In this article, Paul Brady summarises the new arrangements under which SPCs are continuing in the UK after Brexit.
The main fact relating to patents that has been in every newsletter and other report since Brexit first raised its head in 2016 is that 'Brexit will not affect patents'. That is completely true.
SPCs are valuable extensions of patent rights and, until now, they have been governed in the UK by a pair of EU Regulations (469/2009 and 1610/96). Equivalent legislation for the UK has been put in place by the UK government to ensure that SPCs will continue in the UK after Brexit, mostly by Statutory Instrument 1471/2020. Whilst SPCs will continue to exist in the UK, there are changes in some circumstances. Read on for more detail.
Existing SPCs and SPC applications
Existing SPCs that are in force will continue in force in the UK and no actions are necessary by the SPC owner. Similarly, SPCs that have been granted but had not yet come into force before 1 January 2021 will come into force in the usual way when the base patent expires. Again, no actions are necessary by the SPC owner. Lastly, SPC applications that were filed before 1 January 2021 will continue to be examined by the UK IPO in the same way as previously and no special actions are necessary by the SPC owner.
One of the reasons that this is the case is that marketing authorisations from the European Medicines Agency (EMA) that were granted before 1 January 2021 were automatically converted into equivalent UK authorisations on 1 January 2021. UK national marketing authorisations granted before 1 January 2021 by the UK’s MHRA will, of course, also continue to have effect.
New SPC applications
For an SPC application filed after 1 January 2021, most matters remain the same: applications will continue to be processed by the UK IPO, and it will be necessary to provide documentation showing that there is an authorisation to market the product in the UK and that there is a patent in the UK. As before, it will be necessary to provide details of the first marketing authorisation in the EEA.
However, in the field of medicine authorisations, Brexit has brought about a change and that has a consequence for SPCs.
As the UK has left the European Union, it might be expected that an EU marketing authorisation granted by the EMA after 1 January 2021 does not have effect in the UK. That is not correct. An EMA does has effect in part of the UK, namely in Northern Ireland.
An important and much-debated part of the Brexit agreement is the Northern Ireland Protocol – designed to avoid a hard border between the Republic of Ireland and Northern Ireland. Because of the operation of the Northern Ireland Protocol, Northern Ireland is a single customs and regulatory area with the Republic of Ireland. It follows from this that medicines regulation in Northern Ireland continues to be governed by EU rules. Therefore, an EMA-granted EU MA (which naturally has effect in the Republic of Ireland) has effect in Northern Ireland. This means that the EMA MA does have effect for a part of the UK .
For England, Scotland and Wales
In the nations of England, Scotland and Wales (Great Britain, “GB”), MAs are now only granted by the UK’s Medicines and Health Regulatory Agency (MHRA) and EMA MAs granted after 1 January 2021 do not have effect. A procedure has been put in place to enable EMA MAs to be approved rapidly in the UK. For more detail on the so-called ECDRP see the annex below.
Three types of MA
This combination of marketing authorisation possibilities means that for the territory covered by a UK patent, there are three MA scenarios: MAs covering England, Scotland and Wales only, MAs covering Northern Ireland only, and MAs covering the whole of the UK (such as existing EMA MAs). An SPC can be based on any of these three types of MA. An SPC only provides protection for the territory that is covered by the MA.
All SPCs in the UK will continue to be handled by the UK IPO, whether they are for the whole of the UK or only a part. The UK IPO has updated its filing form for SPC applications. The relevant part now asks for the details of the first authorisation to place the product on the market, which may be a UK, a GB (ie only England, Wales and Scotland), or a NI (Northern Ireland) authorisation.
For a new medicine, the authorisation might be granted first in the EU or it might be granted first in GB. To avoid duplicated effort and a proliferation of SPCs, so the procedure will be that when an SPC application is filed first on the basis of the first MA for one part of the UK and the MA is then granted for the rest of the UK, then the second MA number is simply added to the existing SPC application; it is not necessary to file a new, separate SPC application.
As previously, an SPC application must be filed within the later of 6 months from the date of the marketing authorisation on which it relies, and 6 months from the date of grant of the patent. Where there are different dates for the MAs in NI and GB, the SPC application must be filed within 6 months of the earlier one. As mentioned above, the MA number for the second part of the UK can be added to an SPC application filed for the first part of the UK. The addition of the second MA number has to be done within 6 months of the grant of the second MA. This must also be before the patent expires.
Term of the SPC
The maximum expiry date of an SPC anywhere in the UK is 15 years from the date of the first marketing authorisation in any EEA country. This is unchanged from previously. If MA applicants file their MA applications at the EMA first, then it might be more common in the future for the authorisation for GB not to be the first. In that scenario, the period of patent-like protection whilst the product is on the market in GB will be shorter than the maximum 15 years theoretically available. It will important for MA applicants to coordinate their activities to provide themselves with the longest available protection.
Paediatric extensions to SPCs
The UK government has also implemented legislation to allow 6-month paediatric extensions to SPCs to continue to exist in the UK. The fee and the deadline for filing an SPC extension is unchanged (2 years before the expiry of the SPC). The previous requirement for the medicine to have been authorised in all EU states is no longer in place.
Under legislation introduced in the EU in 2019, the so-called “manufacturing waiver” allows a third party to make an SPC-protected product, or its ingredients without needing the approval of the SPC holder where the manufacture is for export to outside the EU or for stockpiling ahead of a launch in the EU (in the last 6 months of the SPC term). The UK government has also implemented legislation to allow the manufacturing waiver to continue. The requirement remains that the permitted export must be to outside the EU, not simply export to outside the UK. There is a lack of symmetry here, in that for manufacture within an EU state, the UK is now treated as a ‘third country’ and manufacture for export to the UK would be permitted. Arguably, the UK waiver is thus more restrictive on generic manufacturers than it needed to be. In practice, this is unlikely to make a significant practical difference.
The previous case law of the CJEU (to the end of 2020) continues to have direct effectiveness in the UK. However, in the future, the UK’s Courts will be free to diverge from decisions of the CJEU. Many of the referrals to the CJEU on SPC matters have come from the UK courts, so we can perhaps expect numerous SPC cases to be appealed up to the UK’s Supreme Court in the coming years. There have been times when certain commentators have expressed frustration at aspects of CJEU decisions on SPC matters. As this is a complex area of law where conflicting policy objectives need to be balanced, it remains to be seen whether there will be a significant shift. For certain, it will be interesting to see how SPC law continues to develop in the UK and the EU in the coming time.
If you would like to discuss how we can help you with your SPCs, please get in touch with your usual Abel + Imray contact, otherwise, please contact Paul Brady directly.
The EC Decision Reliance Procedure (ECDRP)
We are now in a (further) transition period of 2 years regarding EMA marketing authorisations. During this time (until the end of 2023), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure, when determining an application for a Great Britain Marketing Authorisation (GBMA).
This route is being called the EC Decision Reliance Procedure (ECDRP). The guidance from the UK government is that the intended operation of the ECDRP is submission of the Marketing Authorisation Application to the MHRA immediately on receipt of a positive Committee for Medicinal Products for Human Use (CHMP) opinion, although applications can be submitted any time after the approval of an EMA Marketing Authorisation. The MHRA says it aims to issue a decision concerning the GBMA as soon as possible after the EMA approval and the legislation includes a 67-day maximum timeline.
This route will be available to the EMA centralised MA holder. It requires active steps from them – they will need to file an application for a GB MA.
 The United Kingdom (UK) consists of the countries England, Scotland, Wales and Northern Ireland. Great Britain (GB) consists of the countries England, Scotland and Wales, but not Northern Ireland. It should be noted, however, that patents having the number GBnnnnnnn are effective for the whole of the UK, including Northern Ireland, despite the prefix GB.
Paul Brady Partner