EU Regulation 2025/2645 was published in the Official Journal of the European Union on December 30, 2025, and entered into force directly in all member states on January 19, 2026, without the need for national implementing legislation. This means that, for the first time, a uniform EU system for compulsory licenses in crisis or emergency situations is now available.

How did this come about and what was the original idea?

Actually, an EU regulation (SEP Regulation 4-2023 (EUIPO)) was planned for patents that are indispensable for a technical standard (e.g., 5G, Wi-Fi), so-called SEPs (standard essential patents). This EU regulation was intended to create a transparency and licensing framework with SEP registration, essentiality checks, and more extensive “FRAND” mechanisms (fair, reasonable, and non-discriminatory terms).

However, the SEP Regulation failed miserably and was officially removed from the EU Commission’s work program in February 2025 because no agreement between member states and interest groups was foreseeable.

Strong objections came from large technology patent traders, among others, who argued that regulation would weaken incentives for innovation. Industry also opposed this regulation because it could not agree on the proposed mechanisms. There was also skepticism that the European Union Intellectual Property Office (EUIPO) in Alicante, Spain, which was to be established under this regulation, would have sufficient expertise. This is not surprising, as the EUIPO had previously been responsible exclusively for trademarks and designs and did not have any technically trained staff or experience in the field of SEPs.

But even though the SEP Regulation failed, it was part of a larger modernization project in the field of EU-wide intellectual property law.

Following the failure of the SEP Regulation, the EU undertook a strategic realignment and recognized that a functioning crisis IP instrument was urgently needed, especially since the Covid-19 pandemic.

Regulation 2025/2645, which has now entered into force, was therefore created as a more pragmatic measure focused on crisis management, with clear conditions and a limited scope of application, namely for crisis or emergency situations – unlike the more comprehensive but politically controversial SEP Regulation.

This new EU regulation now harmonizes the legal framework for compulsory licenses across the EU in crises, instead of relying on heterogeneous national systems.

Aim and purpose of the new regulation:

With the introduction of an EU-wide compulsory licensing system (“Union compulsory license”), the European Commission can now allow the use of patented technologies in exceptional crises or emergencies (e.g., health or supply crises) without the consent of the patent holder.

These compulsory licenses apply throughout the EU and no longer just nationally, so that cross-border supply chains can be secured in the event of a crisis.

Conditions for granting:

However, an EU-wide compulsory license may only be granted if:

1. a crisis or emergency mode has been activated under existing EU crisis mechanisms;
2. the use of the patent in question is necessary for the supply of crisis-relevant products;
3. all other options (especially voluntary license agreements) have been exhausted or do not lead to a solution in time;
4. the rights holder has been heard and given the opportunity to comment.

Key features of the system:

– Non-exclusive, time-limited (until the crisis is over) and non-transferable
– License fees (reasonable remuneration) must be paid for the use of the patented teaching, but may be refunded if a patent is not granted
– Products may not be exported—only within the EU
– Licensing is granted as a last resort
– An advisory committee accompanies the procedure

Practical development: How will Regulation 2025/2645 affect the market?

Short term (2026–2028):

The regulation is primarily intended to be a reserve instrument – it should only be activated in very serious crises.

It could become relevant for the first time, particularly in the areas of public health, medical care, and critical infrastructure.

It is hoped that companies and patent holders will strengthen mechanisms for early voluntary licensing in order to avoid a compulsory license imposed by the state.

Example:

Suppose there is a health crisis in the EU and a patent-protected active ingredient is crucial for a life-saving drug that only a single rights holder can supply. Since production cannot be ramped up quickly enough, the Commission activates the crisis mechanism and, after consulting the patent holder, grants an EU-wide compulsory license in accordance with Regulation 2025/2645. Several European manufacturers are allowed to produce the active ingredient for a limited period of time, pay a fixed fee to the patent holder, and thus ensure rapid supply to the population within the EU.

Medium term (2028–2032):

In the medium term, standard processes for the European Commission and advisory boards are to be developed, including procedural standards and evaluation methods for appropriate remuneration.

In many cases, the regulation will act as a “failsafe,” strengthening the EU’s negotiating power in licensing issues during crises, without, however, being used automatically on a massive scale.

Patent holders will be more willing to offer FRAND license agreements at an earlier stage in complex situations in order to prevent impending compulsory licenses.

Long term (2033+):

The EU could use this crisis compulsory licensing regime as a basis for developing further IP coordination mechanisms, e.g., in areas such as climate protection technologies or critical digital standards.

There could be a political debate on further SEP or FRAND reforms that apply outside of crises, based on lessons learned from the failed SEP regulation attempt.

Conclusion:

EU Regulation 2025/2645 is not an SEP regime – it serves a very specific purpose: EU-wide compulsory licenses only in clearly defined crisis situations.

The originally planned SEP regulation has been completely abandoned.

The new regulation is more of a crisis prevention tool, designed to make IP practice in the EU more stable, coordinated, and predictable in the long term, especially in emergency situations.

Our managing partners Dr. Dorothea Hofer and Jürgen Feldmeier have been named IAM Global Leaders 2026!

We are delighted to receive this special award and would like to thank everyone involved.

Handelsblatt and Best Lawyers have honored “Germany’s Best Law Firms 2025” and we are very pleased to have been mentioned here again. This award is based on client feedback and colleague votes, so we would like to express our sincere thanks to all our colleagues and clients who recommended us in such large numbers.
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Handelsblatt and Best Lawyers have honored “Germany’s Best Lawyers 2025” and we are very pleased to have been mentioned here again. This award is based on surveys of commercial lawyers, so we would like to thank all our colleagues who have recommended us so highly.
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We are delighted to announce that our partner Dr. Peter Klein has obtained the European Patent Litigation Certificate issued by the University of Maastricht in cooperation with the Academy of European Law (ERA) in Trier. This includes an extensive practical and theoretical training in the law underlying the Unified Patent Court (#UPC) and related fields of European law so that he is well prepared for representing clients in all proceedings before the Unified Patent Court.

Good news for Prüfer & Partner!

We have been listed in the Chambers & Partners ranking! We are grateful to have received this award in recognition of excellence in IP law, as it demonstrates our commitment and the quality of our work and reflects the strong trust our clients place in us.

The Chambers & Partners ranking is recognized worldwide as it is based exclusively on independent research and feedback from clients and peers.

This success is therefore not only a credit to the passion of all of our firm’s employees, but also a testament to the solid relationships with our clients and partners who have been instrumental in helping us getting here.

We would therefore like to thank our clients for their positive feedback and our employees for their passion and tireless efforts. This recognition motivates us to constantly strive for the best service and to meet the needs of our clients with the highest level of commitment.

We are therefore optimistic about the future, even though we are currently experiencing uncertain times and the development of the global economy resembles a rollercoaster ride. We are ready for the challenges ahead!

We are delighted to have been ranked again this year as “Leading Firm 2025” in Germany in the categories “Patent Prosecution” and “Patent Litigation” by LEGAL 500. Thanks to a strong team, we were able to win this special award.

A special thank you goes out to our clients and colleagues for the great recommendations of our firm:

‘In my eyes, the professional expertise with all the technical support is fantastically positioned and gives me a very good, consistent feeling of information.’

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Standard essential patents, or SEPs for short, are essential for the implementation of certain technology standards in products such as smartphones and vehicles. SEP holders are obliged to grant licenses on fair, reasonable and non-discriminatory (so-called “FRAND”) terms. It is therefore not surprising that for years there have been frequent legal disputes regarding the licensing obligation and, in particular, the conditions, i.e. the amount of the license fees. As a result, a middle ground has been sought for years to find an amicable and satisfying solution for both sides, i.e. licensor and licensee.

As early as 2022, there was a proposal to form so-called LNGs, Licensing Negotiating Groups, which can be seen as a kind of cooperative purchasing group for licenses from SEPs, in order to make license negotiations more efficient by reducing the number of necessary negotiations and thus lowering transaction costs.

After the European Commission had in principle endorsed the proposal of these LNGs as a possible approach and issued corresponding guidelines for them, the German Federal Cartel Office (FCO) has now officially accepted the establishment of the ‘Automotive Licensing Negotiation Group’ (ALNG). The ALNG is a cooperation initiative between BMW, Mercedes-Benz, Thyssenkrupp and VW. The aim is to enable the participating companies to jointly negotiate licenses for standard-essential patents (SEP) required for the implementation of technologies such as 4G or 5G in vehicles.

The FCO came to this conclusion after examining the proposal in accordance with §§ 1, 2 GWB in conjunction with § 32c(2) GWB and Article 101 TFEU. Andreas Mundt, the President of the FCO, emphasized that the cooperation is breaking new ground in terms of antitrust law and that the toleration of the ALNG is subject to the following conditions (see FCO press release dated June 10, 2024):

• Market shares: For joint procurement measures (e.g. joint license negotiations), European competition law sets a threshold of 15% for the joint market share. If this threshold is not exceeded, it is assumed that the members of the purchasing group do not have so much market power that their efforts restrict competition. It is important to note that the threshold applies to both the purchasing/licensing market and the downstream market for the sale of end products.
  In the case of ALNG, the FCO assumed that the combined market share of the (current and potential future) participants in the licensing of general mobile communications technologies will not exceed 15%, while this threshold may be exceeded in the licensing of automotive-specific SEPs. Accordingly, the ALNG is explicitly limited to the licensing of non-automotive standards, in this case specifically general mobile SEPs.
  As regards the downstream markets for the sale of final products (motor vehicles), the FCO considers the threshold at least partially to be exceeded. However, since the costs for licensing SEPs in the area of general mobile communications technologies are comparatively low (regularly less than 1% of the total production costs of a motor vehicle), the FCO concluded that a restriction of competition is also unlikely in these markets.
• Openness: The FCO also considered it necessary and therefore required that the ALNG remain open to providers that could also be entitled to and interested in licensing the respective SEPs.
• Voluntary negotiations: The FCO required the ALNG members to also offer bilateral negotiations with SEP holders and patent pools in order to further mitigate the possible effects of bundling of buyer power.
• Measures to limit information exchange: In order to prevent the exchange of competitively sensitive information between ALNG members, the FCO required the implementation of precautionary organizational measures, which the ALNG had offered earlier. These measures are designed to limit the exchange of information to what is strictly necessary for the joint licensing efforts.
• Notification of future changes: Finally, the FCO required the ALNG to notify it of any future expansion of the scope of activities and any other material changes.

The establishment of licensing negotiation groups (LNGs) such as the ALNG is a relatively new development in the market. While the ALNG emphasizes the advantages of such cooperation, licensors express concerns that such groups could shift bargaining power to their disadvantage. However, the FCO has decided that the ALNG in its planned form does not raise any serious competition concerns as long as the established framework conditions are adhered to.

So far, the ALNG appears to be the only “buying syndicate” for FRAND licenses. In the future, however, smaller SMEs could also join forces to form such LNGs in order to negotiate more cost-efficiently lower-priced FRAND licenses with SEP holders or SEP pools, not only in the 4G/5G/6G area, but in all areas in which standards have been developed, such as IoT, robotics, coding, etc.

However, it remains to be seen whether further LNGs will be formed, following the example of the ALNG and relying on its toleration by the FCO. Critical voices see the FCO’s market definition as too broad, for example, or see a loss of time and efficiency due to the possibility of (downstream) bilateral negotiations between individual ALNG members and SEP holders.

On 1 September 2024, ROMANIA will become the 18th member state of the UPC. The ratification of the Agreement on a Unified Patent Court (UPCA) was signed on 31 May 2024. The whole article can be read here.