Extract from the Register of European Patents

About this file: EP1178808

EP1178808 - NON-AQUEOUS PHARMACEUTICAL COMPOSITION FOR DERMAL USE TO TREAT PSORIASIS COMPRISING A VITAMIN D, A CORTICOSTEROID AND A SOLVENT COMPONENT [Right-click to bookmark this link]
Former [2002/07]PHARMACEUTICAL COMPOSITION
[2011/50]
StatusThe patent has been granted
Status updated on  27.04.2012
Database last updated on 22.03.2019
Most recent event   Tooltip24.01.2019New entry: Despatch of communication that the patent will be maintained as amended 
Applicant(s)For all designated states
LEO PHARMA A/S
Industriparken 55
2750 Ballerup / DK
[2012/22]
Former [2003/16]For all designated states
Leo Pharma A/S
Industriparken 55
2750 Ballerup / DK
Former [2002/07]For all designated states
LEO PHARMACEUTICAL PRODUCTS LTD. A/S (LOVENS KEMISKE FABRIK PRODUKTIONSAKTIESELSKAB)
Industriparken 55
2750 Ballerup / DK
Inventor(s)01 / DIDRIKSEN, Erik
Fuglehavevej 14
DK-2750 Ballerup / DK
02 / HØY, Gert
Stenkrogen 36
DK-4040 Jyllinge / DK
 [2012/01]
Former [2002/07]01 / DIDRIKSEN, Erik
Fuglehavevej 14
DK-2750 Ballerup / DK
02 / HOY, Gert
Stenkrogen 36
DK-4040 Jyllinge / DK
Representative(s)Carpmaels & Ransford LLP
One Southampton Row
London WC1B 5HA / GB
[N/P]
Former [2013/20]Carpmaels & Ransford
One Southampton Row London
WC1B 5HA / GB
Former [2012/22]Samuels, Lucy Alice , et al
Gill Jennings & Every LLP The Broadgate Tower
20 Primrose Street
London
EC2A 2ES / GB
Former [2011/33]Samuels, Lucy Alice , et al
Gill Jennings & Every LLP The Broadgate Tower 20 Primrose Street London
EC2A 2ES / GB
Former [2002/07]Thalsoe-Madsen, Kine Birgit
Leo Pharmaceutical Products, Industriparken 55
2750 Ballerup / DK
Application number, filing date00901483.827.01.2000
[2002/07]
WO2000DK00033
Priority number, dateDK1956000019923.04.1999         Original published format: DK 56199
[2002/07]
Filing languageEN
Procedural languageEN
PublicationType: A1  Application with search report
No.:WO0064450
Date:02.11.2000
Language:EN
[2000/44]
Type: A1 Application with search report 
No.:EP1178808
Date:13.02.2002
Language:EN
The application has been published by WIPO in one of the EPO official languages on 02.11.2000
[2002/07]
Type: B1 Patent specification 
No.:EP1178808
Date:30.05.2012
Language:EN
[2012/22]
Search report(s)International search report - published on:EP02.11.2000
ClassificationInternational:A61K9/06, A61K47/10, A61K31/56, A61K31/573, A61K31/59, A61K31/593, A61K47/06, A61K9/00
[2011/50]
Former International [2002/07]A61K31/59, A61K31/56, A61K31/593, A61K31/573, A61P17/06
Designated contracting statesAT,   BE,   CH,   CY,   DE,   DK,   ES,   FI,   FR,   GB,   GR,   IE,   IT,   LI,   LU,   MC,   NL,   PT,   SE [2002/07]
Extension statesAL23.11.2001
LT23.11.2001
LV23.11.2001
MK23.11.2001
RO23.11.2001
SI23.11.2001
TitleGerman:NICHT-WÄSSRIGE PHARMAZEUTISCHE ZUSAMMENSETZUNG ZUR ANWENDUNG AUF DER HAUT FÜR DIE BEHANDLUNG VON PSORIASIS ENTHALTEND EIN VITAMIN D, EIN CORTICOSTEROID UND EINE LÖSUNGSMITTELKOMPONENTE[2012/01]
English:NON-AQUEOUS PHARMACEUTICAL COMPOSITION FOR DERMAL USE TO TREAT PSORIASIS COMPRISING A VITAMIN D, A CORTICOSTEROID AND A SOLVENT COMPONENT[2011/50]
French:COMPOSITION PHARMACEUTIQUE NON AQUEUSE A USAGE DERMIQUE POUR LE TRAITEMENT DU PSORIASIS A BASE D'UNE VITAMINE D, D'UNE CORTICOSTEROIDE ET D'UN COMPOSANT SOLVANT[2012/01]
Former [2002/07]PHARMAZEUTISCHE ZUSAMMENSETZUNGEN
Former [2002/07]PHARMACEUTICAL COMPOSITION
Former [2002/07]COMPOSITION PHARMACEUTIQUE
Entry into regional phase23.11.2001National basic fee paid 
23.11.2001Designation fee(s) paid 
23.11.2001Examination fee paid 
Examination procedure12.08.2000Request for preliminary examination filed
International Preliminary Examining Authority: EP
23.11.2001Examination requested  [2002/07]
08.04.2004Despatch of a communication from the examining division (Time limit: M04)
29.07.2004Reply to a communication from the examining division
09.05.2005Observations by third parties
27.05.2005Despatch of a communication from the examining division (Time limit: M06)
22.11.2005Reply to a communication from the examining division
13.07.2006Observations by third parties
29.04.2008Despatch of a communication from the examining division (Time limit: M08)
10.12.2008Reply to a communication from the examining division
07.02.2010Observations by third parties
09.11.2011Date of oral proceedings
01.12.2011Minutes of oral proceedings despatched
12.12.2011Communication of intention to grant the patent
27.03.2012Fee for grant paid
27.03.2012Fee for publishing/printing paid
Divisional application(s)EP11188330.2   Application deemed to be withdrawn  : 08.11.2011
EP11196067.0  / EP2455083
EP11196069.6  / EP2450043
EP14187329.9  / EP2915534
EP16185207.4  / EP3146969
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  08.04.2004
Opposition(s)Opponent(s)01  27.02.2013  01.03.2013  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
5 Basel Street, P.O. Box 3190
Petah Tiqva 49131 / IL
Opponent's representative
D Young & Co LLP
Briton House
Briton Street
Southampton SO14 3EB / GB
 02  27.02.2013  19.04.2013  ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Greiner, Elisabeth, et al
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 03  28.02.2013  07.03.2013  ADMISSIBLE
PENTAFARMA S.A.
Rua da Tapada Grande no. 2
Abrunheira
2710-089 Sintra / PT
Opponent's representative
Hoffmann Eitle, et al
Patent- und Rechtsanwälte PartmbB
Arabellastraße 30
81925 München / DE
 [2018/29]
Former [2015/35]
Opponent(s)01  27.02.2013  01.03.2013  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
5 Basel Street, P.O. Box 3190
Petah Tiqva 49131 / IL
Opponent's representative
D Young & Co LLP
Briton House
Briton Street
Southampton SO14 3EB / GB
 02  27.02.2013  19.04.2013  ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Opresnik, Marko, et al
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana / SI
 03  28.02.2013  07.03.2013  ADMISSIBLE
PENTAFARMA S.A.
Rua da Tapada Grande no. 2
Abrunheira
2710-089 Sintra / PT
Opponent's representative
Hoffmann Eitle, et al
Patent- und Rechtsanwälte PartmbB
Arabellastraße 30
81925 München / DE
Former [2015/24]
Opponent(s)01  27.02.2013  01.03.2013  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
5 Basel Street, P.O. Box 3190
Petah Tiqva 49131 / IL
Opponent's representative
Gallagher, Kirk James
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
 02  27.02.2013  19.04.2013  ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Opresnik, Marko, et al
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana / SI
 03  28.02.2013  07.03.2013  ADMISSIBLE
PENTAFARMA S.A.
Rua da Tapada Grande no. 2
Abrunheira
2710-089 Sintra / PT
Opponent's representative
Hoffmann Eitle, et al
Patent- und Rechtsanwälte PartmbB
Arabellastraße 30
81925 München / DE
Former [2013/17]
Opponent(s)01  27.02.2013  01.03.2013  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
5 Basel Street, P.O. Box 3190
Petah Tiqva 49131 / IL
Opponent's representative
Gallagher, Kirk James
D Young & Co LLP 120 Holborn
London EC1N 2DY / GB
 02  27.02.2013   
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
HOFFMANN EITLE, et al
Patent- und Rechtsanwälte
Arabellastrasse 4
81925 München / DE
 03  28.02.2013  07.03.2013  ADMISSIBLE
PENTAFARMA S.A.
Rua da Tapada Grande no. 2
Abrunheira
2710-089 Sintra / PT
Opponent's representative
HOFFMANN EITLE, et al
Patent- und Rechtsanwälte
Arabellastrasse 4
81925 München / DE
Former [2013/15]
Opponent(s)01  27.02.2013  01.03.2013  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
5 Basel Street, P.O. Box 3190
Petah Tiqva 49131 / IL
Opponent's representative
Gallagher, Kirk James
D Young & Co LLP 120 Holborn
London EC1N 2DY / GB
 02  27.02.2013   
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
HOFFMANN EITLE, et al
Patent- und Rechtsanwälte
Arabellastrasse 4
81925 München / DE
 03  28.02.2013  07.03.2013  ADMISSIBLE
PENTAFARMA, Sociedade Técnico-Medicinal, SA
Rua da Tapada Grande, n° 2
Abrunheira
2710-089 Sintra / PT
Former [2013/14]
Opponent(s)01  27.02.2013   
Teva Pharmaceutical Industries Ltd.
5 Basel Street, P.O. Box 3190
Petah Tiqva 49131 / IL
Opponent's representative
Gallagher, Kirk James
D Young & Co LLP 120 Holborn
London EC1N 2DY / GB
25.04.2013Invitation to proprietor to file observations on the notice of opposition
07.01.2014Reply of patent proprietor to notice(s) of opposition
20.10.2014Date of oral proceedings
27.11.2014Despatch of interlocutory decision in opposition
27.11.2014Despatch of minutes of oral proceedings
23.08.2018Legal effect of interlocutory decision in opposition
25.01.2019Despatch of communication that the patent will be maintained as amended
Appeal following opposition09.02.2015Appeal received No.  T0142/15
07.04.2015Statement of grounds filed
23.08.2018Result of appeal procedure: appeal of the opponent was rejected
27.01.2015Appeal received No.  T0142/15
07.04.2015Statement of grounds filed
23.08.2018Result of appeal procedure: appeal of the opponent was rejected
12.01.2015Appeal received No.  T0142/15
24.03.2015Statement of grounds filed
23.08.2018Result of appeal procedure: appeal of the opponent was rejected
23.08.2018Date of oral proceedings
28.08.2018Minutes of the oral proceedings despatched
Fees paidRenewal fee
31.01.2002Renewal fee patent year 03
20.01.2003Renewal fee patent year 04
26.01.2004Renewal fee patent year 05
20.01.2005Renewal fee patent year 06
27.01.2006Renewal fee patent year 07
29.01.2007Renewal fee patent year 08
25.01.2008Renewal fee patent year 09
30.01.2009Renewal fee patent year 10
25.01.2010Renewal fee patent year 11
25.01.2011Renewal fee patent year 12
25.01.2012Renewal fee patent year 13
Lapses during opposition  TooltipMC31.01.2013
[2013/37]
Cited inInternational search[X]WO9414453  (LEO PHARM PROD LTD [DK], et al) [X] 1-30 * page 22, line 15 - page 24, line 17; figures 1-3; claim - *;
 [X]EP0129003  (YISSUM RES DEV CO [IL]) [X] 1-30 * page 6, line 3 - line 9 * * page 11, line 13 - line 22 * * page 13; claim - *;
 [A]WO9415912  (LEO PHARM PROD LTD [DK], et al) [A] 1-30 * the whole document *;
 [A]WO9112807  (LEO PHARM PROD LTD [DK]) [A] 1-30 * the whole document *;
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 [A]US5886038  (GLENN THOMAS M [US], et al) [A] 1-30 * the whole document *;
 [PA]US5990100  (ROSENBERG E WILLIAM [US], et al) [PA] 1-30 * the whole document *;
 [A]EP0544391  (TEVA PHARMA [IL], et al) [A] 1-30 * page 8, line 29 - page 9, line 37; claim - *
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 [X]  - RUZICKA T ET AL, "Comparison of calcipotriol monotherapy and a combination of calcipotriol and betamethasone valerate after 2 weeks' treatment with calcipotriol in the topical therapy of psoriasis vulgaris: a multicentre, doucle-blind, randomized study", BRITISH JOURNAL OF DERMATOLOGY, (1998), vol. 138, pages 254 - 258, XP002900975 [X] 1-30 * page 257 *

DOI:   http://dx.doi.org/10.1046/j.1365-2133.1998.02070.x
ExaminationUS5185150
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DOI:   http://dx.doi.org/10.1016/S0190-9622(98)70171-9
    - BELLIBONI N, "[CLINICAL TRIAL OF AN OINTMENT CONTAINING CORTICOSTEROIDS ASSOCIATED WITH NITROFURAZONE AND VITAMINS A AND D].", MEDLINE, US NATIONAL LIBRARY OF MEDICINE (NLM), BETHESDA, MD, US, (196402), Database accession no. NLM14136754
    - "Daivonex", Vidal, Paris, Editions du Vidal, (1996), page 414
    - BUNDGAARD H ET AL, "Studies on the stability of corticosteroids VI. Kinetics of the rearrangement of betamethasone-17-valerate to the 21-valerate ester in aqueous solution", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 7, no. 3, doi:10.1016/0378-5173(81)90105-8, ISSN 0378-5173, (19810101), pages 197 - 203, (19810101), XP023844654

DOI:   http://dx.doi.org/10.1016/0378-5173(81)90105-8
    - KOSHY K T, "Vitamin D: an update", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, US, (19820201), vol. 71, no. 2, doi:10.1002/JPS.2600710203, ISSN 0022-3549, pages 137 - 153, XP009147023

DOI:   http://dx.doi.org/10.1002/jps.2600710203
    - KRAGBALLE K ET AL, "Calcipotriol cream with or without concurrent topical corticosteroid in psoriasis: tolerability and efficacy", BRITISH JOURNAL OF DERMATOLOGY, WILEY-BLACKWELL PUBLISHING LTD, GB, (19980101), vol. 139, ISSN 0007-0963, pages 649 - 654, XP003025976
    - ORTONNE J P, "Psoriasis: new therapeutic modality by calcipotriol and betamethasone dipropionate", NOUV. DERMATOL,, (19940101), vol. 13, no. 10, pages 746 - 751, XP003025977
    - Burger, Wachter, Hunnius Pharmazeutisches Wörterbuch, Berlin, Walter de Gruyter, (19930101), page 863, 7
    - VAN DE KERKHOF P ET AL, "Mixed treatment comparison of a two-compound formulation (TCF) product containing calcipotriol and betamethasone dipropionate with other topical treatments in psoriasis vulgaris", CURRENT MEDICAL RESEARCH AND OPINION 2011 INFORMA HEALTHCARE GBR LNKD- DOI:10.1185/03007995.2010.541005, (201101), vol. 27, no. 1, ISSN 0300-7995, pages 225 - 238
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DOI:   http://dx.doi.org/10.1159/000066440
by applicantEP0129003
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DOI:   http://dx.doi.org/10.1016/S0190-9622(97)70217-2
    - PATEL B. ET AL, "Compatibility of calcipotriene with other topical medications", JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, (199806), vol. 38, no. 6, pages 1010 - 1011, XP009047646

DOI:   http://dx.doi.org/10.1016/S0190-9622(98)70171-9
    - BELLIBONI N., "Experimentacao clinica com pomada de corticosteroide associada a nitrofurazona e vitaminas A, D", O HOSPITAL, (196402), vol. 65, no. 2, pages 351 - 357, XP001206515
    - BUNDGAARD H. AND HANSEN J., "Studies on the stability of corticosteroids VI. Kinetics of the rearrangement ofbetamethasone-17-valerate to the 21-valerate ester in aqueous solution", INTERNATIONAL JOURNAL OF PHARMACEUTICS, (19810101), vol. 7, no. 3, pages 197 - 203, XP023844654

DOI:   http://dx.doi.org/10.1016/0378-5173(81)90105-8
    - KRAGBALLE K. ET AL, "Calcipotriol cream with or without concurrent topical corticosteroid in psoriasis: tolerability and efficacy", BRITISH JOURNAL OF DERMATOLOGY, (1998), vol. 139, pages 649 - 654, XP003025976
    - ORTONNE J.P., "Psoriasis: new therapeutic modality by calcipotriol and betamethasone dipropionate", NOUV. DERMATOL., (1994), vol. 13, no. 10, pages 746 - 751, XP003025977