SPCs are an important additional form of protection, particularly for the pharmaceutical industry, by which the normal maximum 20 year term of patents relating to medicinal or plant protection products can effectively be extended, usually by up to 5 years, in order to compensate to some extent for the time taken to obtain authorisation to place the relevant product on the market.
Whilst SPC applications are examined and granted nationally by the patent offices of individual EU member states, SPCs in the member states, including the UK, derive their legal basis from EU regulations that have effect across the European Economic Area (EEA). Following Brexit, the EU regulations relating to SPCs will no longer automatically apply to the UK, and an alternative legal basis for an equivalent UK SPC system will therefore need to be put in place for obtaining SPC protection in the UK, and transitional legislation enacted to recognise existing SPC rights. How a UK SPC system might look post-Brexit will depend on the UK’s eventual relationship with the EU. SPC systems of other countries that are closely connected with, but outside, the EU, such as Norway and Switzerland may therefore provide some insight.
If the UK were to become an EEA member state, like Norway, obligations under EEA membership would subject the UK to large parts of EU legislation, and the existing SPC regulations would most likely apply once more to the UK. Thus, in this model, the UK would effectively opt back into the current SPC regime, with essentially no change for UK SPC holders and applicants. The UK courts would however no longer be bound to refer questions on points of SPC law to the EU court (CJEU), referring instead to the EFTA court. This change could in principle give UK courts greater leeway in reaching decisions, although in practice it seems likely that the UK courts would continue to follow the EU’s jurisprudence relating SPCs closely.
Were the UK to remain outside the EEA, for example joining only the European Free Trade Association (EFTA), like Switzerland, it would not be bound by EU rules other than by negotiated agreement with the EU. Thus, we could envisage the UK enacting new SPC legislation mirroring essentially the provisions of the EU SPC regulations, ie similar to the Swiss model, or re-enacting the current EU legislation en masse as UK national law.
Alternatively, UK legislators in consultation with stakeholders may see Brexit as an opportunity to address perceived shortcomings in the current EU SPC regime. A modified UK SPC law more favourable to innovator companies could be drafted, for example allowing UK SPCs with a longer term, or extending their scope to include other subject matter such as medical devices. A further modification could see the term of UK SPCs being calculated based on the date of the 1st marketing authorisation (MA) in UK, instead of the 1st MA in the EEA.
In any event, given the importance of the life sciences and pharmaceutical industries to the UK economy, it is expected that provisions will be put in place to ensure that existing UK SPC rights are preserved and that SPC protection will continue to be available in the UK. We fully anticipate a smooth transition when Brexit occurs. In the meantime, applicants continue to be able to apply for SPCs in Europe, including in the UK, without any change in practice.