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DRAFT REPORT (COM(2023)0221 – C90152/2023 – 2023/0126(COD))

On the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products

JURI-PR-753702

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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The draft report sets out Parliament's first-reading position on the proposed regulation on a unitary supplementary protection certificate for plant protection products. It amends the Commission proposal to define 'economically linked' holders, require applicant responsibility for submitted information, and add consent and compliance conditions. It changes rules on oppositions, appeals, examiner expertise, the register and evidence, and asks the Commission to assess a central authorisation procedure for plant protection products.

Committee position. The rapporteur proposes that Parliament adopt its first-reading position with 24 amendments to the Commission proposal, covering definitions, application requirements, examination, opposition and appeal procedures, examiner expertise, the register, evidence and evaluation.

Key points

  1. Defines 'economically linked' holders of basic patents as those controlling, controlled by or under common control with each other.
  2. Requires the applicant to be responsible for the accuracy of information and documentation submitted with the application.
  3. Adds the consent of a third party under Article 6(2) to the documents to be filed and to the compliance checks for issuing an examination opinion.
  4. Requires the Office to give reasons in decisions rejecting an opposition as inadmissible, in opposition decisions and when notifying the opponent.
  5. Requires the Office to deal jointly with several oppositions against an examination opinion and issue one single decision.
  6. Requires participating offices to appoint designated examiners based on relevant expertise and sufficient experience for the centralised examination procedure.
  7. Sets the criteria for the pool of examiners as relevant expertise and sufficient experience in patents and supplementary protection certificates, and limits use of the exemption in Article 10(5) of Regulation [COM(2023) 223].
  8. Requires the Office to take its decision no later than three months after the appeal or opposition period expires or a final decision is issued, and to inform the applicant without undue delay.
  9. Allows revocation where the certificate was granted contrary to Articles 3 and 6.
  10. Requires a written statement of grounds of appeal, including supporting evidence, within 4 months of notification, and makes the Boards annul or alter an opinion that is not in line with the appeal decision.
  11. Requires respect for Article 166(9) of Regulation (EU) 2017/1001 and adds the status of oppositions and appeals to the register.
  12. Requires verification that a summonsed expert is free of any conflict of interest, and asks the Commission to evaluate the regulation and assess a central authorisation procedure for plant protection products under the European Food Safety Authority.

Who is affected

  • Applicants for unitary certificates, who must ensure the accuracy of submitted information and documentation.
  • Holders of basic patents, who are covered by the definition of 'economically linked'.
  • Competent national authorities acting as participating offices, which must appoint examiners meeting expertise and experience criteria.
  • Opponents and appellants, who face requirements on reasoning, joint decisions and evidence for appeal grounds.
  • The Commission, which must evaluate the regulation and report to Parliament and the Council.

Figures and deadlines

  • 6 months: period for the Office to issue a decision on an opposition, unless the case is complex.
  • 2 months: period from notification of a decision to file a notice of appeal.
  • 4 months: period from notification of a decision to file a written statement of grounds of appeal.
  • 1 month: minimum period of notice in a summons for oral evidence, unless a shorter period is agreed.
  • five years after the date of application, and every five years thereafter: when the Commission shall evaluate the implementation of the regulation.

Legal basis: Article 294(2) and Article 118, first paragraph, of the Treaty on the Functioning of the European Union.