24. November 2020
Supplementary protection certificates (SPCs) can extend exclusivity rights to a medicinal product for up to five years on top of the underlying patent protection.
They are therefore valuable assets for pharmaceutical and biotechnology companies and an obstacle to generic and biosimilar market entry. SPCs are also based on EU law.
As the UK approaches a turning point in the Brexit process on 31 December 2020, let's look at how these important rights will be affected.
Has Brexit happened already? The Prime Minister's office insists it has (and some say 10 Downing Street has even banned the word!).
This is because the UK actually left the EU at 11pm on 31 January 2020. On this date the European Union (Withdrawal) Act 2018 (2018 Act) repealed the European Communities Act 1972, by which EU law ultimately takes effect in the UK.
But, at the same time, the similarly titled European Union (Withdrawal Agreement) Act 2020 (2020 Act) implemented in UK law the Withdrawal Agreement – that is, Boris Johnson's “oven-ready deal” – agreed between the UK and EU, which includes the "Northern Ireland Protocol" among other matters.
This "saved" much of EU law (including that relevant to patents and the regulation of life sciences products) so that it continues to apply in the UK until the end of an "Implementation Period".
The Implementation Period ends at 11pm on 31 December 2020 and the application of the great majority of EU law in the UK ends with it.
Whether or not the UK and EU strike a free-trade deal by the end of December 2020, section 3(1) 2018 Act currently states that direct EU legislation, so far as it is operative immediately before the end of the Implementation Period, will also form part of domestic law on and after that day.
This includes Regulation 469/2009 which governs SPCs in EU law, as amended recently in respect of manufacturing stockpile and waiver by Regulation 2019/933. The SPC system (including existing SPCs and applications) will therefore continue in UK law, but there will be some modifications to allow for the UK's new circumstances.
As the law presently stands, the Northern Ireland Protocol will have an impact on SPCs. The Protocol will take effect after 31 December 2020 and place Northern Ireland (NI) in the UK customs territory and, for the most part, under UK law. However, it also commits NI to align with certain EU regulatory laws on goods, including medicinal products. But it doesn't apply to Great Britain (GB), which is free to diverge in these areas.
As a result, it will be possible to obtain separate marketing authorisations for (UK)NI (compliant with EU law) and (UK)GB, as well as for the UK as a whole.
There won't be separate SPCs, but the consequence of separate marketing authorisations is that a single SPC may be granted based on whichever NI, GB or UK authorisation or combination of authorisations the applicant has at the point of application.
If the SPC enters into force with a marketing authorisation covering only one of GB or NI, the protection provided by the SPC extends only to that territory. But, up until the SPC comes into force, an applicant can submit an additional marketing authorisation to make the full complement, allowing protection to extend to the whole of the UK.
Although the grant of an SPC will be based on the first UK authorisation to place the product on the market as a medicinal product, the period of duration of the SPC will be based on the first authorisation for the product in either the EEA or the UK.
The recently introduced manufacturing waiver will continue to apply in the UK. In particular – after some chopping and changing in the draft legislation – third parties will be permitted to manufacture SPC protected products in the UK without the rightsholder’s consent if they are for export outside of the UK and EU. Stockpiling will also be permitted during six months prior to expiry of the UK SPC if it is for sale in the UK or EU upon that expiry.
The Paediatric Regulation (1901/2006), which permits extension of an SPC by six months when a paediatric investigation plan (PIP) is approved, will be restated in the Human Medicines Regulations 2012 (2012/1916), also with necessary modifications.
After 31 December, the MHRA will make decisions for the UK based on the administration of its own system of paediatric investigation plans.
Over the years, the CJEU's rulings on the SPC Regulation have become somewhat notorious for a lack of clarity and consistency.
After 31 December, existing EU case law on these issues will continue to have authority in the UK, but only at the level of first instance – the Court of Appeal and Supreme Court will be able to depart from these decisions when they consider it right to do so. The English courts will therefore have a chance to do a better job than the CJEU.
The biggest problem, however, has been with the drafting of the SPC Regulation itself, which has seemed ill equipped to keep pace with the nature and variety of developments in medicinal products (most notably those for second medical uses).
For the time being, the terms of UK SPC law will remain substantially the same as those in the SPC Regulation. But, the whole of the UK is now free to go its own way on SPC law, and so the opportunity for UK legislators to overhaul this system now beckons.
If you would like to discuss any of the issues raised in this article, please contact a member of our Patents & Innovation team.
von mehreren Autoren