Extract from the Register of European Patents

EP About this file: EP3145488

EP3145488 - LIQUID PHARMACEUTICAL COMPOSITION [Right-click to bookmark this link]
StatusOpposition rejected
Status updated on  26.07.2024
Database last updated on 01.04.2026
FormerThe patent has been granted
Status updated on  19.06.2020
FormerGrant of patent is intended
Status updated on  26.05.2020
FormerExamination is in progress
Status updated on  16.03.2018
FormerRequest for examination was made
Status updated on  24.02.2017
FormerThe international publication has been made
Status updated on  16.12.2016
Most recent event   Tooltip26.07.2024Opposition rejectedpublished on 28.08.2024  [2024/35]
Applicant(s)For all designated states
Fresenius Kabi Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg v.d.H. / DE
[2018/30]
Former [2017/13]For all designated states
Ares Trading S.A.
Zone Industrielle de l'Ouriettaz
1170 Aubonne / CH
Inventor(s)01 / RINALDI, Gianluca
Via Silvestrini 9
I-00015 Monterotondo (RM) / IT
02 / FRATARCANGELI, Silvia
C.so Risorgimento 3
I-03024 Ceprano (FR) / IT
03 / DEL RIO, Alessandra
Via Ildebrando Vivanti 108
I-00144 Roma / IT
 [2017/13]
Representative(s)D Young & Co LLP
3 Noble Street
London EC2V 7BQ / GB
[N/P]
Former [2020/30]D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
Former [2017/13]Merck Serono S.A. Intellectual Property
Zone Industrielle de l'Ouriettaz
1170 Aubonne / CH
Application number, filing date15723695.115.05.2015
[2017/13]
WO2015EP60818
Priority number, dateEP2014016975523.05.2014         Original published format: EP 14169755
[2017/13]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2015177059
Date:26.11.2015
Language:EN
[2015/47]
Type: A1 Application with search report 
No.:EP3145488
Date:29.03.2017
Language:EN
The application published by WIPO in one of the EPO official languages on 26.11.2015 takes the place of the publication of the European patent application.
[2017/13]
Type: B1 Patent specification 
No.:EP3145488
Date:22.07.2020
Language:EN
[2020/30]
Search report(s)International search report - published on:EP26.11.2015
ClassificationIPC:A61K9/00
[2017/13]
CPC:
A61K39/39591 (EP,CN,DK,IL,US); A61K47/12 (DK,IL,US); A61K47/26 (DK,IL,US);
A61K9/00 (DK,IL); A61K9/0019 (EP,DK,IL,US); A61P1/00 (EP,IL);
A61P1/04 (EP,IL); A61P17/06 (EP,IL); A61P19/00 (EP,IL);
A61P19/02 (EP,IL); A61P29/00 (EP,IL); A61P37/00 (EP,IL);
A61P37/06 (EP,IL); C07K16/241 (EP,CN,IL,US); A61K2039/505 (CN,IL);
C07K2317/21 (EP,CN,IL,US); C07K2317/94 (EP,CN,IL,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 [2017/13]
Extension statesBANot yet paid
MENot yet paid
Validation statesMANot yet paid
TitleGerman:FLÜSSIGE PHARMAZEUTISCHE ZUSAMMENSETZUNG[2017/13]
English:LIQUID PHARMACEUTICAL COMPOSITION[2017/13]
French:COMPOSITION PHARMACEUTIQUE LIQUIDE[2017/13]
Entry into regional phase16.12.2016National basic fee paid 
16.12.2016Designation fee(s) paid 
16.12.2016Examination fee paid 
Examination procedure16.12.2016Examination requested  [2017/13]
16.12.2016Date on which the examining division has become responsible
15.12.2017Amendment by applicant (claims and/or description)
15.03.2018Despatch of a communication from the examining division (Time limit: M04)
12.04.2018Reply to a communication from the examining division
20.07.2018Despatch of a communication from the examining division (Time limit: M04)
16.10.2018Reply to a communication from the examining division
04.02.2019Despatch of a communication from the examining division (Time limit: M04)
29.05.2019Reply to a communication from the examining division
16.07.2019Observations by third parties
02.03.2020Date of oral proceedings
09.03.2020Despatch of a communication from the examining division (Time limit: M02)
09.03.2020Minutes of oral proceedings despatched
10.03.2020Reply to a communication from the examining division
22.04.2020Observations by third parties
27.05.2020Communication of intention to grant the patent
10.06.2020Fee for grant paid
10.06.2020Fee for publishing/printing paid
10.06.2020Receipt of the translation of the claim(s)
Divisional application(s)EP20186550.8  / EP3741358
EP21175530.1  / EP3939566
Opposition(s)Opponent(s)01  22.07.2020  26.04.2021  ADMISSIBLE
Biogen Inc.
225 Binney Street
Cambridge, MA 02142 / US
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
 02  22.07.2020  22.04.2021  WITHDRAWN
Samsung Bioepis UK Limited
950 Great West Road
Brentford
Middlesex TW8 9ES / GB
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
 03  22.04.2021  26.04.2021  ADMISSIBLE
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft / NL
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
 [2021/22]
Former [2021/16]
Opponent(s)01  22.07.2020   
Biogen Inc.
225 Binney Street
Cambridge, MA 02142 / US
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
 02  22.07.2020   
Samsung Bioepis UK Limited
950 Great West Road
Brentford
Middlesex TW8 9ES / GB
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
Former [2020/35]
Opponent(s)01  22.07.2020   
Biogen Inc.
225 Binney Street
Cambridge, MA 02142 / US
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
 02  22.07.2020   
Samsung Bioepis UK Limited
950 Great West Road
Brentford
Middlesex TW8 9ES / GB
Opponent's representative
Patent Boutique LLP
10A Printing House Yard
Hackney Road
London E2 7PR / GB
06.05.2021Invitation to proprietor to file observations on the notice of opposition
13.09.2021Reply of patent proprietor to notice(s) of opposition
15.12.2021Cancellation of oral proceeding that was planned for 28.06.2022
28.06.2022Date of oral proceedings
26.10.2022Date of oral proceedings
22.12.2022Despatch of minutes of oral proceedings
22.12.2022Date of despatch of rejection of opposition
20.06.2024Legal effect of rejection of opposition [2024/35]
Appeal following opposition28.02.2023Appeal received No.  T0466/23
28.02.2023Payment of appeal fee
02.05.2023Statement of grounds filed
20.06.2024Result of appeal procedure: appeal of the opponent was rejected
18.07.2024Despatch of the decision of the Board of Appeal
20.06.2024Date of oral proceedings
Fees paidRenewal fee
10.05.2017Renewal fee patent year 03
25.04.2018Renewal fee patent year 04
15.05.2019Renewal fee patent year 05
15.05.2020Renewal fee patent year 06
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Lapses during opposition  Tooltipdeleted
[2022/23]
Former [2021/25]AL22.07.2020
Cited inInternational search[XY] WO2013164837  (CADILA HEALTHCARE LTD et al.)
 [XY] WO2009073569  (ABBOTT LAB et al.)
 [XY] US2004033228  (KRAUSE HANS-JUERGEN et al.)
 [Y] US2010137213  (FERNANDEZ JASON E et al.)
 [XY] US2010278822  (FRAUNHOFER WOLFGANG et al.) [X] 1,2,5-11,15,16 * example - *[Y] 1-16
 [XY] WO2011104381  (NOVO NORDISK AS et al.) [X] 1,2,5,6,8-11,15,16 * page 145, paragraph 1 *[Y] 1-16
Examination  ZHENG J Y ET AL: "Influence of pH, buffer species, and storage temperature on physicochemical stability of a humanized monoclonal antibody LA298", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER, NL, vol. 308, no. 1-2, 3 February 2006 (2006-02-03), pages 46 - 51, XP027972782, ISSN: 0378-5173, [retrieved on 20060203]
by applicantWO9729131
   PENNICA, D. ET AL., NATURE, vol. 312, 1984, pages 724 - 729
   DAVIS, J. M. ET AL., BIOCHEMISTRY, vol. 26, 1987, pages 1322 - 1326
   JONES, E. Y. ET AL., NATURE, vol. 338, 1989, pages 225 - 228
OppositionIN1606MUM2012
 WO2014039903
 WO2015177057
 WO2015177058
 IN1606MUM2012
 WO2014039903
 WO2015177057
 WO2015177058
   "Alternative buffers for pharmaceutical anti-TNFalpha monoclonal antibody formulations [Elektronische Ressource]", PAPDEOTT002384, 6 February 2013 (2013-02-06), pages 10 pp, XP009188701
   JAMEEL FEROZ ; HERSHENSON SUSAN: "Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals", 26 July 2010, JOHN WILEY & SONS, INC. , Hoboken, N.J. , ISBN: 978-0-470-11812-2, article NICHOLAS W. WARNE: "Formulation Development of Phase 1-2 Biopharmaceuticals: An Efficient and Timely Approach : Jameel/Manufacturing Biopharmaceuticals", pages: 147 - 159, XP055752685, DOI: 10.1002/9780470595886.ch6

DOI:   http://dx.doi.org/10.1002/9780470595886.ch6
   "Therapeutic Monoclonal Antibodies: From Bench to Clinic", 1 January 2009, article V. K. SHARMA, ET AL.: "Chapter 30: The Formulation and Delivery of Monoclonal Antibodies", pages: 675 - 709, XP055593299
   "National Formulary", UNITED STATES PHARMACOPEIA, vol. 37, no. 32, 1 May 2014 (2014-05-01), pages 765, 766, 5828, XP055961246
   "Peptides and Proteins as Parenteral Solutions", 1 January 2006, CRC PRESS, article ANONYMOUS: "Pharmaceutical Formulation Development of Peptides and Proteins", pages: 155, XP055961250
   "Formulation and process development strategies for manufacturing biopharmaceuticals.", 26 July 2010, WILEY , New York , ISBN: 9780470118122, article SAMPATHKUMAR KRISHNAN, MONICA M. PALLITTO, MARGARET S. RICCI: "Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins", pages: 383 - 427, XP055188652, DOI: 10.1002/9780470595886.ch16

DOI:   http://dx.doi.org/10.1002/9780470595886.ch16
   "Alternative buffers for pharmaceutical anti-TNFalpha monoclonal antibody formulations [Elektronische Ressource]", PAPDEOTT002384, 6 February 2013 (2013-02-06), pages 10 pp, XP009188701
   JAMEEL FEROZ ; HERSHENSON SUSAN: "Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals", 26 July 2010, JOHN WILEY & SONS, INC. , Hoboken, N.J. , ISBN: 978-0-470-11812-2, article NICHOLAS W. WARNE: "Formulation Development of Phase 1-2 Biopharmaceuticals: An Efficient and Timely Approach : Jameel/Manufacturing Biopharmaceuticals", pages: 147 - 159, XP055752685, DOI: 10.1002/9780470595886.ch6

DOI:   http://dx.doi.org/10.1002/9780470595886.ch6
   "Therapeutic Monoclonal Antibodies: From Bench to Clinic", 1 January 2009, article V. K. SHARMA, ET AL.: "Chapter 30: The Formulation and Delivery of Monoclonal Antibodies", pages: 675 - 709, XP055593299
   "National Formulary", UNITED STATES PHARMACOPEIA, vol. 37, no. 32, 1 May 2014 (2014-05-01), pages 765, 766, 5828, XP055961246
   "Peptides and Proteins as Parenteral Solutions", 1 January 2006, CRC PRESS, article ANONYMOUS: "Pharmaceutical Formulation Development of Peptides and Proteins", pages: 155, XP055961250
   "Formulation and process development strategies for manufacturing biopharmaceuticals.", 26 July 2010, WILEY , New York , ISBN: 9780470118122, article SAMPATHKUMAR KRISHNAN, MONICA M. PALLITTO, MARGARET S. RICCI: "Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins", pages: 383 - 427, XP055188652, DOI: 10.1002/9780470595886.ch16

DOI:   http://dx.doi.org/10.1002/9780470595886.ch16
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