New Regulation (EU) 2025/2645: EU compulsory licenses for crisis management

On 30 December 2025, Regulation (EU) 2025/2645 of 16 December 2025 was published in the Official Journal of the European Union. The Regulation establishes a European framework for the granting of compulsory licenses in situations of crisis or emergency with a cross-border dimension, enabling the European Commission to grant a “Union compulsory license” with effect across the entire internal market.

Objectives and scope of the Regulation

The Regulation aims to ensure the possibility of granting Union compulsory licences where a crisis or emergency affects the EU and a crisis/emergency mode has been activated under specific EU instruments. Its logic is clearly linked to the internal market: to avoid fragmented responses based on national licences, which are ill-suited to addressing cross-border supply chains.

The IP rights covered by the Regulation include patents, utility models and supplementary protection certificates (SPCs).

In addition, the Regulation operates without prejudice to copyright frameworks, sui generis database rights and trade secrets. Importantly, it does not impose any obligation to disclose trade secrets.

The mechanism may only be activated in the context of crisis or emergency modes declared under EU instruments, such as those relating to serious cross-border threats to health.

Last-resort nature and requirements

As a measure of last resort, the Commission may only grant a Union compulsory license if all key conditions are met, including:

• A crisis or emergency mode has been declared under a relevant EU mechanism.
• The Commission concludes that use of the protected invention is necessary to supply relevant crisis products in the EU.
• Other means (including voluntary agreements) are not available within a reasonable timeframe or do not ensure access.
• The patent owner has been given the opportunity to submit observations.

Content and limits of the license: scope, duration, territory and licensee capacity

Union compulsory licenses are subject to strict limitations:

• They are non-exclusive and, in principle, non-transferable.
• Their scope and duration are strictly limited to the objective and duration of the crisis or emergency.
• Territorial scope is strictly limited to the EU.
• They automatically expire when the crisis or emergency mode ends.
• They may only be granted to entities with the capacity to exploit the invention rapidly and appropriately (including facilities, know-how and supply chains).

At a minimum, the Commission must specify the affected rights (patent/application/SPC/utility model), the right holder, the licensee, the duration, the remuneration, the product identification and the maximum quantity to be manufactured or marketed.

It is also noteworthy that certain strategic sectors, such as gas, microchips and defense, are excluded from the scope of the Regulation.

Remuneration: “adequate” and linked to economic value and public funding

Remuneration is not symbolic. The licensee must pay adequate remuneration, determined by the Commission. In setting the amount, the following factors are taken into account:

• The economic value of the authorised activities.
• The circumstances of the case, including any public funding received for the development of the invention.
• The opinion of the advisory body and the observations of the parties.

Furthermore, if a licensed published application does not ultimately result in the grant of a patent, the owner must reimburse the remuneration paid (mutatis mutandis for utility models).

Entry into force

The Regulation will enter into force 20 days after its publication, i.e. on 19 January 2026.