Anonymous
Guest
Anonymous
Guest
Monday, 14 February 2011
From Philippe de Jong (Altius, Brussels) comes details of a fascinating recent decision from the Antwerp Court of Appeal in a case concerning SPCs for combination products. The case is Novartis v Teva, case 2010/RK/456, decided on 9 February 2011. Explains Philippe:
"The Antwerp Court of Appeal ordered Teva not to launch prematurely a generic version of Novartis’ blockbuster drug Co-Diovan. The product which Teva intended to launch on 12 February 2011 – the expiry date of Novartis’ basic patent for valsartan (EP 443 983 B1) – contained, like Co-Diovan, valsartan and hydrochlorothiazide or ‘HCTZ’ as its active ingredients. However, this combination of valsartan and HCTZ is protected until 25 September 2012 by a Belgian SPC.
Teva launched a nullity action against this SPC before the Antwerp Commercial Court and also contested its prima facie validity in the summary proceedings which Novartis subsequently brought against Teva.
The main argument raised by Teva in support of its nullity allegations was that the product valsartan+HCTZ was not protected by the basic patent within the meaning of Article 3(a) of SPC Regulation 469/2009 because the combination of valsartan and HCTZ was not specifically disclosed in the claims of the basic patent.
From Philippe de Jong (Altius, Brussels) comes details of a fascinating recent decision from the Antwerp Court of Appeal in a case concerning SPCs for combination products. The case is Novartis v Teva, case 2010/RK/456, decided on 9 February 2011. Explains Philippe:
"The Antwerp Court of Appeal ordered Teva not to launch prematurely a generic version of Novartis’ blockbuster drug Co-Diovan. The product which Teva intended to launch on 12 February 2011 – the expiry date of Novartis’ basic patent for valsartan (EP 443 983 B1) – contained, like Co-Diovan, valsartan and hydrochlorothiazide or ‘HCTZ’ as its active ingredients. However, this combination of valsartan and HCTZ is protected until 25 September 2012 by a Belgian SPC.
Teva launched a nullity action against this SPC before the Antwerp Commercial Court and also contested its prima facie validity in the summary proceedings which Novartis subsequently brought against Teva.
The main argument raised by Teva in support of its nullity allegations was that the product valsartan+HCTZ was not protected by the basic patent within the meaning of Article 3(a) of SPC Regulation 469/2009 because the combination of valsartan and HCTZ was not specifically disclosed in the claims of the basic patent.