Article 13 (1) of Regulation EC No. 469/2009 (concerning the supplementary protection certificate for medicinal products, “SPC”) provides that SPCs are calculated on the basis of “the date of first authorisation to place the product one the market in the Community”. Existing SPC regulation is however ambiguous on this point and EU member states have adopted divergent practices.
By decision of 2 October 2014 the Oberlandesgericht Wien has referred questions to CJEU on a preliminary ruling regarding the calculation of SPCs term under Article 13 (1) of Regulation EC No. 469/2009.
The referral concerned two queries: a) whether the date of an MA (Market Authorization) has to be determined according to Community law or that of the member state where the SPC application is filed; b) whether (under Community law) “the date of the first authorisation” – as per Article 13(1) of the Regulation – is the date the MA actually issued or the date the applicant is notified.
The CJEU issued its Decision on 6 October 2015 in the case C-471/14, Seattle Genetics Inc. v Österreichisches Patentamt (full text here).
Confirming both the conclusions and the arguments submitted by the Advocate General Niilo Jääskinen in his Opinion as of September 10, 2015, the Court clarified: a) that, since Article 13(1) of aforesaid Regulation contains no express reference to the laws of the member states, it is necessary to adopt an independent and uniform interpretation that will be valid throughout the EU; b) that the date of the first authorisation is a matter of Community law, not of the legislation of the member state where the marketing authorisation has effect. The Court declared that the EU legislator chose to use the Regulation as the legal instrument to create a standard SPCs system.
In evaluating the second question, the CJEU further pointed out that SPCs were created to ensure sufficient protection to encourage pharmaceutical research, in light of the fact the period of exclusivity granted by patents concerning pharmaceutical products is insufficient to cover the R&D investment necessary.
In this context, the right to market a new drug arises on the date the patent holder becomes aware that the MA has been issued.
The Court therefore answered the second question by confirming that it is the date of notification of the MA that is to be considered the “date of the first authorisation”, this is the date to be taken into account in calculating the term of SPC.
As a result of this ruling, SPCs holders will benefit from a longer term of protection – by up to some weeks. Furthermore, a number of SPCs will likely need to have their duration recalculated.
Court of Justice, Eighth Chamber, 6 October 2015, C-471/14, Seattle Genetics Inc. v Österreichisches Patentamt.