Bolar Revisited: What the Revised EU Pharma Package Means for Generics, Suppliers and Originators

The EU Pharma Package is often described as a harmonisation project. That is true, and there is more. For generic and biosimilar companies, for suppliers in the pharmaceutical value chain, and for originators facing impending market entry, the more relevant shift is practical: the revised Bolar exemption moves competitive activity forward in time. Preparation for market entry will increasingly take place while patent protection is still in force. In practice, key elements of market competition, including pricing and market access, may now be determined before patent expiry.

The Bolar exemption has always sat at the intersection of patent law and pharmaceutical regulation. It allows companies to complete the regulatory steps required for market entry before patent expiry, so that products can be launched immediately afterwards. In the EU, the concept was codified in Article 10(6) of Directive 2001/83/EC, introduced by Directive 2004/27/EC in March 2004. Its application, however, has never been fully uniform, and Member States filled key gaps in different ways.

Under the agreed new framework, the Bolar exemption now expressly covers activities necessary for marketing authorisation, health technology assessment, pricing and reimbursement, and the submission of procurement tender applications. It also expressly extends to third-party suppliers and service providers. This redefines where regulatory preparation ends and infringing conduct begins.

I. The previous framework and its limits

Under the existing regime, the Bolar exemption covers studies and trials required for obtaining a marketing authorisation. That core scenario has never been the real difficulty. The challenges arose at the margins.

Member States diverged on several minor yet essential points when implementing the Directive. Some allowed a broader range of preparatory acts, including activities linked to pricing, reimbursement or non-EU approvals. Others took a narrower approach and limited the exemption more strictly to regulatory submissions for generics and biosimilars.

These differences shaped practical behaviour. They influenced where clinical trials were conducted, how supply chains were structured and also the timing when patent holders tried to obtain interim relief. Regulatory steps such as pricing applications or tender participation were, in some jurisdictions, treated as indicators of imminent infringement.

The distinction between the Bolar exemption and the research exemption was also partially blurred. The research exemption protects work aimed at generating new technical knowledge. The Bolar exemption serves a different function: It permits the use of patented inventions to meet regulatory requirements. In practice, the two may overlap, while they are not interchangeable. Where an activity primarily served regulatory purposes, reliance on the research exemption alone tended to prove not sufficient.

II. The new Article 85: a functional approach

Article 85 of the new directive adopts a functional approach. The goal is to harmonize the Bolar exemption across the EU and clarify its scope. It identifies the regulatory processes that justify the use of patented inventions and extends the exemption to the acts needed to complete them.

The provision expressly covers activities carried out for the purposes of obtaining a marketing authorisation, conducting health technology assessment, securing pricing and reimbursement approval, and submitting procurement tender applications. This reflects the reality of market entry. Regulatory approval, pricing decisions and procurement are closely connected. The revised framework treats them as such.

The exemption also extends to a broad range of acts, including manufacture, supply, storage, import, use and purchase, and related acts, where these are carried out exclusively for the permitted purposes. It expressly includes third-party suppliers and service providers. This aligns the legal framework with established industry practice.

All these activities need to be “necessary” and “exclusively” directed at the permitted purpose. This requirement introduces a functional test with room for interpretation. The limits will therefore be determined by how national courts interpret these terms in concrete cases. The central question will no longer be whether preparatory acts exist, but whether those acts are tied to a regulatory objective.

The directive further clarifies that intellectual property rights, as such, are not a valid ground for refusing, suspending or revoking decisions adopted in the relevant regulatory processes. This does not prevent patent enforcement. It does, however, reduce the relevance of regulatory conduct as a proxy for infringement and limits the role of regulatory procedures as leverage in patent disputes.

In a nutshell, the following activities will not constitute a patent or SPC infringement under the new rules:

• Carrying out health technology assessment.
• Obtaining approvals for pricing and reimbursement.
• Conducting studies, trials and other activities needed to obtain a marketing authorization for a generic or biosimilar, a hybrid or a bio-hybrid product.
• Fulfilling practical requirements linked to any of the above activities.
• Participating in procurement tenders for the sale of a medicinal product after the patent or SPC has expired.
• Any supporting activities for the abovementioned purposes, including the sale, offer, manufacture, use, purchase and import of the medicinal product or processes.
• Third-party suppliers and service providers who perform any of these activities benefit from the same protection.

Even though this sounds relatively clear and unambiguous, it makes sense to take a closer look at some aspects:

1. The outer limit: no placing on the market

The expansion of the exemption is paired with a clear limit. It does not extend to the placing of medicinal products on the market.

In straightforward cases, that boundary is clear. In practice, it will not always be. Large-scale manufacturing, stockpiling or binding commercial commitments may indicate that a company has moved beyond regulatory preparation. The assessment will turn on purpose and context. That is where the legal uncertainty now lies.

2. Procurement procedures and early competition

The inclusion of procurement tenders is one of the most consequential changes. Companies may now submit procurement tender applications before patent expiry, provided that this does not entail sale, an offer for sale or placing on the market during the protection period.

This brings competition forward in a decisive way. In many healthcare systems, tenders effectively determine market access, pricing and volumes well before the first unit is supplied. The practical consequence is that competitive positioning may be established before patent expiry, with the actual supply becoming a downstream step.

At the same time, the boundary is sensitive. The distinction between a permitted tender submission and a prohibited offer for sale is likely to become one of the central fault lines in future litigation. Tender structures that create binding supply obligations, or that exert economic or legal pressure to supply before expiry, may fall outside the exemption. The assessment will depend on the specific design of the procedure, the legal nature of the commitments and the economic reality of the arrangement.

3. Third parties and supply chains

Article 85 now expressly includes third-party suppliers and service providers. This addresses a long-standing uncertainty and reflects how pharmaceutical supply chains operate in practice.

The issue had been contentious in the past. The Astellas/Polpharma litigation illustrated the divergence within Europe. The Düsseldorf Higher Regional Court accepted that third-party conduct could fall within the exemption under certain conditions, while the Polish Supreme Court took a more restrictive view. The Court of Justice (CJEU - Case C-661/13: Request for a preliminary ruling from the Higher Regional Court of Düsseldorf) did not resolve the issue, as the case was settled before a ruling was delivered.

The new provision provides greater clarity: Contract manufacturers, API suppliers and research organisations may rely on the exemption where their activities serve regulatory purposes. That allows supply chains to be structured more flexibly across jurisdictions.

The focus will now shift to purpose and attribution. Where activities serve both regulatory and commercial aims, the scope of the exemption may lead to uncertainty.

4. Enforcement under the new framework

The reform changes the evidentiary landscape for patent enforcement before expiry. Regulatory acts such as pricing applications, reimbursement procedures, health technology assessment submissions or tender participation will generally carry less weight as indicators of imminent infringement where they fall within the Bolar exemption.

To initiate legal actions, patent holders will need to identify additional risks that go beyond these acts. Relevant indicators may include large-scale manufacturing, the creation of commercial stock or binding commitments anticipating supply before patent or SPC expiry. A regulatory dossier alone will no longer suffice.

This raises the threshold for interim relief and increases the importance of internal evidence. Production data, supply arrangements and internal planning documents will become central in assessing whether conduct remains within the permitted scope. However, this type of intelligence and documentation is notoriously difficult to obtain.

The interaction with the Unified Patent Court (UPC) adds a further layer. Logically, Article 27(d) UPCA refers to the Bolar exemption in Directive 2001/83/EC and therefore captures subsequent amendments. It is obvious that the UPC will apply the law as it currently stands. The revised provision will therefore serve as a benchmark in future UPC proceedings in which the Bolar exemption is invoked as a defence, and it is expected that the UPC will play a decisive role in shaping the interpretation of the new law, including its limits. Divergences between the UPC and national courts cannot be excluded, given that the exemption is set out in a directive and its precise contours depend on national implementation and interpretation.

5. Data exclusivity and parallel protection

The broader Bolar exemption now also allows generics to conduct studies and prepare regulatory submissions during patent protection, while it does not affect the EU data and market exclusivity regime. Under the revised framework, the standard period remains eight years of regulatory data protection followed by one year of market protection, with possible additional extensions under specific conditions (the revised 8+1(+1)(+1) system). Early regulatory preparation under the Bolar exemption therefore does not enable earlier market entry where those exclusivity periods apply.

III. Remaining questions

The revised framework is clearer than the previous regime, and it continues to evolve.

The territorial reach of the exemption remains open. It is not settled whether activities carried out in the EU for the purpose of obtaining marketing authorisations in third countries fall within its scope. The new Directive neither expressly includes nor excludes an extension of the Bolar exemption to trials and studies conducted in the EU for non-EU regulatory applications. The limited reference to Regulation (EU) 2021/2282 for HTA-related activities may indicate a more restrictive, EU-focused interpretation. This approach risks entrenching existing divergences among Member States. Under the current legal framework, such differences already exist: some Member States, such as Germany, extend the scope of the exemption to cover activities supporting applications outside the EU, while others, such as France, do not. It remains to be seen how Member States will implement the directive and change their existing national regimes.

Finally, the concepts of necessity and exclusivity, as already discussed above, will require further development. The grey area will lie where regulatory preparation and commercial planning overlap. This margin of interpretation allows for a certain extension of activities, provided that they can be justified as being linked to a regulatory objective.

IV. Practical consequences

The reform shifts the timing and structure of market entry.

For generic and biosimilar companies, the key change is the ability to align regulatory authorisation, health technology assessment, pricing and reimbursement procedures and public procurement tenders at an earlier stage. These processes can now be prepared in parallel and, in many cases, brought close to completion before patent expiry, enabling a coordinated day-one entry strategy. This requires an integrated organisation of regulatory, market access and supply functions. Industry participants should therefore anticipate earlier and more coordinated market entry dynamics, increasing both competitive pressure on originators and the need for integrated regulatory and commercial planning on the generic side.

All preparatory activities must be structured and documented to satisfy the exclusive-purpose requirement of the Bolar exemption. It is also advisable to review existing contracts with suppliers and service providers to take full advantage of the new legal certainty. Particular care is required in procurement contexts: tender participation must remain strictly limited to regulatory or administrative preparation and must not extend into pre-expiry commercial conduct or commitments that could be construed as market entry.

For suppliers, inclusion within the exemption provides legal certainty, provided that activities are strictly confined to permitted preparatory purposes. This requires clear contractual purpose limitation and documentation linking performance to regulatory, health technology assessment, pricing or procurement-related activities. Where services pursue mixed regulatory and commercial objectives, the application of the exemption becomes uncertain.

For originators, harmonisation provides greater legal certainty, even though the expanded scope of application may lead to earlier generic competition. Enforcement shifts away from regulatory filings as indicators of imminent market entry towards factual market preparation. This includes manufacturing scale-up, stockpiling, supply chain activation and early contractual structuring. Monitoring must therefore extend earlier in the value chain, with enforcement becoming increasingly fact-intensive and dependent on logistical and economic evidence.

Innovators should align their strategies with the new legal framework with a view to securing sufficiently long market exclusivity through patent protection, supplementary protection certificates and regulatory data and market protection. They must expect earlier generic and biosimilar market entry with corresponding earlier revenue erosion and should respond by strengthening patent portfolio strategies, reinforcing layered exclusivity positions and ensuring preparedness for rapid substitution once protection expires.

Conclusion

The revised Bolar exemption brings the legal framework closer to how pharmaceutical markets operate in practice. It enables earlier preparation, closer integration of regulatory and commercial planning and more predictable market entry.

At the same time, it shifts competition into the pre-expiry phase and sharpens the boundary between lawful preparation and infringement. Future disputes will turn on purpose, context and evidence. That is where the decisive questions will be resolved.

The revised Bolar exemption has not yet entered into force. Following formal adoption of the EU Pharmaceutical Package by the European Parliament and the Council, the relevant provisions of the new Directive will require transposition by the Member States. EU-wide application of the revised regime is therefore expected around 2028.

This article was created in collaboration with our research assistant Philipp Wiese.