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Patent details

2016C015 Product name: Efmoroctocog alfa

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Basic information

Application number:
2016C/015
Type:
Certificate
SPC type:
Medical
Basic patent number:
047759469
Status:
Active
Publication number:
2016C015
1rst applicant's nationality:
Procedural language:
French

Paediatric extension

SPC Extension filing date:
30/07/2020
SPC Extension agent/owner name:
KIRKPATRICK
SPC Extension status:
Granted
SPC Extension grant date:
08/08/2025
SPC Extension Rejection Date:

Marketing authorization

Marketing authorization number:
EU/1/15/1046
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
23/11/2015
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
06/04/2016
First marketing authorization date:
23/11/2015
Grant date:
09/08/2023
Activation date:
06/05/2024
BE Publication date:
09/05/2016
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
06/05/2029
SPC/SPC Extension Expiration (if granted and all annual fees paid):
06/11/2029
Rejection date:
Withdrawal date:

Applicant

1

Name:
Bioverativ Therapeutics Inc.
Legal Form:
Inc.
From:
04/01/2018
Address:
225 Second Avenue, Waltham, MA 02451, United States (US)
To:

2

Name:
Biogen Hemophilia Inc.
Legal Form:
From:
09/05/2016
Address:
250 Binney Street, Cambridge MA 02142, United States (US)
To:
04/01/2018

Agent

1

Name:
KIRKPATRICK
Legal Form:
S.A.
From:
08/10/2018
Address:
Avenue Wolfers 32, 1310, LA HULPE, Brabant wallon, Belgium (BE)
To:

2

Name:
BLOCH Gérard
Legal Form:
From:
09/05/2016
Address:
-, -, -, Belgium (BE)
To:
08/10/2018

Publication

Bulletin

1

Bulletin heading:
CO
Journal edition number:
2018/02
Publication date:
28/02/2018
Description:
Contains data concerning registered assignments or changes of the names of applicants and holders

2

Bulletin heading:
SPC
Journal edition number:
2020/19
Publication date:
26/08/2020
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

3

Bulletin heading:
SPC
Journal edition number:
2024/09
Publication date:
27/05/2024
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

4

Bulletin heading:
SPC
Journal edition number:
2023/16
Publication date:
29/09/2023
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

5

Bulletin heading:
SPC
Journal edition number:
2025/15
Publication date:
09/10/2025
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Deed

Change of owner(s)

Change Kind / Decision Type:
Change of owner(s) name
Deed number:
RC2018100005A
Registration date:
04/01/2018
License effective date:
License expiration date:
Scope of license:
Deed filer:
KIRKPATRICK
Bulletin edition number:
Text:
Country code:
Updated license number:
Terminated license number:

Removed pledgee

Name:
Address:

Changed pledgee

Name:
Address:

Removed usufructuary

Name:
Address:

Added usufructuary

Name:
Address:

Changed usufructuary

Name:
Address:

Annual fee

Annual fee(s) Due Date:
01/06/2026
Annual fee number:
23
Annual fee amount:
750 Euro
Expected payer:
Last annual fee payment date:
10/04/2025
Last annual fee paid number:
22
Last annual fee paid amount:
700 Euro
Payer:
C.P.A.
Filing date Document type Publication Type Document Description Number of pages File Type
30/07/2020 General Document Other 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_0_generaldocument_20200731_084651969.pdf
04/01/2018 Request For Change Deed or extract stating the change of the rights 5 PDF /2/2/9/1/1/0721511922/docs/2016c015_1_rfc_20180105_081834025.pdf
06/04/2016 General Document Other 41 PDF /2/2/9/1/1/0721511922/docs/2016c015_2_generaldocument_20160504_031020468.pdf
10/01/2018 Outgoing Correspondence 2 PDF /2/2/9/1/1/0721511922/docs/2016c015_3_outgoingcorrespondence_20180112_032624357.pdf
08/08/2025 Publication I2E 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_4_i2edocument_20250808_083152553.pdf
17/04/2025 General Document Other 5 PDF /2/2/9/1/1/0721511922/docs/2016c015_5_generaldocument_20250418_084557413.pdf
17/04/2025 General Document Other 16 PDF /2/2/9/1/1/0721511922/docs/2016c015_6_generaldocument_20250418_084557483.pdf
17/04/2025 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 62 PDF /2/2/9/1/1/0721511922/docs/2016c015_7_marketingauthorization_20250418_084558109.pdf
17/04/2025 Incoming Correspondence (Email) Regularisation of SPC 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_8_incomingcorrespondenceelectronic_20250418_084600099.pdf
13/03/2023 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_9_rfc_20230406_120158427.pdf
31/07/2020 Outgoing Correspondence 2 PDF /2/2/9/1/1/0721511922/docs/2016c015_10_outgoingcorrespondence_20200805_114130316.pdf
30/07/2020 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_11_marketingauthorization_20200731_084654872.pdf
09/08/2023 Certificate 2 PDF /2/2/9/1/1/0721511922/docs/2016c015_12_spc_medcertificate_20230809_114226727.pdf
30/07/2020 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 42 PDF /2/2/9/1/1/0721511922/docs/2016c015_13_paediatricinvestigationplan_20200731_084656680.pdf
30/07/2020 General Document Other 41 PDF /2/2/9/1/1/0721511922/docs/2016c015_14_generaldocument_20200731_084643182.pdf
04/01/2018 Incoming Correspondence (Post) 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_15_incomingcorrespondencepaper_20180116_040753212.pdf
03/03/2025 Outgoing Correspondence 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_16_outgoingcorrespondence_20250303_123553318.pdf
30/07/2020 General Document Other 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_17_generaldocument_20200731_084648102.pdf
04/01/2018 Incoming Correspondence (Email) Cover letter 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_18_incomingcorrespondenceelectronic_20180105_081837015.pdf
30/07/2020 Application Form 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_19_applicationform_20200731_084700741.pdf
12/04/2016 General Document Other 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_20_generaldocument_20160504_031020198.pdf
08/10/2018 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_21_rfc_20181008_032421542.pdf
04/01/2018 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_22_rfc_20180105_081835872.pdf
06/04/2016 General Document Other 2 PDF /2/2/9/1/1/0721511922/docs/2016c015_23_generaldocument_20160504_031020248.pdf
30/07/2020 General Document Other 17 PDF /2/2/9/1/1/0721511922/docs/2016c015_24_generaldocument_20200731_084649037.pdf
06/04/2016 General Document Other 5 PDF /2/2/9/1/1/0721511922/docs/2016c015_25_generaldocument_20160504_031020523.pdf
06/04/2016 General Document Other 17 PDF /2/2/9/1/1/0721511922/docs/2016c015_26_generaldocument_20160504_031020299.pdf
30/07/2020 General Document Other 5 PDF /2/2/9/1/1/0721511922/docs/2016c015_27_generaldocument_20200731_084652920.pdf
24/11/2022 Incoming Correspondence (Email) Cover letter 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_28_incomingcorrespondenceelectronic_20221125_084519157.pdf
28/11/2022 General Document Other 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_29_generaldocument_20221128_100627656.pdf
30/07/2020 General Document Other 2 PDF /2/2/9/1/1/0721511922/docs/2016c015_30_generaldocument_20200731_084651359.pdf
09/05/2016 General Document Other 2 PDF /2/2/9/1/1/0721511922/docs/2016c015_31_generaldocument_20160511_040810376.pdf
09/08/2023 Administration 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_32_i2document_20230809_co.pdf
31/07/2020 Publication I1E 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_33_i1edocument_20200731_094853690.pdf
09/05/2016 Front Page 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_34_i1frontpage_20160509_150650210.pdf
09/05/2016 Publication I1 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_35_i1document_20160509_150651417.pdf
30/07/2020 General Document Other 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_36_generaldocument_20200731_084653877.pdf
06/04/2016 General Document Other 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_37_generaldocument_20160504_031020407.pdf
06/04/2016 General Document Other 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_38_generaldocument_20160504_031020350.pdf
04/01/2018 Outgoing Correspondence 1 PDF /2/2/9/1/1/0721511922/docs/2016c015_39_outgoingcorrespondence_20180105_081833275.pdf
06/04/2016 Application Form 3 PDF /2/2/9/1/1/0721511922/docs/2016c015_40_applicationform_20160504_031020137.pdf