Santen SPC shake-up: CJEU rules no SPCs for second medical uses

On 9 July 2020 the Court of Justice of the European Union (CJEU) issued its judgement in Santen (C 673/18), ruling out Supplementary Protection Certificates (SPCs) for new therapeutic applications of previously authorised active ingredients.

Santen effectively overturns the CJEU’s 2012 decision in Neurim (C 130/11), which held that grant of an SPC in that case was not precluded by the mere existence of an earlier marketing authorisation for the same active ingredient.

Neurim appeared to endorse a broad interpretation of Article 3(d) of the SPC Regulation, which requires that the authorisation [on which the SPC is based] is the first authorisation to place the product [i.e. active ingredient(s)] on the market as a medicinal product.

There has been debate since 2012 regarding how broadly the Neurim principle should be applied, prompting two referrals from national courts to the CJEU: Abraxis (C 443/17) and Santen (C 673/18).

In the 2019 Abraxis decision the CJEU held that SPCs are not available for new formulations of old active ingredients, without overturning Neurim completely. This led to speculation that a narrower interpretation of Neurim might be endorsed, perhaps limited to new therapeutic uses of old active ingredients.

In Santen the Paris Court of Appeal referred two questions to the CJEU regarding the application of Neurim. The first question concerned how strictly to interpret the concept of a “different application” that might benefit from a new SPC under Neurim. The second question asked whether Neurim requires that the scope of the basic patent be the same as that of the marketing authorisation – that is, limited to the new medical use indicated.

The CJEU noted that the product of an SPC is defined in the SPC Regulation by reference to an active ingredient or combination of active ingredients, and that the protection conferred by the SPC covers any authorised medicinal use of that product. Therefore, the CJEU reasoned that the product is not dependent on use, and so if an active ingredient is used for a new therapeutic application, this does not confer the status of a distinct product.

The CJEU also observed that Article 3(d) of the SPC Regulation does not refer to the limits of the protection of the basic patent. The CJEU acknowledged that there is no need to take into account the limits of the protection of the basic patent to determine which is the first marketing authorisation within the meaning of Article 3(d) of the SPC Regulation, “contrary to what the Court held in paragraph 27 of the judgment in Neurim”.

Santen concludes with the CJEU’s ruling:

Article 3(d) of [the SPC Regulation] must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.

The Santen decision provides welcome clarity, dispelling much of the remaining ambiguity arising from Neurim and endorsing a more literal interpretation of Article 3(d) of the SPC Regulation.

Innovator companies may be disappointed that the narrow interpretation adopted in Santen reduces the availability of SPC protection, with likely repercussions for previous SPC filings based on Neurim.

By contrast, generics companies may welcome the earlier opportunity to enter the market for drugs no longer eligible for SPC protection following Santen.

If you have questions or concerns regarding the effect of the Santen CJEU decision, don’t hesitate to contact Luke Maishman PhD or your usual FRKelly contact.