Judgment of the General Court (Seventh Chamber) of 11 June 2015 —
Laboratoires CTRS v Commission

(Case T‑452/14)

Medicinal products for human use — Orphan medicinal products — Marketing authorisation for the medicinal product Cholic Acid FGK (renamed Kolbam) — Therapeutic indications — Market exclusivity — Article 8(1) of Regulation (EC) No 141/2000

1.                     Actions for annulment — Actionable measures — Concept — Measures capable of affecting a given legal position — Action directed only against the reasoning of a measure — Inadmissibility (Art. 263 TFEU) (see para.51)

2.                     EU law — Interpretation — Acts of the institutions — Statement of reasons — To be taken into consideration — Decisions based on the opinion of a scientific authority — Incorporation of those opinions into the statement of reasons for such decisions (European Parliament and Council Regulation No 726/2004, Art. 3) (see paras 56, 57, 60-62)

3.                     Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Medicinal products similar to an orphan medicinal product already authorised and having the same therapeutic indication — Placing on the market — Market exclusivity — Obligation to ensure effectiveness — Commission’s grant of marketing authorisation drafted in such a way as to encourage a doctor to prescribe a medicinal product for therapeutic indications other than those authorised — Not permissible (European Parliament and Council Regulation No 141/2000, Art. 8(1); European Parliament and Council Directive 2001/83, Art. 87(2)) (see paras 80-82, 88, 95, 97, 134)

Re:

APPLICATION for annulment in part of Commission Implementing Decision C(2014) 2375 of 4 April 2014 granting, in exceptional circumstances, marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Cholic Acid FGK — cholic acid’, an orphan medicinal product for human use, as amended by Commission Implementing Decision C(2014) 6508 of 11 September 2014 transferring and amending the marketing authorisation granted in exceptional circumstances by Decision C(2014) 2375 for ‘Kolbam — cholic acid’, an orphan medicinal product for human use, in so far as that decision in substance indicates that that medicinal product is authorised for the therapeutic indications for Orphacol or, in the alternative, for annulment of Article 1 of that decision.

Operative part

The Court:

1. Annuls Commission Implementing Decision C(2014) 2375 of 4 April 2014 granting, in exceptional circumstances, marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Cholic Acid FGK — cholic acid’, an orphan medicinal product for human use, as amended by Commission Implementing Decision C(2014) 6508 of 11 September 2014 transferring and amending the marketing authorisation granted in exceptional circumstances by Decision C(2014) 2375 for ‘Kolbam — cholic acid’, an orphan medicinal product for human use;

2. Orders the European Commission to bear its own costs and to pay those of Laboratoires CTRS;

3. Orders ASK Pharmaceuticals GmbH to bear its own costs.