SPCs extend the term of patents for medicinal and plant protection products in Europe which have been granted a marketing authorisation (MA). However, Article 3(d) of Regulation (EC) 469/2009 (the SPC Regulation) requires that the MA is the “first authorisation to place the product on the market as a medicinal product”.

This decision relates to the issue of whether an MA can be considered to be the “first authorisation” if it is directed to a new therapeutic application of an active ingredient that has previously been authorised for a different therapeutic use. This issue has been a key topic in the field of SPCs for many years and this decision was hotly anticipated in view of the possibility that the UK Court of Appeal could depart from previous CJEU case law in this area, as it has the power to do following Brexit.

Background to the case

The case relates to an SPC application filed by Merck in respect of the product Mavenclad, which comprises the active ingredient cladribine. Mavenclad is a disease modifying drug for very active relapse remitting multiple sclerosis. The SPC application relied on the basic patent EP1827461 and the marketing authorisation EU/1/17/1212 for Mavenclad.

The SPC application was refused by the UK Intellectual Property Office (UKIPO) examiner for failing to meet the requirement of Article 3(d) of the SPC Regulation, because cladribine had already been the subject of two MAs for a different indication (hairy cell leukaemia). As a result, the UKIPO examiner objected that the MA for Mavenclad could not be the “first authorisation to place the product on the market as a medicinal product”.

Merck appealed the decision by the UKIPO to the Patents Court. However, the Patents Court dismissed the appeal on the grounds that it was bound by the CJEU decision in C-673/18 (Santen), which decided that it is not possible to obtain an SPC for a new therapeutic application of a previously authorised active ingredient.

Merck subsequently appealed that decision to the UK Court of Appeal, which interestingly provided the possibility of the UK diverging from CJEU law and particularly the Santen decision, since post-Brexit, the Court of Appeal (unlike the Patents Court) could decide to diverge from the CJEU position.

The decision of the UK Court of Appeal thus touched on two key areas:

1. Could the UK Court of Appeal depart from the CJEU’s decision in Santen, given that it had already followed it when reaching its own previous decision in Newron?
2. Was Santen wrongly decided, such that the Court of Appeal should depart from its reasoning and therefore allow the possibility to obtain an SPC for a new therapeutic application of a previously authorised active ingredient?

Is the UK Court of Appeal bound by Santen and its own application of this Case law in Newron?

As a first element to the decision, the UK Court of Appeal considered the notion of binding case law. In particular, the court referred to a statutory Instrument entitled the European Union (Withdrawal) Act 2018 (Relevant Court) (Retained EU Case Law) Regulations (SI 2020/1525) outlining that a relevant court (such as the UK Court of Appeal) is bound by retained EU case law so far as there is post-transition case law which modifies or applies the retained EU case law which is binding on the relevant courts.

In the context of the present case, the Santen decision is to be considered “retained EU case law” and relevant to the “post-transition case law” was a recent decision of the UK Court of Appeal in Newron, in which the same court applied Santen in arriving at its decision, albeit in a slightly different context. In view of the above statutory instrument, the court in the present case concluded that it was bound by Newron (and thus Santen) and therefore had no power to depart from this CJEU judgment. For this reason alone, the Court of Appeal dismissed Merck’s appeal.

As part of its decision, the court, and in particular Lewison LJ, noted that there are exceptions to this principle of a court being bound by its own decision as set out in the commonly cited Young v Bristol Aeroplanes Co Ltd [1944] KB 718. These exceptions are:

1. the court is entitled and bound to decide which of two conflicting decisions of its own it will follow;
2. the court is bound to refuse to follow a decision of its own which, though not expressly overruled, cannot stand with a decision of the Supreme Court; and
3. the court is not bound to follow a decision of its own if it is satisfied that the decision was given per incuriam (that is, through lack of due regard to the law or the fact).

Lewison LJ held that none of the above exceptions applied in this case, such that the court was bound by its own decision in Newron.

Was Santen wrongly decided such that the Court of Appeal should depart from it?

Despite the above, the UK Court of Appeal also considered whether, even if it was not bound by Newron (and thus Santen), it would arrive at the conclusion that Santen has been wrongly decided such that the UK Court of Appeal should depart from it. Some had hoped the UK Court of Appeal would steer away from the CJEU ruling in Santen so that it would be possible to obtain SPCs for new therapeutic applications of previously authorised active ingredients.

The Court of Appeal held that even if it could diverge from Santen, it would not in the present circumstances.

The Court of Appeal’s decision in this regard referred to the fact that any criticisms of the Santen decision by Merck were “unsound” and that Santen brought a sense of coherence to the assessment of Article 3(d) of the SPC Regulation. The Court of Appeal also suggested that the Santen decision substantially reduced the legal uncertainty caused by Neurim, where the CJEU somewhat surprisingly suggested that contrary to previous decisions, SPCs could be available for second medical uses of previously authorised products in some circumstances.

Indeed, the Court of Appeal referred to the deficiencies of the Neurim decision in terms of complicating the SPC assessment process, failing to indicate how it aligns with previous case law in this area and failing to “face up to the wholesale reorganisation of the way the regulation would need to be interpreted” based on this decision.

Arnold LJ further highlighted that since SPC law applicable in the UK post-Brexit has not been amended in any relevant respect from the EU SPC Regulation that previously had direct effect in UK law, it follows that it is the will of the UK Parliament that the legislation continue to be harmonised with that of the EU. As a result, the UK courts should continue to interpret the legislation in harmony with the CJEU unless convinced that the CJEU’s interpretation is wrong.

Moreover, Lewison LJ referred to the following six factors relevant for reaching a conclusion as to whether, if it could, the Court of Appeal would depart from the Santen decision as applied in Newron:

1. The power to depart from a previous decision should not be invoked merely because the later court thinks that the earlier decision of that court was wrong.
2. The power should be more sparingly used where the point in issue is the interpretation of a statutory provision, rather than the scope of a principle of the common law.
3. It is relevant to consider whether the earlier decision has been criticised by academics, judges or practitioners.
4. Where the provision in question concerns a legal instrument with international application, it is relevant to consider how that instrument has been interpreted in other jurisdictions.
5. It is relevant to consider whether there has been a relevant change in circumstances since the earlier decision, such as changes in public policy.
6. It is relevant to consider whether the earlier decision defeats the purpose of the provision in question or has given rise to incoherence in the law.

Lewison LJ held that none of these factors applied to this case, such that it would not be suitable to depart from the Santen decision as applied in Newron.

Implications of the decision

The decision of the Court of Appeal acts to maintain the status quo when it comes to the assessment of Article 3(d) of the SPC regulation, which will therefore continue to bar SPCs based on second medical uses of previously authorised active ingredients. In indicating that the Court of Appeal would follow the decision in Santen, the key question when considering an SPC filing strategy remains whether the active ingredient (or combination of active ingredients) has ever before been the subject of an MA for any therapeutic application. If this is the case, it appears likely that the UKIPO will maintain that an SPC is not available.

Of course, it is possible that Merck may seek permission to appeal the decision from the UK Court of Appeal. In this instance and unlike in the present case, the UK Supreme Court would have the option to depart from the Court of Appeal’s previous decision in Newron, and thus the precedent set by Santen. We will continue to monitor the case and keep you informed of developments.

Case details at a glance

Jurisdiction: England & Wales
Decision level: Court of Appeal
Parties: Merck Serono SA (appellant) v The Comptroller-General of Patents, Designs and Trade Marks (respondent).
Date: 28 January 2025
Citation: [2025] EWHA Civ 45
Decision: dycip.com/2025-ewca-civ45

Useful links

• Santen (C-673/18): CJEU takes a restrictive view on “first authorisation” for new therapeutic applications, Sophie Slater, 14 August 2020: dycip.com/santen
• Sheep don't follow authorisation: CJEU decides on Neurim SPC application, Garreth Duncan, 24 July 2012: dycip.com/neurim
• Young v Bristol Aeroplanes Co Ltd [1944] KB 718 (PDF), Incorporated Council of Law Reporting for England and Wales (ICLR): dycip.com/young-bristol