The CJEU has received a new referral from the Danish Sø- og Handelsretten in Genmab v Danish Board of Appeal for Patents and Trade Marks (C‑262/26) that could be significant for the life sciences sector, particularly companies developing combination therapies. So-called “loose combination” therapies provide treatment with multiple drugs, but these are not necessarily combined into a single product, or indeed administered simultaneously.
The product Darzalex® (daratumumab) is authorised in the EU for treatment of multiple myeloma, and may be used alone or in combination with various other therapeutics. Genmab's SPC application leading to the current referral is directed to a combination of the four active ingredients daratumumab, bortezomib, thalidomide and dexamethasone.
The referral concerns the interpretation of the EU SPC Regulation and asks whether a supplementary protection certificate (SPC) can be granted for a new combination of active ingredients where those ingredients are authorised for use together but are not contained in the same physical pharmaceutical product. Instead, the combination comprises separately administered products used as part of a treatment regimen.
The Danish court has referred two questions. First, it asks whether Articles 1(b) and 3(b) of the SPC Regulation permit an SPC for such a “loose combination” of active ingredients. Secondly, if the answer is yes, the court asks whether a Type II variation to an existing marketing authorisation can satisfy the requirement for a valid marketing authorisation under Article 3(b) where the authorised combination consists of separately administered products.
The case will be closely watched by pharmaceutical and biotechnology companies, as combination therapies are increasingly important in fields such as oncology. A ruling confirming SPC availability for authorised treatment combinations that are not physically co-formulated could potentially broaden SPC protection opportunities for innovative therapeutic regimens. Conversely, a restrictive approach would reinforce the existing emphasis on the authorised medicinal product itself rather than the clinical use of separate products in combination.
The referral therefore raises another important question at the intersection of SPC law, regulatory approvals and lifecycle management, and may provide welcome clarification on how the SPC regime applies to modern combination therapies.
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