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

13 December 2018

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 liberalisation of SPCs for previously authorised products. 

Neurim allowed an SPC for a first human use of an active ingredient, finding that a previous marketing authorisation for the same active ingredient for veterinary use could be discounted as outside the scope of the basic patent. Varying interpretations as to the extent of this judgement have been applied ever since. In the present case, Abraxis argued that the reasoning of Neurim should be applied to exclude any earlier marketing authorisation which falls outside the claims of the basic patent for any reason, even if the difference was solely one of formulation of the same active ingredient for the same indication. The UK government submitted observations suggesting that earlier marketing authorisations should only be excluded if they relate to different indications outside the claims of the basic patent. The Czech and Netherlands governments submitted observations suggesting that that earlier marketing authorisations should only be excluded if they relate to veterinary indications (i.e. closely following the specific facts of Neurim).

The AG has disagreed with all of these approaches and has advised that a strict literal interpretation of Article 3(d) should apply. This would mean that even earlier veterinary authorisations would not be discounted when considering which is the first authorisation for the purposes of Article 3(d) – effectively overturning Neurim. The AG found nothing in the preamble and travaux préparatoires that he considered would support deviating from a literal interpretation. The AG also found nothing to support the UK government’s position, which requires a distinction between second and subsequent medical uses of the same active ingredient versus second and subsequent formulations of the same active ingredient. The AG found no basis to separate these two scenarios, since both a new use and a new formulation can in principle give rise to independent patent protection and both can in principle benefit from abbreviated authorisation procedures.

Applying similar reasoning, the AG has advised that if the Court is unwilling to adopt a strict literal interpretation of Article 3(d), they should follow the proposal of the Czech and Netherlands governments to exclude only earlier veterinary authorisations. The AG found some merit in this approach, on the basis that the human authorisation procedure is not significantly altered by the existence of such an earlier veterinary authorisation. This latter approach may be attractive to the Court, since it would permit a ruling that could be characterised as clarifying rather than overturning Neurim. We await the Court’s decision with interest.

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