Proposal for an SPC manufacturing waiver

The European Commission has proposed to amend Regulation 469/2009 concerning Supplementary Protection Certificates (SPCs) by the introduction of a manufacturing waiver. The waiver is intended to entitle EU-based companies to manufacture generic or biosimilar pharmaceutical drugs during the term of an SPC relating to said drugs for the purpose of exporting to non-EU markets where there is no SPC protection.

The proposal has been much debated. The EU Council has recently approved a mandate for negotiations with the EU parliament, and it appears possible that the proposal will be implemented this year. We will continue to monitor the development, and report more information when implementation of the proposal gets closer.

Pharmaceuticals and plant protection products commonly need regulatory approval before they can be marketed. Therefore, patent holders of pharmaceuticals and plant protection products may be delayed in the marketing of their products and cannot make effective use of the entire patent term. The SPC system has been created to compensate for the time loss associated with regulatory approval. The SPC is a sui generis intellectual property right, i.e. an intellectual property right in itself, which extends certain rights associated with a patent. A granted SPC comes into force upon expiry of the patent and has a duration of up to 5 years (in certain cases of up to 5.5 years).

Please do not hesitate to contact us if you would like to have more information about SPCs  and/or the above-mentioned proposal: https://www.valea.eu/en/our-services/patents/spc