Why Santen ends Neurim-style SPCs

The July 9 Santen decision ( C-673/18) from the Court of Justice of the European Union (CJEU) resolves the issues that arose from the earlier Neurim decision ( C-130/11) issued by the same court. Essentially, and unusually, the CJEU reversed its own earlier decision.

Active substances that are repurposed for new uses will no longer be eligible for a supplementary protection certificate (SPC) under the Neurim approach. Repurposed actives that are protected only by such Neurim-type SPCs are now vulnerable to immediate generic competition.

Background

Article 3 of the SPC Regulation 469/2009 requires that, for an SPC to be granted:

(a) The product is protected by a basic patent in force;

(b) A valid authorisation to place the product on the market as a medicinal product has been granted in accordance with directive (2001/83) or directive (2001/82), as appropriate;

(d) The authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product (emphasis added).

Article 3(d) is the real focus of Santen and Neurim. The “product” and related “medicinal product” are defined in article 1 as follows:

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk