What changed between the draft committee report and the plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

9 unchanged paragraphs

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 – C90152/2023 – 2023/0126(COD))

(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,

Changed:– having regard to the report of the Committee on Legal Affairs (A90000/2023),(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

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

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

Added:Recital 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.

Added:Recital 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:Recital 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.

Added:Recital 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.

Added:Recital 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.

Added:Recital 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.

Article 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.

Change 2

Removed:Article 9 – paragraph 1 – point c a (new): (ca) where applicable, the consent of the third party referred to in Article 6(2);

Added:Article 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;

Removed:Article 9 – paragraph 2 a (new): 2a. The applicant shall be responsible for the accuracy of the information and documentation submitted in relation to its application.

Added:Article 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.

Removed:Article 13 – paragraph 2: 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1) and Article 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.

Added:Article 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.

Removed:Article 13 – paragraph 3: 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1) and Article 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.

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

Article 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.

Article 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.

Change 3

Changed:Article 15 – paragraph 10: 10. The Office shall issue a decision on the opposition, including a detailed reasoning for its decision on thethat oppositiondecision, within 6 months, unless the complexity of the case requires a longer period.

Change 4

Changed:Article 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 decisiondecision, and the Office shall mention this in the Register.

Change 5

Removed:Article 16 – paragraph 1 a (new): 1a. Once a competent national authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and whether they have sufficient experience for the centralised examination procedure.

Added:Article 15 – paragraph 12 a (new): 12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.

Removed:Article 17 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates;

Added:Article 16 – paragraph 1: 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 applications for unitary certificates based on relevant expertise and sufficient experience required for the centralised examination procedure.

Change 6

Changed:Article 17 – paragraph 3 – point c:a: (c)(a) thatrelevant thereexpertise isand nosufficient examinerexperience employedin bythe aexamination competentof nationalpatents authorityand makingsupplementary useprotection certificates, ensuring, in particular, that at least one examiner has a minimum of thefive exemptionyears setof outexperience in Articlethe 10(5)examination of Regulationpatents [COM(2023)and 223].supplementary protection certificates;

Change 7

Removed:Article 18 – paragraph 1 – introductory part: No later than three months after the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions:

Added:Article 17 – paragraph 3 – point a a (new): (aa) where possible, geographical balance amongst the participating offices;

Added:Article 17 – paragraph 3 – point c: (c) that there is no examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231].

Added:Article 18 – paragraph 1 – introductory part: After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions, without undue delay:

Article 18 – paragraph 1 a (new): The Office shall inform the applicant of its decision without undue delay.

Change 8

Changed:Article 21 – paragraph 1 – point a: (a) the certificate was granted contrary to Articles 3 and 6;6(2);

Change 9

Removed:Article 26 – paragraph 3: 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 supporting evidence for those grounds, shall be filed within 4 months of the date of notification of the decision.

Added:Article 22 – paragraph 12: 12. To the extent that it has been declared invalid, the unitary certificate shall be deemed not to have had, as from the outset, the effects specified in this Regulation.

Added:Article 26 – paragraph 3: 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 those grounds, shall be filed within 3 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 of 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.

Article 26 – paragraph 5: 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards shall annul or alter the opinion.

Change 10

Removed:Article 27 – paragraph 4 a (new): 4a. The rules set out in Article 166(9) of Regulation (EU) 2017/1001 shall be respected.

Added:Article 27 – paragraph 4: 4. Members of the Boards of Appeal in matters regarding unitary 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 concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law.

Change 11

Changed:Article 3027 – paragraph 14 a (new): The applicant4a. shallArticle be166(9) responsibleof forRegulation the(EU) accuracy2017/1001 ofshall theapply informationto andBoards documentationof submittedAppeal in respectmatters ofregarding itsunitary application.certificates.

Change 12

Added:Article 32 – paragraph 1: 1. Communications addressed to the Office shall be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications are to be submitted electronically.

Added:Article 33 – paragraph 1 – point i: (i) the date and the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect;

Article 33 – paragraph 1 – point k: (k) where applicable, the filing of an opposition, its status and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion;