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Methods Of Treating Fabry Disease In Patients Having A Mutation In The Gla Gene - EP4114390

The patent EP4114390 was granted to Amicus Therapeutics on Dec 4, 2024. The application was originally filed on Mar 5, 2021 under application number EP21715035A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4114390

AMICUS THERAPEUTICS
Application Number
EP21715035A
Filing Date
Mar 5, 2021
Status
Granted And Under Opposition
Nov 1, 2024
Grant Date
Dec 4, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (2)

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TEVA PHARMACEUTICALSSep 4, 2025ADMISSIBLE
BRAND MURRAY FULLERSep 3, 2025ADMISSIBLE

Patent Citations (9) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2010113517
DESCRIPTIONUS6274597
DESCRIPTIONUS6583158
DESCRIPTIONUS6589964
DESCRIPTIONUS6599919
DESCRIPTIONUS6916829
DESCRIPTIONUS7141582
DESCRIPTIONUS8592362
INTERNATIONAL-SEARCH-REPORTWO2009102895

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
DESCRIPTION- "GenBank", Database accession no. X14448.1-
DESCRIPTION- ISHII et al., Biochem. Biophys. Res. Comm., (19960000), vol. 220, pages 812 - 815-
INTERNATIONAL-SEARCH-REPORT[ ] - E R BENJAMIN, "The Validation of Pharmacogenetics for the Identification of Fabry Patients for Treatment with Migalastat Supplementary Information", GENETICS IN MEDICINE, (20160922), vol. 19, no. 4, pages S1 - S95, XP055582559 [ ] * figure 1S *-
INTERNATIONAL-SEARCH-REPORT- Galafold Anonymous, "PRESCRIBING INFORMATION GALAFOLD", (20180801), pages 1 - 29, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf, (20190424), XP055582812 [I] 1-93 * abstract * * table 2 *-
INTERNATIONAL-SEARCH-REPORT- EMMA H. MCCAFFERTY ET AL, "Migalastat: A Review in Fabry Disease", DRUGS, NZ, (20190401), vol. 79, no. 5, doi:10.1007/s40265-019-01090-4, ISSN 0012-6667, pages 543 - 554, XP055723938 [A] 1-93 * the whole document *
INTERNATIONAL-SEARCH-REPORT- SUSAN OOMMEN ET AL, "Inter-assay variability influences migalastat amenability assessments among Fabry disease variants", MOLECULAR GENETICS AND METABOLISM, AMSTERDAM, NL, (20190501), vol. 127, no. 1, doi:10.1016/j.ymgme.2019.04.005, ISSN 1096-7192, pages 74 - 85, XP055747129 [A] 1-93 * abstract * * table 1 *
INTERNATIONAL-SEARCH-REPORT- ELFRIDA R. BENJAMIN ET AL, "The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat", GENETICS IN MEDICINE, US, (20160922), vol. 19, no. 4, doi:10.1038/gim.2016.122, ISSN 1098-3600, pages 430 - 438, XP055582063 [I] 1-93 * abstract * * 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 [A] 1-93 * abstract *
INTERNATIONAL-SEARCH-REPORT- SHIN S H ET AL, "Prediction of response of mutated alpha-galactosidase A to a pharmacological chaperone", PHARMACOGENETICS AND GENOMICS, LIPPINCOTT WILLIAMS & WILKINS, PHILADELPHIA, PA, US, (20080901), vol. 18, no. 9, doi:10.1097/FPC.0B013E32830500F4, ISSN 1744-6872, pages 773 - 780, XP002566495 [I] 1-93 * abstract * * table 1 *
OPPOSITION- Anonymous, "Amicus Therapeutics Announces European Commission Approval for Galafold™ (Migalastat) in Patients with Fabry Disease in European Union", Amicus Therapeutics, (20160531), Amicus Therapeutics, URL: https://ir.amicusrx.com/static-files/2bbf5f00-8e17-43e5-ad99-4d680c7c4388, XP093272419-
OPPOSITION- Anonymous, "Amicus Therapeutics Launches Galafold® (Migalastat) for Fabry Disease in Japan", Amicus Therapeutics, (20180530), Amicus Therapeutics, URL: https://ir.amicusrx.com/node/17466/pdf, XP093272423-
OPPOSITION- Anonymous, "Amicus Therapeutics Launches Galafold™ (Migalastat) for Treatment of Fabry Disease in Spain", Amicus Therapeutics, (20180117), Amicus Therapeutics, URL: https://ir.amicusrx.com/node/17096/pdf, XP093272422-
OPPOSITION- Anonymous, "Amicus Therapeutics Launches Galafold™ (Migalastat) for Treatment of Fabry Disease in the United Kingdom", Amicus Therapeutics, (20170227), Amicus Therapeutics, URL: https://ir.amicusrx.com/static-files/d740450f-392e-4433-bea4-0387e8d1dd95, XP093272420-
OPPOSITION- Anonymous, "Assessment report Galafold - Procedure No. EMEA/H/C/004059/0000", European Medicines Agency, (20160609), pages 1 - 110, (20211129), XP055867090-
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, "HIGHLIGHTS OF PRESCRIBING INFORMATION - GALAFOLD™ (migalastat) capsules, for oral use ", FDA, (20180801), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf, XP093272415-
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- Benjamin Elfrida R., 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, "Supplementary Information - The Validation of Pharmacogenetics for the Identification of Fabry Patients for Treatment with Migalastat ", Genetics in Medicine, Nature Publishing Group US, New York, (20160101), XP093198257-
OPPOSITION- D12 - Union Register of medicinal products for Galafold®, accessed on 14 May 2025-
OPPOSITION- D1 - Non-exhaustive selection of migalastat claims-
OPPOSITION- D6a - Evidence of the online publication date of D6-
OPPOSITION- Winchester Bryan, Elisabeth Young, "Chapter 18 - Biochemical and genetic diagnosis of Fabry disease", Fabry Disease: Perspectives from 5 Years of FOS, Oxford PharmaGenesis, (20060101), XP093272425-
OPPOSITION- Sawada Takaaki, Kido Jun, Yoshida Shinichiro, Sugawara Keishin, Momosaki Ken, Inoue Takahito, Tajima Go, Sawada Hirotake, Mastumoto Shirou, Endo Fumio, Hirose Shinichi, Nakamura Kimitoshi, "Newborn screening for Fabry disease in the western region of Japan", Molecular Genetics and Metabolism Reports, Elsevier, (20200301), vol. 22, doi:10.1016/j.ymgmr.2019.100562, ISSN 2214-4269, page 100562, XP093313208
OPPOSITION- Benjamin et al., "The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat", Genetics in Medicine, (2017), vol. 19, doi:10.1038/gim.2016.122, page 4, XP055582063
OPPOSITION- Carvalho silva Daniela marisa, Marques Nuno, Azevedo Olga, Miltenberger-Miltenyi Gabriel, Bento Dina, Guedes João, Azevedo Pedro, Bispo João, Mota Teresa, Fernandes Raquel, Nzwalo Hipólito, Cabrita Ana, Ramos André, De jesus Ilídio, "p.G360R Is a Pathogenic GLA Gene Mutation Responsible for a Classic Phenotype of Fabry Disease", CARDIOLOGY., KARGER, BASEL., CH, CH , (20190101), vol. 144, no. 3-4, doi:10.1159/000502437, ISSN 0008-6312, pages 125 - 130, XP093313213
OPPOSITION- Chong Yosep, Kim Minyoung, Koh Eun Sil, Shin Seok Joon, Kim Ho-Shik, Chung Sungjin, "Identification of a novel GLA mutation (Y88C) in a Korean family with Fabry nephropathy: a case report", BMC MEDICAL GENETICS, BIOMED CENTRAL, LONDON, GB, GB , (20161201), vol. 17, no. 1, doi:10.1186/s12881-016-0338-7, ISSN 1471-2350, XP093313202
OPPOSITION- Lukas Jan, Cimmaruta Chiara, Liguori Ludovica, Pantoom Supansa, Iwanov Katharina, Petters Janine, Hund Christina, Bunschkowski Maik, Hermann Andreas, Cubellis Maria Vittoria, Rolfs Arndt, "Assessment of Gene Variant Amenability for Pharmacological Chaperone Therapy with 1-Deoxygalactonojirimycin in Fabry Disease", International journal of molecular sciences, Molecular Diversity Preservation International (MDPI), Basel, CH, Basel, CH , vol. 21, no. 3, doi:10.3390/ijms21030956, ISSN 1422-0067, page 956, XP093313206

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