The system of Supplementary Protection Certificates (SPCs) has always straddled EU and national law. While the legal basis for granting them lies in EU Regulations (469/2009 in respect of pharmaceutical and veterinary products, and 1610/96 in respect of plant protection products), they are applied for, examined and granted nationally by the intellectual property office of each EU member state. 

Darren smyth

Darren Smyth

In the UK after the end of the transition period, the legal basis remains those same EU Regulations, which form part of the retained EU law that has effect as UK national law, as amended by the Patents (Amendment) (EU Exit) Regulations 2019. Those amendments require, unsurprisingly, a valid UK marketing authorisation to place the product on the market in the UK, but, perhaps more surprisingly, maintain the rule that the term is determined not by the date of the UK marketing authorisation, but of the earliest marketing authorisation in the UK or the European Economic Area (EEA).

However, the situation regarding SPCs in the UK has been made more complex by the arrangements for medicinal products agreed in the Northern Ireland Protocol of the Withdrawal Agreement. Under Article 5(4) and Annex 2, title 20 of the Protocol, EU law on authorisation to market medicinal products will apply to Northern Ireland. Currently existing marketing authorisations in the UK will continue to have UK-wide effect, provided there is no variation in their terms. But for new marketing authorisations, the situation is different. A 'UK' marketing authorisation issued by the MHRA will in fact only have effect in England, Wales and Scotland. Authorisation to market a medicinal product in Northern Ireland will come from an EU marketing authorisation.

So how will the UK SPC system work when the relevant marketing authorisation in Northern Ireland is an EU authorisation, and a 'UK' authorisation only covers England, Wales and Scotland?

The answer has just emerged in the form of the Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020. The effects of these Regulations on the key issues of an SPC application are as follows. Specific reference is made to the Articles of EU Regulation 469/2009 relating to medicinal products, but the provisions are equivalent in relation to plant protection products.

Term (Article 13)

Starting with what is not affected – since the term of an SPC is in any case calculated with reference to the earliest marketing authorisation in the UK or EEA, the term will not change. As currently, it will be calculated as [date of earliest marketing authorisation] minus [filing date of patent] minus five years, subject to a maximum of five years.

Deadline for filing (Article 7(1))

An SPC application must be filed within six months of the issuance of the first marketing authorisation applicable anywhere in the territory of the UK (not the earliest marketing authorisation in the EEA, in contrast to the provisions for the term of an SPC). This means that application must be made to the UK Intellectual Property Office within six months of the earliest of the UK-issued marketing authorisation covering England, Scotland and Wales only (which for simplicity will be referred to as a 'GB authorisation'), or the EU authorisation covering Northern Ireland (which for simplicity will be referred to as an 'NI authorisation').

Marketing Authorisation Information (Article 8)

The SPC application must give the number and date of the UK, GB or NI authorisation, or where there is more than one such authorisation, of each authorisation. As currently, if there is an earlier marketing authorisation elsewhere in the EEA, details of that authorisation must be given as well.

Under a newly-created Article 13A (1 and 2), if at the time of an SPC application only a GB or NI authorisation exists, and if before the SPC is granted the authorisation in the other territory is issued, then the SPC applicant must provide the details of the other authorisation within six months of its issuance. A similar procedure Article 13A (3 and 4), applies after the SPC is granted but before it comes into force, also with a six month deadline.

Territory of Protection (Article 4)

Article 4 of the SPC Regulation has been amended to specify that the SPC provides protection only in the territory in which an authorisation has been issued before the SPC comes into force (the expiry of the underlying patent). However, if the notification of a subsequent authorisation as required under Article 13A is not filed within the specified 6 months, the SPC will not have effect in the corresponding territory.

Expiry (Article 14)

As mentioned above, UK marketing authorisations will continue to have effect, but if there is a variation of the terms of such an authorisation, this will need to be sought separately for the GB authorisation and the NI authorisation, so at that point the UK authorisation will be withdrawn and replaced by a GB and NI authorisation. Article 14 has been amended to specify that this will not cause the SPC to lapse. However, if the authorisation is completely withdrawn in a territory, consistent with Article 4, the SPC will cease to have effect in that territory.

Outlook

The coming into effect of the Northern Ireland Protocol will considerably complicate the procedure for obtaining SPC protection in the UK. Practitioners and their clients will need to carefully monitor the dates of issuance of authorisations by the UK and EU authorities to ensure that the deadlines are adhered to. The term of the protection in Northern Ireland will generally align to that in England, Scotland and Wales, but the procedure to be followed will depend on which marketing authorisation issues first, and how close the issuance dates are. Under some circumstances, such as failure to timely submit authorisation details, protection in part of the UK could be lost altogether.

 

Darren Smyth is a partner at EIP, London

Topics