A glass half-full: a chance to improve SPCs post-Brexit?

A glass half-full: a chance to improve SPCs post-Brexit?

The United Kingdom (UK) government is currently pursuing its stated policy of leaving the European Union (EU). Negotiations between the remaining 27 EU member states (the EU-27) and the UK are ongoing. In the current version of the draft Withdrawal Agreement between the EU-27 and the UK of 19 March 2018 [1] transitional provisions are made for Supplementary Protection Certificates (SPCs) in Article 56. However, as of the time of writing it is not known whether the actual text of Article 56 had been agreed to by the parties.

In other public statements, the UK has indicated that will incorporate all existing EU law into domestic UK law to provide continuity. The European Union (Withdrawal) Act 2018 specifically incorporates existing EU Regulations into domestic UK law [2]. Consequently, the transposition into UK domestic law of the EU Regulation [3] (EC) No. 469/2009 governing SPCs should still provide for the existence and operation of a system for applying for SPC protection in the UK post-Brexit.

Since SPCs are intellectual property rights, it is difficult to believe that the final withdrawal agreement for the UK from the EU will not include an agreed solution to deal with the transitional provisions mentioned above when the UK leaves the EU. For the operation of a national SPC system in the UK post-Brexit, it can be seen that a similar system for SPCs exists in Switzerland (which also sits outside of the EU system).

One area which has been perhaps as yet overlooked is the opportunity that the new post-Brexit SPC system will provide for the UK to develop and innovate in this area. There are some areas outlined below where the UK could lead the way in improving upon SPC protection without deviating from the minimum existing level of protection provided by the SPC system.

The current SPC system is effectively designed to protect innovation surrounding the development of new therapeutic substances or compositions. The grant of a SPC right is dependent upon the grant of an authorisation to place on the market a new medicine containing such a product. The product must not have been the subject of an SPC previously and the authorisation must be the first to place the product on the market.

These provisions effectively exclude a reformulation of an existing active substance where the new medicine is, for example, a controlled-release or delayed release form, or a different dosage amount or in a different physical form of a medicine already on the market. The marketing authorisation must also have been issued under EU Directive 2001/83/EC or EU Directive 2001/82/EC for medical or veterinary medicines - which therefore excludes medical devices.

Many have criticised the current SPC system for failing to incentivise and protect investment needed to develop medical treatments which also require clinical trials and may also be the subject of patent protection but which fall foul of the restrictions described above.

The comparable system for Patent Term Extension (PTE) in the USA allows for medical devices and reformulated medicines to be protected if the product requires further clinical trials in order to be placed on the market.

Is there now perhaps the chance for these omissions to be corrected and the SPC system to be broadened to protect these important areas for medical research and development in the UK?

If you have any questions please contact Nick Bassil or your usual advisor at Kilburn & Strode.


[1] https://ec.europa.eu/commission/sites/beta-political/files/draft_agreement_coloured.pdf 
[2] http://www.legislation.gov.uk/ukpga/2018/16/contents

[3] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R0469

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