Sittings · Document
On the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast)
Committee on Legal Affairs · Rapporteur: Tiemo Wölken
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
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 – C90149/2023 – 2023/0128(COD))
(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;
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.
Amendment 1
Proposal for a regulation
Recital 11
| Text proposed by the Commission | Amendment |
| (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 by the description of the patent on its filing date. 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 of them is specifically identifiable in the light of all the information disclosed by that patent. | (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. |
Amendment 2
Proposal for a regulation
Recital 12
| Text proposed by the Commission | Amendment |
| (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, either alone or in combination with one or more additional active ingredients, whether for the same application or for a different one. | (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. |
Amendment 3
Proposal for a regulation
Recital 32
| Text proposed by the Commission | Amendment |
| (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 matters, located today at national offices only. To ensure an optimal quality of the examination, 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. | (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. |
Amendment 4
Proposal for a regulation
Recital 40
| Text proposed by the Commission | Amendment |
| (40) 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. | (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. |
Amendment 5
Proposal for a regulation
Recital 41
| Text proposed by the Commission | Amendment |
| (41) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account. | (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. |
Amendment 6
Proposal for a regulation
Article 2 – paragraph 1 – point 15 a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Amendment 7
Proposal for a regulation
Article 3 – paragraph 2
| Text proposed by the Commission | Amendment |
| 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 . | 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. |
Amendment 8
Proposal for a regulation
Article 8 – paragraph 1 – point c a (new)
| Text proposed by the Commission | Amendment |
| (ca) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation; |
Amendment 9
Proposal for a regulation
Article 15 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
| (a) the certificate was granted contrary to Article 3; | (a) the certificate was granted contrary to Articles 3 and 6; |
Amendment 10
Proposal for a regulation
Article 23 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) 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. | 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. |
Amendment 11
Proposal for a regulation
Article 23 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1) 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. | 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. |
Amendment 12
Proposal for a regulation
Article 26 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 are not fulfilled for one or more of the designated Member States. | 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. |
Amendment 13
Proposal for a regulation
Article 26 – paragraph 4 – point c a (new)
| Text proposed by the Commission | Amendment |
| (ca) any evidence the opponent relies on in support of the opposition. |
Amendment 14
Proposal for a regulation
Article 26 – paragraph 6
| Text proposed by the Commission | Amendment |
| 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 this to opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. | 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. |
Amendment 15
Proposal for a regulation
Article 26 – paragraph 8 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Amendment 16
Proposal for a regulation
Article 26 – paragraph 9
| Text proposed by the Commission | Amendment |
| 9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. | 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. |
Amendment 17
Proposal for a regulation
Article 26 – paragraph 10
| Text proposed by the Commission | Amendment |
| 10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition, and the Office shall mention this in the Register. | 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. |
Amendment 18
Proposal for a regulation
Article 26 – paragraph 11
| Text proposed by the Commission | Amendment |
| 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, and the Office shall mention this in the Register. | 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. |
Amendment 19
Proposal for a regulation
Article 26 – paragraph 12 a (new)
| Text proposed by the Commission | Amendment |
| 12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. |
Amendment 20
Proposal for a regulation
Article 27 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications. | 1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications, on the basis of their relevant expertise and their experience in the field. |
Amendment 21
Proposal for a regulation
Article 28 – paragraph 3 – point a
| Text proposed by the Commission | Amendment |
| (a) geographical balance amongst the participating offices; | (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one examiner has a minimum of five years of experience in the examination of patents and supplementary protection certificates; |
Amendment 22
Proposal for a regulation
Article 28 – paragraph 3 – point a a (new)
| Text proposed by the Commission | Amendment |
| (aa) where possible, geographical balance amongst the participating offices; |
Amendment 23
Proposal for a regulation
Article 28 – paragraph 3 – point c
| Text proposed by the Commission | Amendment |
| (c) no more than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). | (c) that there is than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). |
Amendment 24
Proposal for a regulation
Article 29 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision. | 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, including the evidence supporting these grounds, shall be filed within three months of the date of notification of the decision. |
| Any reply to the statement of grounds of appeal shall be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office shall, where applicable, fix a date for oral proceedings within three months following the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the date of the oral hearing, or of the filing of the reply to the statement of grounds of appeal, as applicable. |
Amendment 25
Proposal for a regulation
Article 29 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4a. The Office shall inform the applicant of its decision without undue delay. |
Amendment 26
Proposal for a regulation
Article 29 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards may annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. | 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. |
Amendment 27
Proposal for a regulation
Article 30 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001. | 4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166(5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters shall be taken into account. |
Amendment 28
Proposal for a regulation
Article 30 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to the Boards of Appeal in matters regarding centralised applications for certificates. |
Amendment 29
Proposal for a regulation
Article 34 – paragraph 1 – point j
| Text proposed by the Commission | Amendment |
| (j) the date and a summary of the examination opinion in respect of each of the designated Member States; | (j) the date and the examination opinion in respect of each of the designated Member States; |
Amendment 30
Proposal for a regulation
Article 34 – paragraph 1 – point l
| Text proposed by the Commission | Amendment |
| (l) where applicable, the filing of an opposition, and its outcome, including where applicable a summary of the revised examination opinion; | (l) where applicable, the filing of an opposition, its status and its outcome, including where applicable a summary of the revised examination opinion; |
Amendment 31
Proposal for a regulation
Article 34 – paragraph 1 – point m
| Text proposed by the Commission | Amendment |
| (m) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion; | (m) where applicable, the filing of an appeal, its status and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion; |
Amendment 32
Proposal for a regulation
Article 44 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period. | 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summonsed, the Office or the relevant panel, as applicable, shall be verify that that expert is free of any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period. |
Amendment 33
Proposal for a regulation
Article 56 – paragraph 1
| Text proposed by the Commission | Amendment |
| By [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall carry out an evaluation of the application of Chapter III. | By … [OJ: please insert: five years after the date of application], and every five years thereafter, the Commission shall carry out an evaluation of the application of Chapter III and present a report on the main findings to the European Parliament and to the Council. |
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the report, until the adoption thereof in committee:
| Entity and/or person |
| CropLife Europe |
| Verband der Chemischen Industrie e.V. |
The list above is drawn up under the exclusive responsibility of the rapporteur.
29.6.2023
LETTER OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT
Mr Adrián Vázquez Lázara
Chair
Committee on Legal Affairs
BRUSSELS
Ref.: IPOL-COM-AGRI D(2023)23992
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))
Dear Mr Chair,
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.
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.
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.
Consequently, Coordinators recommended not to give an opinion on the above legislative proposals and to convey this position to you.
This recommendation was endorsed by the AGRI Committee at its meeting on 6 July 2023.
Yours sincerely,
Norbert Lins
6.11.2023
LETTER OF THE COMMITTEE ON LEGAL AFFAIRS
Mr Adrián Vázquez Lázara
Chair
Committee on Legal Affairs
BRUSSELS
Subject: Opinion 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 – C90149/2023 – 2023/0128(COD))
Dear Mr Chair,
The Committee on Legal Affairs has examined the proposal referred to above pursuant to Rule 110 on recasting of Parliament's Rules of Procedure.
Paragraph 3 of that Rule reads as follows:
“If the committee responsible for legal affairs considers that the proposal does not entail any substantive changes other than those identified as such in the proposal, it shall inform the committee responsible for the subject matter thereof.
In such a case, over and above the conditions laid down in Rules 180 and 181, amendments shall be admissible within the committee responsible for the subject-matter only if they concern those parts of the proposal which contain changes.
However, amendments to parts of the proposal which remain unchanged may, by way of exception and on a case-by-case basis, be accepted by the Chair of the committee responsible for the subject matter if he or she considers that this is necessary for pressing reasons relating to the internal logic of the text or because the amendments are inextricably linked to other admissible amendments. Such reasons must be stated in a written justification to the amendments.”
Following the here attached opinion of the Consultative Working Party of the Legal Services of the Parliament, the Council and the Commission, which has examined the recast proposal, and in keeping with the recommendations of the Rapporteur, the Committee on Legal Affairs considers that the proposal in question does not include any substantive changes other than those identified as such and that, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, the proposal contains a straightforward codification of the existing text, without any change in its substance.
In conclusion, at its meeting of 24 October 2023, the Committee on Legal Affairs unanimously decided to recommend that the Committee on Legal Affairs, as the committee responsible, proceed to examine the above proposal in accordance with Rule 110.
Yours sincerely,
Adrián Vázquez Lázara
Encl.: Opinion of the Consultative Working Party.
Annex
| CONSULTATIVE WORKING PARTY OF THE LEGAL SERVICES |
Brussels, 1 August 2023
OPINION
FOR THE ATTENTION OF THE EUROPEAN PARLIAMENT
THE COUNCIL
THE COMMISSION
Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products
COM(2023)0223 of 27.4.2023 – 2023/0128(COD)
Having regard to the Inter-institutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts, and in particular to point 9 thereof, the Consultative Working Party consisting of the respective legal services of the European Parliament, the Council and the Commission met on 6 July 2023 for the purpose of examining the aforementioned proposal submitted by the Commission.
At that meeting, an examination of the proposal for a Regulation of the European Parliament and of the Council recasting Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products resulted in the Consultative Working Party’s establishing, by common accord, as follows.
1. The deletion of recitals 13 and 14 of Regulation (EC) No 1610/96 should have been marked with the grey-shaded type generally used for identifying substantive amendments.
2. The following should have been identified as formal adaptations:
- in the title of the act, the replacement of the words ‘concerning the creation of a supplementary protection certificate’ with the words ‘on the supplementary protection certificate’;
- in Article 3(1), introductory wording, the adding of the word ‘and’;
- in Article 8(1), point (a)(iv) and point (c), the replacement of the words ‘to place’ with the words ‘for placing’;
- in Article 8(2), the replacement of the word ‘require’ with the word ‘provide’;
- in Article 12, the adding of the word ‘that’ and the deletion of the word ‘to’ before the words ‘be subject’.
3. 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’.
In 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.
F. DREXLER E. FINNEGAN D. CALLEJA CRESPO
Jurisconsult Jurisconsult Director-General