The new Belgian Research Exemption: harmonized… but not completely

In line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), most governments have introduced a “research exemption”  in their national patent law, with the aim of promoting research performed to advance science and technology by exempting it from patent infringement.

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  Agreement on a Unified Patent Court (UPCA) may be even greater for Belgium than for other European countries.

Ever since its entry into force in 2005, the Belgian research exemption has been the subject of some controversy. Together with the implementation of the Biotech Directive 98/44/EC into national law, the research exemption of the Belgian patent law of 1984 was amended to exempt from patent infringement “acts on and/or with the subject matter of the patented invention, carried out for scientific purposes”. While most other European countries had an exemption that was limited to research carried out on the patented invention (e.g., to improve on it), the Belgian law also exempted acts carried out with the patented invention from infringement. This arguably encompassed e.g., the screening of compounds using patented screening methods, or the use of other research tools in the development of commercial products. In fact, the “for scientific purposes” limitation was interpreted in the case law to include not only purely scientific acts but also those with a combined scientific and commercial purpose.

While no official statements have been made in writing, representatives of small and large companies located in Belgium have admitted that they have often relied on this exemption. There is speculation as to whether the exemption contributed to some extent to the (remaining) presence of research facilities of major pharma companies. in Belgium.    

But with the launch of the UPCA on June 1^st of this year (2023), a change in the Belgian Research Exemption has come into effect. The new law was already drafted back in 2017 with the aim of harmonizing the rights attributable to the different types of patents that would take effect on Belgian territory (i.e., national patents, Belgian validations of European patents and Unitary patents). The wording of the new research exemption in Article XI.34, §1, sub b) of the Belgian Code of Economic Law (CEL) was taken over from the UPC agreement and thus now specifies that the exclusion applies to “experiments carried out relating to the patented invention”. 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 CJEU 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.

By removing the part relating to experiments performed with the invention, the Belgian research exemption has been harmonized with that of the UPC ensuring legal certainty and avoiding competition between the UPC and the national Courts. It is noted that the exemption now also no longer includes the “for scientific purposes” limitation. Thus, in principle, “experiments” carried out on the invention which are performed with a commercial aim are non-infringing acts.

The  wording in Art. XI.34 §1, sub b CEL was intended to be a literal translation of Art. 27, b of the UPCA which refers to “acts done for experimental purposes relating to the invention”.

As most national laws, the Belgian law also contains a “Bolar exemption” in Art. 6bis §1 of the law of 25 March 1964 on medicinal products  for human use (“Geneesmiddelenwet”). This separate exemption is included in Art. XI.34, §1, sub d CEL and is aimed at allowing the generic industry to prepare the entry onto the market shortly before the expiry of the term of the patent covering the originator product. This provision exempts from patent infringement the carrying out of experiments and tests aimed at obtaining information required for obtaining a market authorization on a therapeutic. Given that this exemption refers to a “therapeutic” its application is limited to generic medicines or biosimilars. This article is unaffected by the harmonization exercise.

Interestingly, and assumingly to reassure the pharmaceutical industry in Belgium, the CEL was additionally changed by including paragraph Art. XI.34, §1/1 CEL indicating that “All acts which are carried out for the evaluation of medicinal products are considered as acts carried out for experimental purposes on the subject of the patented invention, within the meaning of paragraph 1, b)”. This additional provision is more like an additional Bolar exemption, now also including originator products and no longer limited to clinical trials within Belgium or even Europe as was the case with the Bolar exemption in the medicines act.

As research often takes many years it is likely that the recent change in the Belgian law will raise some questions about the impact of the change on ongoing research activities. Acts falling within the exemption under the old law may no longer fall under the exemption now.  The Belgian Patent law as amended specifies that these provisions equally apply to patents that were granted before entry into force of the law but do not affect “rights that had at that time been acquired”. It is to be seen whether or not an “exemption to infringement” could be seen as such an “acquired right” and is currently under scrutiny by the Intellectual Property Council (“Raad voor Intellectuele Eigendom” in Dutch or “Conseil de la Propriété Intellectuelle” in French), of which Dr. Koen Vanhalst of our firm is a member. The Council has recently published an advice to that end which can be found here.

It should be remembered, however, that whether these provisions of the Belgian CEL will apply will depend on whether the relevant patent is enforced before a Belgian Court or before the UPC. If the Patent is a European patent with unitary effect or a European patent which has been validated in Belgium and was not opted out, the Unified Patent Court Agreement will be applied and not the Belgian provisions. The Belgian provisions can only be relied on where the relevant patent has been opted out from the competence of the UPC. Thus, if you are intending to perform experiments with patented medicines, a Freedom To Operate (FTO) analysis will need to take this into account. Due to the presence of Unitary effect also covering Belgium, it is likely that more European patents will be enforceable in Belgium in the future than with the classical validation system where only roughly 11% of the granted European Patents were/are validated in Belgium; hence a FTO exercise will become more relevant for the previously lesser validated countries.

De Clercq & Partners is happy to assist you with determining whether the Belgian or UPC research exemption applies to your activities or to help you determine to what extent you can ensure that third parties respect your patent rights. If you would like to receive more information or assistance do not hesitate to contact one of our IP experts or reach out to us via info@dcp-ip.com.