Dr Christian Tillmanns
Attorney, Meisterernst Rechtsanwälte PartG mbB, Germany
Tillmanns@meisterernst.com

Introduction

Against the backdrop of current discussions on the further development of the Bolar exemption within the framework of the European Union Pharmaceutical Package, this topic fits seamlessly into the central themes of the 12th Annual IBA World Life Sciences Conference in Lisbon, which focuses on the intersections between patent protection, market access, and regulatory harmonisation.

The Bolar exemption represents a key patent law barrier in pharmaceutical law. It allows generic and biosimilar manufacturers to conduct studies and trials to obtain marketing authorisation even during the term of a patent. The origin of the provision is the United States decision Roche v Bolar 733 F2d 858 (Fed Cir 1984), to which the legislature responded with the Hatch-Waxman Act. The aim of the Bolar clause is to enable immediate market entry upon patent expiration (‘day-one entry’) and to prevent a de facto extension of patent protection. It thus serves to balance innovation protection with effective competition in the pharmaceutical market.

Implementation to date in the EU

The legal basis for the Bolar exemption under EU law is found in Article 10(6) of Directive 2001/83/EC. According to this provision, studies and trials, as well as the resulting practical requirements, are not considered infringements of patents or supplementary protection certificates, provided they serve the purpose of obtaining a marketing authorisation. However, precisely because of its deliberately open wording, no uniform interpretation has emerged within the Union. Disputes exist, in particular, regarding which actions are privileged and to what extent third parties involved in a division of labor – such as active ingredient manufacturers or contract developers – are also covered.

In Germany, the Directive’s provision was implemented by section 22(2b) of the German Patent Act (PatG). There, national case law tends toward a function-based interpretation. In this regard, the decision of the Higher Regional Court of Düsseldorf dated 5 December 2013 (Decision of 5 December 2013; Case No I-2 U 68/12 – Market Authorisation Privilege). The court focused on whether the act in question is functionally integrated into a specific authorisation procedure. Accordingly, contract manufacturers may also be entitled to the privilege provided their activities are exclusively, or at least sufficiently closely related, to the preparation of the authorisation. This approach takes into account the international and division-of-labour structure of pharmaceutical value creation.

In contrast, the Polish Supreme Court, the Sąd Najwyższy, took a more restrictive approach in its judgment of 23 October 2013 (Case No IV CSK 92/13). It rejected an exemption under Bolar for an API manufacturer acting as a subcontractor for the generic drug applicant and emphasised the exceptional nature of the provision. While this more formal approach strengthens patent protection, it complicates the practical implementation of complex marketing authorisation projects.

The Italian Corte Suprema di Cassazione, in its judgment of 5 July 2024, No 18372, has developed a middle-ground approach. Contract manufacturers may generally invoke the Bolar exemption, but only in the case of a specific order and strict purpose limitation to a particular marketing authorisation procedure. Purely commercial stockpiling activities remain excluded.

Overall, this reveals a fragmented legal landscape across the EU, which, from the perspective of internationally active companies, leads to significant legal uncertainty and underscores the need for harmonisation

Analysis of the Bolar clause in Article 85 of the proposed Directive (‘Pharma Package’)

Article 85 of the proposed Directive within the EU Pharmaceutical Package¹ represents a fundamental development of the existing Bolar exemption and addresses the interpretative uncertainties that have become apparent in practice. The aim is to ensure consistent application across the EU while simultaneously facilitating actual market access for generics, biosimilars, and hybrid and biohybrid medicines.

Central to this is the significant expansion of the scope of application. At the EU policy level, tensions emerged between the Parliament and the Council during the legislative process. The European Parliament pursued a consistently functional approach and advocated for the comprehensive inclusion of all preparatory acts relevant to market entry, including HTA procedures, price negotiations, and tenders. The Council, on the other hand, emphasised the need for a more restrictive approach to safeguard patent protection and viewed business-related activities in particular with skepticism. In the trilogue, the Parliament’s position ultimately prevailed to a large extent, albeit with the clear limitation that no commercial use may take place during the term of protection.

While Article 10(6) of Directive 2001/83/EC primarily focuses on traditional marketing authorisation procedures, Article 85 now explicitly covers activities related to Health Technology Assessments (HTA). This becomes relevant, for example, in the evaluation of health technologies under the HTA Regulation (EU) 2021/2282. The regulation establishes a Union-wide framework for the joint clinical assessment of medicinal products and certain medical devices, with the aim of harmonising the scientific basis for national reimbursement decisions and accelerating access to innovative therapies, whereby the clinical assessment takes place primarily at the EU level, while pricing and reimbursement decisions remain the responsibility of the Member States. Equally relevant and even more closely linked to subsequent market entry are the new Bolar derogations for pricing and reimbursement procedures as well as for public procurement procedures. It is conceivable, for example, that this could allow negotiations on reimbursement amounts for medicines under statutory health insurance to begin earlier as under the current legal framework, since in Germany, for instance, these follow the benefit assessment, for which documents pursuant to Section 35(1) of the German Social Code, Book V (SGB V) must regularly be submitted no later than upon market entry.

With regard to public procurement procedures, it should be emphasised that these are now expressly covered by the text. Whereas previously classification had to be based on a functional assessment, Article 85 establishes a clear legal basis in this respect. This increases legal certainty, particularly for companies that must align their market entry strategy with public procurement processes at an early stage.

Compared to previous case law, this represents a significant shift toward a broader interpretation of the Bolar exemption. In particular, preparatory acts that were previously subject to only limited privileges – such as under the Italian interpretation – are now covered. This establishes a uniform standard across the EU that better accommodates the practical requirements of international approval and market entry strategies.

At the same time, the expansion raises new questions of demarcation. The line between permissible preparatory acts and impermissible commercial use remains not entirely clear-cut even under Article 85, particularly in scenarios where preparatory measures already have market-related effects. Another point that has not yet been conclusively clarified concerns the personal scope of application of the provision. The wording of Article 85 states that the privileged activities are carried out ‘in particular’ by generic manufacturers, biosimilar manufacturers, and manufacturers of hybrid medicinal products and for subsequent variations. This wording suggests that the scope of application is not exclusively limited to these groups. Nevertheless, it remains unclear whether and to what extent originator drug manufacturers can also invoke the Bolar clause, for example in the context of further developments or lifecycle management.

From a legal theory perspective, there is much to be said for a function-based interpretation, in which the purpose of the action is decisive rather than the status of the acting company. However, the explicit highlighting of certain groups of manufacturers could, in practice, lead to a narrower interpretation or at least open the door to corresponding lines of argumentation.

Finally, the role of contract manufacturers remains unclear. Despite the expanded wording, there are no concrete criteria for demonstrating the required purpose limitation, meaning that legal uncertainties are likely to persist in the future.

Conclusion

The reform of the Bolar exemption in Article 85 of the EU Pharmaceutical Package represents a significant step toward the harmonisation and functional development of European pharmaceutical law. The explicit inclusion of key market access instruments significantly strengthens the practical effectiveness of the regulation. At the same time, questions of interpretation remain, the clarification of which will be of considerable importance for legal certainty – particularly in an international context.

Notes

1     No 6367/26 LIMITE, provisonal text available at: https://data.consilium.europa.eu/doc/document/ST-6367-2026-INIT/en/pdf.