BETA

40 Amendments of Alessandra BASSO related to 2023/0129(COD)

Amendment 58 #
Proposal for a regulation
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
2023/11/14
Committee: JURI
Amendment 60 #
Proposal for a regulation
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’).
2023/11/14
Committee: JURI
Amendment 64 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 66 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 68 #
Proposal for a regulation
Recital 12
(12) The Union compulsory licence should also apply to published patent applications for national patents and for European patents. As the grant of a patent after the publishing of the patent application can take years, targeting only inventions protected by a granted patent could prevent an effective and timely crisis response. In crises, solutions can derive from the latest state-of-the-art technology. Moreover, certain national patent legislations, as well as the European Patent Convention, provide for protection of patent applicants with regard to unconsented use of their inventions and the corresponding possibility for such applicants to licence the use of their patent application rights. In order to ensure that a Union compulsory licence on a published patent application continues to keep its effects once the patent is granted, the Union compulsory licence for published patent applications should extend to the patent once granted to the extent that the crisis- relevant product still falls within the scope of the patent claims.deleted
2023/11/14
Committee: JURI
Amendment 70 #
Proposal for a regulation
Recital 14
(14) When a compulsory licence has been granted, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as it impedes the authorisation of generic medicinal products. This would result in serious negative consequences for Union compulsory licences granted to tackle a crisis, as this could hamper access to the medicinal products needed to address the crisis. For this reason, Union pharmaceutical legislation (cf. Art. 80 para. 4 of Directive (EU) No XXX/XX [COM(2023)192]) provides for the suspension of data exclusivity and market protection when a compulsory licence has been issued to tackle a public health emergency. Such suspension is allowed only in relation to the compulsory licence granted and its beneficiary and must comply with the objectives, the territorial scope, the duration, and the subject- matter of the granted compulsory licence. The suspension means that the data exclusivity and market protection produce no effect in relation to the licensee of the compulsory licence while that licence is in effect. When the compulsory licence ends, the data exclusivity and market protection resume their effect. The suspension should not result in an extension of the original duration of the regulatory data protection.deleted
2023/11/14
Committee: JURI
Amendment 71 #
Proposal for a regulation
Recital 15
(15) In order to ensure as much coherence as possible with existing crisis mechanisms and with other Union legislation, the definition of a ‘crisis- relevant product’ should be based on the definition adopted in the Single Market Emergency Instrument (SMEI) but should be more general in order to cover products related to different kinds of crises or emergencies.Deleted
2023/11/14
Committee: JURI
Amendment 74 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 78 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 127 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
(a) patents, including published patent applications;
2023/11/14
Committee: JURI
Amendment 136 #
Proposal for a regulation
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).
2023/11/14
Committee: JURI
Amendment 137 #
Proposal for a regulation
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).
2023/11/14
Committee: JURI
Amendment 144 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 161 #
Proposal for a regulation
Article 5 – paragraph 2
2. A Union compulsory licence for an invention protected by a published patent application shall cover a patent granted based on that application, provided that the granting of that patent takes place while the Union compulsory licence is valid.deleted
2023/11/14
Committee: JURI
Amendment 164 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 167 #
Proposal for a regulation
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:
2023/11/14
Committee: JURI
Amendment 184 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 186 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 194 #
Proposal for a regulation
Article 7 – paragraph 3 – introductory part
3. Before proposing the granting of a Union compulsory licence, the Commission shall first notify the relevant rights-holder that a Union compulsory licence may be granted. The right to be heard of the right holder before adopting a proposal pursuant to Article 7(7) shall be ensured. Article 19 shall apply mutatis mutandis. The Commission shall then give the rights-holder and the identified licensees an opportunity to comment on the following:
2023/11/14
Committee: JURI
Amendment 204 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 205 #
Proposal for a regulation
Article 7 – paragraph 4
4. The Commission shall notify the rights-holder and the licensee as soon as possible of the fact that a Union compulsory licence may be granted. Wherever the identification of the rights- holders is possible and does not cause significant delay, the Commission shall notify them individually.deleted
2023/11/14
Committee: JURI
Amendment 207 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 217 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 219 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 224 #
Proposal for a regulation
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;
2023/11/14
Committee: JURI
Amendment 226 #
Proposal for a regulation
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;
2023/11/14
Committee: JURI
Amendment 227 #
Proposal for a regulation
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;
2023/11/14
Committee: JURI
Amendment 231 #
Proposal for a regulation
Article 8 – paragraph 2
2. By way of derogation from paragraph 1, point (e), the Commission may determine the remuneration after the granting of the licence, by way of an implementing act, where that determination requires, further investigation and consultation. This implementing act shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).deleted
2023/11/14
Committee: JURI
Amendment 232 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 235 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 240 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 242 #
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
3. When determining the remuneration, the Commissionfollowing elements shall be consider the followinged:
2023/11/14
Committee: JURI
Amendment 246 #
Proposal for a regulation
Article 9 – paragraph 4
4. If the published patent application for which a compulsory licence has been granted does not subsequently lead to the granting of a patent, the rights-holder shall refund the remuneration paid under this article to the licensee.deleted
2023/11/14
Committee: JURI
Amendment 257 #
Proposal for a regulation
Article 10 – paragraph 3
3. The European Anti-Fraud Office (OLAF) in cooperation with the relevant national authorities of the Member States may, at the request of the rights-holder or on its own initiative, request access to books and records kept by the licensee, for the purpose of checking whether the content and the conditions of the Union compulsory licence, and in general the provisions of this Regulation, have been complied with.deleted
2023/11/14
Committee: JURI
Amendment 270 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 273 #
Proposal for a regulation
Article 14 – paragraph 2
2. Where necessary, the Commission shall decide upon reasoned request by the rights-holder or the licensee or on its own initiative on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.deleted
2023/11/14
Committee: JURI
Amendment 275 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 277 #
Proposal for a regulation
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.
2023/11/14
Committee: JURI
Amendment 279 #
Proposal for a regulation
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).
2023/11/14
Committee: JURI
Amendment 299 #
Proposal for a regulation
Annex I
[...]deleted
2023/11/14
Committee: JURI