Pharmaceutical Product With Increased Stability Comprising Immunoglobulins - EP3763384

The patent EP3763384 was granted to CSL Behring on Aug 28, 2024. The application was originally filed on Dec 3, 2015 under application number EP20186174A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3763384

CSL BEHRING
Application Number
EP20186174A
Filing Date
Dec 3, 2015
Status
Granted And Under Opposition
Jul 26, 2024
Grant Date
Aug 28, 2024
External Links
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OCTAPHARMAMay 28, 2025ULLRICH & NAUMANN PARTG MBBADMISSIBLE

Patent Citations (17) New

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

Citation PhasePublication Number
DESCRIPTIONWO2011104315
DESCRIPTIONWO2012022734
DESCRIPTIONWO2014041307
OPPOSITIONFR2995213
OPPOSITIONUS2008072992
OPPOSITIONUS2015224264
OPPOSITIONWO03039632
OPPOSITIONWO2011104315
OPPOSITIONWO2014140097
SEARCHEP2361636
SEARCHEP3202389
SEARCHFR2995213
SEARCHGB2471726
SEARCHWO03039632
SEARCHWO2012151247
SEARCHWO2014140095
SEARCHWO2014140097

Non-Patent Literature (NPL) Citations (19) 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
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DESCRIPTION- R.S.SHAPIRO, Annals of Allergy, Asthma & Immunology, (20130000), vol. 111, no. 1, pages 51 - 56
OPPOSITION- Anonymous, "2.6.17 Test for anticomplementary activity of immunoglobulin", European Pharmacopoeia 6.0, (20080101), pages 191 - 193, XP093284761
OPPOSITION- Anonymous, "2.7.9 Test for Fc Function of immunoglobulin", European Pharmacopoeia, (19970101), pages 117 - 118, XP093284758
OPPOSITION- Anonymous, "Human normal immunoglobulin for intravenous administration", European Pharmacopoeia (1997:0918), (19970101), pages 963 - 965, XP093284753
OPPOSITION- Anonymous, "Polymer Prefillable Syringes - SCHOTT TopPac", Schott, (20140817), pages 1 - 2, Schott, URL: https://web.archive.org/web/20140817210705/http://www.schott.com/pharmaceutical_packaging/english/products/syringes/polymer_syringes.html, (20250606), XP093284742
OPPOSITION- D10 - Gammanorm, Fachinformationen
OPPOSITION- D11 - Decision dated April 28, 2025, in the opposition proceedings on the parent application EP 3 226 895
OPPOSITION- Toppac Schott, "Schott TopPac Brochure Polymer Prefillable Syringes", Schott TopPac - Brochure, (20220117), pages 1 - 13, Schott TopPac - Brochure, URL: https://adelphi-hp.com/assets/images/pdf/schott_toppac_syringes.pdf, (20250606), XP093284733
OPPOSITION- Shihong Li, Christian Schöneich, Ronald T. Borchardt, "Chemical instability of protein pharmaceuticals: Mechanisms of oxidation and strategies for stabilization", Biotechnology and Bioengineering, (19951205), vol. 48, no. 5, doi:10.1002/bit.260480511, ISSN 0006-3592, pages 490 - 500, XP055040145
OPPOSITION- Wei Wang , Satish Singh, David L Zeng, Kevin King, Sandeep Nema, "Antibody structure, instability, and formulation", Journal of pharmaceutical sciences, (20070101), vol. 96, no. 1, doi:10.1002/jps.20727, ISSN 0022-3549, pages 1 - 26, XP009084505
OPPOSITION- Yoshino Keisuke, Nakamura Koji, Yamashita Arisa, Abe Yoshihiko, Iwasaki Kazuhiro, Kanazawa Yukie, Funatsu Kaori, Yoshimoto Tsuyoshi, Suzuki Shigeru, "Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System", Journal of pharmaceutical sciences, (20140501), vol. 103, no. 5, doi:10.1002/jps.23945, ISSN 0022-3549, pages 1520 - 1528, XP055961235
OPPOSITION- Mark Cornell Manning ; Danny K. Chou ; Brian M. Murphy ; Robert W. Payne ; Derrick S. Katayama, "Stability of Protein Pharmaceuticals: An Update", Pharmaceutical Research, NL , (20100209), vol. 27, no. 4, doi:10.1007/s11095-009-0045-6, ISSN 1573-904X, pages 544 - 575, XP019793935
OPPOSITION- Torosantucci Riccardo, Schöneich Christian, Jiskoot Wim, "Oxidation of Therapeutic Proteins and Peptides: Structural and Biological Consequences", Pharmaceutical Research, Berlin/Heidelberg, (20140301), vol. 31, no. 3, doi:10.1007/s11095-013-1199-9, ISSN 0724-8741, pages 541 - 553, XP093122784
OPPOSITION- Bolli, R. ; Woodtli, K. ; Bartschi, M. ; Hofferer, L. ; Lerch, P., "l-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions", Biologicals, GB , (20100101), vol. 38, no. 1, doi:10.1016/j.biologicals.2009.09.002, ISSN 1045-1056, pages 150 - 157, XP026978067
OPPOSITION- Thanae Georgakopoulos; Owen C. Tatford; Vladimir Gurevich; Joseph Bertolini;, "C1q aggregate binding for the determination of anti-complementary activity of immunoglobulin products", Biologicals, GB , (20101117), vol. 39, no. 1, doi:10.1016/j.biologicals.2010.11.002, ISSN 1045-1056, pages 38 - 42, XP028139184
OPPOSITION- Daniel J Kroon , Alysia Baldwin-Ferro , Praful Lalan, "Identification of sites of degradation in a therapeutic monoclonal antibody by peptide mapping", Pharmaceutical Research, Berlin/Heidelberg, (19921101), vol. 9, no. 11, doi:10.1023/A:1015894409623, ISSN 0724-8741, pages 1386 - 1393, XP002079908
OPPOSITION- Buchacher A., Schluga P., Müllner J., Schreiner M., Kannicht C., Weinberger J, "Anticomplementary activity of IVIG concentrates - important assay parameters and impact of IgG polymers", Vox Sanguinis, CH , (20090101), vol. 98, doi:10.1111/j.1423-0410.2009.01271.x, ISSN 0042-9007, pages e209 - e218, XP007914915
SEARCH- Gregory A Sacha ET AL, "7th Annual Pre-Filled Syringes Forum", (20140519), URL: http://www.pharmaedresources.com/brochures/PreFilledMay2014.pdf, (20150210), XP055168850 [A] 1-23 * page 2, column r *

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