Combination-product SPCs: the CJEU's 2024 test, and why the combination is the weak point

What was decided

Many blockbusters are sold both alone and in fixed-dose combinations, and originators have often taken a second SPC on the combination to extend protection after the single-substance SPC runs out. Two references, from Finland (Teva’s challenge to the sitagliptin/metformin SPC) and Ireland (Clonmel’s challenge to the ezetimibe/simvastatin SPC), asked the Court of Justice when that is allowed.

The Court answered on 19 December 2024. A combination A+B is a different product from A, so an earlier SPC on A does not of itself bar an SPC on A+B (Article 3(c) of the SPC Regulation). But under Article 3(a) the combination must fall under the invention covered by the basic patent: the test from the 2018 Teva v Gilead case applies even where the patent’s claims expressly name the combination. A patent whose inventive contribution is substance A alone will not support an SPC on A plus a known substance B simply because the claims list B among possible partners.

Since then national courts have not applied the test uniformly, in particular on whether the patent application as filed must contain data supporting the combination, and in July 2026 a further question reached the Court (C-262/26) on “loose combinations”, where a product is authorised as a monotherapy but labelled for use with another medicine.

Timeline

Date	Event
25 July 2018	Teva v Gilead (C-121/17): the two-part test for what a basic patent protects
2022	Finnish and Irish courts refer the sitagliptin/metformin and ezetimibe/simvastatin questions
19 December 2024	CJEU judgment in joined cases C-119/22 and C-149/22
2025–26	National courts diverge on the data requirement
July 2026	New referral, C-262/26 (daratumumab, loose combinations)

What it means if you are…

A generics or launch planner. The combination SPC is usually the weaker of the two. Where the single substance is off protection and the combination still carries an SPC, the SPC is worth testing against this judgment before the plan assumes the register date. Several combination SPCs have been revoked or narrowed on exactly this ground.

A parallel trader. Combination products often have different SPC positions in different countries, because the national offices granted them on different reasoning years ago and the courts are now correcting them one country at a time. The combination’s SPC date in one register does not predict the next.

A wholesaler or buyer. Expect combination-product generics to arrive earlier than the register suggests in some countries and not others, and expect that to change as C-262/26 and the national cases work through.

Status and what to watch

C-262/26 and the national follow-on decisions. Any product sold as a fixed-dose combination, or authorised alone but labelled for combination use, is affected.