EU drug approval can occur before a country joins EU
ECJ judge says first authorisation date determines expiry of patents across EU
A European Court of Justice (ECJ) judge has argued that the date medicines are approved in a European Union (EU) country, which could be before it became a member state, determines the expiry date of patents across the EU.
Generics (UK) Ltd has claimed that a 1963 Austrian authorisation, which expired in 2001, should be considered as the baseline for a supplementary protection application by Synaptech Inc, also of the UK, for the neuro-muscular medicine Galantamine. The company argued that because Austria was not then a member state, a 2000 Swedish market approval decision should be used, enabling it to secure additional protection to 2012. But advocate general Paolo Mengozzi has ruled that because the Austrian authorisation ultimately allowed the drug to be sold in the EU, it should constitute the first authorisation.