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Monday 14 February 2011

Antwerp court stops infringement of valsartan/HCTZ SPC based on patent claiming valsartan alone

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. Novartis argued that a product is protected by a patent if it infringes that patent. In view of the absolute protection for valsartan under the basic patent, any medicinal product containing valsartan, whether alone or in combination with other active ingredients, would infringe and thus be “protected by” the basic patent. 
The Court of Appeal followed Novartis’ reasoning, referring to the application of the “infringement test” in a number of European countries. The fact that in other countries a different test was applied could not affect the prima facie validity of the SPC. Particularly in view of the various pending references to the ECJ from the English courts about the correctness of this different test, the Court of Appeal concluded that the final word on which test to apply should be left for the full trial before the Antwerp Commercial Court, which will take place in April 2011. The preliminary injunction was therefore granted until a decision in the case on the merits is issued or until 31 May 2011, whichever is earlier".
Philippe has kindly provided both the Flemish original and an English translation.

1 comment:

B.S.Reddy said...

Thanks for providing this information in the blog.It is very nice decision. However, I have a question, It seems the SPC term of Valsartan extended (Under PIP)for further 6 months. The same is not extended in BE? If it is valid in BE then the same is applicable for Combination product also? Please clarify.

Best regards,