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Extract from the Register of European Patents

EP About this file: EP3250191

EP3250191 - TABLETS COMPRISING GLP-1 AGONIST AND ENTERIC COATING [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  15.12.2023
Database last updated on 09.04.2026
FormerGrant of patent is intended
Status updated on  03.09.2023
FormerExamination is in progress
Status updated on  06.04.2019
FormerRequest for examination was made
Status updated on  03.11.2017
FormerThe international publication has been made
Status updated on  01.09.2017
Most recent event   Tooltip02.01.2026New entry: Date of oral proceedings 
Applicant(s)For all designated states
Novo Nordisk A/S
Novo Allé
2880 Bagsværd / DK
[2017/49]
Inventor(s)01 / NISSEN, Birgitte
Novo Allé
2880 Bagsværd / DK
02 / NIELSEN, Flemming Seier
Novo Allé
2880 Bagsværd / DK
03 / GARIBAY, Patrick William
Novo Allé
2880 Bagsværd / DK
 [2017/49]
Application number, filing date16701684.928.01.2016
[2017/49]
WO2016EP51795
Priority number, dateEP2015015300029.01.2015         Original published format: EP 15153000
EP2015016258907.04.2015         Original published format: EP 15162589
WO2015EP5744207.04.2015         Original published format: PCT/EP2015/057442
EP2015018873707.10.2015         Original published format: EP 15188737
[2017/49]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2016120378
Date:04.08.2016
Language:EN
[2016/31]
Type: A1 Application with search report 
No.:EP3250191
Date:06.12.2017
Language:EN
The application published by WIPO in one of the EPO official languages on 04.08.2016 takes the place of the publication of the European patent application.
[2017/49]
Type: B1 Patent specification 
No.:EP3250191
Date:17.01.2024
Language:EN
[2024/03]
Search report(s)International search report - published on:EP04.08.2016
ClassificationIPC:A61K9/28, A61K9/50, A61K35/00, A61K38/26, A61P3/04, A61P3/10
[2023/38]
CPC:
A61K38/26 (EP,CN,US); A61K9/2886 (EP,CN,US); A61K35/00 (US);
A61K38/1709 (EP,US); A61K38/2278 (CN); A61K9/0053 (US);
A61K9/2013 (CN); A61K9/282 (US); A61K9/2846 (EP,CN,US);
A61K9/5026 (US); A61P3/04 (EP); A61P3/10 (EP);
A61P43/00 (EP) (-)
Former IPC [2017/49]A61K9/28, A61K9/50, A61K35/00
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 [2017/49]  
Extension statesBANot yet paid
MENot yet paid
Validation statesMANot yet paid
MDNot yet paid
TitleGerman:TABLETTEN MIT GLP-1-AGONISTEN UND MAGENSAFTRESISTENTEM ÜBERZUG[2017/49]
English:TABLETS COMPRISING GLP-1 AGONIST AND ENTERIC COATING[2017/49]
French:COMPRIMÉS CONTENANT UN AGONISTE DE GLP-1 ET REVÊTEMENT GASTRO-RÉSISTANT[2017/49]
Entry into regional phase29.08.2017National basic fee paid 
29.08.2017Designation fee(s) paid 
29.08.2017Examination fee paid 
Examination procedure08.08.2017Date on which the examining division has become responsible
29.08.2017Examination requested  [2017/49]
19.03.2018Amendment by applicant (claims and/or description)
10.04.2019Despatch of a communication from the examining division (Time limit: M04)
09.07.2019Reply to a communication from the examining division
19.05.2020Despatch of a communication from the examining division (Time limit: M04)
25.09.2020Reply to a communication from the examining division
03.05.2021Despatch of a communication from the examining division (Time limit: M04)
08.09.2021Reply to a communication from the examining division
13.01.2023Despatch of a communication from the examining division (Time limit: M04)
19.01.2023Reply to a communication from the examining division
04.09.2023Communication of intention to grant the patent
11.12.2023Fee for grant paid
11.12.2023Fee for publishing/printing paid
11.12.2023Receipt of the translation of the claim(s)
Opposition(s)Opponent(s)01  17.10.2024  18.10.2024  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Maiwald GmbH
Elisenhof
Elisenstraße 3
80335 München / DE
 [2024/48]
Former [2024/47]
Opponent(s)01  17.10.2024   
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Maiwald GmbH
Elisenhof
Elisenstraße 3
80335 München / DE
29.10.2024Invitation to proprietor to file observations on the notice of opposition
26.02.2025Reply of patent proprietor to notice(s) of opposition
24.11.2026Date of oral proceedings
Fees paidRenewal fee
31.01.2018Renewal fee patent year 03
31.01.2019Renewal fee patent year 04
31.01.2020Renewal fee patent year 05
01.02.2021Renewal fee patent year 06
31.01.2022Renewal fee patent year 07
31.01.2023Renewal fee patent year 08
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  TooltipCY28.01.2016
HU28.01.2016
CZ17.01.2024
HR17.01.2024
MC17.01.2024
PL17.01.2024
RO17.01.2024
SK17.01.2024
SM17.01.2024
TR17.01.2024
IE28.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
[2026/04]
Former [2025/41]CY28.01.2016
HU28.01.2016
CZ17.01.2024
HR17.01.2024
MC17.01.2024
PL17.01.2024
RO17.01.2024
SK17.01.2024
SM17.01.2024
IE28.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2025/37]CY28.01.2016
CZ17.01.2024
HR17.01.2024
MC17.01.2024
PL17.01.2024
RO17.01.2024
SK17.01.2024
SM17.01.2024
IE28.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2025/10]CZ17.01.2024
HR17.01.2024
MC17.01.2024
PL17.01.2024
RO17.01.2024
SK17.01.2024
SM17.01.2024
IE28.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/51]CZ17.01.2024
HR17.01.2024
MC17.01.2024
PL17.01.2024
RO17.01.2024
SK17.01.2024
SM17.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/49]CZ17.01.2024
HR17.01.2024
PL17.01.2024
RO17.01.2024
SK17.01.2024
SM17.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/48]CZ17.01.2024
HR17.01.2024
PL17.01.2024
SM17.01.2024
CH31.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/47]HR17.01.2024
PL17.01.2024
SM17.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/36]HR17.01.2024
PL17.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/34]HR17.01.2024
NO17.04.2024
RS17.04.2024
GR18.04.2024
IS17.05.2024
Former [2024/33]NO17.04.2024
IS17.05.2024
Former [2024/32]IS17.05.2024
Cited inInternational search[X] WO2014191545  (NOVO NORDISK AS et al.) [X] 1-15 * the whole document * * examples 1-9; claims 1-15 *
 [X] US2011142889  (LEE WILLIAM W et al.) [X] 1-15 * the whole document * * examples 1-17; claims 1-37 *
 [X] WO2009118722  (ORAMED PHARMACEUTICALS INC et al.) [X] 1-15 * the whole document * * claims 1-62 *
 [X] WO2014060472  (NOVO NORDISK AS et al.) [X] 1-15 * the whole document * * claims 1-15 *
 [A]   KNUDSEN LOTTE B ET AL: "Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration", JOURNAL OF MEDICINAL CHEMISTRY, AMERICAN CHEMICAL SOCIETY, US, vol. 43, no. 9, 4 May 2000 (2000-05-04), pages 1664 - 1669, XP002201014, ISSN: 0022-2623, DOI: 10.1021/JM9909645 [A] 1-15 * the whole document *

DOI:   http://dx.doi.org/10.1021/jm9909645
ExaminationWO2011084618
OppositionWO2014177683
 WO2010020978
 WO2011094531
 WO2006097537
   ASHOK KATDARE; MAHESH V. CHAUBAL: "Excipient development for pharmaceutical, biotechnology, and drug delivery systems", 1 January 2006, INFORMA HEALTHCARE , New York, ISBN: 978-0-8493-2706-3, article BAI JANE P.F, JIAN-HWA GUO , MAHESH V. CHAUBAL: "Chapter 12 Use of Nonactive Pharmaceutical Excipients in Oral Drug Formulations: Biopharmaceutical Classification System Considerations", pages: 181 - 195, XP093232462
   ANONYMOUS: "Eudragit Acrylic polymers for solid oral dosage forms", EVONK, vol. V 2.3, 1 August 2012 (2012-08-01), pages 1 - 16, XP093232470
   ANONYMOUS: "A Comparison of Delayed Release Film Coating Systems for Pharmaceutical Dosage Forms", ACRYL-EZE - COLORCON, 1 April 2011 (2011-04-01), pages 1 - 5, XP093232478
   ANONYMOUS: "Product Information ", ACRYL-EZE - COLORCON, 1 January 2011 (2011-01-01), pages 1 - 5, XP093232488
   RAYMOND C ROW , PAUL J SHESKEY , MARIAN E QUINN: "Handbook of Pharmaceutical Excipients sixth Edition", 1 January 2009, PHARMACEUTICAL PRESS, article ANONYMOUS : "Polymethacrylates", pages: 525 - 533, XP093232497
   C BEGLINGER, B POILER, E ARBIT, C GANZONI, S GASS, I GOMEZ-ORELLANA, J DREWE: "Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: A Proof-of-concept Study in Healthy Subjects", CLINICAL PHARMACOLOGY AND THERAPEUTICS, vol. 84, no. 4, 1 October 2008 (2008-10-01), US , pages 468 - 474, XP008149454, ISSN: 0009-9236, DOI: 10.1038/clpt.2008.35 * 468 - 474 *
   ROBERT E STEINERT, BIRK POLLER, M CRISTINA CASTELLI, JUERGEN DREWE, CHRISTOPH BEGLINGE: "Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects.", AMERICAN JOURNAL OF CLINICAL NUTRITION, vol. 92, no. 4, 1 October 2010 (2010-10-01), pages 810 - 817, XP002677085, ISSN: 0002-9165, DOI: 10.3945/ajcn.2010.29663

DOI:   http://dx.doi.org/10.3945/ajcn.2010.29663
   STEINERT ROBERT E , POLLER BIRK , CASTELLI M CRISTINA , DREWE JUERGEN , BEGLINGER CHRISTOPH: "Orally Administered Glucagon-Like Peptide-1 Affects Glucose Homeostasis Following an Oral Glucose Tolerance Test in Healthy Male Subjects", CLINICAL PHARMACOLOGY AND THERAPEUTICS, vol. 86, no. 6, 1 December 2009 (2009-12-01), US , pages 644 - 650, XP002635568, ISSN: 0009-9236, DOI: 10.1038/clpt.2009.159

DOI:   http://dx.doi.org/10.1038/clpt.2009.159
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.