A supplementary protection certificate, commonly abbreviated to SPC, is a ‘sui generis’, or an ‘extension of a patent that is under a specific set of rights’. Each member state of the European Union has the right to issue SPCs, which are most frequently requested for medicinal products including plant protection and drugs.
Supplementary Protection Certificate (SPC) explained
EU member states have the right to issue supplementary protection certificates for the protection of a patent while the regulatory approval of the patent is pending. Essentially, drugs and plants including herbicides and insecticides pending patent approval can obtain a SPC provided the products are capable of meeting the required standards in order to qualify for the certificate.
A SPC is governed by two main regulations within the EU, these are;
- Council Regulation (EEC) No 1768/92 of 18 June 1992
- Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996
Why obtain a SPC?
A product that is already protected under a patent can obtain further protection through obtaining a supplementary protection certificate.
Qualifying for a SPC
The European Court of Justice (ECJ) provides that a supplementary protection certificate is applicable where a product is;
- Protected by a patent
- Subject to an administrative authorization procedure
- Not places on the market within the EEA as a medicinal product prior to SPC application
How does a SPC work?
Once the certificate is obtained, it will come into force when the product’s current patent rights expire.
Validity of a SPC?
A supplementary protection certificate is valid for a period of 5 years; however, for all human medicinal products the SPC validity period can be extended to 5.5 years.