Activities of Gilles LEBRETON related to 2023/0129(COD)
Legal basis opinions (0)
Amendments (48)
Amendment 58 #
Proposal for a regulation
Recital 3
Recital 3
(3) The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’)3 . The provisions of this Regulation should be consistent with TRIPS Agreement's obligations, in particular with respect to the protection of trade secrets. _________________ 3 OJ L 336, 23.12.1994, p. 214
Amendment 60 #
Proposal for a regulation
Recital 6
Recital 6
(6) Therefore, it is necessary to establish a compulsory licence for crisis or emergency management at Union level. Under this system, the Commissionuncil should be the institution empowered to grant a compulsory licence that is valid throughout the Union and that allows the manufacturing and distribution of products necessary to address a crisis or emergency in the Union (‘Union compulsory licence’).
Amendment 64 #
Proposal for a regulation
Recital 8
Recital 8
(8) These mechanisms provide for the activation of an emergency or crisis mode and aim at providing the means to address Union emergencies. By allowing the Commissionuncil to grant a compulsory licence when a crisis or emergency mode has been activated by a Union legal act, the necessary synergy between the existing crisis mechanisms and a Union wide compulsory licencing scheme is achieved. In such a case, the determination of the existence of a crisis or emergency depends solely on the Union legal act underlying the crisis mechanism and the crisis definition included therein. For the sake of legal certainty, the crisis mechanisms that qualify as Union emergency or extreme urgency measures and that can trigger a Union compulsory licence should be listed in an Annex to this Regulationpunctually listed.
Amendment 66 #
Proposal for a regulation
Recital 9
Recital 9
(9) To ensure optimal efficiency of the Union compulsory licence as a tool to address crises, it should be made available in respect of a granted patent or utility model, of a published patent application or a supplementary protection certificate. The Union compulsory licence should equally apply to a national patents, European patents and European patents with unitary effect.
Amendment 68 #
Proposal for a regulation
Recital 12
Recital 12
Amendment 70 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 71 #
Proposal for a regulation
Recital 15
Recital 15
Amendment 74 #
Proposal for a regulation
Recital 16
Recital 16
(16) A Union compulsory licence authorises the use of a protected invention without the consent of the rights-holder. Therefore, it must only be granted exceptionally and under conditions that take into account the interests of the rights- holder. This includes and the availabilities of possible licensees. This includes an in-depth dialogue phase with the right-holder, a screening of possible licensees, a clear determination of the scope, duration and territorial coverage of the licence. In the context of a Union level crisis mechanism, the crisis mode or emergency mode is activated or declared for a limited period of time. Where a Union compulsory licence is granted within such framework, the duration of the licence shall not extend beyond the duration of the activated or declared crisis or emergency mode. In order to ensure that the compulsory licence fulfils its objective as well as its conditions, the use of the invention should only be authorised to a qualified person able to manufacture the crisis-relevant product and to pay a reasonable remuneration to the rights-holder. The granting of a compulsory licence is in any case preceded by a stage enabling the right holder and the possible licensee to negotiate in order to reach a voluntary agreement, which should remain the preferred option.
Amendment 78 #
Proposal for a regulation
Recital 17
Recital 17
(17) When considering the granting of a Union compulsory licence, the Commission should, in order to be able to take a well-informed decision, bthe assisted byance of an advisory body must be envisaged. The consultation of the advisory body should arise early in the discussions on the need to issue a compulsory licence under the relevant instrument. Discussions on whether there is a need for a Union compulsory licence will often start already in the context of the work of the advisory body involved in the context of the relevant Union crisis or emergency mechanisms. In such case, there is no need for the Commission to convene the advisory body but rather to swiftly indicate that that body also has the competence to assess the need for compulsory licensing at Union level, and the conditions thereof. In the latter case, each Member State may indicate one expert on intellectual property to take part in the work of the advisory body. Clarification as regards the competence of the advisory body should be given early in the process, as soon as concrete consideration of using compulsory licensing at Union level is expressed by the Commission.
Amendment 80 #
Proposal for a regulation
Recital 18
Recital 18
(18) The participation of an advisory body aims at guaranteeing a comprehensive, thorough, and concrete assessment of the situation, taking into consideration the individual merits of each situation. It is therefore important that the advisory body has the right composition, expertise, and procedures to support the Commission when deciding on whether to propose to the Council to grant a Union compulsory licence and under what conditions. Union crisis mechanisms usually include the setting-up of an advisory body ensuring coordination of action of the Commission and relevant bodies and agencies, the Council and the Member States. In this respect, an advisory group is set up under SMEI. Regulation (EU) No 2022/2371 provides for a Health Crisis Board and under Regulation (EU) No XXX/XX (Chips Act) [COM/2022) 46], the Commission relies on the Semiconductor Board. Those advisory bodies have the right composition, expertise, and procedures to address the crises and emergencies for which they have been set-up. When compulsory licensing is being discussed in the context of such crisis instrument, relying on the advisory body set-up for the specific instrument allows the Commission to be adequately advised and avoid duplication of advisory bodies, leading to incoherences between processes. The competent advisory bodies shall be listed, together with the corresponding crisis mechanisms, in an Annex to this Regulation. In case the Union crisis mechanism does not provide for an advisory body composed by representatives of all Member States, the Commission should set up an ad hoc advisory body for the granting of the Union (the ‘ad hoc advisory body’).
Amendment 86 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Commission should propose to the Council to grant the Union compulsory licence in the light of the non-binding opinion of the advisory body. Persons, in particular the licensee and the rights- holder, whose interests may be affected by the Union compulsory licence should be given the opportunity to submit their comments. These elements should enable the Commission to consider the individual merits of the situation and determine, on that basis, the adequate conditions of the licence, including an adequate remuneration to be paid by the licensee to the rights-holder. To avoid overproduction of products manufactured under a Union compulsory licence, the Commission should also consider any existing compulsory licences at national level.
Amendment 91 #
Proposal for a regulation
Recital 22
Recital 22
(22) When informed of advanced discussions as regards the granting of a Union compulsory licence, the rights- holder should have the possibility to propose a voluntary agreement, which should the circumstances of the Union crisis or emergency, including the urgency of the situation, allow itremain the preferred option. The rights-holder should also be given the opportunity to comment on the need for a Union compulsory licence and on the conditions of the licence, including remuneration, should it be granted. To this end, the rights-holder should be allowed to provide the Commission with written or oral comments and any information the rights- holder considers useful to allow the Commission to make a fair, comprehensive, and thorough assessment of the situation. The Commission should allow the rights-holder a reasonable period of time to provide comments and information, considering the situation of the rights-holder and the urgency of the situation. The comments of the rights- holder should, where relevant, be transmitted by the Commission to the competent advisory body. In order for confidential information to be shared with the Commission, the Commission shall ensure a safe environment for the sharing of this information and should take measures to preserve the confidentiality of the documents provided by the rights- holder in the context of that procedure. Once a Union compulsory licence has been granted, the Commission should notify the rights-holder as soon as reasonably practicable. The CJEU's judicial review of the grounds and the conditions under which a Union compulsory licensing has been granted should be possible.
Amendment 93 #
Proposal for a regulation
Recital 24
Recital 24
(24) The Commission should, assisted by the advisory body, make its best efforts to identify in its decision the patent, patent applicationthe patent, supplementary protection certificate and utility model related to the crisis-relevant products, and the rights- holders of those intellectual property rights. In certain circumstances, the identification of intellectual property rights and of their respective rights- holders may require lengthy and complex investigations. In such cases, a complete identification of all intellectual property rights and of their rights-holders may seriously undermine the efficient use of the Union compulsory licence to swiftly tackle the crisis or the emergency. Therefore, where the identification of all those intellectual property rights or rights- holders would significantly delay the granting of the Union compulsory licence, the Commission should be able to initially only indicate in the licence the non- proprietary name of the product for which it is sought. The Commission should nevertheless identify all applicable and relevant intellectual property rights and their rights-holder as soon as possible and amend the implementing act accordingly. The amended implementing act should also identify any necessary safeguards and remuneration to be paid to each identified rights-holder.
Amendment 97 #
Proposal for a regulation
Recital 25
Recital 25
Amendment 98 #
Proposal for a regulation
Recital 27
Recital 27
(27) The licensee should pay an adequate remuneration to the rights-holder as determined by the Commission. The amount of the remuneration should be determined considering the economic value of the exploitation authorised under the licence to the licensee and to the Member States concerned by the crisis, any public support received by the rights-holder to develop the invention, the degree to which development costs have been amortized as well as humanitarian circumstances relating to the granting of the Union compulsory licence. In addition, the Commission should consider the comments made by the rights-holder and the assessment made by the advisory body with regard to the amount of the remuneration. In any case, the remuneration should not exceed 4 % of the total gross revenue generated by the licensee through the acts under the Union compulsory licence. This percentage is the same as the one provided for under Regulation 816/2006. In the event of a compulsory licence granted on the basis of a published patent application that ultimately does not lead to the granting of a patent, the rights-holder would have no ground to receive remuneration under the compulsory licence, as the subject matter for the receipt of the remuneration has not materialised. In such circumstances, the rights-holder should refund the remuneration it received under the compulsory licence.
Amendment 104 #
Proposal for a regulation
Recital 32
Recital 32
(32) The relation between the rights- holder and the licensee should be governed by the principle of good faith. The rights- holder and licensee should work towards the success of the Union compulsory licence and collaborate, where necessary, to ensure that the Union compulsory licence effectively and efficiently fulfils its objective. The Commission may act as an enabler in achieving the good-faith cooperation between the rights-holder and the licensee, taking into account interests of all parties. In that respect, the Commission should also be entitled to takepropose to the Council additional measures in line with Union law to ensure that the compulsory licence meets its objective and ensure that necessary crisis- relevant goods can be made available in the Union. Such additional measures may include requesting further information which is deemed indispensable to achieve the objective of the compulsory licence. These measures should always include adequate safeguards to ensure the protection of the legitimate interests of all parties and should ensure the protection of trade secrets as defined in Article 2 of the Directive (EU) 2016/943. Such data should be protected against the disclosure and the use without the consent of trade secrets' holder. Steps should be taken to ensure that the data are protected against unfair commercial use.
Amendment 110 #
Proposal for a regulation
Recital 33
Recital 33
(33) In order to respond appropriately to the crisis situations, the Commission should be authorimay proposed to review the conditions of the Union compulsory licence and adapt them to changed circumstances. This should include the modification of the compulsory licence to indicate the complete list of rights and rights-holders covered by the compulsory licence, where this complete identification had not be done initially. This should also include the termination of the licence if the circumstances which led to it cease to exist and are unlikely to recur. When deciding on the revision of the Union compulsory licence, the Commission may decideis required to consult the competent advisory body for that purpose. If the Commission intends to change essential components of the Union compulsory licence, such as its duration or remuneration, or if the change itself could be the subject of a separate compulsory licence, it should be required to consult the advisory body.
Amendment 115 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commissionuncil as regards the granting, complementing, modification or termination of a Union compulsory license, the determination of the remuneration to be paid to the rights- holder, the procedural rules for the ad hoc advisory body and the characteristics allowing the identification of products produced under a Union compulsory licence. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council12 . The advisory procedure should be used for the adoption of implement and the characteristics allowing the identification of products produced under a Union compulsory licence, and to the Commission for the procedural rules for the ad hoc advisory body. Those powers should be exercised ing acts granting, complementing, modifying or terminating a Union compulsory licence, and implementing acts determining the remuneration. The choice of the advisory procedure is justified given that those implementing acts would be adopted in the context of a procedure with considerable participation of the Member States through the consultation of the advisory bodycordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council12 . The examination procedure should be used for the adoption of implementing acts establishing procedural rules for the ad hoc advisory body and implementing acts establishing the characteristics allowing the identification of products produced under a Union compulsory licence.. _________________ 12 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 121 #
Proposal for a regulation
Recital 40
Recital 40
(40) Union compulsory licensing for crisis management is a tool that is only used in exceptional circumstances and as a last resort measure. The evaluation should therefore be conducted only where a Union compulsory licence has been granted by the Commission. The evaluation report should be submitted by the last day of the third year following the granting of the Union compulsory licence, to allow an adequate and substantiated assessment of this Regulation.
Amendment 136 #
Proposal for a regulation
Article 3 – paragraph 1 – point a a (new)
Article 3 – paragraph 1 – point a a (new)
(aa) "Crisis" means the following crisis or emergency modes: – Public health emergency at Union level formally recognized by means of a Commission implementing act under Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU; – Emergency framework activated by the adoption of a Council Regulation under Article 3 of Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level; – Crisis stage activated by a Council implementing act under Article 23 of Regulation (EU) 2023/1781 of the European Parliament and the Council of 13 September 2023 establishing a framework of measures for strengthening Europe’s semiconductor ecosystem and amending Regulation (EU) 2021/694 (Chips Act).
Amendment 137 #
Proposal for a regulation
Article 3 – paragraph 1 – point a b (new)
Article 3 – paragraph 1 – point a b (new)
(ab) "Advisory Body" means the advisory body deemed competent according to the relevant legislation on the crisis mode or emergency instrument triggered, in particular: – the Advisory Committee on public health emergencies under Article 24 of Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross- border threats to health and repealing Decision No 1082/2013/EU; – the Health Crisis Board under Article 5 of Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis of relevant medical countermeasures in the event of a public health emergency at Union level; – the European Semiconductor Board under Article 28 of Regulation (EU) 2023/1781 of the European Parliament and the Council of 13 September 2023 establishing a framework of measures for strengthening Europe’s semiconductor ecosystem and amending Regulation (EU) 2021/694 (Chips Act).
Amendment 144 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
The Commissionuncil may grant a Union compulsory licence where a crisis mode or an emergency mode listed in the Annex to this Regulationunder in Article 3 (aa) has been activated or declared in accordance with one of the Union acts listed in that Annexherein.
Amendment 161 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 164 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When the Commission considers the granting of a Union compulsory licence, it shall without undue delay consult an advisory bod is considered, an advisory body shall be consulted without undue delay.
Amendment 167 #
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. The advisory body referred to in paragraph 1 shall be the advisory body competent for the Union crisis or emergency mechanism as listed in Annex I to this Regulation (the ‘competent advisory body’).under Article 3 (ab), with the participation of intellectual property experts appointed by Member States. For the purposes of the present Regulation, the competent advisory body shall give assistance and advise the Commission as regards the following tasks:
Amendment 184 #
Proposal for a regulation
Article 6 – paragraph 4 – point b a (new)
Article 6 – paragraph 4 – point b a (new)
(ba) shall, in any case, engage in a preliminary dialogue with the right holder, whose right to be heard shall always be guaranteed, and encourage the reaching of voluntary licensing agreements.
Amendment 186 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. In the absence of any existing competent advisory body composed by representatives of all Member States, the tasks referred to in paragraph 2 shall be performed by an ad hoc advisory body set up by the Commission (the ‘ad hoc advisory body’). The Commission shall chair the ad hoc advisory body and ensure its secretariat. Each Member State shall have the right to be represented in the ad hoc advisory body.
Amendment 204 #
Proposal for a regulation
Article 7 – paragraph 3 – point c
Article 7 – paragraph 3 – point c
(c) the conditions under which the Commission intends to grant the Union compulsory licence, includingpropose to the Council the amougrant of the remunerationUnion compulsory licence.
Amendment 205 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 207 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. When the Commission considers that the conditions for the granting of a Union compulsory licence are met, it shall without undue delay publish a notice to inform the public about the initiation of the procedure under this article. This notice shall also include, where already available and relevant, information on the subject of the compulsory licence and an invitation to submit comments in accordance with paragraph 3. The notice shall be published in the Official Journal of the European Union.
Amendment 217 #
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. Where the Commission find, taking into consideration the opinion provided by the advisory body, considers that the requirements for a Union compulsory licence are met, the Commission shall grant itpropose to the Council to grant it. The Council may grant a Union compulsory licensing by means of an Council implementing act. The implementing act shall be adopted in accordance with the advisory procedure referred to in Article 24(2).duration and the definition of the crisis-relevant products shall be specified in the implementing act. On duly justified imperative grounds of urgency relating to the impacts of the crisis, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 24(4). In case of procedure under Article 24(4), the implementing act shall remain in force for a period not exceeding 12 months.
Amendment 219 #
Proposal for a regulation
Article 7 – paragraph 8
Article 7 – paragraph 8
8. When adopting the implementing act, the Commission shall ensure the protection of confidential information shall be protected. While respecting the confidentiality of the information, ithe Commission shall be ensured that any information relied on for the purpose of its decision is disclosed to an extent that allows to understand the facts and considerations that led up to the adoption of the implementing act.
Amendment 224 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the patent, patent application, supplementary protection certificate or utility model for which the licence is granted or, where the identification of those rights would significantly delay the granting of the licence, the non-proprietary name of the products which are to be manufactured under the licence;
Amendment 226 #
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) the right-holder, provided they can be identified with reasonable efforts having regard to the circumstances, including the urgency of the situation;
Amendment 227 #
Proposal for a regulation
Article 8 – paragraph 1 – point d
Article 8 – paragraph 1 – point d
(d) the duration for which the Union compulsory licence is granted, with an initial suspension period the duration of which shall not be less than ten days from the day following the day of publication of the Union compulsory license in the Official Journal of the European Union, for the purpose of a possible judicial review;
Amendment 231 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 232 #
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8a Review by the Court of Justice of the European Union 1. The Court of Justice of the European Union has jurisdiction to review the grounds and the conditions under which a Union compulsory licence has been granted. 2. An implementing act granting a Union compulsory licence shall not take effect before the end of an initial suspension period which shall not be less than 10 calendar days from the day following the day of publication of the Union compulsory license in the Official Journal of the European Union. 3. The right-holder or the licensee may lodge, before the expiry of the suspension period, an application for annulment of the implementing act. Such an application shall have a suspensive effect.
Amendment 235 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The licensee shall pay anright holder shall be paid adequate remuneration toin the rights-holder. The amount of the remuneration shall be determined by the Commission and specified in the Union compulsory licencecircumstances of each case, taking into account the economic value of the authorization.
Amendment 240 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The remuneration shall not exceed 4 % ofbe determined based on the total gross revenue generated by the licensee through the relevafrom the pertinent activities under the Union compulsory licence.
Amendment 242 #
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. When determining the remuneration, the Commissionfollowing elements shall be consider the followinged:
Amendment 246 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 257 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 270 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Commission shall propose to the Council to review the Union compulsory licence upon reasoned request by the rights-holder or the licensee or on its own initiative and shall, where needed, to modify the specifications referred to in Article 8 or to establish additional measures complementing the Union compulsory licensing to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee. The Council shall act by means of an implementing act. Where necessary, the Union compulsory licence shall be modified to indicate the complete list of rights and rights-holders covered by the compulsory licence.
Amendment 273 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
Amendment 275 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. A Union compulsory licence may be terminated by the Commissionuncil by means of an implementing act where the circumstances which led to it cease to exist and are unlikely to recur or where the licensee fails to comply with the obligations laid down in this Regulation.
Amendment 277 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. When the Commission considers the proposal of modifying, adopting additional measures as referred to in paragraph 21, or terminating the Union compulsory licence, it may consult the advisory body referred to in Article 6.
Amendment 279 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The implementing acts referred to in paragraph 1, 2 and 3 shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).
Amendment 299 #
Proposal for a regulation
Annex I
Annex I