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Administrative Decision Number1996/028
Date23 September 2009
SectionPatents and SPC's
Decision in Respect of an Application by E.I. Du Pont De
Nemours & Company for the Grant of an Extension of Duration
of the SPC No. 1996/028 for COZAAR
1. This decision relates to an application by E.I. Du Pont De Nemours and
Company (hereinafter ‘Du Pont’) for the grant of an extension of the duration of the SPC
No. 1996/028 which was lodged with the Patents Office on 23 February 2009. The SPC
had been granted to Du Pont on 25 June 1997 (with an expiry date of 2 September
2009) in respect of the medicinal product “COZAAR which contains Losartan potassium”
(hereinafter COZAAR). The active ingredient, Losartan potassium, is used to treat high
blood pressure in humans and was protected by Irish patent No. 69984 (granted on 16
October 1996). Merck Sharp & Dohme Limited (hereinafter ‘Merck’) holds a licence from
Du Pont under both the patent and the SPC and it also has a Marketing Authorisation
(MA) for COZAAR in Ireland.
2. In support of the application on 23 February 2009, the Applicant submitted a
number of additional documents and these may be identified as follows:-
D1 a copy of SPC No. 1996/028 for COZAAR.
D2 a copy of a Commission Decision of 22 January 2009 for a new oral formulation of
COZAAR suitable for paediatric use.
D3 supporting assertions made by the Merck, the Marketing Authorisation holder.
These were to the effect that (i) the active ingredient “Losartan potassium” was marketed
as “COZAAR and/or associated names” in all the Member States of the EU; (ii)
applications for authorisation of a paediatric indication for “COZAAR and/or associated
names” and a new oral paediatric formulation of “COZAAR and/or associated names”
had been made in all Member States under Article 8 of the Paediatric Regulation; and
(iii) a confirmation that “COZAAR and/or associated names” was authorised to be placed
on the market in all Member States and the details of these authorisations were to be
found in Annex I of document D2.
D4 a Preliminary Variation Assessment Report (PVAR) issued by the College ter
Beoordeling van Geneesmiddelen (CBG - Medicines Evaluations Board of The
Netherlands) on 28 January 2008. This relates to a “Type II Variation” application to the
Marketing Authorisation for COZAAR.
D5 an email issued by the CBG to the Concerned Member States (CMS) on 13
February 2009 with the subject “Type II Variation application email from RMS
confirming clock off”.
D6 - a certified copy of the positive Opinion on compliance with an agreed paediatric
investigation plan (PIP) for COZAAR issued by the Paediatric Committee (PDCO) of the
European Medicines Agency (EMEA) on 6 February 2009.
D7 copies of the Irish Marketing Authorisations for 50 and 100 mg tablet forms of
COZAAR and for an ‘Initiation Pack” containing both 12.5 and 50mg tablets.
As there are a number of abbreviated expressions used throughout this decision I have
listed them in an attached Annex Glossary of Terms’
3. On 2 March 2009 the Applicant submitted a copy of the Irish Marketing
Authorisation for the oral paediatric formulation of COZAAR that had been issued by the
Irish Medicines Board on 27 February 2009 arising out of the Commission Decision of 22
January 2009 (document D8). On 7 July 2009 the Applicant submitted the following
supporting documentation: lists of national MAs which had issued by that date for both
the new paediatric formulation and a Type II variation of COZAAR (accompanied by an
disk containing copies of all the authorisations), plus a copy of the “end of procedure”
email sent by the CBG to all CMS in relation to the Type II variation application which
included a statement of compliance with the PIP (document D9). The Applicant also
submitted further written arguments in support of its case and confirmed that only
Greece remained to issue both MAs. On 9 July 2009 the Applicant submitted copies of
both the oral paediatric formulation and the Type II variation MAs issued by Greece. On
17 July 2009 the Applicant submitted further written submissions for the Examiner in
support of its application. On 22 July the Applicant submitted documentation from the
Lithuanian Medicines Agency confirming the issue of the updated MA for the paediatric
indication of COZAAR on 1 July 2009.

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