IP Verse

Pharmaceutical Formulations Of Tnf-Alpha Antibodies - EP2822591

The patent EP2822591 was granted to Cadila Healthcare on May 2, 2018. The application was originally filed on Mar 5, 2013 under application number EP13742519A. The patent is currently recorded with a legal status of "Revoked".

EP2822591

CADILA HEALTHCARE
Application Number
EP13742519A
Filing Date
Mar 5, 2013
Status
Revoked
Jul 16, 2021
Grant Date
May 2, 2018
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (2)

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BOULT WADE TENNANTFeb 1, 2019BOULT WADE TENNANTADMISSIBLE
GRUNECKER PATENT UND RECHTSANWALTE PARTG MBBFeb 1, 2019GRUNECKER PATENTADMISSIBLE

Patent Citations (14) New

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

Citation PhasePublication NumberPublication Link
EXAMINATIONWO2007092772
INTERNATIONAL-SEARCH-REPORTWO2004016286
INTERNATIONAL-SEARCH-REPORTWO2010077422
OPPOSITIONEP2238985
OPPOSITIONIN0610MUM2012
OPPOSITIONIN1606MUM2012
OPPOSITIONIN3031MUM2012
OPPOSITIONWO2004016286
OPPOSITIONWO2004055164
OPPOSITIONWO2011104381
OPPOSITIONWO2012089778
OPPOSITIONWO2013011076
OPPOSITIONWO2013186230
OPPOSITIONWO2014039903

Non-Patent Literature (NPL) Citations (17) 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
INTERNATIONAL-SEARCH-REPORT- MAITY HARIPADA ET AL, "Effects of arginine on photostability and thermal stability of IgG1 monoclonal antibodies", CURRENT PHARMACEUTICAL BIOTECHNOLOGY, BENTHAM SCIENCE PUBLISHERS, NL, (20091201), vol. 10, no. 8, ISSN 1389-2010, pages 761 - 766, XP009148288 [Y] 1-14,17-21,23-41 * abstract *-
INTERNATIONAL-SEARCH-REPORT- ROBERT J FALCONER ET AL, "Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients", JOURNAL OF CHEMICAL TECHNOLOGY & BIOTECHNOLOGY, (20110707), vol. 86, no. 7, doi:10.1002/jctb.2657, ISSN 0268-2575, pages 942 - 948, XP055076799 [Y] 1-14,17-21,23-41 * abstract *
INTERNATIONAL-SEARCH-REPORT- MARK CORNELL MANNING ET AL, "Stability of Protein Pharmaceuticals: An Update", PHARMACEUTICAL RESEARCH, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NL, (20100209), vol. 27, no. 4, doi:10.1007/S11095-009-0045-6, ISSN 1573-904X, pages 544 - 575, XP019793935 [Y] 1-12,15-20,22-41 * page 557 - page 559 *
INTERNATIONAL-SEARCH-REPORT- TIM J KAMERZELL ET AL, "Protein excipient interactions: Mechanisms and biophysical characterization applied to protein formulation development", ADVANCED DRUG DELIVERY REVIEWS, ELSEVIER, vol. 63, no. 13, doi:10.1016/J.ADDR.2011.07.006, ISSN 0169-409X, (20110726), pages 1118 - 1159, (20110729), XP028320148 [Y] 1-14,17-21,23-41 * table 1 *
OPPOSITION- "Croda Tween T" 80", Printout of product page from Croda International PLC for Tween T'' 80, to show equivalence with the term ''polysorbate 80'' ., pages 1 - 2-
OPPOSITION- Fields Gregg B, Alonso O V, Stigter Dirk, Dill Ken A, "Theory for the Aggregation of Proteins and Copolymersf", J. Phys. Chem, (19920101), pages 3974 - 3981, J. Phys. Chem, URL: https://pubs.acs.org/doi/pdf/10.1021/j100189a013, (20210316), XP055786249-
OPPOSITION- "HUMIRA® (adalimumab) abbott Laboratories", HUMIRA®, (20020000), pages 1 - 15, XP055560756-
OPPOSITION- MAGGIO, E. T., "Use of excipients to control aggregation in peptide and protein formulations", J. Excipients and Food Chem ., (20100000), vol. 1, no. 2, pages 40 - 49, XP055560599-
OPPOSITION- Nema, "Table of operable pH ranges for common formulation buffers", Pharmaceutical Dosage Forms, Parenteral Medications, Informa, (19840101), pages 235 - 235, XP055786226-
OPPOSITION- Summary of pKa and hydropathy values of amino acids, URL: http://www.chem.ucla.edu/ ~rebecca/153A/amino_acids.pdf-
OPPOSITION- Nicholas W Warne, "6 FORMULATION DEVELOPMENT OF PHASE 1-2 BIOPHARMACEUTICALS: AN EFFICIENT AND TIMELY APPROACH", Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, (20100805), pages 147 - 159, doi:10.1002/9780470595886, XP055188650
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- FALCONER et al., "Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients", J Chem Technol Biotechnol, (20110000), vol. 86, pages 942 - 948, XP055076799
OPPOSITION- FALCONER, R. J. et al., "Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients", J. Chem. Technol. Biotechnol., (20110000), vol. 86, pages 942 - 948, XP055076799
OPPOSITION- Li Y, Mach H, Blue J T, "High throughput formulation screening for global aggregation behaviors of three monoclonal antibodies.", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US, (20110601), vol. 100, no. 6, doi:10.1002/jps.22450, ISSN 0022-3549, pages 2120 - 2135, XP002712419
OPPOSITION- Tim J. Kamerzell et al, "Protein excipient interactions: Mechanisms and biophysical characterization applied to protein formulation development", Advanced Drug Delivery Reviews, Elsevier, Amsterdam , NL, Amsterdam , NL, (20110726), vol. 63, no. 13, doi:10.1016/j.addr.2011.07.006, ISSN 0169-409X, pages 1118 - 1159, XP028320148
OPPOSITION- Gharia Mihir, Sudhakar A, "Reduced Injection Site Pain with Succinate Buffer-Based Adalimumab Biosimilar (ZRC-3197) Injection (SUFFER Study): An Observational Study", Indian Journal of Rheumatology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20190101), vol. 14, no. 2, doi:10.4103/injr.injr_154_18, ISSN 0973-3698, page 151, XP055786241

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