In Short: The duration of an SPC should be calculated on the basis of the date on which the applicant is notified of the decision granting marketing authorisation. As a result, SPC owners gain a few days of additional protection.
In the EU member states, the duration of an SPC is to be calculated based on the "date of the first authorisation to place the product on the market in the Community" (Art. 13(1) of Regulation (EC) No. 469/2009). Many marketing authorisations such as EMA approvals have two "dates": The date of the decision granting marketing authorisation, and the later date of notification on which the applicant is notified of the decision granting marketing authorisation. Up to now, there was an inconsistency across Europe as to which of these dates should be used for calculating the duration of an SPC. For instance, the German Patent and Trademark Office used the date of the decision, whereas the UK Intellectual Property Office, the Belgian and Portuguese Patent Offices used the date of notification. As a result, SPCs with different durations were granted. The duration of the SPCs differed only by a few days. However, each day of additional protection counts since it is of considerable economic interest to the SPC owner.
Seattle Genetics is the holder of a European patent with an application date of July 31, 2003. Takeda, a company based in the UK, was granted a marketing authorisation for the medicinal product "Adcetris" containing the active ingredient "Brentuximab vedotin", which is protected by the Seattle Genetics' patent. The marketing authorisation for Adcetris was issued on October 25, 2012. However, Takeda was given notification of the decision granting marketing authorisation only five days later, i.e. on October 30, 2012. Seattle Genetics filed an SPC application based on Takeda's marketing authorisation with the Austrian Patent Office, which granted an SPC. However, the Austrian Patent Office fixed the expiry date for the SPC as October 25, 2027. Apparently, the Austrian Patent Office had calculated the expiry date of the Austrian SPC based on the date of the decision granting marketing authorisation. Therefore, Seattle Genetics filed an action for correction of the Austrian Patent Office's decision to the effect that the SPC expires only on October 30, 2027 with the Oberlandesgericht Wien. Due to the diverging practice across Europe, the Oberlandesgericht Wien has referred this case to the CJEU.
Results of the Decision of the CJEU
- The "date of the first authorisation to place the product on the market in the Community" in Art. 13(1) of Regulation (EC) No. 469/2009 is determined by Community law.
- The date on which the applicant is notified of the decision granting marketing authorisation should be used for calculating the duration of an SPC.
Impacts on the Practice
- On one hand, the decision is of significant importance for SPC owners, who will gain a few days of additional protection. On the other hand, the decision clarifies the duration of SPCs in EU member states and thus provides legal certainty to both innovative companies and to generic companies.
- SPC owners should check the basis of the calculation of the duration of their SPCs. Where the term of the SPCs has been granted based on the date of the decision granting marketing authorisation, actions for corrections should be filed. For further information please do not hesitate to contact the attorneys of Isenbruck Bösl Hörschler LLP