Waiving goodbye to SPC rights

The European Commission is considering whether ‘export waivers’ should be introduced in order to partly relax the rules on supplementary protection certificates. Gareth Morgan of Olswang explains more.

At perhaps no other time during the 20-year lifespan of the supplementary protection certificate (SPC) has more legislative attention been given to determining whether it is fit for purpose. Other key questions concern whether the encroachment of heightened levels of regulation into industrial sectors other than pharmaceuticals and agrichemicals justifies similar intellectual property right ‘top up’ regimes being put in place.

First there is momentum building within the EU for a small, but significant, relaxation to the scope of the SPC right granted to holders of patents where there has been a delay in bringing a pharmaceutical product to market as a result of compliance with EU regulatory requirements for medicines. The reason this groundswell has built up is that the SPC right is co-extensive with the scope of the underlying patent, insofar as the patent relates to the medicinal product that is being marketed under the SPC.

The result of this scope is that often companies outside the EU are able to set up, manufacture and prepare to enter non-EU markets where no SPC right exists, whereas EU generics and biosimilar manufacturers are not able to set up their own manufacturing because the scope of the SPC prevents manufacturing for the purposes of preparing for commercial sale, even if that sale concerned an export to a non-EU territory with no exclusivity right protecting the product.