The Advocate General's (AG) Opinion in Case C-471/14 Seattle Genetics before the Court of Justice of the European Union (CJEU) has issued.

Many Marketing Authorisations have two key 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 for determining when to file a request for a Supplementary Protection Certificate (SPC) – the name given to PTE in Europe - and its maximum term. For example, the UK Intellectual Property Office (UK IPO) uses the date of notification similar to the Belgian, Portuguese and Slovenian patent Offices. In many other European Union (EU) countries, however, the earlier date of the marketing authorisation is used. Consequently, SPCs have been granted in EU countries with different terms.

This issue came before the Austria’s Court of Appeal 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. It was not clear to the Court whether Community law or local law should apply, the Court referred two questions to the CJEU. 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?

The AG confirms that it is Community law which applies in answer to the first question. Regarding the second question, the AG opines that it is the date of notification which should be used. The AG’s Opinion conforms with the approach taken by the UK, Belgian, Slovenian and Portuguese Patent Offices.

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.

The AG’s opinion is not binding on the CJEU, but is taken into consideration by the CJEU when coming to their decision.