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Brexit: Patents and Supplementary Protection Certificates

Posted on 16 December 2020

Updated on the 16th December 2020

Patents

The existing regime for obtaining patent protection via a UK patent granted by the UK Intellectual Property Office (UKIPO) or for a European Patent designating the UK via the European Patent Office will not change following the end of the Brexit transition period. The UK is a participating member state of the European Patent Convention and this will continue to be the case after 1 January 2021. 

Further, to the fairly limited extent that EU law has harmonised aspects of patent law and practice – e.g., relating to the conditions for patenting biotechnological inventions and certain exemptions for pharmaceutical product testing – these laws will continue to apply in the UK, as they have already been implemented into UK law.

The more significant impact of Brexit on patent protection and enforcement concerns the likelihood of the long-anticipated Unitary Patent and Unified Patent Court (UPC) coming into effect in the EU.  For a period after the Brexit referendum vote in June 2016, many had hoped that the UK could continue to participate in the UPC at least – based on the argument that it was an international court – and indeed the Theresa May Government took steps to ratify the UPC Agreement in April 2018.  However, in a change of policy direction, the Boris Johnson Government announced in July 2020 the UK would not seek to be involved any longer, concluding that participation in a court applying EU law, and bound by the European Court of Justice (CJEU), would be 'inconsistent' with its post-Brexit aim of being an 'independent self-governing nation'. 

In the meantime, a challenge to the UPC Agreement before the German Constitutional Court has led to the ratification process recommencing in Germany. This process continues, with the UPC Preparatory Committee recently noting with approval the Bundestag's vote to approve the legislation for the UPC Agreement and its Protocol on provisional application. Milan meanwhile appears to be the favourite to take the coveted life sciences seat (previously allocated to London) in the UPC's Central Division. 

Of course, one unresolved question is how attractive the UPC and Unitary Patent will be without the UK, bearing in mind that many patent holders were already sceptical about entrusting their portfolios to the regime, planning to opt their existing European Patents out of the UPC's jurisdictional reach. 

Supplementary Protection Certificates (SPCs)

SPCs provide a period of additional protection for patented medicines and agrochemicals of up to five years after a patent expires, in order to compensate for the period involved in obtaining regulatory approvals. Whilst SPCs operate as national rights, they derive from the EU's SPC Regulation – this legislation will be retained in UK law after 1 January 2021, but adapted for the UK context.

Accordingly, the general approach to SPCs will remain the same, albeit with some important points of detail to note, as set out below. Generally, it is well-known that the SPC Regulation is a much-criticised piece of EU legislation, having been the subject of a number of referrals for interpretation, including from the UK Courts, to the CJEU in recent years. Existing decisions of the CJEU by the end of the transition period will be retained EU case law, but may be overturned by the Supreme Court or the Court of Appeal. Future decisions of the CJEU will not be binding. It seems likely that, no longer constrained by the CJEU's approach, the UK Courts will welcome the opportunity to diverge in the approach to certain issues relating to SPCs.

Pending applications for SPCs

The UK/EU Withdrawal Agreement provides that any application for an SPC that is pending before the end of the transition period should be considered in accordance with the EU law in force at that time. Any SPCs granted based on these applications will provide the same protection as existing SPCs.

The UKIPO has issued guidance in relation to SPCs after 1 January 2021.

New applications for SPCs after 1 January 2021

There will be no significant change to the process involved in applying for an SPC at the UKIPO, though note below the consequences where authorisations are in place covering different parts of the UK (and the further guidance provided by the UKIPO).

An application for an SPC in the UK after 1 January 2021 will need to be based on a marketing authorisation that allows the product to be sold on the UK market. This will be either a marketing authorisation granted by the UK's MHRA or one granted by the European Medicines Agency before 1 January 2021, which has been converted into a UK authorisation. However, the calculation of the duration of the SPC will be based upon the first authorisation to place the product on the market in either the UK or the EEA. 

Manufacturing waiver

In July 2019, a new SPC manufacturing waiver took effect in the EU, which provides an exception to SPC infringement for the making of medicines in the EU for export to non-EU countries where protection has expired or does not exist, or for storing products in the six-month period before expiry of the SPC for a Day One EU launch.

Following a call for views by the Government on the UK version of the waiver, third parties will be able to rely on an exception to infringement in relation to making in the UK for export to countries outside of the UK and EU and, in the final six months of the SPC, to store in the UK for sale in the UK or EU on expiry. Originally, the Government had proposed to permit making for export to countries outside of the UK (i.e., including to the EU) but concerns were expressed that this would have an adverse effect on innovators, particularly relating to EU accession sates.

The UK Government has also decided against requiring a logo to replicate the 'EU Export' logo used for the EU manufacturing waiver, settling on the use of the words 'UK Export' alone (but with power to make additional labelling requirements if necessary). A new form will be available to notify the UKIPO of an intention to rely upon the manufacturing waiver (no later than three months before starting to do so). We discuss the manufacturing waiver in the UK post-Brexit in more detail here.

What happens when the SPC takes effect?

Changes are also needed to the SPC system to take account of the Northern Ireland (NI) protocol. Under the protocol, NI will still be bound by EU law for the authorisation of medicines and plant protection products. Accordingly, there will be separate marketing authorisations for NI and for GB (England, Scotland, Wales) and also for the whole of the UK.

The SPC will remain a UK-wide right, so there will not be separate SPCs for GB and NI. However, the Government has published legislation which will allow an SPC to be granted based on whichever GB/UK/NI authorisation or combination of authorisations the applicant has at the time of its application - but the protection of the SPC will extend only to the territory where the authorisation relied upon allows the product to be sold.  For example, if the SPC enters into force with a marketing authorisation covering only one of GB or NI, the SPC will provide protection for that territory only. Up until the point that the SPC comes into force (but not after that date), the applicant can submit an additional marketing authorisation, allowing protection to extend to the whole of the UK. 

Paediatric extensions

Under EU law, it is possible to obtain a six month extension to an SPC which relates to a medicine tested for paediatric use. From 1 January 2021, this will be governed by equivalent provisions in the UK's Human Medicines Regulations 2012.  

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