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 unitary supplementary protection certificate for plant protection products

AddedP9_TA(2024)0096

Removed(COM(2023)0221 – C90152/2023 – 2023/0126(COD))

AddedUnitary supplementary protection certificate for plant protection products

AddedCommittee on Legal Affairs

AddedPE753.702

AddedEuropean Parliament legislative resolution of 28 February 2024 on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products (COM(2023)0221 – C9-0152/2023 – 2023/0126(COD))

▸11 unchanged paragraphs

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0221),

– having regard to Article 294(2) and Article 118, first paragraph, of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90152/2023),

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

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the letter from the Committee on Agriculture and Rural Development,

– having regard to the report of the Committee on Legal Affairs (A9-0020/2024),

1. Adopts its position at first reading hereinafter set out;

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 2 a (new): (2a) That situation leads to a lack of protection which penalises plant protection research and the competitiveness of the sector.

AddedP9_TC1-COD(2023)0126

RemovedRecital 17: (17) One of the conditions for the grant of a certificate should be that the product should be 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 and drawings of the patent, on the basis of that person’s general knowledge in the relevant field and of 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 of its 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.

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 unitary supplementary protection certificate for plant protection products

RemovedRecital 18: (18) 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.

Added(Text with EEA relevance)

RemovedRecital 25: (25) The examination of an application for a unitary 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 procedure, in particular as regards qualification and conflicts of interest.

AddedTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

RemovedRecital 28: (28) After the completion of the examination of a unitary certificate 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 Office should implement without undue delay the examination opinion by granting a unitary certificate or rejecting the application, as applicable.

AddedHaving regard to the Treaty on the Functioning of the European Union, and in particular Article 118, first paragraph, thereof,

RemovedRecital 29: (29) 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 the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed.

AddedHaving regard to the proposal from the European Commission,

RemovedRecital 30: (30) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.

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

RemovedArticle 2 – paragraph 1 – point 13 a (new): (13a) ‘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 opinion of the European Economic and Social Committee,

RemovedArticle 3 – paragraph 1 – point b: (b) a valid authorisation to place the product on the market as a plant protection product has been granted in accordance with Regulation (EC) No 1107/2009 in at least one of the Member States in which that basic patent has unitary effect;

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

RemovedArticle 3 – paragraph 2 – subparagraph 2: Where two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending for a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not economically linked, by a competent national authority or by the Office, as applicable. 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.

AddedActing in accordance with the ordinary legislative procedure,

RemovedArticle 9 – paragraph 1 – point c a (new): (ca) where applicable, the consent of the third party referred to in article 6(2) of this Regulation.

AddedWhereas:

RemovedArticle 12 – paragraph 1: If the application for a unitary certificate complies with Article 11(1), the Office shall publish the application in the Register without undue delay.

Added(1) Phytopharmaceutical research plays a decisive role in the continuing improvement in agriculture. Plant protection products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research.

RemovedArticle 13 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Article 3 for all Member States in which the basic patent has unitary effect.

Added(2) The period that elapses between the filing of an application for a patent for a new plant protection product and the authorisation to place that product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.

RemovedArticle 13 – paragraph 2: 2. Where the application for a unitary certificate and the product to which it relates comply with Articles 3 and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant and publish it in the Register without undue delay.

Added(2a) That situation leads to a lack of protection which penalises plant protection research and the competitiveness of the sector. [Am. 1]

RemovedArticle 13 – paragraph 3: 3. Where the application for a unitary certificate and the product to which it relates does not comply with Articles 3 and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant and publish it in the Register without undue delay.

Added(3) Uniform patent and supplementary protection within the internal market, or at least a significant part thereof, should feature amongst the legal instruments which agrochemical undertakings have at their disposal to enhance their competitiveness.

RemovedArticle 15 – paragraph 4 – point c a (new): (ca) any evidence the opponent relies on in support of the opposition.

Added(4) In its Communication of 25 November 2020 entitled ‘Making the most of the EU’s innovative potential – An intellectual property action plan to support the EU’s recovery and resilience’, the Commission highlighted the need to tackle the remaining fragmentation of the Union’s intellectual property system. In that Communication, the Commission noted that, for medicinal products and plant protection products, supplementary protection is only available at national level. At the same time, there is a centralised procedure for granting European patents. In addition, the ‘unitary patent’ as laid down in Regulation (EU) No 1257/2012 enters into force on 1 June 2023 in respect for all Member States having ratified the Agreement on a Unified Patent Court (‘UPC’).

RemovedArticle 15 – 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 the reasoning for its decision to the opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

Added(5) Regulation (EU) No 1257/2012 has created the possibility to provide unitary patents. However, Regulation (EU) No 1257/2012 does not provide for a unitary supplementary protection certificate (‘unitary certificate’).

RemovedArticle 15 – paragraph 9 a (new): 9a. 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(6) In the absence of a unitary certificate, a unitary patent could only be extended by applying for several national certificates in each Member State where protection is sought, preventing the holder of a unitary patent from obtaining unitary protection during the whole combined protection period conferred by that unitary patent and subsequently by these certificates. Therefore, a unitary certificate for plant protection products should be created, that would allow a unitary patent to be extended in a unitary manner. Such a unitary certificate should be applied for on the basis of a unitary basic patent and would have the same legal effects as national certificates in all Member States in which that basic patent has unitary effect. The main feature of such a unitary certificate should be its unitary character.

RemovedArticle 15 – paragraph 10: 10. 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(7) A unitary certificate should provide uniform protection and have equal effect in all Member States where the basic patent it relies upon has unitary effect, except in the case of temporary suspension of the effect to allow for marketing authorisations granted at different times. Consequently, a unitary certificate should only be transferred or revoked, or expire, in respect of all those Member States.

RemovedArticle 15 – paragraph 11: 11. 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(8) Regulation [COM(2023) 223] replaces Regulation (EC) No 1610/96 of the European Parliament and of the Council, and includes new provisions establishing a centralised procedure for the examination of supplementary protection certificates for plant protection products.