Paclitaxel - UK

Abraxis had appealed against the decision dated Aug 26, 2016 of refusal by the UK Intellectual Property Office (UK IPO) to grant an SPC covering Abraxis’ nab-paclitaxel product, Abraxane™. Abraxane is a new formulation of the known medicine, paclitaxel, and includes paclitaxel formulated as albumin bound nanoparticles (referred to by Abraxis as nab-paclitaxel).

Arnold J (High Court of England and Wales) in his decision on Jan 13, 2017 has made a further referral to the CJEU, this time concerning the interpretation of Article 3(d) of Regulation 469/2009 (the “SPC Regulation”), namely: “Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”

Arnold J in his analysis considered that it was clear that paclitaxel and not nab-paclitaxel was the active ingredient for the purposes of Art 1(b). However, in relation to Art 3(d), Arnold J did not consider it clear whether new formulations could be awarded an SPC. Abraxis accepted that the facts of Neurim case relate only to the award of SPCs for new therapeutic uses of old active ingredients, but argued that Neurim could also apply to new formulations of old active ingredients. Arnold J therefore stated he would refer the question set out above to the CJEU.