The CJEU Rules that Companies Can Seek Orphan Status for a New Product Containing the Same Active Substance as an Existing Orphan Product

The CJEU Rules that Companies Can Seek Orphan Status for a New Product Containing the Same Active Substance as an Existing Orphan Product

July 30, 2019, Covington Alert

On July 29, 2019, the Court of Justice of the European Union (“CJEU”) issued its judgment in Case C-359/18 P, Shire Pharmaceuticals Ireland v. EMA, dismissing the European Medicines Agency’s (“EMA”) appeal and reconfirming the position set by the General Court. Covington represented Shire Pharmaceuticals Ireland (“Shire”), which was recently acquired by Takeda.