European Court of Justice rules on Supplementary Protection Certificates

The European Court of Justice has ruled that Supplementary Protection Certificates (SPCs) for pharma patents start on the date they are notified to the applicant, ruling in favor of US biotech Seattle Genetics (Nasdaq: SGEN).

The ruling concerns the duration of supplementary patent protection afforded to the innovative pharma industry. Legislation in the European Union provides the possibility of an SPC to compensate a patent-holder for the erosion of patent protection it suffers due to the long regulatory process that culminates in marketing authorization being granted. There has been disagreement, however, over how to calculate the duration of an SPC. The new Court of Justice ruling determined that the date is that on which the decision to grant a marketing authorization is notified to the applicant.

This decision is expected to benefit the pharma industry by ending uncertainty for innovative and generic medicine manufacturers since the additional two to five days typically seen between the granting of a marketing authorization and the notification to the applicant can be of real commercial value. Although SPC regime is harmonized within the EU, patents are a national right and SPCs are granted by national patent offices. The new ruling means that divergence should no longer exist between member states on the relevant date for calculating the SPC term. This will allow competing generics companies certainty over when patent protection will end.