Following a hearing at the CJEU reported in our earlier note here, the opinion of Advocate General Saugmandsgaard Øe in Abraxis Bioscience LLC v Comptroller General of Patents C-443/17 was delivered today (available here).

The SPC application underlying this case relates to Abraxane, which contains albumin-bound paclitaxel nanoparticles and allows the treatment of metastatic adenocarcinoma of the pancreas as well as metastatic breast cancer and non-small cell lung cancer. It is the first product of this type that was authorised in Europe. Abraxis’s SPC application was based on the Abraxane authorisation and a related patent to such nanoparticles.

In view of earlier authorisations for conventional paclitaxel products which are, however, not within the scope of Abraxis’s patent, the CJEU was asked by the UK High Court 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” (reported in our earlier note here).

In its opinion, the Advocate General considers possible interpretations of the concept of ‘first authorisation to place the product on the market as a medicinal product’ in Article 3(d) of the SPC Regulation, in view of other requirements of the SPC Regulation and the CJEU’s earlier case law. The Advocate General then recommends that the Court answers the referred question in the negative.

The opinion is not binding on the Court, which is expected to give its verdict soon.

Carpmaels & Ransford is representing the SPC applicant.