European Commission announces initiative to create a unitary SPC

“Supplementary protection certificates (SPCs) are intellectual property rights extending patent protection for specific medicinal and plant protection products. While this regime is fit for purpose, differences between EU countries in its administration and enforcement create inefficiencies. This initiative will put in place a unitary SPC and/or a single (‘unified’) procedure for granting national SPCs. This will make SPCs more accessible and efficient, and benefit the health sector.”

Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right for a maximum of five years. They aim to offset the loss of patent protection for pharmaceutical and plant protection products that occurs due to the compulsory lengthy testing and clinical trials these products require prior to obtaining regulatory marketing approval.

The Commission’s IP Action Plan published in November 2020 heralded the development of unitary SPCs. Having completed a detailed legal and economic evaluation of the SPC system, the Commission concluded that:

“while the SPC system remains relevant, it suffers from fragmented implementation across Member States. This translates into inefficiencies and a lack of transparency and predictability, which hampers innovators and generic producers, and eventually harms patients.”

and floated the possibility of introducing  a unified SPC grant mechanism and/or creating a unitary SPC title.

With the final coming into force of the Unified Patent Court Agreement following formal ratification by Germany, the Commission clearly sees the timing as now right to begin work on a new unitary SPC regulation, A call for evidence will begin shortly and the Commission, rather ambitiously, proposes adoption of a new regulation in the first quarter of 2022.