(The original Italian version is also published on Diritto 24 – Il Sole 24 Ore)

On 15 January, the European Court of Justice (“ECJ”) ruled in Case C- 631/13 concerning supplementary protection certificates (“SPCs”). As is known, this is a very relevant matter in the life sciences industry, which we discussed among other thingshere on this blog. In this case, the subject was whether it is possible to obtain a valid SPC for a protein contained in a covalent bond with other active ingredients in the medicine for which the marketing authorisation (“MA”) was granted.

In essence, the holder of the basic patent on protein D had applied for an SPC in Germany for the same protein. This, however, was not the only active ingredient of a medicinal product for which an MA had been granted; instead, it was contained in a vaccine provided with an MA (called “Synflorix”) in which it was conjugated, as the carrier protein, to pneumococcal polysaccharide serotypes. The SPC application had been rejected by the competent German office precisely because the protein D is not present as such in Synflorix, but is covalently bound to other active ingredients, for which it would not be the subject of an MA as a medicinal product within the meaning of EU Regulation no. 469/2009 (the “Regulation”). Hence, according to the office, it could not be granted an SPC, as the latter can only be granted when, among other things, the “product” (aka the active ingredient or combination of active ingredients) as a medicinal product is covered by an MA.

Following a series of complaints and appeals by the holder of the patent, the issue landed at the ECJ to which the referring German court referred three questions.

In the first question, the referring court asked whether the Regulation precludes the possibility that an active ingredient can give rise to the grant of an SPC on the sole ground that the active ingredient is covalently bound to other active ingredients forming part of a medicinal product. In this regard, the Court notes that the Regulation makes no distinction depending on whether the active ingredient is covalently bound to other active ingredients, which is why that fact does not preclude the granting of the SPC. What matters instead is that the active ingredient is really such, i.e. that it is a substance that “has a pharmacological, immunological or metabolic action of its own”.

In the second question, the referring court asked whether the Regulation precludes the grant of an SPC for an active ingredient the therapeutic effect of which does not fall within the therapeutic indications covered by the wording of the MA: the MA for Synflorix does not in fact mention the therapeutic effects of protein D. The ECJ recalls in this respect that, on the one hand, a patented product cannot be the subject of an SPC if it has not been granted an MA as a medicinal product and, on the other hand, the protection conferred by the SPC is to extend only to the product covered by the MA “for any use of the product as a medicinal product that has been authorised before the expiry of the certificate”. In light of this, the Court believes that “the use of a product which has not been authorised, as a medicinal product, by the MA may not be covered by an SPC”, and that therefore “an active ingredient whose therapeutic effects do not fall within the therapeutic indications for which an MA was granted may not give rise to the grant of an SPC”.

In the third question, the referring court finally asked whether the Regulation precludes the grant of an SPC “for a product referred to in the marketing authorisation of a paediatric vaccine as the carrier protein of an active ingredient, on the ground that that protein, as an adjuvant, enhances the effect of an active ingredient, without that effect being expressly mentioned in the marketing authorisation”. In response, the ECJ first notes that in the present case the protein D is actually not an adjuvant; accordingly, the Court considers that the question of the referring court should be reformulated, and that the court is rather interested in establishing whether a carrier protein used in a medicinal product conjugated to a pneumococcal polysaccharide, although not having a therapeutic effect of its own that is covered by the wording of the MA, may be considered to be a “product” to the aims of the Regulation. In this respect, the Court highlights that there is nothing in the Regulation that explicitly settles the matter, but that nonetheless it was clarified that only a substance that “has a pharmacological, immunological or metabolic action of its own” can be considered to be a “product”. The Court therefore concludes that such protein can be categorised as a product “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”.