A patent usually protects an invention for up to 20 years from the date the patent is filed.
However, new medicines cannot be marketed for several years after the discovery of the active drug and filing for a patent. This is due to the time required to conduct clinical trials and obtain regulatory approval. Therefore, additional protections are available for new medicines:
- a Supplementary Protection Certificate (SPC) – this can extend protection for up to five years
- a Paediatric Extension (PE) – this can extend an SPC for an additional six months
Protection for a new drug entity can therefore last for up to 25 years and six months.