Escitalopram again, this time in Belgium

Escitalopram is in the news again. The Belgian District Court has very recently given judgment in Ratiopharm, Tiefenbacher v Lundbeck, an action which is of great interest in Benelux circles on account of the parallel proceedings in which a decision is currently keenly awaited.

On 3 October the Belgian District Court invalidated the contested SPC, since the marketing authorization for escitalopram referred to in Lundbeck’s SPC application was not the first marketing authorization for the product under Article 3(d) of the SPC Regulation. According to the court, the SPC should have designated the marketing authorization for citalopram, not the marketing authorization for escitalopram. The court additionally found that a previous SPC had been granted for the same product (Article 3(c) of the same Regulation).

The District Court took the view, with reference to the Court of Justice ruling in Case C-431/04 MIT, that in the racemic mixture citalopram, only the S-enantiomer (es-citalopram) had "a therapeutic effect of its own". Accordingly the active substance (or "product") in citalopram and es-citalopram is the same, namely: es-citalopram. The court refers, inter alia, to the decision of the CBG (the Dutch MEB), which had decided that there were no cliniacally relevant differences between citalopram and es-citalopram and that es-citalopram was to be considered a line extension of citalopram. The court also explicitly deviated from the earlier decision of the German Federal Supreme Court (which had held the SPC valid) because, in its view, the German decision was not in line with the SPC case law of the Court of Justice -- in particular, its understanding of the word “product”.

An English translation of the Belgian District Court has been kindly provided by an anonymous benefactor. you can read it here.