On 15 October 2014 the Oberlandesgericht Österreich referred questions to the CJEU on a preliminary ruling regarding the calculation of the SPC term under Article 13 of the SPC regulation. The case has been assigned the reference number C-471/14 (Seattle Genetics). The referral not only asks whether under Community law the authorisation’s notification or the decision date should be used to calculate the SPC term, but crucially first asks whether Community law even applies, or whether instead the relevant date should be determined under national law. The referred questions are (translated from the original German-language decision):
1. Is the date of the first authorisation to place the product on the market in the Community under Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products determined under Community law, or does the Regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?
2. If the CJEU affirms that the date under question 1 is determined under Community law: which is the relevant date – that of the authorisation or that of the notification?
The need for a referral in this area has been clear, particularly since the UKIPO’s change of practice a year ago to use the date of notification rather than the date of the decision to calculate the SPC term based on centralised authorisations (BL O/418/13 – GENZYME). This approach typically results in a few extra days of term, which can be very valuable. Belgium, Slovenia and most recently Portugal use a similar approach, but other national patent offices have resisted, arguing either that the SPC regulations make it clear that the date of the decision is the relevant date, or that in the absence of a CJEU ruling on the matter there is no need for them to change their practice.
The referral is based on Austrian SPC application no. SZ 39/2012 (“Brentuximab vedotin or pharmaceutically acceptable salts thereof”). The applicant (Seattle Genetics) applied for the SPC based on EP 1 545 613 and Takeda’s authorisation EU/1/12/794/001 for Adcetris (Brentuximab vedotin). The authorisation is dated 25th October 2012, but was notified 5 days later, on 30th October 2012. In calculating the SPC term, the Austrian patent office used the decision date of the authorisation, but Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30th October 2027. In its reasoning, Seattle Genetics referred to the practice in the UK, Belgium, Slovenia and Portugal, as well as Art. 13 and Recital 9 of the Regulation, and the authorisation itself which states that the authorisation is valid from the date of notification. The Austrian Oberlandesgericht seems to think that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date.
It will be interesting to see what the CJEU says. It would be short-sighted if the CJEU only answered these questions with reference to Article 13, though. Whatever the answers, SPC applicants will want to know if the same logic applies to Articles 3(d) and 7 as well ...Thanks so much, Daniel, for taking the trouble to share this with us.