Insight
Research exemptions under Belgian patent law before and after
1 June 2023
A research exemption is a provision in patent law that allows researchers to perform Research and Development (R&D) on patented inventions without infringing on the patent holder's rights. In Belgium, the research exemption was one of the broadest in Europe until 31 May 2023.
This exemption included all acts performed for scientific purposes and left sufficient room for R&D activities exempted from patent infringement. As of 1 June 2023, the research exemption in Belgium is aligned with that in the UPC agreement and the exemption no longer includes R&D acts performed using a patented invention.
In addition to the above exemption for scientific research, Belgian legislation already had broad provisions specifically aimed at R&D for medicines before 1 June 1 2023, with the goal of enabling a rapid market introduction of medicines. This so-called Bolar exemption allowed (pre)clinical trials during the term of patents. Similar provisions have been implemented in the UPC agreement, but herein they are limited to generics and biosimilars (the so-called 'classic’ Bolar exemption).
Non-generic and non-biosimilar medicines
Non-generic and non-biosimilar medicines do not fall under the classic Bolar exemption, which means that clinical trials of innovative medicines that were exempt under the ‘old’ Belgian research exemption will no longer fall under the new modified research exemption, nor the classic Bolar exemption, as of 1 June 2023.
'Bolar+' exemption
Under the UPC agreement, all UPC member states are required to adhere to minimum harmonization, but allow them to provide for a broader Bolar exemption. This was done in Belgium, France and Germany, among others (the Netherlands retained the traditional Bolar exemption). Belgium wanted a Bolar exemption that also covered R&D of innovative medicines. Therefore, a further amendment was made and from 1 June 2023, the new Belgian research exemption (the so-called 'Bolar+' exemption) will apply and include R&D of innovative medicines.
For national Belgian patents, the situation seems simple. The Belgian court must apply national law for this, and the broad Belgian provision will be applied.
Unitary patent
From 1 June 2023, it will be possible to apply for a unitary patent once a European patent has been granted. These European patents with unitary effect can only be enforced through the UPC, which will rely on the (more limited) classic Bolar exemption. Under European patents with unitary effect, a company conducting activities with innovative medicines in Belgium is not expected to be able to rely on the Belgian Bolar+ exemption.
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