Giving his opinion in a case between Merck Sharp & Dohme and the German Patent Office, Yves Bot addressed an aspect of the SPC Regulation that has caused controversy as it has been interpreted differently in EU member states.
SPCs enable manufacturers of pharmaceutical and veterinary products to gain up to five years extra exclusivity in the EU to compensate for the time taken in gaining marketing approval.
Where the time from patent filing to marketing approval is less than five years, the SPC would be mostly useless as it would not extend the life of the patent. In these circumstances, it is sometimes referred to as a negative-term or zero-term SPC.
Negative-term SPCs though are important for the filing of paediatric extensions, which depend on the applicant having an SPC (even a negative-term one).
Bot’s advice that they can be granted is therefore likely to welcomed by the drugs industry, and could encourage research into medicines for children.
His opinion is broadly in line with the approach taken by the UK IP Office. But other EU member states took different positions in their submissions to the court.
The question was referred by Germany’s Federal Patent Court in a case involving a diabetes drug. The European patent was filed in July 2002 and the marketing authorisation was in March 2007.
The German office refused to grant an SPC on the grounds that the period between the two dates was only four years, eight months and 16 days.
The drug is sold by Merck as Januvia.
The Advocate General’s opinion is likely but not certain to be followed by the Court, which is expected to give its judgment later this year.
The opinion is available on the CJEU website, but is not yet in English.
