Register information Protection certificate

DE file number : 12 2010 000 047.5 (Status: pending/in force, Query started: May 11, 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	Pending/in force
21	DE file number	DAKZ	12 2010 000 047.5
	Use	VZ	Medicinal products
95	Product name	TIEZ	Denosumab
54	Title of basic patent	TIGZ	ANTIKÖRPER GEGEN OPGL
51	IPC main class	ICM (ICMV)	A61K 39/395 (2006.01)
51	IPC secondary class(es)	ICS (ICSV)	G01N 33/53 (2006.01), C07K 16/28 (2006.01), A61P 19/08 (2006.01)
94	Start of term of protection	LB	Jun 26, 2022
94	End of term of protection	LE	Nov 28, 2025
22	DE application date	DAT	Nov 26, 2010
	Date of publication of application for a certificate	OT	May 5, 2011
	Date of publication of grant of certificate	PET	Aug 14, 2019
71/73	Applicant/owner	INH	Amgen Fremont Inc., One Amgen Center Drive, 91320-1799 Thousand Oaks, CA, US; Amgen Inc., One Amgen Center Drive, 91320-1799 Thousand Oaks, CA, US
74	Representative	VTR	df-mp Patentanwälte Rechtsanwälte PartG mbB, 80333 München, DE
	Address for service		df-mp Patentanwälte Rechtsanwälte PartG mbB, 80333 München, DE
	Due date	FT FG	Jun 30, 2025 Annual fee for the 24th year Patent fees
	Patent division in charge		44
68	DE file number of basic patent	GAKZ	602 35 989.9
68	EP file number of basic patent	GEAKZ	02 74 9660.3
43	Date of first publication	EVT	May 5, 2011
92 92 92	Domestic authorisation	GIS GIN GIT	Europäische Kommission EU/1/10/618/004 2010-05-26
92 92 92	Domestic authorisation	GIS GIN GIT	Europäische Kommission EU/1/10/618/001 2010-05-26
92 92 92	Domestic authorisation	GIS GIN GIT	Europäische Kommission EU/1/10/618/002 2010-05-26
92 92 92	Domestic authorisation	GIS GIN GIT	Europäische Kommission EU/1/10/618/003 2010-05-26
93 93 93 93	EU authorisation	GES GEC GEN GET	Europäische Kommssion EU EU/1/10/618/001-004 2010-05-26
	Date of the first transfer into DPMAregister	EREGT	May 27, 2011
	Date of the (most recent) update in DPMAregister	REGT	Apr 29, 2025 (Show all update days)(Hide all update days) Apr 29, 2025 Domestic authorisations: changed Apr 23, 2025 Procedures: Supplementary protection certificate procedure, Supplementary protection certificate - new notification exception, 25.02.2025: changed Procedures: Supplementary protection certificate procedure, Supplementary protection certificate - update notification exception, 15.04.2025: new Apr 18, 2025 St.36: changed (technical change) Apr 10, 2025 Procedures: Supplementary protection certificate procedure, Supplementary protection certificate - new notification exception, 25.02.2025: changed Mar 4, 2025 Domestic authorisations: changed Mar 1, 2025 Domestic authorisations: changed Procedures: Supplementary protection certificate procedure, Supplementary protection certificate - new notification exception, 25.02.2025: new Jan 22, 2025 Domestic authorisations: changed Jan 14, 2025 Representative: changed Address for service: changed Domestic authorisations: changed Aug 7, 2024 Domestic authorisations: changed May 28, 2024; Feb 3, 2024; Dec 14, 2023; Nov 24, 2023; Nov 23, 2023; Nov 17, 2023; Nov 1, 2023; Jun 3, 2023; Mar 9, 2023; Feb 2, 2023; Jan 31, 2023; May 26, 2022; Apr 30, 2022; Jan 25, 2022; Jul 6, 2021; Feb 4, 2021; Dec 15, 2020; Aug 28, 2020; Jul 2, 2020; May 28, 2020; Mar 10, 2020; Mar 3, 2020; Jan 21, 2020; Jan 16, 2020; Jan 9, 2020; Jan 8, 2020; Jan 4, 2020; Aug 14, 2019; Jul 16, 2019; Jul 11, 2019; May 8, 2019; Mar 14, 2019; Dec 7, 2018; Jul 11, 2015; Jul 6, 2014; May 3, 2014; Mar 29, 2014; Mar 25, 2014; Feb 26, 2014; Sep 3, 2013; Aug 28, 2013; Aug 27, 2013; Aug 3, 2013; Jun 26, 2013; Jun 18, 2013; Mar 16, 2013; Feb 15, 2013; 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	Jan 17, 2011	May 5, 2011	Details anzeigen
2	New applicant/owner details	New applicant/owner details	Dec 6, 2018		Details anzeigen
3	Supplementary protection certificate procedure	Decision to grant supplementary protection certificate by Patent Division	May 7, 2019		Details anzeigen
4	Supplementary protection certificate procedure	Supplementary protection certificate granted	Jun 12, 2019	Aug 14, 2019	Details anzeigen
5	Supplementary protection certificate procedure	Application for an extension of the duration (medicinal product for paediatric use)	Dec 23, 2019	Feb 13, 2020	Details anzeigen
6	Supplementary protection certificate procedure	Decision by the patent division on granting the application for an extension of the duration (medicinal products for paediatric use)	Mar 2, 2020		Details anzeigen
7	Supplementary protection certificate procedure	Decision on grant of the application for an extension of the duration (medicinal product for paediatric use) has become final	Apr 7, 2020	Jul 2, 2020	Details anzeigen
8	Supplementary protection certificate procedure	New notification pursuant to point (b) of Art. 5(2) Regulation (EC) no. 469/2009	Jan 25, 2023	Mar 9, 2023	Details anzeigen
9	Supplementary protection certificate procedure	New notification pursuant to point (b) of Art. 5(2) Regulation (EC) no. 469/2009	Feb 25, 2025	Apr 10, 2025	Details anzeigen
10	Supplementary protection certificate procedure	Update of an existing notification pursuant to point (c) of Art. 5(2) Regulation (EC) no. 469/2009	Apr 15, 2025		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	Jan 17, 2011
	Issue number	HN	18
	Year	PJ	2011
	Publication date	VT	May 5, 2011
	Type of publication	PART	Bibliographic data
	Part	HT	Part 7
68	DE file number of basic patent	GAKZ	602 35 989.9
68	EP file number of basic patent	GEAKZ	02 74 9660.3

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	Dec 6, 2018
71/73	Applicant/owner	INH	Amgen Fremont Inc., 91320-1799 Thousand Oaks, CA, US; Amgen Inc., 91320-1799 Thousand Oaks, CA, US
71/73	Previous applicant/owner	INHF	Amgen Fremont Inc., 94555 Fremont, Ca., US, Amgen Inc., Thousand Oaks, Calif., 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 7, 2019

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	Jun 12, 2019
Issue number	HN	33
Year	PJ	2019
Publication date	VT	Aug 14, 2019
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 an extension of the duration (medicinal product for paediatric use)
Date of legal/procedural status	VSTT	Dec 23, 2019
Issue number	HN	7
Year	PJ	2020
Publication date	VT	Feb 13, 2020
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	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	Mar 2, 2020
Date of update of the procedure	REGT	Dec 15, 2020

View procedures Supplementary protection certificate procedure (No.: 7)
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	Apr 7, 2020
Issue number	HN	27
Year	PJ	2020
Publication date	VT	Jul 2, 2020
Type of publication	PART	Bibliographic data
Part	HT	Part 7

View procedures Supplementary protection certificate procedure (No.: 8)
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	Jan 25, 2023
Issue number	HN	10
Year	PJ	2023
Publication date	VT	Mar 9, 2023
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 25.01.2023 Name and address of the maker: TEVA BioTech GmbH, 89079 Ulm, DE Type of notification: New notification Purpose of making: Export Member State in which making is to take place: Deutschland Number of certificate granted in the Member State of making: 12 2010 000 047.5 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 2010 000 047.5
Date of update of the procedure	REGT	Mar 9, 2023

View procedures Supplementary protection certificate procedure (No.: 9)
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	Feb 25, 2025
Issue number	HN	15
Year	PJ	2025
Publication date	VT	Apr 10, 2025
Type of publication	PART	Bibliographic data
Part	HT	Part 7
Notification exception		Date of receipt: 25.02.2025 Name and address of the maker: Celltrion Healthcare Hungary Kft., 1062 Budapest, HU 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 2010 000 047.5 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 2010 000 047.5 Number of marketing authorisation, or the equivalent of such authorisation, in each third country of export: Australien (AU) 42991
Date of update of the procedure	REGT	Apr 23, 2025

View procedures Supplementary protection certificate procedure (No.: 10)
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	Apr 15, 2025
Notification exception		Date of receipt: 25.02.2025 Name and address of the maker: Celltrion Healthcare Hungary Kft., 1062 Budapest, HU 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 2010 000 047.5 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 2010 000 047.5 Number of marketing authorisation, or the equivalent of such authorisation, in each third country of export: Australien (AU) 42991
Date of update of the procedure	REGT	Apr 23, 2025