The data exclusivity period is relevant to authorised medicines. It protects the originator’s investment in clinical trials.
The way it works: 8 + 2 (+1)
To obtain authorisation for a new medicine, originator companies must present evidence of the safety and efficacy of the medicine based on data obtained through lengthy and expensive clinical trials. Eight years after authorisation has been obtained, competing producers who wish to obtain authorisation for generic and biosimilar medicines can make an "abridged" application for authorisation of their generic/biosimilar products relying on the data initially provided by the originator. They must then wait a further two years before putting their generic or biosimilar product on the market.
This period of exclusivity (8+2) is referred to as the data exclusivity period and offers a ten-year period during which the originator can recoup its investment in clinical trials free from generic competition. An advantage of the system is that, on the one hand, it preserves the incentive to innovate by providing an exclusivity period and on the other it avoids the need to do unnecessary, repeat medical trials on humans or animals in relation to the generic products.
The exclusivity period may be extended by one year (+1) to a maximum of 11 years if the authorisation holder obtains authorisation for one or more new therapeutic indications during the first eight years. The new indication(s) must bring "significant benefit" compared with existing therapies, and this will be assessed during the authorisation process. Medicines which have complied with an agreed paediatric investigation plan and orphan medical products (products for rare diseases) may also qualify for extensions.
Interaction with patent protection
The patent regime is independent of the data exclusivity regime. A data exclusivity period may exist even where there has been no patent - or where the patent has been revoked for invalidity - and it may overlap with patent protection. In some cases, data exclusivity may extend beyond the term of patent protection, particularly where - as is common - patent protection has been applied for at the research stage.