Changes from plenary report to adopted text

Added2. Notwithstanding paragraph 1, where a basic patent has been granted in respect of a product that is the subject of an authorisation held by a third party, a certificate for that product shall not be granted to the holder of the basic patent without the consent of that third party.

AddedArticle 7 Application for a certificate

Added1. The application for a certificate shall be lodged within 6 months of the date on which the authorisation referred to in Article 3(1), point (b), to place the product on the market as a medicinal product was granted.

Added2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within 6 months of the date on which the patent is granted.

Added3. The application for an extension of the duration may be lodged at the same time when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1), point (d), or Article 8(2), respectively, are fulfilled.

Added4. The application for an extension of the duration of a certificate already granted shall be lodged not later than 2 years before the expiry of the certificate.

AddedArticle 8 Content of the application for a certificate

Added1. The application for a certificate shall contain the following :

Added(a) a request for the grant of a certificate, stating in particular:

Added(i) the name and address of the applicant;

Added(ii) if the applicant has appointed a representative, the name and address of that representative;

Added(iii) the number of the basic patent and the title of the invention;

Added(iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3 (1), point (b), and, if this authorisation is not the first authorisation for placing the product on the market in the Union , the number and date of that authorisation;

Added(b) a copy of the authorisation to place the product on the market, as referred to in Article 3(1), point (b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 35 of Regulation (EU) 2019/6;

Added(c) where the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Union , information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication or, in the absence of such a notice, any other document proving that the authorisation has been issued, the date on which it was issued and the identity of the product authorised ;

Added(d) where the application for a certificate for a medicinal product includes a request for an extension of the duration:

Added(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;

Added(ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006;

Added(da) if applicable, the consent of the third party referred to in Article 6(2) of this Regulation; [Am. 23]

Added(db) information on any direct public financial support received for research related to the development of the product. [Am. 24]

Added2. Where an application for a certificate is pending, an application for an extension of the duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1, point (d), of this Article and a reference to the application for a certificate already filed.

Added3. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1, point (d), and a copy of the certificate already granted.

Added4. Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.

AddedArticle 9 Lodging of an application for a certificate

Added1. The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(1), point (b), to place the product on the market was obtained, unless the Member State designates another authority for that purpose.

AddedThe application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.

Added2. Notification of the application for a certificate shall be published by the authority referred to in paragraph 1. The notification shall contain all of the following information:

Added(a) the name and address of the applicant;

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) where applicable, an indication that the application includes an application for an extension of the duration.

Added3. Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.

AddedArticle 10 Grant of the certificate or rejection of the application for a certificate

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.

Added6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.

AddedArticle 11 Publication

Added1. The authority referred to in Article 9(1) shall publish, as soon as possiblewithout undue delay, notification of the fact that a certificate has been granted. The notification shall contain all of the following information: [Am. 25]

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.

Added(fa) information on any direct public financial support received for research related to the development of the product. [Am. 26]

Added2. The authority referred to in Article 9(1) shall publish, as soon as possible, 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).

Added3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.

Added4. The authority referred to in Article 9(1) shall publish, as soon as possible, the information listed in Article 5(5), together with the date of notification of that information. It shall also publish, as soon as possible, any changes to the information notified in accordance with Article 5(2), point (c) .

AddedArticle 12 Fees

Added1. Member States may require that the certificate be subject to the payment of annual fees.

Added2. Member States may require that the notifications to in Article 5(2), points (b) and (c), be subject to the payment of a fee.

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. The periods laid down in paragraphs 1 and 2 of this Article shall be extended by 6 months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of that Article may be extended only once.