Changes from plenary report to adopted text

Removed- in Article 11(1), introductory wording, and in Article 11(2), the adding of the words ‘as soon as possible’.

Added(5) ‘maker’ means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out.

Removed2. The following should have been identified as formal adaptations:

Added(6) ‘national application’ means an application for a certificate made before a competent national authority pursuant to Article 9;

Removed- in the title of the act, the replacement of the word ‘concerning’ with the word ‘on’;

Added(7) ‘centralised application’ means an application made before the Office pursuant to Article 20 with a view to the grant of certificates, for the product identified in the application, in the designated Member States;

Removed- in Article 8(1), point (d), the adding of the words ‘for a medicinal product’;

Added(8) ‘centralised application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 30 of this Regulation and Article 36 of Regulation (EC) No 1901/2006;

Removed- in Article 8(2), the replacement of the words ‘extended duration’ with the words

Added(9) ‘designated Member State’ means a Member State for which a certificate is sought under the centralised examination procedure laid down in Chapter III, as identified in a centralised application for a certificate;

Removed‘extension of the duration’.

Added(10) ‘European patent’ means a patent granted by the European Patent Office (EPO) under the rules and procedures laid down in the European Patent Convention (‘EPC’);

RemovedIn consequence, examination of the proposal has enabled the Consultative Working Party to conclude, without dissent, that the proposal does not comprise any substantive amendments other than those identified as such. The Working Party also concluded, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, that the proposal contains a straightforward codification of the existing legal text, without any change in its substance.

Added(11) ‘unitary patent’ means a European patent which benefits from unitary effect in those Member States participating in the enhanced cooperation laid down in Regulation (EU) No 1257/2012;

RemovedF. DREXLER E. FINNEGAN D. CALLEJA CRESPO

Added(12) ‘competent national authority’ means the national authority that is competent, in a given Member State, for the grant of certificates and for the rejection of applications for certificates, as referred to in Article 9(1).

RemovedJurisconsult Jurisconsult Director-General

Added(12a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder. [Am. 15]

AddedChapter II National applications for a certificate

AddedArticle 3 Conditions for obtaining a certificate

Added1. A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application , all of the following conditions are fulfilled :

Added(a) the product is protected by a basic patent in force;

Added(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC.../... [2023/0132(COD)],Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, as appropriate; [Am. 16]

Added(c) the product has not already been the subject of a certificate;

Added(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.

Added2. By way of derogation from paragraph 1, a certificate shall not be granted under this Chapter, in a Member State, on the basis of a national application where the requirements of Article 20(1) are fulfilled for the filing of a centralised application in which that Member State would be designated.

Added3. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders, where they are not economically linked. The same principle shall apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents. [Am. 17]

AddedArticle 4 Scope of the protection

AddedWithin the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.

AddedArticle 5 Effects of the certificate

Added1. The certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

Added2. By way of derogation from paragraph 1, and in accordance with Regulation (EU).../... [2023/0130(COD)], the certificate shall not confer protection against certain acts which would otherwise require the consent of the the certificate holder, if all of the following conditions are met: [Am. 18]

Added(a) the acts comprise any of the following :

Added(i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or [Am. 19]

Added(ii) any related act that is strictly necessary for thethat making, in the Union, referred to in point (i), or for the actual export itself; or [Am. 20]

Added(iii) the making, no earlier than 6 months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or [Am. 21]

Added(iv) any related act that is strictly necessary for the making, in the Union, as referred to in point (iii), or for the actual storing itself, provided that such related act is carried out no earlier than 6 months before the expiry of the certificate. [Am. 22]

Added(b) the maker, through appropriate and documented means, notifies the authority referred to in Article 9(1) in the Member State in which that making is to take place, and informs the certificate holder, of the information referred to in paragraph 5 no later than 3 months before the start date of the making in that Member State, or no later than 3 months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier;

Added(c) if the information referred to in paragraph 5 of this Article changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect;

Added(d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex II, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;

Added(e) the maker complies with paragraph 9 of this Article and, if applicable, with Article 12(2).

Added3. Paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing.

Added4. The information provided to the certificate holder for the purposes of paragraph 2, points (b) and (c), shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.

Added5. For the purposes of paragraph 2, point (b), the maker shall provide all of the following information :

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

Added(b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;

Added(c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;

Added(d) the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making;

Added(e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.

Added6. For the purposes of notification to the authority under paragraph 2, points (b) and (c), the maker shall use the standard form for notification set out in Annex III.

Added7. Failure to provide the information referred to in paragraph 5, point (e), with regard to a third country shall only affect exports to that third country, and those exports shall not benefit from the exception laid down in paragraph 2 .

Added8. The maker shall ensure that medicinal products made pursuant to paragraph 2, point (a) (i), do not bear an active unique identifier within the meaning of Delegated Regulation (EU) 2016/161.

Added9. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker that performs acts falling under paragraph 2, point (a), is fully informed and aware of all of the following:

Added(a) that those acts are subject to paragraph 2;

Added(b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in paragraph 2, point (a)(i), or the placing on the market of the product, or the medicinal product containing that product, referred to in paragraph 2, point (a)(iii), could infringe the certificate referred to in that paragraph where, and for as long as, that certificate applies.

Added10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.

AddedParagraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.

AddedParagraph 2 shall not apply to certificates that have taken effect before 1 July 2019.

AddedArticle 6 Entitlement to the certificate

Added1. The certificate shall be granted to the holder of the basic patent or to the successor in title of that holder .