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Drastic changes in Belgium for the research exemption as well as the clinical trial exemption
Intro
The research exemption for patents has long been a vital mechanism in striking a balance between protecting inventors’ rights and promoting scientific exploration. Within Europe, Belgium historically provided a notoriously broad exemption relating to research. However, on the 1st of June this year, the Unified Patent Court will start. One of the aims of the new patent court is harmonization and Belgium and other countries that will join the system have aligned their patent law. The changes that have been introduced in the Belgian law will have an immediate impact on companies, universities and institutes and concern general research as well as research and development for medicines specifically.
The research exemption
The research exemption is a provision in the law of most countries that permits researchers and innovators to perform research activities on patented inventions without infringing on the patent holder’s rights. In Belgium, the research exemption in force until May 31st is the following:
The rights conferred by a patent shall not extend to (…) acts done for scientific purposes on and/or with the subject-matter of the patented invention
The legislator confirmed that the exemption should be interpreted broadly by the courts and not only covers purely scientific activities, but also activities with mixed commercial and scientific objectives. The wording of the exemption itself is also considered to be very broad because it allows third parties to use the patented invention without the patentee’s consent, to research the invention itself (e.g. to determine the functioning, the function, the efficacy or the operation of the invention), but also to use the patented invention as a tool to research other things (see the insert for an example). The latter is not permitted in most other countries.
From June 1st, however, the research exemption will be aligned to the one in the Unified Patent Court agreement and will read:
The rights conferred by a patent shall not extend to (…) acts done for experimental purposes relating to the subject-matter of the patented invention
As is immediately apparent from the wording of the new provision, the exemption no longer provides for acts done with the subject-matter of the invention. It is generally expected that the use of a research tool to investigate something else will no longer be covered by the research exemption from June 1st onwards.
Companies, universities and institutes that felt confident in using e.g. patent screening assays, genetic modification tools and research devices should carefully reevaluate the impact of the new situation.
The Bolar exemption for medicines
In addition to the research exemption, there are provisions specifically for the research and development of medicines. The goal is to allow a sufficiently fast entry of drugs onto the market by allowing preclinical and clinical trials to proceed during the life of patents. The mechanism is generally referred to as the ‘Bolar exemption’. Belgium, as other EU countries, has implemented the EU Directive in this respect. Of note, this EU exemption is restricted to generic and biosimilar products that aim to rely on the marketing authorization of an originator. This exemption will remain mostly unchanged after June 1st.
For non-generic and non-biosimilar medicines, the situation is much less clear. Although there is no court decision on this situation specifically, most considered that preclinical and clinical trials with innovative medicines would be covered by the above-mentioned ‘old’ research exemption that would also apply to mixed scientific and commercial research.
With the amendments of the patent law for June 1st, Belgium aimed to provide Bolar exemption that would clearly cover the research and development of innovative medicines. During the legal preparations, it was discussed that an amendment was needed because the ‘old’ research exemption did not cover this situation. From June 1st, the law provides:
All acts performed for the purpose of the evaluation of medicinal products are considered to be acts done for experimental purposes relating to the subject-matter of the patented invention within the meaning of [“the research exemption”]
Belgium has thus chosen to maintain the narrow EU “Bolar exemption” for generic and biosimilar medicines and to further add a broad provision that all acts for the authorization of medicines fall within the “research exemption” that has been described above. As we will discuss, this blanket provision has a great risk of providing unwarranted comfort to companies that perform activities in Belgium.
For European patents with unitary effect
From June 1st, it will be possible to request unitary effect for all the countries that joined the Unified Patent Court system, once the patent is granted. These European patents with unitary effect can exclusively be enforced through the newly established Unified Patent Court (UPC). The Court will apply the UPC agreement, which provides its own set of exemptions, including the research exemption and narrow Bolar exemption, but excluding the broad Belgian exemption. Thus, if a company performs activities with innovative medicines in Belgium, it is expected not to be able to rely on the Belgian broad exemption. This is further reinforced by the requirement in the EU Regulation associated with the UPC, which states that all the limitations (exemptions) of the patent right must be uniform in all UPC member states. As not all countries have implemented the broad provision from Belgium, the exemption is not uniform and the Belgian provision is in conflict with the higher-ranking EU law. For completeness, it is furthermore pointed out that the EU Regulation specifies that the limitations of the patent are determined by the law in the country of the original applicant of the patent. Thus, if the broad Belgian provision for innovative medicines would be applicable, it would be a limitation for those patents that were filed by Belgian applicants, but would not be linked to the actual place of the activities.
For European patents without unitary effect
With few exceptions, European patents without unitary effect can be enforced for at least seven years before the UPC as well as before the national courts. These patents include all European patents granted before June 1st and those granted afterwards for which the patent holder did not request unitary effect. In this case, there is a significant possibility that the judges of the UPC will rely on the exemptions in the UPC agreement only and, thus, not on the broad Belgian provision. On the other hand, the Belgian judge is expected to apply the Belgian law, including the broad Belgian provision. It thus seems quite reasonable that the outcome might be different on whether the case is treated before the UPC or the national court. Taking into account that the patent holder may normally choose the venue of enforcement, this may again lead to unpleasant surprises for companies that rely on the broad Belgian exemption for innovative medicines.
For national Belgian patents
For national Belgian patents, the situation appears to be rather straightforward. The Belgian court has to apply the national law and it is to be expected that the broad Belgian provision will be applied, exempting the acts performed for medicinal approval, subject to the caveat below.
The possible conflict with the European Patent Convention
As described above, the European patent with unitary effect is expected to have narrower limitations (i.e. be broader) than a national Belgian patent. For a European patent without unitary effect, there may be an impact depending on the court that handles the case. However, the European Patent Convention requires that a European patent (i.e. with or without unitary effect) must confer the same rights as a national patent. It seems that there are at least some arguments available to support that this will not be the case from June 1st onwards and, perhaps, that the broad Belgian exemption cannot be applied because it conflicts with the international agreements that Belgium acceded to.
The Pharma Package
On April 26th, the European Commission published a proposal for new legislation for medicinal products. This is currently draft legislation and it remains to be seen if and in which form the law will ultimately enter into force. The current proposal also comprises a modified Bolar exemption. An important proposed change concerns a clarification that the exemption not only applies to the party performing the research and development of the medicine, but also to third party suppliers and service providers (think API manufacturers and CROs). However, the new proposal is still provided for generics and biosimilars. This time, it also includes hybrids and bio-hybrids that wish to provide a scientific bridge to the originators data. In its current draft form, the new Bolar exemption would not cover innovative therapies that require a full application for a marketing authorization.
The take-away messages
In conclusion, on June 1st, the research exemption in Belgium will be restricted drastically and will in general no longer cover the use of a patented invention as a tool during research. Entities are strongly advised to reevaluate their freedom-to-operate situation when using patented products and methods in the course of their research.
Acts performed for the evaluation of generic and biosimilar medicines will in most cases be exempted from patent infringement in view of the EU Bolar exemption, which has also been implemented in Belgium.
For the evaluation of innovative medicines, such as the necessary preclinical and clinical studies, Belgium implemented a very broad exemption in its national law. However, as analyzed above, there is a significant risk associated with relying on this broad exemption. Specifically, when European patents would be enforced by the patent holder before the Unified Patent Court, it appears more likely than not that the court will not apply the broad Belgian provision. Even before the Belgian court, a patent holder might bring the argument that the broad Belgian provision cannot be applied because it conflicts with international agreements that Belgian acceded to.