The question concerned the duration of supplementary patent protection afforded to the innovative pharmaceutical industry. EU legislation provides the possibility of a supplementary protection certificate (“SPC”) to compensate a patent holder for the erosion of patent term suffered due to the lengthy regulatory process leading to the grant of marketing authorisation (“MA”) for medicinal products. In the EU, no medicinal product may be commercially exploited before the relevant authority has issued such an MA.
However, there has been divided opinions as to how the duration of an SPC should be calculated. EU legislation provides that the SPC duration is to be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. But what constitutes the date of the first MA? Is it the date when the decision granting the MA is adopted by the relevant authority? Or, is it the date on which the applicant is notified of the decision, which is typically a few days later?
In agreement with the recent opinion of the Advocate General, the CJEU has now settled this issue: the relevant date is the date on which the decision is notified to the applicant.
Not only has the CJEU’s ruling put an end to the uncertainty faced by the pharmaceutical industry regarding the duration of effective patent protection afforded to medicinal products, the additional two to five days typically seen between grant of an MA and notification to the applicant can be of significant commercial value, when added to the duration of an SPC. Proprietors of an SPC with a full 5 years added duration to the patent will not be affected by this decision.
Please contact our SPC expert Jan Mondrup Pedersen if you have questions in this regard.
