[Guest Post] UK SPCs: Clinging to nurse, or fear of something worse? (Merck v Comptroller [2025] EWCA Civ 45)

The recent English Court of Appeal decision in Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks [2025] EWCA Civ 45 (28 January 2025) was a significant moment for the UK's post-Brexit approach to Supplementary Protection Certificates (SPCs). Despite hopes that the UK might chart its own course away from EU precedent, the Court has opted to maintain alignment with CJEU rulings on second medical use SPCs. Katfriend Paul England (Taylor Wessing) explores for IPKat why the Court chose to not to forge its own path, and the implications for pharmaceutical patent protection in the UK going forward.

Over to Paul: 

"The decision of the English Court of Appeal in Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks [2025] EWCA Civ 45 (28 January 2025) will disappoint those hoping the UK would depart from CJEU authority on the issue of SPCs for second medical indications. However, as the Court suggests, there is more at stake.

UK choosing it's way on SPCs

What nurse?

Not very long ago, it seemed like the majority of references to the Court of Justice of the European Union (CJEU) on the interpretation of Regulation 469/2009 on supplementary protection certificates (SPC Regulation) came from the English courts. It is fair to say that some of this apparent dependency was born of frustration at the existing case law of the CJEU and a desire that it should be cleared up. This all changed with Brexit; specifically, after the SPC Regulation was retained in UK domestic law after the end of the implementation period, on 31 December 2020, further to the European Union (Withdrawal) Act 2018 (2018 Act) and associated statutory instruments.

What would the English courts do now, when seeking to interpret the SPC Regulation? As it happened, after 31 December, the courts had not entirely escaped the CJEU’s reach. Whilst courts would no longer refer to the CJEU for rulings on points of EU law, existing EU case law on the SPC Regulation would continue to have binding authority on the first instance courts of the UK, as ‘retained EU case law’ (now called ‘assimilated EU case law’), (see Industrial Cleaning Equipment (Southampton) Ltd v Intelligent Cleaning Equipment Holdings Co Ltd [2023] EWCA Civ 1451).

But what about the Court of Appeal and Supreme Court? Can they depart from these decisions? The position is this:

• The Supreme Court has the power to depart from a CJEU judgment on the same basis that it would depart from one of its own precedents (see s6(5) of the 2018 Act, and the Practice Statement (Judicial Precedent) [1966] 1 WLR 1234).
• The Court of Appeal also has a power to depart (as a ‘relevant court’ under paragraph 3(b) European Union (Withdrawal) Act 2018 (Relevant Court) (Retained EU Case Law) Regulations (SI 2020/1525)).

The principles to be applied by the Court of Appeal in deciding whether to depart from any retained EU case law are the same as those to be applied by the Supreme Court. However, that power may only be used by the Court of Appeal if it is not already bound by the retained EU case law. It is bound by retained EU case law so far as there is case law which modifies or applies that retained EU case law and which is binding on the relevant court (paragraph 4(2) European Union (Withdrawal) Act 2018 (Relevant Court) (Retained EU Case Law) Regulations (SI 2020/1525)).

In other words, if the Court of Appeal is bound under paragraph 4(2), that is the end of the matter. Even if the Court of Appeal is not bound by retained EU case law, it may still decide not to depart from it.

What were the Court’s options here?

The reader might find it useful to have Article 3 of the SPC Regulation to hand:

Article 3: Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.

In Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (Case C-130/11), 19 July 2012, the CJEU ruled that melatonin for the treatment of insomnia in humans could be the subject of a SPC on the basis of a marketing authorisation granted in 2007 for this use. This was despite the fact that melatonin for regulating the seasonal breeding of sheep had already been the subject of a marketing authorisation granted in 2001. In other words, Article 3(d) of the SPC Regulation permitted SPC protection based on a new marketing authorisation of a known active ingredient if it is for a ‘different application’. The CJEU had followed the Advocate General’s Opinion in this respect by adopting a ‘teleological’ approach to the meaning of ‘product’ rather than a strict one: the court should look to the purpose of the SPC Regulation which, very broadly, is to provide sufficient protection for the investment made in the research and development of medicinal products.

Eight years later, however, in Santen v Director of the French Patent Office (Case C-673/18), 9 July 2020, the CJEU made a different decision. In this case, Santen had sought an SPC for a ciclosporin eye drop emulsion for the treatment of keratitis based on its patent ‘Ophthalmic oil-in-water type emulsion with stable positive zeta potential’ and a central marketing authorisation for Ikervis. The active ingredient of Ikervis is ciclosporin indicated for the treatment of severe keratitis in adult patients with dry eye disease. Ciclosporin had not previously been authorised for this indication, but it had been the subject of an earlier marketing authorisation for the product Sandimmun. Sandimmun indications include the treatment of an eye inflammation condition called endogenous uveitis.

The SPC application had been rejected by the director of the French Patent Office under Article 3(d) of the SPC Regulation, on the basis that the marketing authorisation for Ikervis would not be the first to place the product on the market as a medicinal product. The director of the French Patent Office held that the Neurim decision, which allowed subsequent SPCs for ‘different applications’ of the same active ingredient did not apply, because the indications in both Ikervis and Sandimmun both related to inflammatory diseases of the eye. Upon referral to the CJEU, it was ruled that Article 3(d) must be interpreted to mean that a marketing authorisation for a new therapeutic use of an active substance or a combination of active substances, which has already been the subject of a marketing authorisation for another therapeutic use, is not a ‘first authorisation’.

Along comes the Merck Serono case. This concerned an application by Merck Serono for a SPC for a pharmaceutical called cladribine. Merck relied on a basic patent for the use of cladribine for treating multiple sclerosis, and a 2017 marketing authorisation for the medicinal product MAVENCLAD which contains cladribine as an active ingredient and is indicated for the treatment of highly active relapsing remitting multiple sclerosis.

The UKIPO Comptroller's Hearing Officer refused the application, because of the existence of an earlier marketing authorisation for a medicinal product containing cladribine as an active ingredient, contrary to Article 3(d) SPC Regulation and according to Santen. In fact there were two earlier marketing authorisations for a medicinal product containing cladribine as an active ingredient, for the treatment of hairy cell leukaemia. When the case came to the Patents Court, it then held itself to be bound by the CJEU authority in Santen too, because it is retained case law.

Why the Court of Appeal was obliged to cling to nurse

At the Court of Appeal, Merck argued that Santen was wrongly decided and that the Court of Appeal should depart from it. (Cue excitement (from some parts of the pharmaceutical industry, but not all) at the prospect that the UK may make a decisive break from CJEU authority). But, it didn’t. Why? The reason lay in an earlier decision of the Court of Appeal in Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trademarks And Designs [2024] EWCA Civ 128 (15 February 2024) (IPKat). 

Recall that the Court of Appeal 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 Court of Appeal. In Newron, Santen had been identified as overruling Neurim. Per Birss LJ:

“In my judgment therefore Newron is a decision which applies Santen and it does so as part of the ratio decidendi. The fact that the specific aspect of the Regulation in issue in Newron was Art 3(b) whereas it is Art 3(d) which is in issue in the present case does not alter that conclusion. …, the conclusion in Newron would be (much) weaker without the application of Santen.”

As a result, a previous decision of the Court of Appeal was binding and that decision applied Santen.

Avoiding something worse

Santen therefore applied to the Merck Serono case. However, the Court of Appeal went on to explain that, even if it had not been bound by Santen, it would not have departed from it. This was because the Court considered Santen to have brought the scheme of the SPC Regulation back into a measure of coherence, and substantially reduced the legal uncertainty that had been caused by Neurim. What did it mean by this, given that Merck had argued that the teleological reasoning of the CJEU in Neurim was careful and correct and should be followed, otherwise the SPC Regulation “will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose” as Jacob LJ had stated in the Court of Appeal in Neurim?

The answer, the Court said, was illustrated by the case of Abraxis Bioscience Llc v The Comptroller-General of Patents [2017] EWHC 14 (Pat), 13 January 2017. Here Arnold J had referred further questions to the CJEU which only arose because of Neurim. The applicant in Abraxis had a patent and marketing authorisation for a known cancer drug paclitaxel formulated in a new way as albumin bound nanoparticles. The Patent Office refused the application under Article 3(d) because of the existence of an earlier marketing authorisation for the same active ingredient formulated differently. The applicant argued that, although Neurim was about a second use, the same policy considerations should apply to a new formulation and so a SPC should be granted. This result would be hard to reconcile with other CJEU decisions such as MIT, which provide that SPCs cannot be obtained for a new formulation of a known active ingredient.

The real cure

The overarching problem with Neurim, as the Court said, was that it did not face up to the wholesale reorganisation of the way the SPC Regulation would need to be interpreted. In particular, it caused complications that disrupted the SPC scheme, making it more difficult to administer when it was meant to be simple. The Court concluded that:

“What the cases show, taken as a whole, is that to achieve the potentially worthy policy objective a process of judicial interpretation of the Regulation cannot achieve that result without creating more uncertainties. The only way to achieve the result sought would be by legislation.”

In other words, SPCs cannot be granted for second medical uses in the UK under the existing SPC Regulation, however sensible the idea of second medical use may be. Over to the UK legislator to re-draft it.

Further reading

• Book Review: A Practitioner's Guide to European Patent Law by Paul England (Jan 2020)
• Does the Irish Court of Appeal in Merck v Clonmel part ways from the CJEU's Santen Article 3(d) decision? (May 2021)
• The SPC alphabet: Are combination product SPCs precluded by Article 3(a), (c) and/or (d)? (Dec 2021)
• UK takes uncompromising approach to interpretation of "the product" under Art. 3(a) SPC Regulation (Newron v Comptroller [2023] EWHC 1471) (Sep 2023)