Register information Protection certificate

DE file number : 12 2009 000 025.7 (Status: not pending/lapsed, Query started: July 18, 2025)

Please note: This English version is a non-binding translation of the German register excerpt. Only the German version of the register excerpt is legally binding.

Master data
INID	Criterion	Field	Content
	Type of IP right	SART	Protection certificate
	Status	ST	Not pending/lapsed
21	DE file number	DAKZ	12 2009 000 025.7
	Use	VZ	Medicinal products
95	Product name	TIEZ	Ustekinumab
54	Title of basic patent	TIGZ	ANTIKÖRPER GEGEN IL-12, ZUSAMMENSETZUNGEN, VERFAHREN UND VERWENDUNGEN
51	IPC main class	ICM (ICMV)	C12N 15/13 (2006.01)
51	IPC secondary class(es)	ICS (ICSV)	C07K 16/24 (2006.01), C12N 15/79 (2006.01), C12N 5/10 (2006.01), A61K 39/395 (2006.01), C07K 16/42 (2006.01), A61P 37/00 (2006.01), G01N 33/50 (2006.01), G01N 33/577 (2006.01)
94	Start of term of protection	LB	Aug 8, 2021
94	End of term of protection	LE	Jul 20, 2024
22	DE application date	DAT	May 13, 2009
	Date of publication of application for a certificate	OT	Sep 17, 2009
	Date of publication of grant of certificate	PET	Oct 22, 2015
71/73	Applicant/owner	INH	Janssen Biotech, Inc., 800/850 Ridgeview Drive, 19044 Horsham, Pa., US
74	Representative	VTR	Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB, 22607 Hamburg, DE
	Address for service		Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB, 22607 Hamburg, DE
	Patent division in charge		44
68	DE file number of basic patent	GAKZ	601 38 711.2
68	EP file number of basic patent	GEAKZ	01 95 9598.2
43	Date of first publication	EVT	Sep 17, 2009
92 92 92	Domestic authorisation	GIS GIN GIT	Europäische Kommission EU/1/08/494/002 2009-01-16
92 92 92	Domestic authorisation	GIS GIN GIT	Europäische Kommission EU/1/08/494/001 2009-01-16
93 93 93 93	EU authorisation	GES GEC GEN GET	Europäische Kommission EU EU/1/08/494/001 2009-01-16
93 93 93 93	EU authorisation	GES GEC GEN GET	Europäische Kommission EU EU/1/08/494/002 2009-01-16
	Date of the first transfer into DPMAregister	EREGT	May 27, 2011
	Date of the (most recent) update in DPMAregister	REGT	Oct 10, 2024 (Show all update days)(Hide all update days) Oct 10, 2024 Procedures: Administrative procedure, IP right lapsed through expiry of term of protection, 20.07.2024: changed Sep 3, 2024 Domestic authorisations: changed Aug 6, 2024 Domestic authorisations: changed Jul 23, 2024 Status: changed Procedures: Administrative procedure, IP right lapsed through expiry of term of protection, 20.07.2024: new Apr 18, 2024; Mar 13, 2024; Mar 12, 2024; Mar 9, 2024; Feb 15, 2024; Feb 2, 2024; Jan 11, 2024; Nov 16, 2023; Oct 19, 2023; Oct 13, 2023; Oct 11, 2023; Oct 6, 2023; Sep 28, 2023; Sep 26, 2023; Sep 23, 2023; Sep 13, 2023; Aug 26, 2023; Aug 25, 2023; Aug 5, 2023; Aug 1, 2023; Jul 13, 2023; Jun 7, 2023; Jun 6, 2023; Aug 31, 2022; Aug 10, 2022; Aug 4, 2022; Jun 29, 2022; Mar 30, 2022; Jan 25, 2022; Jan 20, 2022; Jan 19, 2022; Dec 16, 2021; Dec 9, 2021; Aug 10, 2021; Apr 24, 2021; Apr 23, 2021; Apr 22, 2020; Mar 27, 2020; Mar 13, 2020; Mar 12, 2020; Mar 3, 2020; Jan 9, 2020; Jul 16, 2019; Jun 22, 2017; May 16, 2017; Nov 16, 2016; Oct 13, 2016; Sep 6, 2016; Sep 3, 2016; Oct 22, 2015; Sep 15, 2015; Jul 11, 2015; May 23, 2015; May 13, 2015; Jan 14, 2015; Jul 6, 2014; May 3, 2014; Mar 2, 2014; Feb 25, 2014; Nov 19, 2013; Nov 15, 2013; Mar 16, 2013; Feb 12, 2013; Dec 30, 2011; Nov 1, 2011; Oct 11, 2011; 31.05.2011; May 31, 2011 Historical data not available for this/these date(s) May 27, 2011 Date of the first transfer into DPMAregister

Procedural data
No.	Kind of procedure	Legal status	Date of legal/procedural status	Publication date	Alle Details anzeigen
1	Supplementary protection certificate procedure	Application for supplementary protection certificate effectively filed	Jul 2, 2009	Sep 17, 2009	Details anzeigen
2	New applicant/owner details	New applicant/owner details	Jan 13, 2015		Details anzeigen
3	Supplementary protection certificate procedure	Decision to grant supplementary protection certificate by Patent Division	May 22, 2015		Details anzeigen
4	Supplementary protection certificate procedure	Supplementary protection certificate granted	Aug 8, 2015	Oct 22, 2015	Details anzeigen
5	Supplementary protection certificate procedure	Application for rectification of the duration	Aug 31, 2016	Oct 13, 2016	Details anzeigen
6	Supplementary protection certificate procedure	Application for the rectification of the duration has been withdrawn/is deemed withdrawn	Dec 1, 2016		Details anzeigen
7	Publications	Other <with further information such as lien, etc>	Jun 22, 2017	Jun 22, 2017	Details anzeigen
8	Supplementary protection certificate procedure	Application for rectification of the duration	Feb 24, 2020	Apr 23, 2020	Details anzeigen
9	Supplementary protection certificate procedure	Application for an extension of the duration (medicinal product for paediatric use)	Feb 24, 2020	Apr 23, 2020	Details anzeigen
10	Supplementary protection certificate procedure	Decision by the patent division to grant the application for the rectification of the duration	Jan 18, 2022		Details anzeigen
11	Supplementary protection certificate procedure	Decision by the patent division on granting the application for an extension of the duration (medicinal products for paediatric use)	Jan 19, 2022		Details anzeigen
12	Supplementary protection certificate procedure	Decision to grant the application for the rectification of the duration has become final	Mar 1, 2022	Aug 4, 2022	Details anzeigen
13	Supplementary protection certificate procedure	Decision on grant of the application for an extension of the duration (medicinal product for paediatric use) has become final	Mar 1, 2022	Aug 4, 2022	Details anzeigen
14	Supplementary protection certificate procedure	New notification pursuant to point (b) of Art. 5(2) Regulation (EC) no. 469/2009	May 31, 2023	Jul 13, 2023	Details anzeigen
15	Supplementary protection certificate procedure	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009	Jul 27, 2023	Sep 7, 2023	Details anzeigen
16	Supplementary protection certificate procedure	New notification pursuant to point (b) of Art. 5(2) Regulation (EC) no. 469/2009	Aug 23, 2023	Nov 2, 2023	Details anzeigen
17	Publications	Other <with further information such as lien, etc>	Nov 2, 2023	Nov 2, 2023	Details anzeigen
18	Supplementary protection certificate procedure	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009	Dec 22, 2023	Feb 15, 2024	Details anzeigen
19	Supplementary protection certificate procedure	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009	Mar 6, 2024	Apr 18, 2024	Details anzeigen
20	Administrative procedure	IP right lapsed through expiry of term of protection	Jul 20, 2024	Oct 10, 2024	Details anzeigen

View procedures Supplementary protection certificate procedure (No.: 1)
INID	Criterion	Field	Content Close details
	Type of procedure	VART	Protection certificate procedure
	Legal/procedural status	VST	Application for supplementary protection certificate effectively filed
	Date of legal/procedural status	VSTT	Jul 2, 2009
	Issue number	HN	38
	Year	PJ	2009
	Publication date	VT	Sep 17, 2009
	Type of publication	PART	Bibliographic data
	Part	HT	Part 7
68	DE file number of basic patent	GAKZ	601 38 711.2
68	EP file number of basic patent	GEAKZ	01 95 9598.2

View procedures New applicant/owner details (No.: 2)
INID	Criterion	Field	Content Close details
	Type of procedure	VART	New applicant/owner details
	Legal/procedural status	VST	New applicant/owner details
	Date of legal/procedural status	VSTT	Jan 13, 2015
71/73	Applicant/owner	INH	Janssen Biotech, Inc., 19044 Horsham, Pa., US
71/73	Previous applicant/owner	INHF	Centocor Ortho Biotech Inc., 19044 Horsham, Pa., US

View procedures Supplementary protection certificate procedure (No.: 3)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Decision to grant supplementary protection certificate by Patent Division
Date of legal/procedural status	VSTT	May 22, 2015

View procedures Supplementary protection certificate procedure (No.: 4)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Supplementary protection certificate granted
Date of legal/procedural status	VSTT	Aug 8, 2015
Issue number	HN	43
Year	PJ	2015
Publication date	VT	Oct 22, 2015
Type of publication	PART	Bibliographic data
Part	HT	Part 7

View procedures Supplementary protection certificate procedure (No.: 5)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Application for rectification of the duration
Date of legal/procedural status	VSTT	Aug 31, 2016
Issue number	HN	41
Year	PJ	2016
Publication date	VT	Oct 13, 2016
Type of publication	PART	Bibliographic data
Part	HT	Part 7

View procedures Supplementary protection certificate procedure (No.: 6)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Application for the rectification of the duration has been withdrawn/is deemed withdrawn
Date of legal/procedural status	VSTT	Dec 1, 2016

View procedures Publications (No.: 7)
Criterion	Field	Content Close details
Type of procedure	VART	Publications
Legal/procedural status	VST	Other <with further information such as lien, etc>
Date of legal/procedural status	VSTT	Jun 22, 2017
Issue number	HN	25
Year	PJ	2017
Publication date	VT	Jun 22, 2017
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Supplementary information	INFO	Bezeichnung des Wirkstoffes/Erzeugnisses lt. Erteilungsbeschluss geänder in "Ustekinumab".

View procedures Supplementary protection certificate procedure (No.: 8)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Application for rectification of the duration
Date of legal/procedural status	VSTT	Feb 24, 2020
Issue number	HN	17
Year	PJ	2020
Publication date	VT	Apr 23, 2020
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Date of update of the procedure	REGT	Dec 9, 2021

View procedures Supplementary protection certificate procedure (No.: 9)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Application for an extension of the duration (medicinal product for paediatric use)
Date of legal/procedural status	VSTT	Feb 24, 2020
Issue number	HN	17
Year	PJ	2020
Publication date	VT	Apr 23, 2020
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Date of update of the procedure	REGT	Apr 24, 2021

View procedures Supplementary protection certificate procedure (No.: 10)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Decision by the patent division to grant the application for the rectification of the duration
Date of legal/procedural status	VSTT	Jan 18, 2022
Date of update of the procedure	REGT	Jan 19, 2022

View procedures Supplementary protection certificate procedure (No.: 11)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Decision by the patent division on granting the application for an extension of the duration (medicinal products for paediatric use)
Date of legal/procedural status	VSTT	Jan 19, 2022
Date of update of the procedure	REGT	Jan 20, 2022

View procedures Supplementary protection certificate procedure (No.: 12)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Decision to grant the application for the rectification of the duration has become final
Date of legal/procedural status	VSTT	Mar 1, 2022
Issue number	HN	31
Year	PJ	2022
Publication date	VT	Aug 4, 2022
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Date of update of the procedure	REGT	Aug 4, 2022

View procedures Supplementary protection certificate procedure (No.: 13)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Decision on grant of the application for an extension of the duration (medicinal product for paediatric use) has become final
Date of legal/procedural status	VSTT	Mar 1, 2022
Issue number	HN	31
Year	PJ	2022
Publication date	VT	Aug 4, 2022
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Date of update of the procedure	REGT	Aug 4, 2022

View procedures Supplementary protection certificate procedure (No.: 14)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	New notification pursuant to point (b) of Art. 5(2) Regulation (EC) no. 469/2009
Date of legal/procedural status	VSTT	May 31, 2023
Issue number	HN	28
Year	PJ	2023
Publication date	VT	Jul 13, 2023
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 31.05.2023 Name and address of the maker: FYB202 Project GmbH, 82152 Planegg, DE Type of notification: New notification Purpose of making: Export and storing Member State in which making is to take place: Deutschland Number of certificate granted in the Member State of making: 12 2009 000 025.7 Member State in which first related act (if any) prior to making is to take place: Deutschland Number of certificate granted in Member State of first related act (if any) prior to making: 12 2009 000 025.7
Date of update of the procedure	REGT	Jul 13, 2023

View procedures Supplementary protection certificate procedure (No.: 15)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009
Date of legal/procedural status	VSTT	Jul 27, 2023
Issue number	HN	36
Year	PJ	2023
Publication date	VT	Sep 7, 2023
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 27.07.2023 Name and address of the maker: FYB202 Project GmbH, 82152 Planegg, DE Type of notification: Update of an existing notification Purpose of making: Storing Member State in which making is to take place: Deutschland Number of certificate granted in the Member State of making: 12 2009 000 025.7 Member State in which first related act (if any) prior to making is to take place: Deutschland Number of certificate granted in Member State of first related act (if any) prior to making: 12 2009 000 025.7
Date of update of the procedure	REGT	Aug 25, 2023

View procedures Supplementary protection certificate procedure (No.: 16)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	New notification pursuant to point (b) of Art. 5(2) Regulation (EC) no. 469/2009
Date of legal/procedural status	VSTT	Aug 23, 2023
Issue number	HN	44
Year	PJ	2023
Publication date	VT	Nov 2, 2023
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 23.08.2023 Name and address of the maker: FYB202 Project GmbH, 82152 Planegg, DE Type of notification: New notification Purpose of making: Export and storing Member State in which making is to take place: Deutschland Number of certificate granted in the Member State of making: 12 2009 000 025.7 Member State in which first related act (if any) prior to making is to take place: Deutschland Number of certificate granted in Member State of first related act (if any) prior to making: 12 2009 000 025.7
Date of update of the procedure	REGT	Oct 19, 2023

View procedures Publications (No.: 17)
Criterion	Field	Content Close details
Type of procedure	VART	Publications
Legal/procedural status	VST	Other <with further information such as lien, etc>
Date of legal/procedural status	VSTT	Nov 2, 2023
Issue number	HN	44
Year	PJ	2023
Publication date	VT	Nov 2, 2023
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Supplementary information	INFO	die Kleinteilepublikation "Aktualisierung einer bestehenden Mitteilung gemäß Art. 5 Abs. 2 Buchstabe c VO (EG) Nr. 469/2009 (Arzneimittel)" vom 19.10.2023 gilt als nicht abgegeben
Date of update of the procedure	REGT	Oct 6, 2023

View procedures Supplementary protection certificate procedure (No.: 18)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009
Date of legal/procedural status	VSTT	Dec 22, 2023
Issue number	HN	7
Year	PJ	2024
Publication date	VT	Feb 15, 2024
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 22.12.2023 Name and address of the maker: FYB202 Project GmbH, 82152 Planegg, DE Type of notification: Update of an existing notification Purpose of making: Export and storing Member State in which making is to take place: Deutschland Number of certificate granted in the Member State of making: 12 2009 000 025.7 Member State in which first related act (if any) prior to making is to take place: Deutschland Number of certificate granted in Member State of first related act (if any) prior to making: 12 2009 000 025.7 Number of marketing authorisation, or the equivalent of such authorisation, in each third country of export: Nummer der Genehmigung für das lnverkehrbringen in Kanada ist noch nicht erteilt. Nachfolgend die von der kanadischen Behörde für die Anmeldung zugewiesene Dossier ID: e279373; sowie die Submission Control Number: 279373.
Date of update of the procedure	REGT	Feb 2, 2024

View procedures Supplementary protection certificate procedure (No.: 19)
Criterion	Field	Content Close details
Type of procedure	VART	Protection certificate procedure
Legal/procedural status	VST	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009
Date of legal/procedural status	VSTT	Mar 6, 2024
Issue number	HN	16
Year	PJ	2024
Publication date	VT	Apr 18, 2024
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 06.03.2024 Name and address of the maker: FYB202 Project GmbH, 82152 Planegg, DE Type of notification: Update of an existing notification Purpose of making: Storing Member State in which making is to take place: Deutschland Number of certificate granted in the Member State of making: 12 2009 000 025.7 Member State in which first related act (if any) prior to making is to take place: Deutschland Number of certificate granted in Member State of first related act (if any) prior to making: 12 2009 000 025.7
Date of update of the procedure	REGT	Apr 18, 2024

View procedures Administrative procedure (No.: 20)
Criterion	Field	Content Close details
Type of procedure	VART	Administrative procedure
Legal/procedural status	VST	IP right lapsed through expiry of term of protection
Date of legal/procedural status	VSTT	Jul 20, 2024
Issue number	HN	41
Year	PJ	2024
Publication date	VT	Oct 10, 2024
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Date of update of the procedure	REGT	Oct 10, 2024