In a decision that maintains the status quo, the Court of Appeal in the UK has dismissed Merck Serono’s appeal against the High Court’s decision that UK SPCs remain unavailable for new medical indications of previously approved drugs (Merck Serono v Comptroller [2025] EWCA Civ 45 (28 January 2025)).
Birss LJ, in his leading judgment, held that the Court of Appeal was bound by its own earlier decision in Newron Pharmaceuticals SPA v Comptroller [2024] EWCA Civ 128 (15 February 2024), in which it decided not to depart from the CJEU’s ruling in Santen (C-673/18).
Even if not bound, the Court said that it would have reached the same conclusion. In balancing the interests of patentees with other stakeholders, the Court of Appeal prioritised the coherent operation of the SPC system, holding “it is necessary to have bright-line rules even if they sometimes deprive meritorious inventions of extended protection”.
Merck Serono’s SPC and Appeal
Merck Serono applied for an SPC for cladribine, based on its patent for the use of cladribine for treating multiple sclerosis. As discussed in our previous note, here, Merck Serono was granted a Marketing Authorisation (“MA”) for the medicinal product “Mavenclad”, which contains cladribine and is indicated for the treatment of highly active relapsing remitting multiple sclerosis. However, earlier Mas were granted for the medicinal products “Leustat” and “Letak”, both of which contain cladribine and were indicated for the treatment of a different disease: hairy cell leukaemia.
As such, the High Court previously upheld the UK Intellectual Property Office’s decision that Merck Serono’s SPC did not meet the requirements of Article 3(d) of the SPC Regulation, because the MA for Mavenclad was not the first to place cladribine on the market as a medicinal product.
In its appeal, Merck Serono accepted that the “product” of an SPC under Articles 1(b) and 3 of the SPC Regulation was to be interpreted narrowly (i.e. without “reading in” the application or use of the product). However, Merck Serono submitted that “the first authorisation to place the product on the market as a medicinal product” under Article 3(d) should be interpreted as the first relevant authorisation – “relevant” meaning, for example, the first authorisation falling within the scope of the basic patent (a requirement the earlier MAs did not fulfil).
Before analysing the Court of Appeal’s decision in detail, it is useful to briefly revisit the CJEU’s previous case law regarding Article 3(d).
The changing approach of the CJEU: Neurim and Santen
Up until its judgment in Neurim (C-130/11), a consistent line of CJEU case law held that Article 3(d) precluded the grant of an SPC where an earlier MA had been granted for the active ingredient in question, even where the later approved indication was different and did not overlap with the earlier indication. In other words, a ‘new medical use’.
Following a referral from the Court of Appeal in the UK, the CJEU in Neurim departed from its established position and found that the grant of an SPC was not precluded by the existence of an earlier MA for the same active ingredient. Following Neurim, however, divergent and inconsistent approaches were applied by different national patent offices and so a further referral to the CJEU was made in Santen (C-673/18). The CJEU then reversed its position on SPCs for new medical uses in Santen, overturning Neurim and effectively returning to its previous position that SPCs were not available for new indications of previously approved active substances.
Santen applied by the UK Court of Appeal in Newron
Last year, the Court of Appeal explicitly applied Santen in its decision to refuse Newron’s application for an SPC for a loose combination of three active ingredients: safinamide, levodopa, and a peripheral decarboxylase inhibitor (“PDI”). The MA relied upon was for the medicinal product “Xadago®” and this MA listed safinamide as the sole active ingredient and referred to levodopa and a PDI in the “use” section of the MA. It was undisputed that the basic patent related to the combination of the three active ingredients, and that the “product” under Article 1(b) of the SPC Regulation was this combination. The key question under Article 3(b) of the SPC Regulation was whether the MA authorised this combination of three active ingredients to be placed on the market as a medicinal product.
Following Santen and not Neurim, the Court of Appeal decided that an active ingredient’s intended use is not to be considered when determining the “product”, meaning that one or more active ingredients mentioned only in the context of a particular use in an MA do not form part of the “product” itself. In view of this, the Court of Appeal held that safinamide alone was the subject of the MA, meaning that there was no valid authorisation under Article 3(b) to place the “product”, i.e. the combination of three active ingredients, on the market and so Newron’s SPC could not be granted.
The Court of Appeal is bound by Newron, so could not depart from Santen
According to the Court of Appeal, the only issue it needed to decide in Merck Serono’s appeal was whether it should depart from Santen and apply Neurim instead. Despite the UK’s departure from the EU, certain UK courts (including the Court of Appeal) are bound by retained EU case law in particular circumstances. Specifically, the test for whether the Court of Appeal is bound by retained EU case law (i.e. Santen) is set out in paragraph 4 of the European Union (Withdrawal) Act 2018 (Relevant Court) (Retained EU Case Law) (the “2020 Regulations”), which reads:
4(1) A relevant court is not bound by any retained EU case law except as provided in paragraph 2.
(2) A relevant court is bound by retained EU case law so far as there is post-transition case law which modifies or applies that retained EU case law and which is binding on the relevant court.
The Court of Appeal held that it was bound by Santen in Merck Serono’s appeal case because, under paragraph 4(2) of the 2020 Regulations, their own earlier judgment in Newron constitutes “post-transition case law” that applies Santen.
Contrary to Merck Serono’s arguments, Birss LJ also held that the approval and application of Santen was in fact part of the operative decision in Newron and was therefore binding. Even though the specific aspect of the SPC Regulation considered in Newron was Article 3(b), whereas Merck Serono’s appeal concerned Article 3(d), the reasoning in Newron was relevant because it was centered on whether the “product” in the SPC Regulation depends on the manner of its use.
The Court of Appeal would have followed Santen even if it were not bound by Newron
Notably, in obiter dicta the Court of Appeal stated that it would not in any case have departed from Santen. Even bearing in mind that the Explanatory Memorandum to the SPC Regulation supports the notion of granting SPCs based on patents for new therapeutic uses of known products, Birss LJ was unswayed by Merck Serono’s arguments in support of the “teleological reasoning” of the CJEU in Neurim.
Birss LJ held that a balanced approach to the SPC Regulation must also take account of other objectives including public health, the interests of third parties and, importantly, simplicity of administration of the SPC regime, having taken the objectives Merck Serono highlighted in the Explanatory Memorandum into account.
Merck Serono had submitted that further SPCs did not necessarily need to be granted for all types of basic patent (e.g. new formulations or dosage regimens concerning a known product), but that further SPCs should at least be available for new medical uses. However, Birss LJ noted that “a process of judicial interpretation of the Regulation”, for example in Neurim, would create more uncertainties in its application and that the mechanism of achieving this “potentially worthy policy objective” would require amendment of primary legislation instead. In the appeal hearing, Arnold LJ also highlighted the previous difficulty in applying Neurim as evidenced by divergent case law, multiple CJEU referrals, and academic criticisms.
Ultimately, the Court of Appeal found that Neurim had led to unhelpful inconsistencies in the operation of the SPC system, while Santen had brought “the scheme of the Regulation back into a measure of coherence, and substantially reduced the legal uncertainty caused by Neurim”.
Where does this leave the UK SPC system?
This decision is not the news that innovators would have been hoping for: it confirms that the case law set out in Santen continues to apply in the UK, namely that a new use of an already-approved active ingredient cannot be the sole basis for obtaining an SPC.
The Court of Appeal has again reached precisely the opposite conclusion to Neurim regarding the protection of new uses of known therapeutics. This latest judgment acknowledges that this restrictive approach may deprive worthwhile innovations of protection, but considers this a price worth paying for legal certainty. The UK courts also appear keen to align themselves with the CJEU, as evidenced by the Court of Appeal’s consecutive decisions in Newron and Merck Serono and, for example, the comments Mr. Justice Meade made in his judgment in Halozyme v Comptroller [2024] EWHC 3202 Pat (16 December 2024) – that the result of a pending reference to the CJEU regarding the interpretation of “active ingredient” in the SPC Regulation “will not be binding on this Court but could well be persuasive”. Therefore, it does not appear likely that SPCs will be available in the UK for new medical uses unless the primary legislation itself is amended, as explained below.
Birss LJ and Arnold LJ appear to agree that if there were to be changes to the UK’s current SPC system in pursuit of the “potentially worthy policy objective” of protecting new medical indications, this must be achieved by new primary legislation rather than judicial interpretation of the SPC Regulation. This position is consistent with Birss LJ’s previous comments in Newron explaining that the ‘balance’ between various interests at stake set out in the Explanatory Memorandum of the SPC Regulation “is itself struck by the terms of the SPC Regulation” and “is not a balancing exercise which courts are invited to undertake on a case by case basis”. Notably, Arnold LJ commented that “the assimilated version of the SPC Regulation that applies in the UK post-Brexit has not relevantly been amended. It follows that it remains the will of Parliament that the legislation should continue to be harmonised with that of the EU”.
Originally published in the CIPA Journal