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METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT

Publication No. EP4324522

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App No. EP23219949

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Filed by Amicus Therapeutics, Inc.

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Filed on 2018-05-30

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Issued/Published on 2025-12-10

Official EPO Register

Publication No. EP4324522 A2

Application No. EP23219949 Filed: 2018-05-30

Grant Date 2025-12-10 Mention of grant

Active Oppositions 3 Active EPO Oppositions

Patent Abstract / Summary

[0001] Provided are methods for treatment of Fabry disease in a patient having renal impairment and/or elevated proteinuria. Certain methods comprise administering to the patient about 100 to about 150 mg free base equivalent of migalastat or salt thereof at a frequency of once every other day. Certain methods also provide for the stabilization of renal function, reducing left ventricular mass index, reducing plasma globotriaosylsphingosine and/or increasing α-galactosidase A activity in the patient.

IPC Classifications

A61K31/445, A61P13/12 A61P13/12

Priority Claims

US 201762512458P Date: 2017-05-30

US 201862626953P Date: 2018-02-06

Designated Contracting States (38 EPC States)

AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

Parties & Representation

Applicants

Amicus Therapeutics, Inc.

3675 Market Street, Philadelphia, PA 19104

Inventors (1)

Castelli, Jeff

Cranbury, New Jersey, 08512

Representatives / Agents

Hoffmann Eitle

Patent- und Rechtsanwälte PartmbB, Arabellastraße 30

D Young & Co LLP

3 Noble Street, London EC2V 7BQ

Maiwald GmbH

Elisenhof, Elisenstraße 3

Brand Murray Fuller LLP

First Floor, 111 Wardour Street, London W1F 0UH

Key Procedural Dates

Request-For-Examination 2023-12-22

First-Examination-Report-Despatched 2024-05-07

Patent Oppositions

Official opposition proceedings filed against European Patent EP4324522 under EPC Article 99.

3 ACTIVE OPPONENTS

Opponent Company

TEVA PHARMACEUTICAL INDUSTRIES, LTD.

124 Dvora HaNevi'a St., IL

Representative

D Young & Co LLP

Filing Date

2026-09-08

Opposition in Progress

Opponent Company

Maiwald GmbH

Elisenhof, DE

Representative

Maiwald GmbH

Filing Date

2026-09-09

Opposition in Progress

Opponent Company

Brand Murray Fuller LLP

First Floor, 111 Wardour Street, GB

Representative

Brand Murray Fuller LLP

Filing Date

2026-09-10

Opposition in Progress

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71 Events Recorded

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Cited documents and prior art referenced in search and examination reports.

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Non-Patent Scientific Literature (NPL)

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- D5 - Screenshots of WayBack Machine webpage capture dated 7 April 2017 for http://galafoldamenabilitytable.com/api/?mutation_type=Amenable&data_type=htmltable; and screenshots of WayBack Machine’s Site Map feature for www.galafoldamenabilitytable.com, which was used to access the amenability data

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- PINTOS GUILLEM, ARNAIZ JOAN ALBERT, CLOPÉS ANNA, DIEGO LAURA, FERRER PAU, GALVEZ PABLO, MONTORO JOSE BRUNO, PONS JOAN, PONTES CARI: "Migalastat (Galafold ): per al tractament a llarg termini d’adults i adolescents de 16 anys i majors amb diagnòstic confirmat de malaltia de Fabry (deficiència d’α-galactosidasa A) i portadors de mutacions susceptibles a respondre al tractament", MIGALASTAT (GALAFOLD ) FOR THE TREATMENT OF FABRY DISEASE, CATSALUT, DEPARTMENT OF HEALTH, GENERALITAT OF CATALONIA, BARCELONA, 1 March 2017 (2017-03-01), Barcelona, pages 1 - 28, XP093389622, Retrieved from the Internet <URL:https://hdl.handle.net/11351/3657>

- D21 - WayBack Machine snapshot - URLs retrieved fromhttps://www.galafoldamenabilitytable.com/

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- D21b - WayBack Machine snapshot – amenable mutations publicly disclosed as of 07 April 2017

- D21c - Text of amenable mutations from WayBack Machine result of D21b

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- CITRO VALENTINA, CAMMISA MARCO, LIGUORI LUDOVICA, CIMMARUTA CHIARA, LUKAS JAN, CUBELLIS MARIA, ANDREOTTI GIUSEPPINA: "Supplementary File S1 : The Large Phenotypic Spectrum of Fabry Disease Requires Graduated Diagnosis and Personalized Therapy: A Meta-Analysis Can Help to Differentiate Missense Mutations", INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, MDPI AG, SWITZERLAND, vol. 17, no. 12, 1 December 2017 (2017-12-01), Switzerland, pages 1 - 2, XP093389701, ISSN: 1422-0067, DOI: 10.3390/ijms17122010

- DOMINIQUE P. GERMAIN, DERRALYNN A. HUGHES, KATHLEEN NICHOLLS, DANIEL G. BICHET, ROBERTO GIUGLIANI, WILLIAM R. WILCOX, CLAUDIO FELI: "Treatment of Fabry's Disease with the Pharmacologic Chaperone Migalastat", THE NEW ENGLAND JOURNAL OF MEDICINE, MASSACHUSETTS MEDICAL SOCIETY, USA, vol. 375, no. 6, 11 August 2016 (2016-08-11), USA, pages 545 - 555, XP055527557, ISSN: 0028-4793, DOI: 10.1056/NEJMoa1510198

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- MAKIKO YASUDA, JUNAID SHABBEER, STACY D BENSON, IRENE MAIRE, ROGER M BURNETT, ROBERT J DESNICK: "Fabry disease: characterization of alpha-galactosidase A double mutations and the D313Y plasma enzyme pseudodeficiency allele.", HUMAN MUTATION, JOHN WILEY & SONS, INC., US, vol. 22, no. 6, 1 December 2003 (2003-12-01), US , pages 486 - 492, XP002329167, ISSN: 1059-7794, DOI: 10.1002/humu.10275

- D29 - Non-exhaustive selection of migalastat claims

- UMEDA TOSHIKO, HASHIMOTO SEIJI, NORIYASU KAZUYUKI, TAKAMURA AYUMI, FUJISAKI MIWA, ETO YOSHIKATSU: "Identification of a novel GLA mutation (F69 L) in a Japanese patient with late-onset Fabry disease", HUMAN GENOME VARIATION, SPRINGER SCIENCE AND BUSINESS MEDIA LLC, vol. 2, no. 1, 12 November 2015 (2015-11-12), pages 15044 - 3, XP093436561, ISSN: 2054-345X, DOI: 10.1038/hgv.2015.44

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- PAN XIAOXIA, OUYANG YAN, WANG ZHAOHUI, REN HONG, SHEN PINGYAN, WANG WEIMING, XU YAOWEN, NI LIYAN, YU XIALIAN, CHEN XIAONONG, ZHANG: "Genotype: A Crucial but Not Unique Factor Affecting the Clinical Phenotypes in Fabry Disease", PLOS ONE, PUBLIC LIBRARY OF SCIENCE, US, vol. 11, no. 8, 25 August 2016 (2016-08-25), US , pages e0161330 - 16, XP093436564, ISSN: 1932-6203, DOI: 10.1371/journal.pone.0161330

- TURAÇA LAURO THIAGO, PESSOA JULIANA GILBERT, MOTTA FABIANA LOUISE, MUÑOZ ROJAS MARIA VERÔNICA, MÜLLER KAREN BARBOSA, LOURENÇO CHAR: "New mutations in the GLA gene in Brazilian families with Fabry disease", JOURNAL OF HUMAN GENETICS, SPRINGER NATURE, SINGAPORE, vol. 57, no. 6, 1 June 2012 (2012-06-01), Singapore, pages 347 - 351, XP093436586, ISSN: 1434-5161, DOI: 10.1038/jhg.2012.32

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- DERRALYNN A HUGHES, KATHLEEN NICHOLLS, SUMA P SHANKAR, GERE SUNDER-PLASSMANN, DAVID KOELLER, KHAN NEDD, GERARD VOCKLEY, TAKASHI HA: "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, vol. 54, no. 4, 1 April 2017 (2017-04-01), England, pages 288 - 296, XP055690446, ISSN: 0022-2593, DOI: 10.1136/jmedgenet-2016-104178

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US	US20260097027A1	A1	2026-04-09	Espacenet
US	USRE48608E	E	2021-06-29	Espacenet
WO	WO2009102895A2	A2	2009-08-20	Espacenet
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WO	WO2018222655A1	A1	2018-12-06	Espacenet

Official File Inspection EPC Art. 128 Public Dossier

Complete European Patent Register Dossier (148 Total Documents)

The full inspection file for Application EP23219949 contains 148 total documents, including all notices of opposition, proprietor counter-statements, examination communications, third-party observations, and procedural forms. Below are all major recorded procedural filings and publication specifications.

Open 148-Doc Register Dossier

Recorded Filings & Patent Specifications

Official publication specifications, opposition filings, proprietor replies, and procedural submissions.

33 Filings Listed

European Patent Specification - Granted Patent (B1)

Publication Specification

Date: 2025-12-10 Procedure: Grant EP4324522B1

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Official European Patent Register Full Dossier

Publication Specification

Date: 2025-12-10 Procedure: All Proceedings (Examination & Opposition) EP23219949

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European Search Report (A3)

Publication Specification

Date: 2024-05-22 Procedure: Publication EP4324522A3

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European Patent Application without Search Report (A2)

Publication Specification

Date: 2024-02-21 Procedure: Publication EP4324522A2

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New entry: Communication of a notice of opposition and request to file observations + time limit

Dossier Filing

Date: 2026-09-24 Procedure: Opposition EPIDOSNOBS2

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Invitation to proprietor to file observations on the notice of opposition

Procedural Step

Date: 2026-09-24 Procedure: Opposition OBSO

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Opposition filed

Dossier Filing

Date: 2026-09-18 Procedure: Opposition 0009260

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Opposition filed

Dossier Filing

Date: 2026-09-11 Procedure: Opposition 0009260

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(Expected) grant

Dossier Filing

Date: 2025-11-07 Procedure: Grant 0009210

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New entry: Payment of fee for grant

Dossier Filing

Date: 2025-11-01 Procedure: Grant EPIDOSNIGR3

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New entry: Payment of fee for publishing/printing

Dossier Filing

Date: 2025-11-01 Procedure: Examination EPIDOSNIGR5

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New entry: Receipt of the translation of the claim(s)

Dossier Filing

Date: 2025-11-01 Procedure: Examination EPIDOSNIGR7

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METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT

Patent Abstract / Summary

IPC Classifications

Priority Claims

Designated Contracting States (38 EPC States)

Parties & Representation

Applicants

Inventors (1)

Representatives / Agents

Key Procedural Dates

Patent Oppositions

TEVA PHARMACEUTICAL INDUSTRIES, LTD.

Maiwald GmbH

Brand Murray Fuller LLP

Legal Status & Event History

Patent & Non-Patent Citations

Cited Patent Documents

Non-Patent Scientific Literature (NPL)

Worldwide Patent Family

Complete European Patent Register Dossier (148 Total Documents)

Recorded Filings & Patent Specifications

European Patent Specification - Granted Patent (B1)

Official European Patent Register Full Dossier

European Search Report (A3)

European Patent Application without Search Report (A2)

New entry: Communication of a notice of opposition and request to file observations + time limit

Invitation to proprietor to file observations on the notice of opposition

Opposition filed

Opposition filed

(Expected) grant

New entry: Payment of fee for grant

New entry: Payment of fee for publishing/printing

New entry: Receipt of the translation of the claim(s)

New entry: Communication of intention to grant a patent

Intention to grant the patent

New entry: Renewal fee paid

Renewal fee payment

New entry: Reply to examination report

New entry: Despatch of examination report + time limit

Communication from the examining division

First examination report

Date on which the examining division has become responsible

Change - classification

Publication of search report

The date on which the examining division becomes responsible, has been established

New entry: Renewal fee paid

Renewal fee payment

Publication in section I.1 EP Bulletin

Request for examination filed

Change - representative

New entry: Renewal fee paid

Renewal fee payment

Language of the procedure

International searching authority