As the UK’s departure from the EU’s legal system approaches in January 2021, more details are now available about how we expect the UK’s SPC system to continue to function. The UK Government has moved all EU SPC law into UK national law, but to make this retained EU legislation work in practice a few details have been updated. These changes have procedural implications for all those who will file SPCs in the UK in 2021 and beyond. While substantive divergence from the EU seems unlikely at present, applicants may want to file SPCs in the UK in 2020, where they can, in order to benefit from a stronger link to the current EU system.
On 31st January 2020, the UK left the EU. However, under the terms of the Withdrawal Agreement between the UK and the EU, the UK continues to apply EU law and the UK is treated as if it were still a member state during the transition period. The transition period will come to an end on 31st December 2020, which will bring some important procedural changes to how SPC applications are processed in the UK.
UK SPC applications filed before 31st December 2020
During the transition period the UK’s SPC regime continues to operate exactly as it did pre-Brexit. UK SPCs granted before the transition period expires will, of course, remain valid, and there will be no change to their term. Moreover, under the terms of the Withdrawal Agreement, all pending SPC applications filed in the UK by 31st December 2020 will continue to be examined in the same way under the EU provisions even after the end of the transition period, and will provide the same rights once granted. We therefore recommend that applicants file SPC applications before the end of 2020, if possible, to increase the level of certainty.
UK SPC applications filed after the transition period ends
From 1st January 2021, following the transition period, the UK’s SPC regime will remain largely unchanged. The Patents (Amendment) (EU Exit) Regulations 2019 will import much of the current EU SPC legislation into UK law, and the majority of the processes for applying for an SPC are therefore also set to remain the same.
For new SPC applications filed from 1st January 2021, applicants will require, as they did under the EU regime, a UK patent granted by the EPO or the UKIPO, and a marketing authorisation (MA) valid in the UK. Where the product has already been authorised by the EMA before 2021, that EMA MA will become a UK MA via a system of grandfathering in order to keep authorised products on the market. So, new SPC applications filed from 1st January 2021 could be based on existing EMA authorisations that have been grandfathered into UK MAs. Alternatively, new UK SPC applications could be based on MAs granted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
New UK Marketing Authorisations
This brings us on to a key procedural change: after the end of the transition period, UK MAs will come in three different varieties having different territorial scopes across the UK. This complexity is due to Northern Ireland’s continued alignment with the EU in relation to medicinal products post-Brexit. This means there will be three types of MAs that apply within the UK:
- MAs for Northern Ireland (NI) granted as part of the EMA’s centralised procedure,
- GB MAs valid in Great Britain only (i.e. England, Scotland and Wales), granted by the MHRA,
- and UK MAs valid across the whole UK (e.g. grandfathered EMA MAs).
This means that, after the transition period, a specific product may have two authorisations covering different parts of the UK – in many cases a Great Britain MA and a separate Northern Ireland MA.
The current SPC system is not designed to accommodate marketing authorisations which cover only part of the UK. As a result, new legislation (Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020) has been enacted with the aim of providing SPC applicants with a system which is as similar as possible to the current regime, while adjusting for the new MAs. The legislation seeks to ensure that an SPC may be granted if there is an MA which allows the product to be sold anywhere within the UK. This MA must fulfil the same requirements as in the current system – it must be valid for placing the product on the market and must be the first such authorisation for its particular territory.
Practical implications – deadline, scope and term
Where the deadline for filing SPCs is set by the first authorisation date, the deadline for filing a UK SPC will be six months from the earliest authorisation anywhere in the UK. As EMA MAs will continue to take effect in Northern Ireland, the grant of an EMA MA will continue to set the deadline for a UK SPC filing in the normal way, unless a GB MA is issued earlier. For the normal situation where the EMA MA is the first MA granted in Europe, this means that the deadline for filing the UK SPC application will remain aligned with the deadline in the EU. Of course, the deadline for filing SPCs is the later of the first authorisation and patent grant, so there will be no change to the deadline for filing the UK SPC where patent grant occurs last.
Another practical change is that the territorial scope of a UK SPC will extend to only the parts of the UK for which a valid MA has been granted on filing the SPC application, unless the applicant subsequently applies for the UK SPC to be extended to cover the whole of the UK under new Article 13A. Applicants wishing to extend the territorial scope of their UK SPC to the remaining part of the UK in this way will be required to inform the UKIPO of the grant of the first MA in the remaining part of the UK before the SPC comes into force, and within six months of the grant of that MA.
It will therefore be crucial for applicants to closely monitor the grant of new EMA and UK MAs in order to ensure that no opportunities for supplementary protection are missed. In the normal scenario, where the EMA issues the first authorisation, this will mean monitoring for the later authorisation by the UK’s MHRA and then informing the UK IPO accordingly within the new deadlines mentioned above.
The term of UK SPCs will continue to be calculated on the basis of the earliest authorisation date in any of the UK and the European Economic Area (EEA). This in effect maintains the status quo, but means if authorisation in GB lags significantly behind authorisation by the EMA some useful exclusivity in GB will be lost. As with any new regime for obtaining MAs and SPCs, forward planning on the regulatory front and a smooth liaison between IP and regulatory teams will be important.
Six month paediatric extensions to UK SPCs continue to be available for medicinal products that have been tested for paediatric use. Again, the relevant EU Regulations apply during the transition period, and any paediatric extension applications filed before the end of the transition period will continue to be dealt with under the EU regime.
From 1st January 2021, equivalent provisions will be introduced under the UK Human Medicines Regulations. The window during which applications for an extension can be filed will end two years prior to SPC expiry, mirroring the filing period permitted by the EU legislation. The conditions for grant of a paediatric extension will also remain much the same, requiring applicants to complete an agreed paediatric investigation plan (PIP) and then update the relevant regulatory documentation. However, under the UK system, applicants will not need to provide evidence of corresponding authorisations in all EEA states to get the six months SPC extension (a requirement under the equivalent EU scheme). This change to the UK system potentially opens the door for a paediatric extension to be granted where it was previously closed for products with a completed PIP that are not approved in all EEA states.
There is an additional change for SPC applications filed after 1st January 2021, which reflects the fact that multiple MAs for different parts of the UK may be associated with the SPC. For these SPCs, the territorial scope of the SPC extension will be limited to the part(s) of the UK for which an associated PIP has been completed by the deadline of two years prior to SPC expiry. If only one MA associated with an SPC has been updated to reflect the fact that a PIP has been completed, the extension will provide protection only in the territory of that particular MA, even if the territorial scope of the underlying SPC is wider. New Article 13B provides a mechanism by which a further application can be made for the paediatric extension to provide protection in the rest of the UK, if the conditions for granting the extension have been met for the MA relating to the rest of the UK by the deadline of two years prior to SPC expiry.
SPC manufacturing waiver
A manufacturing waiver was implemented into the EU SPC legislation from 1st July 2019, permitting generic and biosimilar manufacturers in the EU to manufacture medicines protected by an SPC for export to countries where parallel protection does not exist or has expired. The waiver also permits manufacturing for stockpiling during the six months leading up to SPC expiry, to facilitate launch of generic and biosimilar products immediately upon SPC expiry. The waiver is applicable with immediate effect from its 1st July 2019 enactment date only to SPCs based on applications filed after this date. For SPCs filed before 1st July 2019, but which come into force on or after that date, the manufacturing waiver will apply, but only from 2nd July 2022. SPCs in force before 1st July 2019 are exempt.
UK legislation (The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020) has recently been enacted confirming that the manufacturing waiver will be retained after the end of the transition period, with no significant changes relative to the EU system. In particular the territorial scope of the waiver remains unchanged at the end of the transition period, and third parties will be allowed to manufacture SPC-protected products in the UK, without the rightsholder’s consent, either for export outside of the UK and EU or for stockpiling in the UK for sale in the UK or EU once the SPC has expired.
Substantive matters and case law
No substantive changes to the SPC system have been announced. However, the interpretation of the UK SPC legislation will no longer be subject to the decisions of the CJEU. It remains to be seen whether and to what extent the UK courts will continue to apply CJEU decisions regarding the interpretation of the EU SPC Regulation to the equivalent UK legislation. For example, the recent Royalty Pharma decision from the CJEU (C-650/17) appears to be at odds with the “core inventive advance” test proposed by the High Court of England and Wales for ascertaining whether a product is protected by a basic patent in the sense of Article 3(a) of the SPC Regulation. The potential for the UK judiciary to re-shape the interpretation of the SPC legislation presents opportunities for SPC applicants to influence SPC law and practice under the new system.
Impact for the remaining EU member states
The EU Regulations will cease to apply to the UK at the end of the transition period. Given that the first MA to be granted in the EU determines both the term of the SPC under Article 13 of Regulation 469/2009, and its fate if an earlier authorisation has been granted with effect in the EU in accordance with Article 3(b), it is important to know which MA is the “first authorisation” in the EU. In view of the transition period, any UK MA granted up until 31st December 2020 will continue to be relevant for calculating the term of EU SPCs, and for deciding their fate. However, any authorisation granted by a UK competent authority after the end of the transition period will no longer be considered the “first authorisation” for the purposes of the EU SPC Regulation.