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Methods Of Enhancing And/Or Stabilizing Cardiac Function In Patients With Fabry Disease - EP4176877

The patent EP4176877 was granted to Amicus Therapeutics on Dec 4, 2024. The application was originally filed on Aug 28, 2018 under application number EP22194251A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4176877

AMICUS THERAPEUTICS
Application Number
EP22194251A
Filing Date
Aug 28, 2018
Status
Granted And Under Opposition
Nov 1, 2024
Grant Date
Dec 4, 2024
External Links
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Patent Summary

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Patent Family

Patent Oppositions (3)

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

Patent Citations (11) 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
OPPOSITIONEP4176877
OPPOSITIONWO2019046277
SEARCHUS2016324839

Non-Patent Literature (NPL) Citations (23) 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-
OPPOSITION- Anonymous, "Assessment report Galafold Procedure No. EMEA/H/C/004059/0000", European Medicines Agency, (20160401), European Medicines Agency, URL: https://www.ema.europa.eu/en/documents/assessment-report/galafold-epar-public-assessment-report_en.pdf, XP093182211-
OPPOSITION- D10a - Supplementary information to TM10-
OPPOSITION- D13 - Non-exhaustive selection of migalastat claims-
OPPOSITION- D16a - Evidence of the publication date of D16 (8 May 2017)-
OPPOSITION- D20 - Union Register of medicinal products for Galafold®, accessed on 14 May 2025-
OPPOSITION- Jovanovic A., Schimann R, Nicholls K, Feldt-Rasmussen U4 Bichet Dg, Hughes Da, Jain V, Yu J, Castelli Jp, Skuban N, Barth Ja, Giugliani R, "2667 Improvements in Cardiac Mass With Long-Term Migalastat Treatment in Patients With Fabry Disease: Results From Two Phase 3 Trials (FACETS and ATTRACT)", Poster presentation at the 13th International Congress of Inborn Errors of Metabolism, (20170905), XP093313634-
OPPOSITION- Kampmann Christoph, "Chapter 37 Enzyme replacement therapy and the heart ", Fabry Disease: Perspectives from 5 Years of FOS, Oxford: Oxford PharmaGenesis, (20060101), XP093313642-
OPPOSITION- Kubo Toru, "Fabry disease and its cardiac involvement", Journal of General and Family Medicine, (20171001), vol. 18, no. 5, doi:10.1002/jgf2.76, ISSN 2189-7948, pages 225 - 229, XP093313635
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- Seydelmann Nora; Wanner Christoph; Störk Stefan; Ertl Georg; Weidemann Frank , "Fabry disease and the heart", Best Practice & Research Clinical Endocrinology & Metabolism, BAILLIERE TINDALL, LONDON, GB, GB , (20141016), vol. 29, no. 2, doi:10.1016/j.beem.2014.10.003, ISSN 1521-690X, pages 195 - 204, XP029171975
OPPOSITION- on behalf of the Fabry Outcome Survey investigators ; Mehta, A. ; Beck, M. ; Elliott, P. ; Giugliani, R. ; Linhart, A. ; Sunder-Plassmann, G. ; Schiffmann, R. ; Barbey, F. ; Ries, M. ; Clarke, J., "Enzyme replacement therapy with agalsidase alfa in patients with Fabry's disease: an analysis of registry data", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20091212), vol. 374, no. 9706, doi:10.1016/S0140-6736(09)61493-8, pages 1986 - 1996, XP026801844
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- 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
OPPOSITION- Giugliani Roberto, Niu Dau-Ming, Ramaswami Uma, West Michael, Hughes Derralynn, Kampmann Christoph, Pintos-Morell Guillem, Nicholls Kathleen, Schenk Jörn-Magnus, Beck Michael, "A 15-Year Perspective of the Fabry Outcome Survey", Journal of Inborn Errors of Metabolism and Screening, (20160729), vol. 4, doi:10.1177/2326409816666298, ISSN 2326-4098, page 232640981666629, XP093313638
OPPOSITION- Hisao Yoshikawa;Makoto Suzuki;Go Hashimoto;Yukiko Kusunose;Takenori Otsuka;Masato Nakamura;Kaoru Sugi, "Midwall ejection fraction for assessing systolic performance of the hypertrophic left ventricle", CARDIOVASCULAR ULTRASOUND, BIOMED CENTRAL, LONDON, GB, GB , (20121120), vol. 10, no. 1, doi:10.1186/1476-7120-10-45, ISSN 1476-7120, page 45, XP021136395
OPPOSITION- Germain Dominique P, "Fabry disease", Orphanet Journal of Rare Diseases, BioMed Central Ltd, Lo, Lo , (20101122), vol. 5, no. 1, doi:10.1186/1750-1172-5-30, ISSN 1750-1172, page 30, XP021090410
SEARCH- Ales Linhart, "The heart in Fabry disease - Fabry Disease", Oxford PharmaGenesis, (20060101), URL: https://www.ncbi.nlm.nih.gov/books/NBK11576/, (20220601), XP055927308 [A] 1-15 * p. 3, chapter LV function *-
SEARCH- Germain DP Schiffmann, "Cardiac Outcomes With Long-term Migalastat Treatment in Patients With Fabry Disease: Results From Phase 3 Trials", 14th Annual WORLDSymposium, San Diego, CA, (20180205), pages LB - 18, URL: https://www.amicusrx.com/app/uploads/World2018/World2018-Amicus-Cardiac-Outcomes-migalastat.pdf, (20181127), XP055527467 [XP] 1-15 * the whole document *-
SEARCH- MEHTA A. ET AL ON BEHALF OF THE FABRY OUTCOME SURVEY INVESTIGATORS, "Enzyme replacement therapy with agalsidase alfa in patients with Fabry's disease: an analysis of registry data", LANCET, ELSEVIER, AMSTERDAM, NL, vol. 374, no. 9706, doi:10.1016/S0140-6736(09)61493-8, ISSN 0140-6736, (20091212), pages 1986 - 1996, (20091212), XP027527330 [Y] 5 * abstract *
SEARCH- DOMINIQUE P. GERMAIN ET AL, "Treatment of Fabry's Disease with the Pharmacologic Chaperone Migalastat", THE NEW ENGLAND JOURNAL OF MEDICINE, - NEJM -, US, (20160811), vol. 375, no. 6, doi:10.1056/NEJMoa1510198, ISSN 0028-4793, pages 545 - 555, XP055527557 [X] 1-4,6-12,14,15 * whole document, particularly p. 550-551, chapter "Echocardiographic variables"; Table 2 * [Y] 5

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