What changed between the plenary report and the adopted text

Removed:LETTER OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT

Added:(23) Therefore, it is necessary to complement the existing national procedures for the grant of certificates for plant protection products with a centralised procedure. That procedure should make it possible, where the basic patent is a European patent, including a unitary patent, to request the grant of national certificates for two or more designated Member States through the filing and examination of a single ‘centralised’ application. Following the grant of certificates under the centralised procedure, these certificates should be equivalent to the certificates granted under national procedures and be subject to the same rules.

Removed:Mr Adrián Vázquez Lázara

Added:(24) Regulation (EU) No 2017/1001 of the European Parliament and of the Council has established, under its Article 2, a European Union Intellectual Property Office (‘the Office’). In the interest of the internal market, the centralised procedure should be carried out by a single examining authority. This can be achieved by the Office being given the task of examining applications for certificates under the centralised procedure in accordance with this Regulation.

Removed:Chair

Added:(25) In order to provide for a simplified examination of a centralised application, its filing should be available only on the basis of a European patent, including a unitary patent. The centralised application should not be available on the basis of a set of independent national patents, as their claims are likely to be different, resulting in greater complexity in examination compared to the situations where the basic patent is a European patent.

Removed:Committee on Legal Affairs

Added:(26) Since marketing authorisations for a given plant protection product may be granted at different dates in different Member States, the Member States that could be validly designated in a centralised application for certificates for a certain plant protection product would be severely restricted, if it were to be required that authorisations should have been granted in all Member States designated in the application. The grant of certificates on the basis of such a centralised application should therefore be allowed where marketing authorisations have at least been applied for in all designated Member States, provided that such authorisations are granted before the end of the examination process. For this reason, the examination opinion should not be adopted earlier than 18 months from the filing of the centralised application. Where no authorisation has been granted in a designated Member State before that period has elapsed, however, the Office should, in respect of that Member State, suspend the examination proceedings, and resume them, on request, provided that such an authorisation is eventually granted before the expiry of the basic patent.

Removed:BRUSSELS

Added:(27) The Office should have the possibility to charge a fee for the centralised application for a certificate, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.

Removed:Ref.: IPOL-COM-AGRI D(2023)23992

Added:(28) An applicant should also be allowed to lodge a ‘combined application’ that would include an application for a unitary certificate as set out in Regulation [OP, please insert reference to COM(2023)0221]. Such a combined application should undergo a single examination procedure.

Removed:Subject: Opinion on the Commission’s proposals for regulations on the unitary supplementary protection certificate and the supplementary protection certificate for plant protection products (COM(2023)0221 – C90152/2023 – 2023/126(COD)) and (COM(2023)0223 – C90149/2023 – 2023/128(COD))

Added:(29) In order to avoid double protection, it should not be possible to grant certificates – whether national certificates or unitary certificates – for the same product in the same Member State based on both a national application and a centralised application.

Removed:Dear Mr Chair,

Added:(30) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.

Removed:I refer to the Commission’s proposals for regulations on the unitary supplementary protection certificate [2023/0126 (COD)] and the supplementary protection certificate [2023/0128 (COD)] for plant protection products.

Added:(31) The Office should examine the centralised application for certificates and issue an examination opinion. That opinion should state the reasons for which it is positive or negative in respect of each of the designated Member States.

Removed:AGRI Coordinators considered the matter at their meeting of 23 May. They noted that the proposals are intended to complement the unitary patent system, and would not substantially modify the existing regime for supplementary protection certificate.

Added:(32) The examination of a centralised application for a certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the Office and the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest. [Am. 3]

Removed:Unitary supplementary protection certificates are an important tool for this kind of products and for fostering innovation. Since the adoption of Regulation (EC) No 1107/2009, only very few substances have been approved while more and more substances are losing their approval, which leaves farmers with less tools to achieve the Union’s goals. We urge the Committee on Legal Affairs to consider the situation of farmers.

Added:(33) Where the Office finds that the conditions for grant of a certificate are fulfilled in one or more of the Member States designated in a centralised application, but are not fulfilled in one or more of the other ones, including where in one of the designated Member States the basic European patent has different claims which do not cover the product, the Office should issue a positive opinion for those designated Members States in which the conditions for obtaining a certificate are fulfilled, and a negative opinion for those in which the conditions are not fulfilled.

Removed:Consequently, Coordinators recommended not to give an opinion on the above legislative proposals and to convey this position to you.

Added:(34) To safeguard third parties’ procedural rights and ensure a complete system of remedies, third parties should be able to challenge an examination opinion, by initiating opposition proceedings within a short duration following the publication of that opinion, and that opposition may result in that opinion being amended.

Removed:This recommendation was endorsed by the AGRI Committee at its meeting on 6 July 2023.

Added:(35) After the completion of the examination of a centralised application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the opinion should be transmitted to the respective national patent offices of the designated Member States.

Removed:Yours sincerely,

Added:(36) Where the examination opinion is positive for one or several Member States, the respective competent national authorities should grant a certificate in accordance with the applicable domestic rules, in particular as regards publication, registration in relevant databases and the payment of annual fees.

Removed:Norbert Lins

Added:(37) Where the examination opinion is negative for one or several Member States, the respective competent national authorities should reject the application in accordance with the applicable domestic rules.

Removed:6.11.2023

Added:(38) For the sake of coherence and legal certainty, the same substantive provisions should apply to national applications and to centralised applications regarding in particular the scope, the conditions for obtaining certificates, the subject-matter of protection and effect of certificates, and their publication. The centralised procedure would result in the grant of national certificates fully identical to those granted on the basis of national applications.