Marketing authorisation: the right to challenge

A decision by the CJEU on a Latvian case should make it easier in the future to challenge an MA granted for a generic version of a reference product, as Trevor Cook of WilmerHale explains.

Since the EU regime of data exclusivity for pharmaceuticals was amended in late 2005, in large part to reflect Court of Justice of the EU (CJEU) case law in the 1990s and early 2000s, there has been little case law on the interpretation of the new legislation. This situation is now starting to change.

In order to secure a marketing authorisation (MA) for a new medicinal product, in addition to demonstrating satisfactory quality, applicants must file extensive clinical and non-clinical data to support its safety and efficacy in accordance with article 8(3)(i) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

According to article 10, an application for a generic MA of a medicinal product previously authorised under article 8 can be sought eight years after the first MA in the EU for the active substance in the ‘reference medicinal product’, but such a generic MA cannot take effect until ten years after the first MA for the active substance.