Extract from the Register of European Patents

About this file: EP2317997

EP2317997 - LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF [Right-click to bookmark this link]
StatusNo opposition filed within time limit
Status updated on  26.05.2017
Database last updated on 23.08.2017
Most recent event   Tooltip11.08.2017Lapse of the patent in a contracting state
New state(s): SI
published on 13.09.2017 [2017/37]
Applicant(s)For all designated states
Vivus, Inc.
900 E.Hamilton Ave Suite 550
Campbell CA 95008 / US
[2017/03]
Former [2016/52]For all designated states
Vivus, Inc.
351 E. Evelyn Avenue
Mountain View, CA 94041 / US
Former [2016/29]For all designated states
Vivus, Inc.
1172 Castro Street
Mountain View, CA 94040 / US
Former [2011/19]For all designated states
Vivus, Inc.
1172 Castro Street
Mountain View, CA 94040 / US
Inventor(s)01 / NAJARIAN, Thomas
2787 Rodman Drive
Los Osos CA 93402 / US
02 / TAM, Peter, Y.
404 Wembley Court
Redwood City CA 94061 / US
03 / WILSON, Leland, F.
164 East Creek Drive
Menlo Park CA 94025 / US
 [2011/19]
Representative(s)Cooley (UK) LLP
Dashwood
69 Old Broad Street
London EC2M 1QS / GB
[2016/29]
Former [2013/15]Mintz Levin Cohn Ferris Glovsky and Popeo LLP
Alder Castle
10 Noble Street
London EC2V 7JX / GB
Former [2011/19]Finnie, Isobel Lara , et al
Mintz Levin Cohn Ferris Glovsky and Popeo Intellectual Property LLP Alder Castle 10 Noble Street London
EC2V 7JX / GB
Application number, filing date09763479.409.06.2009
[2011/19]
WO2009US46804
Priority number, dateUS2008013595309.06.2008         Original published format: US 135953
[2011/19]
Filing languageEN
Procedural languageEN
PublicationType: A1  Application with search report
No.:WO2009152189
Date:17.12.2009
Language:EN
[2009/51]
Type: A1 Application with search report 
No.:EP2317997
Date:11.05.2011
Language:EN
The application has been published by WIPO in one of the EPO official languages on 17.12.2009
[2011/19]
Type: B1 Patent specification 
No.:EP2317997
Date:20.07.2016
Language:EN
[2016/29]
International and Supplementary
search report(s)
International search report -
published on:
EP17.12.2009
ClassificationInternational:A61K31/35, A61K31/137, A61P3/04, A61K31/135, A61K9/16, A61K9/48, A61K9/50, A61K31/357, A61K31/7048, A61K31/00, A61K47/38
[2016/11]
Former International [2011/19]A61K31/35, A61K31/137, A61P3/04
Designated contracting statesAT,   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,   SE,   SI,   SK,   TR [2016/29]
Former [2011/19]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,  SE,  SI,  SK,  TR 
TitleGerman:NIEDRIG DOSIERTE TOPIRAMAT/PHENTERMIN-ZUSAMMENSETZUNG UND ANWENDUNGSVERFAHREN[2011/19]
English:LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF[2011/19]
French:COMPOSITION DE TOPIRAMATE/PHENTERMINE À FAIBLE DOSE ET SES PROCÉDÉS D UTILISATION[2011/19]
Entry into regional phase07.01.2011National basic fee paid 
07.01.2011Designation fee(s) paid 
07.01.2011Examination fee paid 
Examination procedure07.01.2011Examination requested  [2011/19]
12.04.2011Amendment by applicant (claims and/or description)
05.07.2012Despatch of a communication from the examining division (Time limit: M06)
25.04.2013Reply to a communication from the examining division
06.11.2013Observations by third parties
17.01.2014Despatch of a communication from the examining division (Time limit: M06)
21.08.2014Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time
15.10.2014Reply to a communication from the examining division
10.02.2016Cancellation of oral proceeding that was planned for 16.02.2016
16.02.2016Date of oral proceedings (cancelled)
09.03.2016Communication of intention to grant the patent
31.05.2016Fee for grant paid
31.05.2016Fee for publishing/printing paid
31.05.2016Receipt 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  05.07.2012
Opposition(s)21.04.2017No opposition filed within time limit [2017/26]
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the examination report
15.10.2014Request for further processing filed
15.10.2014Full payment received (date of receipt of payment)
Request granted
27.10.2014Decision despatched
The application is deemed to be withdrawn due to failure to reply to the examination report
25.04.2013Request for further processing filed
25.04.2013Full payment received (date of receipt of payment)
Request granted
14.05.2013Decision despatched
Fees paidRenewal fee
27.06.2011Renewal fee patent year 03
30.03.2012Renewal fee patent year 04
27.06.2013Renewal fee patent year 05
27.06.2014Renewal fee patent year 06
10.06.2015Renewal fee patent year 07
10.06.2016Renewal fee patent year 08
Lapses during opposition  TooltipCZ20.07.2016
EE20.07.2016
HR20.07.2016
LT20.07.2016
LV20.07.2016
PL20.07.2016
RO20.07.2016
SI20.07.2016
SK20.07.2016
BG20.10.2016
NO20.10.2016
IS20.11.2016
[2017/37]
Former [2017/31]CZ20.07.2016
EE20.07.2016
HR20.07.2016
LT20.07.2016
LV20.07.2016
PL20.07.2016
RO20.07.2016
SK20.07.2016
BG20.10.2016
NO20.10.2016
IS20.11.2016
Former [2017/21]HR20.07.2016
LT20.07.2016
LV20.07.2016
PL20.07.2016
NO20.10.2016
IS20.11.2016
Former [2017/11]HR20.07.2016
LT20.07.2016
PL20.07.2016
NO20.10.2016
IS20.11.2016
Former [2017/09]LT20.07.2016
NO20.10.2016
Former [2017/07]LT20.07.2016
Cited inInternational search[X]US2004002462  (NAJARIAN THOMAS [US]) [X] 1-41 * column 3, line 5-34; column 12, line 59 - column 15, line 6 *;
 [X]WO2006063078  (ELAN CORP PLC [IE], et al) [X] 1-3,8,11,12,23-27 * page 11, line 21 - page 12, line 7; page 14, line 4-22; page 16, line 7-9 *;
 [A]  - ROSENSTOCK J ET AL, "A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients", DIABETES CARE 200705 US, (200705), vol. 30, no. 6, ISSN 0149-5992 0149-5992, pages 1480 - 1486, XP002538362 [A] 1-41 * page 1484-1485, paragraph entitled "Conclusions" *

DOI:   http://dx.doi.org/10.2337/dc06-2001
Examination   - GARVEY W T ET AL, "Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study", THE AMERICAN JOURNAL OF CLINICAL NUTRITION, AMERICAN SOCIETY FOR NUTRITION, US, vol. 95, no. 2, doi:10.3945/AJCN.111.024927, ISSN 0002-9165, (20120201), pages 297 - 308, (20111207), XP002734676

DOI:   http://dx.doi.org/10.3945/ajcn.111.024927
    - GADDE KISHORE M ET AL, "Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial", LANCET (NORTH AMERICAN EDITION), (201104), vol. 377, no. 9774, ISSN 0140-6736, pages 1341 - 1352,
    - David B. Allison ET AL, "Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP)", OBESITY RESEARCH, US, (20111103), vol. 20, no. 2, doi:10.1038/oby.2011.330, ISSN 1930-7381, pages 330 - 342, XP055243843

DOI:   http://dx.doi.org/10.1038/oby.2011.330
    - ANONYMOUS, "VIVUS Reports Third Quarter 2007 Financial Results and Highlights", (20071109), pages 1 - 6, URL: http://www.sec.gov/Archives/edgar/data/881524/000110465907081447/a07-28993_1ex99d1.htm, (20160210), XP055248952
    - "HIGHLIGHTS OF PRESCRIBING INFORMATION QSYMIA", (20130401), page 36PP, URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf, (20160210), XP055249005
    - ANONYMOUS, "HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPAMAX; SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPAMAX", (20141201), page 72PP, URL: http://www.topamax.com/sites/default/files/topamax.pdf#zoom=100, (20160210), XP055249011
    - BOOTSMA H P R ET AL, "Topiramate in clinical practice: long-term experience in patients with refractory epilepsy referred to a tertiary epilepsy center", EPILEPSY AND BEHAVIOR, ACADEMIC PRESS, SAN DIEGO, CA, US, (20040601), vol. 5, no. 3, doi:10.1016/J.YEBEH.2004.03.002, ISSN 1525-5050, pages 380 - 387, XP004760397

DOI:   http://dx.doi.org/10.1016/j.yebeh.2004.03.002
    - Miki L Campbell, "THERAPY UPDATE Obesity Pharmacologic options for the treatment of obesity", Am J Health-Syst Pharm-Vol, (20010715), pages 1301 - 1308, URL: http://www.ajhp.org/content/58/14/1301.full.pdf, (20160210), XP055249018
otherUS2004002462
 WO2006063078