blank Quick help
blank Maintenance news

Scheduled maintenance

Regular maintenance outages:
between 05.00 and 05.15 hrs CET (Monday to Sunday).

Other outages
Availability

2022.02.11

More...
blank News flashes

News Flashes

New version of the European Patent Register – SPC proceedings information in the Unitary Patent Register.

2024-07-24

More...
blank Related links

Release notes
European Patent Register Assistant
European Patent Register Resource Book
European Patent Register – pocket guide
FAQ - European Patent Register
Federated Register (Flyer)
Global Dossier (Flyer)
Register events
Deep link coverage
Federated Register content
The Patent Information Tour
Fair use charter

Extract from the Register of European Patents

EP About this file: EP2504332

EP2504332 - AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE [Right-click to bookmark this link]
StatusPatent maintained as amended
Status updated on  12.02.2021
Database last updated on 20.12.2024
Most recent event   Tooltip10.11.2023Lapse of the patent in a contracting state
New state(s): AL		published on 13.12.2023  [2023/50]
Applicant(s)For all designated states
Genzyme Corporation
50 Binney Street
Cambridge, MA 02142 / US
[2018/29]
Former [2014/23]For all designated states
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142 / US
Former [2012/40]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
25 Northrop Street
Hopedale, MA 01747 / 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
 [2012/40]
Representative(s)Garner, Stephen, et al
Mathys & Squire The Shard
32 London Bridge Street
London SE1 9SG / GB
[2021/11]
Former [2014/23]Potter Clarkson LLP
The Belgrave Centre
Talbot Street
Nottingham, NG1 5GG / GB
Former [2013/37]Potter Clarkson LLP
The Belgrave Centre
Talbot Street
Nottingham
NG1 5GG / GB
Former [2013/34]Stevens, Ian Edward, et al
Potter Clarkson LLP The Belgrave Centre
Talbot Street
Nottingham NG1 5GG / GB
Former [2012/40]Snodin, Michael D.
Potter Clarkson LLP
Park View House
58 The Ropewalk
Nottingham NG1 5DD / GB
Application number, filing date10785289.924.11.2010
[2021/11]
WO2010US57952
Priority number, dateUS20090264748P27.11.2009         Original published format: US 264748 P
[2012/40]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2011066352
Date:03.06.2011
Language:EN
[2011/22]
Type: A1 Application with search report 
No.:EP2504332
Date:03.10.2012
Language:EN
The application published by WIPO in one of the EPO official languages on 03.06.2011 takes the place of the publication of the European patent application.
[2012/40]
Type: B1 Patent specification 
No.:EP2504332
Date:04.06.2014
Language:EN
[2014/23]
Type: B2 New European patent specification 
No.:EP2504332
Date:17.03.2021
Language:EN
[2021/11]
Search report(s)International search report - published on:EP03.06.2011
ClassificationIPC:C07D405/06, A61K31/4025, A61P35/00
[2012/40]
CPC:
A61K31/4025 (EP,CN,IL,KR,US); C07D405/06 (EP,CN,IL,KR,US); A61K31/445 (KR);
A61K31/7004 (KR); A61K45/06 (IL,KR,US); A61P3/00 (KR);
A61P35/00 (EP,IL); A61P43/00 (KR); C07D319/16 (EP,IL,US);
C07D319/18 (CN); C07B2200/13 (CN,KR) (-)
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 [2012/40]
Extension statesBA26.06.2012
ME26.06.2012
TitleGerman:EINE AMORPHE UND EINE KRISTALLINE FORM VON GENZ 112638 HEMITARTRATE ALS INHIBITOR DER GLUCOSYLCERAMID SYNTHASE[2013/52]
English:AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE[2012/40]
French:UNE FORME AMORPHE ET UNE FORME CRYSTALLINE DU GENZ 112638 HÉMITARTRATE EN TANT QUE INHIBITEUR DE LA SYNTHASE GLUCOSYLCÉRAMIDE[2013/52]
Former [2012/40]AMORPHE UND KRISTALLINE FORM VON GENZ-112638-HEMITARTRAT ALS HEMMER DER GLUCOSYLCERAMIDSYNTHASE
Former [2012/40]FORME AMORPHE ET CRISTALLINE DE L'HÉMITARTRATE DE GENZ 112638 AU TITRE D'INHIBITEUR DE LA GLUCOSYLCÉRAMIDE SYNTHÉTASE
Entry into regional phase26.06.2012National basic fee paid 
26.06.2012Designation fee(s) paid 
26.06.2012Examination fee paid 
Examination procedure26.06.2012Examination requested  [2012/40]
30.01.2013Amendment by applicant (claims and/or description)
08.05.2013Despatch of a communication from the examining division (Time limit: M06)
11.11.2013Reply to a communication from the examining division
18.12.2013Communication of intention to grant the patent
16.04.2014Fee for grant paid
16.04.2014Fee for publishing/printing paid
16.04.2014Receipt of the translation of the claim(s)
Divisional application(s)EP14164650.5  / EP2796457
EP16159714.1   Application withdrawn  : 20.06.2016
EP16175117.7  / EP3133070
EP19182732.8  / EP3599237
EP21160074.7  / EP3896069
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  08.05.2013
Opposition(s)Opponent(s)01  27.02.2015  05.03.2015  ADMISSIBLE
SANDOZ AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 [2020/22]
Former [2017/10]
Opponent(s)01  27.02.2015  05.03.2015  ADMISSIBLE
SANDOZ AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Herzog, Fiesser & Partner Patentanwälte PartG mbB
Isartorplatz 1
80331 München / DE
Former [2015/15]
Opponent(s)01  27.02.2015  05.03.2015  ADMISSIBLE
SANDOZ AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Ladendorf, Oliver
Kraus & Weisert
Patentanwälte PartGmbB
Thomas-Wimmer-Ring 15
80539 München / DE
15.04.2015Invitation to proprietor to file observations on the notice of opposition
25.02.2016Reply of patent proprietor to notice(s) of opposition
07.11.2016Date of oral proceedings
12.12.2016Despatch of interlocutory decision in opposition
12.12.2016Despatch of minutes of oral proceedings
08.09.2020Legal effect of interlocutory decision in opposition
10.11.2020Despatch of communication that the patent will be maintained as amended
09.02.2021Fee for printing new specification paid
Appeal following opposition22.02.2017Appeal received No.  T0478/17
24.04.2017Statement of grounds filed
08.09.2020Result of appeal procedure: appeal of the opponent was rejected
08.09.2020Date of oral proceedings
Fees paidRenewal fee
11.12.2012Renewal fee patent year 03
18.11.2013Renewal fee patent year 04
Penalty fee
Additional fee for renewal fee
30.11.201203   M06   Fee paid on   11.12.2012
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  TooltipMC04.06.2014
SM04.06.2014
IS04.10.2014
AL24.11.2020
CY24.11.2020
LV24.11.2020
MT24.11.2020
[2023/50]
Former [2022/30]MC04.06.2014
SM04.06.2014
IS04.10.2014
CY24.11.2020
LV24.11.2020
MT24.11.2020
Former [2021/38]MC04.06.2014
SM04.06.2014
IS04.10.2014
CY24.11.2020
LV24.11.2020
Former [2021/35]MC04.06.2014
SM04.06.2014
IS04.10.2014
CY24.11.2020
Former [2016/22]MC04.06.2014
SM04.06.2014
IS04.10.2014
Former [2015/32]MC04.06.2014
IS04.10.2014
Former [2015/12]IS04.10.2014
Cited inInternational search[I]WO2006053043  (GENZYME CORP [US], et al) [I] 1-93 * formula VIII; page 13, paragraph [0062] - page 14, paragraph [0064] * * page 24, paragraph [0114] - page 25, paragraph [0116]; example 3 ** claims 29,44 *;
 [I]  - MCEACHERN, KERRY ANNE ET AL, "A specific and potent inhibitor of glucosylceramide synthase for substrate inhibition therapy of Gaucher disease", MOLECULAR GENETICS AND METABOLISM, vol. 91, no. 3, ISSN 1096-7192, (20070516), pages 259 - 267, XP002617211 [I] 1-93 * page 260, column r, paragraph 1 *

DOI:   http://dx.doi.org/10.1016/J.YMGME.2007.04.001
by applicantUS5302609
 US5472969
 US5525616
 US5849326
 US5916911
 US5945442
 US5952370
 US6030995
 US6051598
 US6255336
 US6569889
 US6610703
 US6660749
 US6916802
 WO2006053043
 US7253185
 US2009001773
    - SVENSSON, M. ET AL., "Epithelial Glucosphingolipid Expression as a Determinant of Bacterial Adherence and Cytokine Production", INFECT. AND IMMUN., (1994), vol. 62, pages 4404 - 4410
    - INOKUCHI, J. ET AL., "Antitumor Activity in Mice of an Inhibitor of Glycosphingolipid Biosynthesis", CANCER LETT., (1987), vol. 38, pages 23 - 30
    - HAKOMORI, S., "New Directions in Cancer Therapy Based on Aberrant Expression of Glycosphingolipids: Anti-adhesion and Ortho-Signaling Therapy", CANCER CELLS, (1991), vol. 3, pages 461 - 470
    - INOKUCHI, J. ET AL., "Inhibition of Experimental Metastasis of Murine Lewis Long Carcinoma by an Inhibitor of Glucosylceramide Synthase and its Possible Mechanism of Action", CANCER RES., (1990), vol. 50, pages 6731 - 6737
    - ZICHE, M. ET AL., "Angiogenesis Can Be Stimulated or Repressed in In Vivo by a Change in GM3 :GD3 Ganglioside Ratio", LAB. INVEST., (1992), vol. 67, pages 711 - 715
    - U. ANDERSSON ET AL., BIOCHEM. PHARM., (2000), vol. 59, pages 821 - 829
    - U. ANDERSSON ET AL., BIOCHEM. PHARM., (2004), vol. 67, pages 697 - 705
    - H.S. OVERKLEEFT ET AL., J. BIOL. CHEM., (1998), vol. 273, pages 26522 - 26527
    - WANG, AM ET AL., AM. J. HUM. GENET., (1996), vol. 59, page A208
    - ZIEGLER, RJ ET AL., MOLEC. THER., (2007), vol. 15, no. 3, pages 492 - 500
    - Y-H. XU ET AL., AM. J. PATHOL., (2003), vol. 163, pages 2093 - 210 1
    - K. MCEACHERN ET AL., J. GENE. MED., (2006), vol. 8, pages 719 - 729
    - T. DOERING, J. BIOL. CHEM., (1999), vol. 274, pages 11038 - 11045
    - G.A. GRABOWSKI ET AL., ANN. INT. MED., (1995), vol. 122, pages 33 - 39
    - S.M. VAN PATTEN ET AL., GLYCOBIOLOGY, (2007), vol. 17, pages 467 - 478
    - K.A. MCEACHERN, MOL. GENET. METAB., (2007), vol. 91, pages 259 - 267
    - Y-H. XU ET AL., AM. J PATHOL., (2003), vol. 163, pages 2093 - 2101
    - Y.-H. XU. ET AL., AM. J. PATHOL., (2003), vol. 163, pages 2093 - 2101
    - A. ABE ET AL., J. CLIN. INV., (2000), vol. 105, pages 1563 - 1571
    - H. ZHAO ET AL., DIABETES, (2007), vol. 56, pages 1341 - 1349
    - S.P.F. MILLER ET AL., J. LAB. CLIN. MED., (1996), vol. 127, pages 353 - 358
    - B.N. AMES, METHODS ENZYMOL., (1966), vol. 8, pages 115 - 118
    - K. MCEACHERN ET AL., J. GENE MED., (2006), vol. 8, pages 719 - 729
    - T. DOERING ET AL., J. BIOL. CHEM., (1999), vol. 274, pages 11038 - 11045
 US20010611304
 US20080137214
 US20080102541
OppositionWO2006053043
    - "Genetic Diseases - Genzyme contiunues to expand on its leadership position as a pioneering provider of innovative healthcare solutions for genetic diseases", Genzyme, (20080000), page 12, XP055377995
    - Genzyme, "gaucher | genzyme studies", ClinicalTrials.gov archive, (20091126), XP055378002
    - "A Study of the Efficacy and Safety of Genz-112638 in Type 1 Gaucher Patients (NCT00358150)", ClinicalTrials.gov archive, (20090730), XP055378009
    - "A Study of Genz-112638 in Patients With Gaucher Disease(ENGAGE) (NCT00891202)", ClinicalTrials.gov archive, (20091103), XP055378017
    - "A Study of Genz-112638 in Patients With Gaucher Disease Who Have Been Stabilized on Cerezyme (NCT00943111)", ClinicalTrials.gov archive, (20091105), XP055378019
    - Excerpt from IUPAC nomenclature in R-5.7.4 (salts and esters)
    - Zhao et al, Diabetes, (20070000), vol. 56, pages 1210 - 1218
    - Information on clinical trial NCT00358150 dated 22 june 2008, derived from clinicaltrials.gov Archive
    - FDA Center for Drug Evaluation and Research; Summary Review For Regulatory Action on application number 205494Orig1s000 Cerdelga/eliglustat; 19 August 2014
    - Byrn, Pharmaceutical Research, (19950000), vol. 12, no. 7
    - Regulation EC 141/2000 on orphan medicinal products
    - Council directive 65/65/EEC
The EPO accepts no responsibility for the accuracy of data originating from other authorities; in particular, it does not guarantee that it is complete, up to date or fit for specific purposes.