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Abstract

Within the scope of its initiative on ‘Compulsory Licensing in the EU’,8 the European Commission launched a call for evidence on 1 April 2022 and a public consultation on 7 July 2022 with the aim of gathering views from stakeholders. The objective of this initiative is to explore the possibility of revising the framework for compulsory licensing in the EU to make it more ‘adequately prepared and coordinated to tackle future crises’.9 The authors of this position paper welcome the Commission’s attempt to reinvigorate the public discourse on this important subject.

Depending on the issue to be addressed and the extent of the Commission’s willingness to reform, different regulatory approaches are conceivable. Subject to compatibility with the principles of subsidiarity and proportionality, these include:

Rather than making concrete recommendations on the regulatory approach, this paper addresses selected aspects by way of a preliminary, non-exhaustive note on: the proposed reform’s scope and the grounds for a compulsory licence; the requirements of prior negotiation and licensing failure; government use; procedural matters; compulsory licences for patent applications and products; the relation with other regulations and sui generis regimes (i.e. trade secret protection, regulatory data protection and supplementary protection certificates); the concept of adequate remuneration; compulsory licences for European patents with unitary effect; and the exhaustion of products placed on the market under a compulsory licence.

– soft law measures, such as guidelines and recommendations;

– harmonisation of national laws (substantive and/or procedural);10

– judicial cooperation (i.e. mutual recognition of judgments and of decisions in extrajudicial cases);11

– centralisation of granting and/or judicial review competences;

– creation of a supranational compulsory licence;

– or any combination thereof.