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ARTICLE · 24 JULY 2026

Playing Loose – CJEU Asked To Decide On Combination SPCs

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The EU Court of Justice faces a pivotal decision on whether medicines approved as monotherapy but labeled for use in combination with other drugs qualify for Supplementary Protection Certificate (SPC) protection as combinations of active ingredients. This referral, stemming from Genmab's attempts to secure SPC protection for loose combinations including daratumumab, could resolve over a decade of legal uncertainty and fundamentally reshape how pharmaceutical companies approach regulatory strategy for combin

DenmarkIntellectual Property
Garreth Duncan
Garreth Duncan
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In a new referral (C-262/26), the EU’s Court of Justice has been asked to decide whether a medicine which receives a marketing authorisation (MA) as a monotherapy, but labelled with instructions to take it in combination with another medicine (a so-called “loose combination”) is eligible for SPC protection as a combination of active ingredients in the EU. The decision has the potential to resolve over a decade of uncertainty in this area and to shape the pharmaceutical industry’s regulatory strategy on combination products in Europe.

Background – “fixed” and “loose” combinations

Although much research in the pharmaceutical industry is devoted to bringing new medicines to market, considerable research is also directed at combinations of already known medicines. There are many well-known benefits in combining medicines. For example, the two medicines may have a synergistic interaction so that their combined effect is greater than the additive effect of each of them when used alone.

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