A Stable Liquid Formulation Of Fusion Protein With Igg Fc Domain - EP3313373

EP3313373

ALTEOGEN
Application Number
EP16814702A
Filing Date
Jun 23, 2016
Status
Granted And Under Opposition
Oct 25, 2024
Grant Date
Nov 27, 2024
External Links
Slate, Register, Google Patents

Bibliography

The patent EP3313373B1 was granted to Alteogen on Nov 27, 2024 following the initial filing on Jun 23, 2016 under the application number EP16814702A . The current legal status of the patent is Granted And Under Opposition.

Patent Summary

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Patent Oppositions (2)

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DORRIESAug 25, 2025ADMISSIBLE
STORZJul 18, 2025ADMISSIBLE

Patent Citations (21) New

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

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INTERNATIONAL-SEARCH-REPORTKR20120135387
INTERNATIONAL-SEARCH-REPORTKR20150035681
INTERNATIONAL-SEARCH-REPORTKR20150063305
INTERNATIONAL-SEARCH-REPORTUS2015079087
INTERNATIONAL-SEARCH-REPORTWO2006044908
OPPOSITIONCA2962480
OPPOSITIONJP2016088897
OPPOSITIONUS2006217311
OPPOSITIONUS2014323983
OPPOSITIONUS2015017163
OPPOSITIONWO03009817
OPPOSITIONWO2004055164
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Non-Patent Literature (NPL) Citations (22) New

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

Citation PhaseReference TextLink
OPPOSITION- Anonymous, "ARCALYST TM (rilonacept) Injection for Subcutaneous Use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20080201), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf, XP093309854-
OPPOSITION- Anonymous, "Highlights of Prescribing information EYLEA", FDA, (20140101), FDA, (20221016), XP055971644-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - EYLEA™ (aflibercept) Injection", Regeneron Pharmaceuticals, Inc., (20111101), pages 1 - 15, XP055895379-
OPPOSITION- Anonymous, "Lucentis 10 mg/ml solution for injection - ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS", EMA, (20111114), EMA, URL: https://ec.europa.eu/health/documents/community-register/2016/20161114136324/anx_136324_en.pdf, XP093309816-
OPPOSITION- Anonymous, "Lucentis 10 mg/ml solution for injection - ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS", EMA, (20161111), EMA, URL: https://www.ema.europa.eu/en/documents/product-information/lucentis-epar-product-information_en.pdf, XP093309846-
OPPOSITION- Anonymous, "LUCENTIS® (ranibizumab injection) Intravitreal Injection - HIGHLIGHTS OF PRESCRIBING INFORMATION", FDA, (20141001), XP093309855-
OPPOSITION- Anonymous, "Schüttgüter Schüttdichte - Schüttgewicht", MOLLET Füllstandtechnik GmbH, (20220201), MOLLET Füllstandtechnik GmbH, URL: https://www.mollet.de/uploads/tx_cinproducts/00-0_AI_Schuettdichte_AI-SG-00_02-22_de.pdf, XP093309808-
OPPOSITION- D29 - Summons to oral proceedings in the prosecution of the application underlying then patent in dispute, 19 October 2023-
OPPOSITION- Gaozhong Zhu and Y. John Wang , "9. Fornulation of protein- and peptide-based parenteral products 222", Gaozhong Zhu and Y. John Wang , Sandeep Nema, John D. Ludwig, Pharmaceutical Dosage Forms Parenteral Medications, Third Edition, Volume 1 Formulation and Packaging, informa healthcare, (20100101), pages 222 - 253, ISBN 9781420086430, XP009563266-
OPPOSITION- Sampathkunar Krishnan, Monica M. Pallitto and Margareet S. Ricci, "16. DEVELOPMENT OF FORMULATIONS FOR THERAPEUTIC MONOCLONAL ANTIBODIES AND Fc FUSION PROTEINS", Sampathkunar Krishnan, Monica M. Pallitto and Margareet S. Ricci, Jameel Feroz ; Hershenson Susan, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, Hoboken, N.J. , John Wiley & Sons, Inc. , (20100101), pages 384 - 427, ISBN 978-0-470-11812-2, XP009563265-
OPPOSITION- Semeraro F, Et Al., "Aflibercept in wet AMD: specific role and optimal use", DRUG DESIGN, DEVELOPMENT AND THERAPY, (20130101), vol. 7, XP055971638-
OPPOSITION- Wei Wang , Satish Singh, David L Zeng, Kevin King, Sandeep Nema, "Antibody structure, instability, and formulation", Journal of pharmaceutical sciences, Elsevier Inc, (20070101), vol. 96, no. 1, doi:10.1002/jps.20727, ISSN 0022-3549, pages 1 - 26, XP009084505
OPPOSITION- T. Arakawa ; K. Tsumoto ; Y. Kita ; B. Chang ; D. Ejima, "Biotechnology applications of amino acids in protein purification and formulations", Amino Acids ; The Forum for Amino Acid and Protein Research, Springer-Verlag, Vi, Vi , (20070316), vol. 33, no. 4, doi:10.1007/s00726-007-0506-3, ISSN 1438-2199, pages 587 - 605, XP019565540
OPPOSITION- Nicholas W. Warne, "Development of high concentration protein biopharmaceuticals: The use of platform approaches in formulation development", European journal of pharmaceutics and biopharmaceutics, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (20110601), vol. 78, no. 2, doi:10.1016/j.ejpb.2011.03.004, ISSN 0939-6411, pages 208 - 212, XP055534222
OPPOSITION- CHEN BEI,ET AL, "Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms.", Pharmaceutical Research, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20031201), vol. 20, no. 12, doi:10.1023/B:PHAM.0000008042.15988.c0, ISSN 0724-8741, pages 1952 - 1960, XP002386671
OPPOSITION- Jyothi S, Chowdhury H, Elagouz M, Sivaprasad S, "Intravitreal bevacizumab (Avastin) for age-related macular degeneration: a critical analysis of literature", EYE, Nature Publishing Group, GB, GB , (20100501), vol. 24, no. 5, doi:10.1038/eye.2009.219, ISSN 0950-222X, pages 816 - 824, XP093309843
OPPOSITION- Stewart Michael W., Grippon Seden, Kirkpatrick Peter, "Aflibercept", Nature Reviews Drug Discovery, Nature Publishing Group, GB, GB , (20120401), vol. 11, no. 4, doi:10.1038/nrd3700, ISSN 1474-1776, pages 269 - 270, XP093309803
OPPOSITION- Mansour Ahmad M, Al-Ghadban Sara I, Yunis Muhammad H, El-Sabban Marwan E, "Ziv-aflibercept in macular disease", BRITISH JOURNAL OF OPHTHALMOLOGY, BMJ Publishing Group, GB, GB , (20150801), vol. 99, no. 8, doi:10.1136/bjophthalmol-2014-306319, ISSN 0007-1161, pages 1055 - 1059, XP093309850
OPPOSITION- De Oliveira Dias João Rafael, De Andrade Gabriel Costa, Novais Eduardo Amorim, Farah Michel Eid, Rodrigues Eduardo Büchele, "Fusion proteins for treatment of retinal diseases: aflibercept, ziv-aflibercept, and conbercept", International Journal of Retina and Vitreous, (20161201), vol. 2, no. 1, doi:10.1186/s40942-016-0026-y, page 3, XP055927160
OPPOSITION- Meyer Brian K., Shameem Mohammed, "Commercial therapeutic protein drug products", Therapeutic Protein Drug Products, Elsevier, (20120101), pages 1 - 11, doi:10.1533/9781908818102.1, ISBN 978-1-907568-18-3, XP093309796
OPPOSITION- Sumit Goswami, Wei Wang, Tsutomu Arakawa, Satoshi Ohtake, "Developments and Challenges for mAb-Based Therapeutics", Antibodies, vol. 2, no. 3, doi:10.3390/antib2030452, pages 452 - 500, XP055128980
OPPOSITION- Moradi Ahmadreza, "Vascular endothelial growth factor trap-eye (Aflibercept) for the management of diabetic macular edema", World Journal of Diabetes, (20130101), vol. 4, no. 6, doi:10.4239/wjd.v4.i6.303, ISSN 1948-9358, page 303, XP093309849

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