Activities of Geoffroy DIDIER related to 2023/0129(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006
Amendments (70)
Amendment 53 #
Proposal for a regulation
Recital 1
Recital 1
(1) Crises require the setting-up of exceptional, swift, and adequate measures able to provide means to address the consequences of the crisis without unnecessarily and disproportionally affecting citizens or businesses’ rights. In this context, the use of patented products or processes could prove indispensable to address the consequences of a crisis. Voluntary licensing agreements usually suffice to licence the patent rights on these products and allow their supply in the Union territory. Voluntary agreements are the most adequate, quick, and efficient solution to allow the use of patented products, including in crises. Nevertheless, voluntary agreements may not always be available or only under inadequate conditions such as lengthy delivery times. In such cases, compulsory licensing as a last resort can provide a solution to allow access to patented products, in particular products necessary to tackle the consequences of a crisis.
Amendment 56 #
Proposal for a regulation
Recital 2
Recital 2
(2) In the context of the Union crisis or emergency mechanisms, the Union should therefore have the possibility to rely on compulsory licensing. The activation of a crisis or an emergency mode or the declaration of a crisis or a state of emergency addresses obstacles to free movement of goods, services, and persons in crises and shortages of crisis-relevant goods and services. In cases where access to crisis-relevant products and processes protected by a patent cannot be achieved through voluntary cooperation, compulsory licensing is a last resort mechanism that can help in lifting any patent- related barriers and thus ensure the supply of products or services needed to confront an ongoing crisis or emergency. It is therefore important that, in the context of said crisis mechanisms, the Union can rely on an efficient and effective compulsory licensing scheme at Union level, which is uniformly applicable within the Union. This would guarantee a functioning internal market, ensuring the supply and the free movement of crisis-critical products subject to compulsory licencing in the internal market.
Amendment 59 #
Proposal for a regulation
Recital 5
Recital 5
(5) National compulsory licensing systems only operate within the national territory. They are designed to meet the needs of the population of the issuing Member State and to satisfy the public interest of that Member State. This limited territorial reach of a national compulsory licensing system is reinforced by the fact that there is no exhaustion of the patent right regarding products manufactured under a compulsory licence. Consequently, compulsory licensing schemes do not provide an adequate solution for cross- border manufacturing processes, and therefore there is no functioning internal market for product manufactured under a compulsory licence. Apart from the fact that the issuance of multiple national compulsory licences is a high hurdle for cross-border supply within the single market, it also bears the risk of contradicting and incoherent decisions among Member States. Consequently, the current compulsory licensing framework appears inadequate to address the realities of the internal market and its inherent cross-border supply chains. This suboptimal compulsory licensing framework prevents the Union from relying on an additional instrument when facing crises, in particular and when voluntary agreements are unavailable or inadequatand cannot be reached in a due time. At a time where the Union and its Member States are striving to improve their resilience to crises, it is necessary to provide for an optimal compulsory licensing system for crisis management that takes the full advantage of the internal market and allows Member States to support one another in crises.
Amendment 63 #
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 Commission to grant a compulsory licence when a crisis or emergency mode has been activated by athe above mentioned Union legal acts, 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 Regulation.
Amendment 67 #
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 69 #
Proposal for a regulation
Recital 12
Recital 12
Amendment 73 #
Proposal for a regulation
Recital 15
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" and 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.
Amendment 75 #
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, as a last resort mechanism, and under conditions that take into account the interests of the rights- holder. This includes a clear deterlimintation of the scope, duration and territorial coverage of the licence strictly in line with the duration of the crisis and the purpose for which the compulsory licence was granted . 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 and should not in principle exceed 12 months, unless a renewal is required by the continued existence of the circumstances that led to the granting of the licence. . 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.
Amendment 82 #
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 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, the Commission should set up an ad hoc advisory body for the granting of the Union (the ‘ad hoc advisory body’).
Amendment 83 #
Proposal for a regulation
Recital 19
Recital 19
(19) The role of the advisory body is to advise the Commission when discussions arise on the need to rely on compulsory licensing at Union level. It should provide the Commission with a non-binding opinion. Its main tasks include assisting of the Commission in the determination of the necessity to rely on compulsory licensing at Union level, and in the determination of the conditions for such licensing , but they should nevertheless include always representatives of the authorities of the Member States which are competent for the granting of compulsory licences under national law. When the advisory body is already set up, its existing rules of procedure should apply. As regards ad hoc advisory bodies, besides including the right holders and potential licensees or their representatives, they should also be composed of onthose representatives of each Member Statenational competent authorities in order to provide the Commission with information and input concerning the situation on the national level, including information on manufacturing capacities, potential licensees and, if applicable, proposals for voluntary solutions. In addition, the advisory body should have the function of collecting and analysing relevant data, as well as ensuring coherence and cooperation with other crisis relevant bodies at Union and national level in order to ensure an adequate, coordinated and coherent crisis reply at Union level.
Amendment 85 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Commission should 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 before the issuance of such opinion and after being provided with the case file and analyses submitted to or carried out by the advisory body, and with all other relevant information necessary for them to assess the impact of a proposed Union compulsory license on their intellectual property rights. . 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 88 #
Proposal for a regulation
Recital 21
Recital 21
(21) The Commission should guarantee that the rights-holder has the right to be heard before the adoption of the Union compulsory licence. Therefore, the Commission should inform the concerned rights-holder, where possible individually, without undue delay that a Union compulsory licence might be granted. The involvement of the rights- holder should be possible once there are ongoing advancedenabled throughout the discussions inof the relevant advisory body as regards the granting of a Union compulsory licence.
Amendment 89 #
Proposal for a regulation
Recital 22
Recital 22
(22) When informed of advanced discussions as regardsGiven that voluntary agreements are the most suitable way to deal with patented products or processes in a time of crisis, then prior to any decision by the Commission on the granting of a Union compulsory licence, the rights- holder should have the possibility to propose a voluntary agreement, should the circumstances of the Union crisis or emergency, includingall be provided a reasonable opportunity to negotiate a voluntary license with potential licensees selected by the rights holder. By allowing a rights-holder to make use its existing business relationships, a more efficient and effective solution can be achieved. The time period allowed should be sufficient so as to enable good faith and meaningful negotiations, taking into account the urgency of the situation, allow it. The rights-holder should also be given the opportunity to comenter into consultation with the Commission, with a view to reaching agreement 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.
Amendment 94 #
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 application, 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 amendedThe implementing act should also identify any necessary safeguards and remuneration to be paid to each identified rights-holder.
Amendment 96 #
Proposal for a regulation
Recital 25
Recital 25
Amendment 99 #
Proposal for a regulation
Recital 27
Recital 27
(27) The licensee should pay an adequate remuneration toin line with what was previously agreed with the rights- holder as determined by the Commission. The amount of the remuneration should be determined considering. In case such an agreement has not been reached within a reasonable timeframe, such a remuneration shall be determined by the Commission. The amount of the remuneration should be determined considering the total gross revenue generated by the licensee through the acts under the Union compulsory licence, 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, tThe Commission should also 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 105 #
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 take 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, but should preserve the protection of trade secrets and know-how in line with the applicable Union and national law. These measures should always include adequate safeguards to ensure the protection of the legitimate interests of all parties.
Amendment 108 #
Proposal for a regulation
Recital 33
Recital 33
(33) In order to respond appropriately to the crisis situations, the Commission should be authorised 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 decide toshall 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, as well as the rights-holders and licensees.
Amendment 112 #
Proposal for a regulation
Recital 35
Recital 35
(35) Compliance with the relevant obligations imposed under this Regulation should be enforceable by means of fines and periodic penalty payments. To that end, appropriate levels of fines and periodic penalty payments should be laid down and the imposition of fines and periodic penalty payments should be subject to appropriate limitation periods in accordance with the principles of proportionality and ne bis in idem. All decisions taken by the Commission under this Regulation are subject to review by the Court of Justice of the European Union in accordance with the TFEU. The Court of Justice of the European Union should have unlimited jurisdiction in respect of the implementing act granting the compulsory licence, as well as the decisions on fines and penalty payments in accordance with Article 261 TFEU.
Amendment 116 #
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 Commission as regards the granting, complementing, modification or termination of a Union compulsory license, the determination, in the absence of an agreement between the rights-holder and the licensee, 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 implementing 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 body. 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 120 #
Proposal for a regulation
Recital 40
Recital 40
(40) Union compulsory licensing for crisis management is aby definition a last resort tool that is only used in exceptional circumstances. 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 124 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation has the objective to ensure that in crises the Union has access to crisis- relevant products. To this end, if no prior voluntary agreement has been reached between right holder and licensee, this Regulation lays down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis- relevant products to the Member States in the context of a Union crisis or emergency mechanism.
Amendment 128 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) patents, including published patent applications;
Amendment 132 #
Proposal for a regulation
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. This Regulation is without prejudice to the Directive (EU) 2016/943 of the European Parliament and the Council and national legal acts providing for the protection of trade secrets.
Amendment 133 #
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘crisis-relevant products’ means products or processes that are indispensable and are produced in insufficient quantity for responding to a temporary crisis or emergency or for addressing the impacts of a crisis or emergency in the Union; and for which the grant of a compulsory license is the only means of ensuring the sufficient and timely availability and supply of such products or processes, as determined by the Commission through the guidance of the advisory body in accordance with Article 6.
Amendment 140 #
Proposal for a regulation
Article 3 – paragraph 1 – point f a (new)
Article 3 – paragraph 1 – point f a (new)
(fa) ‘crisis’ means a Union wide emergency caused by an exceptional, unexpected and sudden natural or man- made event of extraordinary nature and scale, which triggers activation of a Union emergency or crisis mode as set out in the Annex to this Regulation.
Amendment 142 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
The Commission may only grant a Union compulsory licence as a last resort in the event no voluntary agreement with a view to ensuring the supply of crisis-relevant products can be reached between right- holder and the potential licensee pursuant to paragraph 1, where a crisis mode or an emergency mode listed in the Annex to this Regulation has been activated or declared in accordance with one of the Union acts listed in that Annex.
Amendment 146 #
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
The Commission shall not grant a Union compulsory license in respect of any crisis-relevant product without first providing the rights holders with a reasonable opportunity to negotiate a voluntary license with potential licensees. The time frame for reaching an agreement on such a license shall be sufficient to enable meaningful negotiations with potential partners, taking into account the urgency of the matter.
Amendment 149 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) have a scope and duration that is limited tobe strictly limited with respect to scope, field of use and quantities (volume) necessary to meet the needs in the Union on the basis of the purpose for which the compulsory licence is granted and have duration which is strictly limited to the scope and duration of the crisis or emergency mode in the framework of which it is granted and does not exceed a maximum period of 12 months renewable in case the circumstances that led to it continue to exist;
Amendment 154 #
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) only be granted against payment of an adequate remuneration to the agreed with the rights- holder determined in accordance with Article 9;
Amendment 163 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 165 #
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 mechanismode activated or declared in accordance with a Union act as listed in Annex I to this Regulation (the ‘competent advisory body’). Notwithstanding the applicable rules on the composition of the competent advisory body, for the purposes of this Regulation, it shall always include representatives of all national authorities which are competent for the granting of compulsory licences under national law. Member States shall notify the Commission of the designated competent authorities. Notifications shall be published in the Official Journal of the European Union. For the purposes of the present Regulation, the competent advisory body shall assist and advise the Commission as regards the following tasks:
Amendment 175 #
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) the identification and consultation of the representatives of right holders or their representatives as well as potential licensepotential right holders as well as potential licensees or their respective representatives and consulting other economic operators, and the industry;
Amendment 176 #
Proposal for a regulation
Article 6 – paragraph 2 – point f a (new)
Article 6 – paragraph 2 – point f a (new)
(fa) the assessment of whether the potential licensees are qualified and possess sufficient production capacities and resources, namely in terms of access to relevant technologies to perform all the necessary tasks.
Amendment 177 #
Proposal for a regulation
Article 6 – paragraph 2 – point g a (new)
Article 6 – paragraph 2 – point g a (new)
(ga) to assess whether the conditions for the rights-holder and potential licensees to conduct meaningful negotiations with a view to reach a voluntary agreement pursuant to Article 4(1a) were fulfilled
Amendment 183 #
Proposal for a regulation
Article 6 – paragraph 4 – point b
Article 6 – paragraph 4 – point b
(b) mayshall invite representatives of the European Parliament, representatives of economic operators, right holders, potential licensees, stakeholder organisations, social partners and experts to attend meetings of the advisory body as observers.
Amendment 185 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. In the absence of any existing competent advisory body, 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 bodyThe ad hoc advisory body shall include representatives of all national authorities which are competent for the granting of compulsory licences under national law, as well as the right holders and potential licensees or their representatives. Member States shall notify the Commission of the designated competent authorities. Notifications shall be published in the Official Journal of the European Union.
Amendment 193 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The final opinion of the advisory body shall not be binding on the Commission. The Commission may set a time limit for the advisory body to submit its opinion. The time limit shall be reasonable and appropriate to the circumstances of the situation, taking particular account of the urgency of the matter.
Amendment 197 #
Proposal for a regulation
Article 7 – paragraph 3 – introductory part
Article 7 – paragraph 3 – introductory part
3. Before the granting of a Union compulsory licence, the Commissionissuance of the opinion of the advisory body, the advisory body shall give the rights-holder and the licensee an opportunity to comment on the following:
Amendment 198 #
Proposal for a regulation
Article 7 – paragraph 3 – point a
Article 7 – paragraph 3 – point a
(a) the possibility to reach a voluntary licensing agreement with manufacturers on intellectual property rights for the purpose of manufacturing, using and distributing the crisis-relevant products and the fulfilment of the conditions referred to in pursuant to Article 4(1a) for conducting meaningful negotiations for that purpose;
Amendment 206 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. The Commission shall identify and 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, tThe Commission shall notify them individually.
Amendment 209 #
Proposal for a regulation
Article 7 – paragraph 6 – introductory part
Article 7 – paragraph 6 – introductory part
6. When assessing whether a Union compulsory licence is to be granted, the Commission shall consider the following:
Amendment 210 #
Proposal for a regulation
Article 7 – paragraph 6 – point a
Article 7 – paragraph 6 – point a
(a) follow the opinion referred to in paragraph 2;
Amendment 211 #
Proposal for a regulation
Article 7 – paragraph 6 – point b
Article 7 – paragraph 6 – point b
(b) consider the rights and interests of the rights- holder and the licensee;
Amendment 213 #
Proposal for a regulation
Article 7 – paragraph 6 – point c
Article 7 – paragraph 6 – point c
(c) take into account existing national compulsory licences reported to the Commission in accordance with Article 22 in order to prevent overlaps and a situation of overproduction.
Amendment 218 #
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. Where the Commissionadvisory body concludes, after duly considering the comments submitted by rights-holder and the licensee pursuant to paragraph 3, finds that the requirements for a Union compulsory licence are met, the Commission shall grant it by means of an implementing act. The implementing act shall be adopted in accordance with the advisory procedure referred to in Article 24(2). 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 220 #
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 221 #
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 225 #
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 228 #
Proposal for a regulation
Article 8 – paragraph 1 – point f
Article 8 – paragraph 1 – point f
(f) the international non-proprietary name if any of the crisis-relevant product which is to be manufactured under the Union compulsory licence and its commodity code (CN code) under which the crisis-relevant product is classified, as defined in Council Regulation (EEC) No 2658/87;
Amendment 229 #
Proposal for a regulation
Article 8 – paragraph 1 – point h
Article 8 – paragraph 1 – point h
(h) measures complementing the compulsory licence, which are necessary to achieve the objective of the compulsory licence. These measures shall be without prejudice to the applicable Union and national legal acts on protection of trade secrets and know-how, including Directive (EU) 2016/943.
Amendment 234 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The licensee shall pay an adequate remuneration to the rights-holder. The amount of the remuneration shall be determined by the Commissionagreement between the right holder and the licensee and specified in the Union compulsory licence.
Amendment 238 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
Amendment 241 #
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. In case an agreement pursuant to paragraph 1 cannot be reached in due time, the remuneration shall be determined by the Commission, taking into account the total gross revenue generated by the licensee through the relevant activities under the Union compulsory licence, as well as the additional elements defined in paragraph 3.
Amendment 245 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 247 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point a
Article 10 – paragraph 1 – subparagraph 1 – point a
(a) the number of crisis-relevant products manufactured under the Union compulsory licence does not exceed the defined quantities and what is necessary to meet the needs of the Union;
Amendment 249 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
(aa) provide detailed account of the products produced under the Union compulsory license
Amendment 251 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point b a (new)
Article 10 – paragraph 1 – subparagraph 1 – point b a (new)
(ba) treat information acquired within the Union compulsory license with utmost confidentiality and implement all measures to safeguard such information.
Amendment 256 #
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
(b) impose fines orand periodic penalties on the licensee in accordance with Articles 15 and 16.
Amendment 267 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. In compliance with the good faith obligation, the rights-holder and the licensee shall make their best reasonable efforts to fulfil the objective of the Union compulsory licence, taking into account each other's interests.
Amendment 271 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Commission shall review the Union compulsory licence upon reasoned request by the rights-holder or the licensee or on its own initiative and shall, where needed, modify the specifications referred to in Article 8 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 274 #
Proposal for a regulation
Article 14 – paragraph 2
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 of accelerating the crisis response as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee. Any such additional measures shall be without prejudice to the applicable Union and national legal acts on protection of trade secrets and know how including Directive (EU) 2016/943.
Amendment 276 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. When the Commission considers modifying, adopting additional measures as referred to in paragraph 2, or terminating the Union compulsory licence, it mayshall consult the advisory body referred to in Article 6 as well as the rights-holders and licensees.
Amendment 284 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Before adopting a decision pursuant to Article 15 or 16, the Commission shall gifully involve the licensee or the rights- holder in the procedure and give them the opportunity of being heard on the alleged infringement which is to be made subject to a fine or periodic penalty payments.
Amendment 286 #
Proposal for a regulation
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
2a. Interim measures, including for the suspension of the implementing act granting a compulsory amendments, should be made available in accordance with the rules applicable to the corresponding proceedings before the Court of Justice of the European Union.
Amendment 287 #
Proposal for a regulation
Article 20 – paragraph 2 b (new)
Article 20 – paragraph 2 b (new)
2b. Should the Court of Justice of the European Union decide to annul the implementing act granting a compulsory licence, the right holders should be entitled to compensation for damages in order to restore their position ex-ante.
Amendment 288 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
In accordance with Article 261 TFEU, the Court of Justice of the European Union has unlimited jurisdiction to review decisions by which the Commission has imposed fines or periodic penalty payments. It may cancel, reduce or increase the fine or periodic penalty payment imposed.:
Amendment 289 #
Proposal for a regulation
Article 21 – paragraph 1 a (new)
Article 21 – paragraph 1 a (new)
has granted a compulsory licence. It may cancel or amend its terms and conditions.
Amendment 290 #
Proposal for a regulation
Article 21 – paragraph 1 b (new)
Article 21 – paragraph 1 b (new)
has imposed fines or periodic penalty payments. It may cancel, reduce or increase the fine or periodic penalty payment imposed.
Amendment 291 #
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Standstill period 1. For the purposes of Article 21, paragraph 1, point (a) and point (b), an implementing act granting a Union compulsory license shall not take effect before the end of an initial standstill period of no 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. 2. If a rights-holder, before the expiry of the initial standstill period, lodges an application for annulment of the implementing act and an application to suspend the implementing act before the General Court of the European Union, the implementing act shall not take effect during a subsequent standstill period which shall commence on the day of lodgement of the application for annulment and the application to suspend the implementing act and/or the application for interim measures and shall end either on the day after the day on which the General Court has taken a decision on the application to suspend the implementing act and/or on the application for interim measures, or, if no such decision has been taken by the General Court, within eight weeks, on the day after the last day of the eighth week.