What changed between the plenary report and the adopted text

Added:1. The Office shall examine the following:

Added:(a) whether the application for a unitary certificate complies with Article 9;

Added:(b) whether the application complies with Article 8;

Added:(c) whether the application fee referred to in Article 31(1) has been paid within the prescribed period.

Added:2. Where the centralised application does not satisfy the requirements referred to in paragraph 1, the Office shall request the applicant to take the measures necessary to satisfy those requirements, and shall set a deadline for such compliance.

Added:3. Where the fee referred to in paragraph 1, point (c), has not been paid or has not been paid in full, the Office shall inform the applicant accordingly.

Added:4. 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 for a unitary certificate.

Added:Article 12 Publication of the application

Added:If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay and no later than five working days after the application was lodged. [Am. 30]

Added:Article 13 Examination of the application for a unitary certificate

Added:1. The Office shall assess the application on the basis of all the conditions in Article 3(1)Articles3 and 6(2), for all Member States in which the basic patent has unitary effect. [Am. 31]

Added:2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1)Articles 3 and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant via the electronic platform and publish it in the Register without undue delay. [Am. 32]

Added:3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1)Articles 3 and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant via the electronic platform and publish it in the Register without undue delay. [Am. 33]

Added:4. 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. The Office shall publish the examination opinion in the Register as soon as possible after it is issued. [Am. 34]

Added:5. 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 applications for unitary certificates and prepare examination opinions, as well as the issuance of examination opinions by the Office in electronic form. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55. [Am. 35]

Added:5a. The Office shall issue an examination opinion within six months of publication of the application for a unitary certificate. Without prejudice to Articles 14, 25 and 28, whenever duly justified for reasons of urgency, the applicant may submit a request for an expedited procedure. Where the request for an expedited examination procedure is deemed justified, the Office shall issue an examination opinion within four months from the publication of the application for a unitary certificate. [Am. 36]

Added:Article 14 Observations by third parties

Added:1. 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 in which the basic patent has unitary effect. Such written observations shall be submitted to the Office electronically. [Am. 37]

Added:2. A natural or legal person that has submitted the written observations in accordance with paragraph 1 shall not be a party to the proceedings.

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

Added:Whenever the expedited procedure applies in accordance with Article 13(5a), observations shall be submitted within six weeks after publication of the application in the Register. [Am. 38]

Added:4. Any observations by a third party shall be submitted in writingelectronically in one of the official languages of the Union and state the grounds on which they are based. [Am. 39]

Added:5. 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.

Added:Article 15 Opposition

Added:1. Within a period of 2 months following the publication of the examination opinion in respect of an application for a unitary certificate, any person (‘opponent’) may file with the Office a notice of opposition to that opinion.

Added:2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 are not fulfilled for one or more of the Member States in which the basic patent has unitary effect.

Added:3. 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.

Added:4. The notice of opposition shall contain:

Added:(a) the references of the unitary certificate 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. 40]

Added:5. 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 17. However, the opposition panel shall not include any examiner previously involved in the examination panel that examined the unitary certificate application.

Added:6. 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 as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. [Am. 41]

Added:7. The decision to reject an opposition as inadmissible shall be communicated to the holder of the unitary certificate application, together with a copy of the notice of opposition.

Added:8. A 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.

Added:9. 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.

Added:9a. 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. 42]

Added:10. 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. 43]

Added:11. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition, and the Office shall mention this in the Register.

Added:12. 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 thispublish its full decision in the Register. [Am. 44]

Added:12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. [Am. 45]

Added:12b. All exchanges between the Office, the holder and the opponent shall take place electronically. [Am. 46]

Added:13. 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.

Added:Article 16 Role of competent national authorities

Added:1. 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 applications for unitary certificates based on relevant expertise and sufficient experience required for the centralised examination procedure. [Am. 47]

Added:2. 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.

Added:The 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 examination of applications for unitary certificates.

Added:3. 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.

Added:4. 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.

Added:5. 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, opposition and invalidity proceedings. Each such competent national authority shall update that list in the event of a change.

Added:Article 17 Examination panels

Added:1. The assessments under Articles 13, 15, 19 and 23 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 16(1) from two different participating competent national authorities, under supervision of the Office.

Added:2. 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.

Added:3. 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. 48]

Added:(aa) where possible, geographical balance amongst the participating offices; [Am. 49]

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 set out in Article 10(5) of Regulation [COM(2023) 231]. [Am. 50]

Added:4. The Office shall publish a yearly an overview of the number of procedures, including those for examination, opposition, appeal and invalidity, each competent national authority participated in.