Opportunity knocks: widening access to SPCs


André Guder

The Neurim ruling of the Court of Justice of the European Union sheds light on the requirement of the ‘first marketing authorisation’ for supplementary protection certificates, says André Guder.

On July 19, 2012, the Court of Justice of the European Union (CJEU) issued its ruling in the Neurim case (C-130/11). This decision creates new opportunities for extending the period of effective protection of a product by supplementary protection certificates (SPCs).

In particular, it clarifies that an SPC can be granted for a new, patented medical use of a product for which a marketing authorisation has been obtained, even if an earlier marketing authorisation for a different use of the same product exists.

In the underlying case, Neurim had found that the compound melatonin, a natural hormone that was not patented as such, can be used for treating insomnia in human patients aged 55 or older. A European patent was granted to Neurim for its formulation Circadin. At the time Neurim obtained the authorisation to place Circadin on the market, less than five years of the patent term were left, and Neurim filed an SPC application.

CJEU, Neurim, André Guder, SPCs, first marketing authorisation