30/03/2023
To extend the protection of patented human and veterinary medicinal products, supplementary protection certificates (SPCs) can be obtained. SPCs are national rights that can be obtained for all EU member states and some non-EU states including the UK. For an SPC to be granted, the following four requirements must be met:
- the medicinal product must be protected by a patent;
- there must be a valid marketing authorisation;
- the marketing authorisation must be the first marketing authorisation in the territory; and
- the medicinal product must not have been the subject of a previous SPC.
An SPC application must be filed within the later of six months from the date of the marketing authorisation or the date of the patent.
In accordance with the above requirements, for an SPC to be granted in a given jurisdiction, there needs to be a patent in force in the jurisdiction and a marketing authorisation that covers the jurisdiction. This seems straightforward, but obtaining an SPC at the UK Intellectual Property Office (IPO) has been complicated by the UK’s withdrawal from the EU (“Brexit”) on 31 January 2020. Whilst the patent system remains largely unchanged following Brexit, there have been significant changes to the routes by which human medicinal products are authorised under the Northern Ireland Protocol, which was enacted to prevent a land barrier between Northern Ireland and Ireland following Brexit. These routes look to change again in light of the Windsor Framework, an agreement in principle between the UK Government and EU, which sets out how to overcome various problems which have arisen under the Northern Ireland Protocol.
The current system to obtain an SPC covering the UK is unduly complicated
Prior to Brexit, an authorisation by the European Medicines Agency (EMA) would cover the UK, including Northern Ireland, and the remainder of the EU. Currently, new drugs for the market in Great Britain (England, Scotland and Wales) will need to be authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). However, the Northern Ireland Protocol specifies that the EMA, and not the MHRA, must authorise new drugs for the Northern Ireland market.
Given that different marketing authorisations cover different regions within the UK, it might be assumed that an SPC covering Great Britain and a separate SPC covering Northern Ireland could be obtained. However, this is not the case: only a single SPC covering the whole UK is being granted.
Thus, when applying for an SPC at the UK IPO, the first marketing authorisation covering the UK or a part thereof must be specified. Examination and grant of the SPC is based on the first marketing authorisation. Additional marketing authorisations covering other areas of the UK must also be provided at the time of applying. It is possible for the territorial scope of the SPC to be extended before the SPC comes into force, if marketing authorisations covering other parts of the UK are granted. However, the territorial scope of the SPC cannot be extended after the SPC has come into force. It is thus currently possible, for example, to obtain a UK SPC covering only Northern Ireland if a marketing authorisation for Great Britain is obtained only after the SPC comes into force.
Also, applicants must remember that the deadline for submitting an SPC application at the UK IPO is determined by the date of the first marketing authorisation covering the UK, Great Britain or Northern Ireland. However, the duration of the SPC is determined by the first marketing authorisation in the UK, Great Britain, Northern Ireland or European Economic Area (EEA).
The Windsor Framework should simplify the process for obtaining UK SPCs
The Northern Ireland Protocol presents problems for drug supply in Northern Ireland, not least because Northern Ireland receives the majority of its supply of medicines from Great Britain and not Europe. In addition, the potential for future divergence between the EU and UK approaches for obtaining marketing authorisations and other regulatory issues leads to uncertainty in drug supply.
The Windsor Framework, announced on 27 February 2023, seeks to address these and other problems. The Windsor Framework sets out a single marketing authorisation for Great Britain and Northern Ireland, with the MHRA approving drugs for the whole of the UK market.
This is expected to affect SPC applications, leading to simplification of the currently complicated process. SPC applications filed at the UK IPO will be based on a single marketing authorisation covering the entire UK, making the application process more straightforward.
Outstanding questions
It remains to be seen how the changes in marketing authorisations for medicines set out in the Windsor Framework, assuming it comes into force, will practically affect SPCs. For example, the adoption of a single marketing authorisation is limited to human medicines and does not extend to veterinary medicines, so it is unclear how SPCs for veterinary medicines will be affected.
Separately, there are also questions as to how the Retained EU Law (Revocation and Reform) Bill currently being processed by the UK Parliament might impact on SPCs and other Intellectual Property rights, particularly as current UK SPC law is based almost entirely on EU law incorporated post-Brexit.
In spite of the outstanding questions, a single marketing authorisation for human medicines across the UK to simplify the current UK SPC regime will be welcome.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
