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Supplementary Protection Certificate Details

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Supplementary Protection Certificate (SPC) Summary
SPC No. 2005/001
Date of filing 21/01/2005
Notification of Application Published 23/02/2005
Status Revoked
Notification of Grant Published 24/08/2005
Date of Expiry of SPC 01/04/2019
Applicant Merck Sharp & Dohme Corp.
126 East Lincoln Avenue
Rahway
New Jersey 07065
UNITED STATES OF AMERICA
Patent Number 0720599
Title of Invention HYDROXY-SUBSTITUTED AZETIDINONE COMPOUNDS USEFUL AS HYPOCHOLESTEROLEMIC AGENTS
Date of Expiry of Patent 13/09/2014
Product Type Medicinal Product
Product Identity Ezetimibe, or a pharmaceutically acceptable salt therof, in combination with a cholesterol biosynthesis inhibitor such as simvastatin.
Market AuthorisationIreland Germany 
Authorisation No1091/3/3, 1091/3/4, 1091/4/1, 1091/4/2, 1091/4/3, 1091/4/4  58874.00.00; 58874.01.00; 58874.02.00; 58874.03.00 
Authorisation Date03/12/2004 02/04/2004 
Identity of Product Authorised Ezetimibe in combination with simvastatin 
Market Authorisation Germany 
Authorisation No 58878.00.00; 58878.01.00; 58878.02.00; 58878.03.00 
Authorisation Date 02/04/2004 
Identity of Product Authorised Ezetimibe in combination with simvastatin 
Market Authorisation Germany 
Authorisation No 58866.00.00; 58866.01.00; 58866.02.00; 58866.03.00 
Authorisation Date 02/04/2004 
Identity of Product Authorised Ezetimibe in combination with simvastatin 
Market Authorisation Germany 
Authorisation No 58870.00.00; 58870.01.00; 58870.02.00; 58870.03.00 
Authorisation Date 02/04/2004 
Identity of Product Authorised Ezetimibe in combination with simvastatin 
Address for Service TOMKINS & CO.
5 Dartmouth Road
Dublin 6
IRELAND
Renewal Fees
Year Date Renewed
 25  25/06/2018
 24  26/06/2017
 23  27/06/2016
 22  26/06/2015
 21  27/06/2014
19/07/2012 Change of name and address of proprietor from Schering Corporation, A corporation organised and existing under the laws of the State of New Jersey of 2000 Galloping Hill Road, Kenilworth, New Jersey 07030, United States of America to Merck Sharp & Dohme Corp., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States of America recorded on 12/07/12.
31/05/2018 Controller notified on 30 May 2018 of High Court Proceedings, in which infringement proceedings in respect of SPC 2005/001 have been brought by the petitioners, Merck, Sharp and Dohme Corp against Clonmel Healthcare Limited.
27/02/2019 Controller notified on 27 February 2019 that this matter has been listed for hearing before the High Court on 28 May 2019.
01/05/2019 SPC expired on 01/04/2019.
03/03/2021 Supplementary Protection Certificate No. 2005/001 revoked by Order of the High Court dated 29 November 2019.
27/04/2022 CORRECTION: MEMO DATED 03/03/2021 should read: Supplementary Protection Certificate No. 2005/001 revoked by Order of the High Court dated 11 February 2020.
05/07/2023 Controller notified on 10 September 2021 of Supreme Court decision of 4 August 2021 to grant Merck Sharp & Dohme leave to appeal the Court of Appeal Decision.
09/06/2025 Controller notified on 28/05/2025 that, by way of Order dated 9 April 2025, the Supreme Court ordered that the appeal against the Order and Judgment of the Court of Appeal be dismissed in so far as the Order of the Court of Appeal upheld the Declaration of the High Court that the SPC is invalid pursuant to Article 3(a) of the SPC Regulation and the Order of the High Court that the SPC be revoked. The Supreme Court noted in its Order that this SPC complies with the requirements of Article 3(c) of the SPC Regulation.