In a judgment released today, Lewis J has rejected an application by Orion Corporation, a pharmaceutical company, to refer to the ECJ questions relating to the starting point of its period of data exclusivity under the Medicines Directive.
The Directive gives pharma companies that obtain a marketing authorisation a period of data exclusivity, during which the data from pre-clinical tests and clinical trials that they provide to the regulator when obtaining the authorisation cannot be used by any other company to obtain an authorisation for a similar drug. That period runs from the point at which the first marketing authorisation for the product is obtained in the EU. In the present case, the main issue was that a marketing authorisation was obtained in the Czech Republic in 2002 before its accession to the EU – the authorisation was maintained until several years after the Czech Republic joined the EU in 2004. A generic company had obtained a marketing authorisation from the UK and other EU Member States on the basis that the data exclusivity period ran from 2004 and had expired. Orion challenged the decision of the UK regulator, the MHRA, on the basis that the Czech authorisation did not “start the clock” because the Czech authorities had granted it before accession and, said Orion, had not complied with a number of important conditions surrounding the grant of an authorisation. The MHRA, the UK regulator, argued that the court was not entitled to look behind the Czech authorisation, which had to be treated as valid in 2004 when the Czech Republic joined the EU and therefore started the clock.
The Judge agreed with the MHRA and held that the position was clear: the data exclusivity period began to run in 2004 and had expired. There was no basis for a reference to the ECJ.