EC reveals plans for unitary SPC, compulsory licences
The European Commission will unveil plans to make supplementary protection certificates (SPC) more accessible and efficient for pharmaceutical companies to register and enforce by the end of March.
The Commission called for views to “put in place a unitary SPC and/or a single (unified) procedure for granting national SPCs”.
“While this regime is fit for purpose, differences between EU countries in its administration and enforcement create inefficiencies,” the statement said.
Such a move will make SPCs more accessible and efficient, and benefit the health sector, according to the Commission.
Supplementary protection certificates (SPCs) are an IP right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities.
Under current provisions, an SPC can only be granted in the EU country in which the application is submitted, and where the product is "protected by a basic patent in force".
This move follows the findings of a 2020 study of the evaluation of the SPC Regulation, showing that the national administration system for SPCs “undermines the effectiveness and efficiency of the SPC system”.
In a post outlining the development, 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 is also considering a revised framework for compulsory licensing of patents.
On announcing this potential new framework, the Commission stated that: “EU countries currently regulate and implement the framework for compulsory licensing of patents in the EU using different, fragmented procedures. This means it is not efficient enough to tackle EU-wide crises.
“Also, the efficiency of the current EU procedure on compulsory licensing of patents for export to countries with public health problems (Regulation 816/2006) should be examined,” it added.
This initiative aims to revise the framework so it is adequately prepared and coordinated to tackle future crises, and the Commission is expected to call for a view on this proposal during the third quarter of 2022.
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