Supplementary Protection Certificate (SPC)

Health and food are fundamental to human well-being and survival. Medicinal products and plant protection products are usually the result of time-consuming and costly research. Therefore, it is of great importance for society to encourage further development and improvement of these products.

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 marketing of their products and cannot make effective use of the entire patent term. Supplementary Protection Certificate (SPC) 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 up to 5 years (in certain cases up to 5,5 years).

Importantly, the application for an SPC can only be made within certain time limits and takes place on a national basis. The processing and practice that applies constitutes a separate legal area and has, in recent years, generated many complex issues that have been debated nationally throughout Europe and by the Court of Justice of the European Union.

The SPC group at Valea has extensive experience in the SPC area. We actively work, monitor and comment on developments in Europe as well as Swedish practice. We assist and represent clients in the field of pharmaceuticals, ranging from small molecules to biological products, such as antibody-based technologies and genetic engineering products, and we also assist with plant protection products. For questions regarding supplementary protection certificates, please contact one of the consultants below.