What constitutes the ‘first' relevant marketing authorisation for an SPC?
In an oral hearing at the CJEU in Luxembourg on 21st June 2018, Advocate General Henrik Saugmandsgaard Øe and a panel of five judges heard the submissions of the SPC applicant Abraxis Bioscience LLC (represented by Carpmaels & Ransford LLP and Richard Meade QC) in case C-443/17 relating to Celgene’s blockbuster oncology product ABRAXANE®. The European Commission and the Netherlands Government, both observers to the case, were also represented at the oral hearing.
ABRAXANE® contains albumin-bound paclitaxel nanoparticles and is used to treat a variety of solid tumours including breast, lung and pancreatic cancer. It is the first medicinal product containing albumin-bound paclitaxel nanoparticles authorised in Europe. Abraxis’s SPC application was based on the ABRAXANE® authorisation and a related patent. Conventional paclitaxel products had previously been authorised in Europe. In view of these earlier authorisations, the CJEU was asked whether an SPC could be granted where the marketing authorisation underlying the SPC is the first authorisation within the scope of the relevant basic patent and where “the product is a new formulation of an old active ingredient”. This question from the English High Court was reported in our earlier note here.
Abraxis argued that the earlier authorisations for conventional paclitaxel products do not present a barrier to its SPC, in view of the CJEU’s decision in Neurim Pharmaceuticals C‑130/11. The European Commission sided with Abraxis at the oral hearing, stating that it had revised the position in its earlier written submissions and that it in fact endorsed the granting of an SPC, on the basis of the principles established in Neurim. The hearing itself was notable in that the Advocate General and the panel of judges were actively engaged in discussions towards the end of the sitting.
The Advocate General announced that he will deliver his opinion on 25th October 2018. We will provide an update as soon as there is further news to report.