On 14 February 2020, the Paris Court of Appeal overturned a series of preliminary injunctions against Mylan and Sandoz based on Merck's ezetimibe/simvastatine SPC. These decisions are of specific interest as they are the first to follow a series of injunctions and substantial awards of provisional damages granted against several generics by the High Court of Paris from 2018 to 2019. Commentators following such injunctions and awards of provisional damages had argued that this constituted a landmark change of practice at the High Court in pharmaceutical cases. However, these decisions had not been subject to appellate review. On appeal the court held that, in addition to the relevant SPC being invalid, the measures ordered were disproportionate. The Court of Appeal held that Merck’s SPC suffered from serious grounds of invalidity, thus overturning the previous High Court decision that found this SPC valid and infringed. The Court of Appeal further held that the various product recalls and provisional damages ordered were disproportionate and thus should not have been granted even if the SPC was valid.
A translation of the Mylan decision is attached here and the Sandoz decision here.
