Orphan Medicine

On 11 June 2015, the General Court handed down its judgment in Case T-452/14 Laboratoires CTRS v European Commission (the “CTRS Case”) annulling the Commission’s decision to grant Kolbam a marketing authorisation.  The General Court held that references in Kolbam’s SmPC to the efficacy of Kolbam for indications that Orphacol was authorised circumvented Orphacol’s market exclusivity and could encourage off label prescribing.
Continue Reading General Court Confirms Market Exclusivity Rights in CTRS Case