There have been quite a number of recent developments in European SPC cases relating to combination products. Courts seem to have difficulties in dealing with this issue and various tests regarding validity and infringement have been developed by different national courts.
In today's SPC and Combination Products special, editors Philippe de Jong (Altius) and András Kupecz (Simmons & Simmons) focus on these validity issues and infringement issues. The contributions can both be read jointly and separately.
Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings
(first instance), Pres. Brussels Commercial Court, 12 February 2010, Case No. R.K. 00014/2010
According to the President of the Brussels Commercial Court, the scope of protection of the SPC for the active ingredient Losartan, whose duration had been extended pursuant to Article 36 of the Paediatric Regulation 1901/2006, does not at first sight (“prima facie”) extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients losartan and HCTZ).
The main reason raised by the court is that, since the paediatric extension was applied for and granted only for the Losartan-SPC and not for the separately obtained “Losartan + HCTZ”-SPC, the combination product Cozaar Plus®” could not benefit from the paediatric extension of the Losartan-SPC. Consequently, generic versions of Cozaar Plus® could not fall under the scope of protection of the Losartan-SPC either.