Patent details

300347 Product Name: Combinatie van efavirenz en emtricitabine, desgewenst in de vorm of een farmaceutisch aanvaardbaar zout of een farmaceutisch aanvaardbare ester

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Basic Information

Publication number:
300347
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP0582455
Status:
Refused Art. 10 of the EC Regulations
Application number:
300347
Procedural language:
Dutch
First Applicant Residence Country:

Marketing Authorization

Marketing Authorization Number:
EU/1/07/430/001
Marketing Authorization Type:
EEA
Marketing Authorization Date:
13/12/2007
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
15/05/2008
First Marketing Authorization date:
13/12/2007
Grant date:
Activation date:
03/08/2013
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
15/05/2008
SPC/SPC Extension Expiration Date:
02/08/2018
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:
18/05/2017

Applicant/holder

From:
20/08/2012
 
 

 

Name:
MERCK SHARP & DOHME CORP.
Address:
126 East Lincoln Aveneu, 07033-0530, Rahway, 07065 New Jersey, United States of America (US)

Historical Applicant/holder

From:
20/08/2012
To:
20/08/2012

 

Name:
SCHERING CORPORATION
Address:
2000 Galloping Hill Road, 07033-0530, Kenilworth, New Jersey, United States of America (US)

From:
10/02/2010
To:
20/08/2012

 

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

From:
15/05/2008
To:
10/02/2010

 

Name:
MERCK & CO. INC.
Address:
P.O. Box 2000, 07065-0900, Rahway, New Jersey, United States of America (US)

Agent

Name:
ir. M.F.J.M. Ketelaars c.s.
From:
15/05/2008
Address:
NLO Postbus 29720, 2502 LS, Den Haag, Netherlands (NL)
To:

Opposition

Appeals

Appeal Request Number:
000093
Appeal Filling Date:
27/06/2017
Requestor For Appeal Name:
MERCK SHARP & DOHME CORP.
Appeal Reason:
SPC Application Rejected
Appeal Type:
Internal Appeal
Appeal Status:
Completed
Appeal Decision:
Negative
Appeal Decision Issued Date:
17/10/2017
Appeal Decision Summary:

Publication

Bulletin

1

Bulletin Heading:
VB2
Journal edition number:
42/17
Publication date:
18/10/2017
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

2

Bulletin Heading:
VB1
Journal edition number:
27/17
Publication date:
05/07/2017
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

3

Bulletin Heading:
VRV
Journal edition number:
21/17
Publication date:
24/05/2017
Description:
Lapse or annulment

4

Bulletin Heading:
MED
Journal edition number:
2012/40
Publication date:
03/10/2012
Description:
Other communications

5

Bulletin Heading:
CO
Journal edition number:
2012/36
Publication date:
05/09/2012
Description:
Changes in the Netherlands Patent Register

6

Bulletin Heading:
MED
Journal edition number:
2010/04
Publication date:
01/04/2010
Description:
Other communications

7

Bulletin Heading:
SPC
Journal edition number:
2008/07
Publication date:
01/07/2008
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:
018161-A018161-1
Date Registered:
20/08/2012
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:
Change of owner(s) name
Deed Number:
018358-A018358-1
Date Registered:
20/08/2012
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:
Change of owner(s) name
Deed Number:
54868-A054868-1
Date Registered:
10/02/2010
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:

Other

Note:
Filing date Document type Document Description Number of pages File Type
17/10/2017 Appeal Decision appeal procedure 2 PDF /7/4/3/0/0/0400300347/docs/300347_26_appeal20171017115908402.pdf
06/07/2017 Restoration Outgoing correspondence restoration procedure 1 PDF /7/4/3/0/0/0400300347/docs/300347_9_restoration20170706123313124.pdf
05/07/2017 Outgoing Correspondence Confirmation receipt appeal 1 PDF /7/4/3/0/0/0400300347/docs/300347_8_147700l072.pdf
27/06/2017 Incoming Correspondence Paper Response applicant or agent 2 PDF /7/4/3/0/0/0400300347/docs/300347_25_incomingcorrespondencepaper20170628034118157.pdf
18/05/2017 Outgoing Correspondence Outgoing Letter 6 PDF /7/4/3/0/0/0400300347/docs/300347_27_outgoingcorrespondence20170522010912191.pdf
14/03/2017 Examination Internal New 6 PDF /7/4/3/0/0/0400300347/docs/300347_3_ksr 28.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_12_02 - exhibit as2.pdf
14/03/2017 Examination Internal New 29 PDF /7/4/3/0/0/0400300347/docs/300347_13_05 - exhibit as5.pdf
14/03/2017 Examination Internal New 23 PDF /7/4/3/0/0/0400300347/docs/300347_14_ksr 16.pdf
14/03/2017 Examination Internal New 8 PDF /7/4/3/0/0/0400300347/docs/300347_17_ksr 11.pdf
14/03/2017 Examination Internal New 3 PDF /7/4/3/0/0/0400300347/docs/300347_20_03 - exhibit as3.pdf
14/03/2017 Examination Internal New 13 PDF /7/4/3/0/0/0400300347/docs/300347_21_ksr 10.pdf
14/03/2017 Examination Internal New 33 PDF /7/4/3/0/0/0400300347/docs/300347_23_ksr 6.pdf
14/03/2017 Examination Internal New 16 PDF /7/4/3/0/0/0400300347/docs/300347_24_ksr 21.pdf
14/03/2017 Examination Internal New 4 PDF /7/4/3/0/0/0400300347/docs/300347_28_ksr 3.pdf
14/03/2017 Examination Internal New 9 PDF /7/4/3/0/0/0400300347/docs/300347_30_03 - second expert report of professor seley-radtke (signed) (2).pdf
14/03/2017 Examination Internal New 5 PDF /7/4/3/0/0/0400300347/docs/300347_31_ksr 26.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_36_ksr 22.pdf
14/03/2017 Examination Internal New 43 PDF /7/4/3/0/0/0400300347/docs/300347_39_ksr 27.pdf
14/03/2017 Examination Internal New 7 PDF /7/4/3/0/0/0400300347/docs/300347_41_ksr 29.pdf
14/03/2017 Examination Internal New 2 PDF /7/4/3/0/0/0400300347/docs/300347_42_ksr 5.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_44_ksr 7.pdf
14/03/2017 Examination Internal New 4 PDF /7/4/3/0/0/0400300347/docs/300347_45_ksr 8.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_46_ksr 17.pdf
14/03/2017 Examination Internal New 17 PDF /7/4/3/0/0/0400300347/docs/300347_47_ksr 20.pdf
14/03/2017 Examination Internal New 8 PDF /7/4/3/0/0/0400300347/docs/300347_49_ksr 23.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_50_ksr 9.pdf
14/03/2017 Examination Internal New 4 PDF /7/4/3/0/0/0400300347/docs/300347_52_ksr 15.pdf
14/03/2017 Examination Internal New 8 PDF /7/4/3/0/0/0400300347/docs/300347_53_04 - exhibit as4.pdf
14/03/2017 Examination Internal New 8 PDF /7/4/3/0/0/0400300347/docs/300347_55_ksr 14.pdf
14/03/2017 Examination Internal New 23 PDF /7/4/3/0/0/0400300347/docs/300347_58_02 - signed final 2016 12 16 - dr spaltenstein expert report approved (2).pdf
14/03/2017 Examination Internal New 12 PDF /7/4/3/0/0/0400300347/docs/300347_60_ksr 19.pdf
14/03/2017 Examination Internal New 8 PDF /7/4/3/0/0/0400300347/docs/300347_61_ksr 24.pdf
14/03/2017 Examination Internal New 3 PDF /7/4/3/0/0/0400300347/docs/300347_62_ksr 4.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_63_01 - exhibit as1.pdf
14/03/2017 Examination Internal New 4 PDF /7/4/3/0/0/0400300347/docs/300347_64_ksr 13.pdf
14/03/2017 Examination Internal New 42 PDF /7/4/3/0/0/0400300347/docs/300347_65_pleitnotities090317.pdf
14/03/2017 Examination Internal New 10 PDF /7/4/3/0/0/0400300347/docs/300347_66_ksr 12.pdf
14/03/2017 Examination Internal New 13 PDF /7/4/3/0/0/0400300347/docs/300347_67_ksr 18.pdf
14/03/2017 Examination Internal New 7 PDF /7/4/3/0/0/0400300347/docs/300347_70_ksr 2.pdf
14/03/2017 Examination Internal New 34 PDF /7/4/3/0/0/0400300347/docs/300347_72_01 - expert report of professor katherine seley-radtke (2).pdf
14/03/2017 Examination Internal New 28 PDF /7/4/3/0/0/0400300347/docs/300347_73_exhibit ksr1- cv.pdf
14/03/2017 Examination Internal New 8 PDF /7/4/3/0/0/0400300347/docs/300347_74_ksr 25.pdf
31/01/2017 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_71_outgoingcorrespondence20170201101445752.pdf
24/01/2017 Incoming Correspondence Paper Accompanying letter incoming document 1 PDF /7/4/3/0/0/0400300347/docs/300347_0_incomingcorrespondencepaper20170125103947413.pdf
24/01/2017 Appeal Accompanying letter appeal procedure 7 PDF /7/4/3/0/0/0400300347/docs/300347_18_appeal20170125103947327.pdf
17/01/2017 SPC Documents Summary of the characteristics of the product 10 PDF /7/4/3/0/0/0400300347/docs/300347_2_supplprotectioncertificate20170118025646133.pdf
17/01/2017 Incoming Correspondence Paper Accompanying letter incoming document 17 PDF /7/4/3/0/0/0400300347/docs/300347_19_incomingcorrespondencepaper20170118025645939.pdf
17/01/2017 SPC Documents Summary of the characteristics of the product 13 PDF /7/4/3/0/0/0400300347/docs/300347_33_supplprotectioncertificate20170118025646027.pdf
17/01/2017 Incoming Correspondence Paper Mail 45 PDF /7/4/3/0/0/0400300347/docs/300347_34_incomingcorrespondencepaper20170118030052623.pdf
17/01/2017 SPC Documents Summary of the characteristics of the product 4 PDF /7/4/3/0/0/0400300347/docs/300347_51_supplprotectioncertificate20170118025646080.pdf
01/12/2016 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_48_outgoingcorrespondence20161202022701617.pdf
21/11/2016 Incoming Correspondence Paper Response applicant or agent 1 PDF /7/4/3/0/0/0400300347/docs/300347_5_incomingcorrespondencepaper20161123015850878.pdf
23/08/2016 Outgoing Correspondence Letter to applicant 1 PDF /7/4/3/0/0/0400300347/docs/300347_32_77660l173.pdf
23/08/2016 Outgoing Correspondence Letter to applicant 1 PDF /7/4/3/0/0/0400300347/docs/300347_57_outgoingcorrespondence20160824022624541.pdf
17/08/2016 Incoming Correspondence Paper Response applicant or agent 1 PDF /7/4/3/0/0/0400300347/docs/300347_4_incomingcorrespondencepaper20160819033137115.pdf
16/08/2016 Incoming Correspondence Paper Fax 2 PDF /7/4/3/0/0/0400300347/docs/300347_54_incomingcorrespondencepaper20160817051152345.pdf
19/05/2016 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_15_55921l173.pdf
19/05/2016 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_22_outgoingcorrespondence20160519112624324.pdf
10/05/2016 Incoming Correspondence Paper Incoming correspondence third party 4 PDF /7/4/3/0/0/0400300347/docs/300347_6_incomingcorrespondencepaper20160510035822450.pdf
22/09/2015 Examination Internal New 1 PDF /7/4/3/0/0/0400300347/docs/300347_37_microsoft outlook - stijl voor memo.pdf
14/09/2015 Incoming Correspondence Paper Fax 3 PDF /7/4/3/0/0/0400300347/docs/300347_1_incomingcorrespondencepaper20151001114931234.pdf
14/09/2015 Incoming Correspondence Paper Accompanying letter incoming document 2 PDF /7/4/3/0/0/0400300347/docs/300347_38_incomingcorrespondencepaper20151001114931147.pdf
16/06/2015 Outgoing Correspondence Outgoing Letter 3 PDF /7/4/3/0/0/0400300347/docs/300347_56_outgoingcorrespondence20150616.pdf
16/04/2013 General 1 PDF /7/4/3/0/0/0400300347/docs/300347_75_spc-documents20130416.pdf
06/03/2013 Incoming Correspondence Paper Incoming Correspondence Paper 2 PDF /7/4/3/0/0/0400300347/docs/300347_69_incomingcorrespondencepaper20130306.pdf
09/09/2009 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_10_outgoingcorrespondence20090909.pdf
10/03/2009 Incoming Correspondence Paper Other 7 PDF /7/4/3/0/0/0400300347/docs/300347_11_incomingcorrespondencepaper20090310.pdf
10/03/2009 Incoming Correspondence Paper Other 9 PDF /7/4/3/0/0/0400300347/docs/300347_29_incomingcorrespondencepaper20090310.pdf
06/01/2009 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_43_outgoingcorrespondence20090106.pdf
18/12/2008 General 1 PDF /7/4/3/0/0/0400300347/docs/300347_16_spc-documents20081218.pdf
11/11/2008 Outgoing Correspondence Outgoing Letter 2 PDF /7/4/3/0/0/0400300347/docs/300347_7_outgoingcorrespondence20081111.pdf
15/05/2008 Outgoing Correspondence Outgoing Letter 1 PDF /7/4/3/0/0/0400300347/docs/300347_68_outgoingcorrespondence20080515.pdf
14/05/2008 General 3 PDF /7/4/3/0/0/0400300347/docs/300347_35_spc-documents20080514.pdf
14/05/2008 Application Form First filed application form 2 PDF /7/4/3/0/0/0400300347/docs/300347_40_applicationform20080514.pdf
14/05/2008 General 53 PDF /7/4/3/0/0/0400300347/docs/300347_59_spc-documents20080514.pdf