Extract from the Register of European Patents

About this file: EP2750699

EP2750699 - PHARMACEUTICAL COMBINATION FOR USE IN GLYCEMIC CONTROL IN DIABETES TYPE 2 PATIENTS [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  06.07.2017
Database last updated on 07.12.2019
Most recent event   Tooltip01.10.2019Change: Date of oral proceedings 
01.10.2019Deletion: Despatch of minutes of oral proceedings 
Applicant(s)For all designated states
Sanofi-Aventis Deutschland GmbH
Brüningstraße 50
65929 Frankfurt am Main / DE
[2014/28]
Inventor(s)01 / NIEMÖLLER, Elisabeth
c/o Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt am Main / DE
02 / MÜHLEN-BARTMER, Isabel
c/o Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt am Main / DE
03 / SILVESTRE, Louise
c/o Sanofi-Aventis
Département Brevets
54 rue La Boétie
F-75008 Paris / FR
04 / BOKA, Gabor
c/o Sanofi-Aventis
Département Brevets
54 rue La Boétie
F-75008 Paris / FR
05 / MIOSSEC, Patrick
c/o Sanofi-Aventis
Département Brevets
54 rue La Boétie
F-75008 Paris / FR
 [2014/28]
Representative(s)Weickmann & Weickmann PartmbB
Postfach 860 820
81635 München / DE
[N/P]
Former [2015/30]Weickmann & Weickmann
Postfach 860 820
81635 München / DE
Former [2014/28]Weiss, Wolfgang , et al
Weickmann & Weickmann Patentanwälte Postfach 86 08 20
81635 München / DE
Application number, filing date12756417.727.08.2012
WO2012EP66617
Priority number, dateEP2011017914929.08.2011         Original published format: EP 11179149
[2014/28]
Filing languageEN
Procedural languageEN
PublicationType: A1  Application with search report
No.:WO2013030160
Date:07.03.2013
Language:EN
[2013/10]
Type: A1 Application with search report 
No.:EP2750699
Date:09.07.2014
Language:EN
The application has been published by WIPO in one of the EPO official languages on 07.03.2013
[2014/28]
Type: B1 Patent specification 
No.:EP2750699
Date:22.07.2015
Language:EN
[2015/30]
Search report(s)International search report - published on:EP07.03.2013
ClassificationInternational:A61K38/26, A61K31/155, A61K31/4439
[2014/28]
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 [2014/28]
Extension statesBA26.03.2014
ME26.03.2014
TitleGerman:PHARMAZEUTISCHE KOMBINATION ZUR VERWENDUNG BEI DER GLYKÄMISCHEN KONTROLLE VON PATIENTEN MIT TYP- 2-DIABETES[2014/28]
English:PHARMACEUTICAL COMBINATION FOR USE IN GLYCEMIC CONTROL IN DIABETES TYPE 2 PATIENTS[2014/28]
French:COMBINAISON PHARMACEUTIQUE DESTINÉE À ÊTRE UTILISÉE DANS LE CONTRÔLE DE LA GLYCÉMIE CHEZ DES PATIENTS SOUFFRANT DU DIABÈTE DE TYPE 2[2014/28]
Entry into regional phase26.03.2014National basic fee paid 
26.03.2014Designation fee(s) paid 
26.03.2014Examination fee paid 
Examination procedure08.05.2013Request for preliminary examination filed
International Preliminary Examining Authority: EP
26.03.2014Examination requested  [2014/28]
05.09.2014Amendment by applicant (claims and/or description)
12.02.2015Communication of intention to grant the patent
10.06.2015Fee for grant paid
10.06.2015Fee for publishing/printing paid
10.06.2015Receipt 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  12.02.2015
Opposition(s)Opponent(s)01  22.04.2016  29.04.2016  ADMISSIBLE
Generics (U.K.) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
FRKelly
27 Clyde Road
Dublin D04 F838 / IE
 [2017/39]
Former [2017/20]
Opponent(s)01  22.04.2016  29.04.2016  ADMISSIBLE
Generics (U.K.) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Scannell, Michael
FRKelly
27 Clyde Road
Dublin D04 F838 / IE
Former [2016/22]
Opponent(s)01  22.04.2016   
Generics (U.K.) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
O'Connell, Maura
FRKelly
27 Clyde Road
Ballsbridge
Dublin 4 / IE
03.06.2016Invitation to proprietor to file observations on the notice of opposition
10.10.2016Reply of patent proprietor to notice(s) of opposition
08.06.2017Date of oral proceedings
07.07.2017Despatch of minutes of oral proceedings
07.07.2017Despatch of communication that the patent will be revoked
Appeal following opposition07.09.2017Appeal received No.  T1982/17
17.11.2017Statement of grounds filed
28.04.2020Date of oral proceedings
Fees paidRenewal fee
13.08.2014Renewal fee patent year 03
Lapses during opposition  TooltipAL22.07.2015
MK22.07.2015
RS22.07.2015
SM22.07.2015
LU27.08.2015
IS22.11.2015
[2018/47]
Former [2018/31]MK22.07.2015
RS22.07.2015
SM22.07.2015
LU27.08.2015
IS22.11.2015
Former [2018/02]RS22.07.2015
SM22.07.2015
LU27.08.2015
IS22.11.2015
Former [2017/39]RS22.07.2015
SM22.07.2015
IS22.11.2015
Former [2016/10]RS22.07.2015
IS22.11.2015
Cited inInternational search[A]EP2324853  (SANOFI AVENTIS DEUTSCHLAND [DE]) [A] 1-18 * the whole document *;
 [I]  - U.S. National Institutes of Health, "GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone (GETGOAL-P)", (20110627), URL: http://clinicaltrials.gov/ct2/show/NCT00763815?term=lixisenatide+pioglitazone&rank=1, (20120120), XP002667584 [I] 1-18 * the whole document *
 [XP]  - Pierre Chancel, "NATIXIS CONFERENCE ON DIABETES,", Paris, (20111108), pages 1 - 23, Sanofi, URL: http://en.sanofi.com/Images/29120_2011-11-08_Natixis_Chancel.pdf, (20120120), XP002667585 [XP] 1-18 * page 19 *
 [Y]  - ZINMAN BERNARD ET AL, "Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD).", DIABETES CARE JUL 2009 LNKD- PUBMED:19289857, (200907), vol. 32, no. 7, ISSN 1935-5548, pages 1224 - 1230, XP002667606 [Y] 1-18 * the whole document *

DOI:   http://dx.doi.org/10.2337/DC08-2124
 [Y]  - Sanofi, "Positive Results for Investigational Compound Lyxumia®(Lixisenatide)", (20110624), pages 1 - 5, American Diabetes Associations71st Annual Scientific Sessions, URL: http://en.sanofi.com/Images/28303_20110627_LIXISENATIDE_ADA_en.pdf, (20120120), XP002667607 [Y] 1-18 * page 3 *
by applicantWO0104156
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    - DORMANDY ET AL., LANCET, (2005), vol. 366, pages 1270 - 89
    - YKI-JARVINEN, N ENGL J MED, (2004), vol. 351, pages 1106 - 18
OppositionWO2007006307
 EP2324853
    - "PHASE''.", Glossary Definition, URL: https://clinicaltrials.gov/ct2/help/glossary/phase, (20160226), XP055303219
    - CHRISTENSEN et al., "Lixisenatide, a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus", IDrugs, (20090000), vol. 12, no. 8, pages 503 - 513, XP009163477
    - CAMPÀS C et al., "AVE-0010 - GLP-1 Receptor Agonist Treatment of Diabetes", Drugs of the Future, (20081000), vol. 33, no. 10, pages 838 - 840, XP002572655

DOI:   http://dx.doi.org/10.1358/dof.2008.33.10.1265206
    - BUSE et al., "Use of Twice-Daily Exenatide in Basal Insulin-Treated Patients With Type 2 Diabetes", Annals of Internal Medicine, (20110118), vol. 154, no. 2, pages 103 - 112, XP002630544
    - Lippincott Williams & Wilkins, Remington: The Science and Practice of Pharmacy, USA, (20000000), XP055303325
    - "Body mass index", Wikipedia, (20160226), URL: https://en.wikipedia.org/wiki/Body_mass_index, (20160226), XP055303336
    - "Code of Federal Regulations Phases of an investigation", Food and Drug Administration, CFR - Code of Federal Regulations Title 21, Chapter 1, Subchapter D, Part 312.21, (20150000), XP055303342
    - "Lixisenatide.", Wikipedia, URL: https://en.wikipedia.org/wiki/Lixisenatide, (20160411), XP055120784
    - "Pioglitazone", Wikipedia, URL: https://en.uvikipedia.org/wiki/Pioglitazone, (20160411), XP055303360
    - "Metformin.", Wikipedia, URL: https://en.wikipedia.org/wiki/Metformin, (20160411), XP055290362
    - "Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: report of a WHO/IDF consultation", WHO, (20060000), URL: http://www.who.int/diabetes/publications/Definition%20and%20diagnosis%20of%20diabetes_new.pdf, (20160411), XP055303374
    - RATNER et al., "Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial", Diabetic Medicine, (20100000), vol. 27, no. 9, pages 1024 - 1032, XP002626157

DOI:   http://dx.doi.org/10.1111/J.1464-5491.2010.03020.X
    - "Lixisenatide significantly reduces HbA1c without increasing hypoglycemia in patients uncontrolled on sulfonylureas", Sanofi-aventis Press Release, Paris, France, (20110412), pages 1 - 2, URL: http://en.sanofi.com/Images/28334_20110412_LIXI_GETGOAL_S_EN.pdf, (20160411), XP055006128
    - MIYAZAKI et al., "Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone", Diabetes Care, (20010000), vol. 24, no. 4, pages 710 - 719, XP055303417

DOI:   http://dx.doi.org/10.2337/diacare.24.4.710
    - NATHAN et al., "Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy", Diabetes Care, (20090000), vol. 32, no. 1, pages 193 - 203, XP055302177

DOI:   http://dx.doi.org/10.2337/dc08-9025
    - "Standards of Medical Care in Diabetes-2011", Diabetes Care, (20110100), vol. 34, no. Supplement 1, pages S11 - S61, XP055303426
    - "Sanofi-aventis announces positive top-line Lixisenatide phase III results", Sanofi-aventis Press Release, Paris, France, (20110202), URL: http://en.sanofi.com/Images/13667_20110202_ Lixisenatide_en.pdf, (20160412), XP055302187
    - "Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes''.", U.S. National Institutes of Health, URL: https://clinicaltrials.gov/ct2/show?term=lixisenatide+and+diabetes&rank=5, (20160421), XP055303432
    - "Assessment report - Lyxumia", European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP), (20121128), URL: http://www.ema. europa .eu/docs/en_ GB /document_library/EPAR_- _Public_assessment_report/human/002445/WC500140449.pdf, (20160421), XP055303433
    - "GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone (GETGOAL-P", (20110627), URL: http://clinicaltrials.gov/ct2/show/NCT00763815?term=lixisenatide+pioglitazone&rank=1, (20120120), XP002667584
    - PIERRE CHANCEL, NATIXIS CONFERENCE ON DIABETES, Paris., (20111108), pages 1 - 23, URL: http://en.sanofi.com/Images/29120_ 2011-11-08 _Natixis Chancel.pdf [retrieved on 2012-01-20, XP002667585
    - ZINMAN et al., "Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+ TZD", Diabetes Care, (20090700), vol. 32, ISSN 1935-5548, pages 1224 - 1230, XP002667606

DOI:   http://dx.doi.org/10.2337/DC08-2124
    - "Sanofi: ''Positive Results for Investigational Compound Lyxumia® (Lixisenatide", American Diabetes Associations 71st Annual Scientific Sessions, (20110624), pages 1 - 5, URL: http://en.sanofi.com/Images/28303_20110627LIXISENATIDE_ADA_en.pdf, (20120120), XP002667607