Data exclusivity of registration data is the period of non-reliance and non-disclosure that a government provides to pharmaceutical registration data. This data is the data generated by the innovator pharmaceutical company research based activities and conducting of clinical trials to demonstrate the safety and efficacy of the new medications and that is submitted to Regulatory agencies to support their application for marketing authorizations
Data Exclusivity Period in the EU
The period of data exclusivity in force for innovator products is affected by the outcomes reached in the European Pharmaceutical Legislation review after a compromise was reached between the Council and the European Parliament
The Council Directive provides for an 8 year period of protection, and a 10 year period for marketing protection which can be extended to 11 years if during the first 8 of those 10 years, the MAH gets an authorization for 1 or more new therapeutic indications that are held to be more significant as compared to other current existing therapies.
However, there is no restriction on manufacturing of the generic product during the final 2 years of market protection.
Data Exclusivity in the US:
In 1984, the US enacted a data exclusivity legislation known as The Drug Price Competition and Patent Term Restoration Act, commonly known as the “Hatch-Waxman Act”. Under this Act, approved new drug applications receive 5 years of data exclusivity, whilst approvals of new indication for existing drugs received 3 years of data exclusivity.
Bolar Provision
The legally allowed activity which allow manufacturers of generic pharmaceuticals to use the technology of a patented pharmaceutical to perform work that would assist in the marketing or regulatory approval of the generic product, while the patent is in force is generally known as the “Bolar Provision”. This allows the generic manufacturer to develop the generic product before the patent has expired, and submit the application whilst the marketing exclusivity period is in force, and therefore approved and ready for sale as soon as the patent and marketing exclusivity period is over.
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