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Extract from the Register of European Patents

EP About this file: EP1846030

EP1846030 - FIXED DOSING OF HER ANTIBODIES [Right-click to bookmark this link]
StatusPatent revoked
Status updated on  09.07.2021
Database last updated on 14.05.2024
FormerThe patent has been granted
Status updated on  19.10.2018
FormerGrant of patent is intended
Status updated on  03.10.2018
FormerExamination is in progress
Status updated on  15.06.2017
Most recent event   Tooltip09.07.2021Revocation of patentpublished on 11.08.2021  [2021/32]
09.07.2021Lapse of the patent in a contracting state
New state(s): HU		published on 11.08.2021  [2021/32]
Applicant(s)For all designated states
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990 / US
[2018/47]
Former [2008/38]For all designated states
Genentech, Inc.
1 DNA Way
South San Francisco CA 94080-4990 / US
Former [2007/43]For all designated states
Genentech, Inc.
1 DNA Way
South San Francisco CA 94080-4990 / US
Inventor(s)01 / ALLISON, David E
26 Eastwood Drive
San Mateo, CA 94403 / US
02 / BRUNO, Rene
84 Chemin Des Grives
F-13013 Marseille / FR
03 / LU, Jian-Feng
399 Medea Creek Lane
Oak Park, CA 91377 / US
04 / NG, Chee M.
6813 Tanaqua Lane
Austin, TX 78739 / US
 [2008/24]
Former [2008/16]01 / ALLISON, David E
26 Eastwood Drive
San Mateo, CA 94403 / US
02 / BRUNO, Rene
84 Chemin Des Grives
F-13013 Marseille / FR
03 / LU, Jian-Feng
779 Skyridge Lane, 313
Oak Park, CA 91377 / US
04 / NG, Chee M.
6813 Tanaqua Lane
Austin, TX 78739 / US
Former [2007/43]01 / ALLISON, David E
26 Eastwood Drive
San Mateo, CA 94403 / US
02 / BRUNO, Rene
84 Chemin Des Grives
F-13013 Marseille / FR
03 / LU, Jian-Feng
842 Andromeda Lane
Foster City, CA 94404 / US
04 / NG, Chee M.
741 Columbia Drive
San Mateo, CA 94402 / US
Representative(s)Mewburn Ellis LLP
Aurora Building
Counterslip
Bristol BS1 6BX / GB
[N/P]
Former [2018/47]Walton, Seán Malcolm, et al
Mewburn Ellis LLP
City Tower
40 Basinghall Street
London EC2V 5DE / GB
Former [2007/43]Walton, Seán Malcolm, et al
Mewburn Ellis LLP York House, 23 Kingsway
London WC2B 6HP / GB
Application number, filing date05785414.315.06.2005
[2007/43]
WO2005US21287
Priority number, dateUS20050645697P21.01.2005         Original published format: US 645697 P
[2007/43]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2006078307
Date:27.07.2006
Language:EN
[2006/30]
Type: A1 Application with search report 
No.:EP1846030
Date:24.10.2007
Language:EN
The application published by WIPO in one of the EPO official languages on 27.07.2006 takes the place of the publication of the European patent application.
[2007/43]
Type: B1 Patent specification 
No.:EP1846030
Date:21.11.2018
Language:EN
[2018/47]
Search report(s)International search report - published on:EP27.07.2006
ClassificationIPC:A61K39/395, C07K16/32
[2007/43]
CPC:
C07K16/32 (EP,IL,KR,US); A61K39/39558 (IL,KR,US); A61K39/395 (KR);
A61J1/065 (IL,US); A61K31/337 (EP,IL,US); A61K31/704 (EP,IL,US);
A61K31/7068 (EP,IL,US); A61K38/18 (EP,IL,US); A61K39/3955 (IL,KR,US);
A61K45/06 (IL,US); A61P1/04 (EP); A61P11/00 (EP);
A61P13/08 (EP); A61P15/00 (EP); A61P35/00 (EP);
A61P35/04 (EP); C07K16/22 (IL,KR,US); C07K16/2863 (KR);
C07K16/40 (IL,US); A61K2039/505 (EP,IL,US); A61K2039/54 (US);
A61K2039/545 (EP,IL,KR,US); C07K2317/24 (EP,IL,KR,US); C07K2317/56 (EP,IL,US);
C07K2317/76 (IL,US); C07K2317/94 (IL,US); Y10T428/13 (EP,US) (-)
Designated contracting statesAT,   BE,   BG,   CH,   CY,   CZ,   DE,   DK,   EE,   ES,   FI,   FR,   GB,   GR,   HU,   IE,   IS,   IT,   LI,   LT,   LU,   MC,   NL,   PL,   PT,   RO,   SE,   SI,   SK,   TR [2018/47]
Former [2007/43]AT,  BE,  BG,  CH,  CY,  CZ,  DE,  DK,  EE,  ES,  FI,  FR,  GB,  GR,  HU,  IE,  IS,  IT,  LI,  LT,  LU,  MC,  NL,  PL,  PT,  RO,  SE,  SI,  SK,  TR 
Extension statesAL10.08.2007
BA10.08.2007
HR10.08.2007
LV10.08.2007
MK10.08.2007
YU10.08.2007
TitleGerman:FIXE DOSIERUNG VON HER-ANTIKÖRPERN[2007/43]
English:FIXED DOSING OF HER ANTIBODIES[2007/43]
French:DOSAGE FIXE D'ANTICORPS ANTI-HER[2007/43]
Entry into regional phase10.08.2007National basic fee paid 
10.08.2007Designation fee(s) paid 
10.08.2007Examination fee paid 
Examination procedure10.08.2007Amendment by applicant (claims and/or description)
10.08.2007Examination requested  [2007/43]
04.12.2012Despatch of a communication from the examining division (Time limit: M06)
30.09.2013Reply to a communication from the examining division
02.06.2017Despatch of a communication from the examining division (Time limit: M06)
09.01.2018Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time
14.03.2018Reply to a communication from the examining division
04.10.2018Communication of intention to grant the patent
10.10.2018Fee for grant paid
10.10.2018Fee for publishing/printing paid
10.10.2018Receipt of the translation of the claim(s)
Divisional application(s)EP18207013.6  / EP3698807
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  04.12.2012
Opposition(s)Opponent(s)01  15.08.2019  21.08.2019  ADMISSIBLE
König Szynka Tilmann von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Strasse 11
40545 Düsseldorf / DE
Opponent's representative
Roth, Carla, et al, et al
König-Szynka-Tilmann-von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Straße 11
40545 Düsseldorf / DE
 02  19.08.2019  26.08.2019  ADMISSIBLE
Breuer, Markus
Henkel, Breuer & Partner
Patentanwälte
Brienner Str. 1
80333 München / DE
Opponent's representative
Breuer, Markus, et al, et al
Brienner Straße 1
80333 München / DE
 03  20.08.2019  09.07.2020  WITHDRAWN
Dr. H. Ulrich Dörries
Fünf Höfe, Theatinerstr. 16
80333 München / DE
Opponent's representative
Dörries, Hans Ulrich
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 04  21.08.2019  26.08.2019  ADMISSIBLE
Leeming, John Gerard
J.A. Kemp & Co.
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Opponent's representative
J A Kemp LLP
80 Turnmill Street
London EC1M 5QU / GB
 [N/P]
Former [2020/33]
Opponent(s)01  15.08.2019  21.08.2019  ADMISSIBLE
König Szynka Tilmann von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Strasse 11
40545 Düsseldorf / DE
Opponent's representative
Roth, Carla, et al, et al
König-Szynka-Tilmann-von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Straße 11
40545 Düsseldorf / DE
 02  19.08.2019  26.08.2019  ADMISSIBLE
Breuer, Markus
Henkel, Breuer & Partner
Patentanwälte
Brienner Str. 1
80333 München / DE
Opponent's representative
Breuer, Markus, et al, et al
Brienner Straße 1
80333 München / DE
 03  20.08.2019  09.07.2020  WITHDRAWN
Dr. H. Ulrich Dörries
Fünf Höfe, Theatinerstr. 16
80333 München / DE
Opponent's representative
Dörries, Hans Ulrich
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 04  21.08.2019  26.08.2019  ADMISSIBLE
Leeming, John Gerard
J.A. Kemp & Co.
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Opponent's representative
J A Kemp LLP
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Former [2019/41]
Opponent(s)01  15.08.2019  21.08.2019  ADMISSIBLE
König Szynka Tilmann von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Strasse 11
40545 Düsseldorf / DE
Opponent's representative
Roth, Carla, et al, et al
König-Szynka-Tilmann-von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Straße 11
40545 Düsseldorf / DE
 02  19.08.2019  26.08.2019  ADMISSIBLE
Breuer, Markus
Henkel, Breuer & Partner
Patentanwälte
Brienner Str. 1
80333 München / DE
Opponent's representative
Breuer, Markus, et al, et al
Brienner Straße 1
80333 München / DE
 03  20.08.2019  26.08.2019  ADMISSIBLE
Dr. H. Ulrich Dörries
Fünf Höfe, Theatinerstr. 16
80333 München / DE
Opponent's representative
Dörries, Hans Ulrich
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 04  21.08.2019  26.08.2019  ADMISSIBLE
Leeming, John Gerard
J.A. Kemp & Co.
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Opponent's representative
J A Kemp
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Former [2019/39]
Opponent(s)01  15.08.2019  21.08.2019  ADMISSIBLE
König Szynka Tilmann von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Strasse 11
40545 Düsseldorf / DE
Opponent's representative
Roth, Carla, et al, et al
König-Szynka-Tilmann-von Renesse
Patentanwälte Partnerschaft mbB
Mönchenwerther Straße 11
40545 Düsseldorf / DE
 02  19.08.2019   
Breuer, Markus
Henkel, Breuer & Partner
Patentanwälte
Brienner Str. 1
80333 München / DE
Opponent's representative
Henkel, Breuer & Partner
Patentanwälte
Brienner Strasse 1
80333 München / DE
 03  20.08.2019    WITHDRAWN
Dr. H. Ulrich Dörries
Fünf Höfe, Theatinerstr. 16
80333 München / DE
Opponent's representative
Dörries, Hans Ulrich
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 04  21.08.2019    ADMISSIBLE
Leeming, John Gerard
J.A. Kemp & Co.
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Opponent's representative
J A Kemp
14 South Square
Gray's Inn
London WC1R 5JJ / GB
05.09.2019Invitation to proprietor to file observations on the notice of opposition
10.01.2020Reply of patent proprietor to notice(s) of opposition
09.09.2020Cancellation of oral proceeding that was planned for 10.12.2020
10.12.2020Date of oral proceedings
16.03.2021Cancellation of oral proceeding that was planned for 25.05.2021
23.03.2021Despatch of communication that the patent will be revoked
02.04.2021Legal effect of revocation of patent [2021/32]
25.05.2021Date of oral proceedings
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the examination report
14.03.2018Request for further processing filed
14.03.2018Full payment received (date of receipt of payment)
Request granted
26.03.2018Decision despatched
The application is deemed to be withdrawn due to failure to reply to the examination report
30.09.2013Request for further processing filed
30.09.2013Full payment received (date of receipt of payment)
Request granted
30.05.2017Decision despatched
Fees paidRenewal fee
14.06.2007Renewal fee patent year 03
28.03.2008Renewal fee patent year 04
16.06.2009Renewal fee patent year 05
11.06.2010Renewal fee patent year 06
13.06.2011Renewal fee patent year 07
24.05.2012Renewal fee patent year 08
31.03.2013Renewal fee patent year 09
31.03.2014Renewal fee patent year 10
05.06.2015Renewal fee patent year 11
31.03.2016Renewal fee patent year 12
07.06.2017Renewal fee patent year 13
07.06.2018Renewal fee patent year 14
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  TooltipHU15.06.2005
CY21.11.2018
CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
MC21.11.2018
SI21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
IE15.06.2019
LU15.06.2019
[2021/32]
Former [2021/26]CY21.11.2018
CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
MC21.11.2018
SI21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
IE15.06.2019
LU15.06.2019
Former [2020/27]CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
MC21.11.2018
SI21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
IE15.06.2019
LU15.06.2019
Former [2020/21]CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
MC21.11.2018
SI21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
IE15.06.2019
Former [2020/09]CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
MC21.11.2018
SI21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/50]CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
SI21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/40]CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
SK21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/37]CZ21.11.2018
DK21.11.2018
EE21.11.2018
FI21.11.2018
LT21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/35]CZ21.11.2018
DK21.11.2018
FI21.11.2018
LT21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/34]DK21.11.2018
FI21.11.2018
LT21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/26]FI21.11.2018
LT21.11.2018
BG21.02.2019
IS21.03.2019
PT21.03.2019
Former [2019/22]FI21.11.2018
LT21.11.2018
BG21.02.2019
IS21.03.2019
Former [2019/21]FI21.11.2018
LT21.11.2018
IS21.03.2019
Former [2019/20]LT21.11.2018
Cited inInternational search[A]WO0100238  (GENENTECH INC [US], et al);
 [X]  - MALIK M A ET AL, "Dose-response studies of recombinant humanized monoclonal antibody 2C4 in tumor xenograft models.", PROCEEDINGS OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH ANNUAL MEETING, & 94TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH; WASHINGTON, DC, USA; JULY 11-14, 2003, (200307), vol. 44, ISSN 0197-016X, page 150, XP001246708 [X] 1-40 * the whole document *
 [X]  - BASELGA J ET AL, "PHASE II STUDY OF WEEKLY INTRAVENOUS RECOMBINANT HUMANIZED ANTI-P185HER2 MONOCLONAL ANTIBODY IN PATIENTS WITH HER2/NEU-OVEREXPRESSING METASTATIC BREAST CANCER", JOURNAL OF CLINICAL ONCOLOGY, GRUNE AND STRATTON, NEW YORK, NY, US, (199603), vol. 14, no. 3, ISSN 0732-183X, pages 737 - 744, XP000918166 [X] 1-4,9,13,15,16,18,19,21 * page 738, column R, paragraph 1 *
 [X]  - BASELGA J, "Phase I and II clinical trials of trastuzumab", ANNALS OF ONCOLOGY 2001 NETHERLANDS, (2001), vol. 12, no. SUPPL. 1, ISSN 0923-7534, pages S49 - S55, XP009063466 [X] 1-4,9,13,15,16,18,19,21 * table 2 *

DOI:   http://dx.doi.org/10.1023/A:1011167909059
 [PX]  - AGUS D B ET AL, "PHASE I CLINICAL STUDY OF PERTUZUMAB, A NOVEL HER DIMERIZATION INHIBITOR, IN PATIENTS WITH ADVANCED CANCER", JOURNAL OF CLINICAL ONCOLOGY, GRUNE AND STRATTON, NEW YORK, NY, US, (20050410), vol. 23, no. 11, ISSN 0732-183X, pages 2534 - 2543, XP008058275 [PX] 1-40 * the whole document *

DOI:   http://dx.doi.org/10.1200/JCO.2005.03.184
 [PX]  - NG C ET AL, "Rationale for fixed dosing of pertuzumab by population pharmacokinetic (POP PK) modeling", CLINICAL PHARMACOLOGY & THERAPEUTICS, MOSBY-YEAR BOOK, ST LOUIS, MO, US, (20050205), vol. 77, no. 2, ISSN 0009-9236, page P33, XP004802442 [PX] 1-40 * the whole document *

DOI:   http://dx.doi.org/10.1016/j.clpt.2004.12.019
 [A]  - BASELGA J ET AL, "RECEPTOR BLOCKADE WITH MONOCLONAL ANTIBODIES AS ANTI-CANCER THERAPY", PHARMACOLOGY AND THERAPEUTICS, ELSEVIER, GB, (1994), vol. 64, no. 1, ISSN 0163-7258, pages 127 - 154, XP009011842

DOI:   http://dx.doi.org/10.1016/0163-7258(94)90036-1
 [A]  - LEYLAND-JONES BRIAN, "Dose scheduling-Herceptin(R)", ONCOLOGY (BASEL), (200110), vol. 61, no. Suppl 2, ISSN 0030-2414, pages 31 - 36, XP009063513

DOI:   http://dx.doi.org/10.1159/000055399
 [A]  - FRANKLIN MATTHEW C ET AL, "Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex", CANCER CELL, (200404), vol. 5, no. 4, ISSN 1535-6108, pages 317 - 328, XP002372929

DOI:   http://dx.doi.org/10.1016/S1535-6108(04)00083-2
OppositionWO2004008099
 EP1585966
 WO0100245
 EP1585966
 WO2006063042
 EP1825001
    - BASELGA et al., "PHASE II STUDY OF WEEKLY INTRAVENOUS RECOMBINANT HUMANIZED ANTI-P185HER2 MONOCLONAL ANTIBODY IN PATIENTS WITH HER2/NEU-OVEREXPRESSING METASTATIC BREAST CANCER", JOURNAL OF CLINICAL ONCOLOGY, (19960300), vol. 14, no. 3, pages 737 - 744, XP000918166
    - BASELGA et al., "PHASE I AND II CLINICAL TRIALS OF TRASTUZUMAB", Annals of Oncology, (20010000), vol. 12, pages S49 - S55, XP009063466

DOI:   http://dx.doi.org/10.1023/A:1011167909059
    - NAHTA et al., "The HER-2-targeting antibodies trastuzumab and pertuzumab synergistically inhibit the survival of breast cancer cells", Cancer Research, (20040000), vol. 64, no. 7, pages 2343 - 2346, XP002378994

DOI:   http://dx.doi.org/10.1158/0008-5472.CAN-03-3856
    - BRITTEN, "TARGETING ERBB RECEPTOR SIGNALING: A PAN-ERBB APPROACH TO CANCER", Molecular Cancer Therapeutics, (200410), vol. 3, no. 10, pages 1335 - 1342, XP009058669
    - GSCHWIND et al., "The discovery of receptor tyrosine kinases: tar- gets for cancer therapy", NATURE REVIEWS CANCER, (20040500), vol. 4, no. 5, pages 361 - 370, XP008038394

DOI:   http://dx.doi.org/10.1038/nrc1360
    - GIANNI L. et al., "Open-Label, Phase II, Multicenter, Randomized Study of the Efficacy and Safety of Two Dose Levels of Per- tuzumab, a Human Epidermal Growth Factor Receptor 2 Dimeri- zation Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer", Journal of Clinical Oncology, (20100200), vol. 28, no. 7, pages 1131 - 1137, XP055252498

DOI:   http://dx.doi.org/10.1200/JCO.2009.24.1661
    - anonymous, "A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer", CLINICAL TRIALS.GOV NCT03674112, (20180917), XP055637538
    - Anonymous, "Genentech reports additional data from BioOncology Pipeline at ASCO. Phase I data on Omnitarg (pertuzumab) in solid tumors and first study on Tarceva (erlotinib HG) and Avastin (bevacizumab) combination presented", Genentech Press Release, (20030601), URL: https://www.gene.com/media/press-releases/6228/2003-06-01/genentech-reports-additional-data-from-b, XP055637541
    - R. NAHTA et al., "The HER-2-Targeting Antibodies Trastuzumab and Pertuzumab Synergistically Inhibit the Survival of Breast Cancer Cells", Cancer Research, (20040000), vol. 64, doi:10.1158/0008-5472.CAN-03-3856, pages 2343 - 2346, XP002521223

DOI:   http://dx.doi.org/10.1158/0008-5472.CAN-03-3856
    - CORTES, "Open label, randomized, phase II study of pertuzumab (P) in patients (pts) with metastatic breast cancer (MBC) with low expression of HER2", J Clin Oncol, (20050601), vol. 23, no. 16, XP055634622

DOI:   http://dx.doi.org/10.1200/jco.2005.23.16_suppl.3068
    - SOULE et al., "A human cell line from a pleural effusion derived from a breast carcinoma", JNCI: J Nat Cancer Inst, (19730000), vol. 51, no. 5, pages 1409 - 1416, XP055634632

DOI:   http://dx.doi.org/10.1093/jnci/51.5.1409
    - Information on the origin and nature of the cell line SK - BR -3 .
    - SPICE R, "Technology evaluation: Pertuzumab, Roche/Genentech/Chugai", (20040000), XP009058601
    - REGISTRY, Database accession no. 380610-27-5
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