| 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] | Status | Patent revoked Status updated on 19.05.2025 Database last updated on 11.04.2026 | |
| Former | The patent has been granted Status updated on 12.07.2019 | ||
| Former | Grant of patent is intended Status updated on 20.02.2019 | ||
| Former | Examination is in progress Status updated on 23.01.2019 | ||
| Former | Grant of patent is intended Status updated on 14.06.2018 | ||
| Former | Examination is in progress Status updated on 12.05.2017 | ||
| Former | Request for examination was made Status updated on 17.02.2017 | ||
| Former | The application has been published Status updated on 20.01.2017 | Most recent event Tooltip | 13.03.2026 | Lapse 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 date | 16175117.7 | 24.11.2010 | [2017/08] | Priority number, date | US20090264748P | 27.11.2009 Original published format: US 264748 P | [2017/08] | Filing language | EN | Procedural language | EN | Publication | Type: | 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: | EP | 10.11.2016 | Classification | IPC: | 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);
| Designated contracting states | 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 [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 states | BA | 14.02.2017 | ME | 14.02.2017 | Title | German: | 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 procedure | 17.06.2016 | Date on which the examining division has become responsible | 14.02.2017 | Amendment by applicant (claims and/or description) | 14.02.2017 | Examination requested [2017/12] | 11.05.2017 | Despatch of a communication from the examining division (Time limit: M06) | 21.11.2017 | Reply to a communication from the examining division | 15.06.2018 | Communication of intention to grant the patent | 03.12.2018 | Despatch of communication that the application is deemed to be withdrawn, reason: fee for grant / fee for printing not paid in time | 22.01.2019 | Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO | 21.02.2019 | Communication of intention to grant the patent | 25.06.2019 | Fee for grant paid | 25.06.2019 | Fee for publishing/printing paid | 25.06.2019 | Receipt of the translation of the claim(s) | Parent application(s) Tooltip | EP10785289.9 / 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 | 18.06.2020 | Invitation to proprietor to file observations on the notice of opposition | 08.01.2021 | Reply of patent proprietor to notice(s) of opposition | 26.11.2021 | Date of oral proceedings | 21.02.2022 | Despatch of minutes of oral proceedings | 18.02.2025 | Legal effect of revocation of patent [2025/26] | 19.05.2025 | Despatch of communication that the patent will be revoked | Appeal following opposition | 21.04.2022 | Appeal received No. T1125/22 | 21.04.2022 | Payment of appeal fee | 01.07.2022 | Statement of grounds filed | 18.02.2025 | Result of appeal procedure: revocation of the patent | 19.05.2025 | Despatch of the decision of the Board of Appeal | 21.04.2022 | Appeal received No. T1125/22 | 21.04.2022 | Payment of appeal fee | 29.06.2022 | Statement of grounds filed | 18.02.2025 | Result of appeal procedure: revocation of the patent | 19.05.2025 | Despatch of the decision of the Board of Appeal | 18.02.2025 | Date 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 | 22.01.2019 | Request for further processing filed | 22.01.2019 | Full payment received (date of receipt of payment) Request granted | 04.02.2019 | Decision despatched | Fees paid | Renewal fee | 21.06.2016 | Renewal fee patent year 03 | 21.06.2016 | Renewal fee patent year 04 | 21.06.2016 | Renewal fee patent year 05 | 21.06.2016 | Renewal fee patent year 06 | 10.11.2016 | Renewal fee patent year 07 | 13.11.2017 | Renewal fee patent year 08 | 14.11.2018 | Renewal fee patent year 09 |
| 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 Tooltip | RS | 24.11.2010 | AL | 14.08.2019 | MK | 14.08.2019 | SM | 14.08.2019 | IS | 14.12.2019 | CY | 24.11.2020 | LV | 24.11.2020 | MT | 24.11.2020 | MC | 30.11.2020 | GR | 30.11.2024 | [2026/16] |
| Former [2026/10] | RS | 24.11.2010 | |
| AL | 14.08.2019 | ||
| MK | 14.08.2019 | ||
| SM | 14.08.2019 | ||
| IS | 14.12.2019 | ||
| CY | 24.11.2020 | ||
| LV | 24.11.2020 | ||
| MT | 24.11.2020 | ||
| MC | 30.11.2020 | ||
| Former [2022/30] | AL | 14.08.2019 | |
| MK | 14.08.2019 | ||
| SM | 14.08.2019 | ||
| IS | 14.12.2019 | ||
| CY | 24.11.2020 | ||
| LV | 24.11.2020 | ||
| MT | 24.11.2020 | ||
| MC | 30.11.2020 | ||
| Former [2021/38] | AL | 14.08.2019 | |
| SM | 14.08.2019 | ||
| IS | 14.12.2019 | ||
| CY | 24.11.2020 | ||
| LV | 24.11.2020 | ||
| MC | 30.11.2020 | ||
| Former [2021/35] | AL | 14.08.2019 | |
| SM | 14.08.2019 | ||
| IS | 14.12.2019 | ||
| CY | 24.11.2020 | ||
| MC | 30.11.2020 | ||
| Former [2021/31] | AL | 14.08.2019 | |
| SM | 14.08.2019 | ||
| IS | 14.12.2019 | ||
| MC | 30.11.2020 | ||
| Former [2020/36] | AL | 14.08.2019 | |
| SM | 14.08.2019 | ||
| IS | 14.12.2019 | ||
| Former [2020/28] | AL | 14.08.2019 | |
| SM | 14.08.2019 | ||
| IS | 24.02.2020 | ||
| Former [2020/24] | AL | 14.08.2019 | |
| IS | 24.02.2020 | ||
| Former [2020/15] | AL | 14.08.2019 | |
| IS | 14.12.2019 | ||
| Former [2020/14] | IS | 14.12.2019 | Documents cited: | Search | [XI] WO2008150486 (GENZYME CORP et al.) | [XI] 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), pages S34, XP025772035, ISSN: 1096-7192, [retrieved on 20090113], DOI: 10.1016/J.YMGME.2008.11.103 DOI: http://dx.doi.org/10.1016/j.ymgme.2008.11.103 | [XPI] J.A. SHAYMAN: "Eliglustat tartrate", DRUGS OF THE FUTURE, vol. 35, no. 8, 1 January 2010 (2010-01-01), pages 613 - 620, XP055198504, ISSN: 0377-8282, DOI: 10.1358/dof.2010.035.08.1505566 DOI: http://dx.doi.org/10.1358/dof.2010.035.08.1505566 | by applicant | US6051598 | US5952370 | US5945442 | US5916911 | US6030995 | US7253185 | SVENSSON, M. 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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 | S TOMLINSON ET AL.: "Mechanism of Disease - An Introduction to Clinical Science. 2nd ed.", 2008, CAMBRIDGE UNIVERSITY PRESS, article "Substrate reduction therapy", pages: 63; 64, XP055704205 | E LUKINA ET AL.: "Latest Data on Genz-112638, an Investigational Oral Therapy for Type 1 Gaucher Disease:Phase II Clinical Trial Results After 1 Year of Treatment", CLINICAL THERAPEUTICS, vol. 31, no. C, 2009, pages S194 - S195, XP026786231 | E LUKINA ET AL.: "GENZ-112638, AN INVESTIGATIONAL ORAL THERAPY FOR GAUCHERDISEASE TYPE 1: PHASE 2 CLINICAL TRIAL RESULTS AFTER ONE YEAR OF TREATMENT", HAEMATOLOGICA, vol. 94, no. s2, 2009, pages 41, XP055704206 | ANONYMOUS: "Study of Genzyme Oral Compound for Gaucher Disease Meets Primary Endpoint", SANOFI PRESS RELEASE, 20 February 2009 (2009-02-20), XP055704207, Retrieved from the Internet | MCEACHEM K ET AL.: "24 Genz-112638: A novel orally available ceramide-based inhibitor of glucosylceramide synthase for treating Gaucher disease", MOL GEN & MET, vol. 92, no. 4, 20 November 2007 (2007-11-20), pages S17, XP022354774 DOI: http://dx.doi.org/10.1016/j.ymgme.2007.08.029 | ANONYMOUS: "Drug Metabolism and Pharmacokinetics - an overview", EUR PHARM REV, 12 December 2009 (2009-12-12), XP055704210, Retrieved from the Internet | BELLE D ET AL.: "Genetic Factors in Drug Metabolism", AMER FAMILY PHYSICIAN, vol. 77, no. 11, 1 June 2008 (2008-06-01), pages 1553 - 1560, XP055704212 | VAN SCHAIK RON: "Dose Adjustments Based on Pharmacogenetics of CYP450 Enzymes", THE COMMUNICATIONS AND PUBLICATIONS DIVISION (CPD) OF THE IFCC, vol. 19, no. 1, 3 April 2008 (2008-04-03), pages 42 - 47, XP055704214 | SHARP CF ET AL.: "CYP2D6 genotype and its relationship with metoprolol dose, concentrations and effect in patients with systolic heart failure", THE PHARMACOGENOMICS JOURNAL, vol. 9, no. 3, 1 June 2009 (2009-06-01), pages 175 - 184, XP008134361 DOI: http://dx.doi.org/10.1038/tpj.2009.9 | BOZINA N ET AL.: "Genetic Polymorphism of Metabolic Enzymes P450 (CYP) as a Susceptibility Factor for Drug Response, Toxicity, and Cancer Risk", ARH HG RADA TOKSIKOL, vol. 60, no. 2, 1 June 2009 (2009-06-01), pages 217 - 242, XP055704217 DOI: http://dx.doi.org/10.2478/10004-1254-60-2009-1885 | ZHOU S ET AL.: "Polymorphism of human cytochrome P450 enzymes and its clinical impact", DRUG MET REV, vol. 41, no. 2, 2009, pages 89 - 295, XP055704222 DOI: http://dx.doi.org/10.1080/03602530902843483 | GAEDIGK A ET AL.: "The CYP2D6 Activity Score: Translating Genotype Information into a Qualitative Measure of Phenotype", CLINICAL PHARMACOLOGY AND THERAPEUTICS, vol. 83, no. 2, February 2008 (2008-02-01), pages 234 - 242, XP055704225 DOI: http://dx.doi.org/10.1038/sj.clp | ANONYMOUS: "A Study of Genz-112638 in Patients With Gaucher Disease Who Have Been Stabilized on Cerezyme (ENCORE)", CLINICALTRIALS.GOV STUDY NCT00943111, 5 November 2009 (2009-11-05), XP055378019, Retrieved from the Internet | TERRY D BUTTERS: "Pharmacotherapeutic Strategies Using Small Molecules for the Treatment of Glycolipid Lysosomal Storage Disorders", EXPERT OPINION ON PHARMACOTHERAPY, vol. 8, no. 4, 2007, pages 427 - 435, XP009131356, DOI: 10.1517/14656566.8.4.427 DOI: http://dx.doi.org/10.1517/14656566.8.4.427 | MCEACHERN KERRY ANNE ET AL: "A specific and potent inhibitor of glucosylceramide synthase for substrate inhibition therapy of Gaucher disease", MOLECULAR GENETICS AND METABOLISM, ACADEMIC PRESS, AMSTERDAM, NL, vol. 91, no. 3, 1 July 2007 (2007-07-01), AMSTERDAM, NL, pages 259 - 267, XP002617211, ISSN: 1096-7192, DOI: 10.1016/J.YMGME.2007.04.001 DOI: http://dx.doi.org/10.1016/J.YMGME.2007.04.001 | 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 | ULRICH M. 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