The Bolar Exemption in Europe following the EU Pharma Package

One of the provisions set to change when the EU Pharma Package comes into force in 2028 is the ‘Bolar Exemption’ which sits at the intersection of EU pharmaceutical regulation and patent law. This is a provision of EU law that is designed to allow for timely generic and biosimilar market entry after patent expiry by permitting certain pre-launch activities that would have otherwise constituted patent infringement. 

However, until the launch of the Unified Patent Court (UPC), patent infringement was a matter solely for national law, and the actual interpretation of the EU Bolar Exemption has been inconsistent across the EU Member States. The EU Pharma Package, the full text of which was published in March 2026, significantly revises the EU Bolar Exemption. This revision seeks to harmonise and broaden the Exemption across the EU, but in doing so raises important questions, particularly for patent enforcement before the UPC. 

The Bolar Exemption

The Bolar Exemption is a provision of EU law that allows the use of a pharmaceutical product for pre-launch activities, without infringing a third-party patent or supplementary protection certificate (SPC) protecting the product, provided those activities are necessary for regulatory approval and market access. Its name comes from a US Federal Circuit Court of Appeals decision Roche Products, Inc. v. Bolar Pharmaceutical Co, however its implementation in the EU comes from Article 10(6) of Directive 2004/27/EC of the European Parliament and of the Council, amending Directive 2001/83/EC (the Community code relating to medicinal products for human use). 

This current Article 10(6) of the Directive, which only applies to generic and biosimilar companies, provides that; -

“conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 [i.e. marketing authorisation] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products (emphasis added).” 

The objective of the current Directive is to ensure that regulatory and administrative preparation does not delay lawful competition beyond the end of the term of patent protection.

However, historically it has been unclear exactly how broad this exemption is. Some Member states have interpreted the Exemption narrowly, limiting it to only studies and clinical trials that are strictly required for market authorisation, for example, The Netherlands. Other states have, however, taken a more lenient approach, allowing a much broader set of acts to be exempted with several countries expanding the implemented Directive at the national level to also include innovator companies as well as generic and biosimilar companies in the exemption, for example, Germany. One particularly contentious area has been regarding pricing, reimbursement and tendering activities and whether this was included. Moreover, it was also unclear as to whether the EU Bolar Exemption could be extended to third-party service providers such as contract manufacturers, even when those parties were acting entirely on behalf of a generic applicant.   

Addressing these inconsistencies in the Directive is one of the explicit aims of the EU Pharma Package. 

Changes under the EU Pharma Package

The EU Pharma Package significantly revises this framework by expanding and clarifying the Bolar Exemption in the new Pharmaceutical Directive, which will replace the current Directive 2001/83/EC. 

The revised provision no longer focuses narrowly on studies and trials but instead covers all activities necessary for placing a generic or biosimilar medicinal product on the EU market. It will, therefore, be expanded into a broad market‑entry exemption, covering all acts objectively necessary to prepare a generic or biosimilar for lawful launch after patent or SPC expiry. It does not, however, include an exemption for innovator companies.

In particular:

• The EU Pharma Package expands the Bolar Exemption into a broad market‑entry exemption, expressly covering HTA, pricing and reimbursement procedures, tender participation and third‑party regulatory activities.

• Once the revised EU Bolar exemption enters into force in 2028, the UPC will be bound to apply it as a matter of EU law, creating the prospect of greater consistency in patent enforcement across participating EU Member States (but note the likelihood of different implementation of the new Directive into national laws). 

• The expanded Exemption is likely to raise the threshold for findings of imminent infringement, as regulatory and market‑access readiness alone will no longer suffice to “set the stage” for infringement and an application for a preliminary injunction.

• We believe that enforcement before the UPC will, therefore, most likely shift toward requiring patentees to show evidence of commercial execution, rather than preparatory conduct, raising the bar for obtaining a preliminary injunction. 

These activities are permitted whilst patent or SPC protection is still in force, provided there is no commercial sale, supply or marketing before expiry. Importantly, regulatory data and market exclusivities remain fully intact: the EU Bolar Exemption does not permit any early reliance on originator data or early market entry but prevents regulatory preparation from delaying post‑expiry competition.

We should note at this point that although the United Kingdom is no longer a member of the EU, the Exemption remains embedded in Section 60(5)(i) of the UK Patents Act 1977. The UK amended the original wording of the Directive to a broader interpretation of the Exemption to include exempt innovators, third party manufacturing and HTA from infringement, and, therefore, the proposed changes are likely to lead to more alignment between the UK and the EU Bolar Exemption in the new Directive under the EU Pharma package. 

The UPC’s approach

One of the most significant longer-term implications of the change to the EU Bolar Exemption is that with the establishment of the UPC, questions relating to the scope and limits of the Bolar Exemption for European patents and SPCs can now be assessed by a single, centralised judicial body, rather than by a patchwork of national courts. That is, the UPC is bound to apply EU law by Article 24(1)(a) UPC, of which the amended EU Bolar Exemption will become part once it is enters into force. 

In principle, this offers the prospect of greater consistency and predictability across Europe under the UPC. In particular, the new provisions are likely to influence what the UPC considers ‘imminent infringement’ in context of preliminary injunctions (PIs). Although national laws may incorporate additional wording to the provisions thereby causing an inconsistency across the national courts. 

As things stand following the UPC Court of Appeal’s decision in Boehringer Ingelheim v. Zentiva, the Court applies what is sometimes referred to as the ‘set the stage’ test for this decision. According to this test, infringement is imminent where the alleged infringer has completed all preparations necessary for infringement to occur, such that only the alleged infringer’s “self- restraint” would prevent it from infringing. In particular, the Court held that “completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement”. Pricing and reimbursement is currently the “trigger” for an infringement action and a potential preliminary injunction (PI).

Of course, when the provisions of EU Pharma Package come into force, these actions will be specifically allowed by the EU Bolar Exemption. Activities that the new legislation expressly shields such as HTA, pricing and reimbursement procedures, tender participation and third‑party manufacturing for regulatory purposes will no longer be capable, in themselves, of constituting the act that “sets the stage.”

In practice, this will raise the threshold for patentees. Under the revised regime, a generic may have completed all regulatory, HTA, pricing and reimbursement steps and still fall safely within the EU Bolar Exemption, meaning that the UPC may no longer treat such “launch ready” status as sufficient to establish a risk of imminent infringement. As such, there will no longer be a trigger for a preliminary injunction by the Patent when a third party applies for pricing and reimbursement.  Instead, evidence that the defendant has crossed the boundary from preparation into unprotected commercial execution will almost certainly be required. Until the EU Pharma Package enters into force, however, pricing and reimbursement steps may still be relevant in assessing imminent infringement.

Interestingly, in the same case, Boehringer v Zentiva, the generic sought to rely on the policy direction of the proposed Directive to argue that the Court should interpret the current exemption as in line with the draft proposal. The Court of Appeal rejected this argument, holding that draft or future legislation has no relevance to the interpretation of current law. Until the Pharma Package enters into force, pricing and reimbursement steps may therefore still be relevant in assessing imminent infringement.

Take-aways 

• The EU Pharma Package expands the Bolar Exemption into a broad market‑entry exemption, expressly covering HTA, pricing and reimbursement procedures, tender participation and third‑party regulatory activities.

• Once the revised EU Bolar exemption enters into force in 2028, the UPC will be bound to apply it as a matter of EU law, creating the prospect of greater consistency in patent enforcement across participating EU Member States (but note the likelihood of different implementation of the new Directive into national laws). 

• The expanded Exemption is likely to raise the threshold for findings of imminent infringement, as regulatory and market‑access readiness alone will no longer suffice to “set the stage” for infringement and an application for a preliminary injunction.

• We believe that enforcement before the UPC will, therefore, most likely shift toward requiring patentees to show evidence of commercial execution, rather than preparatory conduct, raising the bar for obtaining a preliminary injunction. 

Our team will be offering a package to assist organisations with reviewing their patent portfolio in order to assess the impact of these changes and to provide you with tailored advice. Many of our attorneys have worked in‑house within the pharmaceutical industry, so we can provide practical, experience‑led advice tailored to your needs.

For more information, and if you would like guidance on strengthening your IP position, navigating the new framework, or assessing how these reforms affect your portfolio, please contact Lindsey Kent, Chris Lindsay, or your usual Abel + Imray advisor.