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Cladribine Regimen For Treating Multiple Sclerosis - EP4070800

The patent EP4070800 was granted to Merck Serono on Oct 16, 2024. The application was originally filed on Dec 20, 2005 under application number EP22166610A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4070800

MERCK SERONO
Application Number
EP22166610A
Filing Date
Dec 20, 2005
Status
Granted And Under Opposition
Sep 13, 2024
Grant Date
Oct 16, 2024
External Links
Slate, Register, Google Patents

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GENERICS UKJul 16, 2025ELKINGTON AND FIFEADMISSIBLE

Patent Citations (15) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0173059
DESCRIPTIONEP0626853
DESCRIPTIONUS5208327
DESCRIPTIONUS5506214
DESCRIPTIONUS6194395
DESCRIPTIONWO0064918
DESCRIPTIONWO2004028462
DESCRIPTIONWO2004087100
DESCRIPTIONWO2004087101
DESCRIPTIONWO9619229
DESCRIPTIONWO9619230
OPPOSITIONWO2004087101
OPPOSITIONWO2006067141
SEARCHEP0626853
SEARCHWO2004087101

Non-Patent Literature (NPL) Citations (47) 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
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EXAMINATION- Anonymous, "EPAR summary for Mavenclad (Cladribine)", EMA/405631/2017, (20170101), pages 1 - 3, URL: https://www.ema.europa.eu/en/documents/overview/mavenclad-epar-summary-public_en.pdf, XP093153687-
EXAMINATION- Anonymous, "NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE", The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use, (20010726), pages 1 - 19, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-investigation-bioavailability-and-bioequivalence_en.pdf, XP093153632-
EXAMINATION- Gavin Giovannoni, "Cladribine to treat relapsing forms of multiple sclerosis", Neurotherapeutics, (20171122), pages 874 - 887, URL: https://pubmed.ncbi.nlm.nih.gov/29168160/, XP093153683-
EXAMINATION- GIOVANNONI GAVIN ET AL, "A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis", NEW ENGLAND JOURNAL OF MEDICINE, THE - NEJM, MASSACHUSETTS MEDICAL SOCIETY, US, (20100204), vol. 362, no. 5, ISSN 1533-4406, pages 416 - 426, XP002601628-
OPPOSITION- Anonymous, "EPAR summary for Mavenclad (Cladribine)", EMA/405631/2017, (20170101), pages 1 - 3, EMA/405631/2017, URL: https://www.ema.europa.eu/en/documents/overview/mavenclad-epar-summary-public_en.pdf, XP093153687-
OPPOSITION- Anonymous, "ICH Topic E4 Dose Response Information to Support Drug Registration - NOTE FOR GUIDANCE ON DOSE RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION (CPMP/ICH/378/95) ", European Medicines Agency; CPMP/ICH/378/95, (19941101), European Medicines Agency; CPMP/ICH/378/95, (20240412), XP093150955-
OPPOSITION- D13 - Graphic illustration of treatment schedules in Example 1-
OPPOSITION- D17 - Graphic illustration of treatment schedules in Example 1 and D2/D16-
OPPOSITION- D18 - Board of Appeal’s decision in case T 1074/20-
OPPOSITION- D19 - Minutes of oral proceedings in case T 1074/20-
OPPOSITION- D20 - Preliminary opinion of the Board in case T 1074/20-
OPPOSITION- D5 - Clinical Study Report (filed with then-applicant’s letter dated 8 September 2015)-
OPPOSITION- GIOVANNONI GAVIN, ET AL, "A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.", New England Journal of Medicine, The - NEJM, Massachusetts Medical Society, US, US , (20100204), vol. 362, no. 5, ISSN 1533-4406, pages 416 - 426, XP002601628-
OPPOSITION- GRIEB P, ET AL., "EFFECT OF REPEATED TREATMENTS WITH CLADRIBINE (2-CHLORODEOXYADENOSINE) ON BLOOD COUNTS IN MULTIPLE SCLEROSIS PATIENTS", Archivum Immunologiae et Therapiae Experimentalis, Birkhaeuser Verlag AG, CH, CH , (19950101), vol. 43, no. 05-06, ISSN 0004-069X, pages 323 - 327, XP008047072-
OPPOSITION- Pawel Grieb et al, "Effect of repeated treatments with cladribine (2-chlorodeoxyadenosine) on blood counts in multiple sclerosis patients", Arch. Immunol. Ther. Exp. , (1995), vol. 43, XP008047072-
OPPOSITION- R. Schmidt, "Dose-finding studies in clinical drug development", Eur. J. Clin. Pharmacol., (1988), vol. 34, pages 15 - 19, XP055350888-
OPPOSITION- R. Selby et al, "Safety and tolerability of subcutaneous cladribine therapy in progressive multiple sclerosis", Can. J. Neurol. Sci., (1998), vol. 25, XP055525281-
OPPOSITION- Zbigniew Stelmasiak et al, "A pilot trial of cladribine (2-chlorodeoxyadenosine) in remittingrelapsing multiple sclerosis,", Med. Sci. Monit, (1998), vol. 4, XP008047060-
OPPOSITION- Gavin Giovannoni, "Cladribine to Treat Relapsing Forms of Multiple Scelerosis", Neurotherapeutics,, (2017), vol. 14, doi:10.1007/s13311-017-0573-4, XP036646074
OPPOSITION- D Giovannoni et al, "Interferon beta in multiple sclerosis: experience in a British specialist multiple sclerosis centre", J. Neurol. Neurosurg. Psychiatry, (2003), vol. 74, doi:10.1136/jnnp.74.7.946, XP055525276
OPPOSITION- Ernest Beutler et al, "Marrow suppression produced by repeated doses of cladribine", cta Haematol, (1994), vol. 91, doi:10.1159/000204236, XP009183282
OPPOSITION- LANGTRY H D, LAMB H M, "CLADRIBINE A REVIEW OF ITS USE IN MULTIPLE SCLEROSIS", BIODRUGS, Adis International Ltd., NZ, NZ , (19980501), vol. 09, no. 05, doi:10.2165/00063030-199809050-00006, ISSN 1173-8804, pages 419 - 433, XP008047073
SEARCH- ELLISON GEORGE W ET AL, "Oral cladribine for multiple sclerosis", NEUROLOGY, & 49TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY; BOSTON, MASSACHUSETTS, USA; APRIL 12-19, 1997, (1997), vol. 48, no. 3 SUPPL. 2, ISSN 0028-3878, pages A174 - A175, XP008047069 [A] 1-18 * the whole document *-
SEARCH- GRIEB PAWEL ET AL, "Effect of repeated treatments with cladribine (2-chlorodeoxyadenosine) on blood counts in multiple sclerosis patients", ARCHIVUM IMMUNOLOGIAE ET THERAPIAE EXPERIMENTALIS, (1995), vol. 43, no. 5-6, ISSN 0004-069X, pages 323 - 327, XP008047072 [ID] 1-18 * abstract * * page 324, column 1, paragraph 3 * * page 326, column 2, paragraph 3 *-
SEARCH- STELMASIAK Z ET AL, "A pilot trial of cladribine (2-chlorodeoxyadenosine) in remitting- relapsing multiple sclerosis", MEDICAL SCIENCE MONITOR 1998 POLAND, (1998), vol. 4, no. 1, ISSN 1234-1010, pages 4 - 8, XP008047060 [ID] 1-18 * abstract * * page 5, column 1, paragraph 2 - column 2, paragraph 1 * * page 7, column 1, paragraph 3 *-
SEARCH- LILIEMARK JAN, "The clinical pharmacokinetics of cladribine", CLINICAL PHARMACOKINETICS, (1997), vol. 32, no. 2, ISSN 0312-5963, pages 120 - 131, XP008134580 [A] 1-18 * abstract * * page 122, column 1, paragraph 2 * * page 122, column 2, paragraph 2 *
SEARCH- LANGTRY H D ET AL, "Cladribine: A review of its use in multiple sclerosis", BIODRUGS 1998 NEW ZEALAND, (1998), vol. 9, no. 5, ISSN 1173-8804, pages 419 - 433, XP008047073 [A] 1-18 * page 422, column 1, paragraph 3 - page 423, column 1, paragraph 1 * * page 423, column 2, paragraphs 1,2 * * page 424, column 1, paragraph 5 * * table III * * page 430, column 1, paragraph 3 * * table IV *

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