Beakers and Bunsens: AG Opinion - SPCs may not be granted for new formulations

17 December 2018

The Advocate General of the CJEU has recently provided their opinion in C-443/17 relating to the grant of SPCs for new and inventive formulations. The referral concerns whether or not the marketing authorisation for the new formulation is the first marketing authorisation in accordance with Article 3(d) of the SPC Regulation (No 469/2009).

Abraxis Bioscience LLC applied for an SPC for a combination of substances containing the active ingredient paclitaxel in the form of nanoparticles bound to albumin (nab-paclitaxel, marketed as Abraxane). Nab-paclitaxel is protected by a basic patent and the SPC is based on the marketing authorisation of Abraxane. However, the UK patent office rejected the SPC because the active ingredient, paclitaxel, has previously been the subject of a marketing authorisation. As a result, it was held that the marketing authorisation of Abraxane was not the first marketing authorisation under Article 3(d) of the SPC Regulation (and, as such, an SPC should not be granted).

The decision was appealed to the UK courts, where Mr Justice Arnold referred the question to the CJEU. The Advocate General’s opinion is that the CJEU should rule that SPCs cannot be granted for new and inventive formulations of a known active ingredient covered by a new marketing authorisation (under Art. 3(d) of the SPC Regulation). The Advocate General believes that the first marketing authorisation must be the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product.

The balance between providing cost-effective healthcare and rewarding innovative drug manufacturers is difficult to maintain. This will be a disappointing opinion for innovators of new and improved formulations. For example, Abraxane is acknowledged to provide benefits to patients beyond the conventional paclitaxel treatment and yet received no extra protection, despite Abraxane being lengthy and expensive to develop.

Joseph Lenthall

Joseph Lenthall

Partner

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