Change and Opportunity: SPCs in the post-Brexit era

Supplementary Protection Certificates (SPCs) are incredibly important IP rights that help compensate for the years of clinical trials and regulatory delay before a new medicinal product can be launched. As discussed in our recent Special Report, over 60 countries worldwide offer Patent Term Extensions (PTEs) or SPCs to support innovation in one of the more unpredictable fields of human endeavour.

Before Brexit, UK SPC rights were a product of EU law, with oversight from the EU Court of Justice (CJEU), but in the post-Brexit era they have become enshrined in UK national law.

New Legal Quirks to Navigate for UK SPCs

A quirky consequence of the Brexit agreements is that a regulatory approval from the European Medicines Agency (EMA) still actually takes effect in one region of the UK: Northern Ireland (NI). The UK medicines regulator – the MHRA – typically now provides a separate regulatory approval for Great Britain (i.e. covering England, Scotland and Wales).

This means that the deadline to file a UK SPC application can be triggered by regulatory approval from either the EMA or the MHRA, and a UK SPC right can be bifurcated in terms of its regional coverage, depending on regulatory approval status in GB & NI respectively.

Post-Brexit prioritisation of the UK Market by Pharma & Life Sciences firms

For any pharma or life-sciences company, the approval phase of a new product is an exciting time. But even within the world’s most well-resourced pharma giants, strategic and practical considerations necessitate a prioritisation of regulatory submissions for a new drug: which countries will be handled first, and which will wait a little longer?

With the UK no-longer in the EU, an additional regulatory approval must now be sought from the MHRA. Some suggested that a post-Brexit UK would find itself low on such priority lists, leading to British drug approvals lagging far behind those of the EU. But to a large extent the pessimists’ vision has not been realised.

Early SPC data from the UKIPO already provides a good number of examples where EU and GB regulatory approvals occurred within 10 days of each other, with many more occurring less than a month or two apart. While it’s possible to supplement an already-filed UK SPC application with a later-occurring EU/GB approval, in all cases handled by Mewburn so far, both of the GB & EU approvals been included up-front in the initially-filed SPC application.

Indeed, it would be difficult to envisage British drug approvals falling significantly behind those of the EU given the UK Government’s shrewd introduction of the ‘European Commission (EC) Decision Reliance Procedure’. This ensures an accelerated regulatory review by the MHRA as soon as a positive opinion has been published by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which usually occurs a few months in advance of formal EU/EMA approval.

A changed landscape for future SPC Case Law Development?

Another consequence of Brexit relates to the future development of SPC case-law. As Sam Bailey recently commented, almost half of all CJEU referrals on SPC cases originated from the UK courts in the pre-Brexit era. CJEU decisions on SPC matters can take some time to be rendered, and are often frustratingly restricted to the specific facts of the case in hand.

In the post-Brexit era the UK courts will have the freedom to give their own decisions much more quickly on SPC cases. And we can hope that they may provide more generally-applicable guidance for SPC practitioners and pharma businesses as they do so. While the EU is free to form divergent decisions on SPC matters relative to the UK courts, it is long-standing informal practice to look carefully at the analysis, reasoning and decision when a given case has already been considered by another leading European court. If the UK starts to lead the way in rendering SPC decisions ahead of the CJEU, it will be interesting to see whether their decisions provide some degree of informal influence on development of wider EU SPC practice in the years to come.

Either way, while the Brexit transition for SPCs may have led to a few quirks, it has all proceeded smoothly, and early data suggests that most drug approvals in the UK are generally staying closely in step with those of the EU despite prophesies to the contrary.