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Extract from the Register of European Patents

EP About this file: EP2771033

EP2771033 - PROTEIN FORMULATIONS CONTAINING AMINO ACIDS [Right-click to bookmark this link]
StatusThe application is deemed to be withdrawn
Status updated on  23.08.2019
Database last updated on 23.04.2024
FormerExamination is in progress
Status updated on  06.01.2017
Most recent event   Tooltip23.08.2019Application deemed to be withdrawnpublished on 25.09.2019  [2019/39]
Applicant(s)For all designated states
Integritybio Inc.
820 Calle Plano
Camarillo, CA 93012 / US
[2014/36]
Inventor(s)01 / CHANG, Byeong, Seon
14735 Sutton Street
Sherman Oaks, CA 91403 / US
 [2014/36]
Representative(s)Grund, Martin
Grund Intellectual Property Group
Patentanwälte und Solicitor PartG mbB
Steinsdorfstraße 2
80538 München / DE
[N/P]
Former [2014/36]Schlich, George
Schlich
9 St Catherine's Road
Littlehampton, West Sussex BN17 5HS / GB
Application number, filing date12843696.126.10.2012
WO2012US62282
Priority number, dateUS201161552688P28.10.2011         Original published format: US 201161552688 P
[2014/36]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2013063510
Date:02.05.2013
Language:EN
[2013/18]
Type: A1 Application with search report 
No.:EP2771033
Date:03.09.2014
Language:EN
The application published by WIPO in one of the EPO official languages on 02.05.2013 takes the place of the publication of the European patent application.
[2014/36]
Search report(s)International search report - published on:KR02.05.2013
(Supplementary) European search report - dispatched on:EP19.01.2016
ClassificationIPC:A61K47/16, A61K47/12, A61K9/08, A61K39/395, A61K38/47, A61K38/48, A61K38/57, A61K47/18, C07K16/10, C07K16/22, C07K16/24, C07K16/28, C07K16/32
[2015/42]
CPC:
A61K47/183 (EP,KR,US); A61K38/47 (EP,KR,US); A61K38/4846 (EP,KR,US);
A61K38/57 (EP,KR,US); A61K39/39591 (EP,KR,US); A61K47/22 (US);
C07K16/1027 (EP,KR,US); C07K16/22 (EP,KR,US); C07K16/241 (EP,KR,US);
C07K16/2863 (EP,KR,US); C07K16/2866 (EP,KR,US); C07K16/2887 (EP,KR,US);
C07K16/32 (EP,KR,US); C12Y302/01022 (EP,KR,US); C12Y302/01045 (EP,KR,US);
C12Y304/21022 (EP,KR,US); A61K47/20 (EP,US); C07K2317/24 (EP,KR,US);
C07K2317/94 (US) (-)
Former IPC [2014/36]A61K47/16, A61K47/12, A61K9/08, A61K39/395
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 [2014/36]
TitleGerman:PROTEINFORMULIERUNGEN MIT AMINOSÄUREN[2014/36]
English:PROTEIN FORMULATIONS CONTAINING AMINO ACIDS[2014/36]
French:FORMULATIONS PROTÉIQUES CONTENANT DES ACIDES AMINÉS[2014/36]
Entry into regional phase28.04.2014National basic fee paid 
28.04.2014Search fee paid 
28.04.2014Designation fee(s) paid 
28.04.2014Examination fee paid 
Examination procedure28.04.2014Examination requested  [2014/36]
15.08.2016Amendment by applicant (claims and/or description)
11.01.2017Despatch of a communication from the examining division (Time limit: M04)
04.04.2017Reply to a communication from the examining division
31.08.2017Despatch of a communication from the examining division (Time limit: M04)
22.12.2017Reply to a communication from the examining division
25.09.2018Despatch of a communication from the examining division (Time limit: M06)
06.04.2019Application deemed to be withdrawn, date of legal effect  [2019/39]
03.05.2019Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time  [2019/39]
Divisional application(s)EP19166363.2  / EP3578203
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  11.01.2017
Fees paidRenewal fee
24.10.2014Renewal fee patent year 03
26.10.2015Renewal fee patent year 04
28.10.2016Renewal fee patent year 05
30.10.2017Renewal fee patent year 06
23.10.2018Renewal fee patent year 07
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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[XP]WO2012138958  (GLAXOSMITHKLINE LLC [US], et al) [XP] 1,2,4,5,7-15 * figures 2-3 *;
 [Y]  - ROBERT J FALCONER ET AL, "Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients", JOURNAL OF CHEMICAL TECHNOLOGY & BIOTECHNOLOGY, (20110707), vol. 86, no. 7, doi:10.1002/jctb.2657, ISSN 0268-2575, pages 942 - 948, XP055076799 [Y] 1,2,4,5,7-15 * The whole document, in particular, Table 1 and p.946, col.2, §3 *

DOI:   http://dx.doi.org/10.1002/jctb.2657
 [Y]  - GOKARN Y R ET AL, Excipients for protein drugs, EXCIPIENT DEVELOPMENT FOR PHARMACEUTICAL, BIOTECHNOLOGY, AND DRUG DELIVERY SYSTEMS,, PAGE(S) 291 - 331, (20060101), XP009179656 [Y] 1,2,4,5,7-15 * The whole document, in particular the Appendix *
 [Y]  - SAMPATHKUMAR KRISHNAN ET AL, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals; Chapter 16: DEVELOPMENT OF FORMULATIONS FOR THERAPEUTIC MONOCLONAL ANTIBODIES AND Fc FUSION PROTEINS, FORMULATION AND PROCESS DEVELOPMENT STRATEGIES FOR MANUFACTURING BIOPHARMACEUTICALS, JOHN WILEY & SONS, INC, HOBOKEN, N.J, PAGE(S) 383 - 427, (20100805), ISBN 978-0-470-11812-2, XP002712418 [Y] 1,2,4,5,7-15 * Thew whole document, in particular, p.403, §3 and p.411, §2 *

DOI:   http://dx.doi.org/10.1002/9780470595886.ch16
 [Y]  - HE F ET AL, "Screening of monoclonal antibody formulations based on high-throughput thermostability and viscosity measurements: Design of experiment and statistical analysis", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, US, vol. 100, no. 4, doi:10.1002/JPS.22384, ISSN 0022-3549, (20110401), pages 1330 - 1340, (20101102), XP002696416 [Y] 1,2,4,5,7-15 * The whole document, in particular, Table 7, p.1338, col.§, §2 *

DOI:   http://dx.doi.org/10.1002/jps.22384
 [Y]  - TIM J KAMERZELL ET AL, "Protein excipient interactions: Mechanisms and biophysical characterization applied to protein formulation development", ADVANCED DRUG DELIVERY REVIEWS, ELSEVIER, AMSTERDAM, NL, vol. 63, no. 13, doi:10.1016/J.ADDR.2011.07.006, ISSN 0169-409X, (20110726), pages 1118 - 1159, (20110729), XP028320148 [Y] 1,2,4,5,7-15 * The whole document, in particular section 1.2.2 on p.1122 *

DOI:   http://dx.doi.org/10.1016/j.addr.2011.07.006
 [Y]  - WERNER MAEDER ET AL, "Local tolerance and stability up to 24 months of a new 20% proline-stabilized polyclonal immunoglobulin for subcutaneous administration", BIOLOGICALS, ACADEMIC PRESS LTD., LONDON, GB, vol. 39, no. 1, doi:10.1016/J.BIOLOGICALS.2010.11.004, ISSN 1045-1056, (20101123), pages 43 - 49, (20101202), XP028139185 [Y] 1,2,4,5,7-15 * The whole documment, in particular Fig.2 *

DOI:   http://dx.doi.org/10.1016/j.biologicals.2010.11.004
 [Y]  - BOLLI R ET AL, "l-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions", BIOLOGICALS, ACADEMIC PRESS LTD., LONDON, GB, vol. 38, no. 1, ISSN 1045-1056, (20100101), pages 150 - 157, (20100306), XP026978067 [Y] 1,2,4,5,7-15 * The whole document, in particular, Table 1 *
 [AP]  - "Case No: HP-2013-000004 Neutral Citation Number: [2014] EWHC 3857 (Pat) IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION PATENTS COURT", Neutral Citation Number: [2014] EWHC 3857 (Pat) IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION PATENTS COURT, (20141121), URL: http://www.aoyamapat.gr.jp/assets/editor/files/Hospira%20UK%20Ltd%20vs%20Genentech%20Inc%20EWHC%203857.pdf, (20150511), XP055188693 [AP] 13 * the whole document *
International search[X]US2007053900  (LIU JUN [US], et al);
 [X]WO2011104381  (NOVO NORDISK AS [DK], et al);
 [X]US2007116700  (LIU JUN [US], et al);
 [X]WO2011109365  (PROGENICS PHARM INC [US], et al);
 [A]WO2010056657  (REGENTS THE UNIVESITY OF TEXAS [US], et al)
Examination   - MARK X YANG ET AL, "Crystalline monoclonal antibodies for subcutaneous delivery", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, NATIONAL ACADEMY OF SCIENCES, US, (20030610), vol. 100, no. 12, doi:10.1073/PNAS.1131899100, ISSN 0027-8424, pages 6934 - 6939, XP002717388

DOI:   http://dx.doi.org/10.1073/PNAS.1131899100
    - STEVEN SHIRE, Stability of monoclonal antibodies mAbs, MONOCLONAL ANTIBODIES: MEETING THE CHALLENGES IN MANUFACTURING, FORMULATION, DELIVERY AND STABILITY OF FINAL DRUG PRO,, PAGE(S) 45 - 92, (20150101), XP009192950

DOI:   http://dx.doi.org/10.1016/B978-0-08-100296-4.00003-8
    - STEVEN SHIRE, Formulation of proteins and monoclonal antibodies mAbs, MONOCLONAL ANTIBODIES: MEETING THE CHALLENGES IN MANUFACTURING, FORMULATION, DELIVERY AND STABILITY OF FINAL DRUG PRO,, PAGE(S) 93 - 120, (20150101), XP009192951

DOI:   http://dx.doi.org/10.1016/B978-0-08-100296-4.00004-X
by applicantWO2012138958
 US2007053900
 WO2011104381
 US2007116700
 WO2011109365
 WO2010056657
    - FALCONER et al., Journal of Chemical Technology & Biotechnology, (20110000), vol. 86, no. 7, pages 942 - 948
    - GOKARN et al., Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems, (20060000), pages 291 - 331
    - SAMPATHKUMAR KRISHNAN et al., Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins, (20100000), pages 383 - 427
    - HE et al., Journal of Pharmaceutical Sciences, American Pharmaceutical Association, (20110000), vol. 100, no. 4, pages 1330 - 1340
    - KAMERZELL et al., Advanced Drug Delivery Reviews, (20110000), vol. 63, no. 13, pages 1118 - 1159
    - MAEDER et al., Biologicals, (20100000), vol. 39, no. 1, pages 43 - 49
    - BOLLI et al., Biologicals, (20100000), vol. 38, no. 1, pages 150 - 157
    - YANG et al., Proceedings of the National Academy of Sciences, US, (20030000), vol. 100, no. 12, pages 6934 - 6939
    - SHIRE, "Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation", Delivery and Stability of Final Drug Pro., (20150000), pages 45 - 92,93-120
    - REUBSAET, J. L.; J. H. BEIJNEN et al., "Analytical techniques used to study the degradation of proteins and peptides: chemical instability", J Pharm Biomed Anal, (19980000), vol. 17, no. 6-7, doi:doi:10.1016/S0731-7085(98)00063-6, pages 955 - 78, XP002626964

DOI:   http://dx.doi.org/10.1016/S0731-7085(98)00063-6
    - WANG, W., "Instability, stabilization, and formulation of liquid protein pharmaceuticals", Int J Pharm, (19990000), vol. 185, no. 2, doi:doi:10.1016/S0378-5173(99)00152-0, pages 129 - 88, XP002616539

DOI:   http://dx.doi.org/10.1016/S0378-5173(99)00152-0
    - Remington's Pharmaceutical Sciences, Mack Publishing Co.
    - Handbook of Pharmaceutical Excipients, APhA Publications
    - "Pharmaceutical excipients in formulations", BANGA, A.K., Therapeutic Peptides and Proteins, Formulation, Processing and Delivery Systems, CRC Press, pages 104 - 116
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.