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.
Genmab applied for an SPC for the four-way combination. The Danish Patent and Trade Mark Office refused the application and that decision was upheld by the Danish Board of Appeal for Patents and Trade Marks.
The dispute concerns two related requirements of the SPC Regulation: whether the loose combination constitutes a “product” within the meaning of Article 1(b), and whether a valid marketing authorisation for that product has been granted for the purposes of Article 3(b).
The Danish Board of Appeal’s position is that the marketing authorisation relates to daratumumab. Although Darzalex is authorised for use in combination with the other three active ingredients, it considers that this does not mean that the four-way combination itself has been authorised as a “product” for the purposes of Article 3(b).
Genmab argues that Article 1(b), which defines a “product” as an active ingredient or combination of active ingredients of a medicinal product, does not distinguish between fixed and loose combinations. It also argues that the Type II variation constitutes a valid marketing authorisation for the four-way combination.
What has the CJEU been asked?
The Danish court has referred two questions. In essence, it asks:
- whether a new combination of active ingredients can qualify for an SPC where the ingredients are authorised for use in combination but are administered separately;
- if so, whether a Type II variation authorising that combination can satisfy the marketing authorisation requirement in Article 3(b).
The CJEU has previously considered SPCs for fixed combinations of active ingredients, but the referring court notes that there appears to be no CJEU case law addressing loose combinations.
The CJEU’s answers should therefore provide important guidance on the treatment of loose combinations under Article 1(b), as well as whether a Type II variation of this kind can satisfy Article 3(b).
Related Material
SPCs to keep the CJEU busy: four referrals to watch – our overview of other pending referrals concerning the interpretation of the SPC Regulation.
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