European Commission addresses SPCs & Brexit

17/05/2018

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Laura Reynolds and Nick Michelmore

On 27 April 2018, the European Commission published a notice to stakeholders on the impact of Brexit on supplementary protection certificates (SPCs) for medicinal products and plant protection products. [1]

An SPC is an IP right, arising under the SPC Regulations[2], which takes effect at the end of the lawful term of a patent and partially compensates for the erosion of the 20-year period of patent protection due to the lengthy and costly regulatory process leading to the grant of a marketing authorisation.

The duration of an SPC is for a period equal to the period from the date on which the application for the basic patent was lodged, to the date of the first authorisation to place the product on the EU market, reduced by a period of five years, and subject to a five year cap[3].

The EC notice addresses two issues arising from the United Kingdom’s withdrawal from the European Union on 30 March 2019 (the ‘withdrawal date’).

Firstly, with respect to how the duration of SPCs will be calculated in the EU-27, the notice confirms that:

  • Any marketing authorisation granted by the UK on or after the withdrawal date will not be considered a first authorisation for purposes of the SPC Regulations; and
  • Any marketing authorisation granted by the UK before the withdrawal date will be considered a first authorisation for the purposes of the SPC Regulations.

Secondly, the notice states that, subject to any transitional arrangement, as of the withdrawal date the SPC Regulations will not apply to the UK.

The notice acknowledges that negotiations between the EU and the UK are ongoing with a view of reaching a withdrawal agreement. It flags in particular the need for clarification as to how pending UK SPC applications submitted before the withdrawal date will be dealt with. The EU’s current position is that if such applications are pending at the withdrawal date, they should be completed in accordance with EU law. [4]

The notice also acknowledges that the date on which EU law will no longer apply to the UK may be pushed back by agreement between the EU and UK. The current draft withdrawal agreement strongly suggests that EU law (and thus the SPC Regulations) will continue to be applicable to the UK until 31 December 2020.[5]

While this notice provides stakeholders with some answers regarding SPCs and Brexit, much remains to be determined. Above all the UK ultimately needs to decide whether it wants a post-Brexit ‘SPC-equivalent’ right and if so, how aligned this right will be with the current EU system.


[1] Notice to Stakeholders - Withdrawal of the United Kingdom and EU Legislation in the field of Supplementary Protection Certificates for Medicinal Products and Plant Protection Products (https://ec.europa.eu/docsroom/documents/29143)

[2] Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96

[3] Extendable by a further 6 months pursuant to the Paediatric Regulation (No 1901/06) if appropriate paediatric studies are carried out

[4] EC position paper on intellectual property rights (including geographical indications) (https://ec.europa.eu/commission/sites/beta-political/files/intellectual_property_rights.pdf)

[5] See Articles 121 and 122 Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (https://ec.europa.eu/commission/sites/beta-political/files/draft_agreement_coloured.pdf )


On 27 April 2018, the European Commission published a notice to stakeholders on the impact of Brexit on supplementary protection certificates (SPCs) for medicinal products and plant protection products.
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