Friday - 20 July 2018

The proposed SPC Export Manufacturing Waiver

The European Commission (EC) recently published a proposed adjustment to the SPC Regulation (Regulation No 469/2009) concerning medicinal products, which would allow EU-based companies to manufacture generic or biosimilar versions of an SPC protected medicine during the term of an SPC, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed.

The EC press release may be found here. The proposed amendment to the SPC Regulation is available here.

The proposal has not yet come into effect, as it still needs to be adopted by the European Parliament and Council. The EC intends to introduce the new provisions by 2019.

Click the image below to download an overview of the proposed adjustment. 

SPC Waiver


For further conversation regarding SPCs , please email Bethany Gibbs on


Bethany has a Master’s degree in natural sciences, specialising in neuroscience, from the University of Cambridge. Bethany has been extensively involved in European prosecution, opposition and appeal work, as well as in the management of patent portfolios and in the provision of freedom-to-operate opinions and associated strategic advice. In addition to patent matters, Bethany has also been involved in advising clients in relation to the filing of supplementary protection certificates (SPCs) across multiple European jurisdictions.