| EP3149480 - RISK-STRATIFICATION OF B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA PATIENTS [Right-click to bookmark this link] | Status | Patent revoked Status updated on 17.09.2021 Database last updated on 09.04.2026 | |
| Former | The patent has been granted Status updated on 23.11.2018 | ||
| Former | Grant of patent is intended Status updated on 19.07.2018 | ||
| Former | Examination is in progress Status updated on 03.11.2017 | ||
| Former | Request for examination was made Status updated on 03.03.2017 | ||
| Former | The international publication has been made Status updated on 21.12.2016 | Most recent event Tooltip | 01.07.2022 | Lapse of the patent in a contracting state New state(s): MK | published on 03.08.2022 [2022/31] | Applicant(s) | For all designated states Amgen Research (Munich) GmbH Staffelseestrasse 2 81477 München / DE | For all designated states Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 / US | [2017/14] | Inventor(s) | 01 /
ZUGMAIER, Gerhard c/o Amgen Research (Munich) GmbH Staffelseestr. 2 81477 Munich / DE | 02 /
KUFER, Peter c/o Amgen Research (Munich) GmbH Staffelseestr. 2 81477 Munich / DE | 03 /
ALEKAR, Shilpa One Amgen Center Drive Thousand Oaks California 91320-1799 / US | [2017/14] | Representative(s) | Schiweck Weinzierl Koch Patentanwälte Partnerschaft mbB Ganghoferstraße 68 B 80339 München / DE | [2018/52] |
| Former [2017/14] | Schiweck, Weinzierl & Koch Patentanwälte Partnerschaft mbB Landsberger Straße 98 80339 München / DE | Application number, filing date | 15727072.9 | 20.05.2015 | [2017/14] | WO2015IB53705 | Priority number, date | US201462005560P | 30.05.2014 Original published format: US 201462005560 P | [2017/14] | Filing language | EN | Procedural language | EN | Publication | Type: | A1 Application with search report | No.: | WO2015181683 | Date: | 03.12.2015 | Language: | EN | [2015/48] | Type: | A1 Application with search report | No.: | EP3149480 | Date: | 05.04.2017 | Language: | EN | The application published by WIPO in one of the EPO official languages on 03.12.2015 takes the place of the publication of the European patent application. | [2017/14] | Type: | B1 Patent specification | No.: | EP3149480 | Date: | 26.12.2018 | Language: | EN | [2018/52] | Search report(s) | International search report - published on: | EP | 03.12.2015 | Classification | IPC: | G01N33/574 | [2017/14] | CPC: |
G01N33/57505 (EP,US);
A61K35/17 (EP,US);
A61K38/1774 (EP,US);
A61P25/00 (EP);
C07K16/2803 (US);
C07K16/2809 (US);
G01N33/5091 (EP,US);
A61K2035/124 (US);
C07K2317/31 (US);
C07K2317/622 (US);
G01N2333/70503 (US);
G01N2800/50 (EP,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 [2017/14] | Extension states | BA | Not yet paid | ME | Not yet paid | Validation states | MA | Not yet paid | Title | German: | RISIKOSTRATIFIZIERUNG VON PATIENTEN MIT AKUTER LYMPHATISCHER B-VORLÄUFER-LEUKÄMIE | [2017/14] | English: | RISK-STRATIFICATION OF B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA PATIENTS | [2017/14] | French: | STRATIFICATION DU RISQUE POUR PATIENTS SOUFFRANT DE LEUCÉMIE AIGUË LYMPHOBLASTIQUE À PRÉCURSEURS B | [2017/14] | Entry into regional phase | 20.12.2016 | National basic fee paid | 20.12.2016 | Designation fee(s) paid | 20.12.2016 | Examination fee paid | Examination procedure | 20.12.2015 | Date on which the examining division has become responsible | 20.12.2016 | Examination requested [2017/14] | 03.07.2017 | Amendment by applicant (claims and/or description) | 03.11.2017 | Despatch of a communication from the examining division (Time limit: M04) | 12.03.2018 | Reply to a communication from the examining division | 27.03.2018 | Despatch of a communication from the examining division (Time limit: M02) | 25.05.2018 | Reply to a communication from the examining division | 20.07.2018 | Communication of intention to grant the patent | 19.11.2018 | Fee for grant paid | 19.11.2018 | Fee for publishing/printing paid | 19.11.2018 | Receipt of the translation of the claim(s) | Divisional application(s) | EP18213926.1 / EP3531133 | EP23192350.9 / EP4303585 | Opposition(s) | Opponent(s) | 01
26.09.2019
01.10.2019
ADMISSIBLE SANOFI 54 rue La Boétie 75008 Paris / FR Opponent's representative Ipsilon 11 rue Saint-Georges 75009 Paris / FR | [N/P] |
| Former [2019/45] | |||
| Opponent(s) | 01
26.09.2019
01.10.2019
ADMISSIBLE SANOFI 54 rue La Boétie 75008 Paris / FR Opponent's representative Nony 11 rue Saint-Georges 75009 Paris / FR | 14.10.2019 | Invitation to proprietor to file observations on the notice of opposition | 21.02.2020 | Reply of patent proprietor to notice(s) of opposition | 04.05.2021 | Date of oral proceedings | 04.05.2021 | Legal effect of revocation of patent [2021/42] | 04.06.2021 | Despatch of minutes of oral proceedings | 04.06.2021 | Despatch of communication that the patent will be revoked | Fees paid | Renewal fee | 10.05.2017 | Renewal fee patent year 03 | 11.05.2018 | Renewal fee patent year 04 |
| Opt-out from the exclusive Tooltip competence of the Unified Patent Court | See the Register of the Unified Patent Court for opt-out data | ||
| 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 | AL | 26.12.2018 | HR | 26.12.2018 | MK | 26.12.2018 | RS | 26.12.2018 | SM | 26.12.2018 | NO | 26.03.2019 | [2022/31] |
| Former [2019/37] | AL | 26.12.2018 | |
| HR | 26.12.2018 | ||
| RS | 26.12.2018 | ||
| SM | 26.12.2018 | ||
| NO | 26.03.2019 | ||
| Former [2019/26] | AL | 26.12.2018 | |
| HR | 26.12.2018 | ||
| RS | 26.12.2018 | ||
| NO | 26.03.2019 | ||
| Former [2019/25] | HR | 26.12.2018 | |
| RS | 26.12.2018 | ||
| NO | 26.03.2019 | ||
| Former [2019/23] | HR | 26.12.2018 | |
| NO | 26.03.2019 | ||
| Former [2019/20] | NO | 26.03.2019 | Cited in | International search | [XI] "BACKGROUND INFORMATION FOR THE PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING 04 DECEMBER 2012", 4 December 2012 (2012-12-04), XP055203294, Retrieved from the Internet | [A] G. TALLEN ET AL: "Long-Term Outcome in Children With Relapsed Acute Lymphoblastic Leukemia After Time-Point and Site-of-Relapse Stratification and Intensified Short-Course Multidrug Chemotherapy: Results of Trial ALL-REZ BFM 90", JOURNAL OF CLINICAL ONCOLOGY, vol. 28, no. 14, 12 April 2010 (2010-04-12), pages 2339 - 2347, XP055203293, ISSN: 0732-183X, DOI: 10.1200/JCO.2009.25.1983 [A] 1-28 * the whole document * * In particular: Title; Abstract; Patients and methods section. * DOI: http://dx.doi.org/10.1200/JCO.2009.25.1983 | [A] DIRK NAGORSEN ET AL: "Blinatumomab: A historical perspective", PHARMACOLOGY & THERAPEUTICS, vol. 136, no. 3, 1 December 2012 (2012-12-01), pages 334 - 342, XP055112692, ISSN: 0163-7258, DOI: 10.1016/j.pharmthera.2012.07.013 [A] 1-28 * the whole document * * In particular: p. 340-341, items 9-11. * DOI: http://dx.doi.org/10.1016/j.pharmthera.2012.07.013 | [A] VISSER J H ET AL: "Prognostic value of day 14 blast percentage and the absolute blast index in bone marrow of children with acute lymphoblastic leukemia", PEDIATRIC HEMATOLOGY AND ONCOLOGY, TAYLOR AND FRANCIS, GB, vol. 18, no. 3, 1 January 2001 (2001-01-01), pages 187 - 191, XP008177028, ISSN: 0888-0018, DOI: 10.1080/08880010151114804 [A] 1-28 * the whole document * * In particular: Title; Abstract; Methods section. * DOI: http://dx.doi.org/10.1080/08880010151114804 | [A] JAN STARY ET AL: "Results of the Randomized I-BFM-SG Trial "Acute Lymphoblastic Leukemia Intercontinental-BFM 2002" in 5060 Children Diagnosed in 15 Countries on 3 Continents", 18 September 2011 (2011-09-18), pages 397 - 398, XP055203224, Retrieved from the Internet | [A] G. BASSO ET AL: "Risk of Relapse of Childhood Acute Lymphoblastic Leukemia Is Predicted By Flow Cytometric Measurement of Residual Disease on Day 15 Bone Marrow", JOURNAL OF CLINICAL ONCOLOGY, vol. 27, no. 31, 5 October 2009 (2009-10-05), pages 5168 - 5174, XP055203226, ISSN: 0732-183X, DOI: 10.1200/JCO.2008.20.8934 [A] 1-28 * the whole document * * In particular: Title; Abstract; Patients and methods section; p. 5170, 2nd column, 2nd paragraph and table 1. * DOI: http://dx.doi.org/10.1200/JCO.2008.20.8934 | by applicant | WO9954440 | WO2007068354 | WO2011051307 | WO2012146394 | WO2010052013 | WO2010052014 | WO2007131092 | WO2008119567 | WO2008119566 | EP0623679 | WO2004106381 | WO2008119565 | GRUPP ET AL., N. ENGL. J. MED., vol. 368, no. 16, 2013, pages 1509 - 1518 | BUERGER ET AL., JOURNAL OF CLINICAL ONCOLOGY, vol. 21, no. 2, 2003, pages 184 - 188 | BADER ET AL., J. CLIN. ONCOL., vol. 27, 2009, pages 377 - 384 | ECKERT ET AL., LANCET, vol. 358, 2001, pages 1239 - 41 | PORTER ET AL., N ENGL J MED., vol. 365, 2011, pages 725 - 33 | GRUPP ET AL., N ENGL J MED., 2013 | HARLOW; LANE: "Antibodies, A Laboratory Manual", 1988, COLD SPRING HARBOR LABORATORY PRESS | HARLOW; LANE: "Using Antibodies: A Laboratory Manual", 1999, COLD SPRING HARBOR LABORATORY PRESS | SKERRA, CURR OPIN BIOTECHNOL., vol. 18, 2007, pages 295 - 304 | HOSSE ET AL., PROTEIN SCI., vol. 15, 2006, pages 14 - 27 | NICAISE ET AL., PROTEIN SCI., vol. 13, 2004, pages 1882 - 91 | NYGREN; UHLN, CURR OPIN STRUCT BIOL., vol. 7, 1997, pages 463 - 9 | KABAT ET AL., SEQUENCES OF PROTEINS OF IMMUNOLOGICAL INTEREST, 1991 | NEEDLEMAN; WUNSCH, J MOL BIOL., vol. 48, 1970, pages 443 - 53 | SMITH; WATERMAN, ADV APPL MATH., vol. 2, 1981, pages 482 - 9 | WOBBIEJ: "Hypothesis", CRICK. J MOL BIOL., vol. 19, 1966, pages 548 - 55, Retrieved from the Internet | FARAMARZ NAEIM; P. NAGESH RAO; WAYNE W. GRODY: "Hematopathology", 2008, ELSEVIER | Opposition | WO2011051307 | WO2012146394 | WO2014122251 | HUPPMANN ET AL.: "Detection of Leukemic Lymphoblasts in CSF is Instrument- Dependent", AM J CLIN PATHOL, vol. 137, no. 5, 2012, pages 795 - 799, XP055635302 DOI: http://dx.doi.org/10.1309/AJCPP4HQ2FXQEZIL | CONTER ET AL.: "Acute Lymphoblastic Leukemia", ORPHANET, December 2004 (2004-12-01), pages 1 - 13, XP055635306, Retrieved from the Internet | ROBIN T. VOLLMER ET AL.: "Blast Counts in Bone Marrow Aspirate Smears: analysis using the poisson probability function, bayes theorem, and information theory.", AM J CLIN PATHOL, vol. 131, no. 2, 2009, pages 183 - 188, XP055635315 * , ; * DOI: http://dx.doi.org/10.1309/AJCPBAYNCU35ZGZG | AMIN ET AL.: "Having a higher blast percentage in circulation than bone marrow: clinical implications in myelodysplastic syndrome and acute lymphoid and myeloid leukemias.", LEUKEMIA, vol. 19, no. 9, 2005, pages 1567 - 1572, XP055397866 DOI: http://dx.doi.org/10.1038/sj.leu.2403876 | BIANCO ET AL.: "Increased Blasts Mimicking Acute Leukemia in a Patient With Polysubstance Abuse", ARCH PATHOL LAB MED, vol. 129, February 2005 (2005-02-01), pages e35 - e38, XP055635326 | WEINKAUFF ET AL.: "Use of Peripheral Blood Blasts vs Bone Marrow Blasts for Diagnosis of Acute Leukemia", AM J CLIN PATHOL, vol. 111, 1999, pages 733 - 740, XP055524636 | FARAMARZ NAEIM, P. NAGESH RAO AND WAYNE W. GRODY: "HEMATOPATHOLOGY", 2008, ACADEMICPRESS, article FARAMARZ NAEIM: "Chapter 1 - Structure and Function of Hematopoietic Tissues", pages: 1 - 26, XP055635340 | MARIASTEFANIA ANTICA: "Acute Leukemia - The Scientist's Perspective and Challenge", 2011, article ABBAS H. ABDULSALAM: "Diagnosis of Acute Leukemia in Under-Resourced Laboratories", pages: 19 - 40, XP055635347 | AMGEN RESEARCH (MUNICH) GMBH: "Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia", CLINICALTRIALS.GOV, 16 November 2011 (2011-11-16), XP055635351, Retrieved from the Internet | AMGEN RESEARCH (MUNICH) GMBH: "Study of the BiTE Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)", CLINICALTRIALS.GOV, 27 September 2010 (2010-09-27), XP055635357, Retrieved from the Internet | AMGEN RESEARCH (MUNICH) GMBH: "Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)", CLINICALTRIALS.GOV, 7 November 2011 (2011-11-07), XP055635360, Retrieved from the Internet | TOPP ET AL.: "Targeted Therapy With the T-Cell-Engaging Antibody Blinatumomab of Chemotherapy-Refractory Minimal Residual Disease in B-Lineage Acute Lymphoblastic Leukemia Patients Results in High Response Rate and Prolonged Leukemia-Free Survival", J CLIN ONCOL, vol. 29, 2011, pages 2493 - 2498, XP055112754 DOI: http://dx.doi.org/10.1200/JCO.2010.32.7270 | MAURILLO ET AL.: "Treatment of Acute Myeloid Leukemia with 20-30% Bone Marrow Blasts", MEDITERR J HEMATOL INFECT DIS, vol. 5, 2013, pages 1 - 13, XP055635371 DOI: http://dx.doi.org/10.4084/mjhid.2013.032 | CHING-HON PUI: "Toward Optimal Central Nervous System-Directed Treatment in Childhood Acute Lymphoblastic Leukemia", JOURNAL OF CLINICAL ONCOLOGY, vol. 21, no. 2, 15 January 2003 (2003-01-15), pages 179 - 181, XP055635380 DOI: http://dx.doi.org/10.1200/JCO.2003.10.032 | BURGER ET AL.: "Diagnostic Cerebrospinal Fluid Examination in Children With Acute Lymphoblastic Leukemia: Significance of Low Leukocyte Counts With Blasts or Traumatic Lumbar Puncture", JOURNAL OF CLINICAL ONCOLOGY, vol. 21, no. 2, 15 January 2003 (2003-01-15), pages 184 - 188, XP055202705 DOI: http://dx.doi.org/10.1200/JCO.2003.04.096 | CANCELA ET AL.: "Incidence and risk factors for central nervous system relapse in children and adolescents with acute lymphoblastic leukemia", REV BRAS HEMATOL HEMOTER., vol. 34, no. 6, 2012, pages 436 - 441, XP055635389 DOI: http://dx.doi.org/10.5581/1516-8484.20120109 | JABBOUR ET AL.: "Central Nervous System Prophylaxis in Adults With Acute Lymphoblastic Leukemia", CANCER, vol. 116, no. 10, 2010, pages 2290 - 2300, XP055635397 | PFEIFER ET AL.: "Risk and Prognosis of Central Nervous System Leukemia in Patients with Philadelphia Chromosome-Positive Acute Leukemias Treated with Imatinib Mesylate", CLINICAL CANCER RESEARCH, vol. 9, 15 October 2003 (2003-10-15), pages 4674 - 4681, XP055635488 | HATHAWAY ET AL.: "Impact of blinatumomab on patient outcomes in relapsed/refractory acute lymphoblastic leukemia: evidence to date", PATIENT RELATED OUTCOME MEASURES, vol. 9, 2018, pages 329 - 337, XP055635491 DOI: http://dx.doi.org/10.2147/PROM.S149420 | DAVIS ET AL.: "Cerebrospinal fluid analysis by flow cytometry in acute lymphoblastic leukemia:is it all that it is cracked up up to be?", LEUKEMIA & LYMPHOMA, vol. 55, no. 7, 2014, pages 1441 - 1443, XP055635497 DOI: http://dx.doi.org/10.3109/10428194.2013.876499 | LAZARUS ET AL.: "Central nervous system involvement in adult acute lymphoblastic leukemia at diagnosis: results from the international ALL trial MRC UKALL XII/ECOG E2993", BLOOD, vol. 108, 2006, pages 465 - 472, XP055635502 DOI: http://dx.doi.org/10.1182/blood-2005-11-4666 | JABBOUR ET AL.: "Adult Acute Lymphoblastic Leukemia", MAYO CLIN. PROC., vol. 80, no. 11, 2005, pages 1517 - 1527, XP055635506 DOI: http://dx.doi.org/10.4065/80.11.1517 | MARTINEZ-LAPERCHE ET AL.: "Detection of occult cerebrospinal fluid involvement during maintenance therapy identifies a group of children with acute lymphoblastic leukemia at high risk for relapse", AM. J. HEMATOL., vol. 88, 2013, pages 359 - 364, XP055635522 DOI: http://dx.doi.org/10.1002/ajh.23407 | ANONYMOUS: "Matter of Record (301) 890-4188", PEDIATRIC ONCOLOGY SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE, 4 December 2012 (2012-12-04), pages 1 - 377 | DIRK NAGORSEN: "Investigation of Blinatumomab in Pediatric Patients with ALL", PRESENTATION, 4 December 2012 (2012-12-04) | ANONYMOUS: "Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, Notice of meeting", FEDERAL REGISTER, vol. 77, no. 180, 17 September 2012 (2012-09-17), pages 57095, XP055635533 |