Changes from plenary report to adopted text

Added2. The filing of the appeal shall have suspensive effect. A decision of the Office that has not been contested shall take effect on the day following the date of expiry of the appeal period referred to in paragraph 3.

Added3. Notice of appeal shall be filed in writing 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 these grounds, shall be filed within 4three months of the date of notification of the decision.

AddedAny 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 following 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. [Am. 24]

Added4. Following an examination of admissibility of the appeal, the Boards of Appeal shall decide on the merits of the appeal.

Added4a. The Office shall inform the applicant of its decision without undue delay. [Am. 25]

Added5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards mayshall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. [Am. 26]

Added6. An action may be brought before the General Court of the European Union against a decision of the Boards of Appeal in relation to appeals, within 2 months of the date of notification of that decision, on grounds of infringement of an essential procedural requirement, infringement of the Treaty on the Functioning of the European Union, infringement of this Regulation or of any rule of law relating to their application or misuse of power. The action shall be open to any party to proceedings before the Board of Appeal adversely affected by its decision. The General Court shall have jurisdiction to annul or to alter the contested decision.

Added7. The decisions of the Boards of Appeal shall take effect on the day following the date of expiry of the period referred to in paragraph 6 or, if an action has been brought before the General Court within that period, as from the date following the day of dismissal of such action or of dismissal of any appeal filed with the Court of Justice of the European Union against the decision of the General Court. The Office shall take the necessary measures to comply with the judgement of the General Court or, in the event of an appeal against that judgement, the Court of Justice.

Added8. The Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the content and form of the notice of appeal referred to in paragraph 3, the procedure for the filing and examination of an appeal and the content and the form of the Boards of Appeal’s decision referred to in paragraph 4.

AddedArticle 30 Boards of Appeal

Added1. In addition to the powers conferred upon it by Article 165 of Regulation (EU) 2017/1001, the Boards of Appeal instituted by that Regulation shall be responsible for deciding on appeals against decisions of the Office taken on the basis of Article 29(1).

Added2. A Board of Appeal in matters regarding centralised applications for certificates shall consist of three members, at least two of whom are legally qualified. Where the Board of Appeal considers that the nature of the appeal so requires, it may call up to two further members for that case.

Added3. There shall be no Grand Board as referenced in Article 165 (2), (3) and 4, as well as Article 167 (2) of Regulation (EU) 2017/1001 in matters regarding centralised applications for certificates. Decisions taken by a single member as under Article 165 (2) of Regulation (EU) 2017/1001 shall not be possible.

Added4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5)166(5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters shall be taken into account. [Am. 27]

Added4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to the Boards of Appeal in matters regarding centralised applications for certificates. [Am. 28]

AddedArticle 31 Delegation of power regarding the Boards of Appeal

AddedThe Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to certificates under this Regulation.

AddedArticle 32 National implementation of a centralised examination opinion

Added1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall transmit the examination opinion and its translations to the competent national authority of each designated Member State.

Added2. In respect of a centralised application, where a positive examination opinion has been issued for one or more designated Member State, the competent national authority of each of those Member States shall grant a certificate in accordance with applicable national rules and procedures.

Added3. By way of derogation from paragraph 2, a Member State may decide not to grant a certificate, where material circumstances, in that Member State, have changed since the filing of the centralised application in respect of one or more of the conditions laid down in Article 15(1), points (b) or (c), or Article 14, first paragraph, point (d). In such a case that Member State shall reject the application insofar as that Member State is concerned.

Added4. A certificate granted by a competent national authority under this Article shall be subject to Articles 4, 5, 11 and 12 to 18, and to the applicable national legislation.

Added5. Where a negative examination opinion has been issued for one or more designated Member State, the competent national authority of each of these Member States shall issue a rejection decision according to its applicable national rules and procedures.

AddedArticle 33 Fees

Added1. The Office shall charge a fee for a centralised application for certificates.

Added2. The Office shall charge a fee for an appeal, and for an opposition.

Added3. The Commission is empowered to adopt implementing acts to determine the amounts of the fees charged by the Office, the time limits within which they have to be paid, and the ways in which those fees are to be paid. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

Added4. Article 12 shall apply to certificates granted under this Chapter.

AddedArticle 34 Register

Added1. As regards centralised applications for certificates for plant protection products, the Register set up under Article 35 of Regulation [OP, please insert reference to COM(2023)0231] shall include, for each centralised application or certificate, all of the following information:

Added(a) the name and address of the applicant or certificate holder;

Added(b) the name and business address of the representative, other than a representative as referred to in Article 37(3);

Added(c) the application as well as its date of lodging and date of publication;

Added(d) whether the application relates to a medicinal product or to a plant protection product;

Added(e) the designated Member States;

Added(f) the number of the basic patent;

Added(g) an identification of the product for which certificates are requested;

Added(h) the numbers and dates of the authorisations to place the product on the market referred to in Article 3(1), point (b), and an identification of the product identified in each of them;

Added(i) the number and date of the first authorisation to place the product on the market in the Union;

Added(j) the date and a summary of the examination opinion in respect of each of the designated Member States; [Am. 29]

Added(k) where applicable, the duration of the certificates to be granted;

Added(l) where applicable, the filing of an opposition, its status and its outcome, including where applicable a summary of the revised examination opinion; [Am. 30]

Added(m) 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; [Am. 31]

Added(n) where applicable and available, the particulars of the certificates granted in each of the designated Member States;

Added(o) where applicable, a mention that the centralised application was rejected in one or more of the designated Member States;

Added(p) where applicable, a mention that a certificate has lapsed or was declared invalid;

Added(q) information on the payment of annual fees, as provided by the relevant competent national authorities.

Added2. The Register shall contain changes to the information referred to in paragraph 1, including transfers, each accompanied by the date of recording of such entry.

Added3. The Register and information referred to in paragraphs 1 and 2 shall be available in all official languages of the Union. The Office may use verified machine translation for the information to be published in the register.

Added4. Competent national authorities shall promptly share with the Office information relating to the grant, lapse, invalidity or transfers of certificates and to the rejection of applications under Chapters II and III, and to the payment of related annual fees.

Added5. The Executive Director of the Office may determine that information other than those referred to in paragraphs 1 and 2 shall be entered in the Register.

Added6. The Office shall collect, organise, make public and store the information referred to in paragraphs 1 and 2, including any personal data, for the purposes laid down in paragraph 8. The Office shall keep the Register easily accessible for public inspection.

Added7. The Office shall provide certified or uncertified extracts from the Register on request and on payment of a fee.

Added8. The processing of the data concerning the entries set out in paragraphs 1 and 2, including any personal data, shall take place for the purposes of:

Added(a) administering the applications in accordance with this Chapter and the acts adopted pursuant to it;

Added(b) maintaining the Register and making it available for inspection by public authorities and economic operators;

Added(c) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system.

Added9. All the data, including personal data, concerning the entries in paragraphs 1 and 2 shall be considered to be of public interest and may be accessed by any third party free of charge. For reasons of legal certainty, the entries in the Register shall be kept for an indefinite period of time.

AddedArticle 35 Database

Added1. In addition to the obligation to keep a Register, the Office shall collect and store in an electronic database all the particulars provided by applicants or any other third party observations pursuant to this Regulation or acts adopted pursuant to it.