What does the Windsor Framework mean for UK SPCs?

Last week the UK Government announced a new agreement in principle, the Windsor Framework, between the UK and the EU on the flow of goods, including medicines, across the Irish Sea. The Windsor Framework does not mention intellectual property. However, changes to the system by which medicines are approved in the UK and NI will have consequences for the UK Supplementary Protection Certificate (SPC) system. At the moment, there are more questions than answers with regards to the implications of the Windsor Framework for UK SPCs. Given the value and importance of SPCs, early clarity on changes to the SPC system is essential. 

Background: Obtaining authorisation for a medicinal product in Europe

SPCs are the mechanism by which innovators in Europe are compensated for the long process of obtaining regulatory approval for a new medicine. An SPC is a maximum 5 year extension to a patent based on a marketing authorisation for the product covered by the patent. The SPC term in Europe is determined by the date of the first approval in the European Economic Area (EEA) (EU + Iceland, Norway and Liechtenstein) (Article 13(1) SPC Regulation). The date of the first approval in a country (either centrally or via national routes) also sets the 6 month deadline for filing an application for an SPC at the relevant national patent office. 

SPCs are the intersection between the European patent system and the EU regulatory procedure for marketing authorisations. To understand the potential implications for the SPC system, it is therefore first necessary to understand the Brexit-related changes to the procedure for achieving a marketing authorisation for a medicine in the EU and UK. 

In the EU, the most common route to approval of a new medicine is the central authorisation procedure (compulsory for many types of medicine). The centralised procedure allows innovators to obtain approval across the EEA for a new medicine via a single-marketing authorisation application submitted to the EMA. The EMA assesses the application and gives a recommendation to the European Commission (EC) on whether the medicine should be approved. Once granted by the European Commission, the Central Marketing Authorisation (CMA) is valid in all EEA member states at the same time.

Before Brexit, the UK was an EU member state. Most medicines were therefore approved in the UK via an application to the EMA for a centralised authorisation. The UK would be covered by this authorisation as a EU member state. Before Brexit, it was also possible to apply for a UK only marketing authorisation by a UK national process. 

Following Brexit, the UK lost its status as an EU member state. An EMA centralised approval thus no longer covers the UK. For a centralised product (i.e. a product that must be approved in the EU via the centralised route), it is now necessary to apply to both the EMA and UK MHRA for approval of a new medicine. Following Brexit, medicines are usually approved in the EEA and UK at different times, depending on which regulatory authority (the EMA or MHRA) approves the medicine first.  

Brexit related changes to SPCs

The Irish Border

The European Patent system for patent grant is separate from the EU. The geographical scope of a EP(UK) patent therefore remained unaffected by Brexit. However, the same was not the case for marketing authorisations and SPCs. 

A UK SPC is based on a patent in force in the UK and a UK marketing authorisation. Before Brexit, the relevant UK marketing authorisation would often have been an EU centralised authorisation, given that the centralised authorisation would have automatically covered the UK.

Following Brexit, it may have been expected that a UK SPC could only be based on a UK marketing authorisation from the MHRA. However, this turned out not to be the case. The process for obtaining a marketing authorisation in the UK following Brexit was complicated by the thorny question of the Irish border.  For the UK, placing a border either between Ireland and Northern Ireland, or Northern Ireland and Great Britain would be fraught with potential political consequences. The EU position was that a border between the EU and the UK needed to be placed somewhere in order to protect the integrity of the EU internal market. 

Solution 1: The Northern Ireland Protocol (NIP)

The UK's current solution to the problem of the Irish border is the Northern Ireland Protocol (NIP). The NIP places a border (of sorts) in the Irish sea between Northern Ireland and the rest of the UK (Great Britain (GB)). Under the NIP, Northern Ireland remains part of the central marketing authorisation process for EU medicines. As such, a product approved by the EMA centralised procedure is currently automatically approved for sale in Northern Ireland. For the rest of the UK (GB), a separate marketing authorisation from the MHRA is needed. Currently, we therefore have a bifurcated system for obtaining marketing authorisation for a medicine in the UK. Both a UK(GB) and EU (NI) approval are needed in order for a medicine to be approved over the whole of the UK (GB+NI). 

Implementation of the NIP changed the UK SPC regulation to take account of the different types of  marketing authorisations now possible in the UK. The UK SPC regulation before amendment was itself based on the EU SPC regulation (Regulation (EU) 2019/933) which was fully incorporated into UK law following Brexit. The amended regulation premitts a UK SPC to be based on either a EU(NI) or UK(GB) approval. The resulting SPC will only cover the territory for which the approval is provided. An SPC based on a EU(NI) approval will thus only extend the UK patent in NI. However, it is possible to broaden the geographical scope of the SPC following a further approval in another UK territory. The deadline for extending the geographical scope of a UK (GB or NI) SPC is the expiry of the basic patent. Importantly, the deadline for filing a UK SPC (NI or GB) remains 6 months from the first approval anywhere in the UK, even if the first approval is an EU(NI) approval. The SPC term for a UK SPC is still calculated from the first approval in the UK or EEA.

Solution 2: The Windsor Framework

Keeping the EU in the picture

The NIP has proved an unsatisfactory political solution to the problem of the Irish border. The legal and regulatory division between the GB and NI created by the NIP has disrupted the links between GB and NI. Many of these disruptions have come from the continued requirement for products sold in NI, including medicines, to follow EU regulations as opposed to UK regulations. Furthermore, it is currently possible for a medicine to be approved in the GB but not NI, and vice versa, leading to questions over access to medicines. 

The Windsor Framework, announced by the UK Prime Minister last week, is an agreement in principle between the EU and UK to resolve the difficulties associated with the implementation of the NIP. The Windsor Framework seeks to "to restore the smooth flow of trade within the UK internal market", and remove unnecessary red tape and legal checks for goods (including medicines) flowing between GB to NI.  

The Windsor Framework directly addresses the issues of medicines. According to the Framework, the EU and UK have agreed in principle that:

"it will be for the MHRA to approve all drugs for the whole UK market...Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency removed from having any role." 

However, the Windsor Framework also seems to suggest that there will remain some role of the EU in NI, such that NI is covered by a "dual-regulatory system": 

"the agreement safeguards frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms. This pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom."

It is currently unclear whether under the dual-regulatory system envisaged by the Windsor Framework, medicines may cross, in either direction, the border between the Republic of Ireland and NI. . 

Questions raised by the Windsor Framework

The UKIPO are currently working through the implications of the Windsor Framework. Implementation of the Windsor Framework will require legislation from parliament, which at least provides the UKIPO as well as IP right and market authorisation holders time to consider the potential risks and consequences of the regulatory changes on the SPC system. 

The first question for the UK SPC system is whether an EMA approval will set the SPC term and the 6 month deadline for filing a UK SPC. Under the NIP, an EMA approval is considered effective in Northern Ireland. An EMA approval therefore sets the 6 month deadline for filing a UK(NI) SPC. The UK(NI) SPC can then be extended to a UK(GB) following a MHRA UK(GB) approval at any time up until expiry of the basic patent. The legal status of an EMA approval in NI under the Windsor Framework is unclear. It is therefore also unclear whether a EMA approval will constitute a UK approval under the UK SPC regulation, and thus set the deadline for filing a UK SPC application. 

The second question is whether a UK (GB+NI) approval under the Windsor Framework may be considered a first approval in the EEA for the purposes of calculating the EEA SPC term and filing deadline. At the moment, the UK grants UK(GB) approvals. If, as the Windsor Framework envisages, there is "unfettered access" between the GB, NI and the Republic of Ireland (EU), then what is the legal effect of the approval under the EU SPC regulation? This situation is reminiscent of the Lichtenstein problem, whereby a first approval in Switzerland (a member of neither the EU or EEA) may be considered as the first approval in EEA, because of the flow of goods from Switzerland to Liechtenstein. A medicine approved first in Switzerland and then in the EU may therefore receive a shorter SPC term across the EEA than if the medicine had been approved first in the EU (although this may now be avoided by listing the medicine on the Switzerland "negative list", such that extension of Swiss approval to Lichtenstein is delayed).

Another interpretation of the Windsor Framework is that an EMA approval will have no legal effect in NI. A read of the corresponding draft EU Regulation to the Windsor Framework, suggests that this is how the EU envisages the new regime operating. In this case, the process for obtaining a UK SPC would be simplified such that a UK SPC would have to be filed based on the UK MHRA approval. However, under such a system, retaining the use of the EEA approval date to calculate the term of the UK SPC starts appearing rather bizarre. 

Final thoughts

SPCs represent some of the most valuable IP rights available. Clarity on the consequences of the Windsor Framework for SPCs is therefore essential. Hopefully the UK IPO will soon release guidance on the implications of the Windsor Framework for SPCs. It is crucial that SPC applicants are given sufficient time to mitigate any risks posed by the new changes, particularly that of inadvertently missing a SPC deadline or shortening an SPC term. 

Further reading

• The fate of UK SPCs in the Brexit era
• European Commission consultation on unitary supplementary protection certificates (SPCs)