What changed between the plenary report and the adopted text

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. 16]

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, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. [Am. 17]

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. 18]

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. 19]

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 notify the opponent of its decision, and the Office shall mention this in the Register. [Am. 20]

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 this in the Register.

Added:12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. [Am. 21]

Added:13. The Commission is empowered to adopt delegated acts in accordance with Article 49 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. 22]

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 and 22 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. 23]

Added:(aa) where possible, geographical balance amongst the participating offices; [Am. 24]

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) 223231]. [Am. 25]

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

Added:5. 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 50.

Added:Article 18 Grant of a unitary certificate or rejection of the application for a unitary certificate

Added: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 take one of the following decisions, without undue delay: [Am. 26]

Added:(a) where the examination opinion is positive, the Office shall grant a unitary certificate;

Added:(b) where the examination opinion is negative, the Office shall reject the application for a unitary certificate.

Added:The Office shall inform the applicant of its decision without undue delay. [Am. 27]

Added:Article 19 Duration of the unitary certificate

Added:1. The unitary certificate shall take effect at the end of the lawful term of the basic patent, namely on the twentieth anniversary of the filing date of the application for that patent, for a period equal to the period which elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place the product on the market in the Union, reduced by a period of 5 years.

Added:2. The duration of the unitary certificate may not exceed 5 years from the date on which it takes effect.

Added:Article 20 Expiry of the unitary certificate

Added:1. The unitary certificate shall lapse in any of the following events:

Added:(a) at the end of the period provided for in Article 19;

Added:(b) if the unitary certificate holder surrenders it;

Added:(c) if the annual fee laid down in accordance with Article 29(3) is not paid in time.

Added:2. Where the authorisation to place the product on the market in accordance with Regulation (EC) No 1107/2009 is withdrawn in a Member State in which the basic patent has unitary effect, the certificate shall cease to have effect in that Member State. This may be decided by the Office of its own motion or at the request of a third party.

Added:Article 21 Invalidity of the unitary certificate

Added:The unitary certificate shall be invalid in any of the following events:

Added:(a) the certificate was granted contrary to Article 3Articles 3 and 6(2); [Am. 28]

Added:(b) the basic patent has lapsed before its lawful term expires;

Added:(c) the basic patent is revoked or limited to the extent that the product for which the unitary certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.

Added:Article 22 Action for a declaration of invalidity

Added:1. Any person may file with the Office an application for a declaration of invalidity of a unitary certificate.

Added:2. An application for a declaration of invalidity may only be filed on the grounds that one or more of the conditions set out in Article 21 are not fulfilled for one or more of the Member States in which the basic patent has unitary effect.