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Predicting Outcome Of Treatment With An Anti- 4 7 Integrin Antibody - EP3237004

The patent EP3237004 was granted to Millennium Pharmaceuticals on May 8, 2024. The application was originally filed on Dec 23, 2015 under application number EP15873834A. The patent is currently recorded with a legal status of "Revoked".

EP3237004

MILLENNIUM PHARMACEUTICALS
Application Number
EP15873834A
Filing Date
Dec 23, 2015
Status
Revoked
Aug 15, 2025
Grant Date
May 8, 2024
External Links
Slate, Register, Google Patents

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POLPHARMA BIOLOGICSFeb 7, 2025SIMMONS & SIMMONS MUNICHADMISSIBLE

Patent Citations (13) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2005095238
DESCRIPTIONUS2012282249
DESCRIPTIONUS2014120084
DESCRIPTIONUS4816567
DESCRIPTIONUS6197582
DESCRIPTIONUS7803904
DESCRIPTIONWO2012135589
DESCRIPTIONWO2012151247
DESCRIPTIONWO2012151248
DESCRIPTIONWO9624673
INTERNATIONAL-SEARCH-REPORTUS2014120084
SEARCHUS2012282249
SEARCHWO2012135589

Non-Patent Literature (NPL) Citations (27) 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- ADEDIGBO A FASANMADE ET AL, "Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis", EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, SPRINGER, BERLIN, DE, (20090916), vol. 65, no. 12, doi:10.1007/S00228-009-0718-4, ISSN 1432-1041, pages 1211 - 1228, XP019756991
EXAMINATION- SHIVASHANKAR RAINA ET AL, "Effect of Serum Albumin Levels on Efficacy of Vedolizumab in Patients with Crohn's Disease", GASTROENTEROLOGY, ELSEVIER INC, US, (20170422), doi:10.1016/S0016-5085(17)31593-7, ISSN 0016-5085, XP085106026
EXAMINATION- I Ordás ET AL, "Anti-TNF Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetics-Based Dosing Paradigms", Clinical Pharmacology and Therapeutics, US, (20120222), vol. 91, no. 4, doi:10.1038/clpt.2011.328, ISSN 0009-9236, pages 635 - 646, XP055513916
EXAMINATION- OSTERMAN MARK T. ET AL, "Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation", ALIMENTARY PHARMACOLOGY & THERAPEUTICS, GB, vol. 49, no. 4, doi:10.1111/apt.15113, ISSN 0269-2813, (20190120), pages 408 - 418, URL: https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fapt.15113, XP093022588
EXAMINATION- FASANMADE A A ET AL, "Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis", BIOSIS, BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US, (201005), Database accession no. PREV201000378050, XP093030385
EXAMINATION- FASANMADE A A ET AL, "Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis", INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, (201005), vol. 48, no. 5, pages 297 - 308, XP093030385
OPPOSITION- Anonymous, "CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125476Orig1s000 PHARMACOLOGY REVIEW(S) - Vedolizumab (Entyvio® ,MLN0002) ", FDA, FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000PharmR.pdf, XP093261605-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - ENTYVIO (vedolizumab) for injection, for intravenous use ", FDA, vol. 25, no. 2, doi:10.1093/mutage/gep048, pages 113 - 123, FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf, XP093261603-
OPPOSITION- Anonymous, "Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis - NCT01177228", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01177228?term=NCT01177228&rank=1&tab=history&a=6#version-content-panel, XP093261595-
OPPOSITION- Anonymous, "Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III) - NCT01224171", Clinical Trials, ClinicalTrials.gov, vol. 32, no. 3, doi:10.7171/jbt.21-3203-007, pages 121 - 133, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01224171?term=NCT01224171&rank=1&tab=history&a=21#version-content-panel, XP093261599-
OPPOSITION- Anonymous, "Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis (GEMINI I) - NCT00783718", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT00783718?term=NCT00783718&rank=1&tab=history&a=26#version-content-panel, XP093261596-
OPPOSITION- Mcknight Whitney, "Faster clearance of vedolizumab associated with less mucosal healing in UC", GI & Hepatology News, GI & Hepatology News, URL: https://www.mdedge9-ma1.mdedge.com/gihepnews/article/89441/gastroenterology/faster-clearance-vedolizumab-associated-less-mucosal, XP093261513-
OPPOSITION- Nathanael L. Dirks & Bernd Meibohm, "Population Pharmacokinetics of Therapeutic Monoclonal Antibodies", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20100101), vol. 49, no. 10, ISSN 0312-5963, pages 633 - 659, XP009558689-
OPPOSITION- Sipponen Taina, Nuutinen Hannu, Turunen Ulla, Färkkilä Martti, "Endoscopic evaluation of Crohnʼs disease activity : Comparison of the CDEIS and the SES-CD", HHS PUBLIC ACCESS AUTHOR MANUSCRIPT, Lippincott Williams & Wilkins, US, US , (20101201), vol. 16, no. 12, doi:10.1002/ibd.21300, ISSN 1078-0998, pages 2131 - 2136, XP093261588
OPPOSITION- Rimola Jordi, Ordás Ingrid, Rodriguez Sonia, García-Bosch Orlando, Aceituno Montserrat, Llach Josep, Ayuso Carmen, Ricart Elena, Panés Julián, "Magnetic resonance imaging for evaluation of Crohnʼs disease : Validation of parameters of severity and quantitative index of activity", HHS PUBLIC ACCESS AUTHOR MANUSCRIPT, Lippincott Williams & Wilkins, US, US , (20110801), vol. 17, no. 8, doi:10.1002/ibd.21551, ISSN 1078-0998, pages 1759 - 1768, XP093261592
OPPOSITION- Adedigbo A. Fasanmade ; Omoniyi J. Adedokun ; Joyce Ford ; Danika Hernandez ; Jewel Johanns ; Chuanpu Hu ; Hugh M. Davis ; Honghui Zhou, "Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis", European Journal of Clinical Pharmacology, Springer, Berlin, DE, Berlin, DE , (20090916), vol. 65, no. 12, doi:10.1007/s00228-009-0718-4, ISSN 1432-1041, pages 1211 - 1228, XP019756991
OPPOSITION- Poole Raewyn M, "Vedolizumab: First Global Approval", Drugs, Adis International Ltd., NZ, NZ , (20140701), vol. 74, no. 11, doi:10.1007/s40265-014-0253-1, ISSN 0012-6667, pages 1293 - 1303, XP009188756
OPPOSITION- I Ordás, D R Mould, B G Feagan, W J Sandborn, "Anti-TNF Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetics-Based Dosing Paradigms", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20120401), vol. 91, no. 4, doi:10.1038/clpt.2011.328, ISSN 0009-9236, pages 635 - 646, XP055513916
OPPOSITION- Sandborn William J, "The future of inflammatory bowel disease therapy: where do we go from here?", Digestive Diseases: clinical reviews, S. Karger AG, CH, CH , (20120101), vol. 30, no. suppl. 3, doi:10.1159/000342742, ISSN 0257-2753, pages 140 - 144, XP009171799
OPPOSITION- Keizer Ron J; Huitema Alwin D R; Schellens Jan H M; Beijnen Jos H, "Clinical pharmacokinetics of therapeutic monoclonal antibodies.", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20100801), vol. 49, no. 8, doi:10.2165/11531280-000000000-00000, ISSN 0312-5963, pages 493 - 507, XP008153881
OPPOSITION- Ole Haagen Nielsen, "New Strategies for Treatment of Inflammatory Bowel Disease", Frontiers in Medicine, vol. 1, doi:10.3389/fmed.2014.00003, XP055172824
OPPOSITION- Fasanmade A.A., Adedokun O.J., Olson A., Strauss R., Davis H.M., "Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis", INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS., DUSTRI-VERLAG, DEISENHOFEN-MUENCHEN., DE, DE , (20100501), vol. 48, no. 05, doi:10.5414/CPP48297, ISSN 0946-1965, pages 297 - 308, XP093030385
SEARCH- "ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS", (20140616), URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002782/WC500168528.pdf, (20160229), XP055253845 [X] 1,2,4,7-9,12 * page 2 - page 3; table 4 * * page 14, paragraph 2 - page 15 * * page 30 * [I] 3,5,6,10,11,13-15-
SEARCH- PARIKH ASIT ET AL, "Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study", INFLAMMATORY BOWEL DISEASES, JOHN WILEY & SONS, INC, UNITED STATES, vol. 18, no. 8, doi:10.1002/IBD.21896, ISSN 1536-4844, (20120731), pages 1470 - 1479, (20111206), XP009500394 [X] 1,2,4,7-9,12 * page 1473 - page 1478 * [I] 3,5,6,10,11,13-15
SEARCH- ROSARIO M ET AL, "DOP058 Pharmacokinetic and pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: Additional results from the GEMINI 1 and 2 studies", JOURNAL OF CROHN'S AND COLITIS, (20140201), vol. 8, doi:10.1016/S1873-9946(14)60083-0, ISSN 1873-9946, XP028617347 [X] 1,2,4,7-9,12 * page s42, column 2 - page s43, column 1 * [I] 3,5,6,10,11,13-15
SEARCH- ROSARIO M ET AL, "P489 Exposure-response relationship during vedolizumab induction therapy in adults with ulcerative colitis", JOURNAL OF CROHN'S AND COLITIS, (20140201), vol. 8, doi:10.1016/S1873-9946(14)60609-7, ISSN 1873-9946, XP028618082 [X] 1,2,4,7-9,12 * S270, P488 * [I] 3,5,6,10,11,13-15
SEARCH- BRUCE E. SANDS ET AL, "Effects of Vedolizumab Induction Therapy for Patients With Crohn's Disease in Whom Tumor Necrosis Factor Antagonist Treatment Failed", GASTROENTEROLOGY, US, (20140901), vol. 147, no. 3, doi:10.1053/j.gastro.2014.05.008, ISSN 0016-5085, pages 618 - 627.e3, XP055253426 [X] 1,2,4,7-9,12 * page 618, column 1 - page 624, column 2 * [I] 3,5,6,10,11,13-15

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