Patent details

300930 Product Name: Cladribine

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Basic Information

Publication number:
300930
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP1827461
Status:
Refused Art. 10 of the EC Regulations
Application number:
300930
Procedural language:
Dutch
First Applicant Residence Country:
Switzerland (CH)

Marketing Authorization

Marketing Authorization Number:
EU/1/17/1212
Marketing Authorization Type:
EEA
Marketing Authorization Date:
24/08/2017
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
22/02/2018
First Marketing Authorization date:
24/08/2017
Grant date:
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
27/02/2018
SPC/SPC Extension Expiration Date:
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:
19/07/2022

Applicant/holder

From:
22/02/2018
 
 

 

Name:
Merck Serono SA
Address:
Centre Industriel, 1267, Coinsins, Vaud, Switzerland (CH)

Agent

Name:
ir. H.A. Witmans c.s.
From:
22/02/2018
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

Opposition

Appeals

1

Appeal Request Number:
000168
Appeal Filling Date:
30/08/2022
Requestor For Appeal Name:
Merck Serono SA
Appeal Reason:
SPC Application Rejected
Appeal Type:
Internal Appeal
Appeal Status:
Completed
Appeal Decision:
Negative
Appeal Decision Issued Date:
14/02/2025
Appeal Decision Summary:

2

Appeal Request Number:
000209
Appeal Filling Date:
26/03/2025
Requestor For Appeal Name:
Merck Serono SA
Appeal Reason:
Negative Appeal Decision
Appeal Type:
External Appeal (on court)
Appeal Status:
Pending
Appeal Decision:
Appeal Decision Issued Date:
Appeal Decision Summary:

Publication

Bulletin

1

Bulletin Heading:
VB1
Journal edition number:
14/25
Publication date:
02/04/2025
Description:
Requests for restoration and notices of objection, notices of objection to Court, notices of objection to appelate court ex NL Patent Law 1995. Opposition(s) filed ex European Patent Convention

2

Bulletin Heading:
VB2
Journal edition number:
08/25
Publication date:
19/02/2025
Description:
Requests for restoration and notices of objection, notices of objection to Court, notices of objection to appelate court ex NL Patent Law 1995 in respect of which a decision has been taken. Opposition(s) decisions ex European Patent Convention

3

Bulletin Heading:
VB1
Journal edition number:
36/22
Publication date:
07/09/2022
Description:
Requests for restoration and notices of objection, notices of objection to Court, notices of objection to appelate court ex NL Patent Law 1995. Opposition(s) filed ex European Patent Convention

4

Bulletin Heading:
VRV
Journal edition number:
29/22
Publication date:
20/07/2022
Description:
Lapse or annulment

5

Bulletin Heading:
SPC
Journal edition number:
10/18
Publication date:
28/02/2018
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Filing date Document type Document Description Number of pages File Type
31/07/2025 Outgoing Correspondence Statement of defence 12 PDF /2/8/8/2/4/0800242882/docs/300930_75_300930667550l159.pdf
11/07/2025 Appeal Appeal 1 PDF /2/8/8/2/4/0800242882/docs/300930_66_appeal20250711111758909.pdf
26/06/2025 Appeal Accompanying letter appeal procedure 5 PDF /2/8/8/2/4/0800242882/docs/300930_49_appeal20250626030142559.pdf
26/06/2025 Appeal Annex 3 PDF /2/8/8/2/4/0800242882/docs/300930_50_appeal20250626032251597.pdf
26/06/2025 Appeal Annex 3 PDF /2/8/8/2/4/0800242882/docs/300930_51_appeal20250626032432983.pdf
26/06/2025 Appeal Annex 19 PDF /2/8/8/2/4/0800242882/docs/300930_52_appeal20250626032834125.pdf
26/06/2025 Appeal Annex 7 PDF /2/8/8/2/4/0800242882/docs/300930_53_appeal20250626032742041.pdf
26/06/2025 Appeal Annex 9 PDF /2/8/8/2/4/0800242882/docs/300930_54_appeal20250626033813558.pdf
26/06/2025 Appeal Annex 10 PDF /2/8/8/2/4/0800242882/docs/300930_55_appeal20250626034007358.pdf
26/06/2025 Appeal Annex 7 PDF /2/8/8/2/4/0800242882/docs/300930_56_appeal20250626032119274.pdf
26/06/2025 Appeal Annex 2 PDF /2/8/8/2/4/0800242882/docs/300930_57_appeal20250626032701956.pdf
26/06/2025 Appeal Annex 4 PDF /2/8/8/2/4/0800242882/docs/300930_58_appeal20250626033252059.pdf
26/06/2025 Appeal Annex 19 PDF /2/8/8/2/4/0800242882/docs/300930_59_appeal20250626033645610.pdf
26/06/2025 Appeal Annex 3 PDF /2/8/8/2/4/0800242882/docs/300930_60_appeal20250626034213678.pdf
26/06/2025 Appeal Annex 4 PDF /2/8/8/2/4/0800242882/docs/300930_61_appeal20250626040202077.pdf
26/06/2025 Appeal Annex 2 PDF /2/8/8/2/4/0800242882/docs/300930_62_appeal20250626040101882.pdf
26/06/2025 Appeal Annex 4 PDF /2/8/8/2/4/0800242882/docs/300930_63_appeal20250626040240937.pdf
26/06/2025 Appeal Annex 131 PDF /2/8/8/2/4/0800242882/docs/300930_64_appeal20250627092749746.pdf
26/06/2025 Appeal Accompanying letter appeal procedure 24 PDF /2/8/8/2/4/0800242882/docs/300930_65_appeal20250626031611775.pdf
26/06/2025 Appeal Annex 20 PDF /2/8/8/2/4/0800242882/docs/300930_67_appeal20250626033322860.pdf
04/04/2025 Appeal Annex 1 PDF /2/8/8/2/4/0800242882/docs/300930_46_appeal20250407114041786.pdf
04/04/2025 Appeal Accompanying letter appeal procedure 1 PDF /2/8/8/2/4/0800242882/docs/300930_47_appeal20250407114041762.pdf
04/04/2025 Appeal Annex 2 PDF /2/8/8/2/4/0800242882/docs/300930_48_appeal20250407114041793.pdf
28/03/2025 Appeal Accompanying letter appeal procedure 1 PDF /2/8/8/2/4/0800242882/docs/300930_42_appeal20250331124217996.pdf
28/03/2025 Appeal Request appeal 1 PDF /2/8/8/2/4/0800242882/docs/300930_43_appeal20250331125037485.pdf
28/03/2025 Appeal Annex 9 PDF /2/8/8/2/4/0800242882/docs/300930_44_appeal20250331125134819.pdf
28/03/2025 Appeal Annex 7 PDF /2/8/8/2/4/0800242882/docs/300930_45_appeal20250331125205346.pdf
14/02/2025 Outgoing Correspondence Decision appeal 7 PDF /2/8/8/2/4/0800242882/docs/300930_29_642076l073.pdf
10/02/2025 Administration Internal New 4 PDF /2/8/8/2/4/0800242882/docs/300930_30_administration20250210133906087.pdf
20/12/2024 Appeal Accompanying letter appeal procedure 1 PDF /2/8/8/2/4/0800242882/docs/300930_31_appeal20241223110113284.pdf
20/12/2024 Appeal Annex 17 PDF /2/8/8/2/4/0800242882/docs/300930_32_appeal20241223110113299.pdf
26/11/2024 Outgoing Correspondence Summons hearing appeal 1 PDF /2/8/8/2/4/0800242882/docs/300930_41_632934l127.pdf
06/11/2024 Outgoing Correspondence Summons hearing appeal 1 PDF /2/8/8/2/4/0800242882/docs/300930_36_630568l127.pdf
12/09/2024 Outgoing Correspondence Confirmation receipt appeal 1 PDF /2/8/8/2/4/0800242882/docs/300930_37_622045l072.pdf
12/09/2024 Outgoing Correspondence Letter appeal procedure 1 PDF /2/8/8/2/4/0800242882/docs/300930_40_621942l522.pdf
09/09/2024 Outgoing Correspondence Letter 2 PDF /2/8/8/2/4/0800242882/docs/300930_34_621530l000.pdf
30/08/2024 Incoming Correspondence Paper Incoming correspondence third party 26 PDF /2/8/8/2/4/0800242882/docs/300930_38_incomingcorrespondencepaper20240902013855793.pdf
29/08/2024 Appeal Annex 20 PDF /2/8/8/2/4/0800242882/docs/300930_35_appeal20240830111245429.pdf
29/08/2024 Appeal Appeal 5 PDF /2/8/8/2/4/0800242882/docs/300930_39_appeal20240830111030762.pdf
21/06/2023 Outgoing Correspondence Letter appeal procedure 2 PDF /2/8/8/2/4/0800242882/docs/300930_21_551540l522.pdf
05/04/2023 Appeal Accompanying letter appeal procedure 10 PDF /2/8/8/2/4/0800242882/docs/300930_33_appeal20230406121601957.pdf
10/01/2023 Outgoing Correspondence Outgoing Letter 2 PDF /2/8/8/2/4/0800242882/docs/300930_27_outgoingcorrespondence20230110114356759.pdf
04/01/2023 Appeal Accompanying letter appeal procedure 1 PDF /2/8/8/2/4/0800242882/docs/300930_28_appeal20230105095955291.pdf
14/10/2022 Outgoing Correspondence Letter 1 PDF /2/8/8/2/4/0800242882/docs/300930_71_509217l000.pdf
31/08/2022 Outgoing Correspondence Confirmation receipt appeal 1 PDF /2/8/8/2/4/0800242882/docs/300930_74_501839l072.pdf
30/08/2022 Appeal Request appeal 2 PDF /2/8/8/2/4/0800242882/docs/300930_25_appeal20220831120337276.pdf
19/07/2022 Outgoing Correspondence Decision refusal 9 PDF /2/8/8/2/4/0800242882/docs/300930_23_481260l527a.pdf
27/06/2022 Examination Internal New 3 PDF /2/8/8/2/4/0800242882/docs/300930_26_examination20220627124551223.pdf
25/05/2022 Administration Internal New 4 PDF /2/8/8/2/4/0800242882/docs/300930_72_administration20220525141331471.pdf
19/04/2022 Administration Internal New 1 PDF /2/8/8/2/4/0800242882/docs/300930_73_administration20220419084402539.pdf
22/09/2021 Outgoing Correspondence Confirmation receipt communication third party 1 PDF /2/8/8/2/4/0800242882/docs/300930_16_436483l037s.pdf
22/09/2021 Outgoing Correspondence Letter communication third party to holder 1 PDF /2/8/8/2/4/0800242882/docs/300930_17_436479l035s.pdf
21/09/2021 SPC Documents Annex third party observations SPC 23 PDF /2/8/8/2/4/0800242882/docs/300930_2_supplprotectioncertificate20210922114426704.pdf
21/09/2021 SPC Documents Annex third party observations SPC 8 PDF /2/8/8/2/4/0800242882/docs/300930_3_supplprotectioncertificate20210922114426802.pdf
21/09/2021 SPC Documents Annex third party observations SPC 2 PDF /2/8/8/2/4/0800242882/docs/300930_13_supplprotectioncertificate20210922114426955.pdf
21/09/2021 SPC Documents Third party observations SPC 4 PDF /2/8/8/2/4/0800242882/docs/300930_19_supplprotectioncertificate20210922114426380.pdf
21/09/2021 SPC Documents Annex third party observations SPC 11 PDF /2/8/8/2/4/0800242882/docs/300930_68_supplprotectioncertificate20210922114426608.pdf
21/09/2021 SPC Documents Annex third party observations SPC 7 PDF /2/8/8/2/4/0800242882/docs/300930_69_supplprotectioncertificate20210922114426880.pdf
21/09/2021 SPC Documents Annex third party observations SPC 3 PDF /2/8/8/2/4/0800242882/docs/300930_70_supplprotectioncertificate20210922114426486.pdf
19/05/2021 Incoming Correspondence Paper Accompanying letter incoming document 8 PDF /2/8/8/2/4/0800242882/docs/300930_18_incomingcorrespondencepaper20210519050604777.pdf
18/03/2021 Outgoing Correspondence Confirmation receipt communication third party 1 PDF /2/8/8/2/4/0800242882/docs/300930_8_400717l037s.pdf
18/03/2021 Outgoing Correspondence Letter communication third party to holder 1 PDF /2/8/8/2/4/0800242882/docs/300930_12_400708l035s.pdf
17/03/2021 SPC Documents Third party observations SPC 4 PDF /2/8/8/2/4/0800242882/docs/300930_9_supplprotectioncertificate20210318112711403.pdf
17/03/2021 SPC Documents Annex third party observations SPC 82 PDF /2/8/8/2/4/0800242882/docs/300930_10_supplprotectioncertificate20210318112900266.pdf
19/01/2021 Incoming Correspondence Paper Accompanying letter incoming document 5 PDF /2/8/8/2/4/0800242882/docs/300930_4_incomingcorrespondencepaper20210119050011383.pdf
26/10/2020 Outgoing Correspondence Letter to applicant 1 PDF /2/8/8/2/4/0800242882/docs/300930_15_374631l173.pdf
16/10/2020 Incoming Correspondence Paper Accompanying letter incoming document 1 PDF /2/8/8/2/4/0800242882/docs/300930_1_incomingcorrespondencepaper20210310023107447.pdf
23/07/2020 Outgoing Correspondence Letter to applicant 3 PDF /2/8/8/2/4/0800242882/docs/300930_20_354145l173.pdf
27/02/2018 Outgoing Correspondence Confirmation receipt request 1 PDF /2/8/8/2/4/0800242882/docs/300930_6_194953l174.pdf
22/02/2018 SPC Documents Annex SPC 20 PDF /2/8/8/2/4/0800242882/docs/300930_0_supplprotectioncertificate20180227110609400.pdf
22/02/2018 SPC Documents Summary of the characteristics of the product 19 PDF /2/8/8/2/4/0800242882/docs/300930_5_supplprotectioncertificate20180227110609242.pdf
22/02/2018 SPC Documents Annex SPC 4 PDF /2/8/8/2/4/0800242882/docs/300930_7_supplprotectioncertificate20180227110609320.pdf
22/02/2018 SPC Documents Accompanying letter SPC 7 PDF /2/8/8/2/4/0800242882/docs/300930_11_supplprotectioncertificate20200922123201514.pdf
22/02/2018 SPC Documents Annex SPC 2 PDF /2/8/8/2/4/0800242882/docs/300930_14_supplprotectioncertificate20200511014511429.pdf
22/02/2018 SPC Documents Marketing Authorization SPC 3 PDF /2/8/8/2/4/0800242882/docs/300930_22_supplprotectioncertificate20180227110609071.pdf
22/02/2018 Application Form First filed application form 3 PDF /2/8/8/2/4/0800242882/docs/300930_24_applicationform20180227110608759.pdf