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Cabazitaxel And Its Use For Treating Cancer - EP3294285

The patent EP3294285 was granted to Aventis Pharma on Dec 18, 2019. The application was originally filed on May 12, 2016 under application number EP16721844A. The patent is currently recorded with a legal status of "Revoked".

EP3294285

AVENTIS PHARMA
Application Number
EP16721844A
Filing Date
May 12, 2016
Status
Revoked
Dec 16, 2022
Grant Date
Dec 18, 2019
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (9)

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MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATESep 18, 2020UEXKULL & STOLBERGADMISSIBLE
ZENTIVASep 18, 2020GREINERADMISSIBLE
STADA ARZNEIMITTELSep 17, 2020HAMM & WITTKOPPADMISSIBLE
GENERICS UKSep 16, 2020TER MEER STEINMEISTER & PARTNERADMISSIBLE
DR REDDYS LABORATORIES BETAPHARM ARZNEIMITTELAug 26, 2020WUNSCHEADMISSIBLE
FRESENIUS KABI DEUTSCHLANDJul 9, 2020-ADMISSIBLE
HEXALJul 1, 2020MAIWALDADMISSIBLE
TEVA PHARMACEUTICALSJun 9, 2020LEDERER & KELLER PATENTANWALTE PARTNERSCHAFT MBBWITHDRAWN
ACCORD HEALTHCAREJun 3, 2020AERAADMISSIBLE

Patent Citations (6) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0817779
DESCRIPTIONUS5847170
DESCRIPTIONWO2005028462
DESCRIPTIONWO9630355
OPPOSITIONWO2011051894
OPPOSITIONWO2016180943

Non-Patent Literature (NPL) Citations (64) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
DESCRIPTION- J. PHARM. SCI., (1975), vol. 64, no. 8, pages 1269 - 1288-
INTERNATIONAL-SEARCH-REPORT- "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 *-
INTERNATIONAL-SEARCH-REPORT- 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 *
INTERNATIONAL-SEARCH-REPORT- 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 *
INTERNATIONAL-SEARCH-REPORT- 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 *
INTERNATIONAL-SEARCH-REPORT- 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
OPPOSITION- "3 Cancer Treatment In Patients with Hepatic Dysfunction", M. JORGER et al, ESMO Handbook of Cancer Treatment in special clinical situations, ESMO Press, (20130000), pages 22 - 29, XP055771210-
OPPOSITION- 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-
OPPOSITION- Afroz Abidi, "Cabazitaxel: A novel taxane for metastatic castration-resistant prostate cancer-currentimplications and future prospects", J. Pharmacol. Pharmacother., (20131000), vol. 4, no. 4, pages 230 - 237, XP055771588-
OPPOSITION- 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-
OPPOSITION- Anonymous, "Australian Public Assessment Report for Cabazitaxel", Therapeutic Goods Administration (TGA), (20120209), pages 1 - 61, XP055770157-
OPPOSITION- Anonymous, "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) APPLICA TION NUMBER: 201023", CENTER FOR DRUG EVALUATION AND RESEARCH, (20100331), pages 1-44, 51 - 76, XP055770059-
OPPOSITION- Anonymous, "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) APPLICA TION NUMBER: 201023", CENTER FOR DRUG EVALUATION AND RESEARCH,, (20100331), pages 1-44, 51 - 76, XP055770059-
OPPOSITION- anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - JEVTANA (cabazitaxel)", (20100600), pages 1 - 25, XP055770144-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - JEVTANA (cabazitaxel)", (20100600), pages 1 - 25, XP055770144-
OPPOSITION- 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-
OPPOSITION- Anonymous, "Mosteller-Formel, Wikipedia", (20190530), pages 1 - 2, URL: https://de.wikipedia.org/w/index.php?title=Mosteller-Formel&oldid=189073314, XP055770179-
OPPOSITION- 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-
OPPOSITION- 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-
OPPOSITION- A P Venook et al, "Phase I and Pharmacokinetic Trial of Paclitaxel in Patients With Hepatic Dysfunction: Cancer and Leukemia Group B 9264", Abstract of Journal of Clinical Oncology, (19980000), vol. 16, no. 5, pages 1811 - 1819, XP055771614-
OPPOSITION- "Assessment Report For Jevtana (cabazitaxel) Procedure No.: EMEA/H/C/002018 UPA", EMA Assessment Report, (20110100), XP055511201-
OPPOSITION- Australian Public Assessment Report (AusPAR) for Cabazitaxel, (20120200), XP055770157-
OPPOSITION- CENTER FOR DRUG EVALUATION AND RESEARCH,, "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S)", (20100331), XP055770059-
OPPOSITION- "CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) APPLICATION NUMBER: 201023", (20100331), XP055770059-
OPPOSITION- 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-
OPPOSITION- DIERAS et al., "Cabzitaxel in patients with advanced solid tumors: Results of a Phase I and pharmacokinetic study", European Journal of Cancer, (20130000), vol. 49, pages 25 - 34, XP055770114-
OPPOSITION- EMA, "Assessment Report For Jevtana (cabazitaxel) Procedure No.: EMEA/H/C/002018", (20110120), XP055511201-
OPPOSITION- Eric Raymond et al, "Dosage Adjustment and pharmacokinetic profile of irinotecan in cancer patients with hepatic dysfunction", Journal of Clinical Oncology, (20020000), vol. 20, no. 21, pages 4303 - 4312, XP055771602-
OPPOSITION- 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-
OPPOSITION- 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-
OPPOSITION- 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-
OPPOSITION- FDA, "Jevtana 60 mg concentrate and solvent for solution for infusion", ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, (20110322), pages 1 - 34, XP055771233-
OPPOSITION- GIBALDI, M. et al., BIOPHARMACEUTICS AND CLINICAL PHARMACOKINETICS, 2nd ed., (19770000), page 123, XP055817897-
OPPOSITION- "Guidance for Industry Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling", Guidance for Industry, (20030500), XP055771219-
OPPOSITION- "Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function", CHMP, (20050217), pages 1 - 10, XP055772570-
OPPOSITION- Hironobu Minami et al, "Population pharmacokinetics of docetaxel in patients with hepatic dysfunction treated in an oncology practice", Cancer Sci, (20090000), vol. 100, no. 1, pages 144 - 149, XP055771619-
OPPOSITION- "JEVTANA (cabazitaxel) Injection", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20100600), pages 1 - 25, XP055770144-
OPPOSITION- "JEVTANA (cabazitaxel) Injection", HIGHLIGHTS OF PRESCRIBING INFORMATION, (201006), pages 1 - 25, XP055770144-
OPPOSITION- "JEVTANA (cabazitaxel) injection", HIGHLIGHTS OF PRESCRIBING INFORMATION, (201801), pages 1 - 28, XP055772501-
OPPOSITION- 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-
OPPOSITION- "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-
OPPOSITION- 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-
OPPOSITION- "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling", FDA Guidance for Industry, (20030500), XP055771219-
OPPOSITION- "Pharmacokinetics in patients with impaired hepatic function: study, design, data analysis, and impact on dosing and labelling", Guidance for Industry, (20030500), XP055771219-
OPPOSITION- "Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment", ClinicalTrials.gov archive, Study NCT01140607, (20100608), XP055770132-
OPPOSITION- "Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment", ClinicalTrials.gov archive, Study NCT01140607, (20140819), XP055770132-
OPPOSITION- "Specific Instructions for the Use of Protocol Templates for Organ Dysfunction Studies", CTEP Organ Dysfunction Working Group Protocol Template, (20141126), XP055772544-
OPPOSITION- 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-
OPPOSITION- 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-
OPPOSITION- FERRON, G.M. et al., "Population pharmacokinetics of cabazitaxel in patients with advanced solid tumors", Cancer Chemother. Pharmacol., (20130000), vol. 71, pages 681 - 692, XP035339913
OPPOSITION- KANG, Y.K. et al., "A Phase I study of cabazitaxel in patients with advanced gastric cancer who have failed prior chemotherapy (GASTANA)", Cancer Chemother. Pharmacol., (20150000), vol. 75, pages 309 - 318, XP035434974
OPPOSITION- 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
OPPOSITION- Field and Michael, "Part II: Liver function in oncology: towards safer chemotherapy use", Lancet Oncol, (20081200), vol. 9, pages 1181 - 1190, XP025695502
OPPOSITION- 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
OPPOSITION- GALSKY et al., "Cabazitaxel", Nature Reviews, Drug Discovery, (20100000), vol. 9, doi:10.1038/nrd3254, XP002623319
OPPOSITION- 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
OPPOSITION- Alain C. 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, (20090000), vol. 15, no. 2, pages 723 - 730, XP002623316
OPPOSITION- 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
OPPOSITION- ECKMANN, K. et al., "Pilot study to assess toxicity and pharmacokinetics of docetaxel in patients with metastatic breast cancer and impaired liver function secondary to hepatic metastases", J. Oncol. Pharm. Practice, (20140000), vol. 20, no. 2, pages 120 - 129, XP055817881
OPPOSITION- 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
OPPOSITION- VENOOK et al., "Phase I and Pharmacokinetic Trial of Paclitaxel in Patients with Hepatic Dysfunction: Cancer and Leukemia Group B 9264", Journal of Clinical Oncology, (19980500), vol. 16, no. 5, pages 1811 - 1819, XP055771666
OPPOSITION- 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
OPPOSITION- SARTOR et al., "Improving Outcomes with Recent Advances in Chemotherapy for Castrate-Resistant Protaste Cancer", Clinical Genitourinary Cancer, (20100000), vol. 8, doi:10.3816/CGC.2010.n.004, XP009149078
OPPOSITION- 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

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