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.


On 30 October 2009, Laboratoires CTRS (“CTRS”) applied for a marketing authorisation (“MA”) for its orphan medicinal product, Orphacol (Cholic Acid).  The Commission finally granted Orphacol an MA on 12 September 2013 following legal proceedings in the European Courts.  Owing to the regulatory incentives of the orphan medicines regime in Europe, Orphacol benefits from a ten year period of market exclusivity from the grant of its MA.  During this period the Commission may not accept an MA application nor grant a MA for a similar medicinal product for the same therapeutic indication as Orphacol unless the other product is deemed “clinically superior”.

On 21 March 2012, FGK Representative Service GmbH (“FGK”) submitted an MA for Cholic Acid FGK (“Kolbam”), whose active ingredient was also cholic acid, for a number of therapeutic indications, including two that were similar to the Orphacol indications.  In November 2013, the CHMP concluded that Kolbam was not clinically superior to Orphacol but adopted a positive opinion for the grant of an MA for Kolbam for the three remaining therapeutic indications.

On 4 April 2014, the Commission granted Kolbam a MA in line with the CHMP’s positive opinion (the “Commission Decision”).  CTRS repeatedly wrote to the CHMP and Commission stating that the references to the Orphacol indications in Kolbam’s summary of product characteristics (“SmPC”) amounted a circumvention of Orphacol’s market exclusivity.


On 17 June 2014, CTRS applied for the annulment of (i) the Commission Decision in so far as it indicated that Kolbam is authorised for the Orphacol indications; or (ii) Article 1 of the Commission Decision that provided that Kolbam’s MA is granted in accordance with the SmPC, amongst other things.  Under the second head of claim, CTRS essentially sought annulment of the Commission Decision, and grant of Kolbam’s MA, as a whole.

The General Court held that CTRS’s first head of claim was inadmissible because CTRS effectively sought annulment of the SmPC and the assessment report (i.e. the reasons the Commission Decision was based on) rather than the Commission Decision itself.   The Commission unsuccessfully argued that the second head of claim was inadmissible.  The General Court held that the operative part of the Commission Decision granting Kolbam’s MA was inextricably linked to the SmPC and assessment report.

CTRS’s main argument for the annulment of the Commission Decision was that references to the safety and efficacy of Kolbam for Orphacol indications in Kolbam’s SmPC and assessment report implied that Kolbam was also authorised for those indications.  This undermined Orphacol’s ten year period of market exclusivity and could encourage off-label prescribing of Kolbam for the Orphacol indications.

General Court Judgment

The General Court upheld CTRS’s argument and stated that Kolbam’s SmPC contains information on the efficacy of Kolbam for indications beyond which Kolbam is authorised.  The Court agreed that this undermined Orphacol’s market exclusivity and could facilitate off label prescribing.  The judgment confirms and upholds market exclusivity protections for originator medicinal products.

The General Court dismissed the Commission’s assertion that as Kolbam was not formally authorised for the Orphacol indications there could not be a breach of Orphacol’s market exclusivity for those indications.  The General Court also considered that CTRS was challenging only the efficacy conclusions for Kolbam for the Orphacol indications, not the presentation of clinical studies carried out by FGK in Kolbam’s assessment report as the Commission suggested.