No second medical use SPCs in the UK
As reported previously, following an appeal lodged by Merck Serono SA (Merck) and following the UK’s departure from the EU, the UK Court of Appeal (CoA) had the potential to diverge from EU law regarding the ability to obtain second medical use Supplementary Protection Certificates (SPCs).
In reaching their decision, Lewison LJ, Arnold LJ and Birss LJ confirmed that the CoA was bound by existing UK case law (Newron), which endorsed existing EU case law (Santen). Further, the CoA confirmed that they would not diverge from existing EU case law even if they were able to do so. The reasoning behind the decision is outlined below.
Introduction
The ability to obtain an SPC for a known, authorised, product for treating a new therapeutic indication (a “second medical use SPC”) has been a topic of controversy in the SPC field for years. Two stand-out decisions issued by the Court of Justice of the European Union (CJEU) on this topic are Neurim and Santen.
Our previous article outlines the history of the controversial second medical use SPC. Briefly, Neurim made it possible to obtain second medical use SPCs in the EU. This was subsequently quashed by Santen. In the EU, it is currently not possible to obtain second medical use SPCs.
The UK Intellectual Property Office (UK-IPO) and High Court cannot diverge from CJEU case law retained by the UK courts following the UK’s departure from the EU. Therefore, Merck’s application for a second medical use SPC for the product Mavenclad® was refused by the UK-IPO and the decision was upheld by the High Court on appeal. Merck further appealed to the CoA, which, under certain circumstances, can diverge from CJEU case law retained by the UK courts following the UK’s departure from the EU. This thus represented the UK’s first opportunity to potentially diverge from the EU’s position on second medical use SPCs.
Merck’s appeal to the CoA centred on a single ground – that the decision of the CJEU in Santen was wrong and that the UK should not apply Santen. Merck argued that Neurim was the correct decision.
As explained below, the CoA decided that it could not (and would not) diverge from the EU’s position in Santen.
CoA could not diverge from the EU’s position
The CoA confirmed that they can depart from the EU’s position if there is a binding UK decision that modifies or applies CJEU case law. For example, if the CoA already issued a decision confirming a particular approach taken by the CJEU as correct, they would be bound by this decision and unable to depart from the teachings of this decision unless specific exceptions applied.
An existing UK CoA decision (Newron) confirmed that Santen was the correct approach regarding second medical use SPCs. The CoA found that none of the exceptions applied allowing the CoA to depart from the teachings of Newron. Therefore, the CoA was bound by, and unable to depart from, Newron meaning that Merck’s appeal had to be dismissed.
CoA would not diverge from the EU’s position
The CoA also decided that they would not diverge from the teachings of Santen, even if they were able to do so. In coming to their conclusion, the CoA reviewed previous CJEU decisions relating to second medical use SPCs and concluded that Neurim was the outlying decision that caused controversy in the SPC field, not Santen (as argued by Merck).
The CoA further confirmed that numerous points needed to be considered if they were to depart from Santen. These points included:
- Departure should not occur simply because the later court thinks the earlier decision is incorrect.
- Whether the point at issue is the interpretation of a statutory provision or the scope of a principle of the common law. If the former, the power to depart should be used sparingly.
- Whether the earlier decision has been challenged by experts.
- What conclusions other jurisdictions have come to if the question concerns a legal instrument with international application. Where possible, unity amongst jurisdictions should be sought.
- Whether there has been a change in circumstances following the earlier decision.
- Whether the earlier decision defeats the purpose of the provision in question or has given rise to incoherence in the law.
In the context of the present case, the CoA found that few, if any, of the above points applied. This, together with the review of CJEU case law surrounding second medical use SPCs, lead the CoA to conclude that they would not depart from the EU’s approach defined in Santen even if they were not bound by existing UK case law.
Conclusion
In dismissing Merck’s appeal, the CoA thus concludes that second medical use SPCs cannot be obtained in the UK, which is consistent with the EU’s approach. While this may be frustrating to pharmaceutical companies hoping to extend the term of patents protecting new therapeutic uses of known products in the UK, it does provide some certainty for third parties seeking to launch generic products.
At this point, it is unclear whether Merck wishes to seek permission to appeal the CoA’s decision to The Supreme Court. This could add a further twist in the tale concerning second medical use SPCs in the UK. We will be following developments closely.
If you have any questions, please contact one of Forresters’ SPC experts.
