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Liquid Pharmaceutical Composition - EP3403646

The patent EP3403646 was granted to Fresenius Kabi Deutschland on Sep 28, 2022. The application was originally filed on May 15, 2015 under application number EP18169979A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3403646

FRESENIUS KABI DEUTSCHLAND
Application Number
EP18169979A
Filing Date
May 15, 2015
Status
Granted And Under Opposition
Aug 26, 2022
Publication Date
Sep 28, 2022
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (4)

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BIOGENOct 5, 2022PATENT BOUTIQUEADMISSIBLE
BIOGENOct 5, 2022POHLMANADMISSIBLE
SAMSUNG BIOEPISOct 5, 2022PATENT BOUTIQUEADMISSIBLE
SAMSUNG BIOEPISOct 5, 2022POHLMANADMISSIBLE

Patent Citations (13) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication Number
DESCRIPTIONWO9729131
OPPOSITIONEP3148510
OPPOSITIONIN1606MUMNP2012
OPPOSITIONUS2023115267
OPPOSITIONWO2004016286
OPPOSITIONWO2013164837
OPPOSITIONWO2013186230
OPPOSITIONWO2014039903
OPPOSITIONWO2015177057
OPPOSITIONWO2015177059
SEARCHWO2011104381
SEARCHWO2013186230
SEARCHWO2014039903

Non-Patent Literature (NPL) Citations (20) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference Text
DESCRIPTION- CHEMICAL ABSTRACTS, Database accession no. 331731-18-1
DESCRIPTION- DAVIS, J. M. et al., Biochemistry, (19870000), vol. 26, pages 1322 - 1326
DESCRIPTION- JONES, E. Y. et al., Nature, (19890000), vol. 338, pages 225 - 228
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OPPOSITION- "Alternative buffers for pharmaceutical anti-TNFalpha monoclonal antibody formulations [Elektronische Ressource]", PAPDEOTT002384, (20130206), page 10 pp, XP009188701
OPPOSITION- Anonymous, "Full prescribing information for ABRILADA. ABRILADAâ„¢ (adalimumab-afzb) injection, for subcutaneous use", HIGHLIGHTS OF PRESCRIBING INFORMATION, FDMA, (20231001), pages 1 - 65, HIGHLIGHTS OF PRESCRIBING INFORMATION , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s007lbl.pdf, (20240311), XP093139849
OPPOSITION- Anonymous, "Full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use", HIGHLIGHTS OF PRESCRIBING INFORMATION, FDMA, (20230701), pages 1 - 78, HIGHLIGHTS OF PRESCRIBING INFORMATION, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059s008lbl.pdf, (20240311), XP093139839
OPPOSITION- SHARMA et al., "The Formulation and Delivery of Monoclonal Antibodies", Therapeutic Monoclonal Antibodies: From Bench to Clinic, pages 675 - 709, XP055593299
OPPOSITION- V. K. Sharma, Et Al., "Chapter 30: The Formulation and Delivery of Monoclonal Antibodies", Therapeutic Monoclonal Antibodies: From Bench to Clinic, (20090101), pages 675 - 709, XP055593299
OPPOSITION- WARNE, "Formulation Development of Phase 1-2 Biopharmaceuticals: An Efficient And Timely Approach", Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, (20100000), XP055188650
OPPOSITION- KRISHNAN et al., "Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins", Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, (20100000), XP055188652
OPPOSITION- Sampathkumar Krishnan, Monica M. Pallitto, Margaret S. Ricci, "Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins", Formulation and process development strategies for manufacturing biopharmaceuticals., New York , Wiley , (20100726), pages 383 - 427, doi:10.1002/9780470595886.ch16, ISBN 9780470118122, XP055188652
OPPOSITION- Nicholas W. Warne, "Formulation Development of Phase 1-2 Biopharmaceuticals: An Efficient and Timely Approach : Jameel/Manufacturing Biopharmaceuticals", Nicholas W. Warne, Jameel Feroz ; Hershenson Susan, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, Hoboken, N.J. , John Wiley & Sons, Inc. , (20100726), pages 147 - 159, doi:10.1002/9780470595886.ch6, ISBN 978-0-470-11812-2, XP055752685
OPPOSITION- Karow A R, Bahrenburg S, Garidel P., "Buffer capacity of biologics--from buffer salts to buffering by antibodies.", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20130301), vol. 29, no. 2, doi:10.1002/btpr.1682, ISSN 8756-7938, pages 480 - 492, XP002712421
OPPOSITION- KAROW et al., "Buffer capacities of Biologics - from buffer salts to buffering by antibodies", Biotechnol Prog, (20130000), vol. 29, no. 2, pages 480 - 492, XP002712421
OPPOSITION- Rau R, "Adalimumab (a fully human anti-tumour necrosis factor alpha monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials.", Annals of the Rheumatic Diseases, BMJ Publ. Group, GB, GB, (20021101), vol. 61, no. supplement 2, doi:10.1136/ard.61.suppl_2.ii70, ISSN 0003-4967, pages ii70 - ii73, XP008128398
OPPOSITION- NGUYEN et al., "Calculation of the equilibrium pH in a multiple- buffered aqueous solution on partitioning of proton buffering: a new predictive formula", Am J Physiol Renal Physiol, (20090000), vol. 296, doi:10.1152/ajprenal.90651.2008, pages F1521 - F1529, XP055979624
OTHER- Lars Hovgaard, Et Al, "8.2.1. Buffers", Pharmaceutical Formulation Development of Peptides and Proteins, CRC Press, (20130101), page 155, XP055579993
OTHER- Reijenga, J.C. Gagliardi, L.G. Kenndler, E., "Temperature dependence of acidity constants, a tool to affect separation selectivity in capillary electrophoresis", Journal of Chromatography A, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20070613), vol. 1155, no. 2, doi:10.1016/j.chroma.2006.09.084, ISSN 0021-9673, pages 142 - 145, XP022114894
OTHER- Tyunina E. Yu.; Badelin V. G.; Kuritsyna A. A., "Molecular Interactions of L-Histidine in an Aqueous Buffer Solution in the Temperature Range of 288-313 K", Russian Journal of Physical Chemistry A, CHEMICAL SOCIETY, LONDON., GB, GB , (20200401), vol. 94, no. 4, doi:10.1134/S0036024420040226, ISSN 0036-0244, pages 731 - 737, XP037093033

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