New answers only muddy the water on supplementary protection certificates

By Dr Matthew Royle, Paul England and Julia Bödeker

Just one month after its ruling in GlaxoSmithKline Biologicals SA (C-210/13) on the application of the supplementary protection certificate regulation 469/2009/EC (SPC Regulation) to vaccine adjuvants, the Court of Justice of the European Union (CJEU) delivered three more important rulings on the same regulation on the same day: 12 December 2013. All the rulings follow from referrals made by national courts, seeking clarification of issues that had arisen as a result of the Court of Justice of the European Union’s (CJEU’s) rulings in Neurim Pharmaceuticals (C- 130/11) and Medeva (C-322/10).

The issues raised are acutely important to understanding the circumstances in which a patent can support the valid grant of an SPC for a product and what constitutes a product in the first place. The issues are these: is an adjuvant an active ingredient and therefore capable of constituting a ‘product’ protectable by an SPC (under article 1[b] SPC Regulation); can more than one SPC be granted on the basis of the same ‘basic patent in force’ (under article 3[a] SPC Regulation); and what does it mean to say that a product, or a process for making that product, must be ‘specified’ or ‘identified’ by a basic patent in force in order to be ‘protected by’ that patent (under article 3[a])?

As discussed below, while the answers to these issues have dealt with the particular factual scenarios in which the references were made, they have also muddied the waters considerably for anyone trying to draw out principles that can be applied more generally. This inevitably means that new questions will need to be addressed by the CJEU in due course. Unless, of course, the commission takes Arnold J’s advice and re-casts the SPC Regulation…

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