Patent details

300727 Product Name: Fidaxomicine

The time of generation of the report may vary depending on the number of the selected files and the pages of each file. If the generation of the consolidated PDF file takes long, you may reduce the number of selected files and proceed with the generation of the PDF in batches.
You have not selected any documents

Basic Information

Publication number:
300727
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP1539977
Status:
SPC in force
Application number:
300727
Procedural language:
Dutch
First Applicant Residence Country:

Paediatric Extension

SPC Extension Filing Date:
23/06/2020
SPC Extension Agent/Owner Name:
Merck Sharp & Dohme Corp. , ir. M.F.J.M. Ketelaars c.s.
SPC Extension Status:
Extension Granted
SPC Extension Grant Date:
11/08/2020
SPC Extension Request Refusal Date:
SPC Extension Revocation Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/11/733/001-004
Marketing Authorization Type:
EEA
Marketing Authorization Date:
07/12/2011
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
25/03/2015
First Marketing Authorization date:
07/12/2011
Grant date:
17/05/2016
Activation date:
15/07/2023
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
25/03/2015
SPC/SPC Extension Expiration Date:
06/06/2027
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
22/09/2022
 
 

 

Name:
Merck Sharp & Dohme LLC
Address:
126 East Lincoln Ave. P.O. Box 2000, 07065, Rahway, New Jersey, United States of America (US)

Historical Applicant/holder

From:
22/09/2022
To:
22/09/2022

 

Name:
Merck Sharp & Dohme Corp.
Address:
126 East Lincoln Ave, 07065, Rahway NJ, United States of America (US)

From:
14/10/2015
To:
14/10/2015

 

Name:
Optimer Pharmaceuticals LLC
Address:
2000 Galloping Hill Road, Kenilworth, New Jersey 07033, United States of America (US)

From:
14/10/2015
To:
22/09/2022

 

Name:
Merck Sharp & Dohme Corp.
Address:
126 East Lincoln Avenue, 07065-0907, Rahway, New Jersey, United States of America (US)

From:
25/03/2015
To:
14/10/2015

 

Name:
Optimer Pharmaceuticals, Inc.
Address:
65 Hayden Avenue, LEXINGTON, MA 02421, United States of America (US)

Agent

Name:
ir. M.F.J.M. Ketelaars c.s.
From:
25/03/2015
Address:
NLO Postbus 29720, 2502 LS, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
29/23
Publication date:
19/07/2023
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
CO
Journal edition number:
40/22
Publication date:
05/10/2022
Description:
Changes in the Netherlands Patent Register

3

Bulletin Heading:
SPC
Journal edition number:
33/20
Publication date:
12/08/2020
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

4

Bulletin Heading:
SPC
Journal edition number:
27/20
Publication date:
01/07/2020
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

5

Bulletin Heading:
SPC
Journal edition number:
20/16
Publication date:
18/05/2016
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

6

Bulletin Heading:
CO
Journal edition number:
08/16
Publication date:
24/02/2016
Description:
Changes in the Netherlands Patent Register

7

Bulletin Heading:
CO
Journal edition number:
08/16
Publication date:
24/02/2016
Description:
Changes in the Netherlands Patent Register

8

Bulletin Heading:
SPC
Journal edition number:
2015/14
Publication date:
01/04/2015
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Deed

Change of owner(s)

Change Kind/ Decision Type:
Merge
Deed Number:
RC202202416A
Date Registered:
22/09/2022
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
dr. R.C. van Duijvenbode c.s.
Journal Edition Number:
Text:
Deed Status:
Country Code:
Updated License Number:
Terminated License Number:

Added Owner(s)

Name:
Merck Sharp & Dohme LLC
Address:
126 East Lincoln Ave. P.O. Box 2000, 07065, Rahway, New Jersey, United States of America (US)

Changed Pledgee

Name:
Address:

Removed Usufructuary

Name:
Address:

Added Usufructuary

Name:
Address:

Changed Usufructuary

Name:
Address:

Change of Address

Change Kind/ Decision Type:
Owner
Deed Number:
RC202202450A
Date Registered:
22/09/2022
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
dr. R.C. van Duijvenbode c.s.
Journal Edition Number:
Text:
Deed Status:
Country Code:
Updated License Number:
Terminated License Number:

Changed Pledgee

Name:
Address:

Removed Usufructuary

Name:
Address:

Added Usufructuary

Name:
Address:

Changed Usufructuary

Name:
Address:

Change of owner(s)

Change Kind/ Decision Type:
Change of Legal Entity
Deed Number:
RC201600220A
Date Registered:
14/10/2015
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
ir. M.F.J.M. Ketelaars c.s.
Journal Edition Number:
Text:
Deed Status:
Country Code:
Updated License Number:
Terminated License Number:

Added Owner(s)

Name:
Optimer Pharmaceuticals LLC
Address:
65 Hayden Avenue, LEXINGTON, MA 02421, United States of America (US)

Changed Pledgee

Name:
Address:

Removed Usufructuary

Name:
Address:

Added Usufructuary

Name:
Address:

Changed Usufructuary

Name:
Address:

Change of Address

Change Kind/ Decision Type:
Owner
Deed Number:
RC201600220B
Date Registered:
14/10/2015
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
ir. M.F.J.M. Ketelaars c.s.
Journal Edition Number:
Text:
Deed Status:
Country Code:
Updated License Number:
Terminated License Number:

Changed Pledgee

Name:
Address:

Removed Usufructuary

Name:
Address:

Added Usufructuary

Name:
Address:

Changed Usufructuary

Name:
Address:

Change of owner(s)

Change Kind/ Decision Type:
Assignment
Deed Number:
RC201600220C
Date Registered:
14/10/2015
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
ir. M.F.J.M. Ketelaars c.s.
Journal Edition Number:
Text:
Deed Status:
Country Code:
Updated License Number:
Terminated License Number:

Added Owner(s)

Name:
Merck Sharp & Dohme Corp.
Address:
126 East Lincoln Avenue, 07065-0907, Rahway, New Jersey, United States of America (US)

Changed Pledgee

Name:
Address:

Removed Usufructuary

Name:
Address:

Added Usufructuary

Name:
Address:

Changed Usufructuary

Name:
Address:

Other

1

Note:

2

Note:

Annual Fee

Annual Fee(s) Due Date:
31/07/2026
Annual Fee Number:
24
Annual Fee Amount:
2200 Euro
Last Annual Payment Date:
18/06/2025
Last Annual Fee Paid Number:
23
Last Annual Fee Paid Amount:
2000 Euro
Payer:
Master Data Center
Filing date Document type Document Description Number of pages File Type
12/08/2020 Outgoing Correspondence Letter 1 PDF /7/2/7/0/0/0400300727/docs/300727_23_359919l000.pdf
11/08/2020 Outgoing Correspondence Decision extension duration 1 PDF /7/2/7/0/0/0400300727/docs/300727_4_359621l504c.pdf
11/08/2020 SPC Documents Certificate SPC 1 PDF /7/2/7/0/0/0400300727/docs/300727_9_supplprotectioncertificate20200812100343031.pdf
24/06/2020 Outgoing Correspondence Confirmation receipt request for extension 2 PDF /7/2/7/0/0/0400300727/docs/300727_20_350556l505.pdf
23/06/2020 Application Form First filed application form 2 PDF /7/2/7/0/0/0400300727/docs/300727_11_applicationform20200624110136371.pdf
23/06/2020 SPC Documents Annex SPC 1 PDF /7/2/7/0/0/0400300727/docs/300727_12_supplprotectioncertificate20200624110136524.pdf
23/06/2020 SPC Documents Annex SPC 3 PDF /7/2/7/0/0/0400300727/docs/300727_13_supplprotectioncertificate20200624110136477.pdf
23/06/2020 SPC Documents Annex SPC 20 PDF /7/2/7/0/0/0400300727/docs/300727_14_supplprotectioncertificate20200624110136656.pdf
23/06/2020 SPC Documents Annex SPC 1 PDF /7/2/7/0/0/0400300727/docs/300727_17_supplprotectioncertificate20201022033737985.pdf
01/09/2016 Examination Internal New 2 PDF /7/2/7/0/0/0400300727/docs/300727_3_email 4 augustus 2016.pdf
23/08/2016 Outgoing Correspondence Letter to applicant 1 PDF /7/2/7/0/0/0400300727/docs/300727_7_outgoingcorrespondence20160824022538143.pdf
21/07/2016 Incoming Correspondence Paper Accompanying letter incoming document 2 PDF /7/2/7/0/0/0400300727/docs/300727_8_incomingcorrespondencepaper20160722012359925.pdf
21/07/2016 SPC Documents Annex SPC 1 PDF /7/2/7/0/0/0400300727/docs/300727_18_supplprotectioncertificate20201022033014265.pdf
17/05/2016 Outgoing Correspondence Outgoing Letter 2 PDF /7/2/7/0/0/0400300727/docs/300727_0_outgoingcorrespondence20160518094514221.pdf
28/04/2016 Incoming Correspondence Paper Accompanying letter incoming document 1 PDF /7/2/7/0/0/0400300727/docs/300727_15_incomingcorrespondencepaper20160502080320845.pdf
02/02/2016 Outgoing Correspondence Outgoing Letter 2 PDF /7/2/7/0/0/0400300727/docs/300727_1_outgoingcorrespondence20201022032404187.pdf
18/06/2015 Incoming Correspondence Paper Accompanying letter incoming document 1 PDF /7/2/7/0/0/0400300727/docs/300727_21_incomingcorrespondencepaper20201022030857830.pdf
18/06/2015 Outgoing Correspondence Outgoing Letter 1 PDF /7/2/7/0/0/0400300727/docs/300727_25_outgoingcorrespondence20150618.pdf
02/04/2015 Outgoing Correspondence Outgoing Letter 2 PDF /7/2/7/0/0/0400300727/docs/300727_2_outgoingcorrespondence20150402.pdf
30/03/2015 Outgoing Correspondence Outgoing Letter 1 PDF /7/2/7/0/0/0400300727/docs/300727_5_outgoingcorrespondence20150330.pdf
25/03/2015 Application Form First filed application form 2 PDF /7/2/7/0/0/0400300727/docs/300727_6_applicationform20150325.pdf
25/03/2015 SPC Documents Summary of the characteristics of the product 8 PDF /7/2/7/0/0/0400300727/docs/300727_10_supplprotectioncertificate20201022030551446.pdf
25/03/2015 SPC Documents Annex SPC 12 PDF /7/2/7/0/0/0400300727/docs/300727_16_supplprotectioncertificate20201022030551555.pdf
25/03/2015 SPC Documents Marketing Authorization SPC 4 PDF /7/2/7/0/0/0400300727/docs/300727_19_supplprotectioncertificate20201022025801874.pdf
25/03/2015 SPC Documents Annex SPC 2 PDF /7/2/7/0/0/0400300727/docs/300727_22_supplprotectioncertificate20201022030150890.pdf
25/03/2015 SPC Documents Annex SPC 3 PDF /7/2/7/0/0/0400300727/docs/300727_24_supplprotectioncertificate20201022030551508.pdf