Extract from the Register of European Patents

About this file: EP2168974

EP2168974 - Process for the preparation of Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP) [Right-click to bookmark this link]
Former [2010/13]Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP) with less than 0.2 % impurity
[2010/14]
StatusPatent revoked
Status updated on  19.10.2018
Database last updated on 27.01.2020
Most recent event   Tooltip19.10.2018Revocation of patentpublished on 21.11.2018  [2018/47]
19.10.2018New entry: Despatch of communication that patent is revoked 
Applicant(s)For all designated states
Bayer Intellectual Property GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein / DE
[2014/26]
Former [2011/34]For all designated states
Bayer Pharma Aktiengesellschaft
Müllerstrasse 178
13353 Berlin / DE
Former [2010/13]For all designated states
Bayer Schering Pharma Aktiengesellschaft
Müllerstrasse 178
13353 Berlin / DE
Inventor(s)01 / Mohr, Jörg-Thorsten
Morgenstr. 43 a
59423, Unna / DE
02 / Nickisch, Klaus
Zescher Str. 14
12307, Berlin / DE
 [2014/27]
Former [2010/13]01 / Mohr, Jörg-Thorsten
Morgenstr. 43 a
59423, Unna / DE
02 / Nickisch, Klaus
Zescher Str. 14
12307, Berlin / DE
Representative(s)König Szynka Tilmann von Renesse Patentanwälte Partnerschaft mbB
Mönchenwerther Straße 11
40545 Düsseldorf / DE
[N/P]
Former [2014/26]BIP Patents
c/o Bayer Intellectual Property GmbH
Creative Campus Monheim
Alfred-Nobel-Straße 10
40789 Monheim / DE
Application number, filing date09100011.711.08.1997
[2010/13]
Priority number, dateDE199613368512.08.1996         Original published format: DE 19633685
[2010/13]
Filing languageDE
Procedural languageDE
PublicationType: A2 Application without search report 
No.:EP2168974
Date:31.03.2010
Language:DE
[2010/13]
Type: A3 Search report 
No.:EP2168974
Date:06.03.2013
Language:DE
[2013/10]
Type: B1 Patent specification 
No.:EP2168974
Date:02.07.2014
Language:DE
[2014/27]
Search report(s)(Supplementary) European search report - dispatched on:EP04.02.2013
ClassificationInternational:C07J53/00
[2010/13]
Designated contracting statesAT,   BE,   CH,   DE,   DK,   ES,   FI,   FR,   GB,   GR,   IE,   IT,   LI,   LU,   MC,   NL,   PT,   SE [2010/13]
TitleGerman:Verfahren zur Herstellung von Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP)[2010/14]
English:Process for the preparation of Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP)[2010/14]
French:Procédé de preparation de Drospirenon (6ß, 7ß; 15ß,16ß-diméthylène-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP)[2010/14]
Former [2010/13]Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP) mit weniger als 0,2 % Verunreinigung
Former [2010/13]Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP) with less than 0.2 % impurity
Former [2010/13]Drospirenon (6ß, 7ß; 15ß,16ß-diméthylène-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP) ayant moins de 0,2 % d'impuretés
Examination procedure06.01.2009Examination requested  [2010/13]
16.01.2012Observations by third parties
17.02.2012Observations by third parties
14.02.2013Observations by third parties
22.03.2013Observations by third parties
06.09.2013Amendment by applicant (claims and/or description)
01.10.2013Observations by third parties
02.10.2013Observations by third parties
21.10.2013Observations by third parties
11.11.2013Observations by third parties
12.11.2013Observations by third parties
23.04.2014Communication of intention to grant the patent
15.05.2014Fee for grant paid
15.05.2014Fee for publishing/printing paid
15.05.2014Receipt of the translation of the claim(s)
Parent application(s)   TooltipEP01250277.9  / EP1149840
EP97937562.3  / EP0918791
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 (EP19970937562) is  04.08.2000
Opposition(s)Opponent(s)01  07.07.2014  18.05.2015  ADMISSIBLE
Industriale Chimica s.r.l.
Via E. H. Grieg, 13
21047 Saronno (VA) / IT
Opponent's representative
Palladino, Saverio Massimo, et al
Notarbartolo & Gervasi S.p.A. Corso di Porta Vittoria, 9
20122 Milano / IT
 02  07.07.2014  31.05.2016  WITHDRAWN
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  07.11.2014  18.05.2015  ADMISSIBLE
Laboratorios Léon Farma, S.A.
C/La Vallina s/n.
Pol. Ind. Navatejera
Leon
24008 Villaquilambre / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner mbB
Bavariaring 26
80336 München / DE
 04  02.10.2014  31.01.2017  WITHDRAWN
Teva Pharmaceutical Industries LTD.
5 Basel Street
49317 Petah-Tiqva / IL
Opponent's representative
Friedrich, Rainer
Df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Fünf Höfe / Theatinerstraße 16
80333 München / DE
 05  02.04.2015  20.05.2015  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Albany Gate
Darkes Lane
Potters Bar
Hertfordshire EN6 1AG / GB
Opponent's representative
Johnson, Stephen William
Venner Shipley LLP Byron House Cambridge Business Park Cowley Road
Cambridge CB4 0WZ / GB
 [N/P]
Former [2017/10]
Opponent(s)01  07.07.2014  18.05.2015  ADMISSIBLE
Industriale Chimica s.r.l.
Via E. H. Grieg, 13
I-21047 Saronno (VA) / IT
Opponent's representative
Palladino, Saverio Massimo, et al
Notarbartolo & Gervasi S.p.A. Corso di Porta Vittoria, 9
20122 Milano / IT
 02  07.07.2014  31.05.2016  WITHDRAWN
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  07.11.2014  18.05.2015  ADMISSIBLE
Laboratorios Léon Farma, S.A.
C/La Vallina s/n.
Pol. Ind. Navatejera
Leon
24008 Villaquilambre / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner mbB
Bavariaring 26
80336 München / DE
 04  02.10.2014  31.01.2017  WITHDRAWN
Teva Pharmaceutical Industries LTD.
5 Basel Street
49317 Petah-Tiqva / IL
Opponent's representative
Friedrich, Rainer
Df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Fünf Höfe / Theatinerstraße 16
80333 München / DE
 05  02.04.2015  20.05.2015  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Albany Gate
Darkes Lane
Potters Bar
Hertfordshire EN6 1AG / GB
Opponent's representative
Johnson, Stephen William
Venner Shipley LLP Byron House Cambridge Business Park Cowley Road
Cambridge CB4 0WZ / GB
Former [2016/30]
Opponent(s)01  07.07.2014  18.05.2015  ADMISSIBLE
Industriale Chimica s.r.l.
Via E. H. Grieg, 13
I-21047 Saronno (VA) / IT
Opponent's representative
Palladino, Saverio Massimo, et al
Notarbartolo & Gervasi S.p.A. Corso di Porta Vittoria, 9
20122 Milano / IT
 02  07.07.2014  31.05.2015  WITHDRAWN
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  07.11.2014  18.05.2015  ADMISSIBLE
Laboratorios Léon Farma, S.A.
C/La Vallina s/n.
Pol. Ind. Navatejera
Leon
24008 Villaquilambre / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner mbB
Bavariaring 26
80336 München / DE
 04  02.10.2014  20.05.2015  ADMISSIBLE
Teva Pharmaceutical Industries LTD.
5 Basel Street
49317 Petah-Tiqva / IL
Opponent's representative
Friedrich, Rainer
Df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Fünf Höfe / Theatinerstraße 16
80333 München / DE
 05  02.04.2015  20.05.2015  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Albany Gate
Darkes Lane
Potters Bar
Hertfordshire EN6 1AG / GB
Opponent's representative
Johnson, Stephen William
Venner Shipley LLP Byron House Cambridge Business Park Cowley Road
Cambridge CB4 0WZ / GB
Former [2015/19]
Opponent(s)01  07.07.2014   
Industriale Chimica s.r.l.
Via E. H. Grieg, 13
I-21047 Saronno (VA) / IT
Opponent's representative
Palladino, Saverio Massimo, et al
Notarbartolo & Gervasi S.p.A. Corso di Porta Vittoria, 9
20122 Milano / IT
 02  07.07.2014   
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Mauerkircherstrasse 45
81679 München / DE
 03  07.11.2014   
Laboratorios Léon Farma, S.A.
C/La Vallina s/n.
Pol. Ind. Navatejera
Leon
24008 Villaquilambre / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner mbB
Bavariaring 26
80336 München / DE
 04  02.10.2014   
Teva Pharmaceutical Industries LTD.
5 Basel Street
49317 Petah-Tiqva / IL
Opponent's representative
Friedrich, Rainer
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 05  02.04.2015   
Generics [UK] Limited (trading as Mylan)
Albany Gate
Darkes Lane
Potters Bar
Hertfordshire EN6 1AG / GB
Opponent's representative
Johnson, Stephen William
Venner Shipley LLP Byron House Cambridge Business Park Cowley Road
Cambridge CB4 0WZ / GB
Former [2014/51]
Opponent(s)01  07.07.2014   
Industriale Chimica s.r.l.
Via E. H. Grieg, 13
I-21047 Saronno (VA) / IT
Opponent's representative
Palladino, Saverio Massimo, et al
Notarbartolo & Gervasi S.p.A. Corso di Porta Vittoria, 9
20122 Milano / IT
 02  07.07.2014   
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte
Mauerkircherstrasse 45
81679 München / DE
 03  07.11.2014   
Laboratorios Léon Farma, S.A.
C/La Vallina s/n.
Pol. Ind. Navatejera
Leon
24008 Villaquilambre / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner mbB
Bavariaring 26
80336 München / DE
 04  02.10.2014   
Teva Pharmaceutical Industries LTD.
5 Basel Street
49317 Petah-Tiqva / IL
Opponent's representative
Friedrich, Rainer
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
09.06.2015Invitation to proprietor to file observations on the notice of opposition
19.10.2015Reply of patent proprietor to notice(s) of opposition
01.02.2017Date of oral proceedings
02.03.2017Despatch of interlocutory decision in opposition
02.03.2017Despatch of minutes of oral proceedings
02.07.2018Legal effect of revocation of patent [2018/47]
11.10.2018Despatch of communication that the patent will be revoked
Appeal following opposition11.05.2017Appeal received No.  T1080/17
12.07.2017Statement of grounds filed
02.07.2018Result of appeal procedure: revocation of the patent
02.05.2017Appeal received No.  T1080/17
02.07.2018Result of appeal procedure: revocation of the patent
28.04.2017Appeal received No.  T1080/17
02.07.2018Result of appeal procedure: revocation of the patent
02.07.2018Date of oral proceedings
10.07.2018Minutes of the oral proceedings despatched
Fees paidRenewal fee
06.01.2009Renewal fee patent year 03
06.01.2009Renewal fee patent year 04
06.01.2009Renewal fee patent year 05
06.01.2009Renewal fee patent year 06
06.01.2009Renewal fee patent year 07
06.01.2009Renewal fee patent year 08
06.01.2009Renewal fee patent year 09
06.01.2009Renewal fee patent year 10
06.01.2009Renewal fee patent year 11
06.01.2009Renewal fee patent year 12
24.08.2009Renewal fee patent year 13
25.08.2010Renewal fee patent year 14
24.08.2011Renewal fee patent year 15
10.08.2012Renewal fee patent year 16
19.08.2013Renewal fee patent year 17
Lapses during opposition  TooltipGB10.08.2017
IE11.08.2017
ES12.08.2017
PT21.08.2017
[2018/14]
Former [2017/51]GB10.08.2017
IE11.08.2017
PT21.08.2017
Former [2017/09]deleted
Former [2016/21]IT11.08.2015
Documents cited:Search[A]EP0075189  (SCHERING AG [DE]) [A] 1 * examples G,H *;
 [A]EP0051143  (SCHERING AG [DE]) [A] 1 * page 10; examples G,H *;
 [A]WO9014344  (GAF CHEMICALS CORP [US]) [A] 1 * the whole document *;
 [A]  - D. BITTLER ET AL, "Synthesis of Spirorenone - A Novel Highly Active Aldosterone Antagonist", ANGEWANDTE CHEMIE. INTERNATIONAL EDITION., WEINHEIM DE, (1982), vol. 21, no. 9, pages 696 - 697, XP002047531 [A] 1 * page 696, column 2; figure 1 *

DOI:   http://dx.doi.org/10.1002/anie.198206961
 [A]  - A. PLATTNER ET AL, "Über Steroide und Sexualhormone. 155. Über 3.alpha,5-dioxy-koprostan und zwei epimere 3,4-Dioxy-cholestane", HELVETICA CHIMICA ACTA., CHVERLAG HELVETICA CHIMICA ACTA. BASEL., (1948), vol. 31, no. 6, ISSN 0018-019X, pages 1822 - 1831, XP002690735 [A] 1 * page 1830, paragraph 3; compounds II, III *

DOI:   http://dx.doi.org/10.1002/hlca.19480310647
 [A]  - B. JANSEN ET AL, "THE CONVERSION OF (-)- AND (+)-DIHYDROCARVONE INTO CHIRAL INTERMEDIATES FOR THE SYNTHESIS OF (-)-POLYGODIAL, (-)-WARBURGANAL AND (-)-MUZIGADIAL", TETRAHEDRON., NLELSEVIER SCIENCE PUBLISHERS, AMSTERDAM., (1989), vol. 45, no. 5, ISSN 0040-4020, pages 1447 - 1452, XP002690736 [A] 1 * page 1450, paragraph 5; compounds 6, 8 *

DOI:   http://dx.doi.org/10.1016/0040-4020(89)80143-7
by applicantDE2652761
 DE3022337
 EP0075189
 EP0051143
    - ANGEW. CHEMIE, (1982), vol. 21, no. 9, pages 696 - 697
otherUS4416985
 EP0075189
 US6121465
    - "Stärke von Brönsted-Säuren und -Basen24", HOLLEMAN A.F. ET AL, Lehrbuch der Anorganischen Chemie, (2007), pages 245 - 248, XP003030755
    - BITTLER D. ET AL, "Synthesis of Spirorenone - A Novel Highly Active Aldosterone Antagonist.", ANGEWANDTE CHEMIE INT. ED. ENGL., (1982), vol. 21, no. 9, pages 696 - 697, XP002047531

DOI:   http://dx.doi.org/10.1002/anie.198206961
OppositionEP1149840
    - "Impurities in Pharmaceutical Substances and Limit Tests", Kasture et al., Pharmaceutical Analysis, 13th ed., Mumbai, Nirali Prakashan, (20071100), vol. 1, page 2.1, XP055297324