| Supplementary Protection Certificate (SPC) Summary | |||||||||||
| SPC No. | 2009/015 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Date of filing | 14/05/2009 | ||||||||||
| Notification of Application Published | 24/06/2009 | ||||||||||
| Status | Granted | ||||||||||
| Notification of Grant Published | 22/05/2013 | ||||||||||
| Date of Expiry of SPC | 19/07/2024 | ||||||||||
| Applicant |
Janssen Biotech, Inc. 800/850 Ridgeway Drive Horsham, PA 19044 UNITED STATES OF AMERICA |
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| Patent Number | 1309692 | ||||||||||
| Title of Invention | ANTI-IL-12 ANTIBODIES, COMPOSITIONS, METHODS AND USES | ||||||||||
| Date of Expiry of Patent | 06/08/2021 | ||||||||||
| Product Type | Medicinal Product | ||||||||||
| Product Identity | Ustekinumab | ||||||||||
| Market Authorisation | Ireland | ||||||||||
| Authorisation No | EU/1/08/494/001-002 | ||||||||||
| Authorisation Date | 16/01/2009 | ||||||||||
| Identity of Product Authorised | STELARA-ustekinumab | ||||||||||
| Address for Service |
FRKelly Waterways House Grand Canal Quay Dublin D02 PD39 IRELAND |
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| Renewal Fees |
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| 01/12/2014 | Change of name and address of applicant(s) from CENTOCOR ORTHO BIOTECH, INC., 800/850 Ridgeway Drive, Horsham, PA19044, United States of America to Janssen Biotech, Inc., 800/850 Ridgeway Drive, Horsham, PA 19044, United States of America recorded on 28/11/2014. | ||||||||||
| 07/11/2016 | The expiry date of SPC No. 2009/015 has been amended to bring it into line with the decision from the Court of Justice of the European Union in Case C-471/14. New expiry date is 19/01/2024. | ||||||||||
| 16/03/2020 | Application for an extension of the duration of Supplementary Protection Certificate No. 2009/015 filed on 12/03/2020. | ||||||||||
| 24/11/2020 | Application for an extension of the duration of Supplementary Protection Certificate No. 2009/015 granted on 24/11/2020. Expiry date of SPC changed from 19/01/2024 to 19/07/2024. | ||||||||||
| 05/02/2023 | Notification of a waiver received on 05 February 2023 in accordance with Article 5(2)(b) of Regulation (EC) No 469/2009 (as amended by Regulation (EU) 2019/933) concerning the Irish Supplementary Protection Certificate 2009/015. | ||||||||||
| 09/06/2023 | Waiver notification received on 05 February concerning Supplementary Protection Certification No. 2009/015 was withdrawn on 22 May 2023. | ||||||||||