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ARTICLE · 16 OCTOBER 2026

CJEU Asked Whether SPCs Can Protect “Loose Combinations” Of Active Ingredients

J A Kemp
J A Kemp
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J A Kemp

J A Kemp

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The Court of Justice of the European Union faces a novel question in a pending referral from Denmark: whether supplementary protection certificates can extend to "loose combinations" of active ingredients that are formulated and administered separately, rather than as a single fixed-dose product. The case involves Genmab's application for SPC protection covering daratumumab in combination with three other cancer drugs, where the marketing authorization was granted through a Type II variation allowing combin

United StatesIntellectual Property
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J A Kemp LLP
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A pending CJEU referral, C-262/26, Genmab, raises a question not previously addressed in the CJEU’s case law: can an SPC protect a “loose combination” of active ingredients that are administered separately?

The referral comes from the Danish Maritime and Commercial Court and concerns Genmab’s SPC application for a combination of daratumumab, bortezomib, thalidomide and dexamethasone. The combination is protected by Genmab’s basic patent, but the four active ingredients are formulated and administered separately – a so-called “loose combination”.

What is the issue?

The marketing authorisation for Darzalex was originally granted for daratumumab as monotherapy. Following a Type II variation, Darzalex was subsequently authorised for use in combination with bortezomib, thalidomide and dexamethasone for the treatment of certain patients with multiple myeloma.

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