Summary

The Court of Justice of the European Union (CJEU) recently considered whether a carrier protein covalently conjugated to the active ingredients of a vaccine could itself be protected by a Supplementary Protection Certificate (SPC). The Court found that while the covalent binding of active ingredients does not preclude the grant of an SPC, a carrier protein can only itself be considered an “active ingredient” if it produces a physiological effect which is covered by the marketing authorisation of the medicine in which it is present.

Background

SPCs can be used to extend the term of patent protection for a medicinal or veterinary product by up to 5 years. To obtain an SPC the active ingredient of the medicinal product must be protected by a patent,
and a valid authorization to market the medicinal product must have been granted.

The Supreme Patent and Trade Mark Adjudication Tribunal of Austria (the “referring court”) sought clarification from the CJEU on the grant of SPCs following an appeal by Mr. Forsgren, the proprietor of patent no. EP0594610B1. The patent relates to Protein D, an IgD-binding protein of Haemophilus influenza. Mr. Forsgren applied for an SPC for Protein D on the basis of its use in Synflorix®, a vaccine containing ten pneumococcal polysaccharide serotypes, eight of which are covalently conjugated to Protein D. The Marketing Authorization for Synflorix® states the therapeutic indications as being immunization against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumonia in infants and children. The SPC was refused by the Patent Office using the reasoning that since Protein D is conjugated to the pneumococcal serotypes, it is not present as such in Synflorix®. At appeal, it was the opinion of the referring court that the grant of an SPC depends on whether Protein D can be considered to be an “active ingredient” of Synflorix®. The referring court decided to stay proceedings pending the preliminary ruling of the CJEU.

Decision

The CJEU found that, in principle, an SPC can be granted for an active ingredient which is covalently bound to other active ingredients present in a medicinal product. However, the Court stated that an SPC cannot be granted for an active ingredient whose effect does not fall within the therapeutic indications covered by the marketing authorisation. Whether or not a carrier protein can be considered an “active ingredient” depends on whether that substance has a pharmacological, immunological or metabolic action of its own which is covered by the marketing authorisation. It is now for the referring court to decide whether or not Protein D constitutes an “active ingredient” of Synflorix®.

Comment

It must be remembered that the purpose of an SPC is to compensate a patent holder for the delay in commercially exploiting an invention due to obtaining a marketing authorization. Given that no data concerning the therapeutic effect of Protein D was included in the marketing authorisation procedure for Synflorix®, that procedure did not delay the commercial exploitation of Protein D. The CJEU’s position that the grant of an SPC must be linked to the indications mentioned in the marketing authorization is therefore no surprise. What is more interesting is the Court’s comment that covalent binding does not preclude the grant of an SPC “in principle”. It remains to be seen whether, in order to obtain an SPC for a carrier protein which has a therapeutic effect of its own that is covered by the marketing authorization, it will be necessary to demonstrate that this effect is provided by both the protein in isolation and its covalently conjugated form, given that covalent binding of proteins can drastically alter their function.