Skip to content

EU – Public consultation on SPCs and Bolar exemptions

13 Oct 2017

European Commission launches a Public consultation on supplementary protection certificates (SPCs) and patent research exemptions, 12 October 2017 – 4 January 2018

The Commission states:

Objective of the consultation
The Single Market Strategy, adopted in October 2015, announced that the Commission will ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’.

In particular, the Strategy aimed to explore a recalibration of certain aspects of patent and supplementary protection certificate (SPC) protection, and announced that this recalibration could comprise the following 3 elements:

– the creation of a European SPC title
– an update of the scope of EU patent research exemptions
– the introduction of an SPC manufacturing waiver

Contributions are particularly sought from:

– originators in the agrochemical and pharmaceutical sectors (large companies, universities, start-ups, small and medium-sized enterprises)
– the EU-based generic and biosimilar medicines and plant protection products industry, and active pharmaceutical ingredients (APIs) suppliers
– innovative sectors whose products require pre-market regulatory authorisation but are not eligible for an SPC
– national authorities
– consumer organisations, patient groups, research and academic institutions, and individual citizens

More information can be found on the Commission website.