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LimeGreenIP News

Brexit: the impact on supplementary protection certificates (SPCs)

On 6 February 2019 the House of Commons and House of Lords approved The Patents (Amendment) (EU Exit) Regulations 2018 (Patent SI), which, if it is signed into law, will come into force on Brexit day (i.e. 29 March 2019 or such later date as agreed as part of an extension). The purpose of the Patent SI is to fix issues relating to the UK patent system, including retained EU law (As defined in section 6(7) of the European Union (Withdrawal) Act 2018), which will occur as a result of Brexit so that the law continues to work effectively. The explanatory memorandum says that the government has aimed to preserve the status quo where possible. Of particular interest is the Patent SI’s approach to the EU Regulations concerning supplementary protection certificates (SPCs) i.e. Regulation 469/2009 for medicinal products and Regulation 1610/96 for plant protection products.

The relevant marketing authorisation

The grant of an SPC is contingent on the existence of a granted marketing authorisation. One change under the Patent SI is that Article 3(b) requires that there must exist a granted UK marketing authorisation before an SPC can be granted in the UK. So where the company has gone down the centralised procedure route, the granted EEA marketing authorisation (with effect in an EEA state according to Directives 2001/83/EC or 2001/82/EC) will no longer count for the purposes of Article 3 because the UK will no longer be part of that scheme.

However, for the purposes of calculating the duration of an SPC under Article 13, the relevant marketing authorisation on which to base the calculation is defined as: “the first authorisation to place the product on the market in the area comprising the European Economic Area and the United Kingdom.” Therefore, an EEA marketing authorisation would count as the first authorisation for this purpose. That could be to the detriment of the SPC holder if the relevant product is authorised earlier in the EEA than it is in the UK because the effective on-market exclusivity period would be reduced where the SPC period starts from the date of the earlier EEA marketing authorisation rather than from the date of the later UK marketing authorisation when the product can actually be placed on the UK market.

Paediatric extensions

A 6 month paediatric extension can be added to an SPC when an agreed paediatric investigation plan is complied with. That extension is currently granted under Article 36 of EU Regulation 1901/2006 which will no longer apply in the UK after Brexit. The explanatory memorandum for the Patent PI states that the Government intends to revoke and restate EU Regulation 1901/2006 through amendments to the Human Medicines Regulations 2012 which will be done by way of a statutory instrument (Article 36 SI). The changes proposed in the Patent SI are therefore consequential upon the Article 36 SI being approved (which happened on 11 March 2019) and the Government has indicated that the Patent SI will not be made (i.e. signed by a minister) until after the Article 36 SI has been made.

Challenging existing SPCs

SPCs granted in the UK before Brexit will remain in force. Under Article 15, the grounds for challenging the validity of an SPC remain the same. However, post-Brexit the challenge should be brought before “the comptroller or the court“. The “comptroller” means the Comptroller-General of Patents, Designs and Trade Marks. The “court” is defined as being: (i) the Unified Patent Court (UPC) if the basic patent is subject to the UPC’s jurisdiction by Schedule A4 to the Patents Act 1977 or; (ii) the High Court (England & Wales), Court of Session (Scotland) or High Court in Northern Ireland.

Given that the UPC’s jurisdiction is supposed to be exclusive for SPCs based on unitary patents or European patents that have not been opted out, it is curious that the Patent SI seems to contemplate that the comptroller also has jurisdiction to hear such challenges. However, this will only become relevant in practice if there is a “no deal” Brexit on 29 March and the UPC comes into force with the UK as a member.