Almirall vs. Mylan -Belgian Court of Appeal Decision

Benito Boone of Crowell & Moring (Brussels) has kindly provided us with the recent Belgian decision on the calculation of the duration of an SPC in the case Almirall vs. Mylan (aceclofenac). In short,

"the Brussels Court of Appeal confirmed an earlier judgement, which stated that the starting point of the calculation of the duration of the SPC (article 13 of the Regulation), is not the first MA granted in accordance with Dir. 65/65/EEC (now 2001/83/EC), but a national MA which dates from before the entry into force
of Dir. 65/65/EEC (even if the national MA was granted without a full assessment: see p. 33, § 22 in fine of the judgment).

The court also refuses to refer the case to the ECJ for a preliminary ruling. "

For a copy of the judgement in Dutch, here. Let us know if you would be interested in a more detailed summary by emailing us here.