Extract from the Register of European Patents

About this file: EP2801355

EP2801355 - Controlled release pharmaceutical compositions comprising a fumaric acid ester [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  24.04.2015
Database last updated on 18.10.2017
Most recent event   Tooltip16.06.2017New entry: Date of oral proceedings 
Applicant(s)For all designated states
Forward Pharma A/S
Østergade 24 A 1.
1100 København K / DK
[2014/46]
Inventor(s)01 / Nilsson, Henrik
Cort Adelersgade 4, st.th.
1053 Copenhagen / DK
02 / Schönharting, Florian
Esplanaden 5, 3. sal
1263 Copenhagen K / DK
03 / Müller, Bernd, W.
Schlotfeldtsberg 14a
24220 Flintbek / DE
04 / Robinson, Joseph, R.
41 Chequamegon Bay
Madison, WI Wisconsin 53719 / US
 [2014/46]
Representative(s)Henkel, Breuer & Partner
Patentanwälte
Erika-Mann Strasse 23
80636 München / DE
[N/P]
Former [2015/21]Weickmann & Weickmann
Postfach 860 820
81635 München / DE
Former [2014/46]Weiss, Wolfgang , et al
Weickmann & Weickmann Postfach 860820
81635 München / DE
Application number, filing date14172398.107.10.2005
[2014/46]
Priority number, dateDK2004000154608.10.2004         Original published format: DK 200401546
DK2004000173610.11.2004         Original published format: DK 200401736
DK2005000021111.02.2005         Original published format: DK 200500211
DK2005000041923.03.2005         Original published format: DK 200500419
US20050691513P16.06.2005         Original published format: US 691513 P
[2014/46]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP2801355
Date:12.11.2014
Language:EN
[2014/46]
Type: B1 Patent specification 
No.:EP2801355
Date:20.05.2015
Language:EN
[2015/21]
Search report(s)(Supplementary) European search report -
dispatched on:
EP14.10.2014
ClassificationInternational:A61K9/20, A61K9/50
[2014/46]
Designated contracting statesAT,   BE,   BG,   CH,   CY,   CZ,   DE,   DK,   EE,   ES,   FI,   FR,   GB,   GR,   HU,   IE,   IS,   IT,   LI,   LT,   LU,   LV,   MC,   NL,   PL,   PT,   RO,   SE,   SI,   SK,   TR [2014/46]
Extension statesAL13.06.2014
BA13.06.2014
HR13.06.2014
MK13.06.2014
YU13.06.2014
TitleGerman:Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester[2014/46]
English:Controlled release pharmaceutical compositions comprising a fumaric acid ester[2014/46]
French:Compositions pharmaceutiques à libération contrôlée comportant un ester d'acide fumarique[2014/46]
Examination procedure13.06.2014Examination requested  [2014/46]
21.11.2014Observations by third parties
22.12.2014Observations by third parties
26.03.2015Communication of intention to grant the patent
09.04.2015Fee for grant paid
09.04.2015Fee for publishing/printing paid
09.04.2015Receipt of the translation of the claim(s)
Parent application(s)   TooltipEP05789026.1  / EP1799196
Opposition(s)Opponent(s)01  09.02.2016  12.02.2016  ADMISSIBLE
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
ul. Peplinska 19
83-200 Starogard Gdanski / PL
Opponent's representative
Murray, Adrian D'Coligny
Pinsent Masons LLP
30 Crown Place
Earl Street
London EC2A 4ES / GB
 02  17.02.2016  23.02.2016  ADMISSIBLE
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Sonn & Partner Patentanwälte
Riemergasse 14
1010 Wien / AT
 03  18.02.2016  23.02.2016  ADMISSIBLE
Strawman Limited
Orchard Lea
Horns Lane
Combe, Witney
Oxfordshire OX29 8NH / GB
Opponent's representative
Moore, Michael Richard
Keltie LLP
No.1 London Bridge
London SE1 9BA / GB
 04  17.02.2016  25.02.2016  ADMISSIBLE
Zentiva k.s.
U kabelovny 130
10237 Praha 10 / CZ
Opponent's representative
Grünecker Patent- und Rechtsanwälte PartG mbB
Leopoldstraße 4
80802 München / DE
 05  18.02.2016  25.02.2016  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Best, Michael
Lederer & Keller
Patentanwälte Partnerschaft mbB
Unsöldstrasse 2
80538 München / DE
 06  19.06.2015  25.02.2016  ADMISSIBLE
Laboratorios Liconsa, S.A.
Gran Via Carlos III, 98, 7th floor
08028 Barcelona / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner mbB
Bavariaring 26
80336 München / DE
 07  19.02.2016  30.03.2016  ADMISSIBLE
Interquim S.A.
Av. Ragull, 60, 3rd floor
08173 Sant Cugal del Vallès / ES
Opponent's representative
Cucarull González, Joan Ramon, et al
Ferrer Internacional S.A.
Patent Department
Joan Buscallà, 1-9
08173 Sant Cugat del Vallès / ES
 08  19.02.2016  25.02.2016  ADMISSIBLE
Biogen MA Inc.
250 Binney Street
Cambridge, MA 02142 / US
Opponent's representative
Pohlman, Sandra M.
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 09  19.02.2016  25.02.2016  ADMISSIBLE
Actavis Group PTC EHF
Reykjavikurvegur 76-78
220 Hafnarfjordur / IS
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB
Jungfernstieg 38
20354 Hamburg / DE
 10  19.02.2016  25.02.2016  ADMISSIBLE
Generics [UK] Limited
Albany Gate Darkes Lane Potters Bar
Hertfordshire EN6 1AG / GB
Opponent's representative
Gillard, Richard Edward
Elkington and Fife LLP
Thavies Inn House
3-4 Holborn Circus
London EC1N 2HA / GB
 11  22.02.2016  01.03.2016  ADMISSIBLE
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel / DE
Opponent's representative
Kernebeck, Thomas
Kernebeck Patentanwalts GmbH
Stiftstraße 2
60313 Frankfurt am Main / DE
 [N/P]
Former [2016/13]
Opponent(s)01  09.02.2016  12.02.2016  ADMISSIBLE
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
ul. Peplinska 19
83-200 Starogard Gdanski / PL
Opponent's representative
Murray, Adrian D'Coligny
Pinsent Masons
30 Crown Place
Earl Street
London
EC2A 4ES / GB
 02  17.02.2016  23.02.2016  ADMISSIBLE
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Sonn & Partner Patentanwälte
Riemergasse 14
1010 Wien / AT
 03  18.02.2016  23.02.2016  ADMISSIBLE
Strawman Limited
Orchard Lea
Horns Lane
Combe, Witney
Oxfordshire OX29 8NH / GB
Opponent's representative
Moore, Michael Richard
Keltie LLP
No.1 London Bridge
London SE1 9BA / GB
 04  17.02.2016  25.02.2016  ADMISSIBLE
Zentiva k.s.
U kabelovny 130
10237 Praha 10 / CZ
Opponent's representative
Grünecker Patent- und Rechtsanwälte PartG mbB
Leopoldstraße 4
80802 München / DE
 05  18.02.2016  25.02.2016  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Best, Michael
Lederer & Keller
Patentanwälte Partnerschaft mbB
Unsöldstrasse 2
80538 München / DE
 06  19.06.2015  25.02.2016  ADMISSIBLE
Laboratorios Liconsa, S.A.
Gran Via Carlos III, 98, 7th floor
08028 Barcelona / ES
Opponent's representative
Schön, Christoph
Dr. Schön, Neymeyr & Partner
Patentanwälte mbB
Bavariaring 26
80336 München / DE
 07  19.02.2016   
Interquim S.A.
Av. Ragull, 60, 3rd floor
08173 Sant Cugal del Vallès / ES
Opponent's representative
Cucarull González, Joan Ramon, et al
Ferrer Internacional, S.A.
Av. Ragull, 60 2nd Floor
08173 Sant Cugat del Vallès / ES
 08  19.02.2016  25.02.2016  ADMISSIBLE
Biogen MA Inc.
250 Binney Street
Cambridge, MA 02142 / US
Opponent's representative
Pohlman, Sandra M.
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstrasse 16
80333 München / DE
 09  19.02.2016  25.02.2016  ADMISSIBLE
Actavis Group PTC EHF
Reykjavikurvegur 76-78
220 Hafnarfjordur / IS
Opponent's representative
Hamm & Wittkopp Patentanwälte PartmbB
Jungfernstieg 38
20354 Hamburg / DE
 10  19.02.2016  25.02.2016  ADMISSIBLE
Generics [UK] Limited
Albany Gate Darkes Lane Potters Bar
Hertfordshire EN6 1AG / GB
Opponent's representative
Gillard, Richard Edward
Elkington and Fife LLP
Thavies Inn House
3-4 Holborn Circus
London EC1N 2HA / GB
 11  22.02.2016   
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel / DE
Opponent's representative
Kernebeck, Thomas
Kernebeck Patentanwalts GmbH
Stiftstraße 2
60313 Frankfurt am Main / DE
Former [2016/12]
Opponent(s)01  09.02.2016  12.02.2016  ADMISSIBLE
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
ul. Peplinska 19
83-200 Starogard Gdanski / PL
Opponent's representative
Murray, Adrian D'Coligny
Pinsent Masons
30 Crown Place
Earl Street
London
EC2A 4ES / GB
 02  17.02.2016   
G. L. Pharma GmbH
Schlossplatz 1
8502 Lannach / AT
Opponent's representative
Sonn & Partner Patentanwälte
Riemergasse 14
1010 Wien / AT
Former [2016/11]
Opponent(s)01  09.02.2016   
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
ul. Peplinska 19
83-200 Starogard Gdanski / PL
Opponent's representative
Murray, Adrian D'Coligny
Pinsent Masons
30 Crown Place
Earl Street
London
EC2A 4ES / GB
06.04.2016Invitation to proprietor to file observations on the notice of opposition
16.12.2016Reply of patent proprietor to notice(s) of opposition
29.01.2018Date of oral proceedings
Fees paidRenewal fee
13.06.2014Renewal fee patent year 03
13.06.2014Renewal fee patent year 04
13.06.2014Renewal fee patent year 05
13.06.2014Renewal fee patent year 06
13.06.2014Renewal fee patent year 07
13.06.2014Renewal fee patent year 08
13.06.2014Renewal fee patent year 09
31.07.2014Renewal fee patent year 10
Lapses during opposition  TooltipCZ20.05.2015
MC20.05.2015
RO20.05.2015
SK20.05.2015
BG20.08.2015
[2016/28]
Former [2016/10]CZ20.05.2015
RO20.05.2015
SK20.05.2015
BG20.08.2015
Former [2015/51]BG20.08.2015
Documents cited:Search[A]US5424332  (SPEISER PETER P [CH], et al) [A] 1-10 * example 1 *;
 [A]US6359003  (JOSHI RAJENDRA KUMAR [CH], et al) [A] 1-10 * column 2, line 54 - column 3, line 13; example 8; claims 1,8,10,11 *;
 [A]US2003013761  (JOSHI RAJENDRA KUMAR [CH], et al) [A] 1-10 * paragraphs [0012] - [0015] - [0019]; examples 1-3 *;
 [A]US6355676  (JOSHI RAJENDRA KUMAR [CH], et al) [A] 1-10 * column 5, lines 1-59; examples 1,2; claims 1-3,19,37; table 1 *;
 [A]US4959389  (SPEISER PETER P [CH], et al) [A] 1-10 * column 1, lines 44-65; examples 1-4; claim 1 *;
 [A]  - KREUTER A ET AL, "TREATMENT OF DISSEMINATED GRANULOMA ANNULARE WITH FUMARIC ACID ESTERS", BMC DERMATOLOGY, BIOMED CENTRAL,, US, (20020319), vol. 2, no. 5, ISSN 1471-5945, XP008047020 [A] 1-10 * the whole document *

DOI:   http://dx.doi.org/10.1186/1471-5945-2-5
by applicantUS6277882
 US6355676
 US6509376
 US4959389
 GB1153927
 WO03004001
 WO03080034
 US6537584
 US5484610
    - LITJENS ET AL., BR. J. CLIN. PHARMACOL., (2004), vol. 58, no. 4, pages 429 - 432,
    - REDDINGIUS W.G., "Bloanalysis and Pharmacokinetics of Fumarates in Humans", DISSERTATION ETH ZURICH NO. 12199, (1997),
    - "Treatment of disseminated granuloma annulare with fumaric acid esters", MC DERMATOLOGY, (2002), vol. 2, no. 5,
    - ALTMEYER ET AL., J. AM. ACAD. DERMATOL, (1994),
    - ALTMEYER PJ ET AL., "Antipsoriatic effect of fumaric acid derivatives. Results of a multicenter double-blind study In 100 patients", J. AM. ACAD. DERMATOL., (1994), vol. 30, pages 977 - 81, XP009076066
    - NAJARIAN DJ; GOTTLIEB AB, "Connections between psoriasis and Crohn's disease", J AM ACAD DERMATOL., (200306), vol. 48, no. 6, doi:doi:10.1067/mjd.2003.540, pages 805 - 21, XP055078766

DOI:   http://dx.doi.org/10.1067/mjd.2003.540
    - OJETTI V ET AL., "High prevalence of celiac disease in psoriasis", AM J GASTROENTEROL, (200311), vol. 98, no. 11, pages 2574 - 5, XP055078772

DOI:   http://dx.doi.org/10.1016/S0002-9270(03)01717-9
    - GUPTA MA; GUPTA AK, "Psychiatric and psychological co-morbidity in patients with dermatologic disorders: epidemiology and management", AM J CLIN DERMATOL., (2003), vol. 4, no. 12, pages 833 - 42,
    - MALLBRIS L ET AL., "Psoriasis phenotype at disease onset: clinical characterization of 400 adult cases", J INVEST DERMATOL., (200503), vol. 124, no. 3, pages 499 - 504,
other   - BURGER A. ET AL, HUNNIUS PHARMAZEUTISCHES WöRTERBUCH, 6.AUFLAGE, WALTERDE GRUYTER, (1986), page 357, XP003035244