Changes from plenary report to adopted text

Added4. Any observations by a third party shall be submitted in writing in one of the official languages of the Union and state the grounds on which they are based.

Added5. Any observations by a third party shall be notified to the applicant. The applicant may comment on the observations within a time limit set by the Office.

AddedArticle 26 Opposition

Added1. Within a period of 2 months following the publication of the examination opinion in respect of a centralised application, any person (‘opponent’) may file with the Office a notice of opposition to that opinion.

Added2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 or 6 are not fulfilled for one or more of the designated Member States. [Am. 37]

Added3. Opposition shall be filed in writing, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the opposition fee has been paid.

Added4. The notice of opposition shall contain:

Added(a) the references of the centralised application against which opposition is filed, the name of its holder, and the identification of the product;

Added(b) the particulars of the opponent and, where applicable, of its representative;

Added(c) a statement of the extent to which the examination opinion is opposed, and of the grounds on which the opposition is based.

Added(ca) any evidence the opponent relies on in support of the opposition. [Am. 38]

Added5. The opposition shall be examined by an opposition panel set up by the Office in accordance with the rules applicable to examination panels as referred to in Article 28. However, the opposition panel shall not include any examiner previously involved in the examination panel that examined the centralised application.

Added6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this toits decision as well as the reasoning for its decision to the opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. [Am. 39]

Added7. The decision to reject an opposition as inadmissible shall be communicated to the holder of the centralised application, together with a copy of the notice of opposition.

AddedA notice of opposition shall be inadmissible where a previous appeal relating to the same subject matter and cause of action has been adjudicated on its merits by the Office, and the decision of the Office on that appeal has acquired the authority of a final decision.

Added8. Where the opposition is not rejected as inadmissible, the Office shall promptly transmit the notice of opposition to the applicant, and shall publish it in the Register. If several notices of opposition have been filed, the Office shall promptly communicate them to the other opponents.

Added9. The Office shall issue a decision on the opposition including a detailed reasoning for that decision within 6 months, unless the complexity of the case requires a longer period. [Am. 40]

Added9a. In cases where several oppositions have been filed against an examination opinion, the Office shall deal with the oppositions jointly and issue one single decision in regards to all oppositions filed. [Am. 41]

Added10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition and notify the opponent of its decision,, and the Office shall mention this in the Register. [Am. 42]

Added11. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall mention this in the Register.

Added12. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by specifying the details of the procedure for filing and examining an opposition.

Added12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. [Am. 43]

AddedArticle 27 Role of competent national authorities

Added1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications, on the basis of their relevant expertise and of their experience in the field. [Am. 44]

Added2. The Office and the competent national authority shall conclude an administrative agreement before that competent national authority is appointed as participating office as referred to in paragraph 1.

AddedThe agreement shall specify the rights and obligations of the parties, in particular the formal undertaking by the competent national authority concerned to comply with this Regulation as regards the centralised examination procedure.

Added3. The Office may appoint a competent national authority as a participating office as referred to in paragraph 1 for 5 years. That appointment may be extended for further periods of 5 years.

Added4. The Office shall, before appointing a competent national authority, or extending its appointment, or before any such appointment expires, hear the competent national authority concerned.

Added5. Each competent national authority appointed under this Article shall provide the Office with a list identifying the individual examiners who are available for participation in examination and opposition proceedings. Each such competent national authority shall update that list in the event of a change.

AddedArticle 28 Examination panels

Added1. The assessments under Articles 24, 26 and 33 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 27(1) from two different participating competent national authorities.

Added2. Examiners shall be impartial in the exercise of their duties and shall declare to the Office any real or perceived conflict of interest upon their designation.

Added3. When setting up an examination panel, the Office shall ensure the following:

Added(a) geographical balance amongst the participating officesrelevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one examiner has a minimum of five years of experience in the examination of patents and supplementary protection certificates; [Am. 45]

Added(aa) where possible, geographical balance amongst the participating offices; [Am. 46]

Added(b) the respective workload of the examiners is taken into account;

Added(c) that there is no more than one examiner employed by a competent national authority making use of the exemption laid downset out in Article 10(5) of this Regulation. [Am. 47]

Added4. The Office shall publish a yearly overview of the number of procedures, including those for examination, opposition and appeal, each competent national authority participated in.

Added5. The Commission is empowered to adopt implementing acts to determine the criteria in the ways the panels are to be set up, and the criteria for the selection of examiners. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.

AddedArticle 29 Appeals

Added1. Any party to proceedings under this Chapter, adversely affected by a decision of the Office, including the adoption of an examination opinion, may appeal the decision to the Boards of Appeal.

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 corresponding evidence relied on, shall be filed within 43 months of the date of notification of the decision. [Am. 48]

Added3a. Any reply to statement of the grounds of appeal shall be submitted in writing within three months from the date of the notification of the statement of the grounds of appeal. Where applicable, the Office shall set a date for an oral hearing within three months after the filing of the reply to the grounds of appeal or within six months of the filing of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable. [Am. 49]

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

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. 50]

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 55 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) 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 should be taken into account. [Am. 51]

Added4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to Boards of Appeal in matters regarding centralised applications for certificates. [Am. 52]

AddedArticle 31 Delegation of power regarding the Boards of Appeal

AddedThe Commission is empowered to adopt delegated acts in accordance with Article 55 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.

AddedSuch transmission shall take place without undue delay within a timeframe allowing the competent national authorities of each designated Member State to grant or reject a certificate, as applicable, according to applicable national procedures, before the expiry of the basic patent. [Am. 53]