Brexit: a fresh start for SPCs?

The UK’s vote to leave the EU may allow Britain to replace the SPC regulation—an often-criticised piece of law—and take a fresh approach to the system governing these rights, say Paul England and Matthew Royle of Taylor Wessing.

Under Regulation (EC) No. 469/2009, the exclusivity term of a pharmaceutical product protected by a patent can be extended by up to five years after that patent expires. This depends on the delay in obtaining a marketing authorisation (MA) for the pharmaceutical product and the subsequent impact that delay has on the period of exclusivity that the product enjoys on the market. This is achieved by the granting of a supplementary protection certificate (SPC) by the national offices of the EU member states in which the European patent has been on the register.

Like other European regulations, the SPC regulation is a legislative instrument that has ‘direct effect’. This means that the regulation is automatically applicable in the member states as soon as it comes into force, without the need for national implementing legislation. Brexit has implications for this.

Once the UK has notified the European Council of its intention to withdraw from the EU under article 50(2) of the Lisbon Treaty, a negotiation process is triggered by which “the union shall negotiate and conclude an agreement with the UK, setting out the arrangements for its withdrawal, taking account of the framework for its future relationship with the union”.