No SPCs for new formulations of previously approved active ingredients

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The European Court of Justice (CJEU) released its judgement in the case Abraxis Bioscience LLC v Comptroller General of Patents (C-443/17) on 21 March 2019. In its ruling, the CJUE held that Article 3(d) of the Supplementary Protection Certificates (SPCs) Regulation, read in conjunction with Article 1(b), must be interpreted as meaning that  the marketing authorization for a new formulation of an old active ingredient cannot be regarded as being the first marketing authorization for that product when that active ingredient has already been the subject of a previous marketing authorization.

This case originates from an appeal filed by Abraxis against the decision of the UK Intellectual Property Office (UKIPO) to refuse an SPC for Abraxane.

New formulations with paclitaxel

Abraxane is a new formulation containing paclitaxel in the form of albumin-bound nanoparticles (nab-paclitaxel). This new formulation provides greater efficacy than earlier formulations of paclitaxel for the treatment of certain cancerus tumors. A marketing authorization had previously been granted in respect of paclitaxel for the treatment of cancers. However, paclitaxel as such is not covered by the scope of protection of the basic patent relied upon for the SPC application.

The UKIPO had refused the SPC application on the grounds that the marketing authorization relied upon by Abraxis was not the first authorization for the active ingredient paclitaxel. Abraxis argued that, based on the conclusions of the CJEU in Neurim (C-130/11), the marketing authorization according to Article 3(d) of the SPC Regulation would be the first marketing authorization falling within the scope of the basic patent, i.e. the authorization for Abraxane.

The English High Court considered the extent of the reasoning in Neurim was not clear and referred the question to the CJUE whether Article 3(d) should be interpreted as permitting the grant of an SPC where the marketing authorization under Article 3(b) is the first authorization 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.

An old active ingredient

The answer of the CJUE was negative. First, the Court held that a carrier which does not have any therapeutic effect on its own cannot be regarded as being an active ingredient within the meaning of Article 1(b) of the SPC Regulation, even if it allows the active ingredient with which it is associated to exercise its therapeutic effect more effectively. Therefore, the CJUE considered that nab-paclitaxel, which consists of active ingredient paclitaxel and a carrier without therapeutic effect, cannot be regarded as being a product different from the product consisting solely of paclitaxel.

Based on a literal interpretation of Article 3(d) that the first marketing authorization of the product as a medicinal product means the first marketing authorization incorporating the active ingredient or the combination of active ingredients of the medicinal product, the CJUE then concluded that marketing authorizations for new formulations of an old active ingredient, such as nab-paclitaxel, do not qualify for first marketing authorization under Article 3(d) of the SPC Regulation.

Finally, the CJUE pointed out that the exception to the narrow interpretation of Article 3(d) of the SPC Regulation in the Neurim judgement did not refer to the case of a new formulation. So, the Court concluded that Neurim cannot be relied on in the case of a marketing authorization for a new formulation of a previously approved active ingredient, even if the marketing authorization for that new formulation was the first to come within the scope of protection conferred by the basic patent relied upon for the SPC application for that new formulation. Its development and the final resolution is available here.

Marta Rodríguez
Associate | Patent Adviser - Chemistry, Materials & Pharma
Marta is an European Patent Attorney and Spanish Patent and Trademark Agent. She joined ABG in 2008 and is an associate in the Chemistry & Materials and Pharma Departments. Her practice is focused on patent prosecution and opinion work in the area of organic chemistry. Before she joined ABG, Marta completed her doctoral thesis on asymmetric synthesis at the Universidad Autónoma de Madrid (1999-2004), including a pre-doctoral stay at the University of Pennsylvania and she worked as a postdoctoral fellow on metal-catalyzed cross-coupling reactions at the Massachusetts Institute of Technology (2004-06) and as a researcher in the area of asymmetric catalysis at the Universidad Autónoma de Madrid (2007-08).
Marta Rodríguez on Linkedin

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