Recitals
- Recital (1)Crises require the carrying out of exceptional, swift, adequate and proportionate measures capable of providing means to address them or…
- Recital (2)In the context of a Union crisis or emergency mode under a crisis or emergency mechanism provided for in a Union legal act listed in the…
- Recital (3)The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency is explicitly…
- Recital (4)All Member States have implemented compulsory licensing frameworks for patents in their national laws. National laws usually allow…
- Recital (5)National compulsory licensing systems operate only within the national territory. They are designed to meet the needs of the population of…
- Recital (6)Therefore, it is necessary to establish a compulsory licensing system for crisis management at Union level, in addition to the national…
- Recital (7)In recent years, the Union has adopted several Union crisis or emergency mechanisms to improve its resilience with regard to crises or…
- Recital (8)Those Union crisis or emergency mechanisms provide for the declaration of a crisis or emergency mode and aim at providing the means to…
- Recital (9)To ensure optimal efficiency of the Union compulsory licence as a tool for addressing crises or emergencies, it should be available in…
- Recital (10)Utility model systems offer protection for technical inventions based on criteria that are, as a general rule, less stringent than those…
- Recital (11)A Union compulsory licence concerning a patent should extend to the supplementary protection certificate where such certificate takes…
- Recital (12)The Union compulsory licence should also apply to published patent applications for national patents and for European patents, as well as…
- Recital (13)It should be clarified that this Regulation is without prejudice to Union law on copyright and related rights, including Directives…
- Recital (14)The Union crisis or emergency mechanisms provide for dedicated measures aimed at ensuring the supply in the Union of products that are…
- Recital (15)When a compulsory licence has been granted, regulatory data protection could prevent the effective use of the compulsory licence as it…
- Recital (16)Matters relating to product liability in relation to crisis-relevant products manufactured or marketed under a Union compulsory licence…
- Recital (17)In order to ensure as much coherence as possible with regard to the existing crisis or emergency mechanisms, the definition of…
- Recital (18)A Union compulsory licence should be granted only where specific conditions are fulfilled. In particular, given the fact that the Union…
- Recital (19)A Union compulsory licence authorises the use of a protected invention without the consent of the right holder. Therefore, such a licence…
- Recital (20)When considering the granting of a Union compulsory licence, the Commission should, in order to be able to take a well-informed decision,…
- Recital (21)The aim of an advisory body participating in the Union compulsory licensing process is to guarantee a comprehensive, thorough, and concrete…
- Recital (22)The role of the competent advisory body is to assist and advise the Commission where discussions arise on the need to grant a Union…
- Recital (23)A Union compulsory licence should be granted only in the context of a Union crisis or emergency mode. In such a context, the discussions…
- Recital (24)The publication of the notice on the initiation of the procedure should serve to inform the public that discussions are ongoing as regards…
- Recital (25)After publishing the notice on the initiation of the procedure, the Commission should request the competent advisory body to disseminate it…
- Recital (26)The work performed under this Regulation by the competent advisory body for the purposes of advising and assisting the Commission should…
- Recital (27)After receiving the opinion of the competent advisory body, the Commission should assess whether to continue the procedure for granting a…
- Recital (28)The right holder concerned should be able to submit comments throughout the procedure for granting a Union compulsory licence. The…
- Recital (29)The Commission should ensure that there is a secure environment for the sharing of confidential information and should take measures to…
- Recital (30)In the implementing act by which it grants a Union compulsory licence, the Commission should identify the patents and, where applicable,…
- Recital (31)The Union compulsory licence should include information enabling the crisis-relevant product in respect of which it is granted to be…
- Recital (32)The licensee should pay adequate remuneration to the right holder. The amount of the adequate remuneration should be determined by the…
- Recital (33)It is imperative that the crisis-relevant products manufactured or marketed under a Union compulsory licence are supplied only within the…
- Recital (34)The Commission should be able to consider, as a matter of its internal organisation, entrusting actions relating to cooperation on…
- Recital (35)A Union compulsory licence in the context of a Union crisis or emergency mechanism should be granted to supply only the internal market…
- Recital (36)Customs authorities should ensure, by applying a risk analysis approach, that crisis-relevant products manufactured or marketed under a…
- Recital (37)Pursuant to the TFEU, and in particular Article 263 thereof, the validity of implementing acts granting a Union compulsory licence and the…
- Recital (38)During the procedure for granting a Union compulsory licence, and after such a licence has been granted, the right holder and the licensee…
- Recital (39)In order to respond appropriately to crisis or emergency situations, the Commission should be empowered to review the conditions of the…
- Recital (40)In addition to the possibility of terminating the Union compulsory licence, the Commission should be authorised to impose fines and…
- Recital (41)Appropriate levels of fines for non-compliance with the obligations laid down in this Regulation, and of periodic penalty payments to put…
- Recital (42)Where a national compulsory licence has been granted for the purposes of addressing a crisis or emergency at national level, which in…
- Recital (43)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission…
- Recital (44)The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the granting, modification…
- Recital (45)The possibility of granting a compulsory licence at Union level should not be available only with regard to the internal market. It should…
- Recital (46)On 1 February 2020, the United Kingdom of Great Britain and Northern Ireland (the United Kingdom) withdrew from the Union. The Agreement on…
- Recital (47)This Regulation provides for a tool of last resort that is to be used only in exceptional circumstances. The application of this Regulation…
- Recital (48)In line with the Union’s efforts to enhance its preparedness for and resilience against crises, the list of Union crisis or emergency…
- Recital (49)Since the objective of this Regulation, namely to facilitate access to crisis-relevant products needed to address crises or emergencies in…
Text as published in the Official Journal; for the authentic version, see EUR-Lex.
