BE – Du Pont et al v. Mylan / Losartan SPC (first instance)

Posted: February 12th, 2010

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.

Read the decision (in Dutch) here.

Read the decision (in English) here.

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