Changes from plenary report to adopted text

Added2. The Register shall contain changes to the information 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. 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.

Added5. 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 7. The Office shall keep the Register easily accessible for public inspection.

Added6. The Office shall provide certified or uncertified extracts from the Register on request and on payment of a fee.

Added7. 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 the following:

Added(a) administering the applications and unitary certificates in accordance with this Regulation 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.

Added8. 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. For reasons of legal certainty, the entries in the Register shall be kept for an indefinite period of time.

Added8a. 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. [Am. 66]

AddedArticle 36 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.

Added2. The electronic database may include personal data, beyond those included in the Register, to the extent that such particulars are required by this Regulation or by acts adopted pursuant to it. The collection, storage and processing of such data shall serve the purposes of:

Added(a) administering the applications and/or certificate registrations as described in this Regulation and in acts adopted pursuant to it;

Added(b) accessing the information necessary for conducting the relevant proceedings more easily and efficiently;

Added(c) communicating with the applicants and other third parties;

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

Added3. The Executive Director shall determine the conditions of access to the electronic database and the manner in which its contents, other than the personal data referred to in paragraph 2 of this Article but including those listed in Article 35, may be made available in machine-readable form, including the charge for such access.

Added4. Access to the personal data referred to in paragraph 2 shall be restricted and such data shall not be made publicly available unless the party concerned has given his express consent.

Added5. All data shall be kept indefinitely. However, the party concerned may request the removal of any personal data from the database after 18 months from the expiry of the unitary certificate or, the case being, the closure of the relevant inter partes procedure. The party concerned shall have the right to obtain the correction of inaccurate or erroneous data at any time.

AddedArticle 37 Transparency

Added1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council shall apply to documents held by the Office.

Added2. The Management Board of the Office shall adopt detailed rules for applying Regulation (EC) No 1049/2001 in the context of this Regulation.

Added3. Decisions taken by the Office under Article 8 of Regulation (EC) No 1049/2001 may be challenged through the European Ombudsman or form the subject of an action before the Court of Justice of the European Union, under the conditions laid down in Articles 228 and 263 TFEU respectively.

Added4. The processing of personal data by the Office shall be subject to Regulation (EC) No 45/2001 of the European Parliament and of the Council.

AddedArticle 38 Representation

Added1. Natural or legal persons having neither their domicile nor their principal place of business or a real and effective industrial or commercial establishment in the European Economic Area shall be represented before the Office in accordance with this Article in all proceedings provided for by this Regulation, other than the filing of an application for a unitary certificate.

Added2. Natural or legal persons having their domicile or principal place of business or a real and effective industrial or commercial establishment in the Union may be represented before the Office by an employee.

AddedAn employee of a legal person may also represent other legal persons which are economically linked with the legal person being represented by that employee.

AddedThe second subparagraph also applies where those other legal persons have neither their domicile nor their principal place of business nor a real and effective industrial or commercial establishment within the Union.

AddedEmployees who represent natural or legal persons shall, at the request of the Office or, where appropriate, of the party to the proceedings, file with the Office a signed authorisation for insertion in the files.

Added3. A common representative shall be appointed where there is more than one applicant or more than one third party acting jointly.

Added4. Only a practitioner established in the Union, entitled to act as a professional representative in patent matters before a national patent office or the European Patent Office, or a lawyer authorised to practise before the courts or tribunals of a Member State, may represent natural or legal persons before the Office.

AddedArticle 39 Supplementary Protection Certificates Division

AddedA Supplementary Protection Certificate Division (‘SPC Division’) shall be set up within the Office and, in addition to the responsibilities under Regulations [COM(2023) 231] and [COM(2023) 223], shall be responsible for implementing the tasks set out in this Regulation and in Regulation [COM(2023) 221], including in particular:

Added(a) receiving and supervising the examination of applications for unitary certificates, applications for an extension of the duration of unitary certificates, appeals and observations by third parties;

Added(b) adopting examination opinions on behalf of the Office in relation to applications for unitary certificates, as well as in relation to applications for an extension of the duration of unitary certificates;

Added(c) deciding on oppositions against examination opinions;

Added(d) deciding on applications for a declaration of invalidity;

Added(e) processing conversion requests;

Added(f) maintaining the register and the database.

AddedArticle 40 Decisions and communications of the Office

Added1. 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 in writingelectronically to the parties. [Am. 67]

Added2. Any decision, opinion, communication or notice from the Office under this Regulation shall indicate the SPC Division and the relevant panel as well as the name or the names of the examiners responsible. It shall be signed by these examiners, or, instead of a signature, carry a printed or stamped seal of the Office. The Executive Director may determine that other means of identifying the SPC Division and the name of the examiners responsible, or an identification other than a seal, may be used where decisions or other communications are transmitted by any technical means of communication.

Added3. 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 in writingelectronically 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. [Am. 68]

AddedArticle 41 Oral proceedings

Added1. If the Office considers that oral proceedings would be expedient they shall be held either at the instance of the Office or at the request of any party to the proceedings.

Added2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public. [Am. 69]

Added3. 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. [Am. 70]

Added4. The Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by setting out the detailed arrangements for oral proceedings.

AddedArticle 42 Taking of evidence

Added1. In any proceedings before the Office, the means of giving or obtaining evidence shall include the following:

Added(a) hearing the parties;

Added(b) requests for information;

Added(c) the production of documents and items of evidence;

Added(d) hearing witnesses;

Added(e) opinions by experts;

Added(f) statements in writing sworn or affirmed or having a similar effect under the law of the State in which the statement is drawn up.

Added2. The relevant panel may commission one of its members to examine the evidence adduced.