Changes from plenary report to adopted text

RemovedDRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

AddedTEXTS ADOPTED

Removedon the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast)

AddedP9_TA(2024)0098

Removed(COM(2023)0223 – C90149/2023 – 2023/0128(COD))

AddedSupplementary protection certificate for plant protection products (recast)

AddedCommittee on Legal Affairs

AddedPE753.705

AddedEuropean Parliament legislative resolution of 28 February 2024 on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) (COM(2023)0223 – C9-0149/2023 – 2023/0128(COD))

▸11 unchanged paragraphs

(Ordinary legislative procedure – recast)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0223),

– having regard to Article 294(2) and Article 114(1) Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90149/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 27 September 2023,

– having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts,

– having regard to Rules 110 and 59 of its Rules of Procedure,

– having regard to the opinion of the Committee on Agriculture and Rural Development,

– having regard to the report of the Committee on Legal Affairs (A9-0023/2024),

A. whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

Changed1. Adopts its position at first reading hereinafter set out;out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 1

RemovedRecital 11: (11) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art in light of the description of the patent on the basis of that person’s general knowledge in the relevant field and on the prior art at the filing date or priority date of the basic patent. This should not necessarily require that the active substance of the product be explicitly identified in the claims or, in the event of a preparation, this should not necessarily require that each active substances be explicitly identified in the claims, provided that each active substance is specifically identifiable in the light of all the information disclosed by that patent on the basis of the prior art at the filing date or priority date of the basic patent.

AddedP9_TC1-COD(2023)0128

RemovedRecital 12: (12) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any derivative such as salts, esters, ethers, isomers, mixtures of isomers, or complexes, equivalent to the product from a phytosanitary perspective, should not have already been the subject of a prior certificate, whether for the same application or for a different one.

AddedPosition of the European Parliament adopted at first reading on 28 February 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast)

RemovedRecital 32: (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.

Added(Text with EEA relevance)

RemovedRecital 40: (40) To safeguard procedural rights and ensure a complete system of remedies, where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed.

AddedTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

RemovedRecital 41: (41) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.

AddedHaving regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof,

RemovedArticle 2 – paragraph 1 – point 15 a (new): (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.

AddedHaving regard to the proposal from the European Commission,

RemovedArticle 3 – paragraph 2: 2. 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.

AddedAfter transmission of the draft legislative act to the national parliaments,

RemovedArticle 8 – paragraph 1 – point c a (new): (ca) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation;

AddedHaving regard to the opinion of the European Economic and Social Committee,

RemovedArticle 15 – paragraph 1 – point a: (a) the certificate was granted contrary to Articles 3 and 6;

AddedHaving regard to the opinion of the Committee of the Regions,

RemovedArticle 23 – paragraph 2: 2. Where the centralised application for a certificate and the product to which it relates comply with Articles 3(1) and 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.

AddedActing in accordance with the ordinary legislative procedure,

RemovedArticle 23 – paragraph 3: 3. Where the centralised application for a certificate and the product to which it relates does not comply with Articles 3(1) and 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.

AddedWhereas:

RemovedArticle 26 – paragraph 2: 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 or 6 are not fulfilled for one or more of the designated Member States.

Added(1) Regulation (EC) No 1610/96 of the European Parliament and of the Council has been substantially amended several times. Since further amendments are to be made, that Regulation should be recast in the interests of clarity.

RemovedArticle 26 – paragraph 4 – point c a (new): (ca) any evidence the opponent relies on in support of the opposition.

Added(2) Research into plant protection products contributes to the continuing improvement in the production and procurement of plentiful food of good quality at affordable prices.

RemovedArticle 26 – paragraph 6: 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate its decision as well as its reasoning for that decision to the opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

Added(3) Plant protection research contributes to the continuing improvement in crop production.

RemovedArticle 26 – paragraph 8 a (new): 8a. In cases where several oppositions have been filed against an examination opinion, the Office shall deal with the oppositions jointly and issue one single decision in respect of all oppositions filed.

Added(4) Plant protection products, especially those that are the result of long, costly research, will continue to be developed in the Union if they are covered by favourable rules that provide for sufficient protection to encourage such research.

RemovedArticle 26 – paragraph 9: 9. The Office shall issue a decision on the opposition, including a detailed reasoning for that decision, within 6 months, unless the complexity of the case requires a longer period.

Added(5) The competitiveness of the plant protection sector, by the very nature of the industry, requires a level of protection for innovation which is equivalent to that granted to medicinal products by Regulation (EC) No 469/2009 of the European Parliament and of the Council [OP, please insert new reference to COM(2023)0231] .

RemovedArticle 26 – paragraph 10: 10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition, and notify the opponent of its decision, and the Office shall mention this in the Register.

Added(6) The period that elapses between the filing of an application for a patent for a new plant protection product and the authorisation to place the said plant protection product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research and to generate the resources needed to maintain a high level of research.

RemovedArticle 26 – paragraph 11: 11. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, notify the opponent of its decision and the Office shall mention this in the Register.

Added(7) This situation leads to a lack of protection which penalises plant protection research and the competitiveness of the sector.

RemovedArticle 26 – paragraph 12 a (new): 12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.