The Impact of Brexit and the EU-UK Trade Deal on Patents and SPCs

Since the European Patent Convention (EPC) is not an EU instrument, it (and the rights of UK-based patent attorneys to represent applicants at the EPO) has not been affected by Brexit. European Patents with a UK designation will continue to be granted by the European Patent Office (EPO). The EPO will also continue to be the forum for post-grant opposition for European Patents (with UK patent attorneys’, solicitors’ and barristers’ still entitled to represent their clients). While the EPC is not mentioned in the EU-UK trade deal, its omission is not significant (and as noted at the outset, it is not an EU instrument). The UK government’s commitment to the EPC has been confirmed in a number of public statements, including, for example, in the negotiating objectives for the US Trade deal.

Amendments to the UK Patents Act 1977 introduced by secondary legislation to implement EU Directives (notably the Biotech Directive) have also been preserved post Brexit. While the EU-UK deal contains provisions about patents, these do not accordingly disrupt that position. The UK will also remain a member of the Paris Convention, thereby preserving the longstanding international approach to claiming priority dates.

As the EU-UK deal is largely silent on civil justice issues, and the UK has not acceded to the Lugano Convention, Brexit has implications for litigation in the UK generally, including patent litigation. This particularly applies to service, jurisdiction, and enforcement of judgments. Parties involved in and/or contemplating UK patent litigation should plan accordingly, taking into account the application of UK common law, the Hague Convention, bilateral arrangements, and/or foreign law.

From a practical perspective, from 01 January 2021, the UK changed its rules to prevent the provision of an address for service outside the UK (or Gibraltar or the Channel Islands) in relation to patents (and other registered IP rights), although a non-UK applicant can use their own non-UK address as the address for service. There are also transitional provisions and in certain circumstances, the UK IPO will now require a change of address for service to the UK (or Gibraltar or the Channel Islands), including e.g. in the event of an invalidity challenge to a granted patent.

After Brexit ultimately led to the UK withdrawing its ratification in July 2020, the UK is not currently expected to participate in the Unitary Patent or Unified Patent Court systems, if and when they become operational. If they do come into effect, UK businesses will still need to consider the availability and applicability of these unified systems in contracting EU member states. But in the UK, UK (and any) businesses will need to protect their inventions via European Patents (designating the UK) or UK national patents and (if necessary) litigate them in the UK courts.

Supplementary Protection Certificates, not so straightforward?

Supplementary Protection Certificates (SPCs) offer extended protection to patented active ingredients in pharmaceutical and plant protection products as a form of incentive for research and compensation for regulatory-related delays that erode patent term. Unlike patents, SPCs were governed by European Regulations and so the impact of Brexit has been more significant.

That said, existing SPCs will continue as they are nonetheless granted and administered on a national basis. The European Regulations previously governing SPCs have also become part of the EU law retained in the UK, subject to changes implemented via IP/SPC-specific statutory instruments (SIs), which adapted them to operate in only the UK market. There were 3 significant SIs, in which the key points were:

  • The 1st SI included a somewhat controversial aspect in that the UK retained a position whereby SPC duration is calculated by reference to the first EEA marketing authorization.   
  • During the transition period, the EU made a significant change to SPC law and introduced waivers allowing medicines to be manufactured during the term of an SPC in specific scenarios (relating to export outside the EU and stockpiling). This was addressed in the UK in a 2nd SI, which incorporated these provisions with a view to preserving their scope so far as possible (albeit there were implications and certain differences arise from the application of these waivers in only the UK market).
  • The 3rd SI was made in order to address the complexities of the Northern Ireland Protocol, which, to prevent a hard border between Northern Ireland and the Republic of Ireland, provided a route for medicines to be authorized in NI according to European law. This has created the possibility that the first marketing authorization for a pharmaceutical product in the UK may occur in NI via a ‘European’ route. Not only might such NI authorizations now trigger the 6-month window for applying for a UK SPC, but UK SPCs may also have a more complex scope if there is a divergence between the underlying authorizations in Northern Ireland and Great Britain.  

Considering the case law governing SPCs, the UK Courts have been the most prolific in terms of referring questions to the CJEU to clarify the European Regulations governing SPC law. It will accordingly be significant (perhaps both for the UK and EU), that such referrals will now come to an end. While prior CJEU decisions are now part of the retained law in the UK, SPC law (and the UK’s general approach to patent term extension) may be an area where UK jurisprudence starts to diverge. In this respect, the EU-UK trade deal contains provisions requiring SPCs to be available (not expressly, but by reference to the need to compensate parties for regulatory delays in the fields where SPCs are currently provided). These provisions are quite general and would not appear to prevent divergence were it to arise. This highlights SPCs as a significant area to watch in relation to the UK’s approach to trade deals with other countries. (The same is true in relation to data/marketing exclusivity rights relating to medicinal products, where the EU-UK trade deal provides for such rights, but does not, for example, specify their duration.)

Andrew Hutchinson en Kevin Cordina (Simmons & Simmons)

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