The UK High Court has upheld Takeda’s supplementary protection certificate (SPC) for lisdexamfetamine (LDX) in [2026] EWHC 2414 (Pat), rejecting a challenge by Aristo Pharma GmbH and Stada Arzneimittal AG.
The decision addresses an important question for SPC law: what constitutes an “active ingredient” under Article 1(b) of the SPC Regulation? The meaning of “active ingredient” for SPC purposes is also before the CJEU in three pending referrals.
Why does the definition of “active ingredient” matter?
LDX is a derivative — effectively a pro-drug — of dextroamphetamine (DEX). Although LDX has no therapeutic activity of its own before conversion to DEX, it has a different pharmacokinetic profile.
The validity of Takeda’s SPC therefore turned on whether LDX itself could be regarded as an “active ingredient”. If not, the relevant first marketing authorisation would have been the earlier approval of DEX, leaving Takeda with no effective SPC term.
The UK High Court’s approach
Although not bound by new CJEU case law, the UK judge gave significant weight to the Advocate General’s opinion in C-456/24, Halozyme, the most advanced of the three pending CJEU referrals.
The Advocate General’s position is, in essence, that the marketing authorisation should determine what constitutes an active ingredient: a substance identified there as an active ingredient should be treated as such for SPC purposes.
The UK judge did not decide whether that precise approach was correct, but described its simplicity as “compelling”. Having regard to EMA guidance, the judge found that LDX has an immunological and/or metabolic action of its own because of its different pharmacokinetic profile. LDX could therefore be regarded as the “active ingredient”.
Diverging European decisions
The decision comes against a background of divergent first-instance decisions elsewhere in Europe concerning Takeda’s corresponding LDX SPCs.
In Germany, the court found the SPC invalid, although an appeal is underway. The German court essentially made its own assessment of whether LDX was an active ingredient, concluding that the meaning of “active ingredient” for SPC purposes differs from the definition applied by the EMA when granting a marketing authorisation.
The UK judge rejected that distinction. The decisions therefore reflect different approaches to the relationship between the regulatory and SPC definitions of an active ingredient.
What happens next at the CJEU?
The UK judgment did not refer to C-794/25, Takeda, which arises from an appeal against a first-instance decision upholding Takeda’s LDX SPC in Denmark.
However, the UK court’s reasoning suggests that the CJEU’s judgment in C-456/24, Halozyme could have important consequences for the Takeda referral as well.
It remains to be seen whether the CJEU adopts an approach consistent with the Advocate General’s opinion and the UK judgment. The UK decision may also be appealed.
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