28/02/2025
A recent Court of Appeal decision (EWCA Civ 45) has addressed the UK’s post-Brexit approach to the interpretation of Article 3(d) of SPC regulation No 469/2009.
Spoiler alert: The UK court has maintained a narrow interpretation of Article 3(d), consistent with the approach of the CJEU.
As today, 28 February 2025, marks Rare Disease Day, we have chosen to review this recent decision, focusing on its implications for orphan drugs.
Orphan drugs
Orphan drugs are medicines intended for the diagnosis, prevention or treatment, of rare human diseases. In the UK, rare diseases are defined as conditions which affect less than 1 in 2,000 people. Whilst individually rare, these conditions are collectively common, with 1 in 17 people being affected by a rare disease.[1]
Since individual orphan drugs target a comparatively small percentage of the population, their development costs can lack return on investment. It is not uncommon for pharmaceutical companies to develop orphan treatments based on existing drugs whilst still relying on patents and supplementary patent certificates (SPC’s) to protect the new treatments.
As orphan drugs disproportionately result from further research into existing drugs, this makes them particularly vulnerable to the interpretation of Article 3(d).
Article 3(d) SPC regulation No 469/2009
Article 3 of SPC regulation No 469/2009, outlines the requirements for obtaining SPC protection. Among these requirements, a valid authorisation to place the product on the market as a medicinal product must be granted (Article 3(b)) and that authorisation must be the first authorisation to place the product on the market as a medicinal product (Article 3(d)). Here, ‘product’ is defined as ‘the active ingredient or the composition of active ingredients in a drug’ (Article 1). There has been ongoing controversy as to whether Article 3(d) should be interpreted narrowly (some might say literally) or teleologically, resulting in a series of case law “flip-flops” on the issue over the past two decades.
A new orphan treatment, even when derived from an existing drug, will require its own marketing authorisation (MA) and so a situation arises in which this new MA is based on the same active ingredient as a previously approved product. Therefore, the interpretation of Article 3(d), and the definition of ‘first authorisation for placing a product on the market’, is of particular significance.
The story of Article 3(d) interpretation
Originally, the wording of Article 3(d) was interpreted literally, meaning that if an MA had already been granted for a product with the same active ingredient, then a subsequent SPC could not be obtained for the later product, even if it treated a different disorder. In other words, the intended use of the later product was irrelevant.
In 2012 this interpretation was turned on its head by the Neurim decision (C-130/11) in which the CJEU (following a referral from the UK courts) ruled that the use of a product was relevant and that an SPC could be based on the approval of a previously approved active ingredient if its new use had not previously been the subject of an MA.
In brief, the Neurim case concerned the drug Circadin, which was a patented formulation of melatonin for use in treating human sleeping disorders. Although melatonin had previously been approved as an active ingredient in the drug Regulin, which regulated reproductivity in sheep, Neurim still had to perform a significant number of clinical trials to get approval of the new use in humans. Advocating the objectives of the SPC Regulation, Neurim argued that an SPC was justified and necessary to recoup their investment.
Whilst the specific facts of the Neurim case seemed to justify an SPC, the CJEU’s broad interpretation of Article 3(d) in their decision opened the door for SPC protection to be granted for any new use of a previously approved active ingredient. This led to legal uncertainty and an (often abused) mechanism for extending patent protection irrespective of the time and effort required to get the approval for the later use.
In 2020 the CJEU looked to address this when, in Santen (Case C – 673/18), they concluded that the interpretation adopted by the court in Neurim should be abandoned and that the original, narrower, interpretation of Article 3(d) should be applied. The intended use of the product, once again, became irrelevant.
Subsequent to Santen, the UK left the EU and as a result was no longer bound by its case law. This raised questions about whether the UK would follow the CJEU on Santen; revert back to the principles of Neurim; or land somewhere between the two.
In a recent case, Merck [2025] EWCA Civ 45, the UK Court of Appeal addressed the interpretation of Article 3(d) in light of assimilated EU case law in the UK.
In brief, Merck sought an SPC for a drug called Mavenclad which contains the active ingredient cladribine for treating multiple sclerosis. The UK Intellectual Property Office (UKIPO) refused their SPC application on the grounds that it did not meet the requirements of Article 3(d) because there were two earlier MA’s, Leustat and Letak, both comprising cladribine as the active ingredient for the treatment of hairy cell leukaemia.
While UK courts are generally no longer bound by assimilated EU case law, they are bound by post-transition case law that already modifies or applies EU case law in a binding UK court (Article 4(2) of the European Union (Withdrawal) Act 2018 Regulations (SI 2020/1525)). In the Merck case, the Court of Appeal referred to its previous decision in Newron [2024] EWCA 1471, where it chose to adopt the Santen doctrine over that of Neurim. As the Court of Appeal should be bound by its earlier decisions, it could not depart from the precedent already set by Newron which had applied the Santen standard.
It is worth noting that the court also evaluated whether it would have followed the Santen decision irrespective of Newron; ultimately concluding that it would. The court reiterated the high standard for departing from EU case law and acknowledged the need for legal certainty balanced with appropriate flexibility to avoid injustice. Lord Justice Birss concluded that the Santen decision provided greater legal certainty and appropriately considered the objectives of the SPC regulation.
So Santen still stands!
Impact of Article 3(d) on orphan drugs
Whilst the clarity that this decision brings may be welcomed by many, it is likely to be seen as a blow for developers of orphan drug medicines who’s research often focuses on new uses of existing drugs. Given the struggles to incentivise research into orphan drug medicines, and the purpose of the SPC regulation to encourage research and help companies recover their investment, this narrow interpretation Article 3(d) does not appear help the situation.
This raises the question of whether a more nuanced interpretation of Article 3(d) is still necessary. One that provides a middle ground which incentivises research into orphan drugs without opening the floodgates to “second medical use” SPCs as we saw post Neurim. We already have bespoke regulatory data protection for orphan drug medicines, could a similar approach be adopted for supplementary protection certificates?
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
[1] The UK Rare Disease Framework Policy Paper, 9 Jan 2021
