General Court (Seventh Chamber) 22 March 2018, T-80/16 (Shire Pharmaceuticals Ireland Ltd v European Medicines Agency.)

JUDGMENT OF THE GENERAL COURT (Seventh Chamber) 22 March 2018(*) (Medicinal products for human use — Validation of an application for designation as an orphan medicinal product — Significant benefit — EMA decision refusing to validate an application for designation as an orphan medicinal product — Article 3(1)(b) and Article 5(1), (2) and (4) of Regulation (EC) No 141/2000) In Case T‑80/16, Shire