Brexit & Supplementary Protection Certificates

Supplementary Protection Certificates (SPCs) are amongst the most important legislation to come out of the EU project for the pharmaceutical and biotech sector.  SPCs can provide up to 5 additional years of monopoly protection (over the normal 20 year patent term) for a marketed medicine.  Their value is emphasised by the large amount of litigation at national and EU level concerning the precise boundaries of SPC law.
 
SPCs are applied for through, and granted by, the UK Intellectual Property Office and are national rights.  Therefore SPCs that have already been granted by the date of Brexit are expected to remain in force without owners needing to take any action.  However, the law that provides for the grant of SPCs is an EU regulation rather than a UK national law.  Thus, the UK will need a replacement legal framework for any patent term extension rights to be available in the UK upon Brexit, or upon the end of any transitional period that may take effect.  The current position is that a transitional period lasting until the end of 2020 is looking likely.
 
The “Great Repeal Bill”, officially entitled the European Union (Withdrawal) Bill, which is currently working its way through the UK Parliament, aims to do just that.  It provides that direct EU law, such as EU regulations, shall be incorporated into domestic UK legislation.  The Bill includes a mechanism to exclude certain direct EU law from its scope but as matters stand it appears likely that the SPC regulation will become part of UK law immediately following Brexit.
 
The EU Withdrawal Bill also proposes giving the UK Government a (controversial) power to enact secondary legislation to fill in legislative gaps that arise upon Brexit.  It may be that there will be issues that arise with the SPC regulation that will need to be solved, for example concerning the marketing authorisation that can be used to support an SPC application.  However, it is difficult to envisage the full scope of the amendments to the law that will be required until the regulatory regime for new medicines has been developed.  A number of models for medicine regulation are believed to be under consideration.
 
It will also be within the power of future governments to amend the scope of SPC law.  For example, the Government may decide that medical devices should fall within the scope of the SPC regime. Alternatively, SPC law in the UK could be entirely re-written to provide a new and hopefully clear encouragement to originator companies to develop and launch medicines in the UK. 
 
In contrast it should be noted that the EU is currently considering whether the SPC regulation requires amendment.  The practical effect of the EU Withdrawal Bill will be to freeze EU legislation in the state it was on the day before exit day.  Therefore, it will require the Government to actively amend UK SPC law if any post-Brexit EU amendments are to be copied over to the UK.
 
Due to the potential changes that may be made on both the UK side and on the EU side, it can be seen that SPC law may soon start to diverge creating a potentially complex legal landscape in an area already considered complex.  Although no benefits of waiting are currently known, potential applicants for SPCs should keep under review whether they are best served by applying early under the existing EU rules or waiting for new UK rules to come into force.

If you have any questions regarding the impact of Brexit on your intellectual property rights, please contact your usual Marks & Clerk advisor or, alternatively, you can direct your question to the chair of our Brexit committee, Graham Burnett-Hall.

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