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METHODS FOR TREATING ATOPIC DERMATITIS BY ADMINISTERING AN IL-4R ANTAGONIST
Publication No.
EP4374919
•
App No.
EP24163612
•
Filed by
Regeneron Pharmaceuticals, Inc.
•
Filed on
2013-09-04
•
Issued/Published on
2025-10-29
Publication No.
EP4374919
A2
Application No.
EP24163612
Filed: 2013-09-04
Grant Date
2025-10-29
Mention of grant
Active Oppositions
8 Active
EPO Oppositions
Patent Abstract / Summary
The present invention provides methods for treating atopic dermatitis (AD). Also provided are methods for improving one or more AD-associated parameter(s), and methods for decreasing the level of at least one AD-associated biomarker in a subject in need thereof. The methods of the present invention comprise administering to a subject in need thereof a pharmaceutical composition comprising an interleukin-4 receptor (IL-4R) antagonist such as an anti-IL-4R antibody.
IPC Classifications
C07K16/28, A61P17/00
A61P17/00
Priority Claims
US 201261697972P
Date: 2012-09-07
US 201261738715P
Date: 2012-12-18
US 201361748588P
Date: 2013-01-03
US 201361764624P
Date: 2013-02-14
US 201361768229P
Date: 2013-02-22
US 201361770091P
Date: 2013-02-27
US 201361782420P
Date: 2013-03-14
US 201361816191P
Date: 2013-04-26
FR 20130056759
Date: 2013-07-10
Designated Contracting States (38 EPC States)
AL
AT
BE
BG
CH
CY
CZ
DE
DK
EE
ES
FI
FR
GB
GR
HR
HU
IE
IS
IT
LI
LT
LU
LV
MC
MK
MT
NL
NO
PL
PT
RO
RS
SE
SI
SK
SM
TR
Parties & Representation
Applicants
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road, Tarrytown, NY 10591
USSanofi Biotechnology
54 rue La Boétie, 75008 Paris
FRInventors (9)
ARDELEANU, Marius
White Plains, NY 10605
USGRAHAM, Neil
Croton-on-Hudson, NY 10520
USHAMILTON, Jennifer D
Hopewell Junction, NY 12533
USKIRKESSELI, Stephane C
75008 Paris
FRKUNDU, Sudeep
New York, NY 10022
USMING, Jeffrey
Bridgewater, NJ 08807
USRADIN, Allen
New York, NY 10128
USROCKLIN, Ross E
Basking Ridge, NJ 07920
USWEINSTEIN, Steven P
Hartsdale, NY 10530
USRepresentatives / Agents
Carpmaels & Ransford LLP
One Southampton Row, London WC1B 5HA
GBJ A Kemp LLP
80 Turnmill Street, London EC1M 5QU
GBMaiwald GmbH
Elisenhof, Elisenstraße 3
DEBoult Wade Tennant LLP
Salisbury Square House, 8 Salisbury Square
GBTer Meer und Partner mbB
Nymphenburger Str. 4, Zugang Dachauer Str. 63
DERückerl, Florian
Dehmel & Bettenhausen, Patentanwälte PartmbB
DEBrand Murray Fuller LLP
First Floor, 111 Wardour Street, London W1F 0UH
GBD Young & Co LLP
3 Noble Street, London EC2V 7BQ
GBTer Meer Steinmeister & Partner
Patentanwälte mbB, Nymphenburger Straße 4
DEKey Procedural Dates
Request-For-Examination
2024-10-16
Mention Of Grant Published
2025-10-29
First-Examination-Report-Despatched
2025-02-14
Patent Oppositions
Official opposition proceedings filed against European Patent EP4374919 under EPC Article 99.
#1
Opponent
Company
Neuefeind, Regina
Maiwald GmbH, DE
Representative
Maiwald GmbH
Filing
Date
Opposition in Progress
2026-07-28
#2
Opponent
Company
Boult Wade Tennant LLP
Salisbury Square House, GB
Representative
Boult Wade Tennant LLP
Filing
Date
Opposition in Progress
2026-07-28
#3
Opponent
Company
Luigi, Rumi
TER MEER und Partner mbB, DE
Representative
Ter Meer und Partner mbB
Filing
Date
Opposition in Progress
2026-07-29
#4
Opponent
Company
Storz, Ulrich
c/o Michalski Hüttermann Patentanwälte mbB, DE
Representative
—
Filing
Date
Opposition in Progress
2026-07-29
#5
Opponent
Company
Sandoz AG
Centralbahnstrasse 4, CH
Representative
Rückerl, Florian
Filing
Date
Opposition in Progress
2026-07-29
#6
Opponent
Company
Brand Murray Fuller LLP
First Floor, 111 Wardour Street, GB
Representative
Brand Murray Fuller LLP
Filing
Date
Opposition in Progress
2026-07-29
#7
Opponent
Company
Hampton Knowles Limited
3 Noble Street, GB
Representative
D Young & Co LLP
Filing
Date
Opposition in Progress
2026-07-29
#8
Opponent
Company
Luigi, Rumi
Ter Meer Steinmeister & Partner Patentanwälte mbB, DE
Representative
Ter Meer Steinmeister & Partner
Filing
Date
Opposition in Progress
2026-07-29
Legal Status & Event History
Official European Patent Office legal and procedural status changes recorded for this file.
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|---|---|---|---|
| 2024-05-29 | AC | DIVISIONAL APPLICATION: REFERENCE TO EARLIER APPLICATION | EP |
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Cited Patent Documents
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* the whole document *
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* abstract *
* figure 1 *
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* abstract *
* table 1 *
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- HAMILTON JENNIFER D, BECK LISA A, REN HAOBO, SIMPSON ERIC, KOSTIC ANA, MING JEFFREY E, CHAUDHRY USMAN, GRAHAM NEIL, RADIN ALLEN : "Biomarkers elevated in atopic dermatitis (AD) are reduced by therapeutic blockade of IL-4 receptor a (IL-4Ra) signaling with dupilumab in patients with moderate-to-severe AD", REGENERON PHARMACEUTICALS, 1 May 2013 (2013-05-01), pages 1 - 4, XP093257625
- D8 - Filing Receipts of all US priority applications detailing named applicants
- D9 - USPTO Pair recordal of assignments of all US priority applications from inventor/applicants to Regeneron, and Sanofi
- D10 - Assignment to Regeneron – reel/frame 030844/0484
- D11 - Assignment to Sanofi – reel/frame 030931/0570
- D12 - Assignment to Sanofi Biotechnology – reel/frame 037055/0414
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- CHARLES BANKHEAD: "IL-4 Antibody Tames Atopic Dermatitis", MEDPAGE TODAY, 3 March 2013 (2013-03-03), pages 1 - 3, XP055566311, Retrieved from the Internet <URL:https://www.medpagetodaY.com/meetingcoverage/aad/37636>
- A GARRIGA: "71st ANNUAL MEETING OF THE AMERICAN ACADEMY OF DERMATOLOGY (AAD)", DRUGS OF THE FUTURE, 1 March 2013 (2013-03-01) - 2013-03-05, pages 275 - 279, XP055566346
- ANONYMOUS: "REGENERON REPORTS FOURTH QUARTER AND FULL YEAR 2011 FINANCIAL AND OPERATING RESULTS", REGENERON, 13 February 2012 (2012-02-13), pages 1 - 8, XP093257995
- 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, 8 May 2011 (2011-05-08) - 2013-05-11, Edinburgh , XP055566280
- ANONYMOUS: "NCT01548404 Study of REGN668 in Adult Patients With Intrinsic Moderate-toSevere Atopic Dermatitis", CLINICALTRIALS.GOV, 7 March 2012 (2012-03-07), pages 1 - 7, XP055566321, Retrieved from the Internet <URL:https://clinicaltrials.gov/ct2/history/NCT01548404?A=1&B=1&C=merged>
- KOSTIC ANA, WEN ZHANG, ANTHONY DORE, BLERTA COOPEY, DOUGLAS MACDONALD, WEN FURY, CALVIN LIN, JENNIFER HAMILTON, BRENDAN CLASSON, N: "F.95. A Fully Human IL4Rα Antibody for Inhibition of IL-4/IL-13-driven Th2 Responses in Allergic Disease", CLINICAL IMMUNOLOGY, vol. 135, 1 January 2010 (2010-01-01), pages S105 - S106, XP093195577, DOI: 10.1016/j.clim.2010.03.317
- TRAN‐HOAI T. NGUYEN; THOMAS B. CASALE: "Immune modulation for treatment of allergic disease", IMMUNOLOGICAL REVIEWS, vol. 242, no. 1, 20 June 2011 (2011-06-20), US , pages 258 - 271, XP071455192, ISSN: 0105-2896, DOI: 10.1111/j.1600-065X.2011.01034.x
- TRAN-HOAI NGUYEN, JEFFREY R STOKES AND THOMAS B CASALE: "Future Forms of Immunotherapy and Immunomodulators in Allergic Disease", IMMUNOL ALLERGY CLIN N AM, 1 January 2011 (2011-01-01), pages 343 - 365, XP055566273, DOI: 10.1016/j.iac.2011.02.003
- ANONYMOUS: "A Phase 2a Study to Investigate the Effects of Repeated Administration of AeroDerm in Subjects With Atopic Eczema", CLINICALTRIALS.GOV, 13 May 2008 (2008-05-13), pages 1 - 6, XP055566335
- DIANE R. MOULD, BRUCE GREEN: "Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies", BIODRUGS, vol. 24, no. 1, 1 February 2010 (2010-02-01), pages 23 - 39, XP009514743, ISSN: 1173-8804, DOI: 10.2165/11530560-000000000-00000
- NATHANAEL L. DIRKS & BERND MEIBOHM: "Population Pharmacokinetics of Therapeutic Monoclonal Antibodies", CLINICAL PHARMACOKINETICS, vol. 49, no. 10, 1 January 2010 (2010-01-01), AU, pages 633 - 659, XP009558689, ISSN: 0312-5963
- "Allergy", 1 January 2012, ELSEVIER , ISBN: 978-0-7234-3658-4, article WERFEL THOMAS, KAPP ALEXANDER: "Atopic dermatitis and allergic contact dermatitis", pages: 263 - 286, XP093235762, DOI: 10.1016/C2009-0-46113-0
- D37 - Form PCT/IB/306 dated 12 November 2014
- "Pharmaceutics: The Science of Dosage Form Design", 1 October 2001, CHURCHILL LIVINGSTONE , article M.E. AULTON: "Chapter 19: Dosage regimes", pages: 275 - 278, XP055404622
- ANONYMOUS: "Study to Assess the Safety of REGN668 (SAR231893) Administered Concomitantly With Topical Corticostroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)", CLINICALTRIALS.ORG, 11 July 2012 (2012-07-11), pages 1 - 6, XP055566394, Retrieved from the Internet <URL:https://clinicaltrials.gov/ct2/history INCTO 1639040?A=1&B=1&C=merged>
- WOLLENBERG A., BARBAROT S., BIEBER T., CHRISTEN‐ZAECH S., DELEURAN M., FINK‐WAGNER A., GIELER U., GIROLOMONI G., LAU S., MURARO A.: "Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I", JEADV , THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, vol. 32, no. 5, 1 May 2018 (2018-05-01), NL , pages 657 - 682, XP093422775, ISSN: 0926-9959, DOI: 10.1111/jdv.14891
- ANONYMOUS: "DUPIXENT® (dupilumab) injection, for subcutaneous use - Highlights of prescribing information", FDA, 1 May 2022 (2022-05-01), XP093257079
- JOOST, TH.V. ; KOZEL, M.M.A. ; TANK, B. ; TROOST, R. ; PRENS, E.P.: "Cyclosporine in atopic dermatitis:Modulation in the expression of immunologic markers in lesional skin", JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, vol. 27, no. 6, 1 December 1992 (1992-12-01), US, pages 922 - 928, XP023982703, ISSN: 0190-9622, DOI: 10.1016/0190-9622(92)70288-Q
- ANONYMOUS: "Record History | ver. 1: 2012-03-07 | NCT01548404 | ClinicalTrials.gov", XP093183339, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01548404?cond=moderate-to-severe%20atopic%20dermatitis&intr=REGN668&rank=3&tab=history&a=1#version-content-panel>
- ANONYMOUS: "Study of Dupilumab in Adult patients With Extrinsic Moderate-toSevere Atopic Dermatitis", CLINICALTRIALS.GOV, 27 August 2015 (2015-08-27), pages 1 - 8, XP055566332, Retrieved from the Internet <URL:https://clinicaltrials.gov/ct2/show/NCT01548404?term=NCT01548404&rank=1>
- "British Society for Allergy and Clinical Immunology Abstracts of the 2013 Annual Meeting", CLINICAL & EXPERIMENTAL ALLERGY, vol. 43, no. 12, 22 November 2013 (2013-11-22), UK , pages 1428 - 1472, XP071887523, ISSN: 0954-7894, DOI: 10.1111/cea.12197
- D49a - BSACI 2013 confirming news report 8–10 July 2013
- RADIN ALLEN, HAOBO REN, PAMELA PAPINO-WOOD, USMAN CHAUDRY, JENNIFER D. HAMILTON: "558 First-in-Human Study of REGN668/SAR231893 (IL-4Ra mAb): Safety, Tolerability and Biomarker Results of a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers", J ALLERGY CLIN IMMUNOL, vol. 131, no. 2, 1 February 2013 (2013-02-01), pages AB158, XP093257087, DOI: 10.1016/j.jaci.2012.12.1224
- REGENERON PHARMACEUTICALS: "Study Results NCT01548404 - Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis", HTTPS://CLINICALTRIALS.GOV, 10 August 2018 (2018-08-10), pages 1 - 10, XP093422792, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01548404?cond=regn668&viewType=Card&rank=10&tab=results>
- ONG PECK Y., BOGUNIEWICZ MARK: "Investigational and Unproven Therapies in Atopic Dermatitis", IMMUNOLOGY AND ALLERGY CLINICS OF NORTH AMERICA, ELSEVIER INC, UNITED STATES, vol. 30, no. 3, 1 August 2010 (2010-08-01), United States, pages 425 - 439, XP009568161, ISSN: 0889-8561, DOI: 10.1016/j.iac.2010.05.002
* pp. 425-439 *
- REGENERON PHARMACEUTICALS: "Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis - NCT01385657", CLINICAL TRIALS, CLINICALTRIALS.GOV, 10 April 2012 (2012-04-10), XP093258214, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01385657?term=NCT01385657&rank=1&tab=history&a=3#version-content-panel>
- REGENERON PHARMACEUTICALS: "Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis - NCT01259323", HTTPS://CLINICALTRIALS.GOV, CLINICAL TRIALS, 31 May 2012 (2012-05-31), pages 1 - 5, XP093422799, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01259323?term=NCT01259323&viewType=Card&rank=1&tab=history&a=5#version-content-panel>
- ARKWRIGHT PETER D., MOTALA CASSIM, SUBRAMANIAN HAMSA, SPERGEL JONATHAN, SCHNEIDER LYNDA C., WOLLENBERG ANDREAS: "Management of Difficult-to-Treat Atopic Dermatitis", THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, vol. 1, no. 2, 1 March 2013 (2013-03-01), NL , pages 142 - 151, XP093283582, ISSN: 2213-2198, DOI: 10.1016/j.jaip.2012.09.002
- T. MORIOKA; K. YAMANAKA; H. MORI; Y. OMOTO; K. TOKIME; M. KAKEDA; I. KUROKAWA; E.C. GABAZZA; A. TSUBURA; Y. YASUTOMI; H. MIZUTANI: "IL‐4/IL‐13 antagonist DNA vaccination successfully suppresses Th2 type chronic dermatitis", BRITISH JOURNAL OF DERMATOLOGY, vol. 160, no. 6, 13 March 2009 (2009-03-13), pages 1172 - 1179, XP071109316, DOI: 10.1111/j.1365-2133.2009.09069.x
- T. BIEBER; M. CORK; S. REITAMO: "Atopic dermatitis: a candidate for disease‐modifying strategy", ALLERGY, vol. 67, no. 8, 4 June 2012 (2012-06-04), UK, pages 969 - 975, XP071461652, ISSN: 0105-4538, DOI: 10.1111/j.1398-9995.2012.02845.x
- D58 - Sequence listing of WO 2010/053751 A1
- FRANKEL HILLARY C., QURESHI ABRAR A.: "Comparative Effectiveness of Topical Calcineurin Inhibitors in Adult Patients with Atopic Dermatitis : ", AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, vol. 13, no. 2, 1 April 2012 (2012-04-01), Singapore, pages 113 - 123, XP093183267, ISSN: 1175-0561, DOI: 10.2165/11597780-000000000-00000
- ANONYMOUS: "STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL - Dupilumab", HTTPS://SEARCHUSAN.AMA-ASSN.ORG, US, 1 January 2012 (2012-01-01), US, pages 1 - 1, XP093422804, Retrieved from the Internet <URL:https://searchusan.ama-assn.org/usan/documentDownload?uri=/unstructured/binary/usan/dupilumab.pdf>
- D60a - Search result showing publication year 2012 for Dupilumab
- D60b - PDF metadata extracted from D60 (“Create date” highlighting added)
- D60c - Information about USAN coucnil
- D60d - D60 revision summary – prepared by Claude Opus 4.8 in response to the prompt: “Can you determine the edit history of the document [i.e. D10]?”
- D61 - Patentee’s letter from examination dated 16 October 2024
- LIN Y T, WANG C T, CHIANG B L: "Role of bacterial pathogens in atopic dermatitis.", CLINICAL REVIEWS IN ALLERGY AND IMMUNOLOGY, vol. 33, no. 3, 1 December 2007 (2007-12-01), US , pages 167 - 177, XP002739302, ISSN: 1080-0549, DOI: 10.1007/s12016-007-0044-5
- "Dose Finding in Drug Development", 1 January 2006, SPRINGER, ISBN: 978-0-387-29074-4, article MARLENE MODI: "Dose-Finding Studies in Phase 1
and Estimation of Maximally Tolerated
Dose", pages: 30 - 48, XP009559022
- PANACCIONE REMO, GHOSH SUBRATA: "Review: Optimal use of biologics in the management of Crohn’s disease", THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, vol. 3, no. 3, 1 May 2010 (2010-05-01), pages 179 - 189, XP055928707, ISSN: 1756-2848, DOI: 10.1177/1756283X09357579
- D65 - Applicant’s letter dated 9 December 2011 from EP09744292.5
- REGENERON PHARMACEUTICALS: "Regeneron Reports First Quarter 2011 Financial and Operating Results", HTTPS://NEWSROOM.REGENERON.COM, REGENERON PHARMACEUTICALS INC., 3 May 2011 (2011-05-03), pages 1 - 5, XP093422824, Retrieved from the Internet <URL:https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-reports-first-quarter-2011-financial-and-operating>
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Official File Inspection
EPC Art. 128 Public Dossier
Complete European Patent Register Dossier (148 Total Documents)
The full inspection file for Application EP24163612 contains 148 total documents, including all notices of opposition, proprietor counter-statements, examination communications, third-party observations, and procedural forms. Below are all major recorded procedural filings and publication specifications.
Recorded Filings & Patent Specifications
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European Patent Specification - Granted Patent (B1)
Publication Specification
Date: 2025-10-29
Procedure: Grant
EP4374919B1
Official European Patent Register Full Dossier
Publication Specification
Date: 2025-10-29
Procedure: All Proceedings (Examination & Opposition)
EP24163612
European Search Report (A3)
Publication Specification
Date: 2024-08-21
Procedure: Publication
EP4374919A3
European Patent Application without Search Report (A2)
Publication Specification
Date: 2024-05-29
Procedure: Publication
EP4374919A2
Change: Communication of a notice of opposition and request to file observations + time limit
Dossier Filing
Date: 2026-10-06
Procedure: Opposition
EPIDOSCOBS2
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0009299OPPO
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Dossier Filing
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0009250
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0009250
Opposition filed
Dossier Filing
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0009260
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Procedure: Examination
RFEE
Language of the procedure
Procedural Step
Procedure: Examination
PROL
International searching authority
Procedural Step
Procedure: Examination
ISAT