9 June 2011

'Negative Term' SPCs – CJEU's Advocate General Paves the Way

'Negative Term' SPCs – CJEU's Advocate General Paves the Way

The Advocate General of the Court of Justice of the European Union (CJEU) has today issued his opinion on Merck's 'negative term' SPC case. The AG considered that an SPC can be granted for a medicine in the EU even when less than five years have elapsed between the filing date of the basic patent and the date of first EU marketing authorization of that medicine. He also considered that the six-month 'paediatric extension' on an SPC (which is granted when paediatric studies have been carried out on a medicine) should begin from the date the SPC expires, even if this date is before the expiry date of the basic patent.

If followed by the full Court, this opinion will assist applicants to obtain SPC protection and paediatric extensions in Europe even in some cases when the regulatory authorities rapidly grant marketing authorisation for that medicine.