SPCs

 

Supplementary Protection Certificates (SPCs) can extend patent protection for biopharmaceutical and agrochemical products and are granted in order to compensate the innovator for loss of effective patent term as a result of the delay in obtaining regulatory marketing authorisation. Whilst the number of SPCs granted across Europe is relatively low, these rights can be extremely valuable to innovators. At present the interplay between the UPC and SPCs is still a work in progress. It is clear that during the transitional period (at least 7 years) SPCs can be opted-out of the jurisdiction of the UPC. Indeed an application to opt-out a European patent will extend to any SPC based on that European patent and this includes SPCs which are granted after lodging the application to opt out the European patent. Extra care needs to be taken when exercising the opt out as the proprietors of the underlying EP need to exercise the opt-out along with the holders of the SPC, even if the EP has expired. If an applicant decides to validate and EP as a UP, the exact procedure for obtaining an SPC based on a UP is as yet not clear. It is likely that at the very least a UP will be able to serve as the basis for national SPCs granted by the national patent offices. Certain industry bodies are pushing for a unitary SPC but this will require further agreements between member states and it is unlikely that an agreement will be reached before the UPC system goes live. Another aspect that will also need consideration will be the possibility for obtaining paediatric extensions on SPCs based on a UP.