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Compulsory licensing of patents

Single market

Currently the compulsory licensing of patents in the EU is regulated and implemented by Member States following different, fragmented procedure. This makes compulsory licensing of patents in the EU not suited to tackle EU-wide crisis situations. In addition, the current EU procedure for issuing compulsory licensing for export of medicines to developing countries is complex and a more efficient procedure could be considered.

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Public consultation

ID: 13357

Lobbying Activity

48 responses

BUSINESSEUROPE opposes EU compulsory licensing scheme for crises

BUSINESSEUROPE, 19 Jul 2023

The organization opposes the EU-wide compulsory licensing mechanism, arguing it violates subsidiarity and proportionality principles. They request that trade secrets and know-how be explicitly excluded from scope, clear definitions of crises be established, and that industry become permanent members of the Advisory Body. They insist remuneration must be negotiated between parties, not determined by the Commission.
This would preserve their patent protections and autonomy in licensing negotiations during crises.
Public health advocates lose faster access to crisis-critical products during emergencies.

Consultation response

Bureau Européen des Unions de Consommateurs, 31 Jul 2023

BEUC welcomes the European Commission's proposal for a regulation on compulsory licensing for crisis management. Such a framework is necessary to enable a swift and appropriate response to a crisis or emergency by guaranteeing the supply and the free movement of crisis-critical patented products in…

Consultation response

American Chamber of Commerce to the European Union, 26 Jul 2023

A predictable and reliable intellectual property system is necessary for companies to innovate. The existing systems of national compulsory licensing already create an appropriate IP environment, and an EU-wide Compulsory License would create unnecessary burdens for businesses. Thus, it is crucial…

AmCham EU urges keeping compulsory licensing as last resort

American Chamber of Commerce to the European Union, 29 Apr 2022

AmCham EU demands that compulsory licensing remain a last resort under global trade rules. They suggest using emergency funding and voluntary agreements to manage future crises.
Protecting patent rights ensures companies can recover their expensive research and development investments.

Consultation response

Bundesverband der Deutschen Industrie e.V., 13 Jul 2023

Please find attached the statement of the Federation of German Industries (BDI) on the proposal for a Regulation on compulsory licensing for crisis management.

German industry opposes new EU rules on compulsory patent licensing

Bundesverband der Deutschen Industrie e.V., 29 Apr 2022

The BDI opposes changes to current laws, arguing that existing frameworks are sufficient for crisis management. They recommend promoting voluntary cooperation between companies and public authorities instead of legislative mandates.
Maintaining the current system protects the R&D investments and competitive advantage of industrial companies.
EU authorities lose a potential unified mechanism to force production of essential goods during emergencies.

DIGITALEUROPE Rejects Need for New EU Patent Licensing Rules

DIGITALEUROPE, 29 Apr 2022

DIGITALEUROPE argues that current national systems work well and opposes new EU intervention. They demand that compulsory licensing remain a narrow exception and a last resort.
Avoiding new EU rules protects the industry from mandatory technology sharing costs.
Public health groups lose faster access to protected technologies during emergencies.

Consultation response

European Federation of Pharmaceutical Industries and Associations, 28 Jul 2023

In its Compulsory Licensing (CL) proposal, the European Commission (EC) posits a new EU-wide CL for crisis response. This harms IP rights and is a dramatic expansion of the ECs role into Member State (MS) remit, where viable CL provisions already exist. CLs are a last resort, all attempts at…

Consultation response

SMEunited aisbl, 31 Jul 2023

In principle, a lean, uniform, efficient system in the internal market is welcomed instead of a patchwork of 27 different procedures across Member States. If supply chains cannot offer the provision of necessary services and goods in case of crisis, regulatory instruments that can ensure this…

Swedish Business Lobby Rejects EU Compulsory Patent Licensing Rules

Confederation of Swedish Enterprise, 29 Apr 2022

The organization argues there is no evidence for a new legislative initiative. They insist that current international and national frameworks already provide sufficient regulation.
The group avoids regulatory changes that might weaken their members' intellectual property rights.

Medicines for Europe urges voluntary licensing over compulsory measures

MEDICINES FOR EUROPE, 28 Jul 2023

The organization requests that compulsory licensing remain exceptional and be used only as a last resort. They advocate for strengthening voluntary licensing mechanisms and adding provisions to address anticompetitive behavior that delays generic market entry.
This would preserve their voluntary licensing deals while enabling intervention against patent holders blocking generic competition.
Patent holders lose leverage if anticompetitive patent practices can trigger compulsory licensing.

Medicines for Europe Urges Priority for Voluntary Patent Licensing

MEDICINES FOR EUROPE, 27 Apr 2022

The organization believes voluntary agreements are the best way to tackle health crises. They argue that compulsory licensing should remain an exceptional, last-resort measure used primarily for anti-competitive practices.
This would allow their members to secure industrial incentives and EU funding for manufacturing.
Public health authorities might find it harder to mandate drug production during emergencies.

Consultation response

Wirtschaftskammer Österreich, 31 Jul 2023

Vorschlag der EU-Kommission für eine Verordnung über die Vergabe von Zwangslizenzen für das Krisenmanagement sowie zur Änderung der Verordnung (EG) 816/2006 - Stellungnahme der Wirtschaftskammer Österreich

Consultation response

Mouvement des Entreprises de France, 28 Jul 2023

MEDEF comments on the European Commissions proposals dated 27 April 2023 for a Regulation on the unitary supplementary protection certificate for plant protection products ; on compulsory licensing for crisis management and amending Regulation (EC) 816/2006 ; on standard essential patents and…

Afep urges EU to avoid new patent licensing legislation

Association Française des Entreprises Privées / French Association of Large Companies, 29 Apr 2022

Afep recommends maintaining the existing legal framework and avoiding additional legislative measures. They support creating an EU coordination mechanism based on sharing best practices between member states.
This ensures large companies maintain exclusive rights to exploit their patents during crises.
EU authorities may lack efficient tools to address future cross-border health emergencies.

Consultation response

EuropaBio, 28 Jul 2023

The COVID-19 pandemic has shown the importance for Europe to have the right tools to respond to major health crises. The EU has already adopted several laws to improve its ability to respond to health emergencies and the coordination between the Member States. National and international instruments…

Consultation response

Verband der Chemischen Industrie e.V., 18 Jul 2023

Please note the attached PDF statement of the VCI.

Johnson & Johnson warns EU patent licensing plans are misguided

Johnson Johnson, 29 Apr 2022

The company believes enhancing compulsory licensing at the EU level is a misguided approach. They argue that voluntary technology transfers are the most effective way to expand production. This framework protects the IP necessary to facilitate medical innovation.
Avoiding mandatory licensing allows the company to protect its long-term research investments.
Generic manufacturers lose the opportunity to produce and scale up affordable treatments.

MSF Urges EU to Reform Patent Licensing for Medicine Access

Médecins Sans Frontières International, 29 Apr 2022

MSF recommends expedited procedures and automatic waivers of data exclusivity for public health needs. They also suggest a coordinated regional approach to improve production and supply.
This would simplify the production and importation of affordable generic medicines globally.
Pharmaceutical companies would lose their exclusive control over clinical data and market protection.

Consultation response

Pfizer Inc., 28 Jul 2023

Pfizer welcomes the opportunity to respond to the proposal. Our purpose Breakthroughs that change patients lives fuels everything we do and reflects our passion for science and our commitment to patients. Alongside this, a strong system of intellectual property (IP) protection provides the economic…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 28 Jul 2023

The development of new medicines requires extensive research and considerable time and resources, the path from basic research to a new authorised medicine is long and involves many uncertainties. To deal with uncertainties, and the long timelines for development and marketing authorisation, IP…

EUCOPE: Compulsory licensing must remain a last resort

European Confederation of Pharmaceutical Entrepreneurs, 28 Apr 2022

EUCOPE argues compulsory licensing must remain a last resort. New rules should respect international agreements and protect data incentives.
Stronger protections allow companies to secure returns on high-risk medical research.

German Bar Association opposes centralized EU patent licensing system

Deutscher Anwaltverein (German Bar Association), 29 Apr 2022

The association rejects a unified EU licensing system and prefers non-legislative coordination. They argue that licensing must remain embedded within existing national legal frameworks.
This protects the consistency of legal practice within national patent enforcement systems.
EU regulators lose the opportunity to establish a centralized legislative crisis mechanism.

Teva Pharmaceuticals urges EU to prioritize voluntary licensing agreements

Teva Pharmaceuticals Europe BV, 29 Apr 2022

Teva believes voluntary cooperation is the most effective way to expand medicine production. They argue compulsory licensing should remain an exceptional last resort used only after voluntary options fail.
Maintaining voluntary models protects the company's control over its patent portfolio and pricing.
Healthcare systems and patients may face higher costs or slower access during crises.

Fraunhofer IIS opposes new EU rules for compulsory patent licensing

Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., 29 Apr 2022

The organization argues there is no demonstrated need for an EU legislative initiative. They believe the current system provides sufficient legal certainty and should remain unchanged.
Maintaining the status quo protects their revenue from patent-dependent contract research.
Public health authorities might find it harder to access technology during emergencies.

Health mutuals urge EU to expand compulsory licensing scope

Association Internationale de la Mutualité, 29 Apr 2022

AIM calls for lifting data and market exclusivity to ensure product availability. They suggest harmonizing national laws while maintaining broad reasons for issuing licenses.
Broad licensing allows mutuals to provide more affordable medical countermeasures to patients.
Pharmaceutical companies lose exclusive control over clinical data and manufacturing secrets.

Consultation response

IP Europe, 31 Jul 2023

IP Europe is a coalition of R&D-intensive organisations whose inventions are protected by Intellectual Property Rights. IP Europes goal is to promote the vital importance of IPR in general, and standard essential patents (SEPs) in particular, to the digital-and knowledge-based economy and to ensure…

IP Europe warns against expanding EU compulsory patent licensing

IP Europe, 29 Apr 2022

IP Europe argues that current national systems work well and opposes EU intervention. They maintain that compulsory licensing must remain an extreme last resort for preventing abuse. The group suggests promoting voluntary industry initiatives instead of new mandates.
Strict IP protection preserves high returns for members' research and development investments.
Governments might face higher costs or slower responses during future health emergencies.

German pharma group opposes EU-wide compulsory patent licensing

Bundesverband der Pharmazeutischen Industrie e.V., 29 Apr 2022

The BPI argues that current international and national laws are sufficient and no additional EU action is needed. They suggest replacing state-led restrictions with voluntary cooperation between companies and authorities. Compulsory licensing must only be used as a last resort to avoid undermining innovation.
Rejecting EU harmonization preserves market exclusivity and protects high-risk investments in new therapies.
Member States lose a coordinated mechanism to quickly secure critical goods during crises.

Austrian Pharma Warns EU Against Weakening Intellectual Property Rights

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 29 Apr 2022

PHARMIG insists intellectual property is essential for innovation and risky investments. They recommend the Commission support voluntary cooperation rather than endangering it with compulsory licenses. If introduced, licenses must require strict crisis definitions and full patent holder involvement.
Stricter licensing requirements help maintain high profit margins and market exclusivity.
Public health authorities may struggle to bypass patents quickly during emergencies.

Consultation response

Stichting Health Action International, 29 Jul 2023

The European Commission proposal COM(2023)224 and accompanying documents is an overdue step forward towards a more nuanced balanced between innovation and access as it aims to streamline and facilitate the use of Compulsory Licenses. It has been a longstanding position of Health Action…

Consultation response

Stichting Health Action International, 29 Apr 2022

Health Action International (HAI) welcomes the step taken by the European Commission towards an enhanced use of Compulsory Licenses (CL) in EU territory; such measure will have a positive impact on access to medicines and health technologies, strengthening the ability of governments to fulfill the…

Consultation response

BIO Deutschland, 21 Jul 2023

Please see attached on behalf of BIO Deutschland e.V.

Consultation response

BIO Deutschland, 29 Apr 2022

BIO Deutschland ist der Deutsche Verband der Biotechnologie-Industrie und mit 360 Mitgliedsunternehmen die Stimme des innovativen Mittelstandes dieser Branche. Als wichtigstes Ziel in der COVID-19-Pandemie begreift BIO Deutschland, dass der Zugang zu Impfstoffen für jedermann ermöglicht wird. Um…

Consultation response

Associazione delle Imprese del farmaco, 29 Apr 2022

A robust intellectual property framework is the essential key to promote innovation and to drive investments towards innovative manufacturing. The COVID19 crisis demonstrates that the current IP system has successfully played a crucial role in enabling innovation and collaboration, between…

Consultation response

Bundesrechtsanwaltskammer, 12 Jul 2023

Please find attached the position paper of the German Federal Bar on compulsory licensing (in German language).

German Federal Bar warns against eroding EU patent protection

Bundesrechtsanwaltskammer, 29 Apr 2022

The organization calls for a clear distinction between emergency management and general technology access. They stress that any harmonization must avoid eroding the substance of patent protection.
Strict licensing conditions would preserve high-value patent assets for the Bar's clients.
Third parties and the green transition could suffer from restricted technology access.

Consultation response

Compagnie Nationale des Conseils en Propriété Industrielle, 29 Apr 2022

La CNCPI, organisme institué par le code de la propriété intellectuelle français et qui représente la profession libérale réglementée regroupant tous les conseils en propriété industrielle français, remercie la Commission européenne pour l’opportunité qui lui est donnée de participer à cet appel à…

Consultation response

Sisvel International S.A., 31 Jul 2023

Sisvel welcomes the opportunity to comment on the European Commission's proposal for a regulation on compulsory licensing in times of crises. Our comments are detailed in the attached document. We remain available to engage in further discussions.

Consultation response

ASOCIACIÓN NACIONAL EMPRESARIAL DE LA INDUSTRIA FARMACÉUTICA, 28 Jul 2023

La propuesta de la CE sobre concesión de Licencias Obligatorias (LO) resulta muy preocupante para FARMAINDUSTRIA al contemplar la suspensión de los derechos de PI e impedir la elección de socios para conceder voluntariamente licencias de fabricación de sus productos sin que se observe base jurídica…

Consultation response

Fachverband der Chemischen Industrie Österreichs, 31 Jul 2023

Der FCIO begrüßt die Harmonisierung des Patentrechtes, welche hier auf die Vergabe von Zwangslizenznen fokussiert. Können Lieferketten die Bereitstellung notwendiger Leistungen/Waren im Krisenfall nicht leisten, werden staatliche Instrumente zur Korrektur unterstützt. Ein solches Instrument darf…

Consultation response

Knowledge Ecology International Europe, 31 Jul 2023

Knowledge Ecology International Europe's (KEI Europe) comments on the Commission's proposal for a regulation on compulsory licensing addresses the following issues. The regulation should not be limited to an emergency. The exceptions for regulatory data protections and market exclusivity are…

Consultation response

Intellectual Property Owners Association, 31 Jul 2023

Attached please find comments by the Intellectual Property Owners Association. Thank you for this opportunity to provide feedback.

Consultation response

IDEMIA France, 31 Jul 2023

IDEMIA very much welcomes this proposal of regulation, which provides for harmonized rules for the compulsory licensing of patents in case of crisis. IDEMIA believes it will ensure a better resilience of the EU and the single market in case of crisis by ensuring swift and efficient mitigation…

Consultation response

Fachverband der Chemischen Industrie Österreichs, 29 Apr 2022

Das derzeit bestehende, sehr robuste System zum Schutz geistigen Eigentums (SgE) in der EU hat dafür gesorgt, dass beträchtliche Investitionen in Forschung zur Entwicklung neuartiger AM (AM) und Impfstoffe, auch jene zur Bekämpfung von COVID-19, getätigt werden konnten. Der SgE hat dafür den…

Consultation response

Knowledge Ecology International Europe, 29 Apr 2022

1. In the European Union (EU)’s revised framework for compulsory licensing of patents, the EU anticipates establishing an EU-level compulsory licence for use in a crisis, acknowledging that a patchwork of fragmented, national compulsory licensing laws are not fit for purpose in dealing with the…

Consultation response

Intellectual Property Owners Association, 28 Apr 2022

Attached please find the comments of the Intellectual Property Owners Association regarding the European Commission’s call for evidence regarding a potentially revised framework for compulsory licensing of patents. Thank you for this opportunity to comment.

Consultation response

IP FEDERATION, 27 Jul 2023

The IP Federation represents IP intensive companies in the United Kingdom - a list of members is at: https://www.ipfederation.com/member-list/ The IP Federation supports the BusinessEurope position paper on compulsory licencing for crisis management submitted on 19 July 2023 and also available…