Judgment has been handed down in Aristo & STADA v Takeda [2026] EWHC 2414 (Pat). This was a decision of HHJ Hacon sitting in the High Court, and concerned the scope of Article 1(b) of the Supplementary Protection Certificate Regulation. In upholding the validity of Takeda’s SPC, the Judge held that the relevant active ingredient in Takeda’s Elvanse product for treating ADHD was the pro-drug lisdexamfetamine, which is converted in the patient’s bloodstream to dexamfetamine and lysine.

Tom Mitcheson KC and Stuart Baran represented Takeda, instructed by Carpmaels & Ransford and Jeremy Heald acted for Aristo, instructed by Venner Shipley.