Unitary supplementary protection certificate for plant protection products

In “A new plan for Europe's sustainable prosperity and competitiveness”

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A supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that can extend a basic patent market exclusivity for medicinal or plant protection product (PPP) by up to 5 years. It aims to offset the time loss of patent protection due to the compulsory and lengthy testing required in the EU for the regulatory marketing authorisation of these products. 

The European patent with unitary effect ('unitary patent') has applied since 1 June 2023, allowing for a single patent that covers all participating Member States in a unitary manner. However, at the moment, the SPC protection is only available at the national level. Therefore, the applicant seeking to extend the protection provided by a unitary patent must follow the national laws in each Member State. This current SPC system is inefficient and costly, generating legal uncertainty.

This proposal originates from the 2020 Intellectual Property Action Plan. It is part of the 'patent legislative package' presented by the Commission in April 2023. It aims to simplify the EU's SPC system and improve its transparency and efficiency by creating a unitary certificate for plant protection products. The proposal's legal basis is Article 118 of the Treaty on the Functioning of the European Union (TFEU). The proposed regulation introduces a unitary SPC that should provide uniform protection in all Member States where the unitary patent applies, i.e. it seeks to complement the unitary patent system and make it more effective. 

The proposed regulation centralizes the granting procedure for the unitary SPC. This unified approach should significantly reduce the administrative burden and costs. At the same time, this system should increase transparency and generate more predictability, which will keep the manufacturers better informed on the protection status of a given product across the EU. The proposal specifies the European Union Intellectual Property Office ('EUIPO') as the central examination authority to assess the formal admissibility of the unitary SPC. Within the EUIPO, its panels would examine the application. The proposed procedure would involve close cooperation of EUIPO with the EU national IP offices since each panel would consist of a member of EUIPO and two qualified examiners, experienced in SPC matters, from two national patent offices in the Member States. After the final decision, the EUIPO would either grant a unitary SPC or reject the application. The applicant could challenge a negative opinion before the EUIPO's Board of Appeal. The third parties would also be able to challenge a positive (or partly positive) opinion by initiating an opposition procedure two months after the publication of the examination opinion. Subsequently, the General Court of the European Union ('General Court') could review the decision of the Board of Appeal. 

The proposal is subject to the ordinary legislative procedure (OLP), requiring the support of both the Council of the EU and the European Parliament. 

The Parliament referred it to the Committee on Legal Affairs (JURI). On 19 July 2023, Tiemo Wölken (S&D, Germany) was appointed as rapporteur. On 13 October 2023, the rapporteur presented his draft report. Ninety-eight amendments were tabled in the Committee. JURI Committee voted in favour of the legislative reports on 24 January 2024. The adopted report mainly contains technical amendments dealing with, among other things, the examination of the unitary SPC application, the opposition procedure, the combined applications, the formation of examination panels, and the appellate process.

During the February II plenary session, on 28 February 2024, the Parliament overwhelmingly approved the report with the JURI Committee's amendments, adopting its first-reading positions for the upcoming inter-institutional negotiation.

On 20 September 2023, the European Economic and Social Committee delivered an opinion on the proposal. It commented mainly on procedural issues, including the role of patent attorneys in the appeal procedure before the General Court and on the protection of the holder of the market authorisation, which, in the EESC's view, should be protected more strongly. 

Within the Council, the proposal is dealt with by the Working Party on Intellectual Property (Patents). On 29 September 2023, the preliminary written comments of the national delegations were distributed among the members of the Working Party.

The Working Party held several meetings on the proposal in the first half of 2024. Many delegations provided written comments and drafting suggestions, such as the potential transfer of jurisdiction over direct invalidity actions concerning unitary SPCs from the EUIPO to the Unified Patent Court to prevent inefficiency and legal uncertainty.

The Working Party on Intellectual Property declared it required further work before taking final decisions on the main aspects of the reform, involving, most notably, the composition of the examination panels, the language regime for unitary SPCs and the financial aspects of the proposal.

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Author: Kamil Baraník, Members' Research Service, legislative-train@europarl.europa.eu

As of 24/01/2025.