In a new referral to the EU’s Court of Justice (C-794/25), the CJEU has been asked to rule on the question whether an approved pro-drug of a previously approved active pharmaceutical ingredient is eligible for SPC protection in the EU independently of the originally approved active. The CJEU’s answer will hopefully provide clarity to the industry and resolve litigation in this field.
Background – Dexamphetamine (DEX) and its pro-drug lisdexamfetamine (LDX)
A pro-drug of an active pharmaceutical ingredient is a compound which typically has no pharmaceutical activity of its own, but is converted to the corresponding active ingredient in the body. Examples of classes of pro-drugs include esters and amides, the ester or amide bond typically being cleaved in the body by the action of one or more enzymes.
