The ability to obtain SPCs in Europe to extend patents for new therapeutic uses of known products, i.e. second medical use SPCs, took a dramatic U-turn in 2020. Since then, it seemed clear that only the first marketing authorisation (MA) for a product can be used to support an SPC application, regardless of the therapeutic application. In practice, this meant that there was little to no chance of obtaining a second medical use SPC.
Following the UK’s departure from the European Union, the UK can diverge from precedents set by Court of Justice of the European Union (CJEU) case law. To date, little divergence has occurred. However, a judgement from the UK High Court relating to Merck Serono’s second medical use UK SPC application has been granted the right to appeal to The UK Court of Appeal and could be the first departure from CJEU case law.
Second medical use SPCs – a brief history
A key requirement for obtaining SPC protection is that the MA used to support an SPC application must be the first MA for that product. This is stipulated in Article 3(d) of the SPC Regulation. However, the interpretation of “first” has been the subject of debate for many years.
Pre-2012, “first” was generally interpreted to mean that only the first MA, regardless of the therapeutic indication, could be relied upon to support an SPC application. However, a change occurred in 2012 when the CJEU issued their judgement in Neurim (C-130/11). Neurim altered the interpretation of “first” such that the MA used to support an SPC application should be the first MA falling within the scope of the claims of the basic patent. Thus, MAs authorising use of a known product to treat a new therapeutic indication could be used to support an SPC application if the basic patent-protected use of the known product to treat the new therapeutic indication even if the known product was the subject of an earlier MA for a differing therapeutic indication. Thus, the ability to obtain second medical use SPCs was born.
Following Neurim, there was an incentive for pharmaceutical companies to develop known active ingredients to treat new therapeutic indications. However, Neurim was soon quashed by the CJEU in 2020 by the issuance of Santen (C-673/18), which reverted back to a pre-2012 definition of “first” meaning that only the first MA authorising placement of the product on the market can be used to support an SPC application, regardless of therapeutic indication. Thus, the issuance of Santen brought an end to the ability to obtain second medical use SPCs in Europe.
Merck’s UK SPC application
On 12 February 2018 (before Santen was issued by the CJEU), Merck applied to the UKIPO for an SPC for the product cladribine. Merck relied on an MA for the cladribine-containing medicinal product MAVENCLAD® indicated for the treatment of highly active relapsing multiple sclerosis and a basic patent protecting MAVENCLAD® for use in treating the same therapeutic indication.
Cladribine had previously been the subject of two earlier MAs. Both MAs authorised cladribine for the treatment of hairy cell leukaemia. Merck argued that Neurim should apply since Neurim was the relevant case law when the SPC application was filed meaning that the later MA specific for highly active relapsing multiple sclerosis should be considered the first MA.
The UKIPO hearing office concluded that Santen had a retroactive effect and so should be applied regardless of the filing date of the SPC application. Therefore, the UKIPO hearing office issued a decision refusing the SPC application as the MA was not the first MA for Cladribine.
High Court appeal
Merck appealed the decision from the UK-IPO. Merck’s appeal was based on three key grounds (all of which were dismissed):
- Santen should not apply retroactively.
Merck argued that second medical use SPCs should be allowed as the legitimate expectation of SPC applicants at the filing date of their SPC application was that this was the case under Neurim and so Santen should not be applied. The High Court dismissed this ground as there was no clear indication that the judgement laid down in Santen had a limited temporal effect. Therefore, the High Court agreed that Santen should be applied retroactively and that Merck’s expectation that a second medical use SPC would be granted cannot actually give rise to a right to be granted an SPC.
- Merck’s case was distinct from Santen.
Merck argued that their case was factually distinct from Santen and so the teachings of Santen should not apply. The High Court dismissed this ground as they believed that Santen should be applied to Article 3(d) of the SPC Regulation generally and that the decisions laid down in Santen are not specific to the facts of the case.
- Santen was wrong.
Merck argued that second medical use SPCs must be allowed by the SPC Regulation. However, only the UK Supreme Court and Court of Appeal can overturn decisions issued by the CJEU and so, regardless of merit, the High Court could not address Merck’s third ground of appeal.
The High Court judge agreed with the Hearing Officer of the UKIPO and issued a decision to dismiss Merck’s appeal.
Court of Appeal?
The High Court Judge has granted Merck permission to appeal against their judgement.
Therefore, assuming Merck lodges an appeal, there is a real prospect that the UK Court of Appeal could diverge from existing CJEU case law and pave the way for second medical use SPCs in the UK. This is particularly true given some of the comments from Court of Appeal Justices on the relevance of Neurim and the ability to obtain second medical use SPCs. If Santen is overturned in the UK, this would again provide pharmaceutical companies with an incentive to invest in research to determine whether known products can be used to treat new therapeutic indications.