Abstract: The interplay of the exclusive right conferred by patents to
innovative pharmaceutical products and the regulatory rules for their marketing
approval seemed to be solved 1993 with the creation of the Supplementary
Protection Certificate, which allowed patent owners to extend on a timely basis
their exclusive rights upon expiration of the patent, thus mitigating, at least
partially, the negative effects of lengthy administrative marketing approvals.
The development of this new IP right through the years has revealed
deficiencies in the system and resulted in a rich body of European case law,
notably as to what constitutes a 'basic patent', 'marketing authorisation' or
'product', which provide key concepts for the requirements of the Supplementary
Protection Certificate. The successive amendments of the Regulation concerning
the Supplementary Protection Certificate for Medicinal Products include the
extension of the original duration of this right upon new requirements
concerning the inclusion of paediatric plans in the marketing authorisation
which form the basis of a SPC application.
Keywords: Supplementary protection certificate, basic patent, marketing authorisation, european union, pharmaceuticals, medicinal product, active ingredients, regulation