This judgment follows the earlier provisional ruling of the District Court of the Hague granting Sanofi a provisional injunction against Pharmachemie and Teva to stop the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any high blood pressure medication comprising irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings.
Sanofi holds a combination-SPC for irbesartan, in the form of a salt and/or a hydrate and hydrochlorothiazide (also known as HCTZ), which SPC is in force until 14 October 2013. The SPC is based on EP 0 454 511 for “Dérivés hétérocycliques N-substitués, leur préparation, les compositions pharmaceutiques en contenant” (hereinafter “EP 511”). An earlier SPC for just irbetasan, referred to in these proceedings as the ‘Mono-SPC’ was also based on this patent, but lapsed in August 2012.
Teva argued that the combination SPC is invalid because: