Patent details
300931
Product Name:
ustekinumab
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Basic Information
Publication number:
300931
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2305817
Status:
Refused Art. 10 of the EC Regulations
Application number:
300931
Procedural language:
Dutch
First Applicant Residence Country:
United States of America (US)
Marketing Authorization
Marketing Authorization Number:
C(2013)6220
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/09/2013
Marketing Authorization Country:
European Union (EU)
Dates
Filing date:
21/03/2018
First Marketing Authorization date:
23/09/2013
Grant date:
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
22/03/2018
SPC/SPC Extension Expiration Date:
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:
21/01/2021
Applicant/holder
From:
21/03/2018
Name:
Ortho Biotech Holding LLC
Address:
7500 Centurion Parkway, Jacksonville, FL 32256, United States of America (US)
Agent
Name:
ir. H.A. Witmans c.s.
From:
21/03/2018
Address:
V.O.
Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:
Publication
Bulletin
1
Bulletin Heading:
VRV
Journal edition number:
04/21
Publication date:
27/01/2021
Description:
Lapse or annulment
2
Bulletin Heading:
SPC
Journal edition number:
14/18
Publication date:
28/03/2018
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
21/01/2021
Outgoing Correspondence
Decision refusal
2
PDF
/2/5/7/2/5/0800252752/docs/300931_4_390591l527a.pdf
06/10/2020
SPC Documents
Annex SPC
4
PDF
/2/5/7/2/5/0800252752/docs/300931_1_supplprotectioncertificate20201006112348372.pdf
06/10/2020
Outgoing Correspondence
Letter to applicant
1
PDF
/2/5/7/2/5/0800252752/docs/300931_12_370566l173.pdf
05/10/2020
SPC Documents
Annex SPC
11
PDF
/2/5/7/2/5/0800252752/docs/300931_3_supplprotectioncertificate20201006100618291.pdf
05/10/2020
Incoming Correspondence Paper
Accompanying letter incoming document
3
PDF
/2/5/7/2/5/0800252752/docs/300931_10_incomingcorrespondencepaper20210310024133961.pdf
13/07/2020
Outgoing Correspondence
Letter to applicant
2
PDF
/2/5/7/2/5/0800252752/docs/300931_11_353781l173.pdf
22/03/2018
Outgoing Correspondence
Confirmation receipt request
1
PDF
/2/5/7/2/5/0800252752/docs/300931_7_199861l174.pdf
21/03/2018
SPC Documents
Annex SPC
2
PDF
/2/5/7/2/5/0800252752/docs/300931_0_supplprotectioncertificate20200511020828369.pdf
21/03/2018
SPC Documents
Accompanying letter SPC
2
PDF
/2/5/7/2/5/0800252752/docs/300931_2_supplprotectioncertificate20200922124154866.pdf
21/03/2018
SPC Documents
Summary of the characteristics of the product
61
PDF
/2/5/7/2/5/0800252752/docs/300931_5_supplprotectioncertificate20180322042457535.pdf
21/03/2018
SPC Documents
Annex SPC
3
PDF
/2/5/7/2/5/0800252752/docs/300931_6_supplprotectioncertificate20180322042457805.pdf
21/03/2018
SPC Documents
Marketing Authorization SPC
4
PDF
/2/5/7/2/5/0800252752/docs/300931_8_supplprotectioncertificate20180322042457634.pdf
21/03/2018
Application Form
First filed application form
3
PDF
/2/5/7/2/5/0800252752/docs/300931_9_applicationform20180322042457330.pdf
21/03/2018
SPC Documents
Annex SPC
61
PDF
/2/5/7/2/5/0800252752/docs/300931_13_supplprotectioncertificate20180322042457893.pdf