What changed between the plenary report and the adopted text

Removed:LETTER OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT

Added:(28) After the completion of the examination of a unitary certificate application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the Office should implement without undue delay the examination opinion by granting a unitary certificate or rejecting the application, as applicable. [Am. 5]

Removed:Mr Adrián Vázquez Lázara

Added:(29) To safeguard procedural rights and ensure a complete system of remedies, where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed. [Am. 6]

Removed:Chair

Added:(30) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account. [Am. 7]

Removed:Committee on Legal Affairs

Added:(31) Any person may challenge the validity of a unitary certificate by lodging with the Office an application for a declaration of invalidity.

Removed:BRUSSELS

Added:(32) The Office should have the possibility to charge a fee for the application for a unitary certificate, as well as other procedural fees such as those for oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act.

Removed:Ref.: IPOL-COM-AGRI D(2023)23992

Added:(33) 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.

Removed:Subject: Opinion on the Commission’s proposals for regulations on the unitary supplementary protection certificate and the supplementary protection certificate for plant protection products (COM(2023)0221 – C90152/2023 – 2023/126(COD)) and (COM(2023)0223 – C90149/2023 – 2023/128(COD))

Added:(34) 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.

Removed:Dear Mr Chair,

Added:(35) 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.

Removed:I refer to the Commission’s proposals for regulations on the unitary supplementary protection certificate [2023/0126 (COD)] and the supplementary protection certificate [2023/0128 (COD)] for plant protection products.

Added:(36) Financial provision should be made to ensure that competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.

Removed:AGRI Coordinators considered the matter at their meeting of 23 May. They noted that the proposals are intended to complement the unitary patent system, and would not substantially modify the existing regime for supplementary protection certificate.

Added:(37) 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.

Removed:Unitary supplementary protection certificates are an important tool for this kind of products and for fostering innovation. Since the adoption of Regulation (EC) No 1107/2009, only very few substances have been approved while more and more substances are losing their approval, which leaves farmers with less tools to achieve the Union’s goals. We urge the Committee on Legal Affairs to consider the situation of farmers.

Added:(38) 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.

Removed:Consequently, Coordinators recommended not to give an opinion on the above legislative proposals and to convey this position to you.

Added:(39) 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.

Removed:This recommendation was endorsed by the AGRI Committee at its meeting on 6 July 2023.

Added:(40) The Commission should regularly report on the operation of this Regulation, in coordination with that required in Regulation [COM(2023) 223].

Removed:Yours sincerely,

Added:(41) This Regulation respects the fundamental rights and observes the principles recognised in particular 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 47 of the Charter.

Removed:Norbert Lins

Added:(42) 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 SPC 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.

Added:(43) 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].

Added:(44) 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,

Added:HAVE ADOPTED THIS REGULATION:

Added:Article 1 Subject matter

Added:This Regulation lays down rules on the unitary supplementary protection certificate (‘unitary certificate’) for plant protection products protected by a European patent with unitary effect and subject, prior to being placed on the market as a plant protection product, to an administrative authorisation procedure as laid down in Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

Added:Article 2 Definitions

Added:For the purposes of this Regulation, the following definitions shall apply:

Added:(1) ‘plant protection products’ means active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

Added:(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;

Added:(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);

Added:(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;

Added:(d) destroy undesirable plants;

Added:(e) destroy parts of plants, check or prevent undesirable growth of plants;

Added:(2) ‘substances’ means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

Added:(3) ‘active substances’ means substances or micro-organisms including viruses, having general or specific action:

Added:(a) against harmful organisms;

Added:(b) or on plants, parts of plants or plant products;

Added:(4) ‘preparations’ means mixtures or solutions composed of two or more substances, of which at least one is an active substance, intended for use as plant protection products;

Added:(5) ‘plants’ means live plants and live parts of plants, including fresh fruit and seeds;

Added:(6) ‘plant products’ means products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves;

Added:(7) ‘harmful organisms’ means pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens;

Added:(8) ‘product’ means the active substance or combination of active substances of a plant protection product;

Added:(9) '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');

Added:(10) ‘unitary patent’ means a European patent which benefits from unitary effect in the Member States participating in the enhanced cooperation laid down in Regulation (EU) No 1257/2012;

Added:(11) 'basic patent' means a unitary patent which protects a product as such, a preparation, 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:(12) 'centralised application' means an application made before the European Union Intellectual Property Office (‘the Office’) pursuant to Chapter III of Regulation [COM(2023) 223] with a view to the grant of certificates, for the product identified in the application, in the designated Member States;

Added:(13) ‘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:(13a) ‘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. 8]

Added:Article 3 Conditions for obtaining a unitary certificate

Added:1. 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: