On Aug 26, 2016, UK Intellectual Property Office rejected the Supplementary Protection Certificate (SPC) application filed by Abraxis BioScience.
The product for which SPC was sought is defined in the application as “paclitaxel formulated as albumin bound nanoparticles” – referred to as “nab paclitaxel”. And the issues was whether SPC application GB/09/046 complies with Article 3(d), having regard to Article (1)(b), of the Regulation. Article 3(d) requires that the supporting marketing authorization is the first authorization for the product in the EU. Article 1(b) defines a product as “the active ingredient or combination of active ingredients of a medicinal product”.
The hearing officer accepted that nab-paclitaxel is more effective and safer than paclitaxel. He held that albumin component of nab-paclitaxel did not have a therapeutic effect on its own and it functioned as a carrier only. The examiner considered that paclitaxel, a well-known anti-cancer drug, was the sole active ingredient in the product and therefore the application did not comply with Article 3(d) as it had been previously received marketing authorisations in the EU. He thus refused the application for SPC of albumin bound paclitaxel.