Further unravelling the SPC Gordian Knot


Avi Toltzis and Penny Gilbert

Further unravelling the SPC Gordian Knot


The CJEU’s decision in Forsgren has brought greater clarity to the scope of the SPC regulation, including whether a substance is an active ingredient, as Avi Toltzis and Penny Gilbert of Powell Gilbert explain.

On January 15, the Court of Justice of the European Union (CJEU) handed down its judgment in Forsgren (C-631/13). The judgment provides further guidance on the eligibility for supplementary protection certificates (SPCs) under articles 1(b) and 3(a), and 3(b) of regulation number 469/200—the SPC regulation.

The basic patent, EP0594610 (registered to Arne Forsgren), relates to protein D, which binds immunoglobulin D and is conserved in Haemophilus influenzae. Protein D is present in Synflorix, a pneumococcal vaccine for which GlaxoSmithKline Biologicals received a European marketing authorisation (MA) in 2009.

Synflorix is a vaccine composed of ten pneumococcal polysaccharide serotypes conjugated to a carrier protein, protein D, and absorbed by aluminium phosphate. The MA states that the vaccine is for use in active immunisation against diseases caused by Streptococcus pneumoniae.

SPCs, CJEU, Forsgren, patent, Synflorix, GlaxoSmithKline