Aristo Pharma GmbH v Takeda Pharmaceuticals USA Inc & Anor

For the purposes of the supplementary protection certificate regime, “active ingredient” in article 1(b) of Regulation (EC) 469/2009 has the same meaning as “active substance” under article 1(3a) of Directive 2001/83/EC. The relevant inquiry is whether the substance has a pharmacological, immunological or metabolic action of its own. That is not a stricter, separate test.

A pro-drug may qualify even though it is pharmacologically inactive in the ordinary sense. A single new molecule derived from an earlier active substance may have its own relevant action where its pharmacokinetic profile produces a significant clinical difference, including a changed dosing frequency. The marketing authorisation and related regulatory material identified lisdexamfetamine as the active ingredient. The SPC was valid and the claims were dismissed.

Aristo Pharma GmbH and Stada Arzneimittal AG brought separate claims challenging the validity of Takeda’s supplementary protection certificate for Elvanse, a lisdexamfetamine product used to treat ADHD.

The claimants argued that dexamfetamine, rather than lisdexamfetamine, was the relevant active ingredient. Since dexamfetamine had an earlier marketing authorisation, they contended that the Elvanse authorisation was not the first authorisation for the product under Regulation (EC) 469/2009. The central issue was whether lisdexamfetamine was an active ingredient within article 1(b) of that Regulation. The court also considered the marketing authorisation, related regulatory documents, the scientific evidence and a German Federal Patent Court decision.

Disposition. The SPC was validly granted and both claims were dismissed.

1. Meaning of active ingredient. The court held that “active substance” under article 1(3a) of Directive 2001/83/EC and “active ingredient” under article 1(b) of Regulation (EC) 469/2009 have the same meaning. Applying the test in Arne Forsgren v Österreichisches Patentamt (C-631/13) EU:C:2015:13, the substance must have a pharmacological, immunological or metabolic action of its own. The words “of its own” exclude an inactive carrier, but do not impose a separate or more rigorous SPC test.
2. Marketing authorisation. On a reasonable reading of the SmPC and Public Assessment Report, lisdexamfetamine was identified as the active substance and active ingredient. Descriptions of it as pharmacologically inactive referred to the ordinary meaning of a pro-drug before administration. They did not exclude it from the specific statutory concept of an active ingredient.
3. Scientific assessment. Lisdexamfetamine was a single new molecule derived from dexamfetamine, not a combination of an active substance with an inactive carrier. Its gradual conversion and distinct pharmacokinetic profile enabled once-daily dosing, whereas regular dexamfetamine required two or three daily doses. The resulting clinical advantage was sufficient evidence of an action of its own. The separate abuse-resistance issue did not need to be decided.
4. Authorities. Massachusetts Institute of Technology (C-431/04) EU:C:2006:291, GlaxoSmithKline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks (C-210/13) EU:C:2013:762 and Abraxis Bioscience LLC v Comptroller-General of Patents (C-443/17) EU:C:2019:238 concerned materially different carrier or formulation situations. The court did not accept the contrary reasoning of the German Federal Patent Court judgment 3Ni 22/22 (EP).
5. Unnecessary issue. The court regarded the Advocate-General’s proposed formal-verification approach in Halozyme, Inc v Úřad průmyslového vlastnictví (C-456/24) EU:C:2026:348 as compelling, but did not decide whether examination must be confined to the marketing authorisation. The issue was unnecessary to the result because lisdexamfetamine was an active ingredient on both the regulatory material and the agreed scientific facts.