Abraxis Bioscience LLC v Comptroller General of Patents (C-443/17) and [2017] EWHC 14(Pat)
Brian Nicholson represented the Comptroller General of Patents in an appeal to the Patents Court (Arnold J) concerning the Comptroller’s refusal to grant a supplementary protection certificate (SPC), on the basis that the application for an SPC did not comply with Article 3(d) of the SPC Regulation (469/2009/EC), in respect of Abraxis’ patent for a product, marketed as ‘Abraxane’, consisting of paclitaxel formulated as albumin bound nanoparticles which Abraxis calls ‘nab-paclitaxel’. Richard Meade QC represented Abraxis.
The Patents Court: (1) upheld the Comptroller’s decision that ‘nab-paclitaxel’ was not a new active ingredient, but rather a new formulation of ‘paclitaxel’ for which a prior Marketing Authorisation had been granted; (2) reached a preliminary view, agreeing with the Comptroller, that the CJEU’s decision in Neurim Pharmaceuticals v. Comptroller-General of Patent (C-268/12) [2013] RPC 23 was limited to new therapeutic uses and did not extend to new formulations for the same application; (3) considered, however, that the proper extent of Neurim was unclear; and (4) consequently made a reference for a preliminary ruling to the CJEU under Article 267 TFEU.
Following submissions to the CJEU by Brian Nicholson on behalf of the United Kingdom, Richard Meade QC for Abraxis, and representations from the Czech, Hungarian, Netherlands and Polish Governments and the European Commission, the CJEU answered the referred question so as to confirm the Comptroller’s and Patents Court views that the Marketing Authorisation for a new formulation of an old active ingredient cannot be regarded as the first Marketing Authorisation when the active ingredient has already been the subject of another Marketing Authorisation.
The case will be remitted to the Patents Court for final determination