The CJEU recently considered a further referral regarding SPCs in Case C-631/13 (Arne Forsgren v Österreichisches Patentamt). 

This case concerns an application for an SPC in Austria from European patent EP0594610, owned by Mr Forsgren.  This patent claims a Protein D product and describes the use of the protein as a vaccine against Haemophilus influenza.  The SPC application directed to Protein D, as covered by the basic patent, also tried to rely upon the marketing authorisation to Synflorix as filed by GlaxoSmithKline Biologicals, where Synflorix is a vaccine against Streptococcus pneumonia and contains pneumococcal polysaccharides covalently bound to Protein D.  However, it was explicitly stated in the marketing authorisation for Synflorix that there was insufficient evidence of any protective effect against Haemophilus influenza.  Thus, the marketing authorisation for Synflorix did not indicate that Protein D would be active against H.influenza

In view of the lack of information in the marketing authorisation regarding the activity of Protein D, the Austrian Supreme Patent and Trade Mark Adjudication Tribunal asked the CJEU whether an SPC should be granted. 

The proprietor of the patent submitted that Protein D in Synflorix would have a vaccine effect against H.influenza and also would act as an adjuvant for pneumococcal polysaccharides.  He argued that there was nothing in the Regulation for SPCs indicating that the marketing authorisation should refer to the therapeutic effect of the active. 

The CJEU firstly indicated that the covalent bonding of Protein D to pneumococcal polysaccharides should not prevent the granting of an SPC. 

They also indicated that for the marketing authorisation for Synflorix to be sufficient to grant an SPC for Protein D, Protein D must be an active ingredient as required by the SPC Regulation and it must produce “a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation”.  This was sent back to the referring court to decide.