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Extract from the Register of European Patents

EP About this file: EP4375659

EP4375659 - A METHOD FOR THE QUANTITATIVE DETERMINATION OF HUMAN SERUM ALBUMIN MONOMER IN VIRUS-CONTAINING PHARMACEUTICAL COMPOSITIONS [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  21.02.2025
Database last updated on 01.04.2026
FormerGrant of patent is intended
Status updated on  16.10.2024
FormerRequest for examination was made
Status updated on  12.07.2024
FormerThe application has been published
Status updated on  27.04.2024
Most recent event   Tooltip06.02.2026Lapse of the patent in a contracting state
New state(s): CZ		published on 11.03.2026  [2026/11]
Applicant(s)For all designated states
Takeda Vaccines, Inc.
75 Sidney Street
Cambridge, MA 02139 / US
[2024/22]
Inventor(s)01 / SOMANADHAN, Brinda
02139 Cambridge / US
 [2024/22]
Representative(s)Maiwald GmbH
Elisenhof
Elisenstraße 3
80335 München / DE
[2024/22]
Application number, filing date23212703.528.11.2023
[2024/22]
Priority number, dateEP2022021002728.11.2022         Original published format: EP 22210027
[2024/22]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP4375659
Date:29.05.2024
Language:EN
[2024/22]
Type: B1 Patent specification 
No.:EP4375659
Date:26.03.2025
Language:EN
[2025/13]
Search report(s)(Supplementary) European search report - dispatched on:EP24.04.2024
ClassificationIPC:G01N30/88
[2024/22]
CPC:
G01N30/88 (EP); G01N2030/8831 (EP); Y02A50/30 (EP)
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,   ME,   MK,   MT,   NL,   NO,   PL,   PT,   RO,   RS,   SE,   SI,   SK,   SM,   TR [2024/33]  
Former [2024/22]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,  ME,  MK,  MT,  NL,  NO,  PL,  PT,  RO,  RS,  SE,  SI,  SK,  SM,  TR 
TitleGerman:VERFAHREN ZUR QUANTITATIVEN BESTIMMUNG VON MENSCHLICHEM SERUMALBUMINMONOMER IN VIRUSHALTIGEN PHARMAZEUTISCHEN ZUSAMMENSETZUNGEN[2024/22]
English:A METHOD FOR THE QUANTITATIVE DETERMINATION OF HUMAN SERUM ALBUMIN MONOMER IN VIRUS-CONTAINING PHARMACEUTICAL COMPOSITIONS[2024/22]
French:PROCÉDÉ POUR LA DÉTERMINATION QUANTITATIVE DE MONOMÈRES D'ALBUMINE SÉRIQUE HUMAINE DANS DES COMPOSITIONS PHARMACEUTIQUES CONTENANT DES VIRUS[2024/22]
Examination procedure05.07.2024Amendment by applicant (claims and/or description)
05.07.2024Examination requested  [2024/33]
05.07.2024Date on which the examining division has become responsible
17.10.2024Communication of intention to grant the patent
14.02.2025Fee for grant paid
14.02.2025Fee for publishing/printing paid
14.02.2025Receipt of the translation of the claim(s)
Opposition(s)Opponent(s)01  18.12.2025  22.12.2025  ADMISSIBLE
COHAUSZ & FLORACK Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB
Bleichstraße 14
40211 Düsseldorf / DE
Opponent's representative
Cohausz & Florack
Patent- & Rechtsanwälte
Partnerschaftsgesellschaft mbB
Bleichstraße 14
40211 Düsseldorf / DE
 [2026/05]
16.01.2026Invitation to proprietor to file observations on the notice of opposition
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  TooltipCZ26.03.2025
ES26.03.2025
HR26.03.2025
PL26.03.2025
SK26.03.2025
SM26.03.2025
NO26.06.2025
RS26.06.2025
GR27.06.2025
IS26.07.2025
[2026/11]
Former [2025/49]ES26.03.2025
HR26.03.2025
PL26.03.2025
SK26.03.2025
SM26.03.2025
NO26.06.2025
RS26.06.2025
GR27.06.2025
IS26.07.2025
Former [2025/48]ES26.03.2025
HR26.03.2025
PL26.03.2025
SM26.03.2025
NO26.06.2025
RS26.06.2025
GR27.06.2025
Former [2025/46]ES26.03.2025
HR26.03.2025
SM26.03.2025
NO26.06.2025
RS26.06.2025
GR27.06.2025
Former [2025/35]HR26.03.2025
NO26.06.2025
RS26.06.2025
GR27.06.2025
Former [2025/34]HR26.03.2025
NO26.06.2025
RS26.06.2025
Former [2025/33]RS26.06.2025
Documents cited:Search[I] US2014186447  (DESAI NEIL P et al.)
 [A] WO2022226342  (AMGEN INC et al.)
 [A] US5178756  (JARRETT III HARRY W et al.)
 [A] US2022081468  (SCHMUDLACH ANDREW WYATT et al.)
by applicantWO2020051328
   SVIRIDOV ET AL., CLINICAL CHEMISTRY, vol. 52, 2006, pages 389 - 397
   HUANG ET AL., J. VIROL., vol. 77, no. 21, 2003, pages 11436 - 11447
   HUANG ET AL., J. VIROLOGY, vol. 77, no. 21, 2003, pages 11436 - 11447
OppositionWO2013006675
 US6210683
 US2014186447
 WO2019112921
   D2 - ONLINE AVAILABILITY OF PRODUCT INFORMATION ON THE TOSOH TSKGEL G3000SWXL COLUMN
   ANONYMOUS: "HUMAN ALBUMIN SOLUTION", EUROPEAN PHARMACOPEIA, 5TH ED., vol. 5, 1 January 2005 (2005-01-01), pages 3218 - 3219, XP093355986
   ANONYMOUS: "rAlbumin Human", UNITED STATES PHARMACOPEIA, NF MONOGRAPHS, 1 January 2008 (2008-01-01), XP093355989
   THEODORE PETERS: "All about albumin : biochemistry, genetics, and medical applications", 1 January 1996, ACADEMIC PRESS, ISBN: 0-12-552110-3, article THEODORE PETERS: "7 - Practical Aspects: Albumin in the Laboratory", pages: 285 - 318, XP009565632, DOI: 10.1016/B978-012552110-9/50009-X
   THEODORE PETERS: "All about albumin : biochemistry, genetics, and medical applications", 1 January 1996, ACADEMIC PRESS, ISBN: 0-12-552110-3, article THEODORE PETERS JR.: "2 - The Albumin Molecule: Its Structure and Chemical Properties", pages: 9 - 75, XP009565634, DOI: 10.1016/B978-012552110-9/50004-0

DOI:   http://dx.doi.org/10.1016/B978-012552110-9/50004-0
   LUIK A.I., NABOKA YU.N., MOGILEVICH S.E., HUSHCHA T.O., MISCHENKO N.I.: "Study of human serum albumin structure by dynamic light scattering: two types of reactions under different pH and interaction with physiologically active compounds", SPECTROCHIMICA ACTA PART A: MOLECULAR AND BIOMOLECULAR SPECTROSCOPY, ELSEVIER, AMSTERDAM, NL, vol. 54, no. 10, 1 September 1998 (1998-09-01), AMSTERDAM, NL, pages 1503 - 1507, XP093355991, ISSN: 1386-1425, DOI: 10.1016/S1386-1425(98)00171-1

DOI:   http://dx.doi.org/10.1016/S1386-1425(98)00171-1
   "Essential Human Virology", 1 January 2016, ELSEVIER, ISBN: 978-0-12-800947-5, article JENNIFER LOUTEN: "Virus Structure and Classification", pages: 19 - 29, XP093152599, DOI: 10.1016/B978-0-12-800947-5.00002-8
   KUHN RICHARD J., ZHANG WEI, ROSSMANN MICHAEL G., PLETNEV SERGEI V., CORVER JEROEN, LENCHES EDITH, JONES CHRISTOPHER T., MUKHOPADHY: "Structure of Dengue Virus: Implications for Flavivirus Organization, Maturation, and Fusion", CELL, vol. 108, no. 5, 8 March 2002 (2002-03-08), pages 717 - 725, XP093355999, DOI: 10.1016/s0092-8674(02)00660-8

DOI:   http://dx.doi.org/10.1016/s0092-8674(02)00660-8
   ANONYMOUS: "Application Overview - Gel Filtration Chromatography with TSKgel columns", TOSOH BIOSCIENCE LLC, 1 May 2011 (2011-05-01), XP093356002
   BOUVIER EDOUARD S.P., KOZA STEPHAN M.: "Advances in size-exclusion separations of proteins and polymers by UHPLC", TRENDS IN ANALYTICAL CHEMISTRY, ELSEVIER, AMSTERDAM, NL, vol. 63, 1 December 2014 (2014-12-01), AMSTERDAM, NL , pages 85 - 94, XP093321811, ISSN: 0165-9936, DOI: 10.1016/j.trac.2014.08.002

DOI:   http://dx.doi.org/10.1016/j.trac.2014.08.002
   HONG PAULA, KOZA STEPHAN, BOUVIER EDOUARD S. P.: "A REVIEW SIZE-EXCLUSION CHROMATOGRAPHY FOR THE ANALYSIS OF PROTEIN BIOTHERAPEUTICS AND THEIR AGGREGATES", JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES, MONTICELLO, NY, US, vol. 35, no. 20, 30 November 2012 (2012-11-30), US , pages 2923 - 2950, XP093230757, ISSN: 1082-6076, DOI: 10.1080/10826076.2012.743724
   QIAN, J. ; TANG, Q. ; CRONIN, B. ; MARKOVICH, R. ; RUSTUM, A.: "Development of a high performance size exclusion chromatography method to determine the stability of Human Serum Albumin in a lyophilized formulation of Interferon alfa-2b", JOURNAL OF CHROMATOGRAPHY A, ELSEVIER, AMSTERDAM, NL, vol. 1194, no. 1, 13 June 2008 (2008-06-13), AMSTERDAM, NL, pages 48 - 56, XP022696673, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2008.01.040

DOI:   http://dx.doi.org/10.1016/j.chroma.2008.01.040
   D16 - EXPERIMENTAL REPORT SUBMITTED BY THE OPPONENT
   EMA: "European Medicines Agency ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS", 1 September 1999 (1999-09-01), pages 1 - 17, XP093024022, Retrieved from the Internet
   ANONYMOUS: "Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adenoassociated viral vectors", EMA; EMEA/CHMP/GTWP/587488/2007 REV. 1; COMMITTEE FOR THE MEDICINAL PRODUCTS FOR HUMAN USE (CHMP), 24 June 2010 (2010-06-24), XP093356006, Retrieved from the Internet
   D19 - MACHINE TRANSLATION OF YONGHONG ET AL. 2020, CHINESE JOURNAL OF PHARMACEUTICAL ANALYSIS, PURITY DETERMINATION OF ONCOLYTIC ADENOVIRUS INJECTION BY SEC-HPLC, 40(1): 48-51
   LI YONGHONG, HAN CHUN-MEI, BI HUA, TAO LEI, LI XIANG, RAO CHUN-MING: "Purity determination of oncolytic adenovirus injection by SEC-HPLC", CHINESE JOURNAL OF PHARMACEUTICAL ANALYSIS, ZHONGGUO YAOXUEHUI, BEIJING, CN, vol. 40, no. 1, 31 January 2020 (2020-01-31), CN , pages 48 - 51, XP093356008, ISSN: 0254-1793, DOI: 10.16155/j.0254-1793.2020.01.07

DOI:   http://dx.doi.org/10.16155/j.0254-1793.2020.01.07
   DENG JAMES Z., RUSTANDI RICHARD R., SWARTZ ANDREW, SHIEH YVONNE, BAKER JACK B., VLASAK JOSEF, WANG SHIYI, LOUGHNEY JOHN W.: "SEC coupled with in-line multiple detectors for the characterization of an oncolytic Coxsackievirus", MOLECULAR THERAPY - ONCOLYTICS, ELSEVIER, vol. 24, 1 March 2022 (2022-03-01), pages 139 - 147, XP093356009, ISSN: 2372-7705, DOI: 10.1016/j.omto.2021.12.009

DOI:   http://dx.doi.org/10.1016/j.omto.2021.12.009
   GAUTAM SAURABH, XIN DONGYUE, GARCIA ALAN PARDO, SPIESSCHAERT BART: "Single-step rapid chromatographic purification and characterization of clinical stage oncolytic VSV-GP", FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY, FRONTIERS RESEARCH FOUNDATION, CH, vol. 10, CH , XP093356013, ISSN: 2296-4185, DOI: 10.3389/fbioe.2022.992069

DOI:   http://dx.doi.org/10.3389/fbioe.2022.992069
   CHI-SAN WU: "Handbook of Size Exclusion Chromatography, Chromatographic science series v69 , 1st edition. ", 1 January 1995, MARCEL DEKKER, INC, US, ISBN: 0-8247-9288-2, article "Molecular Weight-Sensitive Detectors for Size Exclusion Chromatography", pages: 103 - 145, XP009565635
   D24 - EXPERIMENTAL REPORT SUBMITTED BY THE OPPONENT
   ANONYMOUS: "YMC-Pack Diol", YMC (ACCESSED VIA THE WAYBACK MACHINE), 18 February 2020 (2020-02-18), XP093356017, Retrieved from the Internet
   D27 - USERS GUIDE ON THE YMC-PACK DIOL SEC COLUMN SERIES (DATE?)
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.