At the request of the Court of Justice of the European Union (CJEU), Advocate-General (AG) Jääskinen issued an Opinion on 10 September in case C-471/14Seattle Genetics. The Opinion may be a good omen for Supplementary Protection Certificate (SPC) applicants and owners anxious to secure the maximal permissible term of protection.
The term of an SPC is based on the elapsed time between the date of application for the “basic patent” and the date of the first Marketing Authorisation (MA) in the European Economic Area, minus five years. However, the “date” of the MA is ambiguous. Is this the date on which the MA is actually granted, or the date on which the grant of the MA is notified? Often the notification by publication in the EU’s Official Journal is several days after the date of grant. Even a few days of additional SPC term can make a significant commercial difference.
Some countries, including the UK, calculate SPC terms based on the date of publication of the MA in the Official Journal. Others, including Austria, employ the date of grant of the MA. Seattle Genetics appealed against the Austrian patent office’s practice of using the date of grant of the MA, and the Austrian court responsible for the appeal decided to refer two questions to the CJEU. The referred questions ask first whether the “date” of the MA is the date determined by European Community law, or the date on which the MA takes effect under national law; and secondly, if Community law applies, whether the relevant date is the date of grant of the MA, or the date of its publication in the Official Journal.
According to the AG’s Opinion, the proposed answer to the first question is that Community law should apply. In relation to the second question, the Opinion is that the appropriate date to employ in calculating SPC terms is the date of notification.
The Opinion is not binding on the CJEU, although in many cases the CJEU follows the Opinion closely. A final decision is not expected for some time. However, if the Court follows the Opinion this should come as good news for SPC applicants as it will extend the duration of SPC protection available in states which currently employ the MA grant date rather than the notification date.
Various aspects of SPC practice were left unaddressed by the Opinion. Will the CJEU’s final decision have effect on SPCs already granted based on an incorrect date? Will the decision affect the identification of the “first” MA, or the deadline for making SPC applications, which depends on the relevant date? Although these questions were not explicitly asked by the Austrian court, they are all affected by the MA date and so it remains to be seen whether the CJEU addresses these in its decision or whether further referrals may be needed to clarify these points.