Case C-443/17 Abraxis Bioscience. Request for a preliminary ruling. High Court of Justice UK.
Patent Law. Applicant (Abraxis Bioscience) has filed an application for a supplementary protection certificate (SPC) with the Intellectual Property Office of the United Kingdom (UK IPO) . Defendant (Comptroller-General, head of the UK IPO) is responsible for issuing SPC's in the United Kingdom. Applicant requested an SPC for a product called 'nab-paclitaxel'.
The first problem is that the SPC Directive does not contain a definition for the term 'active ingredient'. More specifically, what is the position regarding (i) substances that in any way support an active ingredient to create a certain therapeutic use and (ii) combinations of those substances and active ingredients? The second issue lies in the fact that Article 3(d) requires the marketing authorization that is issued to be the 'first authorization to market that product as a medicinal product'. How should this requirement be interpreted in a situation where there a marketing authorization has already been issued for an active ingredient or combination of active ingredients, but the new authorization is intended for a different formula or another therapeutic use of those active ingredients or combination of active ingredients? As the defendant argues, the judgements in cases C-431/04, C-210/13 and C-631/13 state that SPC's are not meant to be issued exclusively for new formulas. Because this subject has not been directly and fully settled in any of the aforementioned judgements, the Court's position remains unclear. Therefore the referring judge files a request for a preliminary ruling with the CJEU concerning the interpretation of Article 3(d) of the SPC Directive in the matter of the question at hand.
Request for a preliminary ruling:
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?