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Use Of Migalostat In Reducing The Risk Of Cerebrovascular Event In Patients With Fabry Disease - EP3914247

The patent EP3914247 was granted to Amicus Therapeutics on Nov 13, 2024. The application was originally filed on Jan 22, 2020 under application number EP20708283A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3914247

AMICUS THERAPEUTICS
Application Number
EP20708283A
Filing Date
Jan 22, 2020
Status
Granted And Under Opposition
Oct 11, 2024
Publication Date
Nov 13, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (3)

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BRAND MURRAY FULLERAug 13, 2025BRAND MURRAY FULLERADMISSIBLE
SANDOZAug 13, 2025TER MEER STEINMEISTER & PARTNERADMISSIBLE
TEVA PHARMACEUTICALSAug 13, 2025D YOUNGADMISSIBLE

Patent Citations (8) New

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

Citation PhasePublication Number
DESCRIPTIONUS2010113517
DESCRIPTIONUS6274597
DESCRIPTIONUS6583158
DESCRIPTIONUS6589964
DESCRIPTIONUS6599919
DESCRIPTIONUS6916829
DESCRIPTIONUS7141582
DESCRIPTIONUS8592362

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 Text
DESCRIPTION- EL DIB R., PLoS One, (20170000), vol. 12, no. 3, page e0173358
DESCRIPTION- ISHII et al., Biochem. Biophys. Res. Comm., (19960000), vol. 220, pages 812 - 815
INTERNATIONAL-SEARCH-REPORT- RANIERI MICHELA ET AL, "Fabry Disease: Recognition, Diagnosis, and Treatment of Neurological Features", CURRENT TREATMENT OPTIONS IN NEUROLOGY, SPRINGER US, BOSTON, vol. 18, no. 7, doi:10.1007/S11940-016-0414-5, ISSN 1092-8480, (20160526), pages 1 - 18, (20160526), XP035989484 [Y] 1-41 * paragraphs: cerebrovascular involvment, and emerging therapies *
INTERNATIONAL-SEARCH-REPORT- SHENG SEN ET AL, "Fabry's disease and stroke: Effectiveness of enzyme replacement therapy (ERT) in stroke prevention, a review with meta-analysis", JOURNAL OF CLINICAL NEUROSCIENCE, (20190404), vol. 65, doi:10.1016/J.JOCN.2019.03.064, ISSN 0967-5868, pages 83 - 86, XP085707717 [YP] 1-41 * discussion *
INTERNATIONAL-SEARCH-REPORT- GERE SUNDER-PLASSMANN ET AL, "Migalastat for the treatment of Fabry disease", EXPERT OPINION ON ORPHAN DRUGS, (20180504), vol. 6, no. 5, doi:10.1080/21678707.2018.1469978, pages 301 - 309, XP055527565 [I] 1-41 * chapter 7. Clinical efficacy *
INTERNATIONAL-SEARCH-REPORT- DERRALYNN A HUGHES ET AL, "Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study", JOURNAL OF MEDICAL GENETICS, GB, (20161110), vol. 54, no. 4, doi:10.1136/jmedgenet-2016-104178, ISSN 0022-2593, pages 288 - 296, XP055690446 [I] 1-41 * discussion *
OPPOSITION- Amicus Therapeutics, "Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease - NCT02194985", Clinical Trials, clinicaltrials.gov, (20140717), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02194985?term=NCT02194985&rank=1&a=1, XP093306919
OPPOSITION- Amicus Therapeutics, "Open-Label Phase 3 Long-Term Safety Study of Migalastat (AT1001-041) - NCT01458119", Clinical Trials, clinicaltrials.gov, (20111020), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01458119?term=NCT01458119&rank=1&a=1, XP093306916
OPPOSITION- Anonymous, "Amicus Therapeutics Announces Approval of Galafold® (Migalastat) for Fabry Disease in Japan", Amicus Therapeutics, (20180323), Amicus Therapeutics, URL: https://ir.amicusrx.com/node/17336/pdf, XP093306922
OPPOSITION- Anonymous, "Assessment report Galafold", European Medicines Agency, (20160609), pages 1 - 110, URL: https://www.ema.europa.eu/en/documents/assessment-report/galafold-epar-public-assessment-report_en.pdf, (20211129), XP055867083
OPPOSITION- Anonymous, "Galafold 123 mg hard capsules ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS", EMA, (20160526), pages 1 - 50, URL: https://www.ema.europa.eu/en/documents/product-information/galafold-epar-product-information_en.pdf, (20190417), XP055582182
OPPOSITION- Anonymous, "MIGALASTAT (GALAFOLD) - Clinical Review Report", CADTH COMMON DRUG REVIEW, (20180201), CADTH COMMON DRUG REVIEW, URL: https://www.cda-amc.ca/sites/default/files/cdr/clinical/SR0522_Galafold_CL_Report.pdf, XP093298581
OPPOSITION- Anonymous, "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION - PrGALAFOLDTM - Migalastat Capsules 123 mg migalastat (as migalastat hydrochloride)", Canadian product monograph, (20170830), Canadian product monograph, URL: https://pdf.hres.ca/dpd_pm/00041104.PDF, XP093306930
OPPOSITION- Anonymous, "Report on the Deliberation Results (Galafold Capsules 123 mg)", Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau Ministry of Health, Labour and Welfare (Japan), (20180308), Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau Ministry of Health, Labour and Welfare (Japan), URL: https://www.pmda.go.jp/files/000233695.pdf, XP093306926
OPPOSITION- D18 - Union Register of medicinal products for Galafold®, accessed on 14 May 2025
OPPOSITION- D1 - Non-exhaustive selection of migalastat claims
OPPOSITION- D4a - NCT02194985 protocol - last amended in 2015
OPPOSITION- Galafold Anonymous, "PRESCRIBING INFORMATION GALAFOLD", (20180801), pages 1 - 29, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf, (20190424), XP055582812
OPPOSITION- Ranieri Michela; Bedini Gloria; Parati Eugenio Agostino; Bersano Anna, "Fabry Disease: Recognition, Diagnosis, and Treatment of Neurological Features", Current Treatment Options in Neurology, Springer US, New York, New York, (20160526), vol. 18, no. 7, doi:10.1007/s11940-016-0414-5, ISSN 1092-8480, pages 1 - 18, XP035694040
OPPOSITION- Markham Anthony, "Migalastat: First Global Approval", Drugs, Adis International, Auckland, Auckland, (20160701), vol. 76, no. 11, doi:10.1007/s40265-016-0607-y, ISSN 0012-6667, pages 1147 - 1152, XP093306920
OPPOSITION- Emma H. Mccafferty, Scott Lesley J., "Migalastat: A Review in Fabry Disease", Drugs, Adis International, Auckland, Auckland, (20190401), vol. 79, no. 5, doi:10.1007/s40265-019-01090-4, ISSN 0012-6667, pages 543 - 554, XP055723938
OPPOSITION- Wanner Christoph; Arad Michael; Baron Ralf; Burlina Alessandro; Elliott Perry M.; Feldt-Rasmussen Ulla; Fomin Victor V.; Germain Dominique P.; Hughes Derralynn A.; Jovanovic Ana; Kantola Ilkka; Linhart Aleš; Mignani Renzo; Monserrat Lorenzo; Namdar Mehdi; Nowak Albina; Oliveira João-Paulo; Ortiz Alberto; Pieroni Maurizio; Spada Marco; Tylki-Szymańska Anna; Tøndel Camilla; Viana-Baptista Miguel; Weidemann Frank; Hilz Max J., "European expert consensus statement on therapeutic goals in Fabry disease", Molecular Genetics and Metabolism, Academic Press, AMSTERDAM, NL, AMSTERDAM, NL , (20180612), vol. 124, no. 3, doi:10.1016/j.ymgme.2018.06.004, ISSN 1096-7192, pages 189 - 203, XP085420765
OPPOSITION- Fellgiebel, A. Muller, M.J. Ginsberg, L., "CNS manifestations of Fabry's disease", The Lancet Neurology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20060901), vol. 5, no. 9, doi:10.1016/S1474-4422(06)70548-8, ISSN 1474-4422, pages 791 - 795, XP005602788
OPPOSITION- Elfrida R. Benjamin, Maria Cecilia Della Valle, Xiaoyang Wu, Evan Katz, Farhana Pruthi, Sarah Bond, Benjamin Bronfin, Hadis Williams, Julie Yu, Daniel G. Bichet, Dominique P. Germain, Roberto Giugliani, Derralynn Hughes, Raphael Schiffmann, William R. Wilcox, Robert J. Desnick, John Kirk, Jay Barth, Carrolee Barlow, Kenneth J. Valenzano, Jeff Castelli, David J. Lockhart, "The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat", Genetics in Medicine, Nature Publishing Group US, New York, New York, (20170401), vol. 19, no. 4, doi:10.1038/gim.2016.122, ISSN 1098-3600, pages 430 - 438, XP055582063
OPPOSITION- Dominique P. Germain, Derralynn A. Hughes, Kathleen Nicholls, Daniel G. Bichet, Roberto Giugliani, William R. Wilcox, Claudio Feliciani, Suma P. Shankar, Fatih Ezgu, Hernan Amartino, Drago Bratkovic, Ulla Feldt-Rasmussen, Khan Nedd, Usama Sharaf El Din, Charles M. Lourenco, Maryam Banikazemi, Joel Charrow, Majed Dasouki, David Finegold, Pilar Giraldo, Ozlem Goker-Alpan, Nicola Longo, C. Ronald Scott, Roser Torra, Ahmad Tuffaha, Ana Jovanovic, Stephen Waldek, Seymour Packman, Elizabeth Ludington, Christopher Viereck, John Kirk, Julie Yu, Elfrida R. Benjamin, Franklin Johnson, David J. Lockhart, Nina Skuban, Jeff Castelli, Jay Barth, Carrolee Barlow, Raphael Schiffmann, "Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat", The new England journal of medicine, Eli Lily and Company, USA, USA, (20160811), vol. 375, no. 6, doi:10.1056/NEJMoa1510198, pages 545 - 555, XP055527557
OPPOSITION- Gere Sunder-Plassmann, Raphael Schiffmann, Kathleen Nicholls, "Migalastat for the treatment of Fabry disease", Expert Opinion on Orphan Drugs, (20180504), vol. 6, no. 5, doi:10.1080/21678707.2018.1469978, pages 301 - 309, XP055527565
OPPOSITION- Derralynn A Hughes, Kathleen Nicholls, Suma P Shankar, Gere Sunder-Plassmann, David Koeller, Khan Nedd, Gerard Vockley, Takashi Hamazaki, Robin Lachmann, Toya Ohashi, Iacopo Olivotto, Norio Sakai, Patrick Deegan, David Dimmock, François Eyskens, Dominique P Germain, Ozlem Goker-Alpan, Eric Hachulla, Ana Jovanovic, Charles M Lourenco, Ichiei Narita, Mark Thomas, William R Wilcox, Daniel G Bichet, Raphael Schiffmann, Elizabeth Ludington, Christopher Viereck, John Kirk, Julie Yu, Franklin Johnson, Pol Boudes, Elfrida R Benjamin, David J Lockhart, Carrolee Barlow, Nina Skuban, Jeffrey P Castelli, Jay Barth, Ulla Feldt-Rasmussen, "Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study", Journal of medical genetics, BMJ Publishing Group LTD, England, England, (20170401), vol. 54, no. 4, doi:10.1136/jmedgenet-2016-104178, ISSN 0022-2593, pages 288 - 296, XP055690446

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