Extract from the Register of European Patents

EP About this file: EP2608805

EP2608805 - STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS [Right-click to bookmark this link]
StatusPatent maintained as amended
Status updated on  02.05.2025
Database last updated on 11.04.2026
FormerThe patent has been granted
Status updated on  02.06.2017
FormerGrant of patent is intended
Status updated on  14.02.2017
Most recent event   Tooltip02.05.2025Patent maintained (B2 publication)published on 04.06.2025  [2025/23]
Applicant(s)For all designated states
Wyeth LLC
66 Hudson Boulevard East
New York, NY 10001-2192 / US
[2023/21]
Former [2014/10]For all designated states
Wyeth LLC
235 East 42nd Street
New York, NY 10017-5755 / US
Former [2013/27]For all designated states
Wyeth LLC
Five Giralda Farms
Madison, NJ 07940 / US
Inventor(s)01 / KHANDKE, Lakshmi
Pfizer Global Research & Development
Five Giralda Farms
Madison
New Jersey 07940 / US
02 / ARUMUGHAM, Rasappa
Pfizer Global Research & Development
Five Giralda Farms
Madison
New Jersey 07940 / US
03 / LOUN, Bounthon
Pfizer Global Research & Development
575 Maryville Centre Drive
St Louis
Missouri 63141 / US
 [2017/09]
Former [2013/27]01 / KHANDKE, Lakshmi
Pfizer Global Research&Development
Five Giralda Farms
Madison
New Jersey 07940 / US
02 / ARUMUGHAM, Rasappa
Pfizer Global Research&Development
Five Giralda Farms
Madison
New Jersey 07940 / US
03 / LOUN, Bounthon
Pfizer Global Research&Development
575 Maryville Centre Drive
St Louis
Missouri 63141 / US
Representative(s)Pfizer
European Patent Department
23-25 avenue du Docteur Lannelongue
75668 Paris Cedex 14 / FR
[2013/27]
Application number, filing date11757949.022.08.2011
[2017/27]
WO2011IB53684
Priority number, dateUS20100376160P23.08.2010         Original published format: US 376160 P
[2013/27]
Filing languageEN
Procedural languageEN
PublicationType: A2 Application without search report
No.:WO2012025873
Date:01.03.2012
Language:EN
[2012/09]
Type: A2 Application without search report 
No.:EP2608805
Date:03.07.2013
Language:EN
The application published by WIPO in one of the EPO official languages on 01.03.2012 takes the place of the publication of the European patent application.
[2013/27]
Type: B1 Patent specification 
No.:EP2608805
Date:05.07.2017
Language:EN
[2017/27]
Type: B2 New European patent specification 
No.:EP2608805
Date:04.06.2025
Language:EN
[2025/23]
Search report(s)International search report - published on:EP18.05.2012
ClassificationIPC:A61K39/095, A61K47/02, A61K47/34, A61K47/44, G01N33/569
[2013/27]
CPC:
A61K47/02 (EP,KR); A61K39/095 (EP,CN,KR,US); A61K38/164 (EP,CN,US);
C07K14/22 (US); A61K31/194 (CN,US); A61K31/4172 (CN,US);
A61K47/26 (EP); A61K47/34 (KR); A61K47/44 (KR);
A61P31/04 (EP); G01N33/56911 (EP,US); A61K2039/55505 (EP,CN,US);
A61K2039/55555 (EP,CN,US) (-)
C-Set:
A61K31/194, A61K2300/00 (CN);
A61K31/4172, A61K2300/00 (CN);
A61K38/164, A61K2300/00 (CN);
A61K39/095, A61K2300/00 (CN)
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 [2013/27]
TitleGerman:STABILE FORMULIERUNGEN VON NEISSERIA-MENINGITIDIS-RLP2086-ANTIGENEN[2013/27]
English:STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS[2013/27]
French:FORMULATIONS STABLES DES ANTIGÈNES RLP2086 DE NEISSERIA MENINGITIDIS[2017/09]
Former [2013/27]FORMULATIONS STABLES DES ANTIGÈNES RLP2086 DE NEISSERIA MENINGITIDIS& xA;
Entry into regional phase25.03.2013National basic fee paid 
25.03.2013Designation fee(s) paid 
25.03.2013Examination fee paid 
Examination procedure13.03.2013Amendment by applicant (claims and/or description)
25.03.2013Examination requested  [2013/27]
06.03.2014Despatch of a communication from the examining division (Time limit: M06)
15.09.2014Reply to a communication from the examining division
11.03.2016Despatch of a communication from the examining division (Time limit: M06)
20.09.2016Reply to a communication from the examining division
15.02.2017Communication of intention to grant the patent
25.05.2017Receipt of the translation of the claim(s)
26.05.2017Fee for grant paid
26.05.2017Fee for publishing/printing paid
Divisional application(s)EP17172800.9  / EP3246044
EP20216502.3  / EP3831406
EP24177833.1  / EP4417216
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  06.03.2014
Opposition(s)Opponent(s)01  05.04.2018  12.04.2018  ADMISSIBLE
Sanofi Pasteur
14 Espace Henri Vallée
69007 Lyon / FR
Opponent's representative
Ipsilon
11 rue Saint-Georges
75009 Paris / FR
 [N/P]
Former [2018/20]
Opponent(s)01  05.04.2018  12.04.2018  ADMISSIBLE
Sanofi Pasteur
14 Espace Henri Vallée
69007 Lyon / FR
Opponent's representative
Nony
11 rue Saint-Georges
75009 Paris / FR
19.04.2018Invitation to proprietor to file observations on the notice of opposition
28.08.2018Reply of patent proprietor to notice(s) of opposition
13.05.2019Date of oral proceedings
20.09.2019Despatch of minutes of oral proceedings
14.12.2023Despatch of a communication from the opposition division (Time limit: M04)
10.04.2024Reply to a communication from the opposition division
04.07.2024Despatch of a communication from the opposition division (Time limit: M02)
16.07.2024Reply to a communication from the opposition division
04.11.2024Despatch of interlocutory decision in opposition
04.11.2024Legal effect of interlocutory decision in opposition
14.02.2025Despatch of communication that the patent will be maintained as amended
Appeal following opposition19.11.2019Appeal received No.  T3038/19
20.01.2020Statement of grounds filed
06.09.2022Result of appeal procedure: maintenance in amended form
14.12.2022Despatch of the decision of the Board of Appeal
15.11.2019Appeal received No.  T3038/19
17.01.2020Statement of grounds filed
06.09.2022Result of appeal procedure: maintenance in amended form
14.12.2022Despatch of the decision of the Board of Appeal
06.09.2022Date of oral proceedings
Fees paidRenewal fee
02.09.2013Renewal fee patent year 03
01.09.2014Renewal fee patent year 04
31.08.2015Renewal fee patent year 05
31.08.2016Renewal fee patent year 06
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Lapses during opposition  TooltipAL05.07.2017
CY05.07.2017
EE05.07.2017
HR05.07.2017
LT05.07.2017
LV05.07.2017
MC05.07.2017
MK05.07.2017
RS05.07.2017
SM05.07.2017
MT22.08.2017
NO05.10.2017
IS05.11.2017
[2020/33]
Former [2019/51]CY05.07.2017
EE05.07.2017
HR05.07.2017
LT05.07.2017
LV05.07.2017
MC05.07.2017
MK05.07.2017
RS05.07.2017
SM05.07.2017
MT22.08.2017
NO05.10.2017
IS05.11.2017
Former [2019/46]CY05.07.2017
EE05.07.2017
HR05.07.2017
LT05.07.2017
LV05.07.2017
MC05.07.2017
RS05.07.2017
SM05.07.2017
MT22.08.2017
NO05.10.2017
IS05.11.2017
Former [2018/43]EE05.07.2017
HR05.07.2017
LT05.07.2017
LV05.07.2017
MC05.07.2017
RS05.07.2017
SM05.07.2017
MT22.08.2017
NO05.10.2017
IS05.11.2017
Former [2018/24]EE05.07.2017
HR05.07.2017
LT05.07.2017
LV05.07.2017
MC05.07.2017
RS05.07.2017
SM05.07.2017
NO05.10.2017
IS05.11.2017
Former [2018/14]HR05.07.2017
LT05.07.2017
LV05.07.2017
RS05.07.2017
NO05.10.2017
IS05.11.2017
Former [2018/11]HR05.07.2017
LT05.07.2017
RS05.07.2017
NO05.10.2017
IS05.11.2017
Former [2018/07]LT05.07.2017
NO05.10.2017
Cited inInternational search[X] WO2009050586  (NOVARTIS AG et al.) [X] 1,3,4,21-33 * page 5, lines 16,17 * * page 5, line 34 - page 6, line 6 * * page 11, lines 13-35 * * page 24, lines 3-10 * * claim - *
 [I] WO2009104097  (NOVARTIS AG et al.) [I] 1,2,5-14,40-48 * page 9, line 31 - page 10, line 1 * * page 10, line 23 - page 11, line 15 * * page 14, lines 19-35 *
 [X] US2006257413  (ZLOTNICK GARY W et al.) [X] 1,2,5-14,40-48 * paragraphs [0453] , [0454] * * example 2 * * abstract *
 [I] US2009035328  (GRANOFF DAN et al.) [I] 1-39 * paragraphs [0145] - [0147] * * paragraphs [0086] , [0096] , [0097] *
 [E] WO2011161653  (NOVARTIS AG et al.) [E] 1-39 * the whole document *
 [I] WO2009158142  (U S A AS REPRESENTED BY THE SE et al.) [I] 1,15-33 * paragraph [0062]; example -; claim - *
 [Y] US6245892  (OAKS EDWIN V et al.) [Y] 95-107 * column 10, lines 40-53 * * column 11, line 1 - column 12, line 29 *
 [I]   MASIGNANI V ET AL: "Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870", THE JOURNAL OF EXPERIMENTAL MEDICINE, ROCKEFELLER UNIVERSITY PRESS, US, vol. 197, no. 6, 17 March 2003 (2003-03-17), pages 789 - 799, XP002286107, ISSN: 0022-1007, DOI: 10.1084/JEM.20021911 [I] 1,15-33 * page 791, column r, lines 51-60 *

DOI:   http://dx.doi.org/10.1084/jem.20021911
 [Y]   HOUGHTEN R A: "GENERAL METHOD FOR THE RAPID SOLID-PHASE SYNTHESIS OF LARGE NUMBERS OF PEPTIDES: SPECIFICITY OF ANTIGEN-ANTIBODY INTERACTION AT THE LEVEL OF INDIVIDUAL AMINO ACIDS", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF USA, NATIONAL ACADEMY OF SCIENCE, WASHINGTON, DC; US, vol. 82, 1 August 1995 (1995-08-01), pages 5131 - 5135, XP000611717, ISSN: 0027-8424, DOI: 10.1073/PNAS.82.15.5131 [Y] 95-107 * page 5132, column l, line 26 - column r, line 12 *

DOI:   http://dx.doi.org/10.1073/pnas.82.15.5131
by applicantUS2006257413
 US2009202593
 WO0018434
   MCNEIL ET AL., VACCINE, vol. 27, 2009, pages 3417 - 3421
   WOLFF ET AL., BIOTECHNIQUES, vol. 11, no. 4, 1991, pages 474 - 85 [I] 1,15-33 * page 791, column r, lines 51-60 *
   SEDEGAH ET AL., PNAS, vol. 91, 1994, pages 9866 - 9870
   EGAN ET AL., VACCINE, vol. 27, no. 24, 2009, pages 3175 - 3180
OppositionWO2010109323
 US8398988
 WO2004032958
 US2005158334
 WO03009869
 WO2005102384
 WO2007127665
 WO2010028859
 WO2007071786
 WO0045841
 WO2010109323
 WO2004032958
   WANG ET AL.: "Dual effects of Tween 80 on protein stability", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 347, 2008, pages 31 - 38, XP022369793

DOI:   http://dx.doi.org/10.1016/j.ijpharm.2007.06.042
   TREUHEIT ET AL.: "Inverse Relationship of Protein Concentration and Aggregation", PHARMACEUTICAL RESEARCH, vol. 19, no. 4, April 2002 (2002-04-01), pages 511 - 516, XP055480316

DOI:   http://dx.doi.org/10.1023/A:1015108115452
   KERWIN: "Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: Structure and degradation pathways", J PHARMACEUTICAL SCIENCES, vol. 97, no. 8, August 2008 (2008-08-01), pages 2924 - 2935, XP055015864

DOI:   http://dx.doi.org/10.1002/jps.21190
   JIANG ET AL.: "Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease", VACCINE, vol. 28, 2010, pages 6086 - 6093, XP027204839
   GARIDEL, P. ; HOFFMANN, C. ; BLUME, A.: "A thermodynamic analysis of the binding interaction between polysorbate 20 and 80 with human serum albumins and immunoglobulins: A contribution to understand colloidal protein stabilisation", BIOPHYSICAL CHEMISTRY, ELSEVIER, AMSTERDAM, NL, vol. 143, no. 1-2, 1 July 2009 (2009-07-01), NL , pages 70 - 78, XP026140681, ISSN: 0301-4622, DOI: 10.1016/j.bpc.2009.04.004

DOI:   http://dx.doi.org/10.1016/j.bpc.2009.04.004
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