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Extract from the Register of European Patents

EP About this file: EP2691109

EP2691109 - PREVENTION OF HYPOGLYCAEMIA IN DIABETES MELLITUS TYPE 2 PATIENTS [Right-click to bookmark this link]
StatusPatent revoked
Status updated on  15.02.2022
Database last updated on 03.04.2025
Most recent event   Tooltip06.09.2024Change - lapse in a contracting state
Updated state(s): MT		published on 09.10.2024  [2024/41]
Applicant(s)For all designated states
Sanofi-Aventis Deutschland GmbH
Brüningstraße 50
65929 Frankfurt am Main / DE
[2015/29]
Former [2014/06]For all designated states
Sanofi-Aventis Deutschland GmbH
Brüningstraße 50
65929 Frankfurt / DE
Inventor(s)01 / BOKA, Gabor
Sanofi
Département Brevets
54 rue La Boétie
F-75008 Paris / FR
02 / SILVESTRE, Louise
Sanofi
Département Brevets
54 rue La Boétie
F-75008 Paris / FR
03 / MIOSSEC, Patrick
Sanofi
Département Brevets
54 rue La Boétie
F-75008 Paris / FR
 [2014/06]
Representative(s)Weickmann & Weickmann PartmbB
Postfach 860 820
81635 München / DE
[N/P]
Former [2015/29]Weickmann & Weickmann
Postfach 860 820
81635 München / DE
Former [2014/06]Weiss, Wolfgang, et al
Weickmann & Weickmann Postfach 860820
81635 München / DE
Application number, filing date12712106.929.03.2012
WO2012EP55660
Priority number, dateEP2011016027029.03.2011         Original published format: EP 11160270
[2014/06]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2012130955
Date:04.10.2012
Language:EN
[2012/40]
Type: A1 Application with search report 
No.:EP2691109
Date:05.02.2014
Language:EN
The application published by WIPO in one of the EPO official languages on 04.10.2012 takes the place of the publication of the European patent application.
[2014/06]
Type: B1 Patent specification 
No.:EP2691109
Date:15.07.2015
Language:EN
[2015/29]
Search report(s)International search report - published on:EP04.10.2012
ClassificationIPC:A61K38/26, A61K31/64, A61P3/08
[2014/06]
CPC:
A61K38/26 (EP,KR,US); A61K31/155 (EP,US); A61K31/64 (EP,KR,US);
A61P25/00 (EP); A61P25/06 (EP); A61P25/22 (EP);
A61P27/02 (EP); A61P3/00 (EP); A61P3/04 (EP);
A61P3/08 (EP); A61P3/10 (EP); A61P43/00 (EP);
A61P9/00 (EP) (-)
C-Set:
A61K31/155, A61K2300/00 (US,EP);
A61K31/64, A61K2300/00 (US,EP);
A61K38/26, A61K2300/00 (EP,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 [2014/06]
Extension statesBA09.10.2013
ME09.10.2013
TitleGerman:VORBEUGUNG VON HYPOGLYKÄMIE BEI PATIENTEN MIT DIABETES MELLITUS TYP 2[2014/06]
English:PREVENTION OF HYPOGLYCAEMIA IN DIABETES MELLITUS TYPE 2 PATIENTS[2014/06]
French:PRÉVENTION DE L'HYPOGLYCÉMIE CHEZ DES PATIENTS ATTEINTS DU DIABÈTE SUCRÉ DE TYPE 2[2014/06]
Entry into regional phase09.10.2013National basic fee paid 
09.10.2013Designation fee(s) paid 
09.10.2013Examination fee paid 
Examination procedure29.01.2013Request for preliminary examination filed
International Preliminary Examining Authority: EP
09.10.2013Examination requested  [2014/06]
30.04.2014Amendment by applicant (claims and/or description)
09.02.2015Communication of intention to grant the patent
03.06.2015Fee for grant paid
03.06.2015Fee for publishing/printing paid
03.06.2015Receipt 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  09.02.2015
Opposition(s)Opponent(s)01  15.04.2016  21.04.2016  ADMISSIBLE
Generics (U.K.) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
FRKelly
Waterways House
Grand Canal Quay
Dublin D02 PD39 / IE
 [N/P]
Former [2017/40]
Opponent(s)01  15.04.2016  21.04.2016  ADMISSIBLE
Generics (U.K.) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
FRKelly
27 Clyde Road
Dublin D04 F838 / IE
Former [2016/21]
Opponent(s)01  15.04.2016  21.04.2016  ADMISSIBLE
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
25.05.2016Invitation to proprietor to file observations on the notice of opposition
30.09.2016Reply of patent proprietor to notice(s) of opposition
19.10.2017Date of oral proceedings
27.11.2017Despatch of interlocutory decision in opposition
27.11.2017Despatch of minutes of oral proceedings
14.10.2021Legal effect of revocation of patent [2022/12]
03.12.2021Despatch of communication that the patent will be revoked
Appeal following opposition29.01.2018Appeal received No.  T0256/18
09.04.2018Statement of grounds filed
14.10.2021Result of appeal procedure: revocation of the patent
03.12.2021Despatch of the decision of the Board of Appeal
23.01.2018Appeal received No.  T0256/18
15.03.2018Statement of grounds filed
14.10.2021Result of appeal procedure: revocation of the patent
03.12.2021Despatch of the decision of the Board of Appeal
14.10.2021Date of oral proceedings
Fees paidRenewal fee
12.03.2014Renewal fee patent year 03
10.03.2015Renewal fee patent year 04
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  TooltipAL15.07.2015
IS15.07.2015
MK15.07.2015
MT15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
HR29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
RO29.03.2020
SK29.03.2020
HU30.03.2020
SE30.03.2020
SI30.03.2020
DK31.03.2020
EE31.03.2020
MC31.03.2020
NO31.03.2020
BG30.11.2020
[2024/41]
Former [2024/40]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
HR29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
MT29.03.2020
RO29.03.2020
SK29.03.2020
HU30.03.2020
SE30.03.2020
SI30.03.2020
DK31.03.2020
EE31.03.2020
MC31.03.2020
NO31.03.2020
BG30.11.2020
Former [2021/36]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
HR29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
RO29.03.2020
SK29.03.2020
HU30.03.2020
SE30.03.2020
SI30.03.2020
DK31.03.2020
EE31.03.2020
MC31.03.2020
NO31.03.2020
BG30.11.2020
Former [2021/20]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
HR29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
RO29.03.2020
SK29.03.2020
HU30.03.2020
SE30.03.2020
DK31.03.2020
EE31.03.2020
MC31.03.2020
NO31.03.2020
BG30.11.2020
Former [2021/10]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
HR29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
RO29.03.2020
SK29.03.2020
HU30.03.2020
SE30.03.2020
EE31.03.2020
MC31.03.2020
NO31.03.2020
BG30.11.2020
Former [2021/08]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
RO29.03.2020
HU30.03.2020
SE30.03.2020
MC31.03.2020
NO31.03.2020
BG30.11.2020
Former [2021/07]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
IE29.03.2020
LT29.03.2020
LV29.03.2020
RO29.03.2020
MC31.03.2020
NO31.03.2020
Former [2020/50]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
LV29.03.2020
RO29.03.2020
MC31.03.2020
Former [2020/49]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
CY29.03.2020
CZ29.03.2020
FI29.03.2020
RO29.03.2020
MC31.03.2020
Former [2020/48]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
FI29.03.2020
RO29.03.2020
Former [2018/47]AL15.07.2015
IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
Former [2018/31]IS15.07.2015
MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
Former [2018/29]MK15.07.2015
RS15.07.2015
SM15.07.2015
LU29.03.2016
Former [2016/47]RS15.07.2015
LU29.03.2016
Former [2016/11]RS15.07.2015
Cited inInternational search[Y]  - CHRISTENSEN M ET AL, "Lixisenatide, a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus", I DRUGS: THE INVESTIGATIONAL DRUGS JOURNAL, CURRENT DRUGS LTD, GB, (20090801), vol. 12, no. 8, ISSN 2040-3410, pages 503 - 513, XP002572656 [Y] 1-18 * abstract *
 [Y]  - CAMPAS C ET AL, "AVE-0010 GLP-1 Receptor Agonist Treatment of Diabetes", DRUGS OF THE FUTURE, PROUS SCIENCE, ES, (20081001), vol. 33, no. 10, doi:10.1358/DOF.2008.33.10.1265206, ISSN 0377-8282, pages 838 - 840, XP002572655 [Y] 1-18 * p. 838, col. 2, "Fear of hypoglycemia ..." * p. 839, col. 2, §3-§4 * * p. 840, col. 1, §1-§2 *

DOI:   http://dx.doi.org/10.1358/dof.2008.33.10.1265206
 [Y]  - KENDALL DAVID M ET AL, "Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea.", DIABETES CARE MAY 2005 LNKD- PUBMED:15855571, (200505), vol. 28, no. 5, ISSN 0149-5992, pages 1083 - 1091, XP002658236 [Y] 1-18 * abstract * * p. 1087, bridging § col. 2-3 *
 [Y]  - RATNER R E 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, JOHN WILEY & SONS, LTD, GB, vol. 27, no. 9, doi:10.1111/J.1464-5491.2010.03020.X, ISSN 0742-3071, (20100901), pages 1024 - 1032, (20100430), XP002626157 [Y] 1-18 * abstract * * p. 1026, col. 2, §5 * * p. 1030, col. 2, §2, "The risks of hypoglycemia... were low " *;; table 3 *

DOI:   http://dx.doi.org/10.1111/J.1464-5491.2010.03020.X
 [T]  - Anonymous, "Lixisenatide Significantly Reduces HbA1c Without Increasing Hypoglycemia in Patients Uncontrolled on Sulfonylureas", (20110412), pages 1 - 2, URL: http://en.sanofi.com/binaries/20110412_LIXI_GETGOAL_S_EN_tcm28-31652.pdf, (20110902), XP055006128 [T] 1-18 * the whole document *
 [T]  - Anonymous, "Additional positive results from global Phase III program with lixisenatide for Type 2 Diabetes", (20110412), pages 1 - 2, URL: http://files.shareholder.com/downloads/ABEA-58QR0J/0x0x458202/3ccd84a6-5f99-451a-ada0-0a8282da3dad/ZEAL_News_2011_4_12_Company_Releases.pdf, (20110902), XP055006131 [T] 1-18 * the whole document *
by applicantWO0104156
    - "American diabetes association, workgroup on hypoglycemia: Defining and Reporting Hypoglycemia in Diabetes", DIABETES CARE, (2005), vol. 28, no. 5, pages 1245 - 1249
    - KENDALL, DIABETES CARE, (2005), vol. 28, no. 5, pages 1083 - 1091
    - RATNER, DIABET. MED., (2010), vol. 27, pages 1024 - 1032
Opposition   - "PHASE definition", ClinicalTrials.gov, (20160000), URL: https://clinicaltrials.gov/ct2/help/glossary/phase, (20160226), XP055293663
    - sanofi-Aventis, "NCT00713830 A Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea", ClinicalTrials.gov, (20080713), URL: https://clinicaltrials.gov/archive/NCT00713830/2008_07_13, (20160316), XP055302129
    - "New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study", Sanofi-aventis, (20080607), pages 1 - 2, URL: http://en.sanofi.com/Images/14190_080607_AVE0010_ENG.pdf, (20160316), XP002572653
    - Eva Steiness, "Sanofi-Aventis finalize phase IIa clinical study with GLP-1 agonist for type 2 diabetes licensed from Zealand Pharma", Zealand Pharma, (20050303), URL: http://files.shareholder.com/downloads/ABEA-58QR0J/0x0x413116/0144134c-5f2a-40b6-9a34-9cf10d2ef20f/413116.pdf, (20160316), XP055302136
    - "A promising R&D portfolio , well positioned to deliver future growth", Sanofi-aventis, (20070917), URL: http://en.sanofi.com/Images/14435-070917-RD-pdf.pdf, (20160316), XP055302140
    - sanofi-Aventis, "NCT01169779 Efficacy and Safety of Lixisenatide in Patients With T2DM Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period", ClinicalTrials.gov, (20110328), URL: https://clinicaltrials.gov/archive/NCT01169779/2011_03_28, (20160316), XP055302145
    - Sanofi-Aventis, "NCT00866658 Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea", ClinicalTrials.gov, (20100119), URL: https://clinicaltrials.gov/archive/NCT00866658/2010_01_19, (20160316), XP055302148
    - "Low Blood Glucose (Hypoglycemia)", National Institute of Diabetes and Digestive and Kidney Diseases, (20081000), URL: http://www.niddk.nih.gov/health-information/health-topics/Diabetes/hypoglycemia/Pages/index.aspx, (20160316), XP055302151
    - Aquilante, "Sulfonylurea pharmacogenomics in Type 2 diabetes: the influence of drug target and diabetes risk polymorphisms", Expert Rev Cardiovasc Ther, (20100300), vol. 8, no. 3, pages 359 - 372, XP009179549

DOI:   http://dx.doi.org/10.1586/erc.09.154
    - 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
    - SRINIVASAN et al., "Animal models in type 2 diabetes research: An overview", Indian J Med Res, (20070000), vol. 125, no. 3, pages 451 - 472, XP002547471
    - KIM et al., "Retinopathy in Monkeys with Spontaneous Type 2 Diabetes", Investigative Ophthalmology & Visual Science, (20040000), vol. 45, no. 12, pages 4543 - 4553, XP055302181

DOI:   http://dx.doi.org/10.1167/iovs.04-0519
    - JOHNSON et al., "Diabetes, Insulin Resistance, and Metabolic Syndrome in Horses", Journal of Diabetes Science and Technology, (20120000), vol. 6, no. 3, pages 534 - 540, XP055302183

DOI:   http://dx.doi.org/10.1177/193229681200600307
    - Marisol Peron, "Sanofi-aventis Announces Positive Top-line Lixisenatide Phase III Results", Sanofi-aventis, (20110202), URL: http://en.sanofi.com/Images/13667_20110202_Lixisenatide_en.pdf, (20160412), XP055302187
    - 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, XP055302191
    - CAMPÀS et al., "AVE-0010- GLP-1 Receptor Agonist Treatment of Diabetes", Drugs of the Future, (20080000), vol. 33, no. 10, pages 838 - 840, XP002572655

DOI:   http://dx.doi.org/10.1358/dof.2008.33.10.1265206
    - KENDALL et al., "Effects of exenatide (exendin-4) on glycaemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea.", Diabetes Care, (20050500), vol. 28, no. 5, pages 1083 - 1091, XP002658236
    - 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, GB, (20100000), vol. 28, no. 9, pages 1024 - 1032, XP002626157

DOI:   http://dx.doi.org/10.1111/J.1464-5491.2010.03020.X
    - Marisol Peron, "Lixisenatide Significantly Reduces HbA1c Without Increasing Hypoglycaemia in Patients Uncontrolled on Sulfonylureas", Sanofi-aventis, (20110412), URL: http://en.sanofi.com/Images/28334_20110412_LIXI_GETGOAL_S_EN.pdf, (20160316), XP055006128
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.