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Methods For Treating Or Preventing Asthma By Administering An Il-4R Antagonist - EP3107575

The patent EP3107575 was granted to Regeneron Pharmaceuticals on Sep 1, 2021. The application was originally filed on Feb 20, 2015 under application number EP15708991A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3107575

REGENERON PHARMACEUTICALS
Application Number
EP15708991A
Filing Date
Feb 20, 2015
Status
Granted And Under Opposition
Jul 30, 2021
Publication Date
Sep 1, 2021
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (4)

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NEUEFEINDJun 1, 2022MAIWALDADMISSIBLE
D YOUNGMay 25, 2022D YOUNGADMISSIBLE
DR H ULRICH DORRIESMay 4, 2022DORRIESADMISSIBLE
DR H ULRICH DORRIESMay 4, 2022DORRIES, HANS ULRICH , DF-MP DORRIES FRANK-MOLNIA & POHLMANADMISSIBLE

Patent Citations (6) New

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

Citation PhasePublication Number
OPPOSITIONEP14306413
OPPOSITIONNO19983141
OPPOSITIONWO2008054606
OPPOSITIONWO2012047954
OPPOSITIONWO2014031610
OPPOSITIONWO2015127229

Non-Patent Literature (NPL) Citations (39) 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
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, "Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma", Information about clinical study ''NCT01312961, (20140113), pages 1 - 17, Information about clinical study ''NCT01312961, (20220524), XP055924555
OPPOSITION- Anonymous, "Highlights of prescribing information", Symbicort- FDA Drug Label, (20120501), pages 1 - 43, XP055924529
OPPOSITION- Anonymous, "History of Changes for Study: NCT01854047 An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma", ClinicalTrials.gov, (20140203), pages 1 - 10, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT01854047?V_22=View#StudyPageTop, (20220608), XP055928704
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN) ", WHO Drug Information, (20120101), vol. 26, no. 4, pages 401 - 402, XP055928716
OPPOSITION- Anonymous, "Long-Term Safety Evaluation of Dupilumab in Patients With Asthma", Information about clinical study ''NCT02134028, (20150108), pages 1 - 25, XP055924568
OPPOSITION- Anonymous, "Monoclonal antibody appears effective and safe in asthma Phase IIa trial", Eurekalert, (20130521), XP055928713
OPPOSITION- Anonymous, "Warning : Asthma- related death, see full prescribing information for complete boxed warning", DULERA mometasone furoate and formoterol fumarate dihydrate acrosol- FDA Drug label, (20100601), pages 1 - 27, XP055924548
OPPOSITION- Aulton M. E., "Chapter 19: Dosage regimens", Pharmaceutics: The Science of Dosage Form Design. 2nd Ed., Churchill Livingstone, (20011225), pages 265 - 288, XP055880430
OPPOSITION- "Dupilumab", Heavy chain and Light chain amino acid sequences, URL: https://www.genome.jp/entry/D10354
OPPOSITION- Gina Teams, "The global strategy for asthma management and prevention", Global Initiative for Asthma, (20090101), Global Initiative for Asthma, (20181031), XP055520525
OPPOSITION- "History of Changes for Study: NCT01854047", (20140218), URL: https://clinicaltrials.gov/ct2/history/NCT01854047?V_23=View#StudyPageTop, XP055932163
OPPOSITION- "International Nonproprietary Names for Pharmaceutical Substances (INN), List 108", WHO Drug Information, (20120101), vol. 26, no. 4, pages 401 - 471, XP055932074
OPPOSITION- Milo Gibaldi, "Biopharmaceutics and Clinical Pharmacokinetics (passage)", Biopharmaceutics and Clinical Pharmacokinetics, fourth edition, Lea& Febiger , (19910101), page 12, ISBN 978-0-8121-1346-4, XP055408072
OPPOSITION- Nathan Teuscher, "What is a Loading Dose? | Certara", (20130322), URL: https://www.certara.com/knowledge-base/what-is-a-loading-dose/, XP055932172
OPPOSITION- NO19980003141
OPPOSITION- Other evidence - SUMMONS TO ORAL PROCEEDINGS RE EP3227454_
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
OPPOSITION- Radin et al., "Safety, Tolerability and Biomarker Results of a randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers", J. Allergy Clin. Immunol. (Abstracts), (20130201), page AB158, XP055932083
OPPOSITION- "Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis ", Regeneron® Press Release, (20140709), URL: https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-announce-positive-results-phase-2b-study, XP055932117
OPPOSITION- Rispens, Vidarsson, "Human IgG subclasses", Antibody Fc: Linking adaptive and Innate Immunity, chapter , Academic Press , (20131101), pages 159 - 194, ISBN 9780123948182, XP055192983
OPPOSITION- "Sanofi and Regeneron Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Asthma", Press Release, (20141111), 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, XP055932115
OPPOSITION- "Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine", Regeneron® Press Release, (20130521), pages 1 - 3, URL: https://newsroom.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-announce-publication-positive-phase-2a, XP055928700
OPPOSITION- "Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis", Regeneron® Press Release, (20130302), URL: https://newsroom.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data, XP055566341
OPPOSITION- Bice Jeffrey B.; Leechawengwongs Evelyn; Montanaro Anthony, "Biologic targeted therapy in allergic asthma", Annals of Allergy, Asthma, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20140124), vol. 112, no. 2, doi:10.1016/j.anai.2013.12.013, ISSN 1081-1206, pages 108 - 115, XP028815548
OPPOSITION- Wenzel et al., "Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial", The Lancet, AMSTERDAM, NL , (20160427), vol. 388, no. 10039, doi:10.1016/S0140-6736(16)30307-5, ISSN 0140-6736, pages 31 - 44, XP029627526
OPPOSITION- Wenzel Sally; Castro Mario; Corren Jonathan; Maspero Jorge; Wang Lin; Zhang Bingzhi; Pirozzi Gianluca; Sutherland E Rand; Evans Robert R; Joish Vijay N; Eckert Laurent; Graham Neil M H; Stahl Neil; Yancopoulos George D; Louis-Tisserand Mariana; Teper Ariel, "Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20160427), vol. 388, no. 10039, doi:10.1016/S0140-6736(16)30307-5, ISSN 0140-6736, pages 31 - 44, XP029627526
OPPOSITION- Wenzel et al., "Dupilumab in Persistent Asthma with Elevated Eosinophil Levels", The New England journal of medicine, 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, "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- Beck et al., "Dupilumab treatment in adults with moderate-to-severe atopic dermatitis.", New England Journal of Medicine, US , (20140710), vol. 371, no. 2, doi:10.1056/NEJMoa1314768, ISSN 1533-4406, pages 130 - 139, XP009180485
OPPOSITION- Castro Mario, Corren Jonathan, Pavord Ian, Maspero Jorge, Wenzel Sally, Rabe Klaus, Busse William, Ford Linda, Sher Lawrence, Fitzgerald, Katelaris Constance, Tohda Yuji, Zhang Bingzhi, Staudinger Heribert, Pirozzi Gianluca, Amin Nikhil, Ruddy Marcella, Akinlade Bolanle, Khan Asif, Chao Jingdong, Martincova Renata, Graham Neil M.H., Hamilton Jennifer, Swanson Brian, Stahl Neil, Yancopoulos George, Teper Ariel, "Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma", The New England journal of medicine, Massachusetts Medical Society, US, US , (20180628), vol. 378, no. 26, doi:10.1056/NEJMoa1804092, ISSN 0028-4793, pages 2486 - 2496, XP009510100
OPPOSITION- Panaccione Remo, Ghosh Subrata, "Review: Optimal use of biologics in the management of Crohn’s disease", Therapeutic Advances in Gastroenterology, (20100501), vol. 3, no. 3, doi:10.1177/1756283X09357579, ISSN 1756-2848, pages 179 - 189, XP055928707
OPPOSITION- BAMES P J, "SCIENTIFIC RATIONALE FOR INHALED COMBINATION THERAPY WITH LONG-ACTING BETA2-AGONISTS AND CORTICOSTEROIDS", EUROPEAN RESPIRATORY JOURNAL, European Respiratory Society, GB, GB , (20020101), vol. 19, no. 01, doi:10.1183/09031936.02.00283202, ISSN 0903-1936, pages 182 - 191, XP001088412
OPPOSITION- Brian Swanson et al., "Poster 1023: Dupilumab suppresses Th2 inflammation in adult asthma and atopic dermatitis", World Allergy Organization Journal, London, UK , (20140203), vol. 7, no. Suppl 1, doi:10.1186/1939-4551-7-S1-P13, ISSN 1939-4551, page P13, XP021176599
OPPOSITION- Katz et al., "Blood Eosinophil Count Is a Useful Biomarker to Identify Patients with Severe Eosinophilic Asthma", Annals of the American Thoracic Society, (20140501), vol. 11, no. 4, doi:10.1513/AnnalsATS.201310-354OC, ISSN 2329-6933, pages 531 - 536, XP055932152
OPPOSITION- Brusselle et al., "Targeting Immune Pathways for Therapy in Asthma and Chronic Obstructive Pulmonary Disease", Annals of the American Thoracic Society, (20141201), vol. 11, no. Supplement 5, doi:10.1513/AnnalsATS.201403-118AW, ISSN 2329-6933, pages S322 - S328, XP055932126
OPPOSITION- Jin Jing, Sklar Grant Edward, Min Sen Oh Vernon, Chuen Li Shu, "Factors affecting therapeutic compliance: A review from the patient's perspective", THERAPEUTICS AND CLINICAL RISK MANAGEMENT, DOVE MEDICAL PRESS LTD.,, NZ, NZ , (20080201), vol. 4, no. 1, doi:10.2147/TCRM.S1458, ISSN 1176-6336, pages 269 - 286, XP093139695
OPPOSITION- Liang et al., "Moderate Accuracy of Peripheral Eosinophil Count for Predicting Eosinophilic Phenotype in Steroid-Naïve Non-Atopic Adult Asthmatics", INTERNAL MEDICINE, JP , (20120101), vol. 51, no. 7, doi:10.2169/internalmedicine.51.6834, ISSN 0918-2918, pages 717 - 722, XP055932140
OPPOSITION- Possa et al., "Eosinophilic Inflammation in Allergic Asthma", Frontiers in Pharmacology, (20130417), vol. 4, doi:10.3389/fphar.2013.00046, pages 1 - 9, XP055932139

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