Low Frequency Glatiramer Acetate Therapy - EP2949335

The patent EP2949335 was granted to Yeda Research on Jan 4, 2017. The application was originally filed on Aug 19, 2010 under application number EP15171065A. The patent is currently recorded with a legal status of "Revoked".

EP2949335

YEDA RESEARCH
Application Number
EP15171065A
Filing Date
Aug 19, 2010
Status
Revoked
Apr 27, 2021
Grant Date
Jan 4, 2017
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (6)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateRepresentativeOpposition Status

Get instant alerts for new oppositions and patent status changes

MYLAN TEORANTA TRADING MYLAN INSTITUTIONALNov 27, 2017GILL JENNINGS & EVERYINTERVENTION ADMISSIBLE
ALVOGEN IPCOOct 4, 2017HAMM & WITTKOPPADMISSIBLE
G L PHARMAOct 4, 2017HAMM & WITTKOPPADMISSIBLE
HEXALOct 4, 2017BREUERADMISSIBLE
SYNTHONOct 4, 2017HAMM & WITTKOPPADMISSIBLE
GENERICS UK TRADING MYLANOct 3, 2017GILL JENNINGS & EVERYADMISSIBLE

Patent Citations (21) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2002037848
DESCRIPTIONUS2002055466
DESCRIPTIONUS2002077278
DESCRIPTIONUS2003004099
DESCRIPTIONUS2005014694
DESCRIPTIONUS2008013146
DESCRIPTIONUS2009149541
DESCRIPTIONUS6514938
DESCRIPTIONWO0027417
DESCRIPTIONWO0160392
DESCRIPTIONWO0197846
DESCRIPTIONWO2009070298
OPPOSITIONEP2949335
OPPOSITIONUS2007161566
OPPOSITIONWO0020010
OPPOSITIONWO2007081975
OPPOSITIONWO2011022063
OTHEREP2405749
OTHERUS8399413
OTHERUS8969302
SEARCHUS2007161566

Non-Patent Literature (NPL) Citations (61) 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- ANN NEUROL, (2005), vol. 58, pages 840 - 846-
DESCRIPTION- KANSARA V; MITRA A; WU Y, "Subcutaneous Delivery", DRUG DELIV TECHNOL, (200906), vol. 9, no. 6, pages 38 - 42-
DESCRIPTION- LUCA DURELLI, J NEUROL, (2003), no. 4, page 250-
DESCRIPTION- POSER ET AL., NEUROLOGY, (198303), vol. 13, no. 3, pages 227 - 230-
DESCRIPTION- G. COMI ET AL., "European/Canadian Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Glatiramer Acetere on Magnetic Resonance Imaging-Measured Disease Activity and Burden in Patients with Relapsing Multiple Sclerosis", ANN. NEUROL., (2001), vol. 49, doi:doi:10.1002/ana.64, pages 290 - 297, XP009042363
OPPOSITION- Alison Palkhivala, "Doubling the Dose of Glatiramer Acetate Does Not Increase Efficacy", MedScape, (20080922), URL: https://www.medscape.com/viewarticle/580865, XP055579985-
OPPOSITION- BEJAOUI K. et al., "There is no rebound worsening of multiple sclero- sis after stopping disease-modifying therapies", Multiple Sclerosis, (20080000), vol. 14, pages S31 - S32, XP055508582-
OPPOSITION- CAON et al., "P06.141 Randomized, Prospective, Rater-Blinded, Four Year Pilot Study To Compare the Effect of Daily Versus Every Other Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS", Neurology, (20090317), vol. 72, no. 11, page 3, XP009161100-
OPPOSITION- CAON et al., "P06.141 Randomized, Prospective, Rater-Blinded, Four Year Pilot Study To Compare the Effect of Daily Versus Every Other Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS", Neurology, (20090317), vol. 72, no. 11, page A317, XP009161100-
OPPOSITION- "Copaxone 20mg/ml, Solution For Injection, Pre-Filled Syringe", Copaxone UK product label ;, (20090417), pages 1 - 7, XP055579983-
OPPOSITION- "Copaxone 20mg/ml, Solution For Injection, Pre-Filled Syringe", pages 1 - 7, Teva Pharmaceuticals, URL: www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=17516, XP055579983-
OPPOSITION- Costello et al., "Recognizing nonadherence in patients with multiple sclerosis and maintaining treatment adherence in the long term", Medscape J Med., (20080930), vol. 10, no. 9, page 225, XP055579991-
OPPOSITION- Costello et al., "Recognizing nonadherence in patients with multiple sclerosis and maintaining treatment adherence in the long term", Medscape J Med., vol. 10, no. 9, (20080930), URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2580090/?report=printable, XP055579991-
OPPOSITION- "Data Publised In Neurology Showed That Higher Dose Of Copaxone(R) increased Efficacy in Relapsing-Remitting Multiple Sclerosis (Rrms)", Teva News Release, URL: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1554611, XP055607348-
OPPOSITION- "Data Published in Neurology showed that higher dosie of Copaxone(R) increased efficacy in relapsing remitting Mutiple Sclerosis (Rrms)", (20070417), URL: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1554611, XP055581344-
OPPOSITION- DEVONSHIRE et al., "P316 The Global Adherence Project - A multicentre observational study on adherence to disease-modifying therapies in patients suffering from relapsing-remitting multiple sclerosis", Mult. Scler., (20060000), vol. 12, no. S1, page S82, XP055579999-
OPPOSITION- DEVONSHIRE et al., "P316 The Global Adherence Project - A multicentre observational study on adherence to disease-modifying therapies in patients suffering from relapsing- remitting multiple sclerosis", Mult. Scler., (20061200), vol. SI, XP055579999-
OPPOSITION- "Doubling the Dose of Glatiramer Acetate Does Not Increase Efficacy", MedScape, (20080922), XP055579985-
OPPOSITION- "FDA label Rebif PI", www.accessdata.fda.gov, (20020308), URL: https://www.accessdata.fda.gov/drugsatfda_docs/)abe)/2002/ifnbs er030702LB.pdf, XP055508530-
OPPOSITION- Giancarlo Comi, "Results from a phase III, one-year randomized, double-blind, parallel-group, dose-comparison study with glatiramer acetate in relapsing-remitting multiple sclerosis", (20080000), World Congress on Treatment and Research in Multiple Sclerosis, URL: http://www.multiwebcast.com/wctrims/2008/msmontreal/2448/chair.giancarlo.com.r..., XP055607341-
OPPOSITION- Grennero Alfonso, Remington's Pharmaceutical Sciences, Easton, Pennsylvania, Mack Publishing Company, (19900000), pages 1813 - 1827, XP055508569-
OPPOSITION- J.J Jessop, "Review and Evaluation of Pharmacology Toxicology Data", Original NDA Review, NDA 20-622, Copolymer-1 for treatment of relaps- ing-remitting multiple sclerosis, (19960000), XP055508552-
OPPOSITION- KHAN et al., "A phase 3 trial to assess the efficacy and safety of glatiramer acetate injections 40mg administered 3 times a week compared to placebo", 28th Congress of the European Committee for treatment and research in multiple sclerosis, (20121010), XP055607318-
OPPOSITION- KHAN et al., "A phase 3 trial to assess the efficacy and safety of glatiramer acetate injections 40mg administered 3 times a week compared to placebo", Abstract presented at 28th Congress of the European Committee for treatment and research in multiple sclerosis, (20121010), XP055607318-
OPPOSITION- KHAN et al., "P902 Randomized, prospective, rater-blinded, four-year, pilot study to compare the effect of daily versus every - other - day glatiramer acetate 20 mg subcutaneous injections in relapsing -remitting multiple sclerosis", Multiple Sclerosis, (20080000), vol. 14, page S296-
OPPOSITION- KHAN et al., "P902 Randomized, prospective, rater-blinded, four-year, pilot study to compare the effect of daily versus every - other - day glatiramer acetate 20 mg subcutaneous injections in relapsing -remitting multiple sclerosis", Multiple Sclerosis, (20080000), vol. 14, page S296, XP009161078-
OPPOSITION- KHAN O. et al., "Randomized, prospective, rater-blinded, four-year, pilot study to compare the effect of daily versus every-other-day glatiramer acetate 20 mg subcutaneous injections in relapsing- remitting multiple sclerosis", Multiple Sclerosis, (20080900), vol. 14, page S296, XP009161078-
OPPOSITION- M. ROVARIS et al., "Results of a randomised, double-blind, parallel-group study assessing safety and efficacy of 40 mg vs. 20 mg of glatiramer acetate on MRI-measured disease activity in relapsing-remitting multiple sclerosis", Multiple Sclerosis, (20060531), vol. 12, no. 1, page 585, XP009157336-
OPPOSITION- M. ROVARIS et al., "Results of a randomised, double-blind, parallel-group study assessing safety and efficacy of 40 mg vs. 20 mg of glatiramer acetate on MRI-measured disease activity in relapsing-remitting multiple sclerosis", Multiple Sclerosis, (20060531), vol. 12, no. Suppl. 1, page 585, XP009157336-
OPPOSITION- Multiple Sclerosis, (20090000), vol. 15, pages S249 - S250-
OPPOSITION- National litigation referred to in section 1.2(c) above, German nullity claim-
OPPOSITION- "(P01.124) Immunological Responses to Different Doses of Glatiramer Acetate in MS: Analyses from the FORTE Trial", 61st Annual Meeting of American-Academy-of-Neurology; Seattle, WA, USA, April 28 - 29, 2009, vol. 11, no. 3, suppl, (20090428), NEUROLOGY, URL: NEUROLOGY; 61st Annual Meeting of American-Academy-of-Neurology; Seattle, WA, USA, April 28 - 29, 2009, XP002743818-
OPPOSITION- "(P01.124) Immunological Responses to Different Doses of Glatiramer Acetate in MS: Analyses from the FORTE Trial", NEUROLOGY; 61st Annual Meeting of American-Academy-of-Neurology; Seattle, WA, USA, April 28 - 29, 2009,, (20090428), vol. 72, XP002743818-
OPPOSITION- "Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers", Journal of Parenteral Science and Technology, (19880000), vol. 42, no. 2S, pages S1 - S26, XP055253757-
OPPOSITION- "Product Life-Cycle Management for Injectable Drugs: A Good Outlook for Proactive", (20061202), Pharmteceutical Technology, URL: http://www.pharmtech.com/product-life-cycle-management-injectable-drugs-good-outlook- proa ctive-ma rket-pl avers, (20160115), XP055579996-
OPPOSITION- "Product Life-Cycle Management for Injectable Drugs: A Good Outlook for Proactive Market players", (20061202), Pharmtech, URL: http://www.pharmtech.com/product-life-cycle-management-injectable-drugs-good-outlook- proactive-market-players, XP055579996-
OPPOSITION- "Results from a phase III, one-year randomized, double-blind, parallel-group, dose-comparison study with glatiramer acetate in relapsing-re", World Congress on Treatment and Research in Multiple Sclerosis, (20080000), XP055607341-
OPPOSITION- "Teva initiates phase III study to confirm increased efficacy of higher dose of Glatiramer Acetate for the treatment of relapsing-remitting Multiple Sclerosis", Teva press releases, (20060000), XP055581348-
OPPOSITION- "Teva initiates phase III study to confirm increased efficacy of higher dose of Glatiramer Acetate for the treatment of relapsing-remitting Multiple Sclerosi", Teva press releases, (20060000), URL: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1557343, XP055581348-
OPPOSITION- "Teva to Present Positive Data for Glatiramer Acetate 40 mg/1 ml Given Three Times Weekly for Relapsing-Remitting MS", (20121010), Teva, URL: http://www.tevapharm.com/Media/News/Pages/2012/1743500.aspx?year=2012&page..., XP055607303-
OPPOSITION- "Teva to Present Positive Data for Glatiramer Acetate 40 mg/1 ml Given Three Times Weekly for Relapsing-Remitting MS", Teva press release, (20121010), URL: http://www.tevapharm.com/Media/News/Pages/2012/1743500.aspx?year=2012&page..., XP055607303-
OPPOSITION- "View of NCT01067521", ClinicalTrials.gov archive, (20100210), XP055508500-
OPPOSITION- FLECHTER et al., "Comparison of glatiramer acetate (Copaxone(R)) and interferon beta-1b (Betaferon(R)) in multiple sclerosis patients: An open-label 2-year follow-up", J Neurol Sci, (20020515), vol. 197, no. 1-2, pages 51 - 55, XP002679780
OPPOSITION- FLECHTER et al., "Comparison of glatiramer acetate (Copaxone(R)) and interferon beta-1b (Betaferon(R)) in multiple sclerosis patients: An open-label 2-year follow-up", J Neurol Sci, (20020515), vol. 197, pages 51 - 55, XP002679780
OPPOSITION- FLECHTER et al., "Copolymer 1 (glatiramer acetate) in relapsing forms of multiple sclerosis: open multicenter study of alternate-day administration", Clin Neuropharm, (20020000), vol. 25, no. 1, pages 11 - 15, XP009161076
OPPOSITION- FLECHTER et al., "Copolymer 1 (glatiramer acetate) in relapsing forms of multiple sclerosis: Open multicenter study of alternate-day administration", Clin Neuropharm, (20020000), vol. 25, no. 1, pages 11 - 15, XP009161076
OPPOSITION- COHEN et al., "Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS", Neurology, (20070000), vol. 68, no. 12, pages 939 - 944, XP002679784
OPPOSITION- "Impact of dose frequency on compliance and health outcomes: a literature review (1966-2006)", Expert Rev. Pharmacoeconomics Outcomes Res., (20070000), vol. 7, no. 2, pages 187 - 202, XP055579988
OPPOSITION- Shi et al., "mpact of dose frequency on compliance and health outcomes: a literature review (1966-2006)", Expert Rev. Pharmacoeconomics Outcomes Res., (20070000), vol. 7, no. 2, pages 187 - 202, XP055579988
OPPOSITION- SIMPSON et al., "Glatiramer acetate: A review of its use in relapsing-remitting multiple sclerosis", CNS D, (20020000), pages 825 - 850, XP009161077
OPPOSITION- SIMPSON et al., "Glatiramer acetate: A review of its use in relapsing-remitting multiple sclerosis", CNS Drugs, (20020000), pages 925 - 850, XP009161077
OPPOSITION- GAGNON L., "Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions with Comparable Efficacy to Daily Dosing", WCTRMS, (20080921), XP055508581
OTHER- Y.-C. J. WANG, "PARENTERAL FORMULATIONS OF PROTEINS AND PEPTIDES: STABILITY AND STABILIZERS", J. Parent. Sci. Techn., (19880000), vol. 42, no. 2S, pages S4 - S26, XP000984636-
SEARCH- Anonymous, "Teva Provides Update on FORTE Trial", (20080707), Internet, URL: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1554743, (20150831), XP002743817 [I] 1-15 * abstract *-
SEARCH- CAON CHRISTINA ET AL, "Randomized, Prospective, Rater-Blinded, Four Year Pilot Study To Compare the Effect of Daily Versus Every Other Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS", NEUROLOGY, & 61ST ANNUAL MEETING OF AMERICAN-ACADEMY-OF-NEUROLOGY; SEATTLE, WA, USA; APRIL 28 -29, 2009, (200903), vol. 72, no. 11, Suppl. 3, ISSN 0028-3878, page A317, XP009161100 [A] 1-15 * abstract *-
SEARCH- KHAN O ET AL, "Randomized, prospective, rater-blinded, four-year, pilot study to compare the effect of daily versus every - other - day injections in relapsing -remitting multiple", MULT.SCLER. (14, SUPPL. 1, S296, 2008) 0 REF. ISSN: 1352-4585 AV - WAYNE STATE UNIV, SCH MED, DETROIT, MI, USA., (2008), XP009161078 [A] 1-15 * abstract *-
SEARCH- YONG WEE V ET AL, "Immunological Responses to Different Doses of Glatiramer Acetate in MS: Analyses from the FORTE Trial", NEUROLOGY, & 61ST ANNUAL MEETING OF AMERICAN-ACADEMY-OF-NEUROLOGY; SEATTLE, WA, USA; APRIL 28 -29, 2009, (200903), vol. 72, no. 11, Suppl. 3, ISSN 0028-3878, page A39, XP002743818 [I] 1-15 * abstract *-
SEARCH- FLECHTER S ET AL, "Comparison of glatiramer acetate (Copaxone(R)) and interferon beta-1b (Betaferon(R)) in multiple sclerosis patients: An open-label 2-year follow-up", JOURNAL OF THE NEUROLOGICAL SCIENCES, (20020515), vol. 197, no. 1-2, ISSN 0022-510X, pages 51 - 55, XP002679780 [A] 1-15 * abstract *
SEARCH- FLECHTER SHLOMO ET AL, "Copolymer 1 (glatiramer acetate) in relapsing forms of multiple sclerosis: open multicenter study of alternate-day administration.", CLINICAL NEUROPHARMACOLOGY 2002 JAN-FEB LNKD- PUBMED:11852290, (200201), vol. 25, no. 1, ISSN 0362-5664, pages 11 - 15, XP009161076 [A] 1-15 * abstract * * "Comparison of daily with alternate-day treatment" on page 14 and "Drug Supply" on page 12 *
SEARCH- COHEN J A ET AL, "Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS.", NEUROLOGY 20 MAR 2007 LNKD- PUBMED:17372130, (20070320), vol. 68, no. 12, ISSN 1526-632X, pages 939 - 944, XP002679784 [I] 1-15 * abstract *
SEARCH- SIMPSON DENE ET AL, "Glatiramer acetate: A review of its use in relapsing-remitting multiple sclerosis.", CNS DRUGS, (2002), vol. 16, no. 12, ISSN 1172-7047, pages 825 - 850, XP009161077 [A] 1-15 * "Therapeutic efficacy" on page 835 and "Dosage and Administration" on page 844 * * table II *

Download Citation Report

Get a free citation report including examiner, opposition, and international search citations.

Get Citation Report

Dossier Documents

The dossier documents provide a comprehensive record of the patent’s prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent’s legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents