Changes from plenary report to adopted text

AddedArticle 10 Grant of the certificate or rejection of the application

Added1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this Chapter, the authority referred to in Article 9(1) shall grant the certificate.

Added2. The authority referred to in Article 9(1) shall, subject to paragraph 3 of this Article, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Chapter.

Added3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time.

Added4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application.

Added5. Member States may provide that the authority referred to in Article 9(1) is to grant certificates without verifying that the conditions laid down in Article 3(1), points (c) and (d), are met.

AddedArticle 11 Publication

Added1. The authority referred to in Article 9(1) shall publish, as soon as possible, notification of the fact that a certificate has been granted. The notification shall contain all of the following information:

Added(a) the name and address of the holder of the certificate;

Added(b) the number of the basic patent;

Added(c) the title of the invention;

Added(d) the number and date of the authorisation to place the product on the market referred to in Article 3(1), point (b), and the product identified in that authorisation;

Added(e) where relevant, the number and date of the first authorisation to place the product on the market in the Union;

Added(f) the duration of the certificate.

Added2. The authority referred to in Article 9(1) shall publish, as soon as possible, a notification of the fact that the application for a certificate has been rejected. The notification shall contain at least the information listed in Article 9(2).

AddedArticle 12 Annual fees

AddedMember States may require that the certificate be subject to the payment of annual fees.

AddedArticle 13 Duration of the certificate

Added1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a 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.

Added2. Notwithstanding paragraph 1, the duration of the certificate may not exceed 5 years from the date on which it takes effect.

Added3. For the purposes of calculating the duration of the certificate, account shall be taken of a provisional first marketing authorisation only if it is directly followed by a definitive authorisation concerning the same product.

AddedArticle 14 Expiry of the certificate

AddedThe certificate shall lapse in any of the following events:

Added(a) at the end of the period provided for in Article 13;

Added(b) if the certificate holder surrenders it;

Added(c) if the annual fee laid down in accordance with Article 12 is not paid in time;

Added(d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation or authorisations to place on the market in accordance with Regulation (EC) No 1107/2009 or equivalent provisions of national law, as applicable.

AddedFor the purposes of point (d), the authority referred to in Article 9(1) may decide on the lapse of the certificate either of its own motion or at the request of a third party.

AddedArticle 15 Invalidity of the certificate

Added1. The certificate shall be invalid in any of the following events:

Added(a) the certificate was granted contrary to Article 3 Articles 3 and 6; [Am. 9]

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 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.

Added2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent, or before a competent court of a Member State.

AddedArticle 16 Notification of lapse or invalidity

AddedIf the certificate lapses in accordance with Article 14, points (b), (c) or (d), or is invalid in accordance with Article 15, the authority referred to in Article 9(1) shall publish notification thereof.

AddedArticle 17 Appeals

Added1. The decisions of the authority referred to in Article 9(1) or of the body referred to in Article 15(2) taken under this Chapter shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.

Added2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate where the date of the first authorisation to place the product on the market in the Union, contained in the application for a certificate as provided for in Article 8, is incorrect.

AddedArticle 18 Procedure

Added1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent and, where appropriate, the procedural provisions applicable to the certificates referred to in Regulation (EC) No 469/2009 [OP, please insert reference to COM(2023)0231], shall apply to the certificate, unless national law lays down special procedural provisions for certificates.

Added2. Notwithstanding paragraph 1, the procedure for opposition to the grant of a certificate shall be excluded.

AddedChapter III Centralised procedure for certificates

AddedArticle 19 Scope of the centralised application

Added1. Where the basic patent is a European patent, including a unitary patent, and authorisations to place the product on the market have been granted in at least one Member State in accordance with Regulation (EC) No 1107/2009, the procedure in this Chapter may be used.

Added2. A centralised application shall be lodged with the European Union Intellectual Property Office established by Article 2 of Regulation (EU) 2017/1001 (‘the Office’).

Added3. Articles 1 to 7 and 13 to 17 shall apply to centralised applications.

Added4. The centralised application shall be lodged by using a specific application form.

AddedThe Commission is empowered to adopt implementing acts laying down rules on the application form to be used to lodge a centralised application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

AddedArticle 20 Content of the centralised application

AddedThe centralised application shall contain the following:

Added(a) designation of the Member States in which certificates are sought under the centralised procedure;

Added(b) the information referred to in Article 8(1).

AddedArticle 21 Examination of the admissibility of a centralised application

Added1. The Office shall examine the following:

Added(a) whether the centralised application complies with Article 20;

Added(b) whether the centralised application complies with Article 7;

Added(c) whether the application fee referred to in Article 33(1) has been paid within the prescribed period.

Added2. 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.

Added3. 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.