Pharmaceutical companies in the EU are dependent on a right SPC term – Every day counts

The Advocate General's Opinion of the Court of Justice of the European Union (CJEU) referral in Case C-471/14 (Seattle Genetics).
The CJEU decision is expected 6 October 2015 .

On 15 October 2014 the Oberlandesgericht Österreich referred two questions to the CJEU on a preliminary ruling regarding the calculation of the term of a supplementary protection certificate (SPC) pursuant to Article 13 (1) of Regulation (EC) No 469/2009 of the SPC regulation:

Is the date for the first Marketing Authorisation (MA) which is used to determine the SPC term for medicinal products determined according to Community law or under national law?
And if determined under Community law, is the relevant date for determining the SPC term the decision date of the MA or the date of notification?

The date of the first Marketing Authorisation (MA) for a product is used for both the determination of the deadline for filing an SPC application and for calculating the term of an SPC. Contrary to most national MA´s Community MA’s have two dates associated with them, the date of the decision of the MA and the (later) date of the notification of the decision in the Official Journal of the European Union. It poses a problem that the interpretation of Article 13 of the SPC regulation diverges between member states with respect to which of the two dates mentioned above is the effective date for the first MA for the purpose of calculating the duration. 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, e.g. Denmark and Sweden however, the earlier date, i.e. the date of the decision, of the MA is used. This has resulted in SPCs being granted across Europe with different terms. Although the two dates only differ by a few days, those few days without competition can make a substantial difference for the right holder.

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 MA EU/1/12/794/001 for Adcetris (Brentuximab vedotin). The decision of the MA is dated 25 October 2012, but the date of notification was 5 days later, on 30 October 2012 as published in the Official Journal. In calculating the SPC term, the Austrian Patent Office used the decision date of the MA. Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30 October 2027. The decision was appealed and as mentioned above the Oberlandesgericht Österreich referred the question to the CJEU for a preliminary ruling.

The AG’s opinion is very clear and settles that it is Community law which should apply and therefore that it is the date of notification which should be applied when interpreting Article 13 for the calculation of the SPC term.

With regards to the first question, the AG puts emphasis on the original intention of a joint SPC legislation, namely to promote free market movement of pharmaceutical products. At the same time he argues that the Court has consistently held that a provision in EU law without explicit reference to the right of Member States normally is interpreted uniformly throughout the Union. With respect to the second question, the AG bases his opinion on the general legal principle of TEUF that the decision will take effect upon notification of the addressee.

Although the Court may deviate from this principle the consequence of doing so will shorten the duration of the valid SPC and thus be damaging to the applicant.

The AG’s opinion is important for the final decision of the CJEU.

22 September 2015