Impact Assessment: Optimising the Internal Market’s Industrial Property Legal Framework

This impact assessment will look into how to optimise the internal market’s industrial property legal framework relating to supplementary protection certificates (SPC) and patent research exemptions (particularly, Bolar exemptions) for sectors whose products are subject to regulated market authorisations. SPCs are an intellectual property right that constitute an extension (of up to five years) to the term of a patent right (of twenty years). They aim to offset the loss of effective patent protection that occurs due to the compulsory and lengthy testing and clinical trials that products require prior to obtaining regulatory marketing approval. The Bolar patent exemption aims at speeding up the entry of generic medicines into the market by allowing early preparatory development on generics to obtain pre-market regulatory approval even when the SPC of the reference medicine is still in force. The Commission will conduct an evaluation and impact assessment of all relevant provisions and options for modernising the SPC Regulations and the provisions of the Directives dealing with the Bolar exemption.

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