Bolar Exemption Netherlands 2026: Requirements, Limits and UPC Risks for Chemical & Biotech R&D

The bolar exemption Netherlands framework lets companies carry out the testing, analysis and limited manufacture needed to obtain regulatory approval for a medicinal product without infringing a third party’s patent, but the safe harbour has firm edges, and in 2026 the arrival of Unified Patent Court (UPC) enforcement has sharpened the risk of crossing them. For general counsel, regulatory affairs leads and R&D heads at chemical, biotech and food-tech firms operating in or supplying the EU, the practical question is simple: can we test or manufacture for a regulatory dossier in the Netherlands without triggering infringement, and what documentation and contract protection do we need?

This guide answers that question, maps the statutory basis, explains how the bolar exemption Netherlands interacts with the broader experimental-use exception, and sets out a compliance playbook that accounts for pan-EU injunction exposure under the UPC.

What is the bolar exemption Netherlands grants (statutory basis and scope)?

The bolar exemption, often called the regulatory-test exemption, is a statutory carve-out from patent infringement. It permits certain acts that would otherwise infringe a patent where those acts are necessary to obtain a marketing authorisation for a medicinal product. The purpose is to allow a generic or biosimilar developer to complete the studies and prepare the dossier required by regulators before the originator’s patent and any supplementary protection expire, so that approved competing products can reach the market promptly after patent expiry rather than years later.

Statutory basis in the Netherlands

Dutch patent rights are governed by the Rijksoctrooiwet 1995 (the Dutch Patent Act), the national statute that defines the exclusive rights of a patent holder and the exceptions to those rights. The Act sits alongside the European Patent Convention and EU law, and must be read together with the EU framework for medicinal products. The bolar exemption Netherlands version derives from the EU-wide regulatory-test exception introduced into the Community code on medicinal products, Directive 2001/83/EC (as amended), which Member States implemented into national law. The directive establishes the marketing-authorisation framework and the legal basis on which regulatory-test acts are treated as non-infringing.

The exact scope implemented into Dutch law, and how the courts apply it, should be confirmed for any specific activity.

Typical permitted acts

Within the bolar exemption Netherlands practice, the following acts are generally understood to be permitted provided they are genuinely directed at obtaining or supporting a marketing authorisation:

• Analytical and bioequivalence testing. Laboratory characterisation, assays and comparative studies needed to demonstrate quality, safety and efficacy to the European Medicines Agency (EMA) or the national Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG).
• Preclinical and clinical studies. Trials conducted to generate the data package required for a dossier.
• Manufacture of trial and registration batches. Production of quantities reasonably necessary to run those studies and to compile the dossier, including reference and comparator material.
• Stability and specification work. Testing needed to support the chemistry, manufacturing and controls (CMC) sections of the dossier.

The common thread is necessity and purpose. Acts that are reasonably required to secure regulatory approval generally fall inside the exemption; acts that serve a commercial purpose beyond that, such as building pre-launch stock to sell on day one of patent expiry, do not. The EMA’s published guidance on marketing-authorisation procedures and dossier requirements is a practical reference point for determining what a regulator actually expects, and therefore what a developer can legitimately claim is “necessary”.

Experimental-use versus bolar exemption Netherlands, legal differences and practical examples

The bolar exemption is not the only defence available. Dutch patent law also recognises a separate experimental-use exception, a research exemption Netherlands courts have long applied to acts done on the subject matter of the patented invention for experimental purposes. The two overlap but are not interchangeable, and confusing them is a frequent source of risk.

Legal tests for the experimental-use exception Netherlands recognises

The experimental use exception Netherlands law applies covers acts carried out on the patented invention, to investigate how it works, to verify the teaching of the patent, to improve upon it or to establish whether it can be worked. The decisive factor is generally whether the dominant purpose is genuinely experimental or whether it is, in substance, commercial. Research aimed at generating knowledge about the invention typically qualifies; activity whose real aim is to supply a market, or to prepare an immediate commercial launch, typically does not.

When experimental use is not a defence

The experimental-use exception is narrow. Dutch courts have applied restrictive tests where the alleged experimental purpose is mixed with, or subordinate to, a commercial objective. Acts carried out at commercial scale, or where the output is destined for sale rather than for study, generally fall outside the exception. Where the purpose is to obtain a marketing authorisation rather than to experiment on the invention itself, the correct defence is usually the bolar (regulatory-test) exemption rather than the experimental-use exception, which is precisely why characterising the activity correctly at the outset matters.

Two sector examples illustrate the distinction. For a small-molecule chemical compound, bioequivalence testing of a generic against the reference product is paradigm bolar activity; synthesising the molecule purely to study an alternative crystalline form may instead be experimental use. For a biologic, the position is more complex. Manufacturing a biosimilar batch to generate comparability data for a dossier is bolar activity, but the manufacturing process itself may touch separate process and use patents that the regulatory-test exemption does not necessarily cover. That is the heart of the biosimilar bolar Netherlands problem, addressed further below.

Comparison table, bolar exemption, experimental use and clinical trial exception

Read the table as a decision aid, not a licence. The same physical act, manufacturing a batch, can fall inside or outside each defence depending on purpose, scale and destination. Characterise every workstream before it starts.

Scope and limits in practice, CROs, CMOs, clinical trials and dossier manufacturing

Most real-world exposure arises not from a company’s own benchwork but from outsourced activity. When a contract research organisation (CRO) or contract manufacturing organisation (CMO) performs the work, the question of who can rely on the exemption, and whether the chain of acts stays within it, becomes commercially and legally critical.

CRO and CMO practical controls and documentation

The regulatory-test exemption attaches to the purpose of the acts, so a CRO or CMO carrying out work that is necessary to obtain a marketing authorisation may in principle act within the bolar exemption Netherlands framework. The danger is drift: a CMO engaged to make registration batches may, without clear contractual limits, produce quantities, run parallel commercial lines, or retain product in a way that looks like commercial manufacture. To keep outsourced work inside the safe harbour, build the following controls:

• Purpose statement. The contract and each work order should state that the acts are performed solely to support a specified regulatory submission, and reference the dossier or trial they feed.
• Volume and scope limits. Cap batch sizes to quantities reasonably necessary for studies and registration, with any scale-up for commercial launch excluded until a defined trigger (for example, patent expiry or a licence).
• Segregation. Require physical and documentary separation of exemption-based batches from any commercial production, including distinct SOPs and batch records.
• Traceability. Mandate batch labelling that identifies product as “for regulatory/registration use only, not for commercial sale” and full accountability logs for every unit produced.
• No onward supply. Prohibit distribution of exemption-based output beyond the regulatory purpose, including sampling and promotional use.

Clinical trial practice and human-subject research

Clinical trials sit at the intersection of the bolar and clinical-trial frameworks. Studies run to generate dossier data are generally covered, and the supply of investigational product to authorised trial sites is part of that permitted activity. This does not, however, stretch to using trial logistics as a vehicle for commercial seeding. Where trial quantities exceed what the protocol requires, or where product flows to sites and recipients outside the authorised study, the regulatory character of the activity weakens and infringement risk rises. Keep clinical-trial authorisations, ethics approvals and product-accountability records aligned with the volumes actually manufactured, so that the paper trail demonstrates a regulatory rather than a commercial purpose.

UPC enforcement and pan-EU injunction risk, 2026 considerations

Before the UPC, a Dutch developer relying on the bolar exemption Netherlands courts apply faced enforcement that was, in practice, national: an originator had to litigate country by country, and a Dutch defence, if sound, protected Dutch activity. The UPC changes that calculus. A single court can now rule on infringement and grant relief across participating Member States for European patents with unitary effect and for non-opted-out classical European patents. The practical effect is that activity sitting comfortably within a national exemption can be drawn into cross-border proceedings with cross-border consequences.

UPC jurisdiction basics and provisional measures

The Unified Patent Court has jurisdiction over unitary patents and, during the transitional period, over European patents that have not been opted out, across the participating Member States. Among its powers, the UPC can order provisional measures, including preliminary injunctions, under its Rules of Procedure, and those measures can have effect across the court’s territory. For a company whose regulatory testing or dossier manufacture arguably touches a patent still in force, that means a credible exposure to a fast-moving injunction that can reach beyond the Netherlands into other UPC states. The regulatory-test exemption remains available as a defence, but it must now be asserted in a forum where the stakes, speed and geographic reach can all be larger.

A biologic enforcement scenario

Consider a company manufacturing biosimilar registration batches in the Netherlands for an EMA submission. The intended acts are classic bolar activity. But the manufacturing route may use steps protected by separate process patents, and the originator may hold a European patent in force across UPC states. If the originator contends that the process steps fall outside the regulatory-test exemption, because they relate to how the product is made rather than to the regulatory studies themselves, it could seek provisional measures before the UPC. A cross-border preliminary injunction halting the process could stall the entire programme, not merely Dutch operations.

The defence may ultimately succeed, but the cost of being wrong, and the potential breadth of interim relief, can be materially greater than under the old national model. This is why biosimilar bolar Netherlands planning now has to start from the patent landscape, not from the lab.

Defensive measures and the UPC experimental-use defence

Companies can reduce UPC exposure with deliberate strategy rather than reactive litigation. Key levers include:

• Opt-out planning. Opting a classical European patent out of UPC competence is a strategic choice that shapes where future disputes can be brought. For a patentee it affects enforcement options; for a potential defendant assessing the landscape, understanding which relevant patents are opted out, and which are exposed to the UPC, informs where risk concentrates.
• Forum awareness. Because the UPC and national courts can both be relevant depending on opt-out status and patent type, map the forum that would hear any dispute over the specific patents your activity touches, and plan accordingly.
• Evidence readiness. Build the documentary record, study protocols, dossier linkage, volume limits, segregation, before any dispute arises, so that the regulatory-test or experimental-use defence can be asserted immediately and credibly if provisional measures are sought.
• Early freedom-to-operate analysis. Identify in-force patents, including process and use patents, that your contemplated acts could touch, and assess exposure under the UPC’s reach before committing to a manufacturing route.

The consistent message for 2026 is that the bolar exemption Netherlands practice still protects genuine regulatory-test activity, but the margin for error has narrowed because the enforcement forum can be larger, faster and broader.

Risk reduction playbook, documentation, contracts and operational controls

Reliance on any patent infringement exception Netherlands law provides is only as strong as the evidence that the activity fell within it. A dispute is often won or lost on contemporaneous records, not on after-the-fact explanations. The playbook below turns the legal scope into operational discipline.

Operational controls

• Segregation. Keep exemption-based work physically and documentarily separate from commercial operations, with distinct SOPs, equipment logs and batch records.
• Batch marking and traceability. Label every exemption batch “for regulatory/registration use only, not for commercial sale”, and maintain full accountability from manufacture to disposition.
• Volume discipline. Produce only quantities reasonably necessary for the studies and the dossier, and document the basis for those quantities against the study protocols.
• Test charters. Open each workstream with a short charter stating its regulatory purpose, the dossier or trial it supports, and the scale and duration envisaged.
• Record retention. Retain protocols, batch records, regulator correspondence and disposition logs for a period aligned with the relevant limitation and regulatory requirements, so the evidence survives long enough to defend any later claim.

Contractual protections

When engaging CROs and CMOs, the agreement is the primary tool for keeping the chain of acts inside the exemption and for allocating risk if it is challenged. The following sample clause language is illustrative and non-binding; adapt it to the specific engagement with counsel.

• Purpose and scope (sample): “The Services are performed solely to generate data and material necessary to obtain or maintain a marketing authorisation for the Product, in support of [dossier/trial reference], and for no commercial supply purpose.”
• Volume limitation (sample): “The Provider shall manufacture only such quantities as are reasonably necessary for the regulatory purpose, and shall not scale up for commercial supply absent the Client’s prior written instruction following [trigger event].”
• Segregation and marking (sample): “All Product shall be segregated from commercial operations, recorded under dedicated batch documentation, and labelled ‘for regulatory use only, not for sale’.”
• Warranty and compliance (sample): “The Provider warrants that it will perform the Services within applicable regulatory-test exemptions and will not use, supply or dispose of Product otherwise than as instructed by the Client.”
• Audit rights (sample): “The Client may audit the Provider’s records and premises to verify compliance with the purpose, volume, segregation and disposition obligations.”
• Indemnity and insurance (sample): “The Provider shall indemnify the Client against losses arising from the Provider’s unauthorised supply, scale-up or disposition of Product, and shall maintain insurance adequate to that liability.”

These clauses aim to do three things at once: keep the activity within the exemption, create the contemporaneous record needed to prove it, and allocate the financial consequences if a counterparty steps outside the agreed scope.

When the bolar exemption Netherlands may not apply, red flags and lessons

The exemption fails most often not because the law is unclear but because the activity quietly acquired a commercial character. Recognising the red flags early is the cheapest form of risk management.

Stockpiling and pre-marketing manufacture

Manufacturing commercial quantities before patent expiry so that product can be sold immediately on expiry is the classic breach. Even if the molecule and dossier are legitimate, building launch stock is a commercial act, not a regulatory-test act, and generally sits outside the exemption. Keep pre-expiry production tied strictly to registration need, and defer commercial scale-up until a lawful trigger.

Use for quality control destined for sale

Quality-control and stability testing carried out on batches intended for commercial sale, rather than on registration batches, is testing in support of commerce, not of a marketing authorisation. Where the tested output will enter the market, the regulatory-test justification does not generally hold.

Mixed-use batches

Producing a single batch that serves both a dossier and a commercial purpose is a particularly common trap. A mixed-use batch can import the commercial character into the whole, undermining the exemption for the entire volume. Segregate registration batches from commercial batches without exception, and never let the two share documentation. Dutch courts, whose judgments are published through the national judiciary (Rechtspraak), have applied narrow tests to experimental and regulatory-use defences, and a dominant-purpose analysis tends to leave little room for mixed-use arguments.

Practical checklist, step-by-step before you test or manufacture for a dossier

1. Clearance audit (IP). Identify in-force patents, including process and use patents, that the contemplated acts could touch, and assess UPC exposure for each.
2. Patent map (IP). Record opt-out status, territorial scope and expiry for every relevant patent, and flag those exposed to the UPC’s reach.
3. Purpose charter (RA/R&D). Document the regulatory purpose, the dossier or trial supported, and the scale and duration planned.
4. Written lab protocols (R&D/QA). Ensure every study has a protocol linking it to the regulatory submission.
5. Segregated manufacturing (QA/operations). Separate exemption-based production from commercial operations with dedicated SOPs and records.
6. Labelling and traceability (QA). Mark batches “for regulatory use only” and maintain full accountability logs.
7. CRO/CMO contract clauses (procurement/legal). Embed purpose, volume, segregation, warranty, audit and indemnity terms in every engagement.
8. Record retention (legal/QA). Set retention periods that outlast likely limitation and regulatory horizons.
9. Escalation triggers (legal). Define events, a cease-and-desist letter, a UPC filing, a scale-up request, that automatically route to counsel.

Key takeaways and recommended actions

The bolar exemption Netherlands framework remains a reliable shelter for genuine regulatory-test activity, testing, trials and registration-batch manufacture directed at a marketing authorisation. What has changed in 2026 is the enforcement environment: the UPC can now deliver fast, cross-border provisional relief, so the cost of operating near the edge of the exemption is higher than it was under purely national litigation. Act on the following priorities:

• Run a patent-risk audit before any test or manufacture, covering process and use patents and UPC exposure.
• Amend CRO and CMO contracts to lock in purpose, volume, segregation, audit and indemnity protections.
• Assess UPC exposure and opt-out status for the specific patents your programme touches, and plan the forum accordingly.
• Build the evidence record now so that the regulatory-test or experimental-use defence can be asserted instantly if provisional measures are sought.

Three points warrant a bespoke legal opinion rather than reliance on this guide: the precise scope of the bolar exemption Netherlands courts will accept for your specific activity; whether your biosimilar or chemical manufacturing route touches process or use patents outside the exemption; and your UPC exposure and opt-out strategy for the patents in play. For a tailored review, see our Intellectual Property Lawyer Netherlands, Checklist 2026.

This information does not constitute legal advice. Contact Global Law Experts member counsel for a tailored opinion on your specific facts.

Sources

1. Dutch Patent Act (Rijksoctrooiwet 1995), wetten.overheid.nl
2. EUR-Lex, Directive 2001/83/EC (Community code for medicinal products)
3. European Medicines Agency (EMA)
4. Medicines Evaluation Board (CBG-MEB)
5. Unified Patent Court (official site)
6. European Patent Office, European Patent Convention
7. Rechtspraak.nl (Dutch judiciary)