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Methods Of Treating Fabry Disease In Patients Having A Mutation In The Gla Gene - EP3840753

The patent EP3840753 was granted to Amicus Therapeutics on Jul 24, 2024. The application was originally filed on Jan 16, 2019 under application number EP19703514A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3840753

AMICUS THERAPEUTICS
Application Number
EP19703514A
Filing Date
Jan 16, 2019
Status
Granted And Under Opposition
Jun 20, 2024
Grant Date
Jul 24, 2024
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (2)

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BRAND MURRAY FULLERApr 24, 2025BRAND MURRAY FULLERADMISSIBLE
TEVA PHARMACEUTICALSApr 23, 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 (19) 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- E. W. MARTIN, Remington's Pharmaceutical Sciences
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 [I] 1-13,15-18,20-36,38-41,43-47 * table 11SA *
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] 1-13,15-18,20-36,38-41,43-47 * table 2 *
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] 1-13,15-18,20-36,38-41,43-47 * table 11SA *
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] 1-46 * Section 9. Regulatory affairs *
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 [A] 1-47 * table 1 *
OPPOSITION- Anonymous, "Amicus Therapeutics Announces European Commission Approval for Galafold™ (Migalastat) in Patients with Fabry Disease in European Union", Amicus Therapeutics, (20160531), pages 1 - 4, XP093273077
OPPOSITION- Anonymous, "Amicus Therapeutics Launches Galafold® (Migalastat) for Fabry Disease in Japan", Amicus Therapeutics, (20180530), pages 1 - 3, XP093273086
OPPOSITION- Anonymous, "Amicus Therapeutics Launches Galafold™ (Migalastat) for Treatment of Fabry Disease in Spain", Amicus Therapeutics, (20180117), pages 1 - 2, XP093273082
OPPOSITION- Anonymous, "Amicus Therapeutics Launches Galafold™ (Migalastat) for Treatment of Fabry Disease in the United Kingdom", Amicus Therapeutics, (20170227), pages 1 - 3, XP093273079
OPPOSITION- Anonymous, "CADTH COMMON DRUG REVIEW Clinical Review Report", MIGALASTAT (GALAFOLD), CADTH, (20180201), pages 1 - 98, XP093273075
OPPOSITION- D01a: FDA webpage showing date of availability of D1 (box added to final row)
OPPOSITION- D01: FDA label for Galafold™, 10 August 2018, accessible via https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
OPPOSITION- D09: Non-exhaustive selection of migalastat claims
OPPOSITION- D10a: Supplementary information to D10 (file named “HEK Assay_Supplement_Final”)
OPPOSITION- Winchester Bryan, "Chapter 18 Biochemical and genetic diagnosis of Fabry disease", Fabry Disease: Perspectives from 5 Years of FOS, Winchester and Young, (20060101), pages 1 - 12, XP093273088
OPPOSITION- Benjamin et al., "The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat", Genetics in Medicine, (201704), vol. 19, doi:10.1038/gim.2016.122, XP055582063
OPPOSITION- Scott C Garman, "Structure-function relationships in α‐galactosidase A", ACTA PAEDIATRICA, Wiley-Blackwell Publishing Ltd., GB, GB , (20070323), vol. 96, doi:10.1111/j.1651-2227.2007.00198.x, ISSN 0803-5253, pages 6 - 16, XP071697091

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