Can an SPC be granted for an active ingredient covalently bonded to other active ingredients?

January 2015

The judgement in another referral to the CJEU on the subject of SPCs, was given on 15 January 2015, see C-631/13: FORSGREN.

This referral came from Austrian Patent Office regarding to application for an SPC for “Protein D”.  The SPC application was based on a European patent relating to ‘Protein D ‒ an IgD-binding protein of Haemophilus influenzae’. 

Protein D is present in a pneumococcal vaccine for paediatric use named ‘Synflorix’.  Marketing authorisation was granted for ‘Synflorix — Pneumococcal polysaccharide conjugate vaccine (adsorbed)’.  The indications in the marketing authorisation referred to immunisation against certain conditions caused by Streptococcus pneumoniae in infants and children.

Protein D is covalently bonded to pneumococcal polysaccharides in the Synflorix product and is described as a carrier protein.  The applicant (Forsgren) argued that protein D had a therapeutic effect in its own right against Haemophilus influenza bacteria and should therefore be considered to be an active ingredient eligible for SPC protection.  However, this effect was not part of the indication in the marketing authorisation.  

The referring court asked the CJEU the following questions in an attempt to clarify if this complex product was eligible for SPC protection

1.   May an SPC be granted a substance protected by a basic patent (protein D) where the active ingredient is present in a medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but nonetheless retains an effect of its own?

2.   If the answer to question 1 is yes:

(2a) May an SPC be granted where that substance has a therapeutic effect of its own (in this case, as a vaccine against the Haemophilus influenza bacterium) but the marketing authorisation for the medicinal product does not relate to that effect?

(2b) May an SPC be granted where the marketing authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, pneumococcal polysaccharides), where the substance, as an adjuvant, enhances the effect of those substances, but where that effect is not expressly mentioned in the marketing authorisation for the medicinal product?’

The CJEU responded:

1.   That the SPC Regulation does not preclude, in principle, the possibility that an active ingredient can give rise to the grant of an SPC where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product. 

2(a) An active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation, may not give rise to the grant of an SPC.  In relation to this aspect of the referral, the CJEU pointed out that the EPAR for the product stated that there was no supporting data for claims relating to conditions caused by the Haemophilus influenza bacterium (the activity shown by Protein D) and therefore the therapeutic effects of Protein D was not integrated into the marketing authorisation for Synflorix.  As such the commercial use of the patent covering protein D had not been delayed by the regulatory approval of Synflorix.

2(b) The CJEU held that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of the SPC regulation only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.  The CJEU did not rule on whether Protein D present in Synflorix produces the required effect.  Rather, this specific matter was left for the referring court to determine, in the light of all the facts of the dispute in the main proceedings. 

The case will now go back to the Austrian Patent Office for a decision. 

It would seem that there are more and more specific scenarios for complex pharmaceuticals which require clarification by the CJEU.  Is it time for the Commission to review the SPC regulation to bring it into line with current pharmaceutical research and products?  However, given that anything new could be more onerous for the sector, is it a case of better the devil you know?

This update was prepared by Mike Nelson, Partner in our Leeds office. 

If you would like further advice on this or any other matter, please contact Mike at  (Tel: +44(0) 114 274 3700), or your usual HGF representative or visit our Contact Page to get in touch with your nearest HGF office.