On 6 October 2015 the CJEU delivered its judgment in the Seattle Genetics case (C 471/14). The Court’s ruling will be welcomed by SPC applicants, as it ends the current disparity in the duration of protection conferred by SPCs in different EU member states and resolves this in favour of the longer SPC terms currently granted by the UK and various other member states.
The background to the case is summarised here. In brief, the term of an SPC depends, among other factors, on the date of the first Marketing Authorisation (MA) for the relevant product in the European Economic Area. However, there is often a delay between the grant of an MA and its notification to the applicant (for example, by publication of the details in the EU’s Official Journal in the case of an MA granted via the European Medicines Agency’s “centralised procedure”). The SPC Regulation is ambiguous as to whether the grant date or the notification date should be treated as the date of the MA, and different EU member states had adopted divergent practices. An Austrian court, the Oberlandesgericht Wien, therefore referred two questions to the CJEU to clarify the correct practice.
The first question
The first question referred to the CJEU was:
- Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 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?
The CJEU answered as follows:
“Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.”
In reaching this conclusion, the Court referred to the need for “independent and uniform interpretation” of provisions of EU law (here, the SPC Regulation) throughout the EU, and to Recitals 7 and 8 of the SPC Regulation which stated an objective of reaching a “uniform solution at Community level […] preventing the heterogeneous development of national laws” and providing an SPC “under the same conditions” in each member state. The Court held that reliance on national law would undermine the objective of establishing a uniform solution at the EU level.
The second question
The second question referred to the CJEU was:
- 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?
The CJEU answered as follows:
“Article 13(1) of Regulation No 469/2009 is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting Marketing Authorisation was given to the addressee of the decision.”
In reaching this conclusion, the Court noted the “fundamental objective” of the SPC Regulation is “to re-establish a sufficient period of effective protection of a basic patent”. The legislative intent behind the SPC Regulation was to provide protection of a sufficient duration that the SPC would afford “actual” protection, or “adequate effective protection”. In this regard the Court found that “the holder of an SPC is entitled to market his product only from the date on which he is given notification of the decision granting the Marketing Authorisation”. The date of notification is the first date on which the SPC holder can in fact enjoy the benefit of the MA by marketing the authorised product. Furthermore, decisions granting Marketing Authorisations are subject to Article 297(2) of the Treaty on the Functioning of the European Union, which provides that decisions specifying an addressee must be notified to the addressee and take effect upon such notification.
The Court’s judgment should come as good news to SPC applicants, as this may extend the duration of SPCs in those EU member states which have previously relied upon the Marketing Authorisation’s grant date rather than its notification date. However, the consequences for currently-pending and already-granted SPCs remain to be seen.
It is unfortunate that the Court explicitly restricted its conclusions to Article 13(1) of the SPC Regulation. Articles 3(b) and (d) of the SPC Regulation require that the SPC be based upon the “first” Marketing Authorisation. Article 7(1) of the SPC Regulation sets an SPC application deadline of six months from the date of grant of the first Marketing Authorisation. Following the logic behind the Court’s answer to Question 2 it seems that these provisions should also be read having in mind the date of notification, but as the Court did not specifically address these points it cannot be ruled out that further referrals may be needed to confirm this.