CJEU Follows AG Opinion in C-471/14: Supplementary Protection Certificate (SPC) Term
7 October 2015
Both the term of an SPC and the deadline for applying for an SPC may be set by the date of the first Marketing Authorisation for a product. An issue has arisen since many Marketing Authorisations have two dates associated with them: the date of the Marketing Authorisation itself and the (later) date on which the Marketing Authorisation is notified in the EU’s Official Journal. Practice across Europe has begun to diverge as to which of these dates should be used. The UK Intellectual Property Office, for instance, uses the date of notification, as do the Belgian, Slovenian and Portuguese Patent Offices. In many other EU territories, however, the earlier date of the Marketing Authorisation is used. In practical terms this has resulted in SPCs being granted in EU territories with different terms, albeit only differing by a few days in length.
This issue came before the Oberlandesgericht Wien after Seattle Genetics appealed a decision of the Austrian Patent Office to use the date of Marketing Authorisation to calculate the term of an SPC. Given the divergent practice across the EU territories, and the fact that it was not clear whether Community law or local law should apply, the Oberlandesgericht Wien referred two questions to the CJ-EU. The questions referred were:
- Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question?
- If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification?
As reported in our news item of 10 September 2015, the Advocate General (AG)’s preliminary Opinion answered the first question by confirming that it is Community law which applies and the second question by confirming it is the date of notification which should be used. This was in conformity with the approach currently adopted by the UK Intellectual Property Office, and the Belgian, Slovenian and Portuguese Patent Offices.
On 6 October 2015 the CJEU issued its decision following the AG’s Opinion.
The questions referred by the Oberlandesgericht Wien and the decision of the CJEU deal only with Article 13 of the SPC Regulation, which sets the term of an SPC. It is nonetheless slightly disappointing that neither the AG nor the CJEU saw fit also to comment upon other Articles in the SPC Regulation which are affected by the date of the first Marketing Authorisation. In particular, Articles 3(d) and 7, which concern the requirement for an SPC to be based on the earliest Marketing Authorisation in an EU member state, and the deadline for applying for an SPC, respectively. However, it seems likely that the same reasoning would apply to those Articles.