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Methods Of Treating Fabry Patients Having Renal Impairment - EP4062916

The patent EP4062916 was granted to Amicus Therapeutics on Oct 9, 2024. The application was originally filed on May 30, 2018 under application number EP22165669A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4062916

AMICUS THERAPEUTICS
Application Number
EP22165669A
Filing Date
May 30, 2018
Status
Granted And Under Opposition
Sep 6, 2024
Grant Date
Oct 9, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (2)

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BRAND MURRAY FULLERJul 9, 2025BRAND MURRAY FULLERADMISSIBLE
TEVA PHARMACEUTICALSJul 9, 2025D YOUNGADMISSIBLE

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
SEARCHWO2012154681

Non-Patent Literature (NPL) Citations (28) 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. U78027.1-
DESCRIPTION- ISHII et al., Biochem. Biophys. Res. Comm., (19960000), vol. 220, pages 812 - 815-
DESCRIPTION- JOHNSON et al., American College of Clinical Pharmacology, (20150000), vol. 4, no. 4, pages 256 - 261-
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DESCRIPTION- SCHIFFMANN R et al., Nephrol Dial Transplant, (20090000), vol. 24, pages 2102 - 11-
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 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, URL: https://www.ema.europa.eu/en/documents/assessment-report/galafold-epar-public-assessment-report_en.pdf, (20211129), XP055867096-
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, "GALAFOLD ® (migalastat) capsules, for oral use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20250301), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208623s009lbl.pdf, XP093298577-
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- D10 - Union Register of medicinal products for Galafold®, accessed on 14 May 2025-
OPPOSITION- D11 - Screenshots of WayBack Machine webpage capture dated 7 April 2017 for http://galafoldamenabilitytable.com/api/?mutation_type=Amenable&data_type=htmltable-
OPPOSITION- D18 - A collection of screen shots of the webpage https://www.cda-amc.ca/migalastat, accessed on 22 May 2025, as evidence of the publication date of D11;-
OPPOSITION- D1 - Non-exhaustive selection of migalastat claims-
OPPOSITION- D2a - Supplementary information to D2 (file named “HEK Assay_Supplement_Final”)-
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- Tsukimura Takahiro, Nakano Sachie, Togawa Tadayasu, Tanaka Toshie, Saito Seiji, Ohno Kazuki, Shibasaki Futoshi, Sakuraba Hitoshi, "Plasma mutant α-galactosidase A protein and globotriaosylsphingosine level in Fabry disease", Molecular Genetics and Metabolism Reports, Elsevier, (20140101), vol. 1, no. 1, doi:10.1016/j.ymgmr.2014.07.005, ISSN 2214-4269, pages 288 - 298, XP093298574
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- Ataides Thiago Lacerda, Veloso Valeria Sp, Regina Edna, Pereira S, De Souza Mauri F, Cm E Cunha Talita, Rezende Jordana E, Guimaraes Marilia R, Veloso Mariana P, "CLINICAL NEPHROLOGY, PRIMARY AND SECONDARY GLOMERULONEPHRITIS -1 - FP166 P.G35V A NEW MUTATION AND EARLY RENAL MANIFESTATIONS IN FABRY DISEASE", Nephrology Dialysis Transplantation, (20150521), vol. 30, no. 3, doi:10.1093/ndt/gfv171.55, XP093298573
OPPOSITION- Pomeranz Vanesa, Rengel T., Zotta E., Lombi Fernando, Karl A., Forrester Mariano, Araoz A., Schiel A., Muryan A., Canzonieri R., Trimarchi Hernán, Andrews J., "Copious Podocyturia without Proteinuria and with Normal Renal Function in a Young Adult with Fabry Disease", Case Reports in Nephrology, Hindawi Publishing Corporation, (20150101), vol. 2015, no. 2015, doi:10.1155/2015/257628, ISSN 2090-6641, pages 1 - 4, XP093298568
OPPOSITION- Jamboti Jagadish, Forrest Cynthia H, "Fabry disease; early diagnosis improves prognosis but diagnosis is often delayed", Journal of Nephropathology, (20170205), vol. 6, no. 3, doi:10.15171/jnp.2017.22, pages 130 - 133, XP093298570
SEARCH- Emea, "Galafold 123 mg hard capsules", ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, (20160609), pages 1 - 45, URL: https://www.ema.europa.eu/, (20211115), XP055861186 [X] 1-14 * tables 2,3 *-
SEARCH- Emea, "Galafold", EUROPEAN MEDICINES AGENCY, (20160101), URL: https://www.ema.europa.eu/en/medicines/human/EPAR/galafold, (20211115), XP055861177 [A] 1-14-
SEARCH- European Commission, "granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Galafold - migalastat", an orphan medicinal productfor human use", EUROPEAN COMMISSION - COMMISSION IMPLEMENTING DECISION, (20160526), URL: https://ec.europa.eu/health/documents/community-register/html/h1082.htm, (20211115), XP055861180 [A] 1-14-
SEARCH- JOHNSON FRANKLIN K ET AL, "An open-label study to determine the pharmacokinetics and safety of migalastat HCl in subjects with impaired renal function and healthy subjects with normal renal function", CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT UNITED STATES JUL 2017, CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT UNITED STATES JUL 2017, CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT UNITED STATES JUL 2017, (20150630), vol. 4, no. 4, doi:10.1002/CPDD.149, ISSN 2160-7648, pages 256 - 261, XP009507828 [I] 1-14 * page 261, column 1, paragraph 2 * * abstract *
SEARCH- SKUBAN N BARTH J YU J ET AL, "SP002: Clinical outcomes with migalastat in patients with fabry disease basedondegreeof renalimpairment: Results from phase 3 trials", NEPHROLOGY DIALYSIS TRANSPLANTATION; 55TH ANNUAL CONGRESS OF THE EUROPEAN RENAL ASSOCIATION-EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION, ERA-EDTA 2018, OXFORD UNIVERSITY PRESS, GB; COPENHAGEN, DENMARK, (20180501), vol. 33, no. Supplement 1, doi:10.1093/NDT/GFY104.SP002, ISSN 0931-0509, page i346, XP009507822 [XP] 1-14 * table 1 *
SEARCH- WILLIAMS H ET AL, "SP004: Effects of long-term migalastat treatment on renal function by baseline proteinuria in patients (PTS) with fabry disease", NEPHROLOGY DIALYSIS TRANSPLANTATION; 55TH ANNUAL CONGRESS OF THE EUROPEAN RENAL ASSOCIATION-EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION, ERA-EDTA 2018, OXFORD UNIVERSITY PRESS, GB; COPENHAGEN, DENMARK, (20180501), vol. 33, no. Supplement 1, doi:10.1093/NDT/GFY104.SP004, ISSN 0931-0509, pages i347 - i348, XP009507821 [XP] 1-14 * paragraphs [0001] , [0002] *

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