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Extract from the Register of European Patents

EP About this file: EP2451486

EP2451486 - PEGYLATED L-ASPARAGINASE [Right-click to bookmark this link]
StatusPatent maintained as amended
Status updated on  16.12.2022
Database last updated on 16.11.2024
FormerThe patent has been granted
Status updated on  31.03.2017
FormerGrant of patent is intended
Status updated on  01.02.2017
FormerExamination is in progress
Status updated on  16.12.2016
FormerGrant of patent is intended
Status updated on  14.12.2016
Most recent event   Tooltip03.10.2024Change - lapse in a contracting state
State(s) deleted from list of lapses: AL		published on 06.11.2024  [2024/45]
Applicant(s)For all designated states
Jazz Pharmaceuticals II SAS
84 Quai Charles de Gaulle Cité Internationale
69006 Lyon / FR
[2023/03]
Former [2017/44]For all designated states
Jazz Pharmaceuticals II SAS
84 Quai Charles de Gaulle Cité Internationale
69006 Lyon / FR
Former [2012/20]For all designated states
Alize Pharma II
15 Chemin Du Saquin Espace Europeen
69130 Ecully / FR
Inventor(s)01 / ABRIBAT, Thierry
124 Chemin de Montray
F-69110 Sainte Foy Les Lyon / FR
 [2012/20]
Representative(s)Carpmaels & Ransford LLP
One Southampton Row
London WC1B 5HA / GB
[2023/03]
Former [2017/18]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 [2012/20]Stevens, Ian Edward, et al
Potter Clarkson LLP Park View House 58 The Ropewalk Nottingham
NG1 5DD / GB
Application number, filing date10730170.706.07.2010
[2017/18]
WO2010EP59599
Priority number, dateUS20090223320P06.07.2009         Original published format: US 223320 P
WO2010EP5415630.03.2010         Original published format: PCT/EP2010/054156
[2012/20]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2011003886
Date:13.01.2011
Language:EN
[2011/02]
Type: A1 Application with search report 
No.:EP2451486
Date:16.05.2012
Language:EN
The application published by WIPO in one of the EPO official languages on 13.01.2011 takes the place of the publication of the European patent application.
[2012/20]
Type: B1 Patent specification 
No.:EP2451486
Date:03.05.2017
Language:EN
[2017/18]
Type: B2 New European patent specification 
No.:EP2451486
Date:18.01.2023
Language:EN
[2023/03]
Search report(s)International search report - published on:EP13.01.2011
ClassificationIPC:A61K47/60, C12N9/82, A61P35/02
[2017/09]
CPC:
A61K47/60 (EP); C12N9/82 (EP); Y02A50/30 (EP)
Former IPC [2012/20]A61K47/48, C12N9/82, A61P35/02
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,   SE,   SI,   SK,   SM,   TR [2012/20]
Extension statesBA03.02.2012
ME03.02.2012
RS03.02.2012
TitleGerman:PEGYLIERTE L-ASPARAGINASE[2012/20]
English:PEGYLATED L-ASPARAGINASE[2012/20]
French:L-ASPARAGINASE PEGYLÉE[2012/20]
Entry into regional phase03.02.2012National basic fee paid 
03.02.2012Designation fee(s) paid 
03.02.2012Examination fee paid 
Examination procedure03.02.2012Examination requested  [2012/20]
13.09.2012Amendment by applicant (claims and/or description)
04.02.2014Communication of intention to grant the patent
02.06.2014Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
11.07.2014Communication of intention to grant the patent
06.10.2014Observations by third parties
29.10.2014Observations by third parties
06.11.2014Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
11.11.2014Despatch of a communication from the examining division (Time limit: M06)
18.05.2015Reply to a communication from the examining division
12.06.2015Observations by third parties
15.09.2015Communication of intention to grant the patent
05.11.2015Observations by third parties
12.11.2015Observations by third parties
16.12.2015Fee for grant paid
16.12.2015Fee for publishing/printing paid
22.01.2016Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
27.01.2016Despatch of a communication from the examining division (Time limit: M04)
26.05.2016Reply to a communication from the examining division
24.08.2016Communication of intention to grant the patent
12.12.2016Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
12.12.2016Fee for grant paid
12.12.2016Fee for publishing/printing paid
01.02.2017Information about intention to grant a patent
01.02.2017Receipt of the translation of the claim(s)
Divisional application(s)The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  04.02.2014
Opposition(s)Opponent(s)01  02.02.2018  16.02.2018  ADMISSIBLE
Mathys & Squire LLP
The Shard
32 London Bridge Street
London SE1 9SG / GB
Opponent's representative
Titmus, Craig Edward, et al, et al
Mathys & Squire The Shard
32 London Bridge Street
London SE1 9SG / GB
 [2021/10]
Former [2018/11]
Opponent(s)01  02.02.2018    ADMISSIBLE
Mathys & Squire LLP
The Shard
32 London Bridge Street
London SE1 9SG / GB
Opponent's representative
Titmus, Craig Edward, et al, et al
Mathys & Squire LLP The Shard
32 London Bridge Street
London SE1 9SG / GB
23.02.2018Invitation to proprietor to file observations on the notice of opposition
05.07.2018Reply of patent proprietor to notice(s) of opposition
09.09.2019Date of oral proceedings
18.10.2019Despatch of interlocutory decision in opposition
18.10.2019Despatch of minutes of oral proceedings
18.07.2022Legal effect of interlocutory decision in opposition
05.09.2022Despatch of communication that the patent will be maintained as amended
12.12.2022Fee for printing new specification paid
Appeal following opposition17.12.2019Appeal received No.  T3255/19
18.02.2020Statement of grounds filed
04.07.2022Result of appeal procedure: appeal of the opponent was rejected
08.07.2022Despatch of the decision of the Board of Appeal
Fees paidRenewal fee
26.07.2012Renewal fee patent year 03
10.07.2013Renewal fee patent year 04
14.07.2014Renewal fee patent year 05
10.07.2015Renewal fee patent year 06
06.01.2017Renewal fee patent year 07
Penalty fee
Additional fee for renewal fee
31.07.201607   M06   Fee paid on   06.01.2017
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  TooltipEE03.05.2017
SM03.05.2017
BG03.08.2017
IS03.09.2017
[2024/45]
Former [2021/04]EE03.05.2017
SM03.05.2017
BG03.08.2017
IS03.09.2017
AL06.07.2019
Former [2020/05]EE03.05.2017
SM03.05.2017
BG03.08.2017
IS03.09.2017
Former [2018/43]EE03.05.2017
SM03.05.2017
MT06.07.2017
BG03.08.2017
IS03.09.2017
Former [2018/28]EE03.05.2017
SM03.05.2017
BG03.08.2017
IS03.09.2017
Former [2018/23]EE03.05.2017
SM03.05.2017
CY06.07.2017
BG03.08.2017
IS03.09.2017
Former [2018/13]EE03.05.2017
SM03.05.2017
BG03.08.2017
IS03.09.2017
Former [2018/09]EE03.05.2017
BG03.08.2017
IS03.09.2017
Former [2017/51]BG03.08.2017
IS03.09.2017
Cited inInternational search[T]WO03018742  (G UCHREZHDENIE NII BIOMEDITSIN [RU], et al);
ExaminationUS5672662
    - VERONESE F M ET AL, "Improvement of pharmacokinetic, immunological and stability properties of asparaginase by conjugation to linear and branched monomethoxy poly(ethylene glycol)", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, (19960701), vol. 40, no. 3, doi:10.1016/0168-3659(95)00185-9, ISSN 0168-3659, pages 199 - 209, XP004037365

DOI:   http://dx.doi.org/10.1016/0168-3659(95)00185-9
    - LUCIANA SARTORE ET AL, "Accurate evaluation method of the polymer content in Monomethoxy(polyethylene glycol) modified proteins based on Amino acid analysis", APPLIED BIOCHEMISTRY AND BIOTECHNOLOGY ; PART A: ENZYME ENGINEERING AND BIOTECHNOLOGY, HUMANA PRESS INC, NEW YORK, (19911201), vol. 31, no. 3, doi:10.1007/BF02921748, ISSN 1559-0291, pages 213 - 222, XP035175870

DOI:   http://dx.doi.org/10.1007/BF02921748
    - "EPPO quarantine pest Data Sheets on Quarantine Pests: Erwinia chrysanthemi", (20040507), URL: http://www.eppo.int/QUARANTINE/bacteria/Erwinia_chrysanthemi/ERWICH_ds.pdf, (20150818), XP055208233
    - CAMMACK K A ET AL, "PHYSICAL PROPERTIES AND SUBUNIT STRUCTURE OF L-ASPARAGINASE ISOLATED FROM ERWINIA CAROTOVORA", BIOCHEMICAL JOURNAL, PORTLAND PRESS LTD, GB, (19720101), vol. 126, ISSN 0264-6021, pages 361 - 379, XP003035934

DOI:   http://dx.doi.org/10.1042/bj1260361
    - MINTON N P ET AL, "Nucleotide sequence of the Erwinia chrysanthemi NCPPB 1066 l-asparaginase gene", GENE, ELSEVIER, AMSTERDAM, NL, vol. 46, no. 1, doi:10.1016/0378-1119(86)90163-0, ISSN 0378-1119, (19860101), pages 25 - 35, (19860101), XP025904632

DOI:   http://dx.doi.org/10.1016/0378-1119(86)90163-0
    - DAVID FILPULA ET AL, "Sequence of L-asparaginase gene from Erwinia chrysanthemi NCPPB 1125", NUCLEIC ACIDS RESEARCH,, (19881111), vol. 16, no. 21, page 10385, XP001317910
    - Declaration Dr. Micheal Scawen
    - Declaration Dr. David Beer
by applicantUS4179337
 US4670417
 US5252714
 US5672662
 US5766897
 US6113906
 US2002065397
 US2003114647
 WO2004083258
 WO2007103290
 US7419600
 US2009054590
other   - VERONESE F.M., "IMPROVEMENT OF PHARMACOKINETIC, IMMUNOLOGICAL AND STABILITY PROPERTIES OF ASPARAGINASE BY CONJUGATION TO LINEAR AND BRANCHED MONOMETHOXY POLY(ETHYLENE GLYCOL)", JOURNAL OF CONTROLLED RELEASE, (199201), vol. 40, no. 1, pages 199 - 209, XP004037365

DOI:   http://dx.doi.org/10.1016/0168-3659(95)00185-9
    - LUCIANA SARTORE ET AL, "ACCURATE EVALUATION METHOD OF THE POLYMER CONTENT IN MONOMETHOXY(POLYETHYLENE GLYCOL) MODIFIED PROTEINS BASED ON AMINO ACID ANALYSIS", APPLIED BIOCHEMISTRY AND BIOTECHNOLOGY ; PART A: ENZYME ENGINEERING AND BIOTECHNOLOGY, (199112), vol. 31, no. 3, doi:10.1007/BF02921748, pages 213 - 222, XP035175870

DOI:   http://dx.doi.org/10.1007/BF02921748
    - MINTON N.P. ET AL, "NUCLEOTIDE SEQUENCE OF THE ERWINIA CHRYSANTHEMI NCPPB 1066 L-ASPARAGINASE GENE", GENE, (19860101), vol. 45, no. 1, pages 25 - 35, XP025904632

DOI:   http://dx.doi.org/10.1016/0378-1119(86)90163-0
    - CAMMACK K.A ET AL, "PHYSICAL PROPERTIES AND SUBUNIT STRUCTURE OF L-ASPARAGINASE ISOLATED FROM ERWINIA CAROTOVORA", BIOCHEM J., (197201), vol. 126, pages 361 - 379, XP003035934

DOI:   http://dx.doi.org/10.1042/bj1260361
    - FILPULA D. ET AL, "SEQUENCE OF L-ASPARAGINASE GENE FROM ERWINIA CHRYSANTHEMI NCPPB 1125", NUCLEIC ACIDS RESEARCH, (19881111), vol. 16, no. 21, page 10385, XP001317910
Opposition   - SARTORE, L. et al., "Accurate Evaluation Method of the Polymer Content in Monomethoxy(Polyethylene Glycol) Modified Proteins Based on Amino Acid Analysis", Applied Biochemistry and Biotechnology, (19910000), vol. 31, doi:10.1007/BF02921748, pages 213 - 222, XP035175870

DOI:   http://dx.doi.org/10.1007/BF02921748
    - VERONESE, F.M. et al., "Improvement of pharmacokinetic, immunological and stability properties of asparaginase by conjugation to linear and branched monomethoxy poly(ethylene glycol", Journal of Controlled Release, (19960000), vol. 40, doi:10.1016/0168-3659(95)00185-9, pages 199 - 209, XP004037365

DOI:   http://dx.doi.org/10.1016/0168-3659(95)00185-9
    - MULLER H.J. et al., "Use of L-asparaginase in childhood ALL", Critical Reviews in Oncology/Hematology, (19980000), vol. 2B, pages 97 - 113, XP055462234
    - FILPULA, D. et al., "Sequence of L-asparaginase gene from Erwinia chrysanthemi NCPPB 1125", Nucleic Acids Research, (19880000), vol. 16, page 10385, XP001317910
    - James Everitt et al, "Centre for Applied Microbiology & Research - Annual Review 1994/95", Centre for Applied Microbiology & Research (CAMR), (19940000), pages FP, 1 - 15, XP055624493
    - RAU E. R. et al., "Outcome of pediatric patients with acute lymphoblastic leukemia/lymphoblastic lymphoma with hypersensitivity to pegaspargase treated with PEGylated Erwinia asparaginase, pegcrisantaspase: A report from the Children's Oncology Group", Pediatric Blood Cancer, (20180300), vol. 65, no. 3, page e26873, XP055624110

DOI:   http://dx.doi.org/10.1002/pbc.26873
    - Jazz Pharmaceuticals, "A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)", Clinical Trials NCT02257684, (20141006), URL: https://clinicaltrials.gov/ct2/show/NCT02257684, XP055624482
    - Anonymous, "Pegcrisantaspase", Adis Insight - Drug Profile, (20171226), URL: https://adisinsight.springer.com/drugs/800029657, XP055624487
    - MINTON N.P. et al., "Nucleotide sequence of the Erwinia chrysanthemi NCPPB 1066 L-asparaginase gene", Gene, (19860000), vol. 46, no. 1, pages 25 - 35, XP025904632

DOI:   http://dx.doi.org/10.1016/0378-1119(86)90163-0
    - WADE, H.E. et al., "A new L- asparaginase with antitumor activity", The Lancet (Letters to the Editor), (19681005), pages 776 - 777, XP055462205
    - BUCK, P.W. et al., "The Batch production of L-asparaginase from Erwinia carotovora", Journal of General Microbiology, The Society for General Microbiology Sixtieth General Meeting, Microbiological Research Establishment, (19710000), vol. 65, XP055462210
    - SALZER, W. L. et al., "Development of asparaginase Erwinia chrysanthemi for the treatment of acute lymphoblastic leukemia", Ann. N.Y. Acad. Sci., (20140805), vol. 1329, pages 81 - 92, XP055462212

DOI:   http://dx.doi.org/10.1111/nyas.12496
    - SARTORE, L. et al., "Accurate Evaluation Method of the Polymer Content in Monomethoxy(Polyethylene Glycol) Modified Proteins Based on Amino Acid Analysis", Applied Biochemistry and Biotechnology, (19910000), vol. 31, pages 213 - 222, XP035175870

DOI:   http://dx.doi.org/10.1007/BF02921748
    - VERONESE, F.M. et al., "Improvement of pharmacokinetic, immunological and stability properties of asparaginase by conjugation to linear and branched monomethoxy poly(ethylene glycol", Journal of Controlled Release, (19960700), vol. 40, no. 3, pages 199 - 209, XP004037365

DOI:   http://dx.doi.org/10.1016/0168-3659(95)00185-9
    - VERONESE, F.M. et al., "Branched and Linear Poly(Ethylene Glycol): Influence of the Polymer Structure on Enzymological, Pharmacokinetic, and Immunological Properties of Protein Conjugates", Journal of Bioactive and Compatible Polymers, (19970000), vol. 12, pages 196 - 207, XP008038816

DOI:   http://dx.doi.org/10.1177/088391159701200303
    - AVRAMIS, V.I. et al., "Pharmacokinetic/Pharmacodynamic Relationships of Asparaginase Formulations - The Past, the Present and Recommendations for the Future", Clin. Pharmacokinet, (20050000), vol. 44, no. 4, pages 367 - 393, XP008105154

DOI:   http://dx.doi.org/10.2165/00003088-200544040-00003
    - ROBERTS, M.J. et al., "Chemistry for peptide and protein PEGylation", Advanced Drug Delivery Reviews, (20020617), vol. 54, no. 4, pages 459 - 476, XP002354432

DOI:   http://dx.doi.org/10.1016/S0169-409X(02)00022-4
    - VERONESE, F.M. et al., "The Impact of PEGylation on Biological Therapies", Biodrugs, (20080000), vol. 22, no. 5, pages 315 - 329, XP009116032

DOI:   http://dx.doi.org/10.2165/00063030-200822050-00004
    - MÜLLER H.J. et al., "Use of L-asparaginase in childhood ALL", Critical Reviews in Oncology/Hematology, (19980000), vol. 28, pages 97 - 113
    - YONG, W. et al., "L-Asparaginase- Based Regimen in the Treatment of Refractory Midline Nasal/Nasal-Type T/NK- Cell Lymphoma", International Journal of Hematology, (20030000), vol. 78, no. 2, pages 163 - 167, XP036411366

DOI:   http://dx.doi.org/10.1007/BF02983387
    - EGLER, R. et al., "L-asparaginase in the treatment of patients with acute lymphoblastic leukemia", Journal of Pharmacology and Pharmacotherapeutics, (20160000), vol. 7, pages 62 - 71, XP055462282
    - "An effective treatment for leukaemia", CAMR, (19970000), pages 15 - 17
    - Anonymous, "Erwinia chrysanthemi", Data Sheets on Quarantine Pests
    - FILPULA, D. et al., "Sequence of L-asparaginase gene from Erwinia chrysanthemi NCPPB 1125", Nucleic Acids Research, (19880000), vol. 16, no. 21, page 10385, XP001317910
    - CAMMACK, K.A. et al., "Physical properties and subunit structure of L-asparaginase isolated from Erwinia carotovora", Biochem. J., (19720000), vol. 126, pages 361 - 379, XP003035934

DOI:   http://dx.doi.org/10.1042/bj1260361
    - PAPAGEORGIOU, A.C. et al., "Structural and functional insights into Erwinia carotovora L- asparaginase", FEBS Journal, (20080000), vol. 275, pages 4306 - 4316, XP055462308

DOI:   http://dx.doi.org/10.1111/j.1742-4658.2008.06574.x
    - JACCARD, A. et al., "Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study", Blood, (20110000), vol. 117, pages 1834 - 1839, XP055462313

DOI:   http://dx.doi.org/10.1182/blood-2010-09-307454
    - WADA, H. et al., "Antitumor Enzyme: Polyethylene Glycol-modified Asparaginase", Annals New York Academy of Sciences, (19901200), vol. 613, pages 95 - 108, XP055462315
    - Cossar et al., Biosensors & Bioelectronics 5 (1990) 273-289
    - ClinicalTrials.gov record for trial NCT0T551524
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.