BLOG 3
In this third blog in the series on the new EU regulatory framework governing medicinal products, we focus on the key reforms to the Bolar exemption proposed by the EU Parliament, and the initial position taken by the Council of the EU, which was recently adopted on 4 June 2025.
The first and second blogs in this series focused on the current status of reforms to RDP and orphan market exclusivity, the process for marketing authorisations (MAs), supply and shortages of medicines, and transparency of research and development costs in the EU. These blogs can be found here and here. We will be reporting separately on the other key changes to the reforms following the draft adopted by the Council, as the position has, once again, changed.
The current scope
The Bolar exemption provides an exemption to patent infringement for certain activities carried out when preparing an MA application. Generally speaking, it allows for clinical trials to be conducted in the EU for the purposes of obtaining an MA for a generic or biosimilar product while a patent or SPC is still in force.
The current scope of the exemption states that "conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 [related to generic and biological medicinal products] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products."
This directive has been implemented nationally in member states, and some member states have taken the opportunity to broaden the exemption somewhat within their state. For example, some countries such as Germany, Ireland, Poland and Denmark have extended the exemption to cover applications for MAs outside the EU, while Ireland, Poland, Denmark and France have extended the scope of the exemption to MA applications for innovative products. The variations in scope across the EU causes uncertainty for generic manufacturers and originators alike and has resulted in some member states being perceived as more attractive locations for carrying out clinical trials and other activities in preparation of an MA application.
The proposed reforms
The reforms to the Bolar exemption aim to harmonise the position across the EU as well as to make the EU more attractive to pharmaceutical manufacturers. There have been a number of important developments in the proposed scope of the exemption as the proposal has progressed through the Commission, the Parliament and the Council.
The initial reforms proposed by the Commission, at Article 85 of the new Directive 2023/0132, expanded the scope of the exemption to expressly include activities conducted exclusively for the purposes of an application for (i) a marketing authorisation for generic, biosimilar, hybrid or bio-hybrid medicinal products (and subsequent variations); (ii) a health technology assessment (as defined in Regulation (EU) 2021/2282); and (iii) pricing and reimbursement. The Commission explained that the exemption would cover activities such as the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products and processes conducted for one the above purposes, and would apply to third party suppliers/service providers, as well as applicants.
Parliament adopted this expansion of scope proposed by the Commission, however importantly it removed the reference to 'generic, biosimilar, hybrid or bio-hybrid medicinal products' meaning the exemption would no longer be limited to such products, which may allow extension of the scope to innovative products. Parliament's proposal also confirmed that the scope of the exemption would not be limited to activities conducted for the purpose of MA applications – further activities such as those conducted for pricing and reimbursement approval would also be exempt.
The version of the exemption adopted by Parliament did not provide that the exemption would be limited to acts carried out for the purposes of an application for MA within the EU, which provides for the possibility that activities carried out for an MA application outside the EU could fall within the scope of the exemption, an extension which is already in place in some member states under the current exemption. Parliament also clarified, in a new Article 85a of the Directive, that this exemption applies to regulatory and administrative procedures only and confirmed the reformed exemption would not cover the placing of medicinal products on the market. It also made clear that the protection of intellectual property rights would not be a valid ground for a regulator to refuse decisions under Article 85.
The Council's initial position confirmed the scope of the Bolar exemption to cover activities related to obtaining marketing authorisation of "medicinal products", and in particular for generic, biosimilar, hybrid or bio-hybrid medicinal products – which is a narrowing of the exemption from the previous draft proposed by the Parliament.
On the other hand, the Council has expanded the scope further to include an exemption for activities conducted for the purpose of submitting procurement tenders. This means that generic manufacturers would be able to bid in national tenders, for example for hospital contracts, before the patent has expired, provided that the generic medicinal products are only sold, offered for sale, or marketed after the patent expiry. The Council has also removed the new Article 85a, instead confirming in paragraph 2 of Article 85 that decisions concerning such activities referred to above shall not be considered as infringing intellectual property rights.
The current wording of the exemption ('in particular') may still leave room for national courts to interpret it such as to apply to products other than strictly generic, hybrid, or biosimilar products. Overall, the exact wording of the provisions still seems to be the subject of debate at the EU level. But no matter the final form of the exemptions, the direction of the Parliament and Council seems clear – the Bolar exemption is likely to be broadened in scope under the new Directive, which will no doubt have significant implications for patentees.
The next blog in this series will cover some of the further key changes to the reforms adopted by the Council's in its initial position.
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