Extract from the Register of European Patents

EP About this file: EP2949335

EP2949335 - LOW FREQUENCY GLATIRAMER ACETATE THERAPY [Right-click to bookmark this link]
StatusPatent revoked
Status updated on  27.04.2021
Database last updated on 11.04.2026
FormerThe patent has been granted
Status updated on  02.12.2016
FormerGrant of patent is intended
Status updated on  30.11.2016
Most recent event   Tooltip30.04.2021Revocation of patentpublished on 02.06.2021  [2021/22]
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
3 Noble Street
London EC2V 7BQ / GB
[N/P]
Former [2015/49]D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
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
ClassificationIPC:A61K38/02, A61K38/16, A61P25/28, A61K38/07, A61K9/00, A61K31/785
[2016/43]
CPC:
A61K31/19 (EP,US); A61K38/02 (EP,AT,US); A61K31/195 (KR);
A61K38/16 (AT,CN,EA,US); A61K31/198 (EA); A61K9/0019 (AT,CN,US);
A61K31/785 (EP,US); A61K38/07 (US); A61K47/26 (CN);
A61K9/08 (KR); A61P25/00 (EA); A61P3/10 (EP,US) (-)
Former IPC [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, et al
The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al, 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, 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, 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
Breuer, Markus, et al, et al
Sendlinger Straße 29
80331 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
The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 [N/P]
Former [2021/20]
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, et al
MXL The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al, 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, 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, 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
Breuer, Markus, et al, et al
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
Former [2020/18]
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, et al
MXL The Broadgate Tower
20 Primrose Street
London EC2A 2ES / GB
 02  04.10.2017  09.10.2017  ADMISSIBLE
Synthon B.V.
Microweg 22
6545 CM Nijmegen / NL
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB, et al, 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, 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, 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
Breuer, Markus, et al, et al
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
Former [2019/45]
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, 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, 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, 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, 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
Breuer, Markus, et al, et al
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
Former [2018/08]
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, 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, 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, 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, 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, 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
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, 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, 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, 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, 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, et al
Patentanwälte
Brienner Strasse 1
80333 München / DE
 06  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
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, 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, 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, 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, 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, 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, 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, et al
Jungfernstieg 38
20354 Hamburg / DE
 03  04.10.2017    ADMISSIBLE
Alvogen IPCo S.a.r.l.
5 rue Heienhaff
1736 Senningerberg / LU
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al, et al
Jungfernstieg 38
20354 Hamburg / DE
 04  04.10.2017    ADMISSIBLE
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB, et al, 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, 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
10.09.2020Legal effect of revocation of patent [2021/22]
31.03.2021Despatch of communication that the patent will be revoked
Appeal following opposition04.07.2019Appeal received No.  T1343/19
23.09.2019Statement of grounds filed
10.09.2020Result of appeal procedure: revocation of the patent
31.03.2021Despatch of the decision of the Board of Appeal
02.04.2019Appeal received No.  T1343/19
11.09.2019Statement of grounds filed
10.09.2020Result of appeal procedure: revocation of the patent
31.03.2021Despatch of the decision of the Board of Appeal
05.04.2019Appeal received No.  T1343/19
02.09.2019Statement of grounds filed
10.09.2020Result of appeal procedure: revocation of the patent
31.03.2021Despatch of the decision of the Board of Appeal
10.09.2020Date of oral proceedings
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
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Lapses during opposition  TooltipNL04.01.2017
GB21.11.2017
[2018/21]
Former [2017/40]NL04.01.2017
Documents cited:Search[I] US2007161566  (PINCHASI IRIT et al.)
 [A]   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, vol. 197, no. 1-2, 15 May 2002 (2002-05-15), pages 51 - 55, XP002679780, ISSN: 0022-510X

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, vol. 25, no. 1, January 2002 (2002-01-01), pages 11 - 15, XP009161076, ISSN: 0362-5664

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., P902, 2008, XP009161078
 [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, vol. 72, no. 11, Suppl. 3, March 2009 (2009-03-01), & 61ST ANNUAL MEETING OF AMERICAN-ACADEMY-OF-NEUROLOGY; SEATTLE, WA, USA; APRIL 28 -29, 2009, pages A317, XP009161100, ISSN: 0028-3878
 [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, vol. 68, no. 12, 20 March 2007 (2007-03-20), pages 939 - 944, XP002679784, ISSN: 1526-632X

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, vol. 16, no. 12, 2002, pages 825 - 850, XP009161077, ISSN: 1172-7047

DOI:   http://dx.doi.org/10.2165/00023210-200216120-00004
 [I]   ANONYMOUS: "Teva Provides Update on FORTE Trial", 7 July 2008 (2008-07-07), XP002743817, Retrieved from the Internet [retrieved on 20150831]
 [I]   YONG WEE V ET AL: "Immunological Responses to Different Doses of Glatiramer Acetate in MS: Analyses from the FORTE Trial", NEUROLOGY, vol. 72, no. 11, Suppl. 3, March 2009 (2009-03-01), & 61ST ANNUAL MEETING OF AMERICAN-ACADEMY-OF-NEUROLOGY; SEATTLE, WA, USA; APRIL 28 -29, 2009, pages A39, XP002743818, ISSN: 0028-3878
by applicantUS2002055466
 US2005014694
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 US2002037848
 US6514938
 WO0160392
 WO0027417
 WO0197846
 US2008013146
 WO2009070298
 US2009149541
   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., vol. 49, 2001, pages 290 - 297, XP009042363, DOI: doi:10.1002/ana.64

DOI:   http://dx.doi.org/10.1002/ana.64
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   ANN NEUROL, vol. 58, 2005, pages 840 - 846
   KANSARA V; MITRA A; WU Y: "Subcutaneous Delivery", DRUG DELIV TECHNOL, vol. 9, no. 6, June 2009 (2009-06-01), pages 38 - 42
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 EP2405749
   Y.-C. J. WANG: "PARENTERAL FORMULATIONS OF PROTEINS AND PEPTIDES: STABILITY AND STABILIZERS", J. PARENT. SCI. TECHN., vol. 42, no. 2S, 1988, pages S4 - S26, XP000984636
OppositionWO2007081975
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 WO2011022063
 WO2011022063
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 US27468709
 EP2949335
 WO0020010
 WO2011022063
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 US27468709
 EP2949335
 WO0020010
   "View of NCT01067521", CLINICALTRIALS.GOV ARCHIVE, 10 February 2010 (2010-02-10), XP055508500
   "FDA label Rebif PI", WWW.ACCESSDATA.FDA.GOV, 8 March 2002 (2002-03-08), XP055508530, Retrieved from the Internet
   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, 1996, XP055508552
   GRENNERO ALFONSO: "Remington's Pharmaceutical Sciences", 1990, MACK PUBLISHING COMPANY, Easton, Pennsylvania, pages: 1813 - 1827, XP055508569
   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, vol. 14, September 2008 (2008-09-01), pages S296, XP009161078
   GAGNON L.: "Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions with Comparable Efficacy to Daily Dosing", WCTRMS, 21 September 2008 (2008-09-21), 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, vol. 14, 2008, 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, vol. 197, 15 May 2002 (2002-05-15), 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, vol. 25, no. 1, 2002, 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, vol. 14, 2008, pages 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, vol. 72, no. 11, 17 March 2009 (2009-03-17), pages A317, XP009161100
   COHEN ET AL.: "Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS", NEUROLOGY, vol. 68, no. 12, 2007, 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 DRUGS, 2002, 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", 10 October 2012 (2012-10-10), XP055607303, Retrieved from the Internet
   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, 10 October 2012 (2012-10-10), XP055607318
   "Copaxone 20mg/ml, Solution For Injection, Pre-Filled Syringe", pages 1 - 7, XP055579983, Retrieved from the Internet
   "(P01.124) Immunological Responses to Different Doses of Glatiramer Acetate in MS: Analyses from the FORTE Trial", vol. 11, no. 3, suppl, 28 April 2009 (2009-04-28), 61st Annual Meeting of American-Academy-of-Neurology; Seattle, WA, USA, April 28 - 29, 2009, XP002743818, Retrieved from the Internet
   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", 2008, XP055607341, Retrieved from the Internet
   "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, 2006, XP055581348, Retrieved from the Internet
   "Data Publised In Neurology Showed That Higher Dose Of Copaxone(R) increased Efficacy in Relapsing-Remitting Multiple Sclerosis (Rrms)", XP055607348, Retrieved from the Internet
   ALISON PALKHIVALA: "Doubling the Dose of Glatiramer Acetate Does Not Increase Efficacy", MEDSCAPE, 22 September 2008 (2008-09-22), XP055579985, Retrieved from the Internet
   "View of NCT01067521", CLINICALTRIALS.GOV ARCHIVE, 10 February 2010 (2010-02-10), XP055508500
   "Impact of dose frequency on compliance and health outcomes: a literature review (1966-2006)", EXPERT REV. PHARMACOECONOMICS OUTCOMES RES., vol. 7, no. 2, 2007, pages 187 - 202, XP055579988

DOI:   http://dx.doi.org/10.1586/14737167.7.2.187
   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, 30 September 2008 (2008-09-30), XP055579991, Retrieved from the Internet
   "Product Life-Cycle Management for Injectable Drugs: A Good Outlook for Proactive", 2 December 2006 (2006-12-02), XP055579996, Retrieved from the Internet [retrieved on 20160115]
   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, vol. 12, no. 1, 31 May 2006 (2006-05-31), pages 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., vol. SI, December 2006 (2006-12-01), XP055579999
   "Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers", JOURNAL OF PARENTERAL SCIENCE AND TECHNOLOGY, vol. 42, no. 2S, 1988, pages S1 - S26, XP055253757
   MULTIPLE SCLEROSIS, vol. 15, 2009, 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, vol. 197, no. 1-2, 15 May 2002 (2002-05-15), 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, vol. 25, no. 1, 2002, 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, vol. 14, 2008, pages 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, vol. 72, no. 11, 17 March 2009 (2009-03-17), pages 3, XP009161100
   COHEN ET AL.: "Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS", NEUROLOGY, vol. 68, no. 12, 2007, 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, 2002, 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, 10 October 2012 (2012-10-10), XP055607303, Retrieved from the Internet
   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, 10 October 2012 (2012-10-10), XP055607318
   "Copaxone 20mg/ml, Solution For Injection, Pre-Filled Syringe", COPAXONE UK PRODUCT LABEL ;, 17 April 2009 (2009-04-17), pages 1 - 7, XP055579983
   "(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,, vol. 72, 28 April 2009 (2009-04-28), XP002743818
   "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, 2008, XP055607341
   "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, 2006, XP055581348
   "Data Published in Neurology showed that higher dosie of Copaxone(R) increased efficacy in relapsing remitting Mutiple Sclerosis (Rrms)", 17 April 2007 (2007-04-17), XP055581344, Retrieved from the Internet
   "Doubling the Dose of Glatiramer Acetate Does Not Increase Efficacy", MEDSCAPE, 22 September 2008 (2008-09-22), XP055579985
   "View of NCT01067521", CLINICALTRIALS.GOV ARCHIVE, 10 February 2010 (2010-02-10), XP055508500
   SHI ET AL.: "mpact of dose frequency on compliance and health outcomes: a literature review (1966-2006)", EXPERT REV. PHARMACOECONOMICS OUTCOMES RES., vol. 7, no. 2, 2007, pages 187 - 202, XP055579988

DOI:   http://dx.doi.org/10.1586/14737167.7.2.187
   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, 30 September 2008 (2008-09-30), pages 225, XP055579991
   "Product Life-Cycle Management for Injectable Drugs: A Good Outlook for Proactive Market players", 2 December 2006 (2006-12-02), XP055579996, Retrieved from the Internet
   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, vol. 12, no. Suppl. 1, 31 May 2006 (2006-05-31), pages 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., vol. 12, no. S1, 2006, pages S82, XP055579999
   "Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers", JOURNAL OF PARENTERAL SCIENCE AND TECHNOLOGY, vol. 42, no. 2S, 1988, pages S1 - S26, XP055253757
   NATIONAL LITIGATION REFERRED TO IN SECTION 1.2(C) ABOVE, GERMAN NULLITY CLAIM
   MULTIPLE SCLEROSIS, vol. 15, 2009, pages S249 - S250
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