Aristo Pharma v Takeda (EWHC, [2026] EWHC 2414 (Pat), 2026)

Dhenne Avocats · 17 October 2026

Our analysis

Summary

In a judgment of 24 September 2026, the Patents Court (His Honour Judge Hacon) dismissed the claims for invalidity of Takeda’s supplementary protection certificate SPC/GB13/052, which covers lisdexamfetamine, marketed as Elvanse for attention deficit hyperactivity disorder (paras 1, 3 and 121). The generic companies argued that the true active ingredient was dexamfetamine, already authorised, into which lisdexamfetamine is metabolised. The judge held instead that a prodrug can be an active ingredient under the SPC Regulation and that lisdexamfetamine has an action of its own (paras 65 and 102).

Facts and procedure

Aristo Pharma and then STADA sued Takeda in two joined actions heard under the Shorter Trials Scheme. They relied on an earlier marketing authorisation for dexamfetamine, which would deprive the lisdexamfetamine authorisation of first-authorisation status under Article 3(d) of the SPC Regulation (paras 4, 11, 13 and 16). Takeda accepted that the SPC would be invalid if dexamfetamine were the active ingredient (para 5). The German Federal Patent Court had revoked the corresponding German SPC on 4 June 2024, a decision under appeal (para 107).

Question

Is a prodrug that is pharmacologically inactive in vitro, and releases an already authorised substance in the body, a distinct active ingredient within Article 1(b) of the SPC Regulation?

Decision

The judge distinguished MIT and GSK, which concerned combinations including a substance with no therapeutic effect of its own, and Abraxis, since lisdexamfetamine is a single molecule (paras 95 and 96). Read reasonably, the SmPC and the public assessment report identify lisdexamfetamine as the active ingredient, and statements of pharmacological inactivity refer to inactivity in vitro (paras 61 to 75). Under the Forsgren test, which requires a pharmacological, immunological or metabolic action of its own, lisdexamfetamine has an immunological or metabolic action of its own owing to its pharmacokinetic profile, which allows once-daily dosing instead of two or three doses (paras 79 to 81, 102 and 116). That test is the same as the test for an active substance under the Medicinal Products Directive (paras 99 to 103). The judge expressly departed from the German Federal Patent Court (paras 111 to 118) and dismissed the claims (para 121).

Key points for practice

• A prodrug can support an SPC distinct from that of the substance it releases if its own action, in particular a pharmacokinetic one, is shown.
• The reading of the SmPC and the public assessment report carries great weight in identifying the active ingredient.
• The judge found Advocate General Emiliou’s reasoning in Halozyme (C-456/24) compelling, but noted that it could prevent a challenge to an unambiguous finding by the regulator even if its reasoning were irrational. He left the issue open, without deciding the scope of any judicial review of the regulator’s decision (para 106).

Provisions applied

Regulation (EC) No 469/2009

Articles 1(b), 3(d) and 15(1)(a)

Case law cited

MIT (C-431/04), GSK (C-210/13), Forsgren (C-631/13), Abraxis (C-443/17), German Federal Patent Court, 4 June 2024, 3 Ni 22/22 (EP)

Prepared by Dhenne Avocats from the official judgment, consulted on 17 October 2026. Only the official text is authoritative.