With British politicians scrambling to define Brexit, UK pharma companies are currently in the dark about what breaking away from the EU will mean for business. According to experts from patent attorney Beck Greener, one of the (many) difficult questions about Brexit is, what happens to pharma’s intellectual property? Currently, British-based pharma IPs are covered under the European Commission’s Summary of Product Characteristics (SPC), but if an appropriate deal isn’t struck between the UK and EU, it could lead to an IP grey-area.

“SPC protection will almost certainly be available to UK-based pharma companies post-Brexit, but what they’ll have to do in order to obtain that protection largely depends on the outcome of negotiations,” says Jamie Fraser, UK and European patent attorney at Beck Greener. “However, if the Brexit negotiations end in a ‘no-deal’ situation, there may be no other option for UK-based pharma companies than to expand or relocate at least some of their business to an EU member state.”

Fraser recently co-authored a paper outlining the potential consequences of pharma IP and SPCs (1), which raises the possibilities of both “hard Brexit” and “soft Brexit” scenarios. Regarding market authorization (MA) in relation to the EU, the paper stated, “A recent EU Commission and EMA Notice (EMA 2017a) would appear to be a warning shot to UK-based companies who currently hold an MA issued by the EMA. The notice reiterates certain residency and activity requirements for MA holders (EMA 2017b):

EU law requires that marketing authorization holders are established in the EU or EES.

Some activities must be performed in the EU or EEA, related for example to pharmacovigilance, batch release, etc.” (1)

The European Commission has also released a paper discussing potential post-Brexit IP rights (2), in which it is stated that a person or company should continue to be allowed to keep their IP application, but Fraser adds that it is still unclear about what lies ahead for future applications. A factor that could affect the future is the UK repeal bill (depicting what EU laws will be adopted to the UK for ease of transition), and the subsequent amendments that will be made to it. Fraser says, “If the UK intends to directly transcribe existing EU law into the new UK statute, this would mean that the UK would continue to recognize the legal validity of MAs issued by the EMA. Therefore, an SPC granted in the UK that is based on an MA issued by the EMA would continue to be considered valid and in force in the UK.”

Fraser and his co-author explain that the UK could agree to remain bound by EU law for IP matters, although this is difficult to imagine in the current political climate. Instead, Fraser recommends that companies look into the issue so that they are ready to make a move when the situation becomes clearer.