Marketing authorisation relied on in support of an application for a SPC concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.
Abraxis markets a medicinal product, under the name ‘Abraxane’, indicated for the treatment of certain cancers. The medicinal product contains the substance ‘nab-paclitaxel’ and is being protected by EP 612. Abraxane was granted a marketing authorisation (‘MA’) in 2008. Abraxis applied for an SPC on the basis of the basic patent at issue and the MA granted for Abraxane. The application was turned down on the ground that it did not comply with Article 3(d) of Regulation No 469/2009. The Patent Office held that, although that provision permits the grant of an SPC for a new and inventive therapeutic use of an old active ingredient, its scope does not extend to a new and inventive formulation of an old active ingredient. The High Court of Justice (England & Wales), Chancery Division (Patents Court), decided to stay the proceedings and to refer to the Court of Justice for a preliminary ruling.
The Court answers the questions as follows:
"Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient."
IPPT20190321, CJEU, Abraxis Bioscience
C‑443/17 - ECLI:EU:C:2019:238
