Court of Appeal Confirms No Second Medical Use SPCs in UK

Merck Serono SA  v  The Comptroller-General of Patents, Designs, and Trade Marks – Lewison LJ, Arnold LJ and Birss LJ – [2025] EWCA Civ 45 – 28 January 2025

The Court of Appeal confirmed that UK SPCs are not available for second medical use claims, finding that it was bound by its decision in Newron,[1] which, in line with CJEU law, rejected an SPC for a second medical use. Consequently, the CoA could not depart from the equivalent EU position prohibiting such SPCs. However, the Court also confirmed that even if it was able to diverge from the EU view, it would not have done so.

Background

On 13 February 2018, the appellant (“Merck”) applied for an SPC in respect of Mavenclad (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 entitled “cladribine regimen for treating multiple sclerosis” (filed in 2005), and the marketing authorisation (“MA”) EU/1/17/1212 for Mavenclad (granted in 2017).

The SPC application was refused by the UK IPO examiner^[2] for failing to meet the requirement of Article 3(d) of Regulation (EC) 469/2009 (the “SPC Regulation”), because cladribine was formerly the subject of two MAs for a different indication (hairy cell leukaemia) in 1995 (LEUSTAT) and 2004 (LITAK).

Merck appealed from the UK IPO to the Patents Court.^[3]  The Patents Court dismissed the appeal, as it was bound by the CJEU law in Santen^[4] (which prohibits the grant of an SPC for a second medical use). Merck appealed that decision to the UK CoA, which was heard on 11 December 2024. The appeal provided the possibility of the UK diverging from CJEU law, as post-Brexit, the CoA (unlike the Patents Court) could decide to diverge from the CJEU position.

Merck’s appeal was based on a single ground – that Santen has been wrongly decided and the CoA should depart from it.

Decision

The UK CoA dismissed Merck’s appeal, finding that second medical use SPCs remain prohibited in the UK.  The CoA based its decision primarily on its own decision in Newron, but confirmed that even if it was not bound by Newron, it would not have departed from the position in Santen.

Court of Appeal bound by Newron

The Court considered the notion of binding case law, noting that it is itself bound by its own earlier decisions. Lewison LJ noted that are exceptions to this principle as set out in Young v Bristol Aeroplanes Co Ltd [1944] KB 718, namely that:

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.

Lewison LJ held that none of the above exceptions applied in this case, and therefore the Court was bound by Newron.

If not bound by Newron, the Court of Appeal would not depart from Santen

The Court decided that even if it had not been bound by Newron, it would not have been appropriate to depart from the judgment of the CJEU in Santen.  Lewison LJ referred to the following six factors in reaching this conclusion:

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. Changes in public policy are one such change.
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 (Arnold and Birss LJJ agreeing) held that none of the above factors applied to this case.

Whilst Arnold LJ agreed with the reasons of Birss and Lewison LJJ, he noted that the assimilated version of the SPC Regulation in the UK post-Brexit has not been amended.  Therefore, in his view, it remained the will of Parliament that the legislation should continue to be harmonised with that of the EU, such that “the UK courts should continue to interpret the legislation in harmony with the Court of Justice unless convinced that the Court of Justice’s interpretation is wrong”.  Arnold LJ also opined that because there was no realistic prospect of the Court of Justice reversing its ruling in Santen and the fact the Merck cited neither any academic criticism of Santen (nor any decisions of any EU national courts supportive of its case), the appeal ought to be dismissed.

Conclusion

Had the UK diverged from the CJEU position, there may have been a policy incentive for drug manufacturers to consider additional investment and medical research into new uses for known molecules in the UK.  The Judgment, however, maintains the status quo and provides some certainty for third parties.

At the time of writing it is not clear whether Merck has (or will) seek permission to appeal from the UK Supreme Court, which of course if granted, could overturn Newron.

[1] Newron Pharmaceuticals v The Comptroller [2024] EWCA 1471

[2] BL/0484/23

[3] [2023] EWHC 3240 (Ch)

[4] Case C-673/18 Santen SAS v Directeur général de l’Institut national de la propriété industrielle

This article was prepared by Partner and Head of Law Rachel Fetches and IP Solicitor Sian Hope