Supplementary protection certificates

Arne Forsgren v Österreichisches Patentamt

This was a preliminary ruling given by the CJEU on the interpretation of Regulation (EC) No. 469/2009 (the SPC Regulation). No Advocate General’s Opinion was given.

This case is one of a number of decisions from the CJEU in relation to SPCs. This particular decision looks at whether an SPC can be granted for active ingredients which are bonded to other active ingredients.

Mr Forsgren was the proprietor of a European patent for Protein D, an immune binding protein binding to the bacterium Haemophilus influenzae and having a therapeutic effect against middle ear inflammation. Protein D was present as a covalently-bound carrier protein in a paediatric vaccine, SYNFLORIX, for which a marketing authorisation had been granted. The therapeutic indication listed in the marketing authorisation was immunisation against certain diseases caused by the bacterium Streptococcus pneumoniae.

The Austrian Patent Office (Österreichisches Patentamt) had refused to grant an SPC for Protein D on the ground that this protein was just an excipient. The decision was appealed, and the Austrian court referred the following questions to the CJEU:

1. Under Article 1(b) and Article 3(a) and (b) of [Regulation No 469/2009], provided that the other conditions are met, may [an SPC] be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is present in a medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains an effect of its own?

2. If Question 1 is answered in the affirmative:
(a) Under Article 3(a) and (b) of [Regulation No 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against the Haemophilus influenzae bacterium) but the marketing authorisation for the medicinal product does not relate to that effect?

(b) Under Article 3(a) and (b) of [Regulation No 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) 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 Court noted that the SPC Regulation did not distinguish between active ingredients which were and were not covalently bound. Thus, Question 1 was answered positively as follows:

Articles 1(b) and 3(a) of Regulation No 469/2009 must be interpreted as not precluding, 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.

In relation to Question 2(a), the court noted that as no data concerning the therapeutic effects of Protein D against H. influenzae had been provided in obtaining the marketing authorisation, obtaining this authorisation had not delayed commercial use of the Protein D patent. Thus, grant of an SPC would be contrary to the aim of the SPC Regulation to offset delays caused by the need to obtain a marketing authorisation. Accordingly, Question 2(a) was answered in the negative as follows:

Article 3(b) of Regulation No 469/2009 must be interpreted as precluding the grant of an SPC for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Question 2(b) was reformulated as asking whether a carrier protein enhancing the effect of a vaccine could be regarded as a product/active ingredient within the meaning of the SPC Regulation. Previous CJEU case law indicated that adjuvants (substances enhancing therapeutic effect of another substance but without independent therapeutic effect) could not be regarded as active ingredients, but that safeners (substances protecting a plant from herbicide) could be regarded as active ingredients under the analogous Plant Protection Regulation. Question 2(b) was answered as follows:

Article 1(b) of Regulation No 469/2009 must be interpreted as meaning 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 that provision 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, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings.

Case No. C-631/13