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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

A-9-2024-0020

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's amended version of the Commission proposal for a regulation on a unitary supplementary protection certificate for plant protection products. It adds rules on what counts as protection by a basic patent, on economically linked holders, and on examination, opposition and appeal procedures at the Office. It requires the Office to publish applications, examination opinions and decisions without undue delay, to give detailed reasoning in opposition decisions, and to ensure transparency and possible public participation in oppositions. It sets a three-month deadline for appeal grounds and replies, and requires the Boards of Appeal to annul or alter an examination opinion when an appeal succeeds. It requires the Commission to evaluate the regulation five years after application and every five years thereafter, and to assess a central authorisation procedure for plant protection products under the European Food Safety Authority.

Committee position. The Committee on Legal Affairs adopts Parliament's position at first reading with amendments to the Commission proposal, adding rules on patent protection, economically linked holders, examination, opposition and appeal procedures, and a future evaluation.

Key points

  1. Adds a recital stating that the lack of protection penalises plant protection research and the sector's competitiveness.
  2. Specifies that a product is protected by a basic patent if it falls within the claims as interpreted by a skilled person in light of the description, drawings, general knowledge and prior art at the filing or priority date.
  3. Provides that no more than one certificate, national or unitary, may protect the same product in a Member State, and that a product or equivalent derivative must not have been the subject of a prior certificate.
  4. Requires the Office and national authorities to ensure examiners have relevant expertise and sufficient experience, and lays down criteria on qualification and conflicts of interest.
  5. Requires the Office to implement examination opinions without undue delay and to publish applications, opinions and decisions in the Register without undue delay.
  6. Gives applicants and other affected parties a right to appeal within 2 months, before a Board of Appeal, with decisions open to actions before the General Court.
  7. Requires that members of the Boards of Appeal be appointed taking into account relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters.
  8. Defines 'economically linked' holders and allows one certificate per holder where applicants are not economically linked, including for later applications by the same holder.
  9. Requires a valid authorisation in at least one Member State where the basic patent has unitary effect, and consent of a third party where applicable.
  10. Requires the Office to assess applications against Articles 3 and 6(2) for all Member States where the basic patent has unitary effect, and to issue reasoned positive or negative examination opinions.
  11. Sets rules for oppositions: evidence must be filed, inadmissible oppositions rejected with reasoning, multiple oppositions handled jointly with one decision, decisions issued within 6 months, and full transparency with possible public participation.
  12. Sets appeal deadlines: notice within 2 months, grounds within 3 months, reply within 3 months, oral proceedings within 3 or 6 months, and a written decision within 3 months; Boards of Appeal shall annul or alter an opinion.

Who is affected

  • Applicants for unitary supplementary protection certificates, who must meet new conditions and can appeal decisions.
  • Holders of basic patents, who may obtain certificates if not economically linked.
  • National patent offices and their examiners, who participate in examinations and must have relevant expertise.
  • The Office and its Boards of Appeal, which must publish decisions, handle oppositions jointly and meet deadlines.
  • The Commission, which must evaluate the regulation and report to Parliament and the Council.

Figures and deadlines

  • 2 months to file an appeal against a decision of the Office.
  • 6 months for the Office to issue a decision on an opposition, unless complexity requires longer.
  • 3 months to file a written statement of grounds of appeal.
  • 3 months for a reply to the statement of grounds of appeal.
  • 3 months or 6 months for fixing oral proceedings, whichever is earlier.
  • 3 months to issue a written decision after the oral hearing or reply.
  • At least 1 month notice for a summons to give evidence orally.
  • Five years after the date of application, and every five years thereafter, for the Commission's evaluation.

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