Data exclusivity and regulatory protection

Data exclusivity is the regulatory protection granted to the authorisation dossier of a reference medicinal product: for a set period, no generic manufacturer may rely on the results of the pre-clinical and clinical trials of the reference product to obtain its own authorisation. It is independent of the patent and the supplementary protection certificate. Data exclusivity rewards investment in trials, where the patent rewards the invention.

The European data exclusivity regime

First, data protection: for eight years from the first authorisation of the reference product in the Union, nogeneric marketing authorisation or hybrid application may be filed on the basis of its dossier. Next, market protection: for two further years, the authorised generic may not be placed on the market. Finally, one additional year of market protection is granted if, during the first eight years, the holder obtains a new therapeutic indication bringing a significant clinical benefit. This regime, summed up by the formula eight plus two plus one, derives from the Directive on the Community code relating to medicinal products for human use and from the Regulation establishing the centralised procedure, which can be consulted on EUR-Lex. The ongoing reform of European pharmaceutical legislation provides for adjusting these periods.

Data exclusivity and patents

The two protections are cumulative and complementary. The patent may expire before the end of data exclusivity, in particular where clinical development was long, and data exclusivity then protects alone. Conversely, for a medicinal product authorised quickly, the patent and the supplementary protection certificate run well beyond. Data exclusivity does not prevent the filing of a full marketing authorisation application based on the applicant’s own trials, nor theBolar exemption, which authorises the generic’s trials during the life of the patent.

Key points

In practice, the expiry date of data exclusivity is the first marker in the launch timetable of a generic and in the defence timetable of the originator. It combines with the expiry dates of the patent and the certificate, as well as with the exclusivity of orphan medicinal products. The firm draws up these protection timetables and acts in the disputes arising from them, as presented on the page pharmaceutical patents and regulation.