An overview of the European Commission’s proposals for a Regulation on a unitary SPC and the recast of the SPC Regulation

Time and again, the creation of a unitary supplementary protection certificate (uSPC) was considered in the course of the development of the Unitary Patent (UP) and the Unified Patent Court (UPC). On 27 April 2023, the Commission finally published not only the proposal COM(2023)222, a draft Regulation on the creation of a unitary SPC (uSPC / uSPC Regulation), but also the proposal COM(2023)231, a second draft Regulation (SPC Regulation) that fundamentally revises the previous SPC Regulation (EC) No 469/2009.

A unitary SPC and an SPC application in a centralised procedure

According to Art. 5(2) uSPC Regulation, the uSPC proposed by the European Commission is a unitary right providing uniform protection and having equal effect in all Member States in which the basic UP has unitary effect. As a unitary right, it requires only one application, is granted by one authority and can only be limited, transferred, revoked or lapse in respect of all the UPC Member States where it has effect.

On the basis of EPs and UPs, “classical” SPCs without unitary effect remain possible. For these SPCs, the draft SPC Regulation provides for application and examination in a centralised procedure, meaning that the SPC application is filed and examined before one central authority. If this authority reaches a positive examination opinion, the competent national authority of each designated Member State grants a certificate in accordance with applicable national rules and procedures, Art. 32(2) SPC Regulation.

While the uSPC actually comes into existence as a unitary right, SPCs are applied for and examined uniformly in the centralised procedure, but are granted as individual national SPC rights.

The Office

According to the draft proposals, the European Union Intellectual Property Office (EUIPO) in Alicante, Spain shall be competent for the uSPC application, examination and grant and for the centralised SPC application and examination, Art. 18, 20(3) SPC Regulation; Art. 10, Art. 2(8) uSPC Regulation. “Supplementary Protection Certificate Divisions”, or SPC Divisions, shall be set up at the EUIPO for this purpose. Competent national authorities may be appointed by the EUIPO as participating offices in the examination procedure.

The Procedure

Once an application for a uSPC/an SPC has been lodged with the EUIPO, that application is published in a register which is still to be established. The application is examined by an examination panel (one member of the EUIPO, two examiners from different competent national authorities) that finally issues a positive or negative examination opinion. Third party observations may be filed within three months after the publication of the application in the register.

The Remedies

Within two months from the publication of the examination opinion, anyone can file an opposition with the EUIPO, arguing that the conditions for grant are not met. The uSPC/SPC may not be granted before this period has expired. The opposition has suspensive effect and is handled before an opposition panel not previously involved in the examination. An opposition decision shall be given within six months unless the complexity of the case requires a longer period.

Generally, the parties to the proceedings can appeal the EUIPO’s decisions within two months. The appeal has suspensive effect and is heard before the Board of Appeal, i.e. the Boards of Appeal of the European Union trade mark Regulation (EU) 2017/1001. Appeals on points of law may be lodged against decisions of the Board of Appeal to the General Court of the European Union.

TW comment

The centralisation of the SPC examination procedure and the creation of a unitary SPC of course offers several advantages, and the possibility to file an opposition against the examination opinion for a uSPC/an SPC even before the uSPC/SPC is granted can bring about statements on the validity of these rights at an early stage. The extent of these advantages compared to the current procedure will depend on the EUIPO's decision-making practice and the actual speed of the procedure.

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