"Novartis v Actavis: French Court renders a preliminary injunction confirming the scope and effects of an SPC (Valsartan)
After the preliminary injunction rendered on 12 February 2010 enjoining Mylan and Qualimed from marketing a generic drug comprising Losartan and HCTZ on the basis of Du Pont's SPC granted for Losartan, the President of the Paris First Instance Court confirmed on 28 January 2011 that an SPC covering a compound (Valsartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Valsartan alone or in combination with another active ingredient.
The French Judge carried out a combined reading of Article 4 (subject-matter) and Article 5 (effects) in light of the definitions given in Article 1 of the SPC Regulation:
You can read the French decision here and the English translation here.
“Within the limits of the protection conferred by the basic patent (EP No. 0 443 983), the protection conferred by an SPC (SPC No. 97C0050) shall extend only to the active ingredient that is to say valsartan covered by the corresponding MA, for any use of the product as a medicinal product that has been authorised before the expiry of the certificate”,
and added that
"while Article 4 of the Regulation provides some limits to the effects of an SPC, once these are defined, the SPC grants the same rights as those conferred by the basic patent".
Having held that SPC No. 97C0050 has for its subject-matter the sole active ingredient valsartan, the Judge ruled as follows:
"[O]nce this SPC No. 97C0050 is defined, the rights conferred to Novartis are the same as the rights conferred by the basic patent, such that Novartis can oppose to any use of this active ingredient for the treatment of hypertension, alone or in combination with another active ingredient.
Any marketing of a medicinal product containing valsartan as an active ingredient therefore obviously constitutes an infringement, since it infringes the rights that the claimants hold on this active ingredient until 13 November 2011.
The obviousness of the infringement that would result from the arrival of the pharmaceutical products “valsartan hydrochlorothiazide Actavis 80mg/12.5mg” and “valsartan hydrochlorothiazide Actavis 160mg/25mg” before 13 November 2011 is therefore demonstrated".
This decision can be appealed".