Novartis AG - SPC 1999/002

Administrative Decision Number1999/002
Date10 March 2005
SectionPatents and SPC's
Decision in respect of a Request by Novartis AG (SPC 1999/002) for the
Grant of a Supplementary Protection Certificate (Medicinal Products)
under S.I. No. 125 of 1993 (European Communities (Supplementary
Protection Certificate) Regulations, 1993) and Council Regulation EEC
No. 1768/92 of 18 June 1992 concerning the creation of a Supplementary
Protection Certificate for Medicinal Products
1. Introduction.
The matter in hand relates to a request (SPC 1999/002) for the grant of a
Supplementary Protection Certificate from Novartis AG for valsartan or a
pharmaceutically acceptable salt or ester thereof in combination with
hydrochlorothiazide (HCTZ) and with the product name “Co-Diovan”.
2. Background.
A request (1999/002) for the grant of an SPC for “valsartan or a
pharmaceutically acceptable salt or ester thereof in combination with
hydrochlorothiazide” and with the product name “Co-Diovan” was filed on 26
February 1999 by Novartis AG, a Swiss company of Basel, Switzerland.
On the request form, Irish patent 71155 with the title “Acyl compounds” was
given as the basic patent in force as required under Article 3(a) of Council
Regulation (EEC) No. 1768/92 (Regulation 1768/92). In order to satisfy the
Controller that the product was protected by this patent, the Applicant referred
in particular to “Valsartan is disclosed in Example 16 and is specifically
claimed in Claim 26 of patent 71155”.
The Applicant provided under heading 4(i) the required information relating to
the first authorisation to place the product Co-Diovan on the market in Ireland,
namely Product Authorisation No. 13/91/1 issued by the Irish Medicines Board
on 10 December 1998, as well as a facsimile copy of the complete document.

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