Novartis owns a patent on medicinal substance A which expired on 12 February 2011 and an SPC on product A which will expire in November. Novartis currently markets a blockbuster drug composed of A + B (another active ingredient). Actavis took steps to put on the market a generic version of product A + B after the expiration of the patent but before expiration of the SPC. Novartis sued Actavis to obtain an interim banning injunction based on its SPC on A.
On three occasions, French courts had ruled that an SPC confers exactly the same protection scope as a patent so that a product A+ B was considered as infringing an SPC on A.Now for the first time, the Cour d'appel has had a chance to consider the issue. This is how it ruled:
A product, as defined by the EU Regulation, is not restricted to an active ingredient. An SPC, within the meaning of Article 4 of the Regulation, protects a product and not an active ingredient. In this case, the SPC only protects Valsartan as a product.
It follows that, although the medicinal product Valsartan + HCTZ contains the active ingredient Valsartan, it is not the "product" Valsartan within the meaning of the Regulation but another "product" comprising a combination of active ingredients.
Any other interpretation would be contrary to the rule of non-aggregation of sources of protection laid down in Article 3 of the Regulation according to which an SPC cannot protect another product and there can by only one SPC per product per patent holder. The active ingredient HCTZ cannot be considered a mere additional ingredient in the same way as we might view a vitamin.
Accordingly, it does not appear likely that any marketing and sale of a medicinal product containing Valsartan as an active ingredient will constitute an infringement and thus violate the rights owned by Novartis in this active ingredient until 13 November 2011.
Actavis' interpretation of the EU Regulation and its objections to the injunctive and other relief requested by Novartis are genuine and have merit and, contrary to what the lower court summary hearings judge held, remove all obviousness from the allegation of infringement.Thanks so much, Tougane and Grégoire, we do appreciate your kindness.