibit 1028 | |
| 1029 | 2018-12-21 | Petitioner | CSL Exhibit 1029 | |
| 1030 | 2018-12-21 | Petitioner | CSL Exhibit 1030 | |
| 1031 | 2018-12-21 | Petitioner | CSL Exhibit 1031 | |
| 1032 | 2018-12-21 | Petitioner | CSL Exhibit 1032 | |
| 1033 | 2018-12-21 | Petitioner | CSL Exhibit 1033 | |
| 1034 | 2018-12-21 | Petitioner | CSL Exhibit 1034 | |
| 1035 | 2018-12-21 | Petitioner | CSL Exhibit 1035 | |
| 1036 | 2018-12-21 | Petitioner | CSL Exhibit 1036 | |
| 1037 | 2018-12-21 | Petitioner | CSL Exhibit 1037 | |
| 1038 | 2018-12-21 | Petitioner | CSL Exhibit 1038 | |
| 1039 | 2018-12-21 | Petitioner | CSL Exhibit 1039 | |
| 1040 | 2018-12-21 | Petitioner | CSL Exhibit 1040 | |
| 1041 | 2018-12-21 | Petitioner | CSL Exhibit 1041 | |
| 1042 | 2018-12-21 | Petitioner | CSL Exhibit 1042 | |
| 1043 | 2018-12-21 | Petitioner | CSL Exhibit 1043 | |
| 1044 | 2018-12-21 | Petitioner | CSL Exhibit 1044 | |
| 1045 | 2018-12-21 | Petitioner | CSL Exhibit 1045 | |
| 1046 | 2018-12-21 | Petitioner | CSL Exhibit 1046 | |
| 1047 | 2018-12-21 | Petitioner | CSL Exhibit 1047 | |
| 1048 | 2018-12-21 | Petitioner | CSL Exhibit 1048 | |
| 1049 | 2018-12-21 | Petitioner | CSL Exhibit 1049 | |
| 1050 | 2018-12-21 | Petitioner | CSL Exhibit 1050 | |
| 1051 | 2018-12-21 | Petitioner | CSL Exhibit 1051 | |
| 1052 | 2018-12-21 | Petitioner | CSL Exhibit 1052 | |
| 1053 | 2018-12-21 | Petitioner | CSL Exhibit 1053 | |
| 1054 | 2018-12-21 | Petitioner | CSL Exhibit 1054 | |
| 1055 | 2018-12-21 | Petitioner | CSL Exhibit 1055 | |
| 1056 | 2018-12-21 | Petitioner | CSL Exhibit 1056 | |
| 1057 | 2018-12-21 | Petitioner | CSL Exhibit 1057 | |
| 1058 | 2018-12-21 | Petitioner | CSL Exhibit 1058 | |
| 1059 | 2018-12-21 | Petitioner | CSL Exhibit 1059 | |
| 1060 | 2018-12-21 | Petitioner | CSL Exhibit 1060 | |
| 1061 | 2018-12-21 | Petitioner | CSL Exhibit 1061 | |
| 1062 | 2018-12-21 | Petitioner | CSL Exhibit 1062 | |
| 1063 | 2018-12-21 | Petitioner | CSL Exhibit 1063 | |
| 1064 | 2018-12-21 | Petitioner | CSL Exhibit 1064 | |
| 1065 | 2018-12-21 | Petitioner | CSL Exhibit 1065 | |
| 1066 | 2018-12-21 | Petitioner | CSL Exhibit 1066 | |
| 1067 | 2018-12-21 | Petitioner | CSL Exhibit 1067 | |
| 1068 | 2018-12-21 | Petitioner | CSL Exhibit 1068 | |
| 1069 | 2018-12-21 | Petitioner | CSL Exhibit 1069 | |
| 1070 | 2018-12-21 | Petitioner | CSL Exhibit 1070 | |
| 1071 | 2018-12-21 | Petitioner | CSL Exhibit 1071 | |
| 1072 | 2018-12-21 | Petitioner | CSL Exhibit 1072 | |
| 1073 | 2018-12-21 | Petitioner | CSL Exhibit 1073 | |
| 1074 | 2018-12-21 | Petitioner | CSL Exhibit 1074 | |
| 1075 | 2018-12-21 | Petitioner | CSL Exhibit 1075 | |
| 1076 | 2018-12-21 | Petitioner | CSL Exhibit 1076 | |
| 1077 | 2018-12-21 | Petitioner | CSL Exhibit 1077 | |
| 1078 | 2018-12-21 | Petitioner | CSL Exhibit 1078 | |
| 1079 | 2018-12-21 | Petitioner | CSL Exhibit 1079 | |
| 1080 | 2018-12-21 | Petitioner | CSL Exhibit 1080 | |
| 1081 | 2018-12-21 | Petitioner | CSL Exhibit 1081 | |
| 1082 | 2018-12-21 | Petitioner | CSL Exhibit 1082 | |
| 1083 | 2018-12-21 | Petitioner | CSL Exhibit 1083 | |
| 1084 | 2018-12-21 | Petitioner | CSL Exhibit 1084 | |
| 1085 | 2018-12-21 | Petitioner | CSL Exhibit 1085 | |
| 1086 | 2018-12-21 | Petitioner | CSL Exhibit 1086 | |
| 1087 | 2018-12-21 | Petitioner | CSL Exhibit 1087 | |
| 1088 | 2018-12-21 | Petitioner | CSL Exhibit 1088 | |
| 1089 | 2018-12-21 | Petitioner | CSL Exhibit 1089 | |
| 1090 | 2018-12-21 | Petitioner | CSL Exhibit 1090 | |
| 1091 | 2018-12-21 | Petitioner | CSL Exhibit 1091 | |
| 1092 | 2018-12-21 | Petitioner | CSL Exhibit 1092 | |
| 1093 | 2018-12-21 | Petitioner | CSL Exhibit 1093 | |
| 1094 | 2018-12-21 | Petitioner | CSL Exhibit 1094 | |
| 1095 | 2018-12-21 | Petitioner | CSL Exhibit 1095 | |
| 1096 | 2018-12-21 | Petitioner | CSL Exhibit 1096 | |
| 1097 | 2018-12-21 | Petitioner | CSL Exhibit 1097 | |
| 1098 | 2018-12-21 | Petitioner | CSL Exhibit 1098 | |
| 1099 | 2018-12-21 | Petitioner | CSL Exhibit 1099 | |
| 1100 | 2018-12-21 | Petitioner | CSL Exhibit 1100 | |
| 1101 | 2018-12-21 | Petitioner | CSL Exhibit 1101 | |
| 1102 | 2018-12-21 | Petitioner | CSL Exhibit 1102 | |
| 1103 | 2018-12-21 | Petitioner | CSL Exhibit 1103 | |
| 1104 | 2018-12-21 | Petitioner | CSL Exhibit 1104 | |
| 4 | 2019-01-09 | Board | Notice of Filing Date | Notice of Accord Filing Date |
| 5 | 2019-01-11 | Potential Patent Owner | Mandatory Notice | PATENT OWNER¿¿¿S MANDATORY NOTICES PURSUANT TO 37 C.F.R. ¿¿ 42.8(A)(2) |
| 6 | 2019-01-11 | Potential Patent Owner | Power of Attorney | Patent Owner's Power of Attorney |
| 7 | 2019-04-09 | Potential Patent Owner | Preliminary Response | PATENT OWNER¿¿¿S PRELIMINARY RESPONSE |
| 2001 | 2019-04-09 | Potential Patent Owner | Certified file history for 14/855,168 Part 10 of 14 | |
| 2002 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2002 - U.S. Patent 9,616,111 | |
| 2003 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2003 - CSL Behring GmbH v. Shire ViroPharma Inc., IPR2017-01512, Paper 1 (PTAB May 31, 2017) | |
| 2004 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2004 Part 1 of 37 - Certified File History of U.S. Patent No. 10,080,788 | |
| 2005 | 2019-04-09 | Potential Patent Owner | International Patent Application Publication No. WO 2016/131958 | |
| 2006 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2006 - Anas M. Fathallah et al., Anatomical, Physiological and Experimental Factors Affecting the Bioavailability of SC Administered Large Biotherapeutics, 104(2) J. PHARM. SCI. 301 (2015) | |
| 2007 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2007 - Danielle N. McLennan et al., Subcutaneous Drug Delivery and the Role of the Lymphatics, 2(1) DRUG DISCOVERY TODAY: TECHN. 89 (2005) | |
| 2008 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2008 - Order (DI 132), Shire ViroPharma Inc. v. CSL Behring LLC and CSL Behring GmbH, C.A. No 17-414 (MSG) (Consolidated) (D. Del. Jan. 31, 2019) | |
| 2009 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2009 - AM. ACAD. OF ALLERGY, ASTHMA & IMMUNOLOGY, FINAL PROGRAM 2012 ANNUAL MEETING (2012) | |
| 2010 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2010 Part 1 of 4 - CSL Behring LLC, Self Administration Training Video, HAEGARDA,https://www.haegarda.com/dosing-instructions (last visited Apr. 4, 2019) | |
| 2011 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2011 - J. Kasper, G. Winter and W. Friess, Recent Advances and Further Challenges in Lyophilization in EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS 85, 162 (2013) | |
| 2012 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2012 Part 1 of 10 - 129(2) J. ALLERGY & CLIN. IMMUNOL. (SUPPLEMENT) (Feb. 2012) | |
| 2013 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2013 - John F. Carpenter et al., Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps that May Compromise Product Quality, 98(4) J. PHARM. SCI. 1201 (2009) | |
| 2014 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2014 - Affidavit of Translator Szymon Wiktorowicz with English Translation of Ex. 2015 | |
| 2015 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2015 - Zietkiewicz et. al., In Vivo Studies on the Action on the Tissue of the Osmolality of Parenterally Administered Drugs, 23 GRZYBY DROZDZOPODOBNE 869 (1971) | |
| 2016 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2016 - A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration, CLINICALTRIALS.GOV, (last visited 03/12/2019),https://clinicaltrials.gov/ct2/show/results/NCT01095497?view=results | |
| 2017 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2017 - Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase, CLINICALTRIALS.GOV, (last visited 03/12/2019), https://clinicaltrials.gov/ct2/show/results/NCT01426763 | |
| 2018 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2018 - IPR-1512 Ex. 1012 (Declaration of Dr. Timothy Craig) | |
| 2019 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2019 - IPR-1512 Ex. 1013 (Declaration of Dr. Thomas Machnig and Hanno Waldhauser) | |
| 2020 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2020 - IPR-1512 Ex. 1014 (Declaration of Dr. Hubert Metzner) | |
| 2021 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2021 - IPR-1512 Ex. 1015 (Declaration of Dr. Christopher J. Roberts) | |
| 2022 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2022 - Michael J. Akers and Michael R. DeFelippis, Peptides and Proteins as Parenteral Solutions, in PHARMACEUTICAL FORMULATION DEVELOPMENT OF PEPTIDES AND PROTEINS, 149, 151 (Lars Hovgaard et al., ed.2, 2013) | |
| 2023 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2023 - Richard J. Duma et al., Parenteral Drug Administration: Routes, Precautions, Problems, Complications, and Drug Delivery Systems, | |
| 2024 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2024 - Kang & Raymond C. Stevens, Structural Aspects of Therapeutic Enzymes to Treat Metabolic Disorders, 30(12) HUMAN MUTATION 1591 (2009) | |
| 2025 | 2019-04-09 | Potential Patent Owner | Shire Exhibit 2025 - Tapan K. Das, Protein Particulate Detection Issues in Biotherapeutics Development¿¿¿Current Status, 13(2) AAPS PHARMSCITECH 732 (2012) | |
| 8 | 2019-07-02 | Board | Institution Decision | Trial Instituted Document |
| 9 | 2019-11-12 | Petitioner | Other | Petitioners' Request for Refund of Post-Institution Fees |
| 10 | 2019-11-26 | Board | Other | Notice of Refund |
Grounds Asserted