Article 1 · Regulation (EU) 2025/2645

Article 1Objective and subject matter#

This Regulation has the objective of ensuring that a Union compulsory licence may be granted in the context of a crisis or emergency affecting the Union. To that end, this Regulation lays down rules on the conditions and the procedure for granting a Union compulsory licence for intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a crisis or emergency mode which has been declared pursuant to a crisis or emergency mechanism provided for in a Union legal act listed in the Annex (a ‘Union crisis or emergency mechanism’). This Regulation provides that a Union compulsory licence is granted in the public interest and as a measure of last resort where other means, including voluntary agreements to use a protected invention that concerns crisis-relevant products, could not ensure access to those products.

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Defined terms · 8

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competent advisory body
means the advisory body competent under a Union crisis or emergency mechanism as listed in the Annex or, where applicable, the ad hoc advisory body referred to in Article 6(5);
crisis or emergency mode
means a crisis or emergency mode listed in the Annex, which has been declared pursuant to a Union crisis or emergency mechanism;
crisis-relevant product
means a product that is indispensable for responding to a crisis or emergency in the Union, or for addressing the impact of a crisis or emergency in the Union;
customs authorities
means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013 of the European Parliament and of the Council.
protected invention
means any invention protected by any of the intellectual property rights referred to in Article 2(1);
relevant activities
means the act of manufacturing, namely making, or the act of marketing, namely using, offering for sale, selling or importing;
right holder
means the holder or holders of any of the intellectual property rights referred to in Article 2(1);
Union compulsory licence
means a compulsory licence granted by the Commission to exploit a protected invention in order to carry out in the Union relevant activities concerning crisis-relevant products or processes required to manufacture those products;