Insights: No additional protection for new formulations of old active ingredients

In March 2017, the High Court in the UK requested a preliminary ruling from the CJEU on the interpretation of Article 3(d) of the SPC Regulation (EC/469/2009). In particular, the following question was referred:-

“Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”

The CJEU has now handed down its decision and the full judgment can be read here. The CJEU has concluded that an application for an SPC cannot rely on a marketing authorisation (MA) for a new formulation of an old active ingredient if the active ingredient has already been the subject of a MA.

Facts of the case
Proceedings took place between Abraxis Bioscience LLC and the UK’s Comptroller General of Patents, following the UKIPO’s decision to refuse Abraxis’ application for an SPC covering their product, “Abraxane”. Abraxis appealed the decision to the High Court.

Abraxane is an injectable formulation of albumin-bound paclitaxel (nab-paclitaxel) used for the treatment of various types of cancers. Abraxane was granted a MA in 2008 based on evidence that the combination of paclitaxel and albumin was more effective compared to earlier formulations of paclitaxel.

Importantly, paclitaxel has already been marketed under previous MAs. However, Abraxis argued that nab-paclitaxel was a new formulation and that the MA granted for Abraxane was the first MA within the scope of the basic patent (EP0961612) to put this new formulation on the market. They argued that this was sufficient to satisfy Article 3(d) of the SPC Regulation.

In support of this argument, Abraxis referred to an earlier decision, Neurim Pharmaceuticals (C-130/11). In this judgment the CJEU held that the existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application (i.e. a human application) of the same product for which a MA has been granted. By analogy, Abraxis suggested that the existence of an earlier MA for an active ingredient should not preclude the grant of an SPC for a new formulation of that same active ingredient for which a MA has been granted.

Interestingly, the Paris Court of Appeals, also grappling to interpret the ruling of the Neurim case, referred a similar question to the CJEU in October 2018. The Paris Court asked whether the ruling in Neurim Pharmaceuticals should be understood to include not only therapeutic indications and different diseases, but also different formulations, dosages and/or modes of administration.

Preliminary ruling
In answering the question referred by the High Court, the CJEU noted that albumin, while necessary to improve the therapeutic efficacy of paclitaxel, is itself a carrier that possesses no therapeutic activity of its own. Accordingly, the CJEU confirmed that a new formulation of an old active ingredient and a carrier, wherein the carrier has no therapeutic effect, cannot be regarded as a product distinct from an earlier product consisting solely of the active ingredient.

Since nab-paclitaxel is not regarded as a new “product” compared to earlier forms of paclitaxel on the market, the CJEU reasoned that the MA granted for Abraxane cannot be regarded as the first authorisation to place the product on the market as a medicinal product.

The CJEU has therefore favoured a narrow interpretation of Article 3(d), in confirming that an application for an SPC cannot rely on a MA for a new formulation of an old active ingredient if the active ingredient has already been the subject of a MA. The CJEU was also quick to point out that the judgment of Neurim Pharmaceuticals makes no reference to new formulations of old active ingredients and is therefore not considered applicable to the present case. It will be interesting to see whether the referral from the Paris Court of Appeals concludes in the same manner that different dosages and modes of administration of an old active ingredient are also excluded from additional protection.