March 2025 Background of Supplementary Protection Certificates (SPCs)
SPCs are heavily relied on by pharmaceutical companies to extend the period of patent protection.
Under the current regulations, SPCs can only be granted if the product is:
1) protected by a basic patent in force;
2) a marketing authorisation has been issued to place that product on the market as a medicinal product;
3) the product has not already been the subject of an SPC; and
4) the marketing authorisation relied on is the first to place the product on the market as a medicinal product.
Merck Serono v Comptroller-General of Patents
In 2018, Merck filed a SPC application covering the use of cladribine for the treatment of multiple sclerosis based on the marketing authorisation obtained in 2017.The application was initially denied by the UKIPO due to an existence of two earlier marketing authorisations issued in 1995 and 2004 for the treatment of hairy cell leukaemia. The UKIPO’s decision was upheld by the High Court, largely based on Santen C-673/18 (a CJEU case law retained post-Brexit).
Merck appealed to the Court of Appeal (CoA) on the ground that Santen was wrongly decided, and the CoA should depart from this case law as the CJEU had misinterpreted the EU’s SPC regulation and its purpose when closing off the scope for second medical use products to obtain SPCs. Merck further argued that the Neurim case law (Neurim Pharmaceuticals C-130/11) preceding Santen should be restored and relied upon in the UK.
In the recent decision, the CoA dismisses Merck’s appeal and concludes that second medical use SPCs cannot be obtained in the UK, further maintaining that it could not, and would not, diverge from the EU’s approach.
1) The CoA held that it could not diverge from Santen as the case had already been adopted by a previous binding decision of the CoA (Newron Pharmaceuticals v The Comptroller). The CoA is therefore bound by its own previous decision.
2) Even if the CoA could diverge from Santen, it would not in this case as the court held that Santen was correctly decided. The CoA further comments that the Neurim case law caused considerable legal uncertainty, which was ultimately resolved by the Santen decision.
It remains possible that the UK Supreme Court could issue a divergent ruling. At the moment, it is unclear if Merck will seek permission to appeal the CoA’s decision to the Supreme Court.
Consistent with the EU, the CoA held that the SPC regime is confined to protection only for the first authorisation of a product.
Although this decision is likely to come as a disappointment for drug developers who have invested in developing second medical uses for medical products, it will, however, provide some legal certainty for third parties looking to launch their generic medical products.
In summary, second medical use SPCs cannot be obtained in the UK, and the UK court upholds earlier EU rulings on this point.
