The CJEU delivered its judgment last week on the case of Abraxis v Comptroller General of Patents concerning Supplementary Protection Certificates (SPCs) for new formulations of medicinal products.
The Court has ruled that Article 3(d) of Regulation No 469/2009, read in conjunction with Article 1(b) of that Regulation, must be interpreted as meaning that the marketing authorisation (MA) for an SPC concerning a new formulation of an old active ingredient, cannot be regarded as being the first MA for the product concerned as a medicinal product where that active ingredient has already been the subject of an MA as an active ingredient.
The case concerns Abraxis’ application for an SPC for a new formulation (‘nab-paclitaxel’, marketed as Abraxane) of an old active ingredient (paclitaxel).
The referral of the Abraxis case generated particular interest following the CJEU’s judgement C130-11 in the case of Neurim v Comptroller General of Patents. In Neurim, the CJEU ruled that:
“the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.”
Neurim thus appeared to introduce new opportunities for a patentee to pursue SPC protection by arguing that a later MA could be considered the ‘first MA’ within the meaning of Article 3(d), because the application in the later MA is the first to be within the scope of protection of the basic patent being relied on for the SPC.
In the present case, Abraxane is the subject of an MA which was the first MA that came within the scope of the basic patent relied on for the SPC. However, paclitaxel had already been marketed under other, previous MAs. The UK IPO rejected the SPC application on the basis that the MA relied upon for Abraxane was not the first MA within the meaning of Article 3(d). On appeal, The UK court then referred the question of whether approval of a reformulation of an old active ingredient could provide the first relevant MA.
CJEU Judgement in Abraxis
- Interpretation of Article 1(b)
The Court determined that a new formulation of an old active ingredient cannot be regarded as being a ‘product’ that is distinct from the ‘product’ consisting solely of the same ingredient.
The Court explained that the term ‘product’ means the active ingredient or combination of active ingredients, and an active ingredient is one that has a therapeutic effect alone. In the present case, the albumin in ‘nab-paclitaxel’ acts as a carrier of the active ingredient paclitaxel - it does not have any therapeutic effects of its own. Thus, nab-paclitaxel cannot be regarded as a distinct product from paclitaxel.
- Interpretation of Article 3(d)
In light of the scope of ‘product’ above, the Court considered that the first MA for the product as a medicinal product within the meaning of Article 3(d) means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredient at issue. Consequently, the MA granted to nab-paclitaxel was not regarded as being the first MA granted for that product, in view of the earlier MAs granted to paclitaxel.
- Neurim The Court considered that the case law arising from Neurim did not call into question its interpretation of Article 3(d). The interpretation of Article 3(d) in Neurim was termed an ‘exception’, which did not in any case refer to cases of a new formulation of the product at issue. Neurim thus was not overturned, but may well now turn out to be a limited exception, possibly only applying in situations where the previous use of the active substance was a veterinary use – no doubt to be determined by more litigation.
This judgment has provided valuable information for those seeking SPCs for new formulations. There are still questions surrounding other situations e.g. second medical uses and new dosage regimes. Further case law is likely to develop. In particular, it will be interesting to follow the progress of the Santen CJEU referral C-673/18 on a second medical indication.