Extract from the Register of European Patents

EP About this file: EP3133070

EP3133070 - ELIGLUSTAT (GENZ 112638) AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE FOR USE IN A METHOD OF TREATING FABRY'S OR GAUCHER'S DISEASE, THE METHOD COMPRISING ADJUSTING THE INDIVIDUAL THERAPEUTICAL DOSE TO THE P-450 METABOLISM OF THE PATIENT [Right-click to bookmark this link]
StatusPatent revoked
Status updated on  19.05.2025
Database last updated on 11.04.2026
FormerThe patent has been granted
Status updated on  12.07.2019
FormerGrant of patent is intended
Status updated on  20.02.2019
FormerExamination is in progress
Status updated on  23.01.2019
FormerGrant of patent is intended
Status updated on  14.06.2018
FormerExamination is in progress
Status updated on  12.05.2017
FormerRequest for examination was made
Status updated on  17.02.2017
FormerThe application has been published
Status updated on  20.01.2017
Most recent event   Tooltip13.03.2026Lapse of the patent in a contracting state
New state(s): GR
published on 15.04.2026 [2026/16]
Applicant(s)For all designated states
Genzyme Corporation
50 Binney Street
Cambridge, MA 02142 / US
[2018/29]
Former [2017/08]For all designated states
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142 / US
Inventor(s)01 / LIU, Hanlan
80 East Street
Lexington, MA 02420 / US
02 / WILLIS, Chris
7 Overlook Drive
Southborough, MA 01772 / US
03 / BHARDWAJ, Renu
1 Candlelight Way
Ashland, MA 01721 / US
04 / COPELAND, Diane P.
17 Hawks Ridge Road
Billerica, MA 01862 / US
05 / HARIANAWALA, Abizer
10 Wilson Lane
Acton, MA 01720 / US
06 / SKELL, Jeffrey
41 Hundreds Road
Westborough, MA 01581 / US
07 / MARSHALL, John
c/o Sanofi US
55 Corporate Drive
Mail Code 55A-505A
Bridgewater, NJ 08807 / US
08 / KOCHLING, Jianmei
42 Oak Street
Wellesley, MA 02482 / US
09 / PALACE, Gerard
123 Millwood Street
Framingham, MA 01701 / US
10 / PETERSCHMITT, Judith
44 Harrington Street
Watertown, MA 02472 / US
11 / SIEGEL, Craig
15 Bradford Road
Woburn, MA 01801 / US
12 / CHENG, Seng
10 Jennison Circle
Natick, MA 01760 / US
 [2017/08]
Representative(s)Garner, Stephen
Mathys & Squire The Shard
32 London Bridge Street
London SE1 9SG / GB
[N/P]
Former [2017/08]Garner, Stephen
Mathys & Squire LLP The Shard
32 London Bridge Street
London SE1 9SG / GB
Application number, filing date16175117.724.11.2010
[2017/08]
Priority number, dateUS20090264748P27.11.2009         Original published format: US 264748 P
[2017/08]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP3133070
Date:22.02.2017
Language:EN
[2017/08]
Type: B1 Patent specification 
No.:EP3133070
Date:14.08.2019
Language:EN
[2019/33]
Search report(s)(Supplementary) European search report - dispatched on:EP10.11.2016
ClassificationIPC:C07D405/06, A61K45/06, A61K31/4025, A61P35/00
[2017/08]
CPC:
A61K31/4025 (EP,CN,IL,KR,US); C07D405/06 (EP,CN,IL,KR); A61K31/357 (US);
A61K45/06 (IL,US); A61P3/00 (KR,US); A61P3/06 (US);
A61P35/00 (EP,IL); A61P43/00 (KR); C07C59/255 (KR);
C07D319/16 (EP,IL); C07D319/18 (CN); C07B2200/13 (CN) (-)
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 [2017/12]
Former [2017/08]AL,  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 
Extension statesBA14.02.2017
ME14.02.2017
TitleGerman:ELIGLUSTAT (GENZ 112638) ALS INHIBITOR DER GLUCOSYLCERAMIDSYNTHASE ZUR VERWENDUNG IN EINEM VERFAHREN ZUR BEHANDLUNG VON FABRY'S ODER GAUCHER'S ERKRANKUNG, WOBEI DAS VERFAHREN DIE ANPASSUNG DER INDIVIDUELLEN THEARAPEUTISCHEN DOSIS AN DEN P-450 STOFFWECHSEL DES PATIENTEN UMFASST[2017/08]
English:ELIGLUSTAT (GENZ 112638) AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE FOR USE IN A METHOD OF TREATING FABRY'S OR GAUCHER'S DISEASE, THE METHOD COMPRISING ADJUSTING THE INDIVIDUAL THERAPEUTICAL DOSE TO THE P-450 METABOLISM OF THE PATIENT[2017/08]
French:ELIGLUSTAT (GENZ 112638) EN TANT QUE INHIBITEUR DE LA GLUCOSYLCÉRAMIDE SYNTHASE POUR L'UTILISATION DANS UN PROCÉDÉ POUR TRAITÉ LA MALADIE DE FABRY OU DE GAUCHER, LE PROCÉDÉ COMPRENANT AJUSTER LA DOSE INDIVIDUELLE AU MÉTABOLISME DU P-450 DU PATIENT[2022/04]
Former [2017/08]ELIGLUSTAT (GENZ 112638) EN TANT QU' INHIBITEUR DE LA GLUCOSYLCÉRAMIDE SYNTHASE POUR L'UTILISATION DANS UN PROCÉDÉ POUR TRAITER LA MALADIE DE FABRY OU DE GAUCHER, LE PROCÉDÉ COMPRENANT À AJUSTER LA DOSE INDIVIDUELLE AU MÉTABOLISME DU P-450 DU PATIENT
Examination procedure17.06.2016Date on which the examining division has become responsible
14.02.2017Amendment by applicant (claims and/or description)
14.02.2017Examination requested  [2017/12]
11.05.2017Despatch of a communication from the examining division (Time limit: M06)
21.11.2017Reply to a communication from the examining division
15.06.2018Communication of intention to grant the patent
03.12.2018Despatch of communication that the application is deemed to be withdrawn, reason: fee for grant / fee for printing not paid in time
22.01.2019Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
21.02.2019Communication of intention to grant the patent
25.06.2019Fee for grant paid
25.06.2019Fee for publishing/printing paid
25.06.2019Receipt of the translation of the claim(s)
Parent application(s)   TooltipEP10785289.9  / EP2504332
EP14164650.5  / EP2796457
EP16159714.1
Divisional application(s)EP19182732.8  / EP3599237
EP21160074.7  / EP3896069
Opposition(s)Opponent(s)01  13.05.2020  15.05.2020  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
124 Dvora HaNevi'a St.
6944020 Tel Aviv / IL
Opponent's representative
D Young & Co LLP
3 Noble Street
London EC2V 7BQ / GB
 02  14.05.2020  18.05.2020  ADMISSIBLE
Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow Middlesex
HA1 4HF / GB
Opponent's representative
Brand Murray Fuller LLP
50 Eastcastle Street
London W1W 8EA / GB
 03  14.05.2020  28.05.2020  ADMISSIBLE
Hetero Labs Limited
7-2-A2, Hetero Corporate
Industrial Estates
Sanath Nagar
Hyderabad - 500018, Telangana / IN
Opponent's representative
ZBM Patents ApS
Symbion Box:33
Fruebjergvej 3
2100 Copenhagen Ø / DK
 [N/P]
Former [2022/19]
Opponent(s)01  13.05.2020  15.05.2020  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
124 Dvora HaNevi'a St.
6944020 Tel Aviv / IL
Opponent's representative
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
 02  14.05.2020  18.05.2020  ADMISSIBLE
Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow Middlesex
HA1 4HF / GB
Opponent's representative
Brand Murray Fuller LLP
50 Eastcastle Street
London W1W 8EA / GB
 03  14.05.2020  28.05.2020  ADMISSIBLE
Hetero Labs Limited
7-2-A2, Hetero Corporate
Industrial Estates
Sanath Nagar
Hyderabad - 500018, Telangana / IN
Opponent's representative
ZBM Patents ApS
Symbion Box:33
Fruebjergvej 3
2100 Copenhagen Ø / DK
Former [2021/52]
Opponent(s)01  13.05.2020  15.05.2020  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
124 Dvora HaNevi'a St.
6944020 Tel Aviv / IL
Opponent's representative
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
 02  14.05.2020  18.05.2020  ADMISSIBLE
Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow Middlesex
HA1 4HF / GB
Opponent's representative
Accord Healthcare, S.L.U.
World Trade Center
Moll de Barcelona s/n
Edifici Est, 6ª planta
08039 Barcelona / ES
 03  14.05.2020  28.05.2020  ADMISSIBLE
Hetero Labs Limited
7-2-A2, Hetero Corporate
Industrial Estates
Sanath Nagar
Hyderabad - 500018, Telangana / IN
Opponent's representative
ZBM Patents ApS
Symbion Box:33
Fruebjergvej 3
2100 Copenhagen Ø / DK
Former [2020/27]
Opponent(s)01  13.05.2020  15.05.2020  ADMISSIBLE
Teva Pharmaceutical Industries Ltd
5 Basel Street
P.O. Box 3190
49131 Petah Tiqva / IL
Opponent's representative
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
 02  14.05.2020  18.05.2020  ADMISSIBLE
Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow Middlesex
HA1 4HF / GB
Opponent's representative
Accord Healthcare, S.L.U.
World Trade Center
Moll de Barcelona s/n
Edifici Est, 6ª planta
08039 Barcelona / ES
 03  14.05.2020  28.05.2020  ADMISSIBLE
Hetero Labs Limited
7-2-A2, Hetero Corporate
Industrial Estates
Sanath Nagar
Hyderabad - 500018, Telangana / IN
Opponent's representative
ZBM Patents ApS
Symbion Box:33
Fruebjergvej 3
2100 Copenhagen Ø / DK
Former [2020/25]
Opponent(s)01  13.05.2020    ADMISSIBLE
Teva Pharmaceutical Industries Ltd
5 Basel Street
P.O. Box 3190
49131 Petah Tiqva / IL
Opponent's representative
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
 02  14.05.2020    ADMISSIBLE
Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow Middlesex
HA1 4HF / GB
Opponent's representative
Accord Healthcare, S.L.U.
World Trade Center
Moll de Barcelona s/n
Edifici Est, 6ª planta
08039 Barcelona / ES
18.06.2020Invitation to proprietor to file observations on the notice of opposition
08.01.2021Reply of patent proprietor to notice(s) of opposition
26.11.2021Date of oral proceedings
21.02.2022Despatch of minutes of oral proceedings
18.02.2025Legal effect of revocation of patent [2025/26]
19.05.2025Despatch of communication that the patent will be revoked
Appeal following opposition21.04.2022Appeal received No.  T1125/22
21.04.2022Payment of appeal fee
01.07.2022Statement of grounds filed
18.02.2025Result of appeal procedure: revocation of the patent
19.05.2025Despatch of the decision of the Board of Appeal
21.04.2022Appeal received No.  T1125/22
21.04.2022Payment of appeal fee
29.06.2022Statement of grounds filed
18.02.2025Result of appeal procedure: revocation of the patent
19.05.2025Despatch of the decision of the Board of Appeal
18.02.2025Date of oral proceedings
Request for further processing for:The application is deemed to be withdrawn due to failure to fulfill actions required for granting the patent
22.01.2019Request for further processing filed
22.01.2019Full payment received (date of receipt of payment)
Request granted
04.02.2019Decision despatched
Fees paidRenewal fee
21.06.2016Renewal fee patent year 03
21.06.2016Renewal fee patent year 04
21.06.2016Renewal fee patent year 05
21.06.2016Renewal fee patent year 06
10.11.2016Renewal fee patent year 07
13.11.2017Renewal fee patent year 08
14.11.2018Renewal fee patent year 09
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Lapses during opposition  TooltipRS24.11.2010
AL14.08.2019
MK14.08.2019
SM14.08.2019
IS14.12.2019
CY24.11.2020
LV24.11.2020
MT24.11.2020
MC30.11.2020
GR30.11.2024
[2026/16]
Former [2026/10]RS24.11.2010
AL14.08.2019
MK14.08.2019
SM14.08.2019
IS14.12.2019
CY24.11.2020
LV24.11.2020
MT24.11.2020
MC30.11.2020
Former [2022/30]AL14.08.2019
MK14.08.2019
SM14.08.2019
IS14.12.2019
CY24.11.2020
LV24.11.2020
MT24.11.2020
MC30.11.2020
Former [2021/38]AL14.08.2019
SM14.08.2019
IS14.12.2019
CY24.11.2020
LV24.11.2020
MC30.11.2020
Former [2021/35]AL14.08.2019
SM14.08.2019
IS14.12.2019
CY24.11.2020
MC30.11.2020
Former [2021/31]AL14.08.2019
SM14.08.2019
IS14.12.2019
MC30.11.2020
Former [2020/36]AL14.08.2019
SM14.08.2019
IS14.12.2019
Former [2020/28]AL14.08.2019
SM14.08.2019
IS24.02.2020
Former [2020/24]AL14.08.2019
IS24.02.2020
Former [2020/15]AL14.08.2019
IS14.12.2019
Former [2020/14]IS14.12.2019
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DOI:   http://dx.doi.org/10.1358/dof.2010.035.08.1505566
by applicantUS6051598
 US5952370
 US5945442
 US5916911
 US6030995
 US7253185
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OppositionWO2008150486
 WO2008150486
 WO03008399
   PETERSCHMITT J ET AL.: "102. Genz-112638, an investigational oral treatment for Gaucher disease type 1: Preliminary Phase 2 clinical trial results", MOL GEN & MET, vol. 96, no. 2, 1 February 2009 (2009-02-01), pages S34, XP025772035

DOI:   http://dx.doi.org/10.1016/j.ymgme.2008.11.103
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   PETERSCHMITT, J.ET AL: "102. Genz-112638, an investigational oral treatment for Gaucher disease type 1: Preliminary Phase 2 clinical trial results", MOLECULAR GENETICS AND METABOLISM, ACADEMIC PRESS, AMSTERDAM, NL, vol. 96, no. 2, 1 February 2009 (2009-02-01), AMSTERDAM, NL, pages S34, XP025772035, ISSN: 1096-7192, DOI: 10.1016/j.ymgme.2008.11.103

DOI:   http://dx.doi.org/10.1016/j.ymgme.2008.11.103
   PETERSCHMITT, J. LUKINA, E. WATMAN, N. BANIKAZEMI, M. IASTREBNER, M. ROSENBAUM, H. ZIMRAN, A. ARREGUIN, E.A. O'BRI: "73. Preliminary results of a phase II clinical trial of Genz-112638 in patients with type I Gaucher disease", MOLECULAR GENETICS AND METABOLISM, ACADEMIC PRESS, AMSTERDAM, NL, vol. 93, no. 2, 14 January 2008 (2008-01-14), AMSTERDAM, NL, pages 32 - 33, XP022420706, ISSN: 1096-7192, DOI: 10.1016/j.ymgme.2007.10.085

DOI:   http://dx.doi.org/10.1016/j.ymgme.2007.10.085
   MCEACHERN, K. SIEGEL, C. FUNG, J. CHUANG, W.L. HUTTO, E. SUNG, C. BLANKSTEIN, L. PETERSCHMITT, M.J. GRABOWSKI, G.A: "24 Genz-112638: A novel orally available ceramide-based inhibitor of glucosylceramide synthase for treating Gaucher disease", MOLECULAR GENETICS AND METABOLISM, ACADEMIC PRESS, AMSTERDAM, NL, vol. 92, no. 4, 20 November 2007 (2007-11-20), AMSTERDAM, NL, pages 17, XP022354774, ISSN: 1096-7192, DOI: 10.1016/j.ymgme.2007.08.029

DOI:   http://dx.doi.org/10.1016/j.ymgme.2007.08.029
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