ECJ: the “supplementary protection certificate” for protein D in Synflorix. A tough interpretation of Regulation (EC) No.469/2009

On January 15, 2015, the Court of Justice of the European Union (ECJ), in Arne Forsgren v. Österreichisches Patentamt C-631/13, issued a decision regarding the granting of a Supplementary Protection Certificate (SPC), requested by Arne Forsgren, for Protein D used in Synflorix, a vaccine authorized in European Union to protect from diseases caused by the bacterium S.Pneumoniae (full text here). As per the Regulation (EC) No.469/2009, the SPC covers the cost of research leading to the discovery of new “products” in order to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health. In the present case, the Protein D contained in Synflorix is bond to some polysaccharides as a “carrier” and not associated to any pharmacological effect on its own. Based on the concepts provided in Regulation (EC) No.469/2009, can a SPC be attributed to the Protein D, even if this substance is not considered an active ingredient? The commission rejected the request, based on the interpretation of Regulation (EC) No.469/2009 article 1, lett.b and article 3, lett.a and b. according to which the “carrier” protein could be protected by a SPC. Otherwise, in respect of the article 3, lett.b the SPC protection is granted only if Protein D may be categorised as an “active ingredient” and if this action is covered by the therapeutic indications of the marketing authorization. The decision to provide the SPC protection should be carefully taken: potential misapplications may result in risk to monopolize the market, viceversa the refusal to grant supplementary protection might take the interested company in a disadvantageous position in relation to market competitors.

Grazia Maria Gaspari

Court of Justice, 15 January 2015, C-631/13,  Arne Forsgren v. Österreichisches Patentamt

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