Changes from plenary report to adopted text

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 Directive 2001/83/EC or Regulation (EU) 2019/6.

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 certificatewas granted contrary to Article 3 or 6(2); [Am. 27]

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 Revocation of an extension of the duration of a certificate for a medicinal product

Added1. The extension of the duration may be revoked if it was granted contrary to Article 36 of Regulation (EC) No 1901/2006.

Added2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent or before a competent court of a Member State. [Am. 28]

AddedArticle 17 Notification of lapse or invalidity

Added1. If 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 .

Added2. If the extension of the duration is revoked in accordance with Article 16, the authority referred to in Article 9(1) shall publish notification thereof .

AddedArticle 18 Appeals

Added1. The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Article 15(2) and Article 16(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.

Added2a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation. [Am. 29]

AddedArticle 19 Procedure

Added1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless the 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 20 Scope of the centralised application

Added1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted, as appropriate, in accordance with Directive .../... [2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply. [Am. 30]

Added2. When the conditions under paragraph 1 are met, the filing of national applications shall be prohibited, in respect of the same product, in those Member States in which that basic patent is in force.

Added3. A centralised application shall be lodged with the European Union Intellectual Property Office established by Article 2 of Regulation (EU) 2017/1001 (‘the Office’).

Added4. Articles 1 to 7 and 13 to 18 shall apply to centralised applications.

Added5. 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 56.

AddedArticle 21 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 22 Examination of the admissibility of a centralised application

Added1. The Office shall examine the following:

Added(a) whether the centralised application complies with Article 21;

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

Added(c) whether the application fee referred to in Article 34(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.

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 23 Publication of the centralised application

AddedIf the centralised application complies with Article 22, or if an application for an extension of the duration of certificates complies with Article 33(2), the Office shall publish the application, in the Register without undue delay, in the Registerand no later than five working days after. [Am. 31]

AddedArticle 24 Examination of the centralised application

Added1. The Office shall assess the application on the basis of all the conditions in Article 3(1) and (3) and Article 6(2)Article 3(1) for each of the designated Member States. [Am. 32]

Added2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) and (3) and Article 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 and publish the opinion on the dedicated register without undue delay. [Am. 33]

Added3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1) and (3) and Article 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 and publish the opinion on the dedicated register without undue delay. [Am. 34]

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 56.

Added5a. The Office shall adopt an examination opinion within 6 months after publication of the centralised application in the Register. Without prejudice to Articles 25, 26 and 28 of this Regulation, 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 adopt an examination opinion within 4 months from the publication of the application for a unitary certificate. [Am. 35]

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.

Added3a. Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within six weeks after publication of the application in the Register. [Am. 36]