To stimulate the development of new medicines, various forms of ‘supplementary protections’ exist that give companies extended monopoly rights. This includes: Supplementary Protection Certificates (SPCs), which prolong the patent protection for medicinal products by up to five years; paediatric extensions to SPCs; regulatory protection in the form of data and market exclusivity; as well as regulatory protection in the form of the orphan drug regulation which intends to spur development for drugs to treat rare diseases.

Technopolis Group has prepared a report on the impacts of these intertwined mechanisms on pharmaceutical innovation and healthcare costs. This assessment is based on a review of available secondary data sources and literature; an interview programme with experts; a legal analysis on the four instruments; as well as seven case studies that illustrate the combined use of the instruments in real-life settings and the extent to which it was possible to manage patent life beyond the 20-year protection with the corresponding impacts. The study was prepared in collaboration with experts from the University of Liverpool and the University of Amsterdam. While the report has a focus on the Dutch market and was presented to the Dutch Parliament, the major discussion threads are applicable throughout Europe, given the highly international character of SPC/supplementary protection mechanisms. The study, while focused on the IP side, also ties into other cross-cutting analyses where Technopolis has been, in consortia, recently tasked by the European Commission to review the paediatric regulation and the orphan drug regulation

Thyra de Jongh
Principal Consultant

Alfred Radauer