Stabilized Antibody-Containing Liquid Formulations - EP3378486

The patent EP3378486 was granted to Chugai Seiyaku Kabushiki Kaisha on Mar 3, 2021. The application was originally filed on Jan 20, 2011 under application number EP18155113A. The patent is currently recorded with a legal status of "Revoked".

EP3378486

CHUGAI SEIYAKU KABUSHIKI KAISHA
Application Number
EP18155113A
Filing Date
Jan 20, 2011
Status
Revoked
Oct 8, 2025
Publication Date
Mar 3, 2021
External Links
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Patent Summary

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Patent Family

Patent Oppositions (6)

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DR H ULRICH DORRIESDec 3, 2021DORRIESADMISSIBLE
DR H ULRICH DORRIESDec 3, 2021DORRIES, HANS ULRICH , DF-MP DORRIES FRANK-MOLNIA & POHLMANADMISSIBLE
ELKINGTON AND FIFEDec 3, 2021ELKINGTON AND FIFEADMISSIBLE
WOHLFAHRTDec 3, 2021WOHLFAHRTADMISSIBLE
STRAWMANDec 1, 2021PLASSERAUDADMISSIBLE
JAMES POOLENov 23, 2021CARPMAELS & RANSFORDADMISSIBLE

Patent Citations (52) New

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

Citation PhasePublication Number
DESCRIPTIONWO2005US37471
DESCRIPTIONEP0239400
DESCRIPTIONJPH0159878B
DESCRIPTIONWO0166737
DESCRIPTIONWO0233072
DESCRIPTIONWO2005005636
DESCRIPTIONWO2006006693
DESCRIPTIONWO2006044908
DESCRIPTIONWO2006065746
DESCRIPTIONWO2007114319
DESCRIPTIONWO2008071394
DESCRIPTIONWO2008121615
DESCRIPTIONWO2009041613
DESCRIPTIONWO2009041621
DESCRIPTIONWO2009072604
DESCRIPTIONWO2009141239
DESCRIPTIONWO9201047
DESCRIPTIONWO9203918
DESCRIPTIONWO9219759
DESCRIPTIONWO9220791
DESCRIPTIONWO9306213
DESCRIPTIONWO9311236
DESCRIPTIONWO9312227
DESCRIPTIONWO9319172
DESCRIPTIONWO9402602
DESCRIPTIONWO9425585
DESCRIPTIONWO9501438
DESCRIPTIONWO9515388
DESCRIPTIONWO9602576
DESCRIPTIONWO9633735
DESCRIPTIONWO9634096
DESCRIPTIONWO9704801
DESCRIPTIONWO9813388
DESCRIPTIONWO9814580
DESCRIPTIONWO9951743
OPPOSITIONEP1712240
OPPOSITIONUS2005074821
OPPOSITIONUS2007184050
OPPOSITIONUS2007212346
OPPOSITIONWO2004055164
OPPOSITIONWO2004091658
OPPOSITIONWO2006065746
OPPOSITIONWO2007092772
OPPOSITIONWO2008079290
OPPOSITIONWO2008086395
OPPOSITIONWO2008121615
OPPOSITIONWO2008132439
OPPOSITIONWO2009006301
SEARCHUS2004197324
SEARCHWO2004055164
SEARCHWO2008079290
SEARCHWO2009086400

Non-Patent Literature (NPL) Citations (47) 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- "Antibody structure, instability, and formulation", J Pharm Sci, (20070000), vol. 96, no. 1, pages 1 - 26
DESCRIPTION- BETTER, M.; HORWITZ, A. H., Methods Enzymol., (19890000), vol. 178, pages 476 - 496
DESCRIPTION- BIRD, R. E.; WALKER, B. W., Trends Biotechnol., (19910000), vol. 9, pages 132 - 137
DESCRIPTION- Cancer J., (20080500), vol. 14, no. 3, pages 154 - 69
DESCRIPTION- "Challenges in the development of high protein concentration formulations", J Pharm Sci, (20040000), vol. 93, no. 6, pages 1390 - 1402
DESCRIPTION- "Challenges in the development of high protein concentration formulations", J Pharm Sci, (20040000), vol. 93, pages 1390 - 1402
DESCRIPTION- CO, M. S. et al., J. Immunol., (19940000), vol. 152, pages 2968 - 2976
DESCRIPTION- Curr Opin Biotechnol, (20091200), vol. 20, no. 6, pages 708 - 14
DESCRIPTION- Dent. Mater., (20010000), vol. 17, pages 409 - 414
DESCRIPTION- Farmaco., (19990830), vol. 54, no. 8, pages 497 - 516
DESCRIPTION- "Formulation and delivery issues for monoclonal antibody therapeutics", Adv Drug Del Rev, (20060000), vol. 58, no. 5-6, pages 686 - 706
DESCRIPTION- HINTON PR; XIONG JM; JOHLFS MG; TANG MT; KELLER S; TSURUSHITA N, "An engineered human IgGl antibody with longer serum half-life", J Immunol., (20060101), vol. 176, no. 1, pages 346 - 56
DESCRIPTION- HUSTON J. S. et al., Proc. Natl. Acad. Sci. U.S.A., (19880000), vol. 85, pages 5879 - 5883
DESCRIPTION- J. Pharm. Sci., (19970000), vol. 86, pages 1250 - 1255
DESCRIPTION- KIM SJ; PARK Y; HONG HJ., "Antibody engineering for the development of therapeutic antibodies", Mol Cells, (20050831), vol. 20, no. 1, pages 17 - 29, XP055199890
DESCRIPTION- KOHLER, G.; MILSTEIN, C., Methods Enzymol., (19810000), vol. 73, pages 3 - 46
DESCRIPTION- LAMOYI, E., Methods Enzymol., (19860000), vol. 121, pages 652 - 663
DESCRIPTION- PLUCKTHUN, A.; SKERRA, A., Methods Enzymol., (19890000), vol. 178, pages 497 - 515
DESCRIPTION- ROUSSEAUX, J. et al., Methods Enzymol., (19860000), vol. 121, pages 663 - 669
DESCRIPTION- SATO, K. et al., Cancer Res., (19930000), vol. 53, pages 851 - 856
DESCRIPTION- EWERT S; HONEGGER A; PLUCKTHUN A., "Stability improvement of antibodies for extracellular and intracellular applications: CDR grafting to stable frameworks and structure-based framework engineering", Methods, (20041000), vol. 34, no. 2, doi:doi:10.1016/j.ymeth.2004.04.007, pages 184 - 99, XP004526805
DESCRIPTION- TSURUSHITA N; HINTON PR; KUMAR S., "Design of humanized antibodies: from anti-Tac to Zenapax.", Methods, (20050500), vol. 36, no. l, doi:doi:10.1016/j.ymeth.2005.01.007, pages 69 - 83, XP004852554
DESCRIPTION- GHETIE V; POPOV S; BORVAK J; RADU C; MATESOI D; MEDESAN C; OBER RJ; WARD ES, "Increasing the serum persistence of an IgG fragment by random mutagenesis", Nat Biotechnol., (19970700), vol. 15, no. 7, doi:doi:10.1038/nbt0797-637, pages 637 - 40, XP000876642
DESCRIPTION- RAJPAL A; BEYAZ N; HABER L; CAPPUCCILLI G; YEE H; BHATT RR; TAKEUCHI T; LERNER RA; CREA R., "A general method for greatly improving the affinity of antibodies by using combinatorial libraries", Proc Natl Acad Sci USA., (20050614), vol. 102, no. 24, doi:doi:10.1073/pnas.0503543102, pages 8466 - 71, XP002392777
OPPOSITION- HAUTBERGUE et al., "Increasing the sensitivity of cryoprobe protein NMR experiments by using the sole low-conductivity arginine glutamate salt", Journal, of Magnetic Resonance, (20080000), vol. 191, pages 335 - 339, XP022559490
OPPOSITION- Jameel Feroz, "Liquid Formulation Strageties", Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, (20100713), pages 401 - 404,423,424, XP055874793
OPPOSITION- Manz Andreas, Et Al, "Amino Acids", Bioanalytical Chemistry textbook, Imperial College Press, (20040101), pages 2 - 7, XP055873282
OPPOSITION- Rossler R, "Parenteralia", Hagers Handbuch der pharmazeutischen Praxis: Band 5: Methoden, (19990101), pages 758 - 761, XP055874790
OPPOSITION- Zhu Gaozhong, Et Al, "Formulation and protein- and peptide-based parenteral products", Parental Medications Third Edition, (20100101), pages 222 - 253, XP055874783
OPPOSITION- Zumdahl Steven S, "Chapter 8 Applications of Aqueous Equilibria", Chemical Principals, (20090101), pages 300 - 312, XP055874763
OPPOSITION- WANG et al., "Antibody Structure, Instability, and Formulation", Journal of Pharmaceutical Sciences, (20070000), vol. 96, no. 1, doi:10.1002/jps.20727, pages 1 - 26, XP009084505
OPPOSITION- WANG W et al, "ANTIBODY STRUCTURE, INSTABILITY, AND FORMULATION", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US , (20070101), vol. 96, no. 1, doi:10.1002/jps.20727, ISSN 0022-3549, pages 1 - 26, XP009084505
OPPOSITION- MAHLER et al., "Protein Aggregation: Pathways, Induction Factors and Analysis", Journal of Pharmaceutical Sciences, (20090000), vol. 98, no. 9, doi:10.1002/jps.21566, pages 2909 - 2934, XP055321457
OPPOSITION- ARAKAWA et al., "Biotechnology applications of amino acids in protein purification and formulations", Amino Acids, (20070000), vol. 33, doi:10.1007/s00726-007-0506-3, pages 587 - 605, XP019565540
OPPOSITION- ARAWAKA et al., "Biotechnology applications of amino acids in protein purification and formulations", Amino Acids, (20070000), vol. 33, doi:10.1007/s00726-007-0506-3, pages 587 - 605, XP019565540
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- KHEDDO et al., "The effect of arginine glutamate on the stability of monoclonal antibodies in solution", International Journal of Pharmaceutics, (20140000), vol. 473, doi:10.1016/j.ijpharm.2014.06.053, pages 126 - 133, XP055151603
OPPOSITION- Liu H. X., Zhang R. S., Yao X. J., Liu M. C., Hu Z. D., Fan B. T., "Prediction of the Isoelectric Point of an Amino Acid Based on GA-PLS and SVMs", JOURNAL OF CHEMICAL INFORMATION AND COMPUTER SCIENCES., AMERICAN CHEMICAL SOCIETY, COLOMBUS,OHIO., US, US , (20040101), vol. 44, no. 1, doi:10.1021/ci034173u, ISSN 0095-2338, pages 161 - 167, XP055888183
OPPOSITION- Golovanov A P, Hautbergue G M, Wilson S A, Lian L Y., "A simple method for improving protein solubility and long-term stability.", Journal of the American Chemical Society, American Chemical Society, (20040728), vol. 126, no. 29, doi:10.1021/ja049297h , ISSN 0002-7863, pages 8933 - 8939, XP002686711
OPPOSITION- GOLOVANOV et al., "A simple method for improving protein solubility and long-term stability", J. Am. Chem. Soc., (20040000), vol. 126, doi:10.1021/ja049297h, pages 8933 - 8939, XP055535234
OPPOSITION- GOLOVANOV et al., "A simple method for Improving Protein Solubility and Long-Term Stability", J Am. Chem. Soc., (20040000), vol. 126, doi:10.1021/ja049297h, pages 8933 - 8939, XP055535234
OPPOSITION- GOLOVANOV et al., "A Simple Method for Improving Protein Solubility and Long-Term Stability", J. AM. CHEM. SOC., (20040000), vol. 126, doi:10.1021/ja049297h, pages 8933 - 8939, XP055535234
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, New York, (20031201), vol. 20, no. 12, doi:10.1023/B:PHAM.0000008042.15988.c0, ISSN 0724-8741, pages 1952 - 1960, XP002386671
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 US, New York, New York, (20031201), vol. 20, no. 12, doi:10.1023/B:PHAM.0000008042.15988.c0, ISSN 0724-8741, pages 1952 - 1960, XP002386671
OPPOSITION- CHEN et al., "Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms", P harmaceutical Research, (20030000), vol. 20, no. 12, doi:10.1023/B:PHAM.0000008042.15988.c0, pages 1952 - 1960, XP002417746
OPPOSITION- FROKJAER et al., "Protein drug stability: a formulation challenge", Nat. Rev. Drug Discov, (20050000), vol. 4, doi:10.1038/nrd1695, pages 298 - 306, XP002492211
OPPOSITION- Valente Joseph J., Et Al, "Second Virial Coefficient Studies of Cosolvent-Induced Protein Self-Interaction", Biophysical Journal, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20051201), vol. 89, no. 6, doi:10.1529/biophysj.105.068551, ISSN 0006-3495, pages 4211 - 4218, XP055873284

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