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Extract from the Register of European Patents

EP About this file: EP2976101

EP2976101 - METHOD OF TREATMENT [Right-click to bookmark this link]
StatusPatent revoked
Status updated on  02.02.2024
Database last updated on 01.04.2026
FormerThe patent has been granted
Status updated on  17.07.2020
FormerGrant of patent is intended
Status updated on  11.03.2020
FormerExamination is in progress
Status updated on  06.04.2018
Most recent event   Tooltip06.09.2024Lapse of the patent in a contracting state
New state(s): MT		published on 09.10.2024  [2024/41]
Applicant(s)For all designated states
GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
1330 Rixensart / BE
[2020/34]
Former [2016/04]For all designated states
GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
1330 Rixensart / BE
Inventor(s)01 / BAINE, Yaela
GlaxoSmithKline
2301 Renaissance Boulevard
King of Prussia, Pennsylvania 19406 / US
02 / MILLER, Jacqueline
GlaxoSmithKline
2301 Renaissance Boulevard
King of Prussia, Pennsylvania 19406 / US
 [2016/04]
Representative(s)J A Kemp LLP
80 Turnmill Street
London EC1M 5QU / GB
[N/P]
Former [2020/34]J A Kemp LLP
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Former [2016/04]Johnston, Caroline Louise
GlaxoSmithKline
Global Patents (CN925.1)
980 Great West Road
Brentford, Middlesex TW8 9GS / GB
Application number, filing date14711232.017.03.2014
[2016/04]
WO2014EP55355
Priority number, dateUS201361802918P18.03.2013         Original published format: US 201361802918 P
US201361874008P05.09.2013         Original published format: US 201361874008 P
[2016/04]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2014147044
Date:25.09.2014
Language:EN
[2014/39]
Type: A1 Application with search report 
No.:EP2976101
Date:27.01.2016
Language:EN
The application published by WIPO in one of the EPO official languages on 25.09.2014 takes the place of the publication of the European patent application.
[2016/04]
Type: B1 Patent specification 
No.:EP2976101
Date:19.08.2020
Language:EN
[2020/34]
Search report(s)International search report - published on:EP25.09.2014
ClassificationIPC:A61K39/095
[2016/04]
CPC:
A61K39/095 (EP,EA,IL,US); A61K39/102 (EA,IL,US); A61P31/04 (EP,IL);
A61K2039/55 (EA,IL,US); A61K2039/6037 (EP,EA,IL,US); A61K2039/70 (EP,EA,IL,US);
Y02A50/30 (EP,EA,US) (-)
Designated contracting statesAL,   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 [2016/04]
Extension statesBA05.10.2015
ME05.10.2015
TitleGerman:BEHANDLUNGSVERFAHREN[2016/04]
English:METHOD OF TREATMENT[2016/04]
French:PROCÉDÉ DE TRAITEMENT[2016/04]
Entry into regional phase05.10.2015National basic fee paid 
05.10.2015Designation fee(s) paid 
05.10.2015Examination fee paid 
Examination procedure08.01.2015Request for preliminary examination filed
International Preliminary Examining Authority: EP
05.10.2015Amendment by applicant (claims and/or description)
05.10.2015Examination requested  [2016/04]
10.04.2018Despatch of a communication from the examining division (Time limit: M06)
09.10.2018Reply to a communication from the examining division
23.01.2020Cancellation of oral proceeding that was planned for 28.01.2020
28.01.2020Date of oral proceedings (cancelled)
12.03.2020Communication of intention to grant the patent
07.07.2020Fee for grant paid
07.07.2020Fee for publishing/printing paid
07.07.2020Receipt of the translation of the claim(s)
Divisional application(s)The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  10.04.2018
Opposition(s)Opponent(s)01  18.05.2021  20.05.2021  ADMISSIBLE
Sanofi Pasteur
14 Espace Henri Vallée
69007 Lyon / FR
Opponent's representative
Wilding, James Roger, et al, et al
Mathys & Squire The Shard
32 London Bridge Street
London SE1 9SG / GB
 [2021/25]
04.06.2021Invitation to proprietor to file observations on the notice of opposition
13.10.2021Reply of patent proprietor to notice(s) of opposition
27.09.2023Date of oral proceedings
27.09.2023Legal effect of revocation of patent [2024/10]
02.11.2023Despatch of minutes of oral proceedings
02.11.2023Despatch of communication that the patent will be revoked
Fees paidRenewal fee
08.03.2016Renewal fee patent year 03
07.03.2017Renewal fee patent year 04
08.03.2018Renewal fee patent year 05
08.03.2019Renewal fee patent year 06
10.03.2020Renewal fee patent year 07
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  TooltipAL19.08.2020
HR19.08.2020
LT19.08.2020
LV19.08.2020
MC19.08.2020
MK19.08.2020
MT19.08.2020
RS19.08.2020
SM19.08.2020
NO19.11.2020
IS19.12.2020
BE31.03.2021
[2024/41]
Former [2024/22]AL19.08.2020
HR19.08.2020
LT19.08.2020
LV19.08.2020
MC19.08.2020
MK19.08.2020
RS19.08.2020
SM19.08.2020
NO19.11.2020
IS19.12.2020
BE31.03.2021
Former [2022/34]AL19.08.2020
HR19.08.2020
LT19.08.2020
LV19.08.2020
MC19.08.2020
RS19.08.2020
SM19.08.2020
NO19.11.2020
IS19.12.2020
BE31.03.2021
Former [2021/45]AL19.08.2020
HR19.08.2020
LT19.08.2020
LV19.08.2020
MC19.08.2020
RS19.08.2020
SM19.08.2020
NO19.11.2020
IS19.12.2020
Former [2021/25]AL19.08.2020
HR19.08.2020
LT19.08.2020
LV19.08.2020
RS19.08.2020
SM19.08.2020
NO19.11.2020
IS19.12.2020
Former [2021/23]HR19.08.2020
LT19.08.2020
LV19.08.2020
RS19.08.2020
SM19.08.2020
NO19.11.2020
IS19.12.2020
Former [2021/12]HR19.08.2020
LT19.08.2020
LV19.08.2020
RS19.08.2020
NO19.11.2020
IS19.12.2020
Former [2021/07]LT19.08.2020
NO19.11.2020
Cited inInternational search[A] AU2012203419  (GLAXOSMITHKLINE BIOLOG SA et al.) [A] 1-96 * claims 81,90,96 *
 [A]   BORROW RAY ET AL: "Kinetics of Antibody Persistence following Administration of a Combination Meningococcal Serogroup C and Haemophilus influenzae Type b Conjugate Vaccine in Healthy Infants in the United Kingdom Primed with a Monovalent Meningococcal Serogroup C Vaccine", CLINICAL AND VACCINE IMMUNOLOGY, vol. 17, no. 1, January 2010 (2010-01-01), pages 154 - 159, XP002725639 [A] 1-96 * abstract * * tables 1-3 * * page 155, column 1, paragraph 2 *

DOI:   http://dx.doi.org/10.1128/CVI.00384-09
 [A]   GATCHALIAN S ET AL: "The development of a new heptavalent diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C vaccine: a randomized dose-ranging trial of the conjugate vaccine components", INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, INTERNATIONAL SOCIETY FOR INFECTIOUS DISEASES, HAMILTON, CA, vol. 12, no. 3, 1 May 2008 (2008-05-01), pages 278 - 288, XP022618371, ISSN: 1201-9712, [retrieved on 20071105], DOI: 10.1016/J.IJID.2007.08.007 [A] 1-96 * abstract * * page 286, column 1, paragraph 3 - column 2, paragraph 4 *

DOI:   http://dx.doi.org/10.1016/j.ijid.2007.08.007
 [A]   GASPARINI ROBERTO ET AL: "Meningococcal glycoconjugate vaccines", HUMAN VACCINES, vol. 7, no. 2, February 2011 (2011-02-01), pages 170 - 182, XP002725640 [A] 1-96 * abstract *

DOI:   http://dx.doi.org/10.4161/hv.7.2.13717
 [A]   SCHMITT HEINZ-J ET AL: "Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisselia meningitidis serogroup C conjugate vaccine", CLINICAL AND VACCINE IMMUNOLOGY, AMERICAN SOCIETY FOR MICROBIOLOGY, WASHINGTON, DC, US, vol. 14, no. 4, 1 April 2007 (2007-04-01), pages 426 - 434, XP002494483, ISSN: 1556-6811, DOI: 10.1128/CVI.00377-06 [A] 1-96 * abstract * * page 433 *

DOI:   http://dx.doi.org/10.1128/CVI.00377-06
 [XI]   NOLAN TERRY ET AL: "Immunogenicity and Safety of an Investigational Combined Haemophilus influenzae Type B-Neisseria meningitidis Serogroups C and Y-Tetanus Toxoid Conjugate Vaccine", PEDIATRIC INFECTIOUS DISEASE JOURNAL, vol. 30, no. 3, March 2011 (2011-03-01), pages 190 - 196, XP009178427, ISSN: 0891-3668 [X] 1-9,13,15-21,23,26-33,37,39-45,47,60,61,79-81,84-90,94-96 * abstract * [I] 10-12,14,22,24,25,34-36,38,46,48-59,62-78,82,83,91-93

DOI:   http://dx.doi.org/10.1097/INF.0b013e3181fcb2bf
ExaminationUS2008193476
 US2008305127
   ME PICHICHERO: "Meningococcal conjugate vaccine in adolescents and children.", CLIN PEDIATR (PHILA)., vol. 44, no. 6, 1 July 2005 (2005-07-01), pages 479 - 489, XP055464391
   MARKUS KNUF ET AL: "An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered withhexa is immunogenic, with an acceptable safety profile in 1223-month-old children", VACCINE, ELSEVIER, AMSTERDAM, NL, vol. 29, no. 25, 3 March 2011 (2011-03-03), pages 4264 - 4273, XP028217535, ISSN: 0264-410X, [retrieved on 20110309], DOI: 10.1016/J.VACCINE.2011.03.009

DOI:   http://dx.doi.org/10.1016/j.vaccine.2011.03.009
   GARY S. MARSHALL ET AL: "Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States", HUMAN VACCINES, vol. 7, no. 2, 1 February 2011 (2011-02-01), US, pages 258 - 264, XP055639233, ISSN: 1554-8600, DOI: 10.4161/hv.7.2.14170

DOI:   http://dx.doi.org/10.4161/hv.7.2.14170
   GARY S. MARSHALL ET AL: "IMMUNE RESPONSE AND ONE-YEAR ANTIBODY PERSISTENCE AFTER A FOURTH DOSE OF A NOVEL HAEMOPHILUS INFLUENZAE TYPE B AND NEISSERIA MENINGITIDIS SEROGROUPS C AND Y-TETANUS TOXOID CONJUGATE VACCINE (HibMenCY) AT 12 TO 15 MONTHS OF AGE :", PEDIATRIC INFECTIOUS DISEASE JOURNAL., vol. 29, no. 5, 1 May 2010 (2010-05-01), US, pages 469 - 471, XP055639251, ISSN: 0891-3668, DOI: 10.1097/INF.0b013e3181cdd379

DOI:   http://dx.doi.org/10.1097/INF.0b013e3181cdd379
   ANONYMOUS: "Recommendation of the Advisory Committee on Immunization Practices (ACIP) for Use of Quadrivalent Meningococcal Conjugate Vaccine (MenACWY-D) Among Children Aged 9 Through 23 Months at Increased Risk for Invasive Meningococcal Disease", 14 October 2011 (2011-10-14), XP055639261, Retrieved from the Internet [retrieved on 20191105]
   KRISTINA A. BRYANT: "Immunogenicity and Safety of H influenzae Type b- N meningitidis C/Y Conjugate Vaccine in Infants", 29 May 2011 (2011-05-29), pages e1375 - 85, XP055639247, Retrieved from the Internet [retrieved on 20191105]
OppositionEP2014055355
 WO2007111940
 WO9942130
 WO2007000314
   ANONYMOUS: "History of Changes for Study: NCT00667602 ,Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers ", CLINICALTRIALS.GOV ARCHIVE, 3 September 2013 (2013-09-03), pages 1 - 49, XP055954744, [retrieved on 20220825]
   ANONYMOUS: " Glossary of Common Site Terms COVID 19 information", CLINICALTRIALS.GOV, 6 May 2021 (2021-05-06), pages 1 - 19, XP055954747, [retrieved on 20220825]
   ANONYMOUS: "Immuno safety of GSK Vaccine 134612 given at age of 12-15 months 15-18 months post-priming with GSK Vaccine 792014", CLINICALTRIALS.GOV, 21 September 2018 (2018-09-21), pages 1 - 14, XP055954749
   ANONYMOUS: " Glossary of Common Site Terms", CLINICALTRIALS.GOV, 6 May 2021 (2021-05-06), pages 1 - 19, XP055954792
   ANONYMOUS: " Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014 ", CLINICALTRIALS.GOV, vol. NCT00614614, 21 September 2018 (2018-09-21), pages 1 - 14, XP055954801
   ANONYMOUS: "Meningococcal groups C and Y and Haemophilus b Tetanus Toxoid conjugate vaccine", VACCINES, BLOOD & BIOLOGICS, 22 June 2012 (2012-06-22), pages 1 - 1, XP055954803
   ANONYMOUS: "HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MENHIBRIX ", DATASHEET, 1 January 2012 (2012-01-01), pages 1 - 14, XP055954804
   ANONYMOUS .: "GSK receives FDA approval for MenHibrix ", EPR, 14 June 2012 (2012-06-14), pages 1 - 5, XP055954805
   ANONYMOUS: "Commision implementing decision of 20.04.2012 granting marketing authorisation under regulation (EC) N0 726/2004 of the European Parliament and of the council for NIMENRIX-Meningococcal Group A, C, W-135 and Y conjugate vaccine, a medicinal product for human use", EUROPEAN COMMISION DECISION, vol. 20, 20 April 2012 (2012-04-20), pages 1 - 58, XP055954810
   ANONYMOUS .: "GlaxoSmithKline receives European authorisation for Nimenrix", EPR, 27 April 2012 (2012-04-27), pages 1 - 4, XP055954816
   ANONYMOUS: "Result summaries : Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid conjugate vaccine", WEBARCHIVE.ORG, 27 May 2012 (2012-05-27), pages 1 - 1, XP055954819, [retrieved on 20220825]
   ANONYMOUS: "Recommended Childhood and Adolescent Immunization Schedule ---United States 2005", MMWR, vol. 53, no. 51, 7 January 2005 (2005-01-07), pages Q1 - Q3, XP055954823
   ANONYMOUS: "284 Menactra", SANOFI PASTEUR DATASHEET, vol. V0-11, no. L5917, 30 November 2011 (2011-11-30), pages 1 - 36, XP055954833
   ANONYMOUS: "History of Changes for Study: NCT00614614 Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014", CLINICALTRIALS.GOV, 22 November 2011 (2011-11-22), pages 1 - 7, XP055954838
   MATTHEW D SNAPE, PERRETT KP, FORD KJ, JOHN TM, PACE D, YU LM, LANGLEY JM, MCNEIL S, DULL PM, CEDDIA F, ANEMONA A, HALPERIN SA, DOB: "Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial.", JAMA - JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1 January 2008 (2008-01-01), pages 173 - 184, XP055051640, [retrieved on 20130129]
   MARKUS KNUF; ANNA PANTAZI-CHATZIKONSTANTINOU; ULRICH PFLETSCHINGER; IRMINGARD TICHMANN-SCHUMANN; HARTWIG MAURER; LOTHAR MAURER; TH: "An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered withhexa is immunogenic, with an acceptable safety profile in 1223-month-old children", VACCINE, ELSEVIER, AMSTERDAM, NL, vol. 29, no. 25, 3 March 2011 (2011-03-03), AMSTERDAM, NL , pages 4264 - 4273, XP028217535, ISSN: 0264-410X, DOI: 10.1016/j.vaccine.2011.03.009

DOI:   http://dx.doi.org/10.1016/j.vaccine.2011.03.009
   ANONYMOUS: "Commission decision of 31.8.2010", EUROPEAN COMMISSION DECISION, vol. 8, 31 August 2010 (2010-08-31), pages 1 - 72, XP055954844
   ANONYMOUS .: "Sanofi Pasteur announces FDA approval of Menactra", EPR, 22 April 2011 (2011-04-22), pages 1 - 4, XP055954847
   GARY S. MARSHALL, COLIN D. MARCHANT, MARK BLATTER, LEONARD R. FRIEDLAND, EMMANUEL ARIS, JACQUELINE M. MILLER: "Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States", HUMAN VACCINES, LANDES BIOSCIENCE, GEORGETOWN, TX, US, vol. 7, no. 2, 1 February 2011 (2011-02-01), US , pages 258 - 264, XP055639233, ISSN: 1554-8600, DOI: 10.4161/hv.7.2.14170

DOI:   http://dx.doi.org/10.4161/hv.7.2.14170
   ANONYMOUS: "Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial", VACCINE, 6 April 2011 (2011-04-06), pages 1 - 11, XP055954855
   GASPARINI R, PANATTO D.: "Meningococcal glycoconjugate vaccines", HUMAN VACCINES, LANDES BIOSCIENCE, GEORGETOWN, TX, US, vol. 7, no. 2, 1 February 2011 (2011-02-01), US , pages 170 - 182, XP002725640, ISSN: 1554-8600, DOI: 10.4161/hv.7.2.13717

DOI:   http://dx.doi.org/10.4161/hv.7.2.13717
   ANONYMOUS: "Advisory conmittee on immunization practice (ACIP) votes to recommend routine use of combined tetanus, diphteria and Pertussis (Tdap) vaccines for adolescents", WEBARCHIVE, 29 October 2005 (2005-10-29), pages 1 - 2, XP055954866
   ANONYMOUS: "History of Changes for Study: NCT01659996 Study of Menactra in Healthy Subjects at 9 Months and Concomitantly With Pentacel at 15 to 18 Months of Age", CLINICALTRIALS.GOV, 5 February 2013 (2013-02-05), pages 1 - 6, XP055954857
   TROTTER CAROLINE L., CHANDRA MANOSREE, CANO ROSA, LARRAURI AMPARO, RAMSAY MARY E., BREHONY CARINA, JOLLEY KEITH A., MAIDEN MARTIN : "A surveillance network for meningococcal disease in Europe", FEMS MICROBIOLOGY REVIEWS, vol. 31, no. 1, 1 January 2007 (2007-01-01), pages 27 - 36, XP093096182, DOI: 10.1111/j.1574-6976.2006.00060.x

DOI:   http://dx.doi.org/10.1111/j.1574-6976.2006.00060.x
   ANONYMOUS: "Routine childhood immunisations from November 2010", NHS, 1 November 2010 (2010-11-01), pages 1 - 1, XP093096612
   ANONYMOUS: "Factsheet Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) vaccines for children", NHS, 1 August 2006 (2006-08-01), pages 1 - 20, XP093096607
   ANONYMOUS: "Summary of Product Characteristics", 3 June 2009 (2009-06-03), pages 1 - 8, XP093096585, Retrieved from the Internet [retrieved on 20231031]
   ESPOSITO SUSANNA, PRINCIPI NICOLA: "Differences in vaccinations in European Union", HUMAN VACCINES, vol. 4, no. 4, 1 January 2008 (2008-01-01), US , pages 313 - 315, XP093096230, ISSN: 1554-8600, DOI: 10.4161/hv.4.4.5587

DOI:   http://dx.doi.org/10.4161/hv.4.4.5587
   ANONYMOUS: "Hexavalent vaccine", 8 May 2023 (2023-05-08), pages 1 - 4, XP093096231, Retrieved from the Internet [retrieved on 20231030]
   ANONYMOUS: "Assessment report : Nimenrix", 1 March 2011 (2011-03-01), pages 1 - 84, XP055641291, Retrieved from the Internet [retrieved on 20191111]
   VLIEGENTHART, J.F.G.: "Carbohydrate based vaccines", FEBS LETTERS, vol. 580, no. 12, 22 May 2006 (2006-05-22), NL , pages 2945 - 2950, XP025171199, ISSN: 0014-5793, DOI: 10.1016/j.febslet.2006.03.053

DOI:   http://dx.doi.org/10.1016/j.febslet.2006.03.053
   KNUF, M. ; KIENINGER-BAUM, D. ; HABERMEHL, P. ; MUTTONEN, P. ; MAURER, H. ; VINK, P. ; POOLMAN, J. ; BOUTRIAU, D.: "A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children", VACCINE, vol. 28, no. 3, 8 January 2010 (2010-01-08), AMSTERDAM, NL , pages 744 - 753, XP026793745, ISSN: 0264-410X
   BROKER, M. ; DULL, P.M. ; RAPPUOLI, R. ; COSTANTINO, P.: "Chemistry of a new investigational quadrivalent meningococcal conjugate vaccine that is immunogenic at all ages", VACCINE, ELSEVIER, AMSTERDAM, NL, vol. 27, no. 41, 18 September 2009 (2009-09-18), AMSTERDAM, NL , pages 5574 - 5580, XP026502234, ISSN: 0264-410X, DOI: 10.1016/j.vaccine.2009.07.036

DOI:   http://dx.doi.org/10.1016/j.vaccine.2009.07.036
   ANONYMOUS: "Adipic acid dihydrazide", WIKIPEDIA, THE FREE ENCYCLOPEDIA, 14 December 2021 (2021-12-14), XP093113510, Retrieved from the Internet [retrieved on 20231219]
The EPO accepts no responsibility for the accuracy of data originating from other authorities; in particular, it does not guarantee that it is complete, up to date or fit for specific purposes.