The Court of Justice of the European Union (CJEU) has recently handed down yet another judgment (C-631/13) which seeks to clarify what can, and cannot, be protected under EC Regulation No 469/2009 (the SPC Regulation). Here the CJEU has decided that an SPC may be granted for an active ingredient covalently bound to another substance only if the active ingredient for which supplementary protection is sought has a therapeutic effect covered by the wording of the marketing authorisation.
This decision stemmed from a referral by the Austrian Patent Office and seeks to clarify the requirements of Article 3(a) and Article 3(b) of the SPC Regulation which require that in order for a certificate to be granted:
(a) the product must be protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product must have been granted (“a marketing authorisation”).
The decision relates to an SPC application for Protein D, which is protected by the basic patent EP0594610 and has a therapeutic effect against the Haemophilus influenza bacterium. However, the marketing authorisation relied upon by the applicant related to Synflorix; a pneumococcal polysaccharide conjugate vaccine comprising 10 pneumococcal polysaccharides, of which 8 were conjugated to Protein D as a carrier protein. The therapeutic indications covered by the marketing authorisation relate to active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumonia in infants and children from 6 weeks up to 2 years of age. However, they did not extend to the treatment of, or protection against, Haemophilus influenza infection.
The SPC application was refused by the Austrian Patent Office on the grounds that (i) the covalently bound Protein D-pneumococcal polysaccharide conjugates of the medicinal product are not functionally equivalent to the product protected by the basic patent, namely isolated Protein D; and (ii) the marketing authorisation only relates to Protein D as a carrier protein and expressly mentions that there is no evidence of an independent effect of Synflorix as a vaccine against Haemophilus influenza, meaning that the product is not covered by the marketing authorisation. The Austrian Patent Office sought clarification from the CJEU as to whether such objections were valid grounds for refusal of an SPC application.
In answer to point (i) above, the CJEU has now confirmed that an active ingredient covalently bound to other substances is not, in principle, precluded from SPC protection. However it was considered that this depends on whether the active ingredient has a pharmacological, immunological or metabolic action of its own, independently of any covalent binding with other substances. Surely though the right question is not whether the isolated carrier protein has a pharmacological, immunological or metabolic action but rather whether this activity is retained when the carrier protein is present within a conjugate. The CJEU has refrained from making any comment on this point.
Regarding point (ii), the applicant argued that, in addition to its role as a carrier protein, Protein D was in fact used in the formulation of Synflorix to confer protection against Haemophilus influenza infections, and that the absence of a statement of this therapeutic effect in the marketing authorisation was irrelevant. The CJEU disagreed and noted that the scope of protection of an SPC only extends to the authorised use of the medicinal product (Article 4 of the SPC Regulation), in this case active immunisation against Streptococcus pneumonia. Thus, the CJEU concluded that an SPC cannot be granted for an active ingredient whose therapeutic effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.
This decision confirms that, in principle, a carrier protein covalently conjugated to another substance may be considered an active ingredient for the purposes of securing SPC protection. However, in order to be eligible for SPC protection it must be established that the carrier protein itself produces a pharmacological, immunological or metabolic action which is covered by the therapeutic indications of the marketing authorisation.
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