Changes from plenary report to adopted text

Added(34) Annual fees in respect of unitary certificates (also known as renewal fees) should be paid to the Office, which should retain a part of them to cover the expenses generated by carrying out tasks in relation to the grant of unitary certificates while the remaining part would be shared with those Member States in which unitary certificates have effect.

RemovedArticle 18 – paragraph 1 a (new): The Office shall inform the applicant of its decision without undue delay.

Added(35) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. The register should be available in all official languages of the Union. However, the information provided in the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generics or biosimilars, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC, should be based on information provided for in the register. [Am. 17]

RemovedArticle 19 – paragraph 2: 2. Third parties may also submit observations or oppositions in respect of an application for an extension of the duration of a unitary certificate.

Added(36) For the tasks conferred on the Office under this Regulation, the languages of the Office should be all official languages of the Union, to enable actors across the Union to easily apply for unitary certificates or submit third party observations and result in optimal transparency for all stakeholders across the Union. The Office should accept verified translations, into one of the official languages of the Union, of documents and information. The Office may, if appropriate, use verified machine translations.

RemovedArticle 22 – paragraph 1 – point a: (a) the certificate was granted contrary to Articles 3 and 6(2);

Added(37) Financial provision should be made to ensure competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.

RemovedArticle 23 – paragraph 3: 3. An application for a declaration of invalidity shall be filed electronically and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid.

Added(38) The necessary set-up costs related to the tasks conferred to the Office, including the costs of new digital systems, should be financed from the Office’s accumulated budgetary surplus.

RemovedArticle 28 – paragraph 3: 3. Notice of appeal shall be filed electronically at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, including the evidence supporting those grounds, shall be filed electronically within three months of the date of notification of the decision. / Any reply to the statement of grounds of appeal shall be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office shall, where applicable, fix a date for oral proceedings within three months of the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the date of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable.

Added(39) To ensure that Regulation (EU) No 608/2013 of the European Parliament and of the Council also covers unitary certificates, that Regulation should be amended.

RemovedArticle 28 – paragraph 5: 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards shall annul or alter the opinion.

Added(40) In order to supplement certain non-essential elements of this Regulation, the power to adopt acts, in accordance with Article 290 of the Treaty on the Functioning of the European Union, should be delegated to the Commission in respect of: (i) specifying the content and form of the notice of appeal and the content and the form of the Boards of Appeal’s decision, (ii) specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to certificates, (iii) specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office, (iv) setting out the detailed arrangements for oral proceedings, (v) setting out the detailed arrangements for the taking of evidence, (vi) setting out the detailed arrangements for notification, (vii) specifying the details regarding the calculation and duration of time limits and (viii) setting out the detailed arrangements for the resumption of proceedings. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

RemovedArticle 29 – paragraph 4: 4. Members of the Boards of Appeal in matters regarding unitary certificates shall be appointed in accordance with Article 166(5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law.

Added(41) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards: (i) the application forms to be used; (ii) rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine centralised applications and prepare examination opinions, as well as the issuance of examination opinions by the Office, (iii) the criteria in the ways the examination panels are to be set up, and the criteria for the selection of examiners, (iv) the amounts of the applicable fees to be paid to the Office, (v) specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party, and (vi) rules on the financial transfers between the Office and Member States, the amounts of these transfers, and the remuneration to be paid by the Office regarding the participation of competent national authorities. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

RemovedArticle 29 – paragraph 4 a (new): 4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to Boards of Appeal in matters regarding unitary certificates.

Added(42) The Commission should regularly report on the operation of this Regulation, in coordination with that required in Regulation [COM(2023) 231]. The Commission should regularly evaluate the impact of unitary supplementary protection on access to medicines.

RemovedArticle 32 – paragraph 1 a (new): An applicant shall submit an application for a combined centralised application electronically to the Office and in the formats made available by the Office.

Added(43) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union (‘the Charter’). The rules in this Regulation should be interpreted and applied in accordance with those rights and principles. In particular, this Regulation seeks to ensure full respect for the right to property and the right to health care and the right to an effective remedy in Articles 17 and 35 and 47 of the Charter. This also applies to the above-mentioned exception, which maintains the core rights of the certificate, by being limited to the making of a product, or a medicinal product containing that product, only for the purpose of export outside the Union or for the purpose of storing for a limited period of time with a view to entry into the Union market upon expiry of the protection, and to the acts strictly necessary for such making or for the actual export or the actual storing. In the light of those fundamental rights and principles, the exception does not go beyond what is necessary and appropriate in the light of its overall objective, which is to promote the competitiveness of the Union by avoiding relocation and allowing makers of generics and biosimilars established in the Union to compete, on the one hand, on fast-growing global markets where protection does not exist or has already expired, and on the other, on the Union market upon expiry of the certificate.

RemovedArticle 34 – paragraph 1: 1. Communications addressed to the Office shall be effected by electronic means. The Executive Director shall determine under which technical conditions those communications are to be submitted.

Added(44) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the autonomous nature of the unitary certificate being independent from national systems, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

RemovedArticle 35 – paragraph 1 – point i a (new): (ia) information on any direct public financial support received for research related to the development of the product;

Added(45) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on XXX [OP, please add reference once available].

RemovedArticle 35 – paragraph 1 – point j: (j) the date and the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect;

Added(46) Provision should be made for appropriate arrangements to facilitate a smooth implementation of the rules provided for in this Regulation. To allow for sufficient time for the Office to prepare the operational set-up and launch of the procedure to be used for the grant of unitary certificates, as set out in this Regulation, the application of this Regulation should be deferred,

RemovedArticle 35 – paragraph 1 – point m: (m) where applicable, the filing of an opposition, its status and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion;

AddedHAVE ADOPTED THIS REGULATION:

RemovedArticle 35 – paragraph 1 – point n: (n) where applicable, the filing of an appeal, its status and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion;

AddedArticle 1 Subject matter

RemovedArticle 35 – paragraph 8 a (new): 8a. Public authorities shall not use information in the Register for practices of patent linkage. No regulatory or administrative decisions related to generics or biosimilars shall be based on information in the Register. Information in the Registger shall not be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.

AddedThis Regulation lays down rules on the unitary supplementary protection certificate (‘unitary certificate’) for medicinal products protected by a European patent with unitary effect and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Regulation (EC) No 726/2004, or Regulation (EU) 2019/6.

RemovedArticle 40 – paragraph 1: 1. Decisions of the Office under this Regulation shall include examination opinions and shall state the reasons on which they are based. They shall be based only on reasons or evidence on which the parties concerned have had an opportunity to present their comments. Where oral proceedings are held before the Office, the decision may be given orally. Subsequently, the decision or opinion shall be notified electronically to the parties.

AddedArticle 2 Definitions

RemovedArticle 40 – paragraph 3: 3. Decisions of the Office under this Regulation which are open to appeal shall be accompanied by a written communication indicating that any notice of appeal is to be filed electronically at the Office within 2 months of the date of notification of the decision in question. That communication shall also draw the attention of the parties to the provisions laid down in Article 28. The parties may not plead any failure on the part of the Office to communicate the availability of appeal proceedings.

AddedFor the purposes of this Regulation the following definitions shall apply:

RemovedArticle 41 – paragraph 2: deleted

Added(1) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

RemovedArticle 41 – paragraph 3: 3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings.

Added(2) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;

RemovedArticle 42 – paragraph 3: 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summonsed, the Office or the relevant panel, as the case may be, shall verify that that expert is free of any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period.

Added(3) 'European patent' means a patent granted by the European Patent Office (‘EPO’) under the rules and procedures laid down in the European Patent Convention ('EPC');

RemovedArticle 46 – paragraph 2: 2. The application for re-establishment shall be filed electronically within 2 months of the removal of the obstacle to compliance with the time limit. The omitted act shall be completed within this period. The application shall only be admissible within the year immediately following the expiry of the unobserved time limit.

Added(4) ‘unitary patent’ means a European patent which benefits from unitary effect in those Member States participating in the enhanced cooperation laid down in Regulation (EU) No 1257/2012;

RemovedArticle 56 – paragraph 1: By ... [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. Special emphasis shall be given to the effects of opposition under Article 15 and whether the possibility of opposition leads to significant delays in granting unitary certificates and to the effects of this Regulation on the recovery of research and development investments in the light of Directive (EU) XXX/XX [COM(2023)192].

Added(5) 'basic patent' means a unitary patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a unitary certificate;

Added(6) 'application for an extension of the duration' means an application for an extension of the duration of a unitary certificate pursuant to Article 20(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006;

Added(7) 'maker' means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out;

Added(8) 'centralised application' means an application made before the European Union Intellectual Property Office (‘the Office’) pursuant to Chapter III of Regulation [COM(2023) 231] with a view to the grant of certificates, for the product identified in the application, in the designated Member States;

Added(9) ‘competent national authority’ means the national authority that is competent, in a given Member State, for the grant of certificates and for the rejection of applications for certificates.

Added(9a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder. [Am. 18]

AddedArticle 3 Conditions for obtaining a unitary certificate

Added1. A unitary certificate shall be granted by the Office on the basis of a basic patent if, in each of the Member States in which that basic patent has unitary effect, at the date of the application, all of the following conditions are fulfilled:

Added(a) the product is protected by that basic patent in force;

Added(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive .../... [2023/0132(COD)],with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004, as appropriate; [Am. 19]

Added(c) the product has not already been the subject of a certificate, nor of a unitary certificate;

Added(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.

Added2. The holder of more than one patent for the same product shall not be granted more than one certificate or unitary certificate for that product for any given Member State.

AddedWhere two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending in a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not economically linked, by a competent national authority or by the Office, as applicable. The same principle shall apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents. [Am. 20]

AddedArticle 4 Scope of the protection

AddedWithin the limits of the protection conferred by the basic patent, the protection conferred by a unitary certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the unitary certificate.