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
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 remain 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 be 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
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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