A clearer picture for SPCs?

The CJEU’s decision on how an SPC term is to be determined is likely to be welcomed by applicants and owners, but the court has left them to work out how to apply the ruling, say Natalia Wegner-Cribbs and Daniel Wise of Carpmaels & Ransford.

On October 6, the Court of Justice of the European Union (CJEU) delivered its judgment in case C-471/14. It clarified that the term of a supplementary protection certificate (SPC) is determined with reference to the date on which a marketing authorisation is notified to that applicant. This means that in many cases SPC owners that do not already benefit from the maximum five-year term will get some additional term for their products, although it remains to be seen how and to what extent the judgment will be implemented from a practical point of view by the various national patent offices. The judgment may also have implications for aspects of SPC law other than the SPC term, on which the CJEU did not provide any guidance.

The relevant legal framework (article 13 of the Regulation [EC] No 469/2009—the SPC regulation) provides that the SPC term is calculated with reference to the “date of the first authorisation to place the product on the market in the Community”. The dispute arose around the interpretation of this provision. Does it refer to the date on which the decision to grant a marketing authorisation is taken, or that on which the applicant is notified of the decision? Notification typically takes place a few days later than the date of the decision and in the case of centralised authorisations the date of notification is recorded and published in the Official Journal of the European Union (OJEU).

In this case, the decision to grant a marketing authorisation for the medicinal product Adcetris was dated October 25, 2012, but the applicant (Takeda) was notified of the decision five days later, on October 30. The Austrian Patent Office issued the SPC to Seattle Genetics with a term calculated with reference to the decision date. Seattle Genetics challenged this and requested that the relevant date is that of notification, and so the SPC should expire five days later than calculated by the office. The Austrian proceedings were stayed and questions on the interpretation of article 13 were referred to the CJEU.