In the short term, the effect of Brexit on the patents of life science companies operating throughout Europe and the UK can be described simply: Things that previously involved one regulating authority now involve two – the UK Intellectual Property Office (UKIPO) and the European Patent Office (EPO), which is a non-EU framework.
The UK and EU offices are currently operating largely in harmony, especially regarding pharmaceuticals. However, the UK’s impulse to go its own way strongly suggests that over time this will no longer be the case.
The EU has been planning to institute a single application process for clinical trials throughout the EU with an accompanying database for each trial. UK clinical trials will no longer be part of this plan. Clinical trial approvals now fall under the auspices of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The status of UK clinical trials that the EU approved before Brexit remains uncertain. Nor are the UK’s intentions regarding future clinical trial harmonization with the EU fully understood.
However, one known complication is that clinical trial approvals will now need local legal representatives for proceedings in the UK and EU.
Post-Brexit, EU life science-related regulations in the UK are no longer in effect. “Schedule 7, Regulations” of the EU Withdrawal Act established new UK regulations that largely mirrored previous EU rules, at least for now. These regulations intended to fill a regulatory vacuum created at Brexit quickly.
Under Brexit, the UK gave up its access to critical life science benefits available within the EU, such as the EU’s clinical trials portal and its EudraVigilance pharmacovigilance database.
The Brexit agreements do, however, allow the UK to continue to participate in the EU’s research and funding program Horizon Europe for seven years, so long as the UK continues to contribute to its operation financially. This means that UK researchers retain access to EU grants.
Plant protection products
With Brexit, the UK’s own independent plant protection products (PPP) regime assumed the management of pesticides. EU regulations are no longer in effect in England, Scotland, and Wales. However, Northern Ireland continues to respect EU PPP regulations.
Northern Ireland shares a land border with the Republic of Ireland, which hasn’t left the EU. In a controversial effort to avoid hard land borders between the two, Northern Ireland continues to play by some EU rules, including those regarding PPP.
In the Brexit Trade and Cooperation Agreement (TCA), a section — Annex TBT-2 — is referred to as the “Medical Products Annex.” It covers all human and animal medicinal products, including biologics, or ATMPs. The Annex has three primary goals:
• facilitating the availability of medicines in each party’s territory
• establishing conditions for inspections, and harmonizing quality assurance manufacturing policies between the UK and EU
• promoting public health by safeguarding patient safety and animal health and welfare and protecting high consumer and environmental protection levels.
The Medical Products Annex also set up the Working Group on Medicinal Products. The Group is charged with keeping the UK and EU talking as their paths inevitably diverge in the future. The hope is that the Annex can be a living agreement that evolves to keep the two parties in harmony as much as possible.
The Working Group was also tasked with monitoring how well the Medical Product Annex served the parties, both immediately following Brexit and over time.
Supplementary protection certificates
A supplementary protection certificate, or SPC, can be acquired after the expiration of a patent. SPCs are available for a range of regulated biologically active agents, particularly human or veterinary medicines and plant protection products.
Since patents in the life sciences often require an extended period of examination, an SPC extends IP ownership for five years based on the date the product is finally marketed, as documented by the issuance of a marketing agreement or MA. MAs are issued on a national basis.
Before Brexit, MAs were issued under a harmonized system by the MHRA for protection within the UK and the European Medicines Authority (EMA) for Europe, following the same rules.
After Brexit, the UK continued to recognize existing MAs issued by the EMA and the UK’s own MHRA.
New MAs can be acquired for England, Scotland, and Wales through the MHRA. New MAs for Northern Ireland must come not from the MHRA but the EU’s EMA.
The UK can export its life sciences products into the European Economic Area (EEA) after Brexit. However, the EU now enforces the additional inspections and requirements that apply to importing non-EU goods, increasing their final cost in Europe.
IP going forward
The UK and the EU expended a tremendous effort to ensure that the two parties remained as harmonized as possible regarding intellectual property as of January 1, 2021. The TCA alone is massive in its attempt to consider the many ramifications of separation.
Inevitably, not every thread got tied up, and there’s no avoiding the complicating reality that where there was once a single party, now there are two. For life sciences companies especially, this makes any number of things harder.
Of course, as the future unfolds, we’ll see if these early Herculean attempts at cooperation between the UK and EU hold in any event or if the two parties will drift still farther apart.
For more information on Brexit and IP, look out for part 1 of our Brexit series “Still Unsure How Brexit Has Affected Intellectual Property?“. If you have any questions on how Brexit affects your Intellectual Property Translation strategy, contact us.