The fate of UK SPCs in the Brexit era

To prepare for Brexit, the UK has incorporated many provisions of EU law into its own statute. This includes the SPC Regulation (Regulation (EC) No 469/2009). SPC protection in the UK will thus broadly remain unchanged following the transition period. However, in the small-print there are some potentially critical changes for UK SPC holders after the transition period.

SPCs after Brexit: The Basics

The purpose of the SPC Regulation (Regulation (EC) No 469/2009) is to compensate a patentee for the lengthy process of achieving marketing authorisation for a medicinal product. SPCs are national rights that provide an additional period of protection for a medicinal product protected by a patent. The EU SPC Regulation provides a maximum of 5 years additional protection based on the first marketing authorisation for the product in the European Economic Area (EEA). A 2018 statutory instrument (secondary legislation) incorporated the provisions of the SPC Regulation into UK statute in preparation for Brexit.

CIPA has provided some guidance on the fate of existing UK SPC rights and pending SPC applications. Put simply, UK SPCs will be governed by the EU SPC Regulation until the end of the transition period (31 December 2020). UK SPCs granted before the end of the transition period will remain in force after the transition period. After the transition period, UK SPCs will be governed by UK law. The Withdrawal Agreement (Article 56), 2019 amendment to the Patent Rules and related statutory instruments broadly incorporate the provisions of the EU SPC Regulation into UK law with minor amendments to make them UK specific.

The self-professed aim of the UK government has been to retain the status quo on SPCs as much as possible. However, legal uncoupling is never straightforward, and SPCs are no exception to this rule. There are some important nuances in UK SPC law that will have potentially significant consequences for UK SPC right holders.

EU or UK marketing authorisation?

There is a critical nuance with regards to the nature of the relevant "first marketing authorisation" for a UK SPC after the transition period. A UK statutory instrument requires a UK SPC to be based on a UK marketing authorisation. A centralised authorisation from the European Medicine Agency (EMA) for the EEA will thus no longer be able to serve as a relevant marketing authorisation for a UK SPC.

However, according to the 2018 statutory instrument, the term of a UK SPC will run from the earliest marketing authorisation in either the UK or EEA. Therefore, if a UK marketing authorisation is granted after a centralised EMA authorisation, the UK SPC term will still be calculated from the centralised EU authorisation. The SPC term will thus be shorter than if the term was calculated according to the date of the later UK authorisation. See here a briefing document from the BIA on this issue.

The SPC stockpiling and manufacturing waiver

In July of 2019, the SPC stockpiling and manufacturing waiver came to force across the EU (IPKat: SPC manufacturing and stockpiling waiver comes into force). The waiver allows EU-based companies to manufacture a generic or biosimilar version of an SPC-protected product for the purpose of either 1) stockpiling the product in the EU or 2) exporting the product to markets outside of the EU in which there is no IP protection. The waiver applies to the last six months of an SPC term.

The UK government initially proposed to incorporate the relevant SPC Regulation provisions on the waiver into UK law with legislation that, for the most part, simply replaced "EU" with "UK" in the original EU legislation. The waiver in the UK would thus have permitted a third party to make the product in the UK and export the product to markets outside the UK in which there was no IP protection, including EU markets.

However, the UK government's minimalist approach was met with concern from UK industry. Following a stakeholder consultation, the UK Government has now amended their proposal on the waiver. The latest news is that the waiver in the UK will only allow third parties to manufacture in the UK for export to countries outside both the UK and EU (Schedule of Amendment). To bring its new proposal into force, the full statutory instrument, which includes other Brexit related amendments to UK IP law, will need to be passed by both houses of parliament.

Notably, the EU has not made any corresponding changes to the EU SPC Regulation regarding the waiver. Therefore, if there is no SPC protection in the UK, the EU waiver will permit companies to export from the EU into the UK within the last 6 years of an SPC in the EU.

The Northern Ireland Protocol, SPCs and a proliferation of marketing authorisations

Under the Northern Ireland Protocol, EU Regulations relating to medicinal and plant products will continue to apply in Northern Ireland. As a consequence of this, it will be possible to apply to the MHRA for marketing authorisations in different territories of the UK: a UK-wide marketing authorisation, a Northern Ireland only authorisation and/or a Great Britain only marketing authorisation. This situation has necessitated some further changes to the SPC Regulation, which are currently making their way through parliament (SPC (Amendment) (EU Exit) Regulations 2020, SI).

Under the changes proposed, it will be possible to apply for an SPC based on any of the different available marketing authorisations in the UK (UK-wide, GB only, or NI only). The deadline for applying for an SPC will be 6 months from the first marketing authorisation. The SPC will also only apply to the territories that are covered by the marketing authorisation before the SPC takes effect. If the marketing authorisation holder wishes to extend the SPC to additional territories based on a subsequent marketing authorisation, they will have to apply to the UK IPO within 6 months of the subsequent marketing authorisation before the expiry of the patent. After the patent expires and the SPC takes effect, it will not be possible to extend the protection of the SPC to other UK territories (e.g. from including only GB to including the whole UK).  

The UK provisions discussed above are, of course, subject to the outcome of the ongoing negotiations between the EU and UK, should an outcome be reached.