Abraxis Bioscience LLC v The Comptroller General of Patents, High Court of England and Wales, (Arnold J), London, UK, 13 January 2017, Neutral Citation Number: [2017] EWHC 14 (Pat)

Arnold J 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?”

Abraxis had appealed against the 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). As paclitaxel had been the subject of a separate earlier marketing authorisation, Abraxis argued that the active ingredient of Abraxane was not paclitaxel but nab-paclitaxel. As such, the marketing authorisation for Abraxane was the first MA to put that active ingredient on the market and Art 3(d) of the SPC regulation was therefore satisfied. In the alternative, Abraxis contended that it complied with Art 3(d) as this provision should be interpreted as allowing SPCs for new and innovative formulations of old active ingredients.

In his decision Arnold J conducted a review of the case law in relation to Art 1(b) of the SPC Regulation on the meaning of “product” (active ingredient or combination of active ingredients) and Art 3(d). The conclusion of his review was that Art 1(b) was to be interpreted narrowly (as set out in MIT (C-431/04), GSK (C-210/13) and Forsgren (C‑631/13)) but that Art 3(d) should be more broadly interpreted (following Neurim (C-130/11)). He noted in particular that Neurim appears to depart from the earlier CJEU cases of Pharmacia (C-10/03) and Yissum (C-202/05) but that this is not certain as Neurim itself does not refer to these cases.

Following his analysis of the case law Arnold J considered 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 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.

Arnold J offered his view that Art 3(d) should not permit the grant of SPCs for new formulations of old active ingredients. His view is based on the need for the SPC Regulation to offer a “simple and predictable system” which can be uniformly applied by different member states. He considered “to achieve this it is necessary to have bright-line rules even if they sometimes deprive meritorious inventions of extended protection”.

A copy of the judgment can be found here.