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: EP3446700

EP3446700 - METHODS OF USING FVIII POLYPEPTIDE [Right-click to bookmark this link]
StatusThe application is deemed to be withdrawn
Status updated on  16.07.2021
Database last updated on 02.11.2024
FormerExamination is in progress
Status updated on  03.12.2019
FormerRequest for examination was made
Status updated on  30.08.2019
FormerThe application has been published
Status updated on  25.01.2019
Most recent event   Tooltip16.07.2021Application deemed to be withdrawnpublished on 18.08.2021  [2021/33]
Applicant(s)For all designated states
Bioverativ Therapeutics Inc.
225 Second Avenue
Waltham MA 02451 / US
[2019/09]
Inventor(s)01 / JIANG, Haiyan
3 Bayberry Lane
Belmont, MA Massachusetts 02478 / US
02 / NEELAKANTAN, Srividya
7 Lexington Drive
East Walpole, MA Massachusetts 02032 / US
03 / NESTOROV, Ivan
3 Willis Holden Drive
Acton, MA Massachusetts 01720 / US
04 / LI, Shuanglian
10 Carol Lane
Lexington, MA Massachusetts 02420 / US
 [2019/09]
Representative(s)Zwicker, Jörk, et al
ZSP Patentanwälte PartG mbB
Hansastraße 32
80686 München / DE
[N/P]
Former [2019/09]Miller, David James, et al
Mathys & Squire LLP The Shard
32 London Bridge Street
London SE1 9SG / GB
Application number, filing date18174446.730.10.2013
[2019/09]
Priority number, dateUS201261720356P30.10.2012         Original published format: US 201261720356 P
US201361759880P01.02.2013         Original published format: US 201361759880 P
US201361800293P15.03.2013         Original published format: US 201361800293 P
US201361817085P29.04.2013         Original published format: US 201361817085 P
US201361829884P31.05.2013         Original published format: US 201361829884 P
US201361839477P26.06.2013         Original published format: US 201361839477 P
US201361863860P08.08.2013         Original published format: US 201361863860 P
US201361876927P12.09.2013         Original published format: US 201361876927 P
US201361879955P19.09.2013         Original published format: US 201361879955 P
[2019/09]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP3446700
Date:27.02.2019
Language:EN
[2019/09]
Search report(s)(Supplementary) European search report - dispatched on:EP28.01.2019
ClassificationIPC:A61K38/37
[2019/09]
CPC:
C07K14/755 (EP,US); A61K38/00 (US); C07K2319/21 (EP,US);
C07K2319/30 (EP,US); C07K2319/43 (EP,US)
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 [2019/40]
Former [2019/09]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 
TitleGerman:VERFAHREN ZUR VERWENDUNG VON FVIII-POLYPEPTID[2019/09]
English:METHODS OF USING FVIII POLYPEPTIDE[2019/09]
French:PROCÉDÉ D'UTILISATION DE POLYPEPTIDE DU FACTEUR VIII[2019/09]
Examination procedure27.08.2019Amendment by applicant (claims and/or description)
27.08.2019Examination requested  [2019/40]
27.08.2019Date on which the examining division has become responsible
06.12.2019Despatch of a communication from the examining division (Time limit: M06)
03.06.2020Reply to a communication from the examining division
09.09.2020Despatch of a communication from the examining division (Time limit: M06)
20.03.2021Application deemed to be withdrawn, date of legal effect  [2021/33]
13.04.2021Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time  [2021/33]
Parent application(s)   TooltipEP13852306.3  / EP2914293
Divisional application(s)EP21163780.6
Fees paidRenewal fee
13.09.2018Renewal fee patent year 03
13.09.2018Renewal fee patent year 04
13.09.2018Renewal fee patent year 05
20.12.2018Renewal fee patent year 06
15.10.2019Renewal fee patent year 07
14.10.2020Renewal fee patent year 08
Penalty fee
Additional fee for renewal fee
31.10.201806   M06   Fee paid on   20.12.2018
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.
Documents cited:Search[I]WO2011069164  (BIOGEN IDEC INC [US], et al) [I] 1-15 * paragraphs [0070] , [0090] , [0091] * * examples 1, 6, 8 *;
 [IP]WO2013009627  (BIOGEN IDEC HEMOPHILIA INC [US], et al) [IP] 1-15 * example 10 *;
 [IP]WO2013106789  (BIOGEN IDEC INC [US], et al) [IP] 1-15 * example 6 *;
 [I]  - POWELL JERRY S ET AL, Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients., BLOOD 29 MAR 2012, VOL. 119, NR. 13, PAGE(S) 3031 - 3037, (20120329), ISSN 1528-0020, XP002727554 [I] 1-15 * page 3032, column 2, paragraph 2 *

DOI:   http://dx.doi.org/10.1182/BLOOD-2011-09-382846
 [I]  - J. A. DUMONT ET AL, "Prolonged activity of a recombinant factor VIII-Fc fusion protein in hemophilia A mice and dogs", BLOOD, (20120329), vol. 119, no. 13, doi:10.1182/blood-2011-08-367813, ISSN 0006-4971, pages 3024 - 3030, XP055065095 [I] 1-15 * the whole document *

DOI:   http://dx.doi.org/10.1182/blood-2011-08-367813
 [T]  - MAHLANGU JOHNNY ET AL, "Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A", BLOOD, AMERICAN SOCIETY OF HEMATOLOGY, US, (20131113), vol. 123, no. 3, doi:10.1182/BLOOD-2013-10-529974, ISSN 0006-4971, pages 317 - 325, XP009179251 [T] * the whole document *

DOI:   http://dx.doi.org/10.1182/blood-2013-10-529974
 [T]  - C. CHAI-ADISAKSOPHA ET AL, "A systematic review of definitions and reporting of bleeding outcome measures in haemophilia", HAEMOPHILIA, GB, (20151114), vol. 21, no. 6, doi:10.1111/hae.12750, ISSN 1351-8216, pages 731 - 735, XP055342338 [T] * page 733 *

DOI:   http://dx.doi.org/10.1111/hae.12750
 [I]  - U.S. National Library Of Medicine, "Archive History for NCT01458106", (20121025), URL: https://clinicaltrials.gov/ct2/history/NCT01458106?V_7=View#StudyPageTop, (20190115), XP055541953 [I] 1-15 * the whole document *
 [T]  - G. YOUNG ET AL, "Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A", JOURNAL OF THROMBOSIS AND HAEMOSTASIS, GB, (20150423), vol. 13, no. 6, doi:10.1111/jth.12911, ISSN 1538-7933, pages 967 - 977, XP055460215 [T] * the whole document *

DOI:   http://dx.doi.org/10.1111/jth.12911
by applicantEP0154316
 WO8704187
 WO8800831
 WO8803558
 US4757006
 WO8808035
 EP0295597
 US4868112
 US4965199
 EP0401384
 US4994371
 US5004803
 WO9109122
 US5112950
 WO9216221
 US5171844
 WO9320093
 WO9411503
 US5364771
 WO9534326
 US5543502
 US5595886
 US5610278
 US5712122
 US5789203
 US5859204
 US5972885
 US6048720
 US6060447
 US6228620
 US6251632
 US6316226
 US6346513
 US6376463
 US6458563
 US6686179
 WO2004101740
 US2005100990
 US7041635
 WO2006074199
 US7348004
 US7404956
 WO2008155134
 US2009087411
 US2009163699
 US7592010
 US2009264627
 US7632921
 EP2173890
 US2010286067
 US2010292130
 US2012093840
    - PEYVANDI, F. et al., Haemophilia, (20060000), vol. 12, pages 82 - 89
    - RODRIGUEZ-MERCHAN, E.C., Semin. Thromb. Hemost., (20030000), vol. 29, pages 87 - 96
    - LOLLAR, P.; E. T. PARKER, J. Biol. Chem., (19910000), vol. 266, pages 12481 - 12486
    - LOLLAR, P. et al., J. Biol. Chem., (19920000), vol. 267, pages 23652 - 23657
    - MANNUCCI, P.M. et al., N. Engl. J. Med., (20010000), vol. 344, pages 1773 - 1779
    - MANNUCCI, P.M. et al., N. Engl. J. Med., (20010000), vol. 344, pages 1773 - 9
    - HOEBEN R.C. et al., J. Biol. Chem., (19900000), vol. 265, no. 13, pages 7318 - 7323
    - MEULIEN P. et al., Protein Eng., (19880000), vol. 2, no. 4, pages 301 - 6
    - TOOLE et al., Proc. Natl. Acad. Sci. U.S.A., (19860000), vol. 83, pages 5939 - 5942
    - EATON et al., Biochemistry, (19860000), vol. 25, pages 8343 - 8347
    - SARVER et al., DNA, (19870000), vol. 6, pages 553 - 564
    - LAGNER, Behring Inst. Mitt., (19880000), no. 82, pages 16 - 25
    - FATOUROS et al., Intern. J. Pharm., (19970000), vol. 155, no. 1, pages 121 - 131
    - WAKABAYASHI et al., JBC., (20040000), vol. 279, no. 13, pages 12677 - 12684
    - SCHULTE, Thrombosis Res., (20090000), vol. 124, no. 2, pages S6 - S8
    - KRAULIS, FEBS Lett., (19960000), vol. 378, pages 190 - 194
    - LINHULT et al., Protein Sci., (20020000), vol. 11, pages 206 - 213
    - DENNIS et al., J. Biol. Chem., (20020000), vol. 277, pages 35035 - 35043
    - MULLER; KONTERMANN, Curr. Opin. Mol. Ther., (20070000), vol. 9, pages 319 - 326
    - ROOVERSET et al., Cancer Immunol. Immunother., (20070000), vol. 56, pages 303 - 317
    - HOLT et al., Prot. Eng. Design Sci., (20080000), vol. 21, pages 283 - 288
    - TRUSSELET et al., Bioconjugate Chem., (20090000), vol. 20, pages 2286 - 2292
    - "GenBank", Database accession no. NM001063
    - "GenBank", Database accession no. XM002793
    - "GenBank", Database accession no. M12530
    - "GenBank", Database accession no. XM039845
    - "GenBank", Database accession no. XM 039847
    - "GenBank", Database accession no. S95936
    - LI et al., Trends Pharmacol. Sci., (20020000), vol. 23, pages 206 - 209
    - BRANDSMA et al., Biotechnol. Adv., (20110000), vol. 29, pages 230 - 238
    - BAI et al., Proc. Natl. Acad. Sci. USA, (20050000), vol. 102, pages 7292 - 7296
    - KIM et al., J. Pharmacol. Exp. Ther., (20100000), vol. 334, pages 682 - 692
    - WANG et al., J. Controlled Release, (20110000), vol. 155, pages 386 - 392
    - MALIK F et al., Exp. Hematol., (19920000), vol. 20, pages 1028 - 35
    - FRANCIS, Focus on Growth Factors, (19920000), vol. 3, no. 2, pages 4 - 10
    - MEI et al., Blood, (20100000), vol. 116, pages 270 - 279
    - SOMMERMEYER et al., Krankenhauspharmazie, (19870000), vol. 8, pages 271 - 278
    - WEIDLER et al., Arzneim.-Forschung/Drug Res., (19910000), vol. 41, pages 494 - 498
    - CUTLER et al., Hum. Mutat., (20020000), vol. 19, pages 274 - 8
    - CAMERON et al., Thromb. Haemost., (19980000), vol. 79, pages 317 - 22
    - TOOLE, J. J. et al., Nature, (19840000), vol. 312, pages 342 - 347
    - GITSCHIER, J. et al., Nature, (19840000), vol. 312, pages 326 - 330
    - WOOD, W. I. et al., Nature, (19840000), vol. 312, pages 330 - 337
    - VEHAR, G. A. et al., Nature, (19840000), vol. 312, pages 337 - 342
    - TOOLE, J. J. et al., Proc. Natl. Acad. Sci. USA, (19860000), vol. 83, pages 5939 - 5942
    - HEALEY, J. F. et al., Blood, (19960000), vol. 88, pages 4209 - 4214
    - BURMEISTER et al., Nature, (19940000), vol. 372, page 379
    - STORY et al., J. Exp. Med., (19940000), vol. 180, page 2377
    - OGANESYAN et al., Mol. Immunol., (20090000), vol. 46, page 1750
    - VACCARO et al., Nat. Biotechnol., (20050000), vol. 23, page 1283
    - ROUTLEDGE et al., Transplantation, (19950000), vol. 60, page 847
    - FRIEND et al., Transplantation, (19990000), vol. 68, page 1632
    - SHIELDS et al., J. Biol. Chem., (19950000), vol. 276, page 6591
    - WARD; GHETIE, Therapeutic Immunology, (19950000), vol. 2, page 77
    - ARMOUR et al., Eur. J. Immunol., (19990000), vol. 29, page 2613
    - SHIELDS et al., J. Biol. Chem., (20010000), vol. 276, page 6591
    - BRUTLAG et al., Comp. App. Biosci., (19900000), vol. 6, pages 237 - 245
    - RON et al., J. Biol. Chem., (19930000), vol. 268, pages 2984 - 2988
    - DOBELI et al., J. Biotechnology, (19880000), vol. 7, pages 199 - 216
    - J. Biol. Chem, (19930000), vol. 268, pages 22105 - 22111
    - MEI et al., Blood, (20100000), vol. 116, pages 270 - 79
    - WIGLER et al., Cell, (19780000), vol. 14, page 725
    - NEUMANN et al., EMBO J, (19820000), vol. 1, page 841
    - MEI et al., Mol. Biotechnol., (20060000), vol. 34, no. 2, pages 165 - 78
    - KIANG et al., Clin. Pharmacokinet, (20120000), vol. 51, pages 515 - 525
    - POWELL J S; JOSEPHSON N.C; QUON D et al., "Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients", Blood, (20120000), vol. 119, no. 13, pages 3031 - 7
    - BJORKMAN S, C.M.; BERNTOP E, "Pharmacokinetics of Factor IX in patients with hemophilia B.", Eur J Clin Pharmacol, (19940000), vol. 46, pages 325 - 332
    - CARLSSON M, B.S.; BERNTOP E, "Multidose pharmacokinetics of factor IX: Implications for dosing in prophylaxis", Hemophilia, (19980000), vol. 4, pages 83 - 88
    - BJORKMAN S, S.A.; BERNTOP E, "Pharmacokinetics of recombinant factor IX in relation to age of the patients: Implications for dosing in prophylaxis", Hemophilia, (20010000), vol. 7, pages 133 - 139
    - BJORKMAN S, O.M.; SPOTTS G et al., "Population pharmacokinetics of recombinant factor VIII- the relationships of pharmacokinetics to age and body weight", Blood, (20120000), vol. 119, doi:doi:10.1182/blood-2011-07-360594, pages 612 - 618, XP055270011

DOI:   http://dx.doi.org/10.1182/blood-2011-07-360594
    - BJORKMAN S, A.V., "Population pharmacokinetics of plasma-derived factpr IX in adult patients with hemophilia B: Implications for dosing in prophylaxis", Eur J Clin Pharmacol, (20120000), vol. 68, no. 6, pages 969 - 77
    - BEAL, S., "Ways to fit a PK model with some data below the quantification limit", J Pharmacokin Pharmacodyn, (20010000), vol. 28, pages 481 - 504
    - JAE EUN AHN, M.O.K.; ADRIAN DUNNE; THOMAS M. LUDDEN, "Likelihood based approaches to handling data below the quantification limit using NONMEM VI", J Pharmacokin Pharmacodyn, (20080000), vol. 35, no. 4, doi:doi:10.1007/s10928-008-9094-4, pages 401 - 21, XP019645593

DOI:   http://dx.doi.org/10.1007/s10928-008-9094-4
    - COLLINS PW; B.V., FISCHER K et al., "Break-through bleeding in relation to predicted factor VIII levels in patients receiving prophylactic treatment for severe hemophilia A", J Thromb Haemost, (20090000), vol. 7, no. 3, pages 413 - 20
    - LILLICRAP D., "Extending half-life in coagulation factors: where do we stand?", Thromb Res., (20080000), vol. 122, no. 4, pages 2 - 8
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.