Extract from the Register of European Patents

About this file: EP2949335

EP2949335 - LOW FREQUENCY GLATIRAMER ACETATE THERAPY [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  02.12.2016
Database last updated on 22.08.2019
FormerGrant of patent is intended
Status updated on  30.11.2016
Most recent event   Tooltip05.07.2019New entry: Appeal number 
05.07.2019New entry: Date of receipt of notice of appeal 
Applicant(s)For all designated states
YEDA RESEARCH & DEVELOPMENT COMPANY, LTD.
P.O. Box 95
76100 Rehovot / IL
[2015/49]
Inventor(s)01 / Klinger, Ety
16 Agadati Street
39930 Tel Aviv / IL
 [2015/49]
Representative(s)D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
[2015/49]
Application number, filing date15171065.419.08.2010
[2015/49]
Priority number, dateUS20090274687P20.08.2009         Original published format: US 274687 P
US20100337612P11.02.2010         Original published format: US 337612 P
[2015/49]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP2949335
Date:02.12.2015
Language:EN
[2015/49]
Type: B1 Patent specification 
No.:EP2949335
Date:04.01.2017
Language:EN
[2017/01]
Search report(s)(Supplementary) European search report - dispatched on:EP16.10.2015
ClassificationInternational:A61K38/02, A61K38/16, A61P25/28, A61K38/07, A61K9/00, A61K31/785
[2016/43]
Former International [2015/49]A61K38/02, A61K38/16, A61P25/28, A61K38/07, A61K9/00
Designated contracting statesAL,   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,   SE,   SI,   SK,   SM,   TR [2015/49]
Extension statesBA08.06.2015
ME08.06.2015
RS08.06.2015
TitleGerman:NIEDRIGFREQUENTE GLATIRAMERAZETATTHERAPIE[2015/49]
English:LOW FREQUENCY GLATIRAMER ACETATE THERAPY[2015/49]
French:THÉRAPIE À L'ACÉTATE DE GLATIRAMÈRE À BASSE FRÉQUENCE[2015/49]
Examination procedure08.06.2015Examination requested  [2015/49]
21.01.2016Despatch of a communication from the examining division (Time limit: M04)
23.05.2016Reply to a communication from the examining division
19.08.2016Despatch of a communication from the examining division (Time limit: M01)
20.08.2016Reply to a communication from the examining division
27.10.2016Communication of intention to grant the patent
28.11.2016Fee for grant paid
28.11.2016Fee for publishing/printing paid
28.11.2016Receipt of the translation of the claim(s)
06.12.2016Observations by third parties
Parent application(s)   TooltipEP10810282.3  / EP2405749
EP13166080.5  / EP2630962
Opposition(s)Opponent(s)01  03.10.2017  09.10.2017  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Building 4, Trident Place
Mosquito Way, Hatfield
GB-Hertfordshire AL 10 9UL / GB
Opponent's representative
Gill Jennings & Every LLP, et al
MXL The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V./Genthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 03  04.10.2017  13.10.2017  ADMISSIBLE
Alvogen IPCo S.a.r.l.
5 rue Heienhaff
1736 Senningerberg / LU
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 04  04.10.2017  13.10.2017  ADMISSIBLE
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 05  04.10.2017  13.10.2017  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Henkel, Breuer & Partner, et al
Patentanwälte
Brienner Strasse 1
80333 München / DE
 06  27.11.2017  27.11.2017  INTERVENTION ADMISSIBLE
Mylan Teoranta Trading as Mylan Institutional
Inverin
H91 Co. Galway / IE
Opponent's representative
Gill Jennings & Every LLP
APC The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 [2018/08]
Former [2018/01]
Opponent(s)01  03.10.2017  09.10.2017  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Building 4, Trident Place
Mosquito Way, Hatfield
GB-Hertfordshire AL 10 9UL / GB
Opponent's representative
Gill Jennings & Every LLP, et al
MXL The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V./Genthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 03  04.10.2017  13.10.2017  ADMISSIBLE
Alvogen IPCo S.a.r.l.
5 rue Heienhaff
1736 Senningerberg / LU
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 04  04.10.2017  13.10.2017  ADMISSIBLE
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 05  04.10.2017  13.10.2017  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Henkel, Breuer & Partner, et al
Patentanwälte
Brienner Strasse 1
80333 München / DE
 06  27.11.2017   
Mylan Teoranta Trading as Mylan Institutional
Inverin
H91 Co. Galway / IE
Opponent's representative
Gill Jennings & Every LLP
APC The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
Former [2017/47]
Opponent(s)01  03.10.2017  09.10.2017  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Building 4, Trident Place
Mosquito Way, Hatfield
GB-Hertfordshire AL 10 9UL / GB
Opponent's representative
Gill Jennings & Every LLP, et al
MXL The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V./Genthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 03  04.10.2017  13.10.2017  ADMISSIBLE
Alvogen IPCo S.a.r.l.
5 rue Heienhaff
1736 Senningerberg / LU
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 04  04.10.2017  13.10.2017  ADMISSIBLE
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 05  04.10.2017  13.10.2017  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Henkel, Breuer & Partner, et al
Patentanwälte
Brienner Strasse 1
80333 München / DE
Former [2017/46]
Opponent(s)01  03.10.2017  09.10.2017  ADMISSIBLE
Generics [UK] Limited (trading as Mylan)
Building 4, Trident Place
Mosquito Way, Hatfield
GB-Hertfordshire AL 10 9UL / GB
Opponent's representative
Gill Jennings & Every LLP, et al
MXL The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V./Genthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 03  04.10.2017   
Alvogen IPCo S.a.r.l.
5 rue Heienhaff
1736 Senningerberg / LU
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 04  04.10.2017   
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al
Jungfernstieg 38
20354 Hamburg / DE
 05  04.10.2017   
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Henkel, Breuer & Partner, et al
Patentanwälte
Erika-Mann Strasse 23
80636 München / DE
09.11.2017Invitation to proprietor to file observations on the notice of opposition
18.05.2018Reply of patent proprietor to notice(s) of opposition
28.03.2019Date of oral proceedings
13.05.2019Despatch of interlocutory decision in opposition
13.05.2019Despatch of minutes of oral proceedings
Appeal following opposition04.07.2019Appeal received No.  T1343/19
05.04.2019Appeal received No.  T1343/19
02.04.2019Appeal received No.  T1343/19
Fees paidRenewal fee
08.06.2015Renewal fee patent year 03
08.06.2015Renewal fee patent year 04
08.06.2015Renewal fee patent year 05
08.06.2015Renewal fee patent year 06
22.08.2016Renewal fee patent year 07
Lapses during opposition  TooltipNL04.01.2017
GB21.11.2017
[2018/21]
Former [2017/40]NL04.01.2017
Documents cited:Search[I]US2007161566  (PINCHASI IRIT [IL]) [I] 1-15 * paragraphs [0019] , [0021] , [0037]; example 1; claims 1,3 *;
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DOI:   http://dx.doi.org/10.1016/S0022-510X(02)00047-3
 [A]  - 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 *

DOI:   http://dx.doi.org/10.1097/00002826-200201000-00002
 [A]  - 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 *
 [A]  - 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 *
 [I]  - 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 *

DOI:   http://dx.doi.org/10.1212/01.wnl.0000257109.61671.06
 [A]  - 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 *

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 [I]  - 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 *
 [I]  - 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 *
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OppositionWO2007081975
 WO2011022063
 WO2011022063  * (the parent application as filed); *
 US2007161566
 EP2949335  * ; * * ; *
 WO0020010
    - "View of NCT01067521", ClinicalTrials.gov archive, (20100210), XP055508500
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    - 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
    - GAGNON L., "Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions with Comparable Efficacy to Daily Dosing", WCTRMS, (20080921), XP055508581

DOI:   http://dx.doi.org/http://www.peervoice.com/every-other-day-dosing-glatiramer-acetate-reduces-adverse-reactions-comparable-efficacy-daily-dosing-presented-wctrms#
    - 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
    - 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

DOI:   http://dx.doi.org/10.1016/S0022-510X(02)00047-3
    - 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

DOI:   http://dx.doi.org/10.1097/00002826-200201000-00002
    - 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
    - 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
    - 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

DOI:   http://dx.doi.org/10.1212/01.wnl.0000257109.61671.06
    - SIMPSON et al., "Glatiramer acetate: A review of its use in relapsing-remitting multiple sclerosis", CNS D, (20020000), pages 825 - 850, XP009161077

DOI:   http://dx.doi.org/10.2165/00023210-200216120-00004
    - "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
    - 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
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    - "(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
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DOI:   http://dx.doi.org/10.1586/14737167.7.2.187
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    - 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
    - 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
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    - National litigation referred to in section 1.2(c) above, German nullity claim
    - Multiple Sclerosis, (20090000), vol. 15, pages S249 - S250
    - 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

DOI:   http://dx.doi.org/10.1016/S0022-510X(02)00047-3
    - 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

DOI:   http://dx.doi.org/10.1097/00002826-200201000-00002
    - 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
    - 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 * ) Suppl 3; *
    - SIMPSON et al., "Glatiramer acetate: A review of its use in relapsing-remitting multiple sclerosis", CNS Drugs, (20020000), pages 925 - 850, XP009161077

DOI:   http://dx.doi.org/10.2165/00023210-200216120-00004
    - "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
    - 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
    - "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
    - "(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
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