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| OPPOSITION | - Anonymous, "An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma", Information about clinical study ''NCT01854047, (20140218), pages 1 - 35, XP055924563 |
| OPPOSITION | - Anonymous, "Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers", ClinicalTrials.gov; NCT01015027, (20130613), ClinicalTrials.gov; NCT01015027, URL: https://clinicaltrials.gov/study/NCT01015027?term=NCT01015027&rank=1&tab=history&a=7#version-content-panel, XP093231602 |
| OPPOSITION | - Anonymous, "Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects", ClinicalTrials.gov; NCT01537640, (20131205), ClinicalTrials.gov; NCT01537640, URL: https://clinicaltrials.gov/study/NCT01537640?term=NCT01537640&rank=1&tab=history&a=6#version-content-panel, XP093231620 |
| OPPOSITION | - Anonymous, "Dupilumab - ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS", EMEA, (20220901), XP093231635 |
| OPPOSITION | - Anonymous, "GLOBAL STRATEGY FOR ASTHMA MANAGEMENT AND PREVENTION ", Global Initiative for Asthma, (20120101), Global Initiative for Asthma, XP093196049 |
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| OPPOSITION | - Anonymous, "History of Changes for Study: NCT01312961 Efficacy, Safety, and Tolerability of SAR231893 (REGN668) in Patients With Persistent Moderate to Severe Eosinophilic Asthma", ClinicalTrials.gov; NCT01312961, (20140113), ClinicalTrials.gov; NCT01312961, URL: https://clinicaltrials.gov/study/NCT01312961?tab=history&a=36#version-content-panel, XP093231534 |
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| OPPOSITION | - Anonymous, "Monoclonal antibody appears effective and safe in asthma Phase IIa trial", Eurekalert, (20130521), XP055928713 |
| OPPOSITION | - Anonymous, "Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis", ClinicalTrials.gov; NCT01385657, (20130927), ClinicalTrials.gov; NCT01385657, URL: https://clinicaltrials.gov/study/NCT01385657?term=NCT01385657&rank=1&tab=history&a=4#version-content-panel, XP093231626 |
| OPPOSITION | - Anonymous, "Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects", ClinicalTrials.gov; NCT01537653, (20131205), ClinicalTrials.gov; NCT01537653, URL: https://clinicaltrials.gov/study/NCT01537653?term=NCT01537653&rank=1&tab=history&a=7#version-content-panel, XP093231613 |
| OPPOSITION | - Anonymous, "Sanofi and Regeneron Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Asthma", Press Release, (20141111), Press Release, URL: https://www.news.sanofi.us/Sanofi-and-Regeneron-Announce-Positive-Results-from-Phase-2b-Study-of-Dupilumab-in-Patients-with-Moderate-to-Severe-Asthma, (20220616), XP055932115 |
| OPPOSITION | - Anonymous, "Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis", ClinicalTrials.gov; NCT01259323, (20121002), ClinicalTrials.gov; NCT01259323, URL: https://clinicaltrials.gov/study/NCT01259323?term=NCT01259323%20&rank=1&tab=history&a=6#version-content-panel, XP093231622 |
| OPPOSITION | - Anonymous, "Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers", ClinicalTrials.gov; NCT01484600, (20120312), ClinicalTrials.gov; NCT01484600, URL: https://clinicaltrials.gov/study/NCT01484600?term=NCT01484600&rank=1&tab=history&a=2#version-content-panel, XP093231608 |
| OPPOSITION | - D59 - Opposition division 2024 Reasons for the decision in the parent patent (EP 15708991.3); dated 07. March 2024 |
| OPPOSITION | - D65 - List of approved antibodies until 2014 |
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| OPPOSITION | - Firszt, R. ; Kraft, M., "Pharmacotherapy of severe asthma", CURRENT OPINION IN PHARMACOLOGY, ELSEVIER SCIENCE PUBLISHERS,, NL, NL , (20100601), vol. 10, no. 3, ISSN 1471-4892, pages 266 - 271, XP027137700 |
| OPPOSITION | - Gibaldi Milo, "Biopharmaceutics and Clinical Pharmacokinetics (passage)", Gibaldi Milo, Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, 4th ed., (19910101), pages 12 - 13, XP055945117 |
| OPPOSITION | - Gina, "Global Strategy for Asthma Management and Prevention", Global Initiative on Asthma (GINA) Guidelines, (20110101), Global Initiative on Asthma (GINA) Guidelines, (20171025), XP055418987 |
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| OPPOSITION | - Greulich Timm, Haldar Pranab, Agbetile Josua, Bafadhel Mona, Brightling Christopher E, Wardlaw Andrew J, Pavord Ian D, "E5492: FENO and blood eosinophil count as surrogate barkers of eosinophilic airway inflammation in patients with severe asthma", Eur Respir J, (20100922), vol. 36, no. suppl. 54, page 1005s, XP093198745 |
| OPPOSITION | - Jennifer D Hamilton, Lisa A Beck, Haobo Ren, Eric Simpson, Ana Kostic, Jeffrey E Min, Usman Chaudry, Neil Graham And Allen Raden, "Biomarkers elevated in atopic dermatitis (AD) are reduced by therapeutic blockade of IL-4 receptor a (IL-4ralpha) signaling with dupilumab in patients with moderate-to-severe AD. abstract 1042", International Investigative Dermatology, Edinburgh, Edinburgh , (20110508), XP055566280 |
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| OPPOSITION | - Paris, Tarrytown, "SANOFI AND REGENERON ANNOUNCE PUBLICATION OF POSITIVE PHASE 2A RESULTS OF DUPILUMAB IN ASTHMA IN THE NEW ENGLAND JOURNAL OF MEDICINE", New England Journal of Medicine, (20130521), pages 1 - 3, XP055928700 |
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| OPPOSITION | - "Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis", 71st Annual Meeting of the American Academy of Dermatology, (20130302), pages 1 - 3, XP007922251 |
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| OPPOSITION | - Washburn W. Kenneth, Teperman Lewis W., Heffron Thomas G., Douglas David D., Gay Steven, Katz Eliezer, Klintmalm Goran B.G., "A novel three-dose regimen of daclizumab in liver transplant recipients with hepatitis C: A pharmacokinetic and pharmacodynamic study", Liver transplantation, Saunders Philadelphia , PA, US, US , (20060401), vol. 12, no. 4, doi:10.1002/lt.20631, ISSN 1527-6465, pages 585 - 591, XP093231685 |
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| OPPOSITION | - Wenzel Sally; Ford Linda; Pearlman David; Spector Sheldon; Sher Lawrence; Skobieranda Franck; Wang Lin; Kirkesseli Stephane; Rocklin Ross; Bock Brian; Hamilton Jennifer; Ming Jeffrey E; Radin Allen; Stahl Neil; Yancopoulos George D; Graham Neil; Pirozzi Gianluca, "Dupilumab in Persistent Asthma with Elevated Eosinophil Levels", The New England journal of medicine, Massachusetts Medical Society, US, US , (20130627), vol. 368, no. 26, doi:10.1056/NEJMoa1304048, ISSN 0028-4793, pages 2455 - 2466, XP008165248 |
| OPPOSITION | - Wenzel Sally, Ford Linda, Pearlman David, Spector Sheldon, Sher Lawrence, Skobieranda Franck, Wang Lin, Kirkesseli Stephane, Rocklin Ross, Bock Brian, Hamilton Jennifer, Ming Jeffrey E., Radin Allen, Stahl Neil, Yancopoulos George D., Graham Neil, Pirozzi Gianluca, "Protocol for: Dupilumab in persistent asthma with elevated eosinophil levels", The New England journal of medicine, Massachusetts Medical Society, US, US , (20130627), vol. 368, no. 26, doi:10.1056/NEJMoa1304048, ISSN 0028-4793, pages 1 - 288, XP093197891 |
| OPPOSITION | - Wenzel Sally, Ford Linda, Pearlman David, Spector Sheldon, Sher Lawrence, Skobieranda Franck, Wang Lin, Kirkesseli Stephane, Rocklin Ross, Bock Brian, Hamilton Jennifer, Ming Jeffrey E., Radin Allen, Stahl Neil, Yancopoulos George D., Graham Neil, Pirozzi Gianluca, "Supplement to: Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels.", The New England journal of medicine, Massachusetts Medical Society, US, US , (20130627), vol. 368, no. 26, doi:10.1056/NEJMoa1304048, ISSN 0028-4793, pages 1 - 41, XP093197887 |
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| OPPOSITION | - Bartosz Chmielowski, "Ipilimumab: A First-in-Class  T-Cell Potentiator for Metastatic Melanoma", Journal of Skin Cancer, (20130101), vol. 28, no. 4, doi:10.1155/2013/423829, ISSN 20902905, pages 1140 - 8, XP055201588 |
| OPPOSITION | - Tan Antoinette R., Moore Dirk F., Hidalgo Manuel, Doroshow James H., Poplin Elizabeth A., Goodin Susan, Mauro David, Rubin Eric H., "Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors", Clinical Cancer Research, Association for Cancer Research, US, US, (20061101), vol. 12, no. 21, doi:10.1158/1078-0432.CCR-06-0705, ISSN 1078-0432, pages 6517 - 6522, XP093231665 |
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| OPPOSITION | - Metzger-Filho Otto, Winer Eric P., Krop Ian, "Pertuzumab: Optimizing HER2 Blockade", Clinical Cancer Research, Association for Cancer Research, US, US, (20131015), vol. 19, no. 20, doi:10.1158/1078-0432.CCR-13-0518, ISSN 1078-0432, pages 5552 - 5556, XP093231674 |
| OPPOSITION | - Wenzel Sally, "Severe Asthma in Adults", American Thoracic Society 2020 International Conference; May 15-20, 2020, American Thoracic Society, (20050715), vol. 172, no. 2, doi:10.1164/rccm.200409-1181PP, ISSN 1073-449X, pages 149 - 160, XP055944998 |
| OPPOSITION | - J. Corren, W. Busse, E. O. Meltzer, L. Mansfield, G. Bensch, J. Fahrenholz, S. E. Wenzel, Y. Chon, M. Dunn, H. H. Weng, S. L. Lin, "A Randomized, Controlled, Phase 2 Study of AMG 317, an IL-4RÂ Antagonist, in Patients with Asthma", American Journal of Respiratory and Critical Care Medicine, (20100415), vol. 181, no. 8, doi:10.1164/rccm.200909-1448OC, ISSN 1073449X, pages 788 - 796, XP055013586 |
| OPPOSITION | - Borish Larry, "IL-4 and IL-13 Dual Antagonism : A Promising Approach to the Dilemma of Generating Effective Asthma Biotherapeutics", American Thoracic Society 2020 International Conference; May 15-20, 2020, American Thoracic Society, (20100415), vol. 181, no. 8, doi:10.1164/rccm.201002-0147ED, ISSN 1073-449X, pages 769 - 770, XP055944399 |
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