European Court ruling on interpretation of SPC Regulation

06/10/15

The European Court handed down judgment today in the Seattle Genetics case, a reference from the Higher Regional Court, Vienna, Austria, concerning the interpretation of the so-called SPC Regulation – Regulation 469/2009 concerning the supplementary protection certificate for medicinal products.

The reference was made in the context of a dispute between Seattle Genetics and the Austrian Patent Office concerning the expiry date for the supplementary protection certificate granted in respect of the orphan medicinal product Adcetris. The dispute turned on the interpretation of the concept of “the date of the first authorisation to place the product on the market in the [European Union]”, for the purposes of Article 13(1) of the SPC Regulation.

In its judgment, the Court agreed with Seattle Genetics that the date of the first authorisation to place the product on the market in the EU must be given an independent and uniform interpretation throughout the EU. It also agreed with Seattle Genetics that the relevant date for that purpose was the date on which the addressee of the decision granting the marketing authorisation was notified of that decision, rather than the date on which the decision was taken. That was required, in particular, by the objective of the SPC Regulation of providing adequate effective protection to the holder of an SPC.

The result of this will be a requirement to rectify the expiry date of the Adcetris SPC to the date contended for by Seattle Genetics, rather than the date originally set by the Austrian Patent Office.

The judgment is here.