Brexit: a fresh start for SPCs?

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.

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