The End Of Second Medical Use SPCs? AG's Opinion In Abraxis C-443/17 Suggests That Neurim C-130/11 Should Be Over-Turned

The Advocate General, Henrik Saugmandsgaard Øe, has today issued his Opinion in connection with the referral to the CJEU in Abraxis C-443/17. The full text of the Advocate General's Opinion is available here. The Opinion is not binding on the CJEU. It is the role of the Advocates General to propose to the Court, in complete independence, a legal solution to the cases for which they are responsible.

The referral in Abraxis C-443/17 was made by Mr Justice Arnold of the UK High Court in a case concerning an application for an SPC for the oncology product ABRAXANE®. This product comprises the active ingredient paclitaxel formulated in albumin-bound paclitaxel nanoparticles. The following question was referred to the CJEU:

"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 Advocate General's Opinion sets out the following advice to the CJEU:

"Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of such a certificate where the marketing authorisation relied upon in support of the application for a supplementary protection certificate under Article 3(b) of that regulation is not the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product. This is so even in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon is the first to cover the formulation protected by the basic patent relied upon in support of the application for a supplementary protection certificate under Article 3(a) of that regulation."

In reaching his conclusion the AG conducted a detailed review of the preamble and travaux préparatoires of the SPC regulation, together with a consideration of the line of earlier case law which took a literal interpretation of Article 3(d) (most notably Yissum (C‑202/05) and a similar decision relating to plant protection products, BASF (C-258/99)), before revisiting the famous Neurim decision (C-130/11) that had applied a more teleological approach, and which first led to a perceived...