Out-Law News 1 min. read

EU to act on unitary SPCs and compulsory licensing of patents

Plans to make it easier for pharmaceutical companies to register and enforce supplementary protection certificates (SPCs) across the EU will take a step forward before the end of March, according to the European Commission.

The Commission said it would invite evidence to help it shape a proposed new regulation that would “put in place a unitary SPC and/or a single (‘unified’) procedure for granting national SPCs”. It said such a move “will make SPCs more accessible and efficient”.

SPCs serve to extend the life of a patent by up to a maximum of five years for products which are authorised under the relevant regulatory framework in the field of medicinal and plant products.

Under the EU SPC Regulation, SPCs can only be granted if, in the EU country in which the application is submitted, the product is "protected by a basic patent in force" and market authorisation has been issued to place that product on the market as a medicinal product, so long as that authorisation is the first of its kind and an SPC has not already been issued for the product.

Though the SPC Regulation sets out harmonised rules across the EU in relation to SPCs, SPCs must be registered in individual EU member states for them to have effect there. An evaluation of the SPC Regulation published by the Commission in 2020 alongside its pharma strategy found that the national administration system for SPCs “undermines the effectiveness and efficiency of the SPC system”.

Sarah Taylor, European patent expert at Pinsent Masons, said: “The introduction of a unitary SPC would be a logical extension of the forthcoming unitary patent. The timing of this consultation follows hot on the heels of the final preparatory steps being taken for the new Unified Patent Court which we expect will open later this year.”

Separately, the Commission has announced that it will be launching a call for evidence on a new EU regulation concerning the compulsory licensing of patents later this year.

According to the Commission, the existing national system that applies in the EU in relation to compulsory licensing is based on “different, fragmented procedures” and that it is “not efficient enough to tackle EU-wide crises”. It also said that “the efficiency of the current EU procedure on compulsory licensing of patents for export to countries with public health problems … should be examined”.

A proposed new regulation in relation to compulsory licensing of patents is expected to be outlined after the call for evidence concludes. The call for evidence is anticipated to be opened in the third quarter of 2022, the Commission has said.

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