The Bolar and related exemptions in Europe: What activity do they cover?

March 2020

The experimental use exemption to patent infringement is provided by national laws and its interpretation varies from one European country to another. Doubt about the extent to which this exemption protects the conduct of clinical trials and other tests necessary to obtain a marketing authorisation led to the introduction of the Bolar exemption (named after a similar provision in US law), by the Medicinal Products Directive (Directive 2001/83/EC).

The Bolar exemption has itself been applied differently in Europe, with broad application in Germany and narrow application in countries such as the UK and the Netherlands. As a result, the UK has now introduced a further experimental use exemption which is designed to mirror Bolar in Germany. Poland has also introduced draft legislation to implement a broader approach.

What do all these exemptions do and how do they apply?

In this instalment of our Life Sciences Disputes series, we unpack the various exemptions in Germany, the Netherlands, Poland and the UK, addressing what is known about the activities that they cover and what is not.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.


Amanda Ebbutt

Amanda is a senior associate in our London office, specialising in patent law.

Paul England

Paul is a senior professional support lawyer in our London office, specialising in patent law.

Anja Lunze

Anja is a partner in our Munich office, specialising in patent law.

David Mulder

David is an associate in our Amsterdam office, specialising in patents.

Agnieszka Sztoldman

Agnieszka is a senior associate in our Warsaw office, specialising in IP/IT and life sciences.