Changes from plenary report to adopted text

Removed- in Article 3(1), introductory wording, the adding of the word ‘and’;

Added(a) against harmful organisms; or

Removed- in Article 8(1), point (a)(iv) and point (c), the replacement of the words ‘to place’ with the words ‘for placing’;

Added(b) on plants, parts of plants or plant products;

Removed- in Article 8(2), the replacement of the word ‘require’ with the word ‘provide’;

Added(4) ‘preparations’ means mixtures or solutions composed of two or more substances, of which at least one is an active substance, intended for use as plant protection products;

Removed- in Article 12, the adding of the word ‘that’ and the deletion of the word ‘to’ before the words ‘be subject’.

Added(5) ‘plants’ means live plants and live parts of plants, including fresh fruit and seeds;

Removed3. In Article 3(1), point (b), and in Article 8(1), point (c), the words ‘medicinal product’ should be replaced by the words ‘plant protection product’.

Added(6) ‘plant products’ means products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves ;

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(7) ‘harmful organisms’ means pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens;

RemovedF. DREXLER E. FINNEGAN D. CALLEJA CRESPO

Added(8) ‘product’ means the active substance or combination of active substances of a plant protection product;

RemovedJurisconsult Jurisconsult Director-General

Added(9) ‘basic patent’ means a patent which protects a product as such, a preparation , a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for the grant of a certificate;

Added(10) ‘national application’ means an application for a certificate made before a competent national authority pursuant to Article 9;

Added(11) ‘centralised application’ means an application made before the Office pursuant to Article 19 with a view to the grant of certificates, for the product identified in the application, in the designated Member States;

Added(12) ‘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;

Added(13) ‘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’);

Added(14) ‘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;

Added(15) ‘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);

Added(15a) ‘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. 6]

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 Regulation (EC) No 1107/2009 ;

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 plant protection product.

Added2. 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. 7]

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 authorisations to place the corresponding plant protection product on the market and for any use of the product as a plant protection product that has been authorised before the expiry of the certificate.

AddedArticle 5 Effects of the certificates

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

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.

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 plant protection 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.

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 , Part A, section 1, points 1.1 to 1.7 of the Annex to Commission Regulation 283/2013 or Part B, Section 1, points 1.1 to 1.4.3 thereof;

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(ca) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation. [Am. 8]

Added2. Member States may provide that a fee is to be payable upon application for 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.

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 .