Post-Neurim SPCs and Paediatric Obligations: The Need for Coordination

The recent European Court decision in Case C-130/11 Neurim Pharmaceuticals has caused excitement among pharmaceutical companies because of the potential to receive additional supplementary protection certificates (SPC) on second medical use patents. However, while this may increase the length of patent protection, it could also trigger the obligation to carry out paediatric studies under the Paediatric Regulation. The Paediatric Regulation requires such studies to be carried out for previously authorised medicinal products only if they are protected by an SPC or by a patent which qualifies for an SPC. Therefore, by extending the scope of SPC protection, the Court may also have extended the scope of the obligations under the Paediatric Regulation. This advisory highlights the need for a coordinated approach when considering applying for SPCs for "old" active substances.