UK: No SPCs For New Formulations Of Old Active Ingredients, But Neurim Survives (For Now)

Last Updated: 26 March 2019
Article by J A Kemp

The CJEU issued on 21 March 2019 its judgment in the Abraxis C-443/17 case. The full text of the judgment can be found here.

The referral in Abraxis C-443/17 was made by Mr Justice Arnold of the English 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. Paclitaxel had been the subject of earlier marketing authorisations, albeit in different formulations.

Abraxis argued that those earlier marketing authorisations should be disregarded in view of the reasoning in C-130/11 Neurim Pharmaceuticals ("Neurim"). 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. The veterinary and human uses in Neurim were also for different "diseases". Abraxis contended 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.

Mr Justice Arnold considered that it was unclear how broadly the reasoning of C-130/11 Neurim Pharmaceuticals should be applied, and accordingly referred the following question 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 CJEU's answer to this question was as follows:

"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, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient."

In other words, SPCs are not available for new formulations of old active ingredients. In coming to this conclusion, the CJEU relied heavily upon Article 1(b) of the SPC Regulation, which states that "product" means the active ingredient or combination of active ingredients of a medicinal product. The CJEU considered that, according to the Court's settled case law, that Article 1(b) must be interpreted as meaning that:

"a new formulation of an old active ingredient, which ... consists of that active ingredient and a carrier which has no therapeutic effect on its own linked together in the form of nanoparticles, cannot be regarded as being a product distinct from the product consisting solely of that active ingredient even if such a formulation allows that active ingredient to exercise its therapeutic effect with increased efficacy." (see paragraph 31)

On this basis, the CJEU concluded that ABRAXANE® was the same product for the purposes of Article 1(b) as the earlier-authorised paclitaxel-containing products.

The CJEU then considered whether a marketing authorisation for a new formulation of an old active (such as ABRAXANE®) could nevertheless be the first considered the first marketing authorisation within the meaning of Article 3(d) of the SPC regulation, and concluded that:

"an MA granted for a new formulation of an old active ingredient, such as nab-paclitaxel, cannot be regarded as being the first MA granted for that product as a medicinal product within the meaning of Article 3(d) of Regulation No 469/2009, when that active ingredient has already been the subject of an MA." (see paragraph 40)

Notably, in reaching this conclusion the CJEU did not overturn the earlier Neurim decision, which was the approach favoured by Advocate General Henrik Saugmandsgaard Øe in his opinion of 13 December 2018 (see opinion here, with our commentary here). Rather, the CJEU pointed out that Neurim merely concluded that the "existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the SPC application". Further, Neurim did not mention new formulations of an old active ingredient. In the CJEU's view, therefore, Neurim does not "cast doubt" on the narrow interpretation of Article 1(b) discussed above, and consequently is not inconsistent with CJEU's conclusion that SPCs are not available for new formulations of old active ingredients.

Whilst the CJEU's conclusions regarding the unavailability of SPCs for new formulations of old active ingredients will not be popular with innovator companies, there will no doubt be relief that the CJEU did not overturn Neurim.

It is also noteworthy that the CJEU avoided clarifying precisely how broadly Neurim can be applied. In particular, during the proceedings the Czech and Netherlands governments argued that earlier marketing authorisations should only be excluded if they relate to veterinary indications (i.e. closely following the specific facts of Neurim), whilst the UK government argued that any different indications falling outside the claims of the basic patent should be excluded. It is expected that the CJEU will need to decide which approach is correct soon in referral C-673/18 Santen.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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