The last two years have seen a steady flow of referrals to the CJEU for SPC matters. With three referrals already pending (all dealing with various questions around the definition of a medicinal product and the “first” marketing authorisation) there is now news of a fourth case concerned with the SPC manufacturing waiver. In this article we briefly summarise all four SPC cases awaiting the Court’s attention, starting with the most recent referral.
C-371/26, Janssen– SPC manufacturing waiver
A referral to the CJEU on this topic has seemed likely for some time, given divergent views in EU member states. We now know that Danish proceedings between Janssen and Samsung Bioepis over ustekinumab have led to a request for a preliminary ruling.
Janssen and Samsung are engaged in litigation over ustekinumab in several member states with interpretation of the SPC manufacturing waiver a critical factor. For the Danish proceedings, Samsung relied on the waiver to permit manufacture and storage of ustekinumab in Denmark from January 2024 to July 2024, for the purpose of later export to the UK upon expiry of the UK SPC. The dispute centres on whether the waiver permits such “storage for export” (and if so under what circumstances and/or limitations) and additionally whether Samsung’s October 2023 notification of intent to rely on the waiver was valid, given that Samsung did not (at the time) have a UK marketing authorisation and so could not include the relevant reference number. This was supplied later, on 21 May 2024, 7 days after grant and 4 days after publication of the UK marketing authorisation. The Danish court has set out the issues in 4 questions – shown on the final page of the working document for the referral. Formal publication, including in the EU official journal, should follow.
C-15/26, Boehringer – The revenge of Neurim?
Before 2012 it was generally held that the “first” marketing authorisation required by Article 3(d) of the SPC regulation was literally the first approval of a given active or combination, irrespective of any difference in indication or species to be treated. However, following the landmark judgment in C-130/11 Neurim, it became possible to exclude an earlier authorisation, provided it fell outside the scope of the claims of the basic patent relied upon for the SPC application.
Neurim was specifically concerned with a scenario in which SPCs were sought based on a later marketing authorisation for melatonin for sleep disorders in humans, ignoring an earlier authorisation for reproductive regulation in sheep. The judgment did not explicitly state that it was limited to this scenario, however, and after Neurim, many SPC applications were filed (and granted) based on second or further authorisations with any difference relative to an earlier authorisation, provided the patent claims could be written to exclude the earlier authorisation. The filing of “Neurim divisionals” to provide basic patents with such claims became a standard practice.
Subsequently, C-443/17 Abraxis began to reimpose limitations on the interpretation of “first”, by ruling out a further SPC in the case of later authorisation for a new formulation of the same active ingredient in the same indication, but left open the question of different indications. C-673/18 Santen followed and was seen by many as completing the job of reversing Neurim, such that the first authorisation is again interpreted as literally the first authorisation, irrespective of any difference in indication.
However, the German court in the present case is of the view that Santen only concerned a scenario in which the same active was approved for two different indications in humans. As such, they consider it to be arguable that Santen did not necessarily overturn Neurim in its original context, i.e. when there is an earlier veterinary authorisation and a later human authorisation (or vice versa). The present case concerns just such a scenario: Boehringer Ingelheim obtained a veterinary authorisation for ciclesonide for the treatment of airway disease in horses, but there is a prior human marketing authorisation for asthma. Boehringer applied for SPCs after Neurim but before Santen, and contends that an exception for human vs veterinary should apply, given that veterinary approvals require an entirely different regulatory pathway, different clinical trials etc. The referred question was published in the EU official journal in June 2026 and we have previously considered its significance for Article 3(d) in more detail in our separate review.
C-794/25, Takeda – Is a pro-drug a new drug?
Another Danish court has requested clarification in connection with a dispute between Takeda and Stada Arznemittel concerning Lisdexamfetamine (LDX). The compound LDX is a derivative (effectively a pro-drug) of dextroamphetamine (DEX). It has benefits in that it results in longer lasting effects and is less prone to abuse, but has no therapeutic activity of its own. Takeda obtained marketing authorisation for LDX as a new active substance and relied upon that marketing authorisation to secure SPCs, extending their protection for LDX from 2024 to 2028. Stada (seeking to launch a generic version of LDX) have brought invalidity actions in multiple countries, arguing that the true active ingredient is DEX, and thus the marketing authorisation for LDX is not the “first” as required by Article 3(d) of the SPC regulation.
There is divergence among national courts over whether LDX can be regarded as a separate active ingredient for the purposes of the SPC regulation. The German courts in particular engaged in an independent review of whether LDX is a separate active ingredient, concluding it is not. The question referred by the Danish court asks the CJEU to consider the definition of ‘product’ in Article 1(b) of the SPC regulation, and specifically whether a derivative of an active ingredient (i.e. LDX as compared to DEX) can be regarded as meeting this definition (and under what circumstances). If it does not, then the relevant “first” marketing authorisation in this case would be the original approval of DEX, providing no effective SPC term for Takeda. The Danish court also requests clarification as to whether a national court can investigate SPC validity if this pertains to grant of a marketing authorisation by the EMA, given earlier case law which bars national courts from revisiting a decision of a competent EU authority. The questions referred were published in the EU official journal in February 2026.
C-456/24, Halozyme – can an excipient be an active ingredient?
The Czech courts have referred questions on this topic, arising from Halozyme’s attempts to obtain grant of SPCs for two different products, Herceptin Hylecta® and MabThera®. Both of these products comprise an antibody (trastuzumab or rituximab) which is administered together with hyaluronidase. The key question is whether hyaluronidase is an active ingredient and there is divergence between EU member states as to the answer.
If hyaluronidase is an active ingredient, then Halozyme’s SPCs may be validly based on the (later) authorisation of the combination of antibody + hyaluronidase, as a different product relative to the antibody alone. If it is not, then either there is no marketing authorisation for the product of the SPC as a combination, or the product of the SPC is solely the antibody and the relevant “first” marketing authorisation is the earlier authorisations of each antibody alone. In the latter case, Halozyme’s SPCs would have no effective term.
In arguing their case, Halozyme have provided data to show that hyaluronidase has a therapeutic effect in its own right. However, it is expressly referred to as an excipient and is not listed under the active ingredients in the relevant marketing authorisations. The questions referred by the Czech court were published in the EU official journal in September 2024. Essentially the court is asked to consider whether a substance designated as an excipient can ever be regarded as an active ingredient, and if so under what circumstances, and what (if any) evidence of an effect may be taken into account. The preliminaryopinion of the Advocate General was published in April 2026 and takes the firm position that a substance expressly designated as an ‘excipient’ in the marketing authorisation cannot be regarded as an ‘active ingredient’ for the purposes of the SPC regulation. We have discussed the Advocate General’s opinion in more detail in a separate review.
Related content
For a detailed discussion of the SPC manufacturing waiver and the issues raised in C-371/26 Janssen, see our separate briefing.
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