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C1-Inh Compositions And Methods For The Prevention And Treatment Of Disorders Associated With C1 Esterase Inhibitor Deficency - EP2968434

The patent EP2968434 was granted to Shire Viropharma on Jun 28, 2017. The application was originally filed on Mar 17, 2014 under application number EP14762343A. The patent is currently recorded with a legal status of "Revoked".

EP2968434

SHIRE VIROPHARMA
Application Number
EP14762343A
Filing Date
Mar 17, 2014
Status
Revoked
Apr 15, 2022
Grant Date
Jun 28, 2017
External Links
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OCTAPHARMAMar 28, 2018ULLRICH & NAUMANNADMISSIBLE
OCTAPHARMAMar 28, 2018ULLRICH & NAUMANN PARTG MBBADMISSIBLE
CSL BEHRINGMar 28, 2018PLASSERAUDWITHDRAWN

Patent Citations (6) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTUS6090777
OPPOSITIONUS7067713
OPPOSITIONWO2014145519
OTHERWO2009073569
SEARCHWO2011116291
SEARCHWO2013013017

Non-Patent Literature (NPL) Citations (55) 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
EXAMINATION- I. MARTINEZ-SAGUER ET AL., "Abstract AB104: Pharmacokinetic Berinert P Study Of Subcutaneous Versus Intravenous Administration In Subjects With Moderate Hereditary Angioedema - The Passion Study", JOURNAL OF ALLERGY & CLINICAL IMMUNOLOGY, (20110201), vol. 127, XP055344297-
OPPOSITION- "Annex 1: Site-specific Informed Consent Form, corresponding to E2a and Annex 2: File note from Parexe", Martinez-Saguer Declaration I and exhibits-
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OPPOSITION- Anonymous, "CINRYZE (C1 Esterase Inhibitor [Human])", Highlights of prescribing information, (20140900), pages 1 - 18, XP055477372-
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OPPOSITION- "CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase inhibitor in Patients with Hereditary Angioedema", (20120503), URL: https://www.cslbehring.com/sl/cs/enco/1255923338532/news/1255928832614/prdetail.%20%20.., (20170209), XP055344308-
OPPOSITION- DE SERRES et al., "Safety and efficacy of pasteurized C1 inhibitor concentrate (Berinert®P) in hereditary angioedema: a review", Transfusion and Apheresis Science, (20030000), vol. 29, pages 247 - 254, XP055477378-
OPPOSITION- "Exhibit A : clinical trial web page NCT01576523 ; Exhibit B : Site-specific Informed Consent form ( Germany ) ; Exhibit C : File note Parexel ; Exhibit D : Monitoring plan Parexel for CSL830_2001 study, with sign-off sheet) .", Herget declaration and exhibits-
OPPOSITION- GATLIN et al., "Formulation and Administration techniques to minimize Injection Pain and Tissue Damage Associated with Parenteral Products", Injectable Drug Development. Techniques to Reduce Pain and irritation, (19990000), pages 401 - 421, XP008165547-
OPPOSITION- Haixiang Jiang , Hua-Mei Zhang , Michael M. Frank, "Subcutaneous infusion of human C1 inhibitor in swine", Clinical Immunology, (20100000), vol. 136, pages 323 - 328, XP055477333-
OPPOSITION- "Human Albumin Solution", Anonymous, European Pharmacopoeia Fourth Edition, (20010920), pages 1pp, 1309 - 1310, XP055477376-
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OPPOSITION- JIANG et al., "Subcutaneous infusion of human C1 inhibitor in swine", Clinical Immunology, (20100000), vol. 136, pages 323 - 328, XP055477333-
OPPOSITION- LUNN et al., "Cinryzeâ„¢ as the first approved C1 inhibitor in the USA for the treatment of hereditary angioedema: approval, efficacy and safety", Journal of Blood Medicine, (20100000), vol. 1, pages 163 - 170, XP055477354-
OPPOSITION- MARTINEZ-SAGUER et al., "389 Pharmacokinetic Berinert P Study Of Subcutaneous Versus Intravenous Administration In Subjects With Moderate Hereditary Angioedema - The Passion Study", Journal of Allergy & Clinical Immunology, (20110000), vol. 127, XP055344297-
OPPOSITION- "Patienten in klinischen Studien", Guide, (20160101), pages FP - 29, XP055610780-
OPPOSITION- Rote Liste Service GmbH, "CSL Behring® - Hizentra", Zusammenfassung der Merkmale des Arzneimittels, (20170200), pages 1 - 5, XP055477358-
OPPOSITION- SCHRANZ et al., "L21 Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneous (SC) Cinryze (C1 inhibitor (C1 INH) with Recombinant Human Hyaluronidase (rHuPH20) in Subjects with Hereditary Angioedema (HAE)", J ALLERGY CLIN MMUNOL, (20120200), vol. 129, no. 2, XP055344284-
OPPOSITION- SCHRANZ et al., "Safety, Pharmacokinetics (PK) , and Pharmacodynamics (PD) of Subcutaneous (SC) Cinryze® (C1 Esterase Inhibitor [Human]) with Recombinant Human Hyaluronidase (rHuPH20) in Subjects with Hereditary Angioedema (HAE", AAAAI, Orlando, Florida, USA, (20120306), XP055610747-
OPPOSITION- Schranz J, "Abstract AB369: Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneous (SC) Cinryze (C1 inhibitor (C1 INH) with Recombinant Human Hyaluronidase (rHuPH20) in Subjects with Hereditary Angioedema (HAE)", J ALLERGY CLIN MMUNOL, (20120200), vol. 129, no. 2, XP055344284-
OPPOSITION- S. HAAG et al., "Comparison of the viscosity of three subcutaneous immunoglobulin brands (SCIG) Potential implications in clinical use", Xllth Meeting of the European Society for Immunodeficiences /ESID/, Budapest, Hungary, (20061004), XP055477361-
OPPOSITION- "Study synopsis Cinryze® (Cl esterase inhibitor [human]) Protocol 0624-200; Study Report DD0055", Viropharma Study Synopsis, (20110906), URL: http://www.shiretrials.com/-/media/files/clinical%20trials/clinicaltrialsen/clinical%20study%20repo rts/shire-0624-200-clinical-study-report-redact.pdf, XP055610808-
OPPOSITION- "Subcutaneous Cinryze with rHuPH20 produces positive effects in prevention of HAO", BMI Research, (20120306), XP055344292-
OPPOSITION- THE PHARMACEUTICS AND COMPOUNDING LABORATORY, "Subcutaneous", Internet Archive Wayback Machine, (20100614), URL: https://web.archive.org/web/20100614101520/http://pharmlabs.unc.edu/labs/parenterals/subcutaneous.htm, XP055477341-
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OPPOSITION- SOLA R.J. et al., "Effects of Glycosylation on the Stability of Protein Pharmaceuticals", J Pharm Sci., (20090000), vol. 98, no. 4, doi:10.1002/jps.21504, pages 1223 - 45, XP055057795
OPPOSITION- TOURANGEAU et al., "The New Era of C1-Esterase Inhibitor Deficiency Therapy", Curr. Allergy Asthma Rep, (20110000), vol. 11, doi:10.1007/s11882-011-0213-8, pages 345 - 351, XP019946943
OPPOSITION- Drouet C; Alibeu C; Ponard D; Arlaud G J; Colomb M G, "A sensitive method to assay blood complement C1 Inhibitor activity", Clinica Chimica Acta, (19880531), vol. 174, pages 121 - 130, XP023326231
OPPOSITION- Burckbuchler V; Mekhloufi G; Giteau A P; Grossiord J L; Huille S; Agnely F, "Rheological and syringeability properties of highly concentrated human polyclonal immunoglobulin solutions", European Journal of Pharmaceutics and Biopharmaceutics, (20100000), vol. 76, pages 351 - 356, XP027503458
OPPOSITION- VAN DOOM et al., "A phase I study of recombinant human C1 inhibitor in asymptomatic patients with hereditary angioedema", J. Allergy Cli. Immunol., (20050000), vol. 116, no. 4, doi:10.1016/j.jaci.2005.05.019, pages 876 - 883, XP005094482
OPPOSITION- ZURAW B.L. et al., "Phase II study results of a replacement therapy for hereditary angioedema with subcutaneous C1-inhibitor concentrate", Allergy, (20150000), vol. 70, pages 1319 - 1328, XP055610653
OPPOSITION- MARTINEZ-SAGUER et al., "Pharmacokinetics of plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the PASSION study : Subcutaneous Pharmacokinetics of C1-INH", Transfusion, (20140600), vol. 54, pages 1552 - 1561, XP055409488
OPPOSITION- ZURAW et al., "HAE Therapies : past present and future", Allergy, Asthma & Clinical Immunology, (20100000), vol. 6, doi:10.1186/1710-1492-6-23, page 23, XP021079204
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OTHER- CSL Behring, "CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase inhibitor in Patients with Hereditary Angioedema", (20120503), page 1, URL: http://www.cslbehring.com/news-room/Study-of-C1-INH-as-SubQ-Formulation, XP055344308-
OTHER- Csl Behring, "R&D Briefing", (20121206), pages 1 - 100, URL: https://www.yumpu.com/en/document/view/7586864/rampd-briefing-december-2012-cslcom, XP055344327-
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OTHER- MARTINEZ-SAGUER et al., "Abstract AB104: Pharmacokinetic Berinert P Study Of Subcutaneous Versus Intravenous Administration In Subjects With Moderate Hereditary Angioedema - The Passion Study", Journal of Allergy & Clinical Immunology, (20110200), vol. 127, XP055344297-
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OTHER- ViroPharma Incorporated, "ViroPharma Provides Update on Phase 2 Clinical Evaluation of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Recombinant Human Hyaluronidase (rHuPH20)", (20120801), pages 1 - 2, URL: http://www.prnewswire.com/news-releases/viropharma-provides-update-on-phase-2-clinical-evaluation-of-subcutaneous-cinryze-c1-esterase-inhibitor-human-with-recombinant-human-hyaluronidase-rhuph20-164636346.html, XP055344487-
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