Patent details

301085 Product Name: calcifediol in iedere vorm zoals beschermd door het basisoctrooi

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Basic Information

Publication number:
301085
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2481400
Status:
Refused Art. 10 of the EC Regulations
Application number:
301085
Procedural language:
Dutch
First Applicant Residence Country:
Ireland (IE)

Marketing Authorization

1

Marketing Authorization Number:
2202115.00.00
Marketing Authorization Type:
EEA
Marketing Authorization Date:
19/08/2020
Marketing Authorization Country:
Germany (DE)

2

Marketing Authorization Number:
124799
Marketing Authorization Type:
National/EU
Marketing Authorization Date:
22/09/2020
Marketing Authorization Country:
Netherlands (NL)

Dates

Filing date:
30/12/2020
First Marketing Authorization date:
19/08/2020
Grant date:
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
04/01/2021
SPC/SPC Extension Expiration Date:
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:
04/02/2022

Applicant/holder

From:
31/08/2021
 
 

 

Name:
OPKO Renal, LLC
Address:
4400 Biscayne Boulevard, 33137, Miami, FL, United States of America (US)

From:
31/08/2021
 
 

 

Name:
EirGen Pharma Ltd.
Address:
Westside Business Park, Old Kilmeaden Road, X91 YV67, Waterford, Ireland (IE)

Historical Applicant/holder

From:
05/08/2021
To:
31/08/2021

 

Name:
OPKO Ireland Global Holdings, Ltd.
Address:
Boundary Hall Cricket Square P.O. Box 1093, KY1-9006, Grand Cayman, Cayman Islands (KY)

From:
30/12/2020
To:
31/08/2021

 

Name:
Opko Renal, LLC
Address:
4400 Biscayne Blvd, 33137, Miami, Florida, United States of America (US)

Agent

Name:
ir. H.A. Witmans c.s.
From:
30/12/2020
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

Opposition

Objection/ Appeal

1

Request Number:
000161
Filling Date:
18/03/2022
Requestor For Appeal Name:
OPKO Renal, LLC
Reason:
SPC Application Rejected
Type:
Objection
Status:
Completed
Decision:
Withdrawn
Decision Issued Date:
02/12/2022
Decision Summary:

2

Request Number:
000171
Filling Date:
02/12/2022
Requestor For Appeal Name:
OPKO Renal, LLC
Reason:
Rejected objection decision
Type:
Appeal (court)
Status:
Completed
Decision:
Withdrawn
Decision Issued Date:
08/08/2024
Decision Summary:

Publication

Bulletin

1

Bulletin Heading:
VB2
Journal edition number:
33/24
Publication date:
14/08/2024
Description:
Requests for restoration and notices of objection, notices of appeal to Court, notices of appeal to Council of State ex NL Patent Law 1995 in respect of which a decision has been taken. Oppositon(s) decisions ex European Patent Convention

2

Bulletin Heading:
VB2
Journal edition number:
50/22
Publication date:
14/12/2022
Description:
Requests for restoration and notices of objection, notices of appeal to Court, notices of appeal to Council of State ex NL Patent Law 1995 in respect of which a decision has been taken. Oppositon(s) decisions ex European Patent Convention

3

Bulletin Heading:
VB1
Journal edition number:
50/22
Publication date:
14/12/2022
Description:
Requests for restoration and notices of objection, notices of appeal to Court, notices of appeal to Council of State ex NL Patent Law 1995. Opposition(s) filed ex European Patent Convention

4

Bulletin Heading:
VB1
Journal edition number:
12/22
Publication date:
23/03/2022
Description:
Requests for restoration and notices of objection, notices of appeal to Court, notices of appeal to Council of State ex NL Patent Law 1995. Opposition(s) filed ex European Patent Convention

5

Bulletin Heading:
VRV
Journal edition number:
06/22
Publication date:
09/02/2022
Description:
Lapse or annulment

6

Bulletin Heading:
CO
Journal edition number:
38/21
Publication date:
22/09/2021
Description:
Changes in the Netherlands Patent Register

7

Bulletin Heading:
SPC
Journal edition number:
01/21
Publication date:
06/01/2021
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Deed

Change of owner(s)

Change Kind/ Decision Type:
Assignment
Deed Number:
RC202101817A
Date Registered:
31/08/2021
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
dr. T. Wittop Koning PhD
Journal Edition Number:
Text:
Deed Status:
Country Code:
Updated License Number:
Terminated License Number:

Added Owner(s)

1

Name:
OPKO Renal, LLC
Address:
4400 Biscayne Boulevard, 33137, Miami, FL, United States of America (US)

2

Name:
EirGen Pharma Ltd.
Address:
Westside Business Park, Old Kilmeaden Road, X91 YV67, Waterford, Ireland (IE)

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:
RC202101648A
Date Registered:
05/08/2021
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
dr. T. Wittop Koning PhD
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 Address

Change Kind/ Decision Type:
Owner
Deed Number:
RC202100176A
Date Registered:
27/01/2021
License Effective Date:
License Expiration Date:
Scope of License:
Deed Filer:
ir. H.A. Witmans 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:
Filing date Document type Document Description Number of pages File Type
08/08/2024 Appeal Withdrawal appeal procedure 2 PDF /4/1/0/0/4/0800640014/docs/301085_42_appeal20240808124020957.pdf
06/08/2024 Appeal Withdrawal appeal procedure 1 PDF /4/1/0/0/4/0800640014/docs/301085_41_appeal20240808093030915.pdf
01/03/2024 Appeal Accompanying letter appeal procedure 1 PDF /4/1/0/0/4/0800640014/docs/301085_20_appeal20240305013102643.pdf
01/02/2024 Outgoing Correspondence Letter 1 PDF /4/1/0/0/4/0800640014/docs/301085_22_588703l000.pdf
22/01/2024 Appeal Appeal 1 PDF /4/1/0/0/4/0800640014/docs/301085_21_appeal20240122025505406.pdf
03/01/2023 Appeal Annex 1 PDF /4/1/0/0/4/0800640014/docs/301085_35_appeal20230103122342359.pdf
03/01/2023 Appeal Accompanying letter appeal procedure 1 PDF /4/1/0/0/4/0800640014/docs/301085_36_appeal20230103122342258.pdf
02/01/2023 Appeal Accompanying letter appeal procedure 1 PDF /4/1/0/0/4/0800640014/docs/301085_37_appeal20230103122846995.pdf
02/01/2023 Appeal Annex 20 PDF /4/1/0/0/4/0800640014/docs/301085_38_appeal20230103122847037.pdf
02/01/2023 Appeal Annex 14 PDF /4/1/0/0/4/0800640014/docs/301085_39_appeal20230103122847069.pdf
02/01/2023 Appeal Annex 26 PDF /4/1/0/0/4/0800640014/docs/301085_40_appeal20230103122847095.pdf
27/12/2022 Outgoing Correspondence Letter 2 PDF /4/1/0/0/4/0800640014/docs/301085_32_519776l000.pdf
27/12/2022 Outgoing Correspondence Outgoing correspondence 1 PDF /4/1/0/0/4/0800640014/docs/301085_33_outgoingcorrespondence20221227010557805.pdf
27/12/2022 Outgoing Correspondence Letter 1 PDF /4/1/0/0/4/0800640014/docs/301085_34_521706l000.pdf
02/12/2022 Appeal Appeal 2 PDF /4/1/0/0/4/0800640014/docs/301085_29_appeal20221202121850507.pdf
20/10/2022 Outgoing Correspondence Letter to applicant 1 PDF /4/1/0/0/4/0800640014/docs/301085_23_510362l173.pdf
20/10/2022 Outgoing Correspondence Letter to applicant 1 PDF /4/1/0/0/4/0800640014/docs/301085_31_510355l173.pdf
12/08/2022 Appeal Mail appeal procedure 1 PDF /4/1/0/0/4/0800640014/docs/301085_19_appeal20220812023832148.pdf
12/08/2022 Appeal Annex 15 PDF /4/1/0/0/4/0800640014/docs/301085_24_appeal20220812022037075.pdf
12/08/2022 Appeal Annex 4 PDF /4/1/0/0/4/0800640014/docs/301085_25_appeal20220812022037042.pdf
19/05/2022 Outgoing Correspondence Letter to applicant 1 PDF /4/1/0/0/4/0800640014/docs/301085_30_481475l173.pdf
21/03/2022 Outgoing Correspondence Confirmation receipt appeal 1 PDF /4/1/0/0/4/0800640014/docs/301085_9_469534l072.pdf
18/03/2022 Appeal Request appeal 2 PDF /4/1/0/0/4/0800640014/docs/301085_8_appeal20220321023039677.pdf
04/02/2022 Outgoing Correspondence Decision refusal 7 PDF /4/1/0/0/4/0800640014/docs/301085_10_452693l527a.pdf
24/01/2022 Administration Internal New 2 PDF /4/1/0/0/4/0800640014/docs/301085_26_administration20220126150630678.pdf
24/01/2022 Examination Internal New 3 PDF /4/1/0/0/4/0800640014/docs/301085_27_examination20220125140046618.pdf
24/01/2022 Examination Internal New 1 PDF /4/1/0/0/4/0800640014/docs/301085_28_examination20220126145603769.pdf
02/06/2021 Incoming Correspondence Paper Incoming Correspondence Paper 28 PDF /4/1/0/0/4/0800640014/docs/301085_18_incomingcorrespondencepaper20210603104811777.pdf
03/05/2021 SPC Documents Mail SPC 1 PDF /4/1/0/0/4/0800640014/docs/301085_3_supplprotectioncertificate20210503044405056.pdf
03/05/2021 Outgoing Correspondence Letter to applicant 1 PDF /4/1/0/0/4/0800640014/docs/301085_16_409643l173.pdf
03/02/2021 Outgoing Correspondence Letter to applicant 4 PDF /4/1/0/0/4/0800640014/docs/301085_7_393144l173.pdf
03/02/2021 SPC Documents Annex SPC 7 PDF /4/1/0/0/4/0800640014/docs/301085_17_supplprotectioncertificate20210203053531400.pdf
04/01/2021 Outgoing Correspondence Confirmation receipt request 1 PDF /4/1/0/0/4/0800640014/docs/301085_1_387394l174.pdf
30/12/2020 SPC Documents Annex SPC 2 PDF /4/1/0/0/4/0800640014/docs/301085_0_supplprotectioncertificate20210104114505361.pdf
30/12/2020 SPC Documents Annex SPC 6 PDF /4/1/0/0/4/0800640014/docs/301085_2_supplprotectioncertificate20210104114242501.pdf
30/12/2020 SPC Documents Annex SPC 5 PDF /4/1/0/0/4/0800640014/docs/301085_4_supplprotectioncertificate20210104114058605.pdf
30/12/2020 Application Form First filed application form 3 PDF /4/1/0/0/4/0800640014/docs/301085_5_applicationform20210104111721615.pdf
30/12/2020 SPC Documents Marketing Authorization SPC 4 PDF /4/1/0/0/4/0800640014/docs/301085_6_supplprotectioncertificate20210104113451168.pdf
30/12/2020 SPC Documents Annex SPC 14 PDF /4/1/0/0/4/0800640014/docs/301085_11_supplprotectioncertificate20210104114421339.pdf
30/12/2020 SPC Documents Summary of the characteristics of the product 14 PDF /4/1/0/0/4/0800640014/docs/301085_12_supplprotectioncertificate20210104113841974.pdf
30/12/2020 SPC Documents Summary of the characteristics of the product 24 PDF /4/1/0/0/4/0800640014/docs/301085_13_supplprotectioncertificate20210104113239375.pdf
30/12/2020 SPC Documents Annex SPC 2 PDF /4/1/0/0/4/0800640014/docs/301085_14_supplprotectioncertificate20210104112346784.pdf
30/12/2020 SPC Documents Marketing Authorization SPC 2 PDF /4/1/0/0/4/0800640014/docs/301085_15_supplprotectioncertificate20210104112639263.pdf