EP3294285 - CABAZITAXEL AND ITS USE FOR TREATING CANCER [Right-click to bookmark this link] | Status | Patent revoked Status updated on 16.12.2022 Database last updated on 25.09.2024 | |
Former | The patent has been granted Status updated on 15.11.2019 | ||
Former | Grant of patent is intended Status updated on 09.07.2019 | ||
Former | Request for examination was made Status updated on 16.02.2018 | ||
Former | The international publication has been made Status updated on 18.11.2016 | Most recent event Tooltip | 16.12.2022 | Revocation of patent | published on 18.01.2023 [2023/03] | Applicant(s) | For all designated states Sanofi Mature IP 54 rue la Boétie 75008 Paris / FR | [2019/40] |
Former [2018/12] | For all designated states Aventis Pharma S.A. 20, avenue Raymond Aron 92160 Antony / FR | Inventor(s) | 01 /
CHADJAA, Mustapha c/o Sanofi Patent Department 54 rue La Boétie 75008 Paris / FR | 02 /
DEDIEU, Jean-François c/o Sanofi Patent Department 54 rue La Boétie 75008 Paris / FR | 03 /
GUPTA, Sunil c/o Sanofi Patent Department 55 Corporate Drive Mail code 55A-505A Bridgewater, New Jersey 08807 / US | 04 /
SELLAMI, Dalila 1 Cedar Tree Lane Chester NJ 07930 / US | 05 /
SEMIOND, Dorothée c/o Sanofi Patent Department 55 Corporate Drive Mail Code 55A-505A, Bridgewater NJ 08807 / US | [2018/12] | Representative(s) | J A Kemp LLP 80 Turnmill Street London EC1M 5QU / GB | [N/P] |
Former [2019/51] | Sanofi 54, rue La Boétie 75008 Paris / FR | ||
Former [2018/12] | Quellari, Mylène Audrey Séverine, et al Sanofi Département Brevets 54, rue La Boétie 75008 Paris / FR | Application number, filing date | 16721844.5 | 12.05.2016 | [2018/12] | WO2016EP60759 | Priority number, date | EP20150305720 | 13.05.2015 Original published format: EP 15305720 | [2018/12] | Filing language | EN | Procedural language | EN | Publication | Type: | A1 Application with search report | No.: | WO2016180943 | Date: | 17.11.2016 | Language: | EN | [2016/46] | Type: | A1 Application with search report | No.: | EP3294285 | Date: | 21.03.2018 | Language: | EN | The application published by WIPO in one of the EPO official languages on 17.11.2016 takes the place of the publication of the European patent application. | [2018/12] | Type: | B1 Patent specification | No.: | EP3294285 | Date: | 18.12.2019 | Language: | EN | [2019/51] | Search report(s) | International search report - published on: | EP | 17.11.2016 | Classification | IPC: | A61K31/337, A61P35/00 | [2018/12] | CPC: |
A61K31/337 (EP,KR,US);
A61J1/00 (KR,US);
A61P1/16 (EP);
A61P13/08 (EP);
A61P35/00 (EP,KR);
A61J2205/30 (KR,US)
| Designated contracting states | AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR [2018/12] | Extension states | BA | Not yet paid | ME | Not yet paid | Validation states | MA | Not yet paid | MD | Not yet paid | Title | German: | CABAZITAXEL UND DESSEN VERWENDUNG ZUR BEHANDLUNG VON KREBS | [2018/12] | English: | CABAZITAXEL AND ITS USE FOR TREATING CANCER | [2018/12] | French: | CABAZITAXEL ET SON UTILISATION POUR LE TRAITEMENT DU CANCER | [2018/12] | Entry into regional phase | 13.12.2017 | National basic fee paid | 13.12.2017 | Designation fee(s) paid | 13.12.2017 | Examination fee paid | Examination procedure | 23.11.2017 | Date on which the examining division has become responsible | 13.12.2017 | Examination requested [2018/12] | 25.06.2018 | Amendment by applicant (claims and/or description) | 10.07.2019 | Communication of intention to grant the patent | 12.11.2019 | Fee for grant paid | 12.11.2019 | Fee for publishing/printing paid | 12.11.2019 | Receipt of the translation of the claim(s) | Divisional application(s) | EP19209255.9 / EP3643307 | Opposition(s) | Opponent(s) | 01
03.06.2020
28.09.2020
ADMISSIBLE Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Aera A/S, et al, et al Niels Hemmingsens Gade 10, 5th Floor 1153 Copenhagen K / DK | 02
09.06.2020
12.10.2021
WITHDRAWN Teva Pharmaceutical Industries Ltd. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstraße 2 80538 München / DE | 03
01.07.2020
28.09.2020
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald GmbH Elisenhof Elisenstraße 3 80335 München / DE | 04
09.07.2020
28.09.2020
ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | 05
26.08.2020
28.09.2020
ADMISSIBLE Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald GmbH Elisenhof Elisenstraße 3 80335 München / DE | 06
16.09.2020
28.09.2020
ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | 07
17.09.2020
28.09.2020
ADMISSIBLE STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | 08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | 09
18.09.2020
28.09.2020
ADMISSIBLE medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | [N/P] |
Former [2022/18] | |||
Opponent(s) | 01
03.06.2020
28.09.2020
ADMISSIBLE Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Aera A/S, et al, et al Niels Hemmingsens Gade 10, 5th Floor 1153 Copenhagen K / DK | ||
02
09.06.2020
12.10.2021
WITHDRAWN Teva Pharmaceutical Industries Ltd. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstraße 2 80538 München / DE | |||
03
01.07.2020
28.09.2020
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
28.09.2020
ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
28.09.2020
ADMISSIBLE Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
28.09.2020
ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
28.09.2020
ADMISSIBLE STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | |||
09
18.09.2020
28.09.2020
ADMISSIBLE medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | |||
Former [2021/52] | |||
Opponent(s) | 01
03.06.2020
28.09.2020
ADMISSIBLE Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
12.10.2021
WITHDRAWN Teva Pharmaceutical Industries Ltd. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstraße 2 80538 München / DE | |||
03
01.07.2020
28.09.2020
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
28.09.2020
ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
28.09.2020
ADMISSIBLE Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
28.09.2020
ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
28.09.2020
ADMISSIBLE STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | |||
09
18.09.2020
28.09.2020
ADMISSIBLE medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | |||
Former [2021/46] | |||
Opponent(s) | 01
03.06.2020
28.09.2020
ADMISSIBLE Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
12.10.2021
WITHDRAWN Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL Opponent's representative Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstraße 2 80538 München / DE | |||
03
01.07.2020
28.09.2020
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
28.09.2020
ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
28.09.2020
ADMISSIBLE Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
28.09.2020
ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
28.09.2020
ADMISSIBLE STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | |||
09
18.09.2020
28.09.2020
ADMISSIBLE medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | |||
Former [2021/20] | |||
Opponent(s) | 01
03.06.2020
28.09.2020
ADMISSIBLE Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
28.09.2020
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL Opponent's representative Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstraße 2 80538 München / DE | |||
03
01.07.2020
28.09.2020
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
28.09.2020
ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
28.09.2020
ADMISSIBLE Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
28.09.2020
ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
28.09.2020
ADMISSIBLE STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | |||
09
18.09.2020
28.09.2020
ADMISSIBLE medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | |||
Former [2021/08] | |||
Opponent(s) | 01
03.06.2020
28.09.2020
ADMISSIBLE Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
28.09.2020
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL Opponent's representative Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstraße 2 80538 München / DE | |||
03
01.07.2020
28.09.2020
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
28.09.2020
ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
28.09.2020
ADMISSIBLE Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
28.09.2020
ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
28.09.2020
ADMISSIBLE STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | |||
09
18.09.2020
28.09.2020
ADMISSIBLE medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | |||
Former [2020/44] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL Opponent's representative Best, Michael, et al, et al Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstrasse 2 80538 München / DE | |||
03
01.07.2020
Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
08
18.09.2020
23.09.2020
ADMISSIBLE Zentiva, k.s. U kabelovny 130 102 37 Praha 10 - Dolni Mecholupy / CZ Opponent's representative Greiner, Elisabeth, et al, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | |||
09
18.09.2020
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 WEDEL / DE Opponent's representative Uexküll & Stolberg, et al, et al Partnerschaft von Patent- und Rechtsanwälten mbB Beselerstraße 4 22607 Hamburg / DE | |||
Former [2020/43] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL Opponent's representative Best, Michael, et al, et al Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstrasse 2 80538 München / DE | |||
03
01.07.2020
Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
06
16.09.2020
Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
07
17.09.2020
STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE | |||
Former [2020/40] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL Opponent's representative Best, Michael, et al, et al Lederer & Keller Patentanwälte Partnerschaft mbB Unsöldstrasse 2 80538 München / DE | |||
03
01.07.2020
Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
05
26.08.2020
Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH 8-2-337 Road No. 3 /Kobelweg 95 Banjara Hills Hyderabad 500034 Telangana IN / 86156 Augsburg DE / IN Opponent's representative Wünsche, Annelie Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
Former [2020/34] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL | |||
03
01.07.2020
Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
04
09.07.2020
Fresenius Kabi Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg / DE | |||
Former [2020/33] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL | |||
03
01.07.2020
Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Maiwald Patent- und Rechtsanwaltsgesellschaft mbH Elisenhof Elisenstraße 3 80335 München / DE | |||
Former [2020/30] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | ||
02
09.06.2020
16.06.2020
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petach Tikva / IL | |||
Former [2020/28] | |||
Opponent(s) | 01
03.06.2020
Accord Healthcare Sage House, 319 Pinner Road North Harrow Middlesex HA1 4HF / GB Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES | 31.08.2020 | No. 01: Notification indicating deficiencies in the notice of opposition | 31.08.2020 | No. 02: Notification indicating deficiencies in the notice of opposition | 31.08.2020 | No. 03: Notification indicating deficiencies in the notice of opposition | 31.08.2020 | No. 04: Notification indicating deficiencies in the notice of opposition | 31.08.2020 | No. 05: Notification indicating deficiencies in the notice of opposition | 17.09.2020 | No. 01: Reply to notification indicating deficiencies in the notice of opposition | 17.09.2020 | No. 02: Reply to notification indicating deficiencies in the notice of opposition | 18.09.2020 | No. 03: Reply to notification indicating deficiencies in the notice of opposition | 18.09.2020 | No. 04: Reply to notification indicating deficiencies in the notice of opposition | 18.09.2020 | No. 05: Reply to notification indicating deficiencies in the notice of opposition | 05.10.2020 | Invitation to proprietor to file observations on the notice of opposition | 15.04.2021 | Reply of patent proprietor to notice(s) of opposition | 07.09.2021 | Cancellation of oral proceeding that was planned for 16.05.2022 | 16.05.2022 | Date of oral proceedings | 30.08.2022 | Cancellation of oral proceeding that was planned for 14.09.2022 | 02.09.2022 | Despatch of communication that the patent will be revoked | 12.09.2022 | Legal effect of revocation of patent [2023/03] | 14.09.2022 | Date of oral proceedings | Fees paid | Renewal fee | 11.05.2018 | Renewal fee patent year 03 | 15.05.2019 | Renewal fee patent year 04 |
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Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Lapses during opposition Tooltip | HU | 12.05.2016 | AL | 18.12.2019 | CY | 18.12.2019 | CZ | 18.12.2019 | DK | 18.12.2019 | EE | 18.12.2019 | HR | 18.12.2019 | LT | 18.12.2019 | LV | 18.12.2019 | MC | 18.12.2019 | MK | 18.12.2019 | MT | 18.12.2019 | RO | 18.12.2019 | RS | 18.12.2019 | SE | 18.12.2019 | SI | 18.12.2019 | SK | 18.12.2019 | SM | 18.12.2019 | BG | 18.03.2020 | NO | 18.03.2020 | IS | 18.04.2020 | IE | 12.05.2020 | LU | 12.05.2020 | GB | 18.11.2020 | [2022/32] |
Former [2022/28] | HU | 12.05.2016 | |
AL | 18.12.2019 | ||
CY | 18.12.2019 | ||
CZ | 18.12.2019 | ||
DK | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
MC | 18.12.2019 | ||
MT | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SI | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
IE | 12.05.2020 | ||
LU | 12.05.2020 | ||
GB | 18.11.2020 | ||
Former [2021/20] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
DK | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
MC | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SI | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
IE | 12.05.2020 | ||
LU | 12.05.2020 | ||
GB | 18.11.2020 | ||
Former [2021/15] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
DK | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
MC | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SI | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
LU | 12.05.2020 | ||
GB | 18.11.2020 | ||
Former [2021/10] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
DK | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
MC | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SI | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
GB | 18.11.2020 | ||
Former [2020/51] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
DK | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SI | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
Former [2020/47] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
DK | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
Former [2020/40] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
IS | 18.04.2020 | ||
Former [2020/37] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
SK | 18.12.2019 | ||
SM | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/36] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
EE | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/35] | AL | 18.12.2019 | |
CZ | 18.12.2019 | ||
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RO | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/32] | AL | 18.12.2019 | |
HR | 18.12.2019 | ||
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/26] | HR | 18.12.2019 | |
LT | 18.12.2019 | ||
LV | 18.12.2019 | ||
RS | 18.12.2019 | ||
SE | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/23] | LT | 18.12.2019 | |
LV | 18.12.2019 | ||
SE | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/22] | LT | 18.12.2019 | |
SE | 18.12.2019 | ||
BG | 18.03.2020 | ||
NO | 18.03.2020 | ||
Former [2020/21] | NO | 18.03.2020 | Cited in | International search | [X] - "Jevtana (cabazitaxel) Injection, 60 mg/1.5 mL, for intravenous infusion only - Prescribing Information", INTERNET CITATION, (201210), pages 1 - 25, URL: http://products.sanofi.us/jevtana/jevtana.html, (20130514), XP002697031 [X] 1-5,9-12 * page 2, paragraph 2 * * page 11, paragraph 5.6 * * page 17, paragraph 8.7 * | [XI] - JOERGER MARKUS, "Metabolism of the taxanes including nab-paclitaxel.", EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY MAY 2015, (20141114), vol. 11, no. 5, ISSN 1744-7607, pages 691 - 702, XP009185790 [X] 1-5,9-16,18,19 * page 696, column l, paragraph 4.2 * [I] 1-5,9-20 DOI: http://dx.doi.org/10.1517/17425255.2015.983074 | [A] - TSAO CHE-KAI ET AL, "Metabolic and toxicological considerations of newly approved prostate cancer drugs", EXPERT OPINION DRUG METABOLISM & TOXICOLOGY, (201307), vol. 9, no. 7, pages 835 - 846, XP009185791 [A] 1-20 * page 841, column r, paragraph 3.1.8 * * page 842, column l, paragraph 1 * DOI: http://dx.doi.org/10.1517/17425255.2013.789019 | [A] - HEIDENREICH A ET AL, "Cabazitaxel Plus Prednisone for Metastatic Castration-resistant Prostate Cancer Progressing After Docetaxel: Results from the German Compassionate-use Programme", EUROPEAN UROLOGY, ELSEVIER BV, NL, vol. 63, no. 6, doi:10.1016/J.EURURO.2012.08.058, ISSN 0302-2838, (20130601), pages 977 - 982, (20120903), XP002697032 [A] 1-20 * page 981, column r, paragraph 1 * DOI: http://dx.doi.org/10.1016/j.eururo.2012.08.058 | [A] - YOON-KOO KANG ET AL, "A Phase I study of cabazitaxel in patients with advanced gastric cancer who have failed prior chemotherapy (GASTANA)", CANCER CHEMOTHERAPY AND PHARMACOLOGY, (20141209), vol. 75, no. 2, doi:10.1007/s00280-014-2638-y, ISSN 0344-5704, pages 309 - 318, XP055176633 [A] 1-20 * the whole document * DOI: http://dx.doi.org/10.1007/s00280-014-2638-y | by applicant | WO9630355 | US5847170 | EP0817779 | WO2005028462 | - J. PHARM. SCI., (1975), vol. 64, no. 8, pages 1269 - 1288 | Opposition | WO2011051894 | WO2016180943 | - Anonymous, "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) APPLICA TION NUMBER: 201023", CENTER FOR DRUG EVALUATION AND RESEARCH, (20100331), pages 1-44, 51 - 76, XP055770059 | - V. Dieras, A. Lortholary, V. Laurence , R. Delva, V. Girre, A. Livartowski, S. Assadourian, D. Semiond, J.Y. Pierga, "Cabazitaxel in patients with advanced solid tumours: Results of a Phase I and pharmacokinetic study", European Journal of Cancer, (20120910), vol. 49, pages 25 - 34, XP055770114 | - M. Joerger, J. H. Beumer, "Cancer treatment in patients with Hepatic Dysfunction", M. Joerger, J. H. Beumer, Veronika Ballova , Mariano Provencio Pulla, ESMO HANDBOOK OF CANCER TREATMENTS IN SPECIAL CLINICAL SITUATIONS, ESMO Press, (20130000), pages 4pp, v-xii, 22 - 29, XP055770126 | - U.S. National Library of Medicine, "Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment", ClinicalTrials.gov archive, Study NCT01140607, (20140819), pages 1 - 9, XP055770132 | - Daniel P. Petrylak, "Practical guide to the use of chemotherapy in castration resistant prostate cancer", The Canadian Journal of Urology, (20140400), vol. 21, no. Suppl 1, pages 77 - 83, XP055770135 | - "Microtubule-Targeting Drugs", Alfred E. Chang, Patricia A. Ganz, Daniel F. Hayes, Timothy J. Kinsella, Harvey I. Pass, Joan H. Schiller, Richard M. Stone, Victor J. Strecker, Oncology An Evidence-Based Approach, Springer Science+Business Media, Inc., (20060000), pages 2pp, 33 - 35, XP055770139 | - Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - JEVTANA (cabazitaxel)", (20100600), pages 1 - 25, XP055770144 | - Anonymous, "Assessment Report For Jevtana (cabazitaxel) Procedure No.: EMEA/H/C/002018", European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP), (20110120), pages 1 - 66, XP055511201 | - Anonymous, "Australian Public Assessment Report for Cabazitaxel", Therapeutic Goods Administration (TGA), (20120209), pages 1 - 61, XP055770157 | - Anonymous, "Phase 1 Safety and Pharmacokinetic Study ofXRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment", Sanofi, (20150716), pages 1 - 5, XP055770165 | - Anonymous, "Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment", ClinicalTrials.gov archive, Study NCT01140607, (20130000), pages 1 - 11, XP055770172 | - Fabien Calcagno, Thierry Nguyen, Erion Dobi, Cristian Villanueva, Elsa Curtit, Stefano Kim, Philippe Montcuquet, Frangois Kleinclauss, Xavier Pivot and Antoine Thiery-Vuillemin, "Safety and efficacy of cabazitaxel in the docetaxel- treated patients with hormone-refractory prostate cancer", Clinical Medicine Insights: Oncology, (20121220), vol. 7, pages 1 - 12, XP055770176 | - Anonymous, "Mosteller-Formel, Wikipedia", (20190530), pages 1 - 2, URL: https://de.wikipedia.org/w/index.php?title=Mosteller-Formel&oldid=189073314, XP055770179 | - Anonymous, "History of Study NCT01140607. Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment", clinicaltrials.gov Study NCT01140607, (20140819), URL: https://clinicaltrials.gov/ct2/history/NCT01140607?V_35=View#StudyPageTop, XP055771195 | - MITA et al., "Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors", Clin Cancer Res, (20090115), vol. 15, no. 2, page 723, XP002623316 DOI: http://dx.doi.org/10.1158/1078-0432.ccr-08-0596 | - Joerger Markus, "Metabolism of the taxanes including nab-paclitaxel, Expert Opinion on Drug Metabolism & Toxicology", Expert opinion on drug metabolism & toxicology, (20150501), vol. 11, no. 5, pages 691 - 702, XP009185790 DOI: http://dx.doi.org/10.1517/17425255.2015.983074 | - HOOKER et al., "Population Pharmacokinetic Model for Docetaxel in Patients with Varying Degrees of Liver Function: Incorporating Cytochrome P450 3A Activity Measurements", Clin Pharmacol Ther, (20080700), vol. 84, no. 1, pages 111 - 118, XP055770850 DOI: http://dx.doi.org/10.1038/sj.clpt.6100476 | - "3 Cancer Treatment In Patients with Hepatic Dysfunction", M. 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Pharmacol., (20150000), vol. 75, pages 309 - 318, XP035434974 DOI: http://dx.doi.org/10.1007/s00280-014-2638-y | - "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling", FDA Guidance for Industry, (20030500), XP055771219 | - ABRAMS, J. et al., "A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI", Investigator's Handbook, Version 1.2, (20140000), pages 13 - 19, XP055772536 | - "Specific Instructions for the Use of Protocol Templates for Organ Dysfunction Studies", CTEP Organ Dysfunction Working Group Protocol Template, (20141126), XP055772544 | - FERRON, G.M. et al., "Population pharmacokinetics of cabazitaxel in patients with advanced solid tumors", Cancer Chemother. 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Practice, (20140000), vol. 20, no. 2, pages 120 - 129, XP055817881 DOI: http://dx.doi.org/10.1177/1078155213480536 | - GIBALDI, M. et al., BIOPHARMACEUTICS AND CLINICAL PHARMACOKINETICS, 2nd ed., (19770000), page 123, XP055817897 | - "JEVTANA (cabazitaxel) Injection", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20100600), pages 1 - 25, XP055770144 | - "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) APPLICATION NUMBER: 201023", (20100331), XP055770059 | - Australian Public Assessment Report (AusPAR) for Cabazitaxel, (20120200), XP055770157 | - TSAO et al., "Clinical Development of cabazitaxel for the Treatment of Castration- Resistant Prostate Cancer", Clinical Medicine Insights: Oncology, (20110000), vol. 5, pages 163 - 169, XP055772558 DOI: http://dx.doi.org/10.4137/CMO.S6566 | - "Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function", CHMP, (20050217), pages 1 - 10, XP055772570 | - "Pharmacokinetics in patients with impaired hepatic function: study, design, data analysis, and impact on dosing and labelling", Guidance for Industry, (20030500), XP055771219 | - Joerger et al., "Chapter 3 - Cancer treatment in patients with Hepatic Dysfunction", Joerger et al., BALLOVÁ et al., ESMO HANDBOOK OF CANCER TREATMENTS IN SPECIAL CLINICAL SITUATIONS, (20130000), pages 22 - 29, XP055770126 | - anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - JEVTANA (cabazitaxel)", (20100600), pages 1 - 25, XP055770144 | - Anonymous, "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) APPLICA TION NUMBER: 201023", CENTER FOR DRUG EVALUATION AND RESEARCH,, (20100331), pages 1-44, 51 - 76, XP055770059 | - Fda, "Guidance for Industry Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling", FDA Guidance for Industry, (20030500), XP055771219 | - A P Venook, M J Egorin, G L Rosner, T D Brown, T M Jahan, G Batist, R Hohl, D Budman, M J Ratain, C M Kearns, R L Schilsky, "Phase I and pharmacokinetic trial of paclitaxel in patients with hepatic dysfunction: Cancer and Leukemia Group B 9264", Journal of Clinical Oncology, (19980000), vol. 16, no. 5, pages 1811 - 1819, XP055771666 DOI: http://dx.doi.org/10.1200/JCO.1998.16.5.1811 | - Field K M; Michael M, "Part II: Liver function in oncology: towards safer chemotherapy use", Lancet Oncology, (20080000), vol. 9, no. 12, doi:10.1016/S1470-2045(08)70307-3, pages 1181 - 1190, XP025695502 DOI: http://dx.doi.org/10.1016/S1470-2045(08)70307-3 | - Sarantopoulos John; Mita Alain C; He Aiwu; Wade James L; Hsueh Chung-Tsen; Morris John C; Lockhart A Craig; Quinn David I; Hwang Jimmy; Mier James; Zhang Wenping; Wack Claudine; Yin Jian; Clot Pierre-François; Rixe Olivier, "Safety and pharmacokinetics of cabazitaxel in patients with hepatic impairment: a phase I dose-escalation study", Cancer chemotherapy and pharmacology, (20170105), vol. 79, no. 2, pages 339 - 351, XP036149300 DOI: http://dx.doi.org/10.1007/s00280-016-3210-8 |