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Extract from the Register of European Patents

EP About this file: EP2588090

EP2588090 - PHARMACEUTICAL ORAL DOSAGE FORMS COMPRISING DABIGATRAN ETEXILATE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS [Right-click to bookmark this link]
StatusPatent maintained as amended
Status updated on  20.10.2023
Database last updated on 06.07.2024
FormerThe patent has been granted
Status updated on  17.03.2017
FormerGrant of patent is intended
Status updated on  12.12.2016
Most recent event   Tooltip03.05.2024Lapse of the patent in a contracting state
New state(s): CZ		published on 05.06.2024  [2024/23]
Applicant(s)For all designated states
KRKA, tovarna zdravil, d.d., Novo mesto
Smarjeska cesta 6
8501 Novo mesto / SI
[2017/16]
Former [2013/19]For all designated states
Krka Tovarna Zdravil, D.D., Novo Mesto
Smarjeska cesta 6
8501 Novo Mesto / SI
Inventor(s)01 / KROSELJ, Vesna
Gasparijeva 10
1000 Ljubljana / SI
02 / JURSA KSELA, Sonja
Pod Trsko goro 18
8000 Novo mesto / SI
 [2017/16]
Former [2013/19]01 / KROSELJ, Vesna
Gasparijeva 10
1000 Ljubljana / SI
Representative(s)Uexküll & Stolberg
Partnerschaft von
Patent- und Rechtsanwälten mbB
Beselerstraße 4
22607 Hamburg / DE
[2017/16]
Former [2013/19]UEXKÜLL & STOLBERG
Patentanwälte
Beselerstrasse 4
22607 Hamburg / DE
Application number, filing date11732405.301.07.2011
[2017/16]
WO2011EP61140
Priority number, dateSI2010000020912.07.2010         Original published format: SI 201000209
SI2010000019601.07.2010         Original published format: SI 201000196
[2013/19]
Filing languageEN
Procedural languageEN
PublicationType: A2 Application without search report
No.:WO2012001156
Date:05.01.2012
Language:EN
[2012/01]
Type: A2 Application without search report 
No.:EP2588090
Date:08.05.2013
Language:EN
The application published by WIPO in one of the EPO official languages on 05.01.2012 takes the place of the publication of the European patent application.
[2013/19]
Type: B1 Patent specification 
No.:EP2588090
Date:19.04.2017
Language:EN
[2017/16]
Type: B2 New European patent specification 
No.:EP2588090
Date:22.11.2023
Language:EN
[2023/47]
Search report(s)International search report - published on:EP30.08.2012
ClassificationIPC:A61K9/50
[2013/19]
CPC:
A61K9/5078 (EP,US); A61K9/1682 (US); A61K31/4439 (EP,US);
A61K9/1617 (US); A61K9/1623 (US); A61K9/1652 (US);
A61K9/167 (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 [2013/19]
Extension statesBA18.12.2012
ME18.12.2012
TitleGerman:PHARMAZEUTISCHE ORALE DARREICHUNGSFORMEN MIT DABIGATRANETEXILAT SOWIE DESSEN PHARMAZEUTISCH ZULÄSSIGEN SALZEN[2013/19]
English:PHARMACEUTICAL ORAL DOSAGE FORMS COMPRISING DABIGATRAN ETEXILATE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS[2013/19]
French:FORMES PHARMACEUTIQUES POSOLOGIQUES ORALES COMPRENANT DE L'ÉTÉXILATE DE DABIGATRAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES[2013/19]
Entry into regional phase18.12.2012National basic fee paid 
18.12.2012Designation fee(s) paid 
18.12.2012Examination fee paid 
Examination procedure18.12.2012Examination requested  [2013/19]
19.08.2013Amendment by applicant (claims and/or description)
24.02.2014Despatch of a communication from the examining division (Time limit: M04)
07.07.2014Reply to a communication from the examining division
12.11.2014Observations by third parties
06.02.2015Despatch of a communication from the examining division (Time limit: M06)
17.08.2015Reply to a communication from the examining division
09.03.2016Despatch of a communication from the examining division (Time limit: M06)
19.09.2016Reply to a communication from the examining division
13.12.2016Communication of intention to grant the patent
13.02.2017Fee for grant paid
13.02.2017Fee for publishing/printing paid
13.02.2017Receipt 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  24.02.2014
Opposition(s)Opponent(s)01  16.01.2018  24.01.2018  ADMISSIBLE
Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 02  19.01.2018  25.01.2018  ADMISSIBLE
Eder, Michael
Marktstr. 4
80802 Munich / DE
Opponent's representative
Eder, Michael
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 03  19.01.2018  24.01.2018  ADMISSIBLE
Georg Kalhammer/Stephan Teipel
Lederer & Keller
Unsöldstrasse 2
80538 München / DE
 [N/P]
Former [2019/02]
Opponent(s)01  16.01.2018  24.01.2018  ADMISSIBLE
Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Elkington & Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 02  19.01.2018  25.01.2018  ADMISSIBLE
Eder, Michael
Marktstr. 4
80802 Munich / DE
Opponent's representative
Eder, Michael
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 03  19.01.2018  24.01.2018  ADMISSIBLE
Georg Kalhammer/Stephan Teipel
Lederer & Keller
Unsöldstrasse 2
80538 München / DE
Former [2018/13]
Opponent(s)01  16.01.2018  24.01.2018  ADMISSIBLE
Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Thavies Inn House
3-4 Holborn Circus
London EC1N 2HA / GB
 02  19.01.2018  25.01.2018  ADMISSIBLE
Eder, Michael
Marktstr. 4
80802 Munich / DE
Opponent's representative
Eder, Michael
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 03  19.01.2018  24.01.2018  ADMISSIBLE
Georg Kalhammer/Stephan Teipel
Lederer & Keller
Unsöldstrasse 2
80538 München / DE
Former [2018/09]
Opponent(s)01  16.01.2018  24.01.2018  ADMISSIBLE
Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Thavies Inn House
3-4 Holborn Circus
London EC1N 2HA / GB
 02  19.01.2018  25.01.2018  ADMISSIBLE
Eder, Michael
Marktstr. 4
80802 Munich / DE
Opponent's representative
Eder, Michael
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 03  19.01.2018  24.01.2018  ADMISSIBLE
Lederer & Keller Patentanwälte Partnerschaft mbB
Unsöldstr. 2
80538 München / DE
Former [2018/08]
Opponent(s)01  16.01.2018   
Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Thavies Inn House
3-4 Holborn Circus
London EC1N 2HA / GB
06.02.2018Invitation to proprietor to file observations on the notice of opposition
18.06.2018Reply of patent proprietor to notice(s) of opposition
02.05.2019Date of oral proceedings
17.06.2019Despatch of minutes of oral proceedings
10.11.2021Despatch of a communication from the opposition division (Time limit: M02)
06.01.2022Reply to a communication from the opposition division
29.06.2022Despatch of a communication from the opposition division (Time limit: M02)
01.09.2022Reply to a communication from the opposition division
22.02.2023Despatch of interlocutory decision in opposition
04.03.2023Legal effect of interlocutory decision in opposition
11.07.2023Despatch of communication that the patent will be maintained as amended
11.10.2023Fee for printing new specification paid
Appeal following opposition23.08.2019Appeal received No.  T2149/19
28.10.2019Statement of grounds filed
25.06.2021Result of appeal procedure: maintenance in amended form
14.07.2021Despatch of the decision of the Board of Appeal
26.07.2019Appeal received No.  T2149/19
28.10.2019Statement of grounds filed
25.06.2021Result of appeal procedure: maintenance in amended form
14.07.2021Despatch of the decision of the Board of Appeal
25.06.2021Date of oral proceedings
Fees paidRenewal fee
25.07.2013Renewal fee patent year 03
14.07.2014Renewal fee patent year 04
10.07.2015Renewal fee patent year 05
11.07.2016Renewal fee patent year 06
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  TooltipHU01.07.2011
AL19.04.2017
AT19.04.2017
CY19.04.2017
CZ19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
MK19.04.2017
NL19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
TR19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
[2024/23]
Former [2024/21]HU01.07.2011
AL19.04.2017
AT19.04.2017
CY19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
MK19.04.2017
NL19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
TR19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2020/33]HU01.07.2011
AL19.04.2017
AT19.04.2017
CY19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
MK19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
TR19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2020/15]HU01.07.2011
AT19.04.2017
CY19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
MK19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
TR19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2019/51]HU01.07.2011
AT19.04.2017
CY19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
MK19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2019/46]HU01.07.2011
AT19.04.2017
CY19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2019/31]HU01.07.2011
AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2019/30]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
MC19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2018/43]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
LU01.07.2017
MT01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2018/34]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
LU01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2018/23]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
IE01.07.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2018/21]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
CH31.07.2017
LI31.07.2017
IS19.08.2017
Former [2018/11]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
SM19.04.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
IS19.08.2017
Former [2018/10]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RO19.04.2017
RS19.04.2017
SE19.04.2017
SK19.04.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
IS19.08.2017
Former [2018/09]AT19.04.2017
DK19.04.2017
EE19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RS19.04.2017
SE19.04.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
IS19.08.2017
Former [2017/50]AT19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
LV19.04.2017
RS19.04.2017
SE19.04.2017
BG19.07.2017
NO19.07.2017
GR20.07.2017
IS19.08.2017
Former [2017/49]AT19.04.2017
FI19.04.2017
HR19.04.2017
LT19.04.2017
NO19.07.2017
GR20.07.2017
IS19.08.2017
Cited inInternational search[XY]WO2009097156  (BARR LAB INC [US], et al) [X] 9,10,12,13,15-18 * paragraphs [0001] , [0002] , [0010] , [0040]; examples 1,2 * [Y] 1-8,11,14,19-27;
 [Y]WO2010007016  (BOEHRINGER INGELHEIM INT [DE], et al) [Y] 1-8,11,14,19-27* page 2, lines 26-35; example 1 *
by applicantWO9837075
 WO03074056
 WO2005018615
 WO2005023249
 WO2005028468
 WO2009118321
 WO2009118322
 WO2010007016
otherWO2009097156
 WO2010007016
    - MANIVANNAN G.ET AL, "MULTIPARTICULATE DRUG DELIVERY SYSTEM:PELLET& PELLETIZATION TECHNIQUE", DRUG INVENTION TODAY, (201005), vol. 2, no. 5, pages 233 - 237, XP003035614
    - NASTRUZZI C . ET AL, "INFLUENCE OF FORMULATION AND PROCESS PARAMETERS ON PELLET PRODUCTION BY POWDER LAYERING TECHNIQUE", AAPS PHARMSCITECH, (2000), vol. 1, no. 2, pages 1 - 12, XP003035615
OppositionWO2009097156
 WO2010007016
 US2003181488
 WO03074056
    - MANIVANNAN et al., "Multiparticulate drug delivery systems: Pellet and pelletization technique", Drug Invention Today, (20100501), vol. 2, no. 5, pages 233 - 237, XP003035614
    - NASTRUZZI et al., "Influence of formulation and process parameters on pellet production by powder layering technique", AAPS PharmSciTech, (20000000), vol. 1, no. 2, pages 1 - 12, XP003035615
    - J. M. KANDUKURI et al., "Pelletization techniques for oral drug delivery", Int J Pharm Sci, (20090000), vol. 1, no. 2, pages 63 - 70, XP008159757
    - "2.8.3 Protamine sulphate", Anonymous, British National Formulary, BNF 56, BMJ Group, (20080900), page 2pp, 129, XP055510880
    - "CHMP Assessment Report for Pradaxa", European Medicines Agency (EMEA), London, (20080000), pages 1 - 36, XP055003938
    - MANIVANNAN et al., "MULTIPARTICULATE DRUG DELIVERY SYSTEM:PELLET& PELLETIZATION TECHNIQUE", Drug Invention Today, (20100501), vol. 2, no. 5, pages 233 - 237, XP003035614
    - NASTRUZZI et al., "INFLUENCE OF FORMULATION AND PROCESS PARAMETERS ON PELLET PRODUCTION BY POWDER LAYERING TECHNIQUE", AAPS PharmSciTech, (20000000), vol. 1, no. 2, pages 1 - 12, XP003035615
    - DEY N S; MAJUMDAR S; MEB RAO, "Multiparticulate drug delivery systems for controlled release", Tropical Journal of Pharmaceutical Research,, vol. 7, no. 3, (20080901), pages 1067 - 1075, XP002646988
    - R. MANIVANNAN et al., "Multiparticulate drug delivery systems: Pellet & pelletization technique", Drug Invention Today, (20100000), vol. 2, no. 5, pages 233 - 237, XP003035614
    - C. NASTRUZZI et al., "Influence of Formulation and Process Parameters on Pellet Production by Powder Layering Technique", AAPS PharmSciTech, (20000000), vol. 1, no. 2, pages 1 - 12, XP003035615
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.