No SPCs in the UK for New Therapeutic Uses – Court of Appeal Does Not Depart from Santen

A significant decision has been handed down this week by the Court of Appeal in England and Wales which has confirmed that the UK would not depart from the landmark CJEU ruling in Santen (C-673/18; see our briefing note here).

The decision concerns an appeal by Merck against a decision by the UKIPO (later upheld on appeal by the High Court; see the first part of our briefing note here) to refuse an SPC application (SPC/GB18/007) for cladribine. The SPC application at issue in this appeal was based on the authorisation of MAVENCLAD® for treatment of highly active relapsing multiple sclerosis. The application was deemed to contravene Article 3(d) of the SPC regulation because the authorisation of MAVENCLAD® was not the first for the active ingredient, cladribine. The medicinal products LEUSTAT® and LITAK® containing cladribine had already been authorised in 1995 and 2004 for the treatment of hairy cell leukaemia.

In Santen, proper interpretation of Article 3(d) of the regulation was clarified as follows:

“Article 3(d) … must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.”

The Santen decision therefore effectively prohibits the grant of SPCs in the EU based on a marketing authorisation for a new medical use or new formulation of an active ingredient (or combination of active ingredients) that has previously been authorised for other therapeutic applications. Santen explicitly overturned the earlier decision of the CJEU in Neurim (C-130/11), which had held that SPCs may be based on a subsequent marketing authorisation provided there was a suitably limited patent claim.

Santen represents an example of “assimilated EU case law” in the UK post-Brexit. In view of Santen, it was therefore not surprising that the UKIPO decided to refuse Merck’s SPC application for cladribine. Among Merck’s grounds for appeal against the UKIPO’s decision was that Santen was wrongly decided and should be set aside.  The EU Withdrawal Act 2018 allows only the UK Supreme Court (UKSC) to depart from a CJEU judgment established pre-Brexit (e.g. Santen), although a statutory instrument (SI 2020/1525) provides for some exceptional circumstances where this power to depart may be extended to the Court of Appeal. The present case before the Court of Appeal was based on the single ground that Santen was wrongly decided (Merck’s three lines of reasoning are summarised in paragraph 6 of the decision), and therefore hinged entirely on the issue of whether the Court could and should depart from Santen.

In its decision, before determining whether the UK should depart from Santen, the Court deals firstly with the issue of whether it can depart from Santen in light of the provisions of the statutory instrument. This consideration proved to be conclusive in the Court arriving at its decision to dismiss Merck’s appeal.

In brief, a condition laid out by the statutory instrument is that the Court of Appeal may not depart from a CJEU judgment established pre-Brexit where the same Court (post Brexit-transition) has already relied on that CJEU judgment to arrive at a decision. The Court determined that in the case of Newron ([2024] EWCA Civ 128; see the second part our briefing note here) the same court (i.e. the Court of Appeal) applied Santen in arriving at its decision. Accordingly, the Court in the present case concluded that it was bound by Santen and therefore had no power to depart from this CJEU judgment. For this reason alone, Merck’s appeal was dismissed.

Interestingly, all three judges sitting in the Court for this appeal set out their own as to why they believe that it would not have been appropriate for the Court to depart from Santen even if it had the power to do so.  For example, one judge suggested that Merck’s criticism was “unsound”, and credited Santen in bringing to the scheme of the SPC regulation “a measure of coherence” whilst also substantially reducing the “legal uncertainty caused by Neurim”. Such conclusions might be highly influential in the eyes of the UK Supreme Court should Merck decide to pursue this appeal to the UK’s highest Court, and the only Court with the power to depart from Santen.

For rights holders seeking to obtain SPCs in the UK, it therefore remains business as usual, for now.