Changes from plenary report to adopted text

Added4. If the applicant does not satisfy the requirements referred to in paragraph 1 within the deadline referred to in paragraph 2, the Office shall reject the application.

AddedArticle 22 Publication of the centralised application

AddedIf the centralised application complies with Article 21, the Office shall publish the application, without undue delay, in the Register.

AddedArticle 23 Examination of the centralised application

Added1. The Office shall assess the application on the basis of all the conditions in Article 3(1) for each of the designated Member States.

Added2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1)Articles 3(1) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. [Am. 10]

Added3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1)Articles 3(1) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. [Am. 11]

Added4. The Office shall translate the examination opinion in the official languages of all designated Member States. The Office may use verified machine translation to that effect.

Added5. The Commission is empowered to adopt implementing acts laying down 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

AddedArticle 24 Extended conditions for obtaining a certificate

Added1. By way of derogation from Article 3(1), point (b), the Office shall adopt a positive opinion for a given plant protection product, on the basis of a centralised application, for each designated Member State where both of the following conditions are fulfilled:

Added(a) at the date of that application, an authorisation to place the product on the market as a plant protection product has been applied for in accordance with Regulation (EC) No 1107/2009;

Added(b) a valid authorisation was granted before the examination opinion is adopted.

Added2. The examination opinion shall not be adopted earlier than 18 months after the centralised application was filed, unless a valid authorisation to place the product on the market as a plant protection product has been granted in accordance with Regulation (EC) No 1107/2009 in each of the designated Member States, at the filing date of the centralised application.

Added3. In respect of a designated Member State in which no authorisation was granted earlier than 18 months after the centralised application was filed, the Office shall suspend the examination proceedings, and shall resume those proceedings if and when such an authorisation is granted by the competent national authority, and is submitted to the Office by the applicant before the expiry of the basic patent.

AddedArticle 25 Observations by third parties

Added1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates in one or more of the Member States designated therein.

Added2. A natural or legal person that has submitted the written observations in accordance with paragraph 1 shall not be a party to the proceedings.

Added3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register.

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. 12]

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. 13]

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 its reasoning for that decision to the opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. [Am. 14]

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.

Added8a. 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 respect of all oppositions filed. [Am. 15]

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. 16]

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. 17]

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, notify the opponent of its decision and the Office shall mention this in the Register. [Am. 18]

Added12. The Commission is empowered to adopt delegated acts in accordance with Article 54 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. 19]

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 their experience in the field. [Am. 20]

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 23 and 26 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. 21]

Added(aa) where possible, geographical balance amongst the participating offices; [Am. 22]

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

Added(c) no morethat there is than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). [Am. 23]

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 55.

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.