Following a hearing at the CJEU and the opinion of the Advocate General reported in our earlier notes here and here, the Court’s judgment in Abraxis Bioscience LLC v Comptroller General of Patents C-443/17 was delivered on 21 March 2019. The full judgment is available here.
The SPC application relates to Abraxane®, which contains albumin-bound paclitaxel nanoparticles and is indicated in 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 and the SPC application was based on the Abraxane® authorisation and a related patent directed to the innovative albumin-bound nanoparticles.
In view of earlier authorisations for conventional paclitaxel products, which do not fall within the scope of the basic patent and which are not authorised for the treatment of metastatic adenocarcinoma of the pancreas, 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, in the court’s view, “the product is a new formulation of an old active ingredient” (paragraph 62, Abraxis Bioscience LLC v The Comptroller-General of Patents  EWHC 14 (Pat)).
In his opinion in December 2018, Advocate General Saugmandsgaard Øe proposed a broad negative answer to the referred question which some commentators interpreted as potentially reversing the CJEU’s earlier jurisprudence in Neurim. The CJEU did not follow the Advocate General’s proposed broad answer and in March 2019 ruled more narrowly with respect to SPCs deemed to relate to “a new formulation of an old active ingredient”. Specifically, the CJEU said that Article 3(d) of the SPC Regulation “must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient”.
Carpmaels & Ransford represents the SPC applicant in this case.