Article 3d of the SPC-regulation, read in conjunction with Article 1b, must be interpreted as meaning that the marketing authorisation for a new formulation of an old active ingredient cannot be regarded as being the first marketing authorisation for that product, when the active ingredient has already been the subject of a marketing authorisation.

The European Court of Justice (CJEU) handed down its ruling today in the case C-443/17 between Abraxis Bioscience LLC and the Comptroller General of Patents. The reference for a preliminary ruling came from the UK High Court of Justice, where Abraxis sought annulment of the Comptroller’s decision to reject the SPC application for a combination of substances containing the active ingredient paclitaxel in the form of nanoparticle bound to albumin (nab-paclitaxel).

Already before Abraxane (the market name of the medicinal product containing nab-paclitaxel), was put on the market, paclitaxel was marketed for use in eliminating cancer cells. Nab-paclitaxel is a new formulation of paclitaxel, marketed also for use in cancer treatment. Nab-paclitaxel is protected by that basic patent relied upon for the SPC application, but the protection conferred by that patent does not extend to paclitaxel as such.

The preliminary ruling concerned the understanding of Article 3d of the Regulation (EC) 469/2009 (the SPC Regulation), namely if the marketing authorisation for nab-paclitaxel was to be considered as the first authorisation to place the product on the market as a medicinal product.

The national court had asked the CJEU to clarify the scope of the earlier Neurimjudgement (C-130/11), which sets out that the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product, if such application is within the limits of the protection conferred by the basic patent. Specifically, the national court asked if the points of principle in Neurim apply also to new formulations of the product, and not only to new therapeutic uses.

The CJEU answered this in the negative. Firstly, the CJEU refers to the narrow and strict interpretation of ‘product’, and reminds us that a carrier which does not have any therapeutic effects of its own cannot be regarded as being an active ingredient within the meaning of Article 1(b). Consequently, the Court says, a new formulation of an old active ingredient, which, such as nab-paclitaxel, consists of that active ingredient and a carrier which has no therapeutic effect on its own linked together in the form of nanoparticles, cannot be regarded as being a product distinct from the product consisting solely of that active ingredient even if such a formulation allows that active ingredient to exercise its therapeutic effect with increased efficacy.

A literal interpretation of Article 3d presupposes that “the first marketing authorisation for the product” is the first for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue. Therefore, only the authorisation in respect of the first medicinal product placed on the market, consisting of the product concerned, may be regarded as the first marketing authorisation within the meaning of Article 3d.

So, how does that fair with the Neurim teaching?

That is maybe not so clearly spelled out by the CJEU. Rather, the Court focuses on what the Neurim judgement does notsay. In summary, the Court says that Articles 3 and 4 of the SPC-Regulation must be interpreted as meaning that, in a situation such as that in the case which gave rise to that judgment, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC 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 SPC application.

However, the Court did not, in that judgment, cast doubt on the narrow interpretation of the notion of ‘product’. Moreover, it should be noted that the exception to the narrow interpretation of Article 3d as held in the Neurim judgment, does not, in any event, refer to cases of a new formulation of the product at issue. That exception cannot, therefore, in any event, be relied on in the case of a marketing authorisation granted for a new formulation of an active ingredient which has already been the subject of a marketing authorisation, even if the marketing authorisation for that new formulation was the first to come within the scope of the basic patent relied on in support of the SPC application.

The Advocate General had suggested that the Neurim teaching should be limited to the situation where the one marketing authorisation was granted for veterinary use, and the other for human use. The CJEU does not specifically address this, but one may note that the Court has included a reference to one of the marketing authorisations being for a veterinary medicinal product and the other having a different application.

In conclusion, the CJEU has succeeded only in clarifying that the Neurim judgement is an exception to the narrow interpretation of Article 3d. The exact scope of that interpretation, other than that it is not applicable to new formulations of previously authorised products, is still not specified. Again, it is difficult to see a clear path of the guidance from the CJEU, and it remains to be seen if this is only an isolated ruling within the SPC regime, to set boundaries for our understanding of the Neurim judgement, or if it is a swing of the pendulum in the direction preached by the Advocate General.