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Extract from the Register of European Patents

EP About this file: EP2558863

EP2558863 - COMPOSITIONS AND METHODS FOR CHARACTERIZING A MYOPATHY [Right-click to bookmark this link]
StatusOpposition rejected
Status updated on  11.02.2022
Database last updated on 15.07.2024
FormerThe patent has been granted
Status updated on  11.09.2017
Most recent event   Tooltip11.02.2022Opposition rejectedpublished on 16.03.2022  [2022/11]
Applicant(s)For all designated states
The Johns Hopkins University
3400 North Charles Street
Baltimore, MD 21218 / US
[2013/08]
Inventor(s)01 / CASCIOLA-ROSEN, Livia, Angela
3 Stone Hollow Ct.
Pikesville MD 21208 / US
02 / CHRISTOPHER-STINE, Lisa
c/o Johns Hopkins Myositis Center
5200 Eastern Avenue
Mason F. Lord Building
Center Tower, Suite 4500
Baltimore, MD 21224 / US
03 / MAMMEN, Andrew
c/o Johns Hopkins Myositis Center
5200 Eastern Avenue
Mason F. Lord Building
Center Tower, Suite 4500
Baltimore, MD 21224 / US
04 / ROSEN, Antony
3 Stone Hollow Court
Pikesville MD 21208 / US
 [2013/08]
Representative(s)Hiebl, Inge Elisabeth
Kraus & Weisert
Patentanwälte PartGmbB
Thomas-Wimmer-Ring 15
80539 München / DE
[N/P]
Former [2015/41]Adam, Holger
Kraus & Weisert
Patentanwälte PartGmbB
Thomas-Wimmer-Ring 15
80539 München / DE
Former [2013/08]Adam, Holger
Kraus & Weisert Patent- und Rechtsanwälte Thomas-Wimmer-Ring 15
80539 München / DE
Application number, filing date11769677.315.04.2011
[2015/41]
WO2011US32710
Priority number, dateUS20100371798P09.08.2010         Original published format: US 371798 P
US20100324857P16.04.2010         Original published format: US 324857 P
[2013/08]
Filing languageEN
Procedural languageEN
PublicationType: A2 Application without search report
No.:WO2011130647
Date:20.10.2011
Language:EN
[2011/42]
Type: A2 Application without search report 
No.:EP2558863
Date:20.02.2013
Language:EN
The application published by WIPO in one of the EPO official languages on 20.10.2011 takes the place of the publication of the European patent application.
[2013/08]
Type: B1 Patent specification 
No.:EP2558863
Date:07.10.2015
Language:EN
[2015/41]
Search report(s)International search report - published on:KR29.03.2012
(Supplementary) European search report - dispatched on:EP27.08.2013
ClassificationIPC:G01N33/564, G01N33/573
[2015/23]
CPC:
G01N33/573 (EP,US); G01N33/564 (EP,US); G01N2333/902 (EP,US);
G01N2333/904 (US); G01N2800/10 (EP,US)
Former IPC [2013/39]G01N33/564, G01N33/573, G01N33/532, G01N33/534, G01N33/15
Former IPC [2013/08]G01N33/573, G01N33/532, G01N33/534, G01N33/15
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 [2013/08]
Extension statesBANot yet paid
MENot yet paid
TitleGerman:ZUSAMMENSETZUNGEN UND VERFAHREN ZUR CHARAKTERISIERUNG EINER MYOPATHIE[2013/08]
English:COMPOSITIONS AND METHODS FOR CHARACTERIZING A MYOPATHY[2013/08]
French:COMPOSITIONS ET MÉTHODES POUR LA CARACTÉRISATION D'UNE MYOPATHIE[2013/08]
Entry into regional phase04.10.2012National basic fee paid 
04.10.2012Search fee paid 
04.10.2012Designation fee(s) paid 
04.10.2012Examination fee paid 
Examination procedure04.10.2012Examination requested  [2013/08]
24.03.2014Amendment by applicant (claims and/or description)
02.05.2014Despatch of a communication from the examining division (Time limit: M04)
11.09.2014Reply to a communication from the examining division
03.11.2014Observations by third parties
25.03.2015Observations by third parties
17.04.2015Observations by third parties
21.04.2015Date of oral proceedings
28.04.2015Minutes of oral proceedings despatched
13.05.2015Communication of intention to grant the patent
26.08.2015Fee for grant paid
26.08.2015Fee for publishing/printing paid
26.08.2015Receipt of the translation of the claim(s)
Divisional application(s)EP15164007.5  / EP2960652
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  02.05.2014
Opposition(s)Opponent(s)01  06.07.2016    ADMISSIBLE
EUROIMMUN Medizinische Labordiagnostika AG
Seekamp 31
23560 Lübeck / DE
Opponent's representative
Richter, Carsten
EUROIMMUN Medizinische Labordlagnostika AG
Seekamp 31
23560 Lübeck / DE
 [N/P]
Former [2016/32]
Opponent(s)01  06.07.2016    ADMISSIBLE
Euroimmun Medizinische Labordiagnostika AG
Seekamp 31
23560 Lübeck / DE
Opponent's representative
Richter, Carsten
EUROIMMUN Medizinische Labordlagnostika AG
Seekamp 31
23560 Lübeck / DE
16.08.2016Invitation to proprietor to file observations on the notice of opposition
07.12.2016Reply of patent proprietor to notice(s) of opposition
29.08.2017Date of oral proceedings
12.09.2017Despatch of minutes of oral proceedings
12.09.2017Date of despatch of rejection of opposition
29.09.2021Legal effect of rejection of opposition [2022/11]
Appeal following opposition15.11.2017Appeal received No.  T2513/17
15.11.2017Statement of grounds filed
29.09.2021Result of appeal procedure: appeal of the opponent was rejected
14.01.2022Despatch of the decision of the Board of Appeal
29.09.2021Date of oral proceedings
Fees paidRenewal fee
29.04.2013Renewal fee patent year 03
28.04.2014Renewal fee patent year 04
27.04.2015Renewal fee patent year 05
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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  TooltipHU15.04.2011
AL07.10.2015
AT07.10.2015
BE07.10.2015
BG07.10.2015
CY07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
MC07.10.2015
MK07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
TR07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
IE15.04.2016
LU15.04.2016
MT30.04.2016
[2018/46]
Former [2018/38]HU15.04.2011
AT07.10.2015
BE07.10.2015
BG07.10.2015
CY07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
MC07.10.2015
MK07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
TR07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
IE15.04.2016
LU15.04.2016
MT30.04.2016
Former [2018/31]HU15.04.2011
AT07.10.2015
BE07.10.2015
CY07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
MC07.10.2015
MK07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
TR07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
IE15.04.2016
LU15.04.2016
MT30.04.2016
Former [2018/29]HU15.04.2011
AT07.10.2015
BE07.10.2015
CY07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
MC07.10.2015
MK07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
TR07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
IE15.04.2016
LU15.04.2016
Former [2018/28]HU15.04.2011
AT07.10.2015
BE07.10.2015
CY07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
MC07.10.2015
MK07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
IE15.04.2016
LU15.04.2016
Former [2017/38]AT07.10.2015
BE07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
IE15.04.2016
LU15.04.2016
Former [2017/04]AT07.10.2015
BE07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
LU15.04.2016
Former [2017/03]AT07.10.2015
BE07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
Former [2016/49]AT07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SI07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
BE30.04.2016
Former [2016/39]AT07.10.2015
CZ07.10.2015
DK07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
BE30.04.2016
Former [2016/38]AT07.10.2015
CZ07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SK07.10.2015
SM07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
BE30.04.2016
Former [2016/36]AT07.10.2015
CZ07.10.2015
EE07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RO07.10.2015
RS07.10.2015
SK07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
BE30.04.2016
Former [2016/34]AT07.10.2015
CZ07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RS07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
Former [2016/25]AT07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
LV07.10.2015
NL07.10.2015
PL07.10.2015
RS07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
Former [2016/24]AT07.10.2015
FI07.10.2015
HR07.10.2015
LT07.10.2015
NL07.10.2015
PL07.10.2015
RS07.10.2015
NO07.01.2016
GR08.01.2016
IS07.02.2016
PT08.02.2016
Former [2016/23]HR07.10.2015
LT07.10.2015
NL07.10.2015
RS07.10.2015
NO07.01.2016
IS07.02.2016
Former [2016/22]LT07.10.2015
NL07.10.2015
NO07.01.2016
IS07.02.2016
Former [2016/21]LT07.10.2015
NO07.01.2016
Former [2016/20]LT07.10.2015
Documents cited:Search[A]WO2007061995  (NOVARTIS AG [CH], et al) [A] 1-15 * the whole document *;
 [IP]  - LISA CHRISTOPHER-STINE ET AL, "A novel autoantibody recognizing 200-kd and 100-kd proteins is associated with an immune-mediated necrotizing myopathy", ARTHRITIS & RHEUMATISM, (20100523), vol. 62, no. 9, doi:10.1002/art.27572, ISSN 0004-3591, pages 2757 - 2766, XP055075421 [IP] 1,2,4-14 * abstract * * page 2758, column left, paragraph 2 - paragraph 3 * * page 2761 - page 2762, bridging paragraph * * page 2764, column left * * page 2765, column right *

DOI:   http://dx.doi.org/10.1002/art.27572
 [L]  - Christopher-Stine, "A novel autoantibody recognizing 200-kd and 100-kd proteins is associated with an immune-mediated necrotizing myopathy", (20100523), URL: http://onlinelibrary.wiley.com/doi/10.1002/art.27572/full, (20130815), XP055075425 [L] 1,2,4-14 * Document indicating the online publication date of the article of Lisa Christopher-Stine et al. * * the whole document *

DOI:   http://dx.doi.org/10.1002/art.27572
 [XPI]  - ANDREW L. MAMMEN ET AL, "Autoantibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase in patients with statin-associated autoimmune myopathy", ARTHRITIS & RHEUMATISM, (20110301), vol. 63, no. 3, doi:10.1002/art.30156, ISSN 0004-3591, pages 713 - 721, XP055075417 [XP] 15 * abstract * * page 714, column left * * paragraph "Anti-HMGCR ELISA" * * page 719, column right * [I] 1,2,4-14

DOI:   http://dx.doi.org/10.1002/art.30156
 [X]  - CLARK ET AL, "Production and characterization of monoclonal antibodies to rat liver microsomal 3-hydroxy-3-methylglutaryl-coenzyme A reductase.", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, (19820601), vol. 79, no. 12, ISSN 0027-8424, pages 3734 - 3738, XP055075565 [X] 15 * page 3735, column left, paragraph 2 *

DOI:   http://dx.doi.org/10.1073/pnas.79.12.3734
 [A]  - IRA N. TARGOFF, "Autoantibodies and their significance in myositis", CURRENT RHEUMATOLOGY REPORTS, (20080801), vol. 10, no. 4, doi:10.1007/s11926-008-0053-2, ISSN 1523-3774, pages 333 - 340, XP055075592 [A] 1-15 * the whole document *

DOI:   http://dx.doi.org/10.1007/s11926-008-0053-2
 [AD]  - G J D HENGSTMAN ET AL, "Anti-signal recognition particle autoantibodies: marker of a necrotising myopathy", ANNALS OF THE RHEUMATIC DISEASES, (20060525), vol. 65, no. 12, doi:10.1136/ard.2006.052191, ISSN 0003-4967, pages 1635 - 1638, XP055075612 [AD] 1-15 * the whole document *

DOI:   http://dx.doi.org/10.1136/ard.2006.052191
International search[A]US7432067  (NELSON LAWRENCE M [US], et al);
 [A]US2004241169  (LOWY ISRAEL [US], et al)
 [XP]  - MAMMEN, A, L. ET AL., "AUTOANTIBODIES AGAINST 3-HYDROXY-3-METHYLGLUTARYL-COENZYME A REDUCTASE IN PA TIENTS WITH STATIN-ASSOCIATED AUTOIMMUNE MYOPATHY", ARTHRITIS & RHEUMATISM, (201103), vol. 63, pages 713 - 721
 [XP]  - LIVIA A, L, C. ET AL., "A NOVEL AUTOANTIBODY RECOGNIZING 200-kD AND 100-kD PROTEINS IS ASSOCIATED WI TH AN IMMUNE-MEDIATED NECROTIZING MYOPATHY", ARTHRITIS & RHEUMATISM, (201009), vol. 62, pages 2757 - 2766
other   - TAN E.M., "ANTINUCLEAR ANTIBODIES: DIAGNOSTIC MARKERS FOR AUTOIMMUNE DISEASES AND PROBES FOR CELL BIOLOGY", ADVANCES IN IMMUNOLOGY, (1989), vol. 44, pages 93 - 151, XP002909893
    - DAVID GAIST ET AL, "LIPID-LOWERING DRUGS AND RISK OF MYOPATHY: A POPULATION-BASED FOLLOW-UP STUDY", EPIDEMIOLOGY, (200109), vol. 12, no. 5, pages 565 - 569, XP003035098

DOI:   http://dx.doi.org/10.1097/00001648-200109000-00017
    - DALIA DIMITRI ET AL, "MYOPATHY ASSOCIATED WITH ANTI-SIGNAL RECOGNITION PEPTIDE ANTIBODIES: CLINICAL HETEROGENEITY CONTRASTS WITH STEREOTYPED HISTOPATHOLOGY", MUSCLE & NERVE, (20070301), vol. 35, no. 3, pages 389 - 395, XP055183677

DOI:   http://dx.doi.org/10.1002/mus.20693
    - HENGSTMAN G.J.D. ET AL, "ANTI-SIGNAL RECOGNITION PARTICLE AUTOANTIBODIES: MARKER OF A NECROTISING MYOPATHY", ANNALS OF THE RHEUMATIC DISEASES, (20060525), vol. 65, no. 12, doi:10.1136/ARD.2006.052191, pages 1635 - 1638, XP055075612

DOI:   http://dx.doi.org/10.1136/ard.2006.052191
    - CAMELIA STANCU, SIMA ANCA, "STATINS: MECHANISM OF ACTION AND EFFECTS", JOURNAL OF CELLULAR AND MOLECULAR MEDICINE, (200110), vol. 5, no. 4, doi:10.1111/J.1582-4934.2001.TB00172.X, pages 378 - 387, XP055183790

DOI:   http://dx.doi.org/10.1111/j.1582-4934.2001.tb00172.x
    - KAREN E. HANSEN ET AL, "OUTCOMES IN 45 PATIENTS WITH STATIN-ASSOCIATED MYOPATHY", ARCHIVES OF INTERNAL MEDICINE, (20051212), doi:10.1001/ARCHINTE.165.22.2671, pages 2671 - 2676, XP055183791

DOI:   http://dx.doi.org/10.1001/archinte.165.22.2671
    - REEVEST WESTLEY H. ET AL, "HUMAN AUTOANTIBODIES REACTIVE WITH THE SIGNAL-RECOGNITION PARTICLE", CELL BIOLOGY, vol. 83, no. 24, (19861201), pages 9507 - 9511, URL: HTTP://WWW.PNAS.ORG/CONTENT/83/24/9507.FULL.PDF, XP055183792
    - HARSHA GUNAWARDENA ET AL, "MYOSITIS-SPECIFIC AUTOANTIBODIES: THEIR CLINICAL AND PATHOGENIC SIGNIFICANCE IN DISEASE EXPRESSION", RHEUMATOLOGY, (200906), vol. 48, no. 6, doi:10.1093/RHEUMATOLOGY/KEP078, pages 607 - 612, XP055183793

DOI:   http://dx.doi.org/10.1093/rheumatology/kep078
    - "LIST OF SEQUENCE ALIGNMENT SOFTWARE", WIKIPEDIA, THE FREE ENCYCLOPEDIA, (20141004), pages 1 - 21, WARE, URL: HTTP://EN.WIKIPEDIA.ORG/WIKI/LIST_OF_SEQUENCE_ALIGNMENT_SOFT, (20141013), XP003035099
    - PRODUCT DATASHEETOGY, "GOAT ANTI-HMGCR / LDLCQ3 ANTIBODY (OAEB00787)", AVIVA PRODUCT DATASHEET, (2014), URL: HTTP://WWW.FUNAKOSHI.CO.JP/DATA/DATASHEET/ASB/OAEB00787.PDF, XP055183797
Opposition   - TARGOFF, "Antibody to signal recognition particle in polymyositis", Arthritis and Rheum., (19900000), vol. 33, no. 9, pages 1361 - 1370, XP002600454

DOI:   http://dx.doi.org/10.1002/art.1780330908
    - REEVES, "Human autoantibodies reactive with the signal-recognition particle", Proc Natl Acad Sci U S A, (19860000), vol. 83, pages 9507 - 9511, XP055183792
    - DROUOT, "Exploring necrotizing autoimmune myopathies with a novel immunoassay for anti-3-hydroxy-3-methyl-glutaryl-CoA reductase autoantibodies", Arthritis Res Ther., (20140000), vol. 16, no. 1, page R39, XP021177315

DOI:   http://dx.doi.org/10.1186/ar4468
    - DIMITRI et al., "Myopathy associated with anti-signal recognition peptide antibodies: clinical heterogeneity contrasts with stereotyped histopathology", Muscle Nerve, (20070000), vol. 35, no. 3, pages 389 - 395, XP055183677

DOI:   http://dx.doi.org/10.1002/mus.20693
    - TARGOFF, "A novel autoantibody to a 155-kd protein is associated with dermatomyositis", Arthritis Rheum., (20060000), vol. 54, no. 11, pages 3682 - 3689, XP055301233

DOI:   http://dx.doi.org/10.1002/art.22164
    - MAMMEN, "Dermatomyositis and polymyositis - Clinical presentation, autoantibodies, and pathogenesis", Ann NY Acad Sci., (20100100), vol. 1184, no. 1, pages 134 - 153, XP055020326

DOI:   http://dx.doi.org/10.1111/j.1749-6632.2009.05119.x
    - "PM-Scl autoantibodies", ODDIS, C. V et al., Autoantibodies, (19960000), pages 642 - 650, XP055301237

DOI:   http://dx.doi.org/10.1016/B978-044482383-0/50098-4
    - GRABLE-ESPOSITO et al., "Immune-mediated necrotizing myopathy associated with statins", Muscle Nerve, (20100000), vol. 41, no. 2, pages 185 - 190, XP055301238

DOI:   http://dx.doi.org/10.1002/mus.21486
    - "Principles and methods for assessing autoimmunity associated with exposure to chemicals", WHO, Environmental Criteria 236, (20060000), pages 96 - 106 , Seite 149, XP055301239
    - "Chapter 17 - Drug-induced Myopathies", Charles E. Schultz et al, latrogenic Neurology, (19980000), pages 305 - 317, XP055301252
    - NEEDHAM et al., "Progressive myopathy with up-regulation of MHC-I associated with statin therapy", Neuromuscular Disorders, (20070000), vol. 17, no. 2, pages 194 - 200, XP005895431

DOI:   http://dx.doi.org/10.1016/j.nmd.2006.10.007
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.