A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Wednesday, 12 October 2011
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.