How Strict? European Court Of Justice Provides Further Guidance On The Interpretation Of The SPC Regulation

Introduction

Innovators in the European Union ("EU") can extend the period of exclusivity for their new medicinal products up to five years post patent expiry through the grant of a Supplementary Protection Certificate ("SPC"). Unlike US patent term extensions, an SPC does not extend the term of a patent. Instead, an SPC is a sui generis right, the application for which requires a patent in force and a marketing authorisation ("MA") covering the relevant product, and which only extends the period of exclusivity in relation to that product. Exactly what patents and marketing authorisations may be relied upon when applying for an SPC and what is meant by "active ingredient", "product" and "medicinal product" in the SPC Regulation1 has vexed many and been the subject of numerous court proceedings and referrals to the Court of Justice of the European Union ("CJEU").

In this article the author provides an update on what may be understood to constitute an "active ingredient", "product" and "first authorisation" for the purposes of Article 1(b) and Article 3(d) of the SPC Regulation following the CJEU Abraxis2 decision and what further questions remain unanswered in the further preliminary reference to the CJEU in the Santen case.

The SPC Regulation

Article 1(b) of the SPC Regulation defines "product" as the "active ingredient or combination of active ingredients of a medicinal product".

Article 3 of the SPC Regulation sets out the conditions that need to be satisfied in order to obtain an SPC including: (i) Article 3(b), which provides that an MA must have been granted in respect of the product; and (ii) Article 3(d), which provides that the MA referred to in Article 3(b) must be the "first authorisation to place the product on the market as a medicinal product".

Abraxis v Comptroller General of Patents

Abraxis markets nab-paclitaxel under the brand name Abraxane, a medicinal product indicated for the treatment of breast, pancreatic and lung cancers either on its own or in combination with other anticancer treatments under a marketing authorisation granted in 2008 (the "Abraxane MA"). Nabpaclitaxel consists of paclitaxel formulated as albumin bound nanoparticles. The addition of albumin in Abraxane has been shown to give nab-paclitaxel greater efficacy than paclitaxel and other earlier formulations already on the market under previous MAs.

In 2016, the UK Intellectual Property Office ("IPO") rejected Abraxis' SPC application for Abraxane. The hearing officer concluded on the facts that nab-paclitaxel consists of a single active ingredient (paclitaxel), together with a carrier (albumin)...