"It seems however clear that the exemption no longer explicitly covers acts done with the subject-matter of the invention."
Today, the Unified Patent Court (“UPC”) becomes operational. While all eyes are on this breakthrough new court – the first civil law court with a panel of judges coming from different countries – we should not forget that the Agreement on a Unified Patent Court (“UPCA”) brings other developments to the European patent landscape. One that seems often overlooked is the new wording it brings to the (Belgian) research exemption. Let us look at this for a moment.
What is the research exemption?
The research exemption exempts certain research activities that would otherwise qualify as patent infringement. Its purpose is to balance the inventors’ rights against the promotion of scientific research. In that regard, the impact of the UPCA may be even greater for Belgium than for other European countries.
Situation before the 1st of June 2023
Each European country had its own specific rules determining the scope of the research exemption. Compared to the rest of Europe, the Belgian research exemption was considered to be one of the broadest.
Under Article XI.34, §1 sub b) of the Belgian Code of Economic Law (“CEL”), the exclusive rights derived from a patent did not extend to acts on and/or with the patented invention for scientific purposes: it was clear that third parties were allowed to use the patented invention not only to research the invention itself, but also to use the patented invention as a tool to research other subjects. “Scientific purposes” included not only purely scientific acts, but also acts having a mixed (scientific and commercial) purpose.
Situation as from the 1st of June 2023
With a view to a uniform application of patent law throughout Europe, the Belgian research exemption has been aligned with the provisions of the UPCA, which results in an adapted wording of the exemption.
On the one hand, the new Article XI.34 §1, sub b) CEL mirrors Article 27 sub b UPCA and consequently reads “The rights conferred by a patent shall not extend to […] acts done for experimental purposes relating to the subject-matter of the patented invention“. It will be up to the courts and ultimately the ECJ to rule on what is to be qualified as “acts done for experimental purposes” and “relating to” the subject matter of the invention. It seems however clear that the exemption no longer explicitly covers acts done with the subject-matter of the invention.
On the other hand, as regards medicinal products, the new Article XI.34, §1/1 CEL now provides that the research exemption will additionally cover all acts “carried out for the purpose of the evaluation of medicinal products”, even if there is no reference medicinal product. This widens the scope for the exemption to medicinal products further than the so-called “Bolar exemption”, that only covers generic or biosimilar medicinal products.
Conclusion
The research exemption in Belgium has been rewritten anew in line with the UPCA, which raises new doubts on the exact scope of the exemption. Companies using a patented invention as a research tool seem to be less covered than in the past. On the other hand, research for the evaluation of medicinal products now clearly enjoys an increased coverage by the exemption.
CAPE IP
1 June 2023