Extract from the Register of European Patents

About this file: EP1731152

EP1731152 - Sustained analgesia achieved with transdermal delivery of buprenorphine [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  29.03.2013
Database last updated on 06.12.2019
Most recent event   Tooltip01.10.2019Change: Appeal number 
Applicant(s)For:AT  BE  CH  ES  FR  GR  IT  LI  LU  MC  PT 
EURO-CELTIQUE S.A.
1, rue Jean Piret
2350 Luxembourg / LU
For:DE 
Mundipharma Laboratories GmbH
St. Alban-Rheinweg 74
4020 Basel / CH
For:GB 
Napp Pharmaceutical Holdings Limited
Cambridge Science Park Milton Road Cambridge
CB4 0AB / GB
For:NL 
Mundipharma Pharmaceuticals B.V.
De Wel 20
3871 Hoevelaken / NL
For:SE 
Mundipharma AB
Mölndalsvägen 26
412 63 Göteborg / SE
For:IE 
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18 / IE
For:DK 
Norpharma A/S
Frydenlundsvej 30
2950 Vedbaek / DK
For:FI 
Mundipharma OY
Rajatorpantie 41 C
01640 Vantaa / FI
[2016/24]
Former [2016/11]For:AT  BE  CH  ES  FR  GR  IT  LI  LU  MC  PT 
EURO-CELTIQUE S.A.
2, avenue Charles de Gaulle
1653 Luxembourg / LU
For:DE 
Mundipharma Laboratories GmbH
St. Alban-Rheinweg 74
4020 Basel / CH
For:GB 
Napp Pharmaceutical Holdings Limited
Cambridge Science Park Milton Road Cambridge
CB4 0AB / GB
For:NL 
Mundipharma Pharmaceuticals B.V.
De Wel 20
3871 Hoevelaken / NL
For:SE 
Mundipharma AB
Mölndalsvägen 26
412 63 Göteborg / SE
For:IE 
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18 / IE
For:DK 
Norpharma A/S
Frydenlundsvej 30
2950 Vedbaek / DK
For:FI 
Mundipharma OY
Rajatorpantie 41 C
01640 Vantaa / FI
Former [2008/23]For all designated states
EURO-CELTIQUE S.A.
2, avenue Charles de Gaulle
1653 Luxembourg / LU
Former [2006/50]For all designated states
EURO-CELTIQUE S.A.
122 Boulevard de la Petrusse
2330 Luxembourg / LU
Inventor(s)01 / Reder, Robert, F.
1111 Legacy Lane
West Chester, PA 19382 / US
02 / Goldenheim, Paul, D.
4 Bald Hill Place
Wilton, CT 06897 / US
03 / Kaiko, Robert, F.
10 Norfield Woods Road
Weston, CT 06883 / US
 [2013/18]
Former [2007/02]01 / Reder, Robert, F.
1111 Legacy Lane
West Chester, PA 19382 / US
02 / Goldenheim, Paul, D.
4 Bald Hill Place
Wilton, CT 06897 / US
03 / Kaiko, Robert, F.
10 Norfield Woods Road
Weston, CT 06883 / US
Former [2006/50]01 / REDER, Robert, F.
2 Mercia Lane
Greenwich, CT 06830 / US
02 / GOLDENHEIM, Paul, D.
4 Bald Hill Place
Wilton, CT 06897 / US
03 / KAIKO, Robert, F.
10 Norfield Woods Road
Weston, CT 06883 / US
Representative(s)Hansen, Norbert
Maiwald Patentanwalts- und
Rechtsanwaltsgesellschaft mbH
Elisenhof
Elisenstraße 3
80335 München / DE
[N/P]
Former [2013/18]Hansen, Norbert
Maiwald Patentanwalts GmbH
Elisenhof
Elisenstraße 3
80335 München / DE
Former [2006/50]Hansen, Norbert
Maiwald Patentanwalts GmbH Elisenhof Elisenstraße 3
D-80335 München / DE
Application number, filing date06118876.924.02.1998
[2006/50]
Priority number, dateUS19970038919P24.02.1997         Original published format: US 38919 P
US1997093906829.09.1997         Original published format: US 939068
[2006/50]
Filing languageEN
Procedural languageEN
PublicationType: A2 Application without search report 
No.:EP1731152
Date:13.12.2006
Language:EN
[2006/50]
Type: A3 Search report 
No.:EP1731152
Date:14.11.2007
[2007/46]
Type: B1 Patent specification 
No.:EP1731152
Date:01.05.2013
Language:EN
[2013/18]
Search report(s)(Supplementary) European search report - dispatched on:EP12.10.2007
ClassificationInternational:A61F13/00, A61K31/485, A61K9/70, A61P25/04
[2007/41]
Former International [2006/50]A61K31/485, A61K9/70, A61P25/04
Designated contracting statesAT,   BE,   CH,   DE,   DK,   ES,   FI,   FR,   GB,   GR,   IE,   IT,   LI,   LU,   MC,   NL,   PT,   SE [2006/50]
TitleGerman:Verzögerte Analgesie erreicht mit transdermaler Verabreichung von Buprenorphin[2006/50]
English:Sustained analgesia achieved with transdermal delivery of buprenorphine[2006/50]
French:Analgésie à effet prolongé grâce à l'administration transdermale de la buprénorphine[2006/50]
Examination procedure14.08.2006Examination requested  [2006/50]
08.02.2008Despatch of a communication from the examining division (Time limit: M04)
06.06.2008Reply to a communication from the examining division
25.09.2009Despatch of a communication from the examining division (Time limit: M04)
21.01.2010Reply to a communication from the examining division
28.05.2010Despatch of a communication from the examining division (Time limit: M06)
12.01.2011Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time
08.03.2011Reply to a communication from the examining division
02.04.2012Despatch of a communication from the examining division (Time limit: M01)
19.04.2012Reply to a communication from the examining division
03.05.2012Despatch of a communication from the examining division (Time limit: M04)
09.05.2012Reply to a communication from the examining division
19.07.2012Communication of intention to grant the patent
17.09.2012Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
29.10.2012Communication of intention to grant the patent
04.03.2013Fee for grant paid
04.03.2013Fee for publishing/printing paid
Parent application(s)   TooltipEP98906678.2  / EP0964677
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 (EP19980906678) is  28.02.2003
Opposition(s)Opponent(s)01  23.01.2014  31.01.2014  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 02  24.01.2014  31.01.2014  ADMISSIBLE
Gallafent, Alison
Alison Gallafent Ltd
21 Bridge St
Llandeilo SA19 6BN / GB
Opponent's representative
Bird & Bird LLP, et al
Maximiliansplatz 22
80333 München / DE
 03  20.12.2017  03.01.2018  INTERVENTION
tesa Labtec GmbH
Raiffeisenstrasse 4
40764 Langenfeld / DE
Opponent's representative
Bird & Bird LLP
Maximiliansplatz 22
80333 München / DE
 [2018/06]
Former [2018/04]
Opponent(s)01  23.01.2014  31.01.2014  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 02  24.01.2014  31.01.2014  ADMISSIBLE
Gallafent, Alison
Alison Gallafent Ltd
21 Bridge St
Llandeilo SA19 6BN / GB
Opponent's representative
Bird & Bird LLP, et al
Maximiliansplatz 22
80333 München / DE
 03  20.12.2017   
tesa Labtec GmbH
Raiffeisenstrasse 4
40764 Langenfeld / DE
Opponent's representative
Bird & Bird LLP
Maximiliansplatz 22
80333 München / DE
Former [2017/16]
Opponent(s)01  23.01.2014  31.01.2014  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 02  24.01.2014  31.01.2014  ADMISSIBLE
Gallafent, Alison
Alison Gallafent Ltd
21 Bridge St
Llandeilo SA19 6BN / GB
Opponent's representative
Bird & Bird LLP, et al
Maximiliansplatz 22
80333 München / DE
Former [2016/24]
Opponent(s)01  23.01.2014  31.01.2014  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 02  24.01.2014  31.01.2014  ADMISSIBLE
Gallafent, Alison
Alison Gallafent Ltd
21 Bridge St
Llandeilo SA19 6BN / GB
Opponent's representative
Gallafent, Alison, et al
Alison Gallafent
21 Bridge St
Llandeilo SA19 6BN / GB
Former [2015/41]
Opponent(s)01  23.01.2014  31.01.2014  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 02  24.01.2014  31.01.2014  ADMISSIBLE
Gallafent, Alison
Alison Gallafent Ltd
21 Bridge St
Llandeilo SA19 6BN / GB
Opponent's representative
Gallafent, Alison, et al
Alison Gallafent Ltd
21 Bridge St
Llandeilo SA19 6BN / GB
Former [2014/10]
Opponent(s)01  23.01.2014   
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte
Mauerkircherstrasse 45
81679 München / DE
 02  24.01.2014   
Gallafent, Alison
4 George Street
Llandeilo Dyfed
SA19 6AS / GB
Opponent's representative
Gallafent, Alison, et al
Alison Gallafent Ltd
4 George Street
Llandeilo Dyfed
SA19 6AS / GB
Former [2014/09]
Opponent(s)01  23.01.2014   
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Ter Meer Steinmeister & Partner, et al
Patentanwälte
Mauerkircherstrasse 45
81679 München / DE
21.03.2014Invitation to proprietor to file observations on the notice of opposition
29.09.2014Reply of patent proprietor to notice(s) of opposition
09.11.2015Date of oral proceedings
03.03.2016Despatch of interlocutory decision in opposition
03.03.2016Despatch of minutes of oral proceedings
Appeal following opposition02.05.2016Appeal received No.  T0548/16
13.07.2016Statement of grounds filed
10.03.2016Appeal received No.  T0548/16
13.07.2016Statement of grounds filed
07.03.2016Appeal received No.  T0548/16
28.06.2016Statement of grounds filed
14.01.2020Date of oral proceedings
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the examination report
08.03.2011Request for further processing filed
08.03.2011Full payment received (date of receipt of payment)
Request granted
21.03.2011Decision despatched
Fees paidRenewal fee
14.08.2006Renewal fee patent year 03
14.08.2006Renewal fee patent year 04
14.08.2006Renewal fee patent year 05
14.08.2006Renewal fee patent year 06
14.08.2006Renewal fee patent year 07
14.08.2006Renewal fee patent year 08
14.08.2006Renewal fee patent year 09
22.12.2006Renewal fee patent year 10
08.02.2008Renewal fee patent year 11
09.02.2009Renewal fee patent year 12
08.02.2010Renewal fee patent year 13
19.08.2011Renewal fee patent year 14
07.02.2012Renewal fee patent year 15
07.02.2013Renewal fee patent year 16
Penalty fee
Additional fee for renewal fee
28.02.201114   M06   Fee paid on   19.08.2011
Lapses during opposition  TooltipGB23.02.2018
IE24.02.2018
PT06.03.2018
[2018/27]
Former [2018/23]GB23.02.2018
IE24.02.2018
Former [2018/21]GB23.02.2018
Documents cited:Search[X]US4956171  (CHANG YUNIK [US]) [X] 1-11 * examples 1,3 * * column 4, lines 29,45,53 *;
 [Y]US5026556  (DRUST EUGENE G [US], et al) [Y] 1-11 * examples I-IV *;
 [Y]US5486362  (KITCHELL JUDITH P [US], et al) [Y] 1-11 * example 7 *;
 [DY]WO9619975  (LOHMANN THERAPIE SYST LTS [DE], et al) [DY] 1-11 * claims 1-5 *;
 [X]US5240711  (HILLE THOMAS [DE], et al) [X] 1-11 * column 2, line 46 - line 56 *;
 [Y]US4588580  (GALE ROBERT M [US], et al) [Y] 1-11 * column 3, paragraph 1 *
 [Y]  - FRIEND D ET AL, "SIMPLE ALKYL ESTERS AS SKIN PERMEATION ENHANCERS", JOURNAL OF CONTROLLED RELEASE, ELSEVIER SCIENCE PUBLISHERS B.V. AMSTERDAM, NL, (19890601), vol. 9, no. 1, ISSN 0168-3659, pages 33 - 41, XP000007883 [Y] 1-11 * figures 11,12 *

DOI:   http://dx.doi.org/10.1016/0168-3659(89)90031-X
 [Y]  - FRIEND D ET AL, "TRANSDERMAL DELIVERY OF LEVONORGESTREL I: ALKANOLS AS PERMEATION ENHANCERS IN VITRO", JOURNAL OF CONTROLLED RELEASE, ELSEVIER SCIENCE PUBLISHERS B.V. AMSTERDAM, NL, (19880901), vol. 7, no. 3, ISSN 0168-3659, pages 243 - 250, XP000566313 [Y] 1-11 * figures 2,3 *

DOI:   http://dx.doi.org/10.1016/0168-3659(88)90057-0
 [Y]  - ROY S D ET AL, "CONTROLLED TRANSDERMAL DELIVERY OF FENTANYL: CHARACTERIZATIONS OF PRESSURE-SENSITIVE ADHESIVES FOR MATRIX PATCH DESIGN", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN PHARMACEUTICAL ASSOCIATION. WASHINGTON, US, (19960501), vol. 85, no. 5, ISSN 0022-3549, pages 491 - 495, XP000583527 [Y] 1-11 * figure 5 * * page 495, second paragraph *

DOI:   http://dx.doi.org/10.1021/js950415w
ExaminationUS5225199
 US5069909
 US4806341
    - ROY S.D. ET AL., "Transdermal delivery of buprenorphine through cadaver skin", JOURNAL OF PHARMACEUTICAL SCIENCES, (199402), vol. 83, no. 2, pages 126 - 130
OppositionWO9619975
 US5069909
 US5026556
 US4956171
 US4588580
 US4938759
 US5240711
 US5225199
 WO9836728  * , Seite 32 (vollständig) *
 DE4237453
 WO2012065740
 US5171576
    - K. HEILMANN, Therapeutische Systeme, Stuttgart, Ferdinand Enke Verlag, (19840000), pages 26 - 27 , 48-53
    - K. HEILMANN, Therapeutische Systeme, Stuttgart, Ferdinand Enke Verlag, (19840000), pages 67 - 77 , 83-86, XP055449911
    - K. HEILMANN, Therapeutische Systeme, Stuttgart, Ferdinand Enke Verlag, (19840000), pages 104 - 106, XP055449913
    - S.F. GORDON, "Clinical experience with a seven-day estradiol transdermal system for estrogen replacement therapy", Am J Obstet Gynecol, (19950000), vol. 173, no. 3 Part 2, pages 998 - 1004, XP002953772

DOI:   http://dx.doi.org/10.1016/0002-9378(95)90250-3
    - S.D. ROY et al., "TRANSDERMAL DELIVERY OF BUPRENORPHINE THROUGH CADAVER SKIN", Journal of Pharmaceutical Sciences, (19940000), vol. 83, no. 2, pages 126 - 130, XP009079712

DOI:   http://dx.doi.org/10.1002/jps.2600830204
    - EMC, "BuTrans 5, 10 and 20µg/h Transdermal Patch", Summary of Product Characteristics, (20100311), URL: http://www.medicines.org.uk/EMC, XP003035774
    - "Chapter 10", H.C. ANSEL et al., Pharmaceutical Dosage Forms and Drug delivery Systems, WILLIAMS & WILKINS, (19950000), pages 357 - 372, XP055449922
    - Margetts L. et al, "Transdermal drug delivery: principles and opioid therapy", Continuing Education in Anaesthesia, Critical Care and Pain, (20071001), vol. 7, no. 5, pages 171 - 176, XP055395614

DOI:   http://dx.doi.org/10.1093/bjaceaccp/mkm033
    - Guy R. H., "Current Status and Future Prospects of Transdermal Drug Delivery", Pharmaceutical Research, (19961200), vol. 13, no. 12, pages 1765 - 1769, XP009081195

DOI:   http://dx.doi.org/10.1023/A:1016060403438
    - S.D. ROY et al., "Transdermal Delivery of Narcotic Analgesics: Comparative Metabolism and Permeability of Human Cadaver Skin and Hairless Mouse Skin", Journal of Pharmaceutical Sciences, (19940318), vol. 83, no. 12, pages 1723 - 1728, XP055449928

DOI:   http://dx.doi.org/10.1002/jps.2600831215
    - Falbe J. et al, Römpp Chemie Lexikon, Georg Thieme Verlag, (19910000), page 3095, XP055449956
    - J.J. KUHLMAN et al., "Human Pharmacokinetics of Intravenous, Sublingual, and Buccal Buprenorphine", Journal of Analytical Toxicology, (19961001), vol. 20, no. 6, pages 369 - 378, XP008114619
    - "Chapter 3", Hadgraft J. et al, Transdermal Drug Delivery, Marcel Dekker, (19890000), pages 59 - 81, XP055449896
    - A. GÖPFERICH et al., "An improved diffusion/ compartmental model for transdermal drug delivery from a matrix-type device", International Journal of Pharmaceutics, (19910000), vol. 71, no. 3, pages 237 - 243, XP025580080

DOI:   http://dx.doi.org/10.1016/0378-5173(91)90395-5
    - S. KIYOSHI et al., "Species Differences in Percutaneous Absorption of Nicorandil", Journal of Pharmaceutical Sciences, (19910200), vol. 80, no. 2, pages 104 - 107, XP055449853

DOI:   http://dx.doi.org/10.1002/jps.2600800203
    - T. KAKUJI et al., "Stratum Corneum Reservoir Capacity Affecting Dynamics of Transdermal Drug Delivery", Drug Development and Industrial Pharmacy, (19880000), vol. 14, no. 4, pages 561 - 572, XP055449849

DOI:   http://dx.doi.org/10.3109/03639048809151884
    - K. WALTER et al., "Pharmacokinetics of physostigmine in man following a single application of a transdermal system", Br J clin Pharmac, (19950100), vol. 39, pages 59 - 63, XP055449846

DOI:   http://dx.doi.org/10.1111/j.1365-2125.1995.tb04410.x
    - WILDING et al., "Pharmacokinetic evaluation of transdermal buprenorphine in man", International Journal of Pharmaceutics, (19960400), vol. 132, no. 1-2, pages 81 - 87, XP055449841

DOI:   http://dx.doi.org/10.1016/0378-5173(96)85198-2